R23 - Clinical Practice Research Datalink (CPRD) Routine Linkages Application
Medicines and Healthcare Products Regulatory Agency (MHRA) · Agency/Public Body
Expired The latest version ended on 12 August 2026. The September 2026 register still lists the agreement, but its term has passed.
- Reference
- DARS-NIC-15625-T8K6L
- Latest version
- v15.3
- Term of latest version
- 13 February 2026 to 12 August 2026
- Start date
- Before 22 October 2019
- Data controller
- Sole Data Controller
- Commercial purposes
- No
- Sublicensing
- Yes
- Files released to date
- 2,064
Data controllers
Why the data was released
Objective for processing
The controller for GDPR purposes is the Department of Health and Social Care (DHSC); the legal signatory for this agreement (and for the overarching Data Sharing Framework Contract - DSFC) is the Secretary of State for Health and Social Care (acting as part of the Crown), acting through the Clinical Practice Research Datalink (hereinafter referred to as CPRD) within the Medicines and Healthcare products Regulatory Agency (MHRA) (the agency); and the licensee is CPRD, not the wider DHSC nor the agency.
The Clinical Practice Research Datalink (CPRD) is a specialist health data research service provided by the Medicines and Healthcare products Regulatory Agency (the agency), an executive agency of the Department of Health and Social Care (DHSC). The agency regulates medicines, medical devices and blood components for transfusion in the UK and the agency acts as the Executive agency.
The Clinical Practice Research Datalink (CPRD) is a government not for profit research service delivered by the Medicines and Healthcare products Regulatory Agency (MHRA) with support from the National Institute of Health and Care Research (NIHR), that provides access to effectively anonymised health data for studies to safeguard and improve patient and public health. For more than 30 years, CPRD data have supported vital research into health care delivery, drug safety, effectiveness of medicines and risk factors for disease. The linked data supplied by NHS England and shared by CPRD under the NHS England sub-licence can only be used for public health research purposes in accordance with Article 6(1)(e) and Article 9(2)(j) or or drug safety and surveillance in accordance with Article 6(1)(e) and Article 9(2)(g) (reasons of substantial public interest).
Research using CPRD data has resulted in over 3,000 peer-reviewed publications, which have informed drug safety guidance and best clinical practice. Examples of research findings used in everyday NHS care include demonstrating the protective effect of whooping cough vaccination in pregnancy for infants and informing the National Institute of Health and Care Excellence (NICE) blood pressure targets for patients with diabetes. A searchable list of the users and uses of CPRD data is published on the CPRD website https://www.cprd.com/protocol-list. CPRD’s research and data services are based on a sharing data which are effectively anonymised once given to the researcher from longitudinal primary care records contributed by participating GP practices from the four UK nations. Approval to supply data for public health research is granted on an annual basis by the East Midlands - Derby Research Ethics Committee (Database REC reference 21/EM/0265).
CPRD provides researchers under sublicense agreements access to effectively anonymised primary care data linked to secondary health care datasets for both observational research and to supplement clinical trial data. Linked data greatly increases the scale, depth, completeness and value of data available for public health and clinical research. Linked data are also used to assess study feasibility and create lists of eligible patients who could potentially be included in clinical trials. In addition, linked data are used by CPRD to generate derived fields that improve the quality of the primary care data for e.g., ethnicity records. The outputs of such research based on linked data inform clinical guidance and best practice for patients in the UK. The CPRD Research Data Governance (RDG) review process includes lay reviewers. Applications that include non-standard elements that deviate from precedent will be assigned to lay reviewers. In addition, a sample of all applications is reviewed by the independent Central Advisory Committee (CAC) which includes lay representatives as part of CPRD’s assurance process.
Secondary healthcare datasets are provided by NHS England and these data are linked to the primary care data by NHS England. NHS England receives identifiers to enable them to carry out this linkage as described below in 5b processing activities. Continued support is given by Confidentiality Advisory Group (CAG) for the flow of identifiers to NHS England to enable linkage of CPRD primary care data to secondary datasets (CAG reference 21/CAG/0008).
The legal bases for processing the data provided by NHS England are:
o Gathering of GP patient data and collation with other datasets to produce datasets that have been anonymised:
o scientific research in the public interest under Articles 6(1)(e) and 9(2)(j) of the (UK) General Data Protection Regulation
o substantial public interest in relation to drug and device safety under Articles 6(1)(e) and 9(2)(g) of the General Data Protection Regulation.
NHS England has been providing and linking health-related datasets to CPRD primary care data for a number of years. Data linkage is carried out exclusively by NHS England as the Trusted Third Party (TTP) for this purpose. Linked datasets currently available include extracts from Civil Registration data; Hospital Episode Statistics (HES), which encompasses Admitted Patient Care, Critical Care, Outpatient and Accident & Emergency data; Diagnostic Imaging Dataset (DID); and Critical Care data (supplied as a separate dataset by NHS England but integrated with Admitted Patient Care). CPRD primary care data are also linked with the National Disease Registration Service National Cancer Registry data, the Second Generation Surveillance System (SGSS) data (specifically the COVID-19 test result data, including future serological testing as well as current antigen testing) and COVID-19 Hospitalisation in England Surveillance System (CHESS). NHS England also supply Lower Layer Super Output Area based on patient postcode, to enable linkage to deprivation data including Townsend Score and Index of Multiple Deprivation.
CPRD have historically received National Disease Registration Service (NDRS) data from Public Health England (PHE) until the service was transferred to NHS England. CPRD received this data under DARS-NIC-656848-T9J1Q. The data approved for dissemination under DARS-NIC-656848-T9J1Q has now been added to this agreement DARS-NIC-15625-T8K6L. The data disseminated includes:
~ Tumour table (represented by one of the NDRS Cancer Registration products) - this table contains information relating to the individual tumour and to the patient at the time of diagnosis of this tumour for e.g diagnosis date, stage, age at diagnosis, date of start of treatment. This dataset has one row per tumour
~ Treatment table (represented by one of the NDRS Cancer Registration products) – this table contains information about the treatments given for each tumour in the Tumour table. These could include surgeries, chemotherapies, radiotherapies and any other treatments. As multiple treatments are often given for a single tumour this dataset has multiple treatment rows for each tumour.
~ NDRS National Radiotherapy Dataset (RTDS) - RTDS data are linked to individual patients in the Cancer Registration datasets. RTDS is made up of 4 individual tables; RTDS Episodes, RTDS Prescriptions, RTDS Exposures and RTDS Procedures. Individual CPRD studies can request any of these tables.
~ NDRS Systemic Anti-Cancer Therapy Dataset (SACT) - SACT data are linked to individual tumours in the Cancer Registration datasets. SACT is made up of 6 tables; SACT Patient, SACT Tumour, SACT Regimen, SACT Cycle, SACT Drug Detail, SACT Outcome.
Research using CPRD data and services informs clinical guidance and best practice related to drug safety, use of medicines, effectiveness of health policy, health care delivery and disease risk factors. Similarly, the primary care and linked HES data would permit research which would expand understanding about patient access to health services across the patient care pathway and the need for wider care of patients and vulnerable groups as a direct or indirect result of COVID-19 and the availability and capacity of those services or that care.
Patient and Public Involvement and Engagement (PPIE)
For all GP Practices who contribute primary care data to CPRD, CPRD regularly offers to present to their Practice Participation Groups (PPG's) on CPRD, followed by a question and answer session. Between January - July 2024, CPRD has presented at three different PPG's. CPRD hosts an annual PPIE workshop, open to all patients and members of the UK public. The last workshop was held in October 2023, and focused on the development of "Safe Outputs" in the CPRD Trusted Research Environment (TRE). The feedback from participants was incorporated into CPRD's development of the TRE. The next annual workshop is planned to take place at the end of 2024, and will focus on, among other topics, the flow of Confidential Patient Information without consent and outside of the direct care team.
TRUSTED THIRD PARTY DATA LINKAGE
NHS England have previously undertaken some data processing activities on behalf of CPRD, including linking CPRD patient identifiers to patients in the Intensive Care National Audit & Research Centre (ICNARC), data which are managed (collection and processing) by ICNARC, who is the data custodian (see https://cprd.com/cprd-linked-data). Recently NHS England have also linked data from University Hospitals Birmingham (UHB) to the CPRD cohort. These UHB Electronic Health Record data comprise data from a number of different clinical systems held within the Data Controllership of UHB, that are not routinely transferred to NHS England, including prescribing systems (PICS), laboratory systems (Telepath), health record noting (PICS/Clinical Portal/Medisoft) and patient administrative system, Imaging modalities (e.g. XRay: MRI: CT: OCT: Retinal photography) and clinically relevant parameters (ECG and EEG)- some data types will have features extracted and stored as structured data. This data provides a more comprehensive view of the provision of healthcare to patients with multiple long-term health conditions. This data contains more detailed data on patients diagnoses including severity of diseases and prescribing of medications only initiated in secondary care'. In both of these cases, data flowed under Section 251 of the Health and Social Care Act and no NHS England data was released. There will be no linkage to third party datasets with NHS England as a Trusted Third Party under this iteration of the agreement.
National Data Opt outs will be applied to the data prior to it being disseminated to CPRD.
Where individuals have opted out of disease registration by the National Disease Registration Service (NDRS), their data has been permanently removed from the registry and therefore will not be disseminated under this Data Sharing Agreement (DSA). https://digital.nhs.uk/ndrs/patients/opting-out
Processing activities
NHS England receive, process and link Identifiable data directly from participating General Practices (GPs) under the CAG section 251 approval NHS England release Pseudonymised data to CPRD
Annex A of this Data Sharing Agreement states "The customer will provide a cohort to NHS England", the customer in this instance is Optum, Vision, and TPP SystmOne, who provide the cohort to NHS England.
CPRD hold pseudonymised data CPRD release data to researchers and that data is rendered effectively anonymised.
CPRD has established agreements with general practices and agreed contracts with their data processors, the GP clinical IT system providers, enabling the extraction of agreed data from the primary care electronic health record (EHR).
Protecting patient confidentiality is paramount to CPRD. A number of processes and procedures are in place to safeguard the identity and confidentiality of patient data received and supplied by CPRD. An overview of these is presented below, including minimised dataset extraction, data transformation, strong and multiple pseudonymisation, and governance and scrutiny on approvals to use linked data .
The CPRD Policy for 'Anonymisation and Managing the Risk of Identification in Observational Research' sets out the management processes employed to ensure that CPRD appropriately anonymises patient data for observational research purposes and complies with the Information Commissioner's Office (ICO) Code on Anonymisation:
1) Data Linkage
Data collected by CPRD includes all coded patient primary care data, including gender, year-of-birth, and year-and-month of-birth for patients aged 16 and under. CPRD does not receive patient name, address, NHS Number or free text medical notes.
In order to enable the linking of primary care records to other health related data, GP EHR suppliers provide certain patient identifiers directly to NHS England. These are: NHS Number, full date of birth, postcode and gender. CPRD does receive gender, and receives full date-of-birth for patients registered at TPP practices only, but does not receive any of the other identifiers. The Trusted Third Party (NHS England) provides the linkage service for CPRD.
2) Data transformation
CPRD does not release the same linked data to external researchers that it receives from NHS England. This is done to protect patient confidentiality, and also to better facilitate relevant research.
Transformation involves removing the provider codes supplied by NHS England. Data provided by CPRD is matched to the Office for National Statistics (ONS) Region boundaries based on matching the address of the GP practice to the ONS region. This ‘blurs’ the link between hospital activity records and other potential identifiers collected and provided (gender, year-of-birth, date of death and ethnicity). For example, transformation of the CPRD linked Hospital Episode Statistics Admitted Patient Care (HES APC) data involves:
(i) The TOKEN_PERSON_ID (previously encrypted HES_id) field provided to CPRD by NHS England is not released to customers. CPRD creates a pseudonym linked to a unique patient activity record in the HES data.
(ii) Encoding of the record level identifier (epikey). The epikey variable has been encoded by the CPRD to minimise the risk of breaching licensing conditions through linkage of these data to other HES data sources containing patient identifiable information. The epikey is encoded with a new key each time data is processed, so that the epikey for the same record differs in every release of CPRD linked HES APC data. This prevents different researchers from linking patients from the same dataset, or from comparison with older release versions of the data.
(iii) Collating data across years, formatting date and diagnosis fields, and dropping fields (mainly provider and geographical based) from standard release of the data. The episode-level data files received by NHS England are transformed into a normalised data structure containing the following tables:
1. Hospitalisations
2. Episodes
3. Diagnosis
4. Procedures
5. Augmented Care
6. Critical Care
7. Maternity
8. Health Resource Group
(iv) Transformation of the linked data to a common data model (CDM) format (for e.g., the Observational Medical Outcomes Partnership (OMOP) CDM or Sentinel CDM) for the purposes of data standardisation to enable federated analyses, whole-database feasibility counts, and the use of rapid analytics tools like the OMOP Atlas analytical tools. Transformation of the linked data to a CDM format to carry out whole-database studies within CPRD’s Trusted Research Environment, CPRD Safe, for RDG-approved studies.
3) Pseudonymisation process
CPRD has agreed pseudonymisation processes with each GP EHR system provider as well as NHS England used for data linkage. The overarching process for patient data pseudonymisation comprises the following stages to protect patient confidentiality at all times:
(i) GP system provider - the provider replaces the patient identifiers (for e.g., NHS number) in each patient record with a system patient key before its secure transfer to CPRD.
(ii) CPRD - on collection of the patient EHR data, CPRD replaces the original data source patient and practice keys from the GP system provider with a CPRD pseudonym.
(iii) Data linkage - undertaken by NHS England, all linked patient record data are pseudonymised by the TTP before release to CPRD.
(iv) Data release – a subset of the linked data (as appropriate for any given study) is extracted by CPRD to minimise data ultimately shared with third-party researchers (under a sub-licence agreement), where the linked patient key may be replaced again by a different patient key at release where required (double pseudonymisation), establishing yet another layer of separation.
Record level identifiers (such as epikey, attendkey, aekey) are additionally encoded such that the record level pseudonym differs in every distinct release of the linked data.
Combined with the wider processes and procedures noted in this section, the above pseudonymisation process precludes users of linked data from identifying patients from the data provided.
4) Data Governance
Researchers must gain approval for their study protocol requesting access to linked data, from CPRD Research Data Governance (RDG) process. CPRD’s data governance process except for the purpose of feasibility counts or cohort definitions which are conducted within CPRD’s Trusted Research Environment. The RDG process includes the following:
a) Review of research applications to ensure they meet research data governance requirements (for all relevant data controllers) including risks to confidentiality
b) Possible further re-pseudonymisation of the linked data to minimise the risk of disclosure
c) Follow-up with researchers to ensure the linked data are securely destroyed at the end of the study contract period unless covered by an appropriate dataset retention period extension approval
More information on governance can be found https://cprd.com/Data-access
5) Data release and Access Management
All organisations and researchers requesting or funding requests for data go through a due diligence process. Data are only released to bona fide researchers and organisations which comply with the data security standards as laid in CPRD licences and sub-licences as described in the CPRD Data Access policy.
CPRDs Trusted Research Environment (CPRD Safe)
All studies conducted in CPRD Safe are subject to the same RDG process and safeguards as data that is released to research organisations under the previous data release model. CPRD Safe operates in line with the "5 Safes" Framework, and will consider seeking accreditation in line with the NHSE-SDE Framework once this is available.
6) Release of patient level linked data to third-party researchers will only occur after:
a) RDG approval has been obtained and any other approvals (e.g., Research ethics committee if required);
b) Data has been risk assessed in accordance with CPRD's Policy for 'Anonymisation and Managing the Risk of Identification in Observational Research'
c) Researchers must sign a data licence agreement defining terms of use relating to secure access, retention and destruction of the data; and
d) Access to data provided by CPRD which is sub-licensed having been provided by NHS England, is done under terms agreed with NHS England.
CPRD processes patient data and makes it available internally to CPRD researchers. To control third-party access to linked data and minimise data released to third-parties, the CPRD Observational Research Team extract datasets for researchers against a query specification or primary care data defined cohort. The query and its output content will be agreed with the researcher prior to generation of the datasets. This is the only process by which applicants to CPRD may access linked data.
Microsoft Azure Cloud is recorded as data storage addresses as for the purposes of this application. Microsoft Azure is the primary data centre store and is considered to be the initial back-up and recovery. Microsoft are not involved in processing of the data in any way (they only provide a facilities management and site management service). CPRD has confirmed that Microsoft do not have access to the server (neither administrative nor user rights).
6) Provision of linked data to supplement clinical trial data
CPRD’s clinical trial services use pseudonymised CPRD primary care data to create lists of potentially eligible patients that meet approved trial protocol inclusion and exclusion criteria. These lists of pseudonymised patients (with the standard CPRD pseudonymised patient IDs removed) are screened by GPs who obtain consent and randomise patients into the trial. Consented patients are then followed up for a trial protocol specified period of time through the linkage of their Primary and /or linked data. At pre-specified time points (for example - 1 year after first patient is recruited and/or 3 years after the last patient is randomised) CPRD may be requested to provide linked data to supplement the specifically collected clinical trial data. In these instances, there is no need for the flow of identifiers to NHS England for further linkage and CPRD will process the data using the standard CPRD pseudonymised patient IDs to create a trial dataset containing trial information from IRSP, primary care and linked data variables needed for the trial. In these scenarios, linked data will only be provided for Health Research Authority (HRA) Research Ethics Committee (REC) approved, consented patient studies where patients have explicitly consented for the study team to access linked NHS England data by name for the purpose of measuring clinical trial outcomes and adverse outcomes. Any scenarios involving the flow of identifiers to NHS England for the purpose of further linkage are outside the scope of this agreement and will be subject to a separate study-specific DARS application.
7) Information Security Measures
CPRD is part of the MHRA and conforms to the 10 National Data Guardian data security standards as well as to NHS England requirements. CPRD meets NHS England Data Security and Protection Toolkit standards, and details on standards and arrangements are set out in CPRD’s approved System Level Security Policy (SLSP).
CPRD operates to a high level to ensure that when data is transmitted and/or stored it is done so in a way that protects the data. The data centres where CPRD data is stored is compliant with Government standards to operate in a way that meets the full requirements for managing and storing such important data. The measures are always under review and are subject to audit. Security measures include:
• Multifactor authentication for access
• Monitoring of access
• Round the clock security staff presence
• Robust firewalls and other access restrictions
A back-up store of the data (provided by named data processors) mirrors the above features but in an alternative location to allow for business continuity.
8) Data destruction and disposal
Data destruction standards (currently, NHS England ’Destruction and Disposal of Sensitive Data’ guidelines v3.2) have been implemented in MHRA whereby all data is physically destroyed to National Insttitute of Standards and Technology (NIST) 800-88, so no media ever leaves the datacentre, each facility has its own crushing machine so all media is reduced to dust before leaving the datacenters. This ensures compliance with industry standards and regulations, including International Organisation for Standardisation (ISO) 27001.
9) Encryption
Encryption is used for data in transit between secure locations. This will apply to both identifier data for linkage and clinical / research data. Although the clinical data is anonymised, there remains the residual risk of re-identification or the risk of inclusion of disclosive content and data is only intended for processing by authorised recipients. Encryption mitigates the risk and provides assurance.
The default minimum standard for encryption will be Advanced Encryption Standard (AES) 256 using a complex pass-phrase consisting of 8 characters and a mix of upper case, lower case, numeric and special characters.
10) Training
All CPRD staff and licensed data users are appropriately trained and have the necessary understanding of the governance processes pertaining to relevant laws. They will also be aware that any misuse of data may result in disciplinary procedures and, in the case of a severe breach, dismissal and immediate removal from the premises.
Training covering use of data is mandatory for CPRD staff and licence-holders prior to accessing data. Data is kept on restricted servers and drives accessible only to appropriately trained research staff.
NHS England permits CPRD sub-licensees to share data with third parties subject to the third parties collaborating on the same research as the sub-licensee, and subject to the terms, checks and controls carried out by CPRD in relation to sub-licences.
All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract i.e.: employees, agents and contractors of the Data Recipient who may have access to that data).
11) CPRD auditing of study outputs and purposes
Applicants must provide a detailed protocol for assessment and approval through the RDG process (as previously detailed). CPRD routinely checks new publications using CPRD data to ensure concordance with the RDG approved protocol for example, that research team members accessing the data are named in the Protocol (or noted in an amendment), that the processing is within the scope of the aims and methodology indicated in the protocol, and that it has not been undertaken at locations other than those declared in the protocol. There is also a CPRD client audit programme which aims to audit 6 clients per year to ensure compliance with licence terms.
12) Sub-licence
The agreements by which CPRD shares NHS England data with a third-party organisations include all terms of the agreement between NHS England and CPRD. The agreements by which CPRD shares NHS England data with a third-party organisations include all terms of the agreement between NHS England and CPRD. Third-parties are typically, UK academic institutions (33.85%), international academic institutions (12.31%) or global pharmaceutical companies (29.23%). Figures of releases from financial year (FY) 23/24 which also gave the geographical split as: UK (72.75%), EU/EEA (10.08%) Non UK/EU/EEA (17.17%). There were a total of 1171 linked data releases in the financial year 23/24.
Any organisation which is commercial in its nature or has a commercial purpose must demonstrate clearly to CPRD that their request is connected with the provision of health care or adult social care, or the promotion of health. No requests are approved for data where the purpose is for marketing purposes, including promoting or selling products or services, market research or advertising. Any commercial organisation who receives data from CPRD via Sublicense must demonstrate clearly that its commercial interests are proportionately balanced with the benefits to the health and social care system and to the interests of the data subjects.
CPRD ensures that NHS England retains direct rights for audit and/or requiring deletion of data in relation to sub-licensee, and any organisation to whom data is shared by the sub-licensee; and CPRD ensures that NHS England may (under the licensing terms put in place by CPRD) require and enforce remedial action (whether in relation to this or other agreements between NHS England and the organisation) where appropriate. CPRD takes responsibility for the actions and omissions of all sub-licensees and breach of a sub-licence would automatically be regarded as breach of the Data Sharing Framework Contract with NHS England.
In the event of termination or expiry of the Data Sharing Framework Contract between NHS England and the CPRD, all sub-licence rights will be automatically terminated.
CPRD only releases NHS England data to third-parties which must have undergone the New Client Vetting process (see ‘New client or funder request for access to CPRD data’ on our webpage www.cprd.com/Data-access to ensure they are appropriate data recipients) under sub-licence after an RDG approval for health-related research.
The GDPR legal basis for all current release is 6(1)(e) Public interest, 9(2)(j) (in performing public health research) and 9(2)(g) (substantial public interest in relation to drug and device safety). Agreements are in place for 12 months at a time and then extended if retention is justified. Data are shared under a sublicence agreement after they have been subject to anonymisation measures to mitigate the risk of re-identification of individuals by means reasonably likely to be used to low.
CPRD has a searchable online register of all RDG approved studies data releases by CPRD including NHS England linked data. The register is online at www.cprd.com/approved-studies-using-cprd-data
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Expected output
Researchers using linked CPRD data will be producing research publications in peer-reviewed journals and presentations at scientific conferences on an ongoing basis. Target dates for expected outputs will vary by study but on average, publication of findings arising from approved research is expected between 3-4 years after data access. CPRD provides data to researchers in academic institutions, pharmaceutical companies, Governmental centres and research charities. While the typical output is publication in a peer-reviewed academic journal, other outputs may include reports submitted to medicines regulatory bodies or white papers. Some of the research findings may directly translate into clinical guidelines and public health policy.
A selection of recent publications resulting from use of CPRD linked data are presented below.
• Cohen, Alexander T., et al. "Comparison of Clinical Outcomes in Patients with Active Cancer Receiving Rivaroxaban or Low-Molecular-Weight Heparin: The OSCAR-UK Study." Thrombosis and Haemostasis (2024). DOI: 10.1055/a-2259-0662
• Berni, Thomas R., Christopher L. Morgan, and D. Aled Rees. "Rising incidence, health resource utilization, and costs of polycystic ovary syndrome in the United Kingdom." The Journal of Clinical Endocrinology & Metabolism (2024). DOI: 10.1210/clinem/dgae518
• Grønbæk, Lisbet, et al. "Smoking is a Risk Factor for Autoimmune Hepatitis: An English Registry-Based Case–Control Study." Clinical Epidemiology (2024): 23-30. DOI: 10.2147/clep.s439219
• Punyadasa, Dhanusha, et al. "Post-hospitalisation asthma management in primary care: a retrospective cohort study." British Journal of General Practice 74.743 (2024). DOI: 10.3399/bjgp.2023.0214
• Zheng, Bang, et al. "Dementia risk in patients with type 2 diabetes: Comparing metformin with no pharmacological treatment." Alzheimer's & Dementia 19.12 (2023). DOI: 10.1002/alz.13349
Outputs from the studies approved usually have research reports which are submitted to funders (such as the Medical Research Council). Some outputs may inform discussions with national programmes (such as NHS Cancer Screening Programmes and NHS Scotland), charities (such as Cancer Research UK) primary care professionals, policy makers and researchers. In many instances, the papers are also published and are available on Open Access journals. Many of the outputs are also presented at conferences (such as International Society for Pharmacoepidemiology). Many of the outputs have the capacity to not only influence the clinical community but also policy makers, for example clinical guidelines (see Oyinlola et al 2016, https://doi.org/10.1186/s12913-016-1562-8).
A comprehensive list of publications including those using linked data can be found at www.cprd.com/bibliography
Expected measurable benefits
Studies using NHS England data linked to CPRD primary care database are expected and required to demonstrate likely benefits to patients in England which may be via informing better clinical care or public health policies. Some study results may also be used to support regulatory decision making both within and outside the UK, directly affecting the approval or removal of drugs or devices (and hence their availability) or guidance as to their use. Some examples of expected benefits included by researchers in recent RDG applications include:
• Changes in healthcare, diagnosis, and treatment of acute and chronic conditions during the COVID-19 pandemic (RDG reference: 24_003894, see www.cprd.com/approved-studies/changes-healthcare-diagnosis-and-treatment-acute-and-chronic-conditions-during)
•Osteoporotic fractures and kidney injury in people living with an ileostomy (RDG reference: 24_003822, see www.cprd.com/approved-studies/osteoporotic-fractures-and-kidney-injury-people-living-ileostomy)
•A study of the association between diabetes and fibrotic multimorbidity (RDG reference: 24_003977, see www.cprd.com/approved-studies/study-association-between-diabetes-and-fibrotic-multimorbidity)
•Evaluating the relationship between pregnancy complications and health before and after pregnancy using electronic health record data in England (RDG reference: 23_003453, see www.cprd.com/approved-studies/evaluating-relationship-between-pregnancy-complications-and-health-and-after)
•Epidemiology of allergic rhinitis in England: A retrospective cohort study in UK primary care data (RDG reference: 24_003814, see www.cprd.com/approved-studies/epidemiology-allergic-rhinitis-england-retrospective-cohort-study-uk-primary-care)
• Examples of how research using CPRD data benefits public health: https://cprd.com/examples-how-research-using-cprd-data-benefits-public-health
Further examples and other relevant publications resulting from linked data research which have informed clinical practice or public health policy are presented below. Some of the studies referenced are older (published up to 5 years before) as it can take 4-5 years to translate some research findings into clinical guidance or public health policy.
Pearson-Stuttard J, Cheng YJ, Bennett J et al. Trends in leading causes of hospitalisation of adults with diabetes in England from 2003 to 2018: an epidemiological analysis of linked primary care records. The Lancet Diabetes & Endocrinology, Volume 10, Issue 1, 2022. https://doi.org/10.1016/S2213-8587(21)00288-6 November 2021. The number of people with diabetes in the UK has increased substantially over past decades to almost 4 million with increasing costs to the health service.
This research will inform the provision of health services, management and prevention of diabetes and diabetes-related complications.
Masoli JAH, Delgado J, Pilling L et al. Blood pressure in frail older adults: associations with cardiovascular outcomes and all-cause mortality. Age and Ageing, Volume 49, Issue 5, September 2020, Pages 807–813. https://doi.org/10.1093/ageing/afaa028. In a study of 415,980 people, including those often excluded from studies, researchers reported that there was no increased mortality risk with hypertension in adults above 75 years with moderate to severe frailty and all above 85 years. Research supports the move to raise the blood pressure target for frail older people. https://evidence.nihr.ac.uk/alert/new-research-supports-the-move-to-raise-the-blood-pressure-target-for-frail-older-people/
Sheng-Chia Chung, Reecha Sofat, Dionisio Acosta-Mena, Julie A Taylor, Pier D Lambiase, Juan P Casas, Rui Providencia. Atrial fibrillation epidemiology, disparity and healthcare contacts: a population-wide study of 5.6 million individuals. The Lancet Regional Health - Europe, Volume 7, 2021. https://doi.org/10.1016/j.lanepe.2021.100157. From the paper: The study provides comprehensive evidence for the AF burden on population health and healthcare utilisation. We found approximately two in five AF patients had three or more comorbidities at the time of diagnosis.
Benefits reported so far
CPRD publish here https://cprd.com/approved-studies-using-cprd-data a register of all approved studies of which the detail on each study includes a lay and technical summary, the health outcomes to be measured and details on the organisations involved.
There are 3 case studies presented below highlighting how linked CPRD-NHS England data has supported public health research, especially in response to the COVID 19 effort in recent years. Research using linked CPRD data benefits patients in the UK indirectly by contributing to the evidence base for medicine and public health, which in turn informs public health policy, programmes and clinical guidelines.
Case study 1: Higher risks of flu and COVID-19 for cancer survivors (CPRD protocol 20_082).
Older individuals and people with certain health conditions are known to be at higher risk of severe illness if they contract viruses such as flu and COVID-19. This includes people who had certain cancers diagnosed recently and are receiving treatments like chemotherapy. In the UK there are more than two million cancer survivors. To investigate whether people who had cancer some time ago are also at higher risk from flu and COVID-19 a study was carried out using CPRD data. CPRD GOLD was linked to Hospital Episode Statistics Admitted Patient Care (HES APC) database, cancer registrations from the National Cancer Registration and Analysis Service (NCRAS), death registrations from the Office of National Statistics mortality database, and postcode-based index of Multiple Deprivation data. Researchers found that survivors from a wide range of cancers are more likely than people in the general population to be hospitalised or die from flu, even several years after their cancer diagnosis. The raised risks were most likely for blood cancer survivors. Because flu and COVID-19 are both respiratory viruses, this suggested that cancer survivors also have a higher risk of severe COVID-19. The study also showed that cancer survivors were more likely to have other diseases that are associated with increased risk of severe COVID-19, such as heart disease, diabetes, respiratory disease and kidney disease. The findings support the UK policy recommendation to include all blood cancer survivors as one of the priority groups to receive the COVID-19 vaccination. The study findings could also support any work by others to prioritise vaccinations and treatments for longer-term cancer survivors.
Reference 1: Carreira H, Strongman H, Peppa M, McDonald H, dos-Santos-Silva I, Stanway S, Smeeth L, Bhaskaran K. Prevalence of COVID-19-related risk factors and risk of severe influenza outcomes in cancer survivors: a matched cohort study using linked UK electronic health records data. EClinicalMedicine, Volume 29, 100656, December 2020. https://doi.org/10.1016/j.eclinm.2020.100656
https://cprd.com/protocol/covid-19-related-risks-cancer-survivors-matched-cohort-study-using-linked-uk-electronic
Case study 2: Vaccine uptake in pregnancy
Vaccination is an effective way to prevent infectious diseases. However, people with certain social characteristics – such as those living in more deprived areas – may be less likely to receive vaccination. Addressing inequalities in vaccine uptake to prevent infections is a key priority for public health. This cohort study examined the social factors that may be associated with lower uptake of flu vaccine and whooping cough vaccine by pregnant women. It considered a range of social determinants including maternal age, ethnicity, socioeconomic status, number of children in the household and region. The study used linkages between CPRD data, the CPRD GOLD Pregnancy Register, Hospital Episode Statistics (HES) and Office of National Statistics (ONS) small-area-level deprivation data.
The researchers concluded that more targeted campaigns have the potential to reduce vaccine-preventable disease among infants and pregnant women, and to reduce health inequalities. Identifying social factors that are associated with lower vaccination rates could help to design programmes to improve vaccine uptake for specific groups of individuals.
Reference 2: Walker et al. Social determinants of pertussis and influenza vaccine uptake in pregnancy: a national cohort study in England using electronic health records. BMJ Open 2021;11:e046545. https://doi.org/10.1136/bmjopen-2020-046545
https://cprd.com/protocol/social-determinants-uptake-maternal-influenza-and-pertussis-vaccine
Case study 3: Health of mothers of children with a life-limiting condition
More than 86,000 children and young people in England are now living with medical conditions that may ultimately shorten their life and cause death in childhood or young adulthood. Mothers of children with a severe health condition or whose child has died are more likely themselves to die earlier than other mothers.
The lack of studies quantifying the mental health of mothers of children with a life-limiting condition has been highlighted by the National Institute for Health and Care Excellence. In this first part of a larger research programme, researchers used CPRD data to investigate the types of physical and psychological health conditions diagnosed in mothers of children with a life-limiting condition. The CPRD GOLD Pregnancy Register was used to link mothers and their children's healthcare data. The study also used linkages to Hospital Episodes Statistics (HES), Mental Health Minimum Dataset (MHMDS) and Office for National Statistics (ONS) death certificate data.
The study concluded that mothers of children with life-limiting conditions have much higher rates of physical health problems, mental illness, and death. These findings were flagged as an ‘Alert’ for important research by the NIHR. Prior to this study, little research had explored the health of this group of women. Knowing more about the health problems that the women experience could help in the design of specific healthcare interventions.
Reference 3: Fraser et al. Health of mothers of children with a life-limiting condition: a comparative cohort study. Archives of Disease in Childhood 2021;106:987-993. http://dx.doi.org/10.1136/archdischild-2020-320655
https://cprd.com/protocol/life-limiting-conditions-health-children-and-their-mothers
NIHR Evidence - Mothers of children with life-limiting conditions are at risk of serious health problems - Informative and accessible health and care research https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fevidence.nihr.ac.uk%2Falert%2Fchildren-life-limiting-conditions-mothers-more-likely-to-die%2F%3Futm_source%3DNIHR%2Bmailing%2Blist%26utm_campaign%3Dc836e7227e-NEWS_RESEARCH_26_8_2021_COPY_01%26utm_medium%3Demail%26utm_term%3D0_570d86f9cb-c836e7227e-33120976&data=04%7C01%7CRhian.Hortin%40mhra.gov.uk%7Ceeaa93de1cb4421aafec08d9b0242f33%7Ce527ea5c62584cd2a27f8bd237ec4c26%7C0%7C0%7C637734491713613980%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=TKPdVHwcavrPA3jVYfUKdqC0ds9O2bgjo6GzYGJAk34%3D&reserved=0
CPRD have not received any updated data from NHS England for a significant number of months due to technical data production work which has delayed data dissemination as a result yielded benefits can only be provided on the use of the data which they have held historically.
Datasets on the latest version
Legal basis for provision: Health and Social Care Act 2012 - s261(5)(d); Health and Social Care Act 2012 – s261(7)
| Dataset | Type of data | Sensitivity | Frequency | Confidential data |
|---|---|---|---|---|
| Bridge file: Hospital Episode Statistics to Diagnostic Imaging Dataset | Anonymised - ICO Code Compliant | Non-Sensitive | One-Off | Section 251 NHS Act 2006 |
| Bridge file: Hospital Episode Statistics to Mental Health Minimum Data Set | Anonymised - ICO Code Compliant | Non-Sensitive | One-Off | Section 251 NHS Act 2006 |
| Civil Registrations of Death | Anonymised - ICO Code Compliant | Sensitive | One-Off | Section 251 NHS Act 2006 |
| COVID-19 Hospitalization in England Surveillance System | Anonymised - ICO Code Compliant | Non-Sensitive | One-Off | Section 251 NHS Act 2006 |
| COVID-19 SGSS First Positives (Second Generation Surveillance System) | Anonymised - ICO Code Compliant | Non-Sensitive | One-Off | Section 251 NHS Act 2006 |
| CPRD Deprivation | Anonymised - ICO Code Compliant | Sensitive | One-Off | Section 251 NHS Act 2006 |
| CPRD/UHB linkage file (pseudonymised data only) | Anonymised - ICO Code Compliant | Non-Sensitive | One-Off | Section 251 NHS Act 2006 |
| Diagnostic Imaging Data Set (DID) | Anonymised - ICO Code Compliant | Non-Sensitive | One-Off | Section 251 NHS Act 2006 |
| Emergency Care Data Set (ECDS) | Identifiable | Sensitive | One-Off | Section 251 NHS Act 2006 |
| HES-ID to MPS-ID HES Accident and Emergency | Anonymised - ICO Code Compliant | Non-Sensitive | One-Off | Section 251 NHS Act 2006 |
| HES-ID to MPS-ID HES Admitted Patient Care | Anonymised - ICO Code Compliant | Non-Sensitive | One-Off | Section 251 NHS Act 2006 |
| HES-ID to MPS-ID HES Outpatients | Anonymised - ICO Code Compliant | Non-Sensitive | One-Off | Section 251 NHS Act 2006 |
| HES:Civil Registration (Deaths) bridge | Anonymised - ICO Code Compliant | Non-Sensitive | One-Off | Section 251 NHS Act 2006 |
| Hospital Episode Statistics Accident and Emergency (HES A and E) | Anonymised - ICO Code Compliant | Non-Sensitive | One-Off | Section 251 NHS Act 2006 |
| Hospital Episode Statistics Admitted Patient Care (HES APC) | Anonymised - ICO Code Compliant | Non-Sensitive | One-Off | Section 251 NHS Act 2006 |
| Hospital Episode Statistics Critical Care (HES Critical Care) | Anonymised - ICO Code Compliant | Non-Sensitive | One-Off | Section 251 NHS Act 2006 |
| Hospital Episode Statistics Outpatients (HES OP) | Anonymised - ICO Code Compliant | Non-Sensitive | One-Off | Section 251 NHS Act 2006 |
| Maternity Services Data Set (MSDS) v2 | Anonymised - ICO Code Compliant | Non-Sensitive | One-Off | Section 251 NHS Act 2006 |
| Medicines dispensed in Primary Care (NHSBSA data) | Anonymised - ICO Code Compliant | Non-Sensitive | One-Off | Section 251 NHS Act 2006 |
| Mental Health and Learning Disabilities Data Set (MHLDDS) | Anonymised - ICO Code Compliant | Non-Sensitive | One-Off | Section 251 NHS Act 2006 |
| Mental Health Minimum Data Set (MHMDS) | Anonymised - ICO Code Compliant | Non-Sensitive | One-Off | Section 251 NHS Act 2006 |
| Mental Health Services Data Set (MHSDS) | Anonymised - ICO Code Compliant | Sensitive | One-Off | Section 251 NHS Act 2006 |
| MRIS - Bespoke | Anonymised - ICO Code Compliant | Non-Sensitive | One-Off | Section 251 NHS Act 2006 |
| NDRS Cancer Registrations | Anonymised - ICO Code Compliant | Non-Sensitive | One-Off | Section 251 NHS Act 2006 |
| NDRS Cancer Registrations | Anonymised - ICO Code Compliant | Non-Sensitive | One-Off | Section 251 NHS Act 2006 |
| NDRS National Radiotherapy Dataset (RTDS) | Anonymised - ICO Code Compliant | Non-Sensitive | One-Off | Section 251 NHS Act 2006 |
| NDRS Systemic Anti-Cancer Therapy Dataset (SACT) | Anonymised - ICO Code Compliant | Non-Sensitive | One-Off | Section 251 NHS Act 2006 |
| Patient Reported Outcome Measures (Linkable to HES) | Anonymised - ICO Code Compliant | Non-Sensitive | One-Off | Section 251 NHS Act 2006 |
Files released
Files released counts only files released externally by DARS. Access granted in NHS England's own systems, such as its Secure Data Environment, is not included.
This agreement permits sublicensing: the applicant may pass data on to others. Anything passed on is not recorded in this register.
Patient opt-outs were applied to 1,939 of the 2,064 files released under this agreement, across every version. About opt-outs
Files released against version 15.3 of this agreement, summarised by dataset.
| Dataset | Files | First released | Last released | Opt-outs applied |
|---|---|---|---|---|
| NDRS National Radiotherapy Dataset (RTDS) | 18 | June 2026 | June 2026 | Yes |
| NDRS Systemic Anti-Cancer Therapy Dataset (SACT) | 7 | May 2026 | May 2026 | Yes |
| Medicines dispensed in Primary Care (NHSBSA data) | 2 | April 2026 | April 2026 | Yes |
Version history
The register lists each renewal of this agreement as a separate row. This site has 11 versions — earlier versions existed before this site's records begin.
DARS-NIC-15625-T8K6L-v15.3 13 February 2026 to 12 August 2026
- Title
- R23 - Clinical Practice Research Datalink (CPRD) Routine Linkages Application
- Commercial
- No
- Sublicensing
- Yes
- Datasets
- 28
- Files released
- 27
Datasets: Bridge file: Hospital Episode Statistics to Diagnostic Imaging Dataset; Bridge file: Hospital Episode Statistics to Mental Health Minimum Data Set; Civil Registrations of Death; COVID-19 Hospitalization in England Surveillance System; COVID-19 SGSS First Positives (Second Generation Surveillance System); CPRD Deprivation; CPRD/UHB linkage file (pseudonymised data only); Diagnostic Imaging Data Set (DID); Emergency Care Data Set (ECDS); HES-ID to MPS-ID HES Accident and Emergency; HES-ID to MPS-ID HES Admitted Patient Care; HES-ID to MPS-ID HES Outpatients; HES:Civil Registration (Deaths) bridge; Hospital Episode Statistics Accident and Emergency (HES A and E); Hospital Episode Statistics Admitted Patient Care (HES APC); Hospital Episode Statistics Critical Care (HES Critical Care); Hospital Episode Statistics Outpatients (HES OP); Maternity Services Data Set (MSDS) v2; Medicines dispensed in Primary Care (NHSBSA data); Mental Health and Learning Disabilities Data Set (MHLDDS); Mental Health Minimum Data Set (MHMDS); Mental Health Services Data Set (MHSDS); MRIS - Bespoke; NDRS Cancer Registrations; NDRS Cancer Registrations; NDRS National Radiotherapy Dataset (RTDS); NDRS Systemic Anti-Cancer Therapy Dataset (SACT); Patient Reported Outcome Measures (Linkable to HES)
What changed from DARS-NIC-15625-T8K6L-v14.2
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2026-02-13 | |
| End date | 2026-08-12 | |
| Emergency Care Data Set (ECDS): type of data | Identifiable |
Objective for processing
[16 paragraphs unchanged]
Both the RTDS and SACT datasets will be disseminated on an ad-hoc call off basis. Data will only be disseminated for these datasets when CPRD receive specific requests for them. All data files produced will be processed through POS at time of release.
[7 paragraphs unchanged]
Processing activities
[1 paragraph unchanged]
Annex A of this Data Sharing Agreement states "The customer will provide a cohort to NHS England", the customer in this instance is
Egton Medical Information Systems (EMIS)
Optum, Vision,
and
Vision
TPP SystmOne,
who provide the cohort to NHS England.
CPRD hold pseudonymised data CPRD release data to researchers and that data is rendered effectively
anonymised
anonymised.
[4 paragraphs unchanged]
Data collected by CPRD includes all coded patient primary care data, including
[6 words unchanged]
patients aged 16 and under. CPRD does not receive patient name, address,
full date of birth,
NHS Number or free text medical notes.
In order to enable the linking of primary care records to other
[16 words unchanged]
NHS Number, full date of birth, postcode and gender. CPRD does receive
gender
gender, and receives full date-of-birth for patients registered at TPP practices only,
but does not receive any of the other identifiers. The Trusted Third Party (NHS England) provides the linkage service for CPRD.
[71 paragraphs unchanged]
Unchanged: Expected output, Expected measurable benefits, Benefits reported.
DARS-NIC-15625-T8K6L-v14.2 25 April 2025 to 24 April 2026
- Title
- R23 - Clinical Practice Research Datalink (CPRD) Routine Linkages Application
- Commercial
- No
- Sublicensing
- Yes
- Datasets
- 28
- Files released
- 249
Datasets: Bridge file: Hospital Episode Statistics to Diagnostic Imaging Dataset; Bridge file: Hospital Episode Statistics to Mental Health Minimum Data Set; Civil Registrations of Death; COVID-19 Hospitalization in England Surveillance System; COVID-19 SGSS First Positives (Second Generation Surveillance System); CPRD Deprivation; CPRD/UHB linkage file (pseudonymised data only); Diagnostic Imaging Data Set (DID); Emergency Care Data Set (ECDS); HES-ID to MPS-ID HES Accident and Emergency; HES-ID to MPS-ID HES Admitted Patient Care; HES-ID to MPS-ID HES Outpatients; HES:Civil Registration (Deaths) bridge; Hospital Episode Statistics Accident and Emergency (HES A and E); Hospital Episode Statistics Admitted Patient Care (HES APC); Hospital Episode Statistics Critical Care (HES Critical Care); Hospital Episode Statistics Outpatients (HES OP); Maternity Services Data Set (MSDS) v2; Medicines dispensed in Primary Care (NHSBSA data); Mental Health and Learning Disabilities Data Set (MHLDDS); Mental Health Minimum Data Set (MHMDS); Mental Health Services Data Set (MHSDS); MRIS - Bespoke; NDRS Cancer Registrations; NDRS Cancer Registrations; NDRS National Radiotherapy Dataset (RTDS); NDRS Systemic Anti-Cancer Therapy Dataset (SACT); Patient Reported Outcome Measures (Linkable to HES)
What changed from DARS-NIC-15625-T8K6L-v13.4
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2025-04-25 | |
| End date | 2026-04-24 | |
| Bridge file: Hospital Episode Statistics to Diagnostic Imaging Dataset: legal basis | Health and Social Care Act 2012 - s261(5)(d) | |
| Bridge file: Hospital Episode Statistics to Mental Health Minimum Data Set: legal basis | Health and Social Care Act 2012 - s261(5)(d) | |
| COVID-19 SGSS First Positives (Second Generation Surveillance System): legal basis | Health and Social Care Act 2012 - s261(5)(d) | |
| CPRD Deprivation: legal basis | Health and Social Care Act 2012 – s261(7) | |
| CPRD Deprivation: sensitivity | Sensitive | |
| CPRD/UHB linkage file (pseudonymised data only): legal basis | Health and Social Care Act 2012 - s261(5)(d) | |
| Diagnostic Imaging Data Set (DID): legal basis | Health and Social Care Act 2012 - s261(5)(d) | |
| Emergency Care Data Set (ECDS): legal basis | Health and Social Care Act 2012 - s261(5)(d) | |
| HES:Civil Registration (Deaths) bridge: legal basis | Health and Social Care Act 2012 - s261(5)(d) | |
| Hospital Episode Statistics Accident and Emergency (HES A and E): legal basis | Health and Social Care Act 2012 - s261(5)(d) | |
| Hospital Episode Statistics Admitted Patient Care (HES APC): legal basis | Health and Social Care Act 2012 - s261(5)(d) | |
| Hospital Episode Statistics Critical Care (HES Critical Care): legal basis | Health and Social Care Act 2012 - s261(5)(d) | |
| Hospital Episode Statistics Outpatients (HES OP): legal basis | Health and Social Care Act 2012 - s261(5)(d) | |
| MRIS - Bespoke: legal basis | Health and Social Care Act 2012 - s261(5)(d) | |
| Mental Health Minimum Data Set (MHMDS): legal basis | Health and Social Care Act 2012 - s261(5)(d) | |
| Mental Health Services Data Set (MHSDS): legal basis | Health and Social Care Act 2012 - s261(5)(d) | |
| Mental Health and Learning Disabilities Data Set (MHLDDS): legal basis | Health and Social Care Act 2012 - s261(5)(d) | |
| NDRS Cancer Registrations: legal basis | Health and Social Care Act 2012 - s261(5)(d) | |
| NDRS National Radiotherapy Dataset (RTDS): legal basis | Health and Social Care Act 2012 - s261(5)(d) | |
| NDRS Systemic Anti-Cancer Therapy Dataset (SACT): legal basis | Health and Social Care Act 2012 - s261(5)(d) | |
| Patient Reported Outcome Measures (Linkable to HES): legal basis | Health and Social Care Act 2012 - s261(5)(d) |
Objective for processing
[2 paragraphs unchanged]
The Clinical Practice Research Datalink (CPRD) is a government not for profit
[16 words unchanged]
National Institute of Health and Care Research (NIHR), that provides access to
pseudonymised
effectively anonymised
health data for studies to safeguard and improve patient and public health.
[45 words unchanged]
for public health research purposes in accordance with Article 6(1)(e) and Article
9(2)(j).
9(2)(j) or or drug safety and surveillance in accordance with Article 6(1)(e) and Article 9(2)(g) (reasons of substantial public interest).
Research using CPRD data has resulted in over 3,000 peer-reviewed publications, which
[108 words unchanged]
health research is granted on an annual basis by the East Midlands
and
-
Derby Research Ethics Committee (Database REC reference 21/EM/0265).
the data held by CPRD
[3 paragraphs unchanged]
•
o
Gathering of GP patient data and collation with other datasets to produce datasets that have been anonymised:
medical research under Article 9(2)(j); drug and device safety under Article 9(2)(i) of the General Data Protection Regulation.
o scientific research in the public interest under Articles 6(1)(e) and 9(2)(j) of the (UK) General Data Protection Regulation
o substantial public interest in relation to drug and device safety under Articles 6(1)(e) and 9(2)(g) of the General Data Protection Regulation.
[9 paragraphs unchanged]
For all GP Practices who participate in the CPRD research CPRD reach out to join the individual Practice PPIE groups. In 2021 The Primary Care Recruitment Team at CPRD attended and presented at two Public Patient Group (PPG) meetings. One meeting covered a network of 8 practices in Liverpool area and the other was a practice PPG meeting in Kent and Medway area. Another three practice PPG meetings took place between Jan 2022 and April 2022 in Barking London, Sunderland and Bristol. Another PPIE workshop is planned to take place in late 2022.
For all GP Practices who contribute primary care data to CPRD, CPRD regularly offers to present to their Practice Participation Groups (PPG's) on CPRD, followed by a question and answer session. Between January - July 2024, CPRD has presented at three different PPG's. CPRD hosts an annual PPIE workshop, open to all patients and members of the UK public. The last workshop was held in October 2023, and focused on the development of "Safe Outputs" in the CPRD Trusted Research Environment (TRE). The feedback from participants was incorporated into CPRD's development of the TRE. The next annual workshop is planned to take place at the end of 2024, and will focus on, among other topics, the flow of Confidential Patient Information without consent and outside of the direct care team.
[1 paragraph unchanged]
NHS England have previously undertaken some data processing activities on behalf of
[32 words unchanged]
(see https://cprd.com/cprd-linked-data). Recently NHS England have also linked data from University Hospitals
Birminham
Birmingham
(UHB) to the CPRD cohort. These UHB Electronic Health Record data comprise
[125 words unchanged]
and no NHS England data was released. There will be no linkage
to third party datasets with NHS England
as a Trusted Third Party under this iteration of the agreement.
[2 paragraphs unchanged]
Processing activities
In summary,
[1 paragraph unchanged]
Annex A of this Data Sharing Agreement states "The customer will provide a cohort to NHS England", the customer in this instance is Egton Medical Information Systems (EMIS) and Vision who provide the cohort to NHS England.
[10 paragraphs unchanged]
(i) The
TOKEN_PERSON_ID (previously
encrypted
HES_id (now MPS_tokenised_id)
HES_id)
field provided to CPRD by NHS England is not released to customers. CPRD creates a pseudonym linked to a unique patient activity record in the HES data.
[10 paragraphs unchanged]
(iv) Transformation of the linked data to a common data model (CDM)
[10 words unchanged]
or Sentinel CDM) for the purposes of data standardisation to enable federated
analyses
analyses, whole-database feasibility counts,
and the use of rapid analytics tools like the OMOP Atlas analytical tools.
Transformation of the linked data to a CDM format to carry out whole-database studies within CPRD’s Trusted Research Environment, CPRD Safe, for RDG-approved studies.
[16 paragraphs unchanged]
CPRDs Trusted Research Environment (CPRD Safe)
All studies conducted in CPRD Safe are subject to the same RDG process and safeguards as data that is released to research organisations under the previous data release model. CPRD Safe operates in line with the "5 Safes" Framework, and will consider seeking accreditation in line with the NHSE-SDE Framework once this is available.
[30 paragraphs unchanged]
The agreements by which CPRD shares NHS England data with a third-party
[30 words unchanged]
agreement between NHS England and CPRD. Third-parties are typically, UK academic institutions
(69%), research organisations (25%),
(33.85%), international academic institutions (12.31%)
or
life science
global pharmaceutical
companies
(6%).
(29.23%).
Figures of releases from financial
yesr
year
(FY)
21/22
23/24
which also gave the geographical split as: UK
(78%),
(72.75%),
EU/EEA
(9%)
(10.08%)
Non UK/EU/EEA
(13%)
(17.17%).
There were a total of
847
1171
linked data releases in the financial year
21/22.
23/24.
[4 paragraphs unchanged]
The GDPR legal basis for all current release is 6(1)(e) Public
interest
interest, 9(2)(j)
(in performing public health research) and
9(2)(j) research.
9(2)(g) (substantial public interest in relation to drug and device safety).
Agreements are in place for 12 months at a time and then
[25 words unchanged]
re-identification of individuals by means reasonably likely to be used to low.
CPRD has a searchable online register of all RDG approved studies data releases by CPRD including NHS England linked data. The register is online at
www.cprd.com/protocol-list
www.cprd.com/approved-studies-using-cprd-data
In addition, CPRD sends a monthly data release report through to NHS England, for review which details the data recipient organisation, purpose territory of use, and GDPR legal basis for release.
.
Expected output
[2 paragraphs unchanged]
Pearson-Stuttard J, Cheng YJ, Bennett J et al. Trends in leading causes of hospitalisation of adults with diabetes in England from 2003 to 2018: an epidemiological analysis of linked primary care records. The Lancet Diabetes & Endocrinology, Volume 10, Issue 1, 2022. https://doi.org/10.1016/S2213-8587(21)00288-6
• Cohen, Alexander T., et al. "Comparison of Clinical Outcomes in Patients with Active Cancer Receiving Rivaroxaban or Low-Molecular-Weight Heparin: The OSCAR-UK Study." Thrombosis and Haemostasis (2024). DOI: 10.1055/a-2259-0662
Rishi Caleyachetty, Thomas M Barber, Nuredin Ibrahim Mohammed, Francesco P Cappuccio, Rebecca Hardy, Rohini Mathur, Amitava Banerjee, Paramjit Gill. Ethnicity-specific BMI cutoffs for obesity based on type 2 diabetes risk in England: a population-based cohort study. The Lancet Diabetes & Endocrinology,
• Berni, Thomas R., Christopher L. Morgan, and D. Aled Rees. "Rising incidence, health resource utilization, and costs of polycystic ovary syndrome in the United Kingdom." The Journal of Clinical Endocrinology & Metabolism (2024). DOI: 10.1210/clinem/dgae518
Volume 9, Issue 7, 2021. https://doi.org/10.1016/S2213-8587(21)00088-7 .
• Grønbæk, Lisbet, et al. "Smoking is a Risk Factor for Autoimmune Hepatitis: An English Registry-Based Case–Control Study." Clinical Epidemiology (2024): 23-30. DOI: 10.2147/clep.s439219
Ferguson R, Prieto-Alhambra D, Peat G, et al. Influence of pre-existing multimorbidity on receiving a hip arthroplasty: cohort study of 28 025 elderly subjects from UK primary care. BMJ Open 2021;11:e046713.
• Punyadasa, Dhanusha, et al. "Post-hospitalisation asthma management in primary care: a retrospective cohort study." British Journal of General Practice 74.743 (2024). DOI: 10.3399/bjgp.2023.0214
https://doi.org/10.1136/bmjopen-2020-046713 .
• Zheng, Bang, et al. "Dementia risk in patients with type 2 diabetes: Comparing metformin with no pharmacological treatment." Alzheimer's & Dementia 19.12 (2023). DOI: 10.1002/alz.13349
Clarke CS, Williamson E, Denaxas S On behalf of the MACRO programme team, et al. Observational retrospective study calculating health service costs of patients receiving surgery for chronic rhinosinusitis in England, using linked patient-level primary and secondary care electronic data. BMJ Open 2022;12:e055603. https://doi.org/10.1136/bmjopen-2021-055603 .
Roalfe A, Lay-Flurrie SL, Ordonez-Mena JM et al. Long term trends in natriuretic peptide testing for heart failure in UK primary care: a cohort study. European Heart Journal, ehab781. https://doi.org/10.1093/eurheartj/ehab781
Cadogan SL, Powell E, Wing K et al. Anticoagulant prescribing for atrial fibrillation and risk of incident dementia. Heart 2021;107:1898-1904.
http://dx.doi.org/10.1136/heartjnl-2021-319672
[2 paragraphs unchanged]
Expected measurable benefits
[1 paragraph unchanged]
• Estimates of prevalence, incidence and healthcare burden of specific types of psoriasis in England. This study may further the understanding of the burden of these rare diseases in the UK, particularly highlighting differences between the different presentations of psoriasis. (RDG reference: 21_000421, see: https://www.cprd.com/protocol/prevalence-incidence-and-healthcare-burden-generalised-pustular-psoriasis-palmoplantar
• Changes in healthcare, diagnosis, and treatment of acute and chronic conditions during the COVID-19 pandemic (RDG reference: 24_003894, see www.cprd.com/approved-studies/changes-healthcare-diagnosis-and-treatment-acute-and-chronic-conditions-during)
• An understanding of the risks associated with COVID-19 infection in patients with congenital heart disease to inform better clinical management of these patients (RDG reference: 20_000161, see: https://cprd.com/protocol/identifying-clinical-risks-associated-covid-19-patients-congenital-heart-disease-and-0)
•Osteoporotic fractures and kidney injury in people living with an ileostomy (RDG reference: 24_003822, see www.cprd.com/approved-studies/osteoporotic-fractures-and-kidney-injury-people-living-ileostomy)
• An understanding of potential risks associated with various medications prescribed during pregnancy to both mothers and their children, to inform prescribing decisions (RDG reference: 21_000362, see: https://cprd.com/protocol/maternal-prescriptive-drug-use-risks-and-benefits-mothers-and-neonates)
•A study of the association between diabetes and fibrotic multimorbidity (RDG reference: 24_003977, see www.cprd.com/approved-studies/study-association-between-diabetes-and-fibrotic-multimorbidity)
• An understanding of the different presentations of Long Covid and risk factors associated with developing Long Covid among non-hospitalised COVID patients with the aim of developing supportive interventions and treatments (RDG reference: 21_000423, see: https://cprd.com/protocol/long-covid-non-hospitalised-individuals-symptoms-risk-factors-and-syndromes-0)
•Evaluating the relationship between pregnancy complications and health before and after pregnancy using electronic health record data in England (RDG reference: 23_003453, see www.cprd.com/approved-studies/evaluating-relationship-between-pregnancy-complications-and-health-and-after)
• Examining the effects of COVID-19 on primary care management following self-harm in the UK, concluding that despite the challenges experienced by primary healthcare teams during the initial COVID-19 wave, prescribing and consultation patterns following self-harm were broadly similar to pre-pandemic levels (RDG reference 20_001, see: https://cprd.com/protocol/impact-covid-19-primary-care-contact-referrals-follow-care-and-patient-outcomes-after)
•Epidemiology of allergic rhinitis in England: A retrospective cohort study in UK primary care data (RDG reference: 24_003814, see www.cprd.com/approved-studies/epidemiology-allergic-rhinitis-england-retrospective-cohort-study-uk-primary-care)
[6 paragraphs unchanged]
Unchanged: Benefits reported.
Objective for processing
The controller for GDPR purposes is the Department of Health and Social Care (DHSC); the legal signatory for this agreement (and for the overarching Data Sharing Framework Contract - DSFC) is the Secretary of State for Health and Social Care (acting as part of the Crown), acting through the Clinical Practice Research Datalink (hereinafter referred to as CPRD) within the Medicines and Healthcare products Regulatory Agency (MHRA) (the agency); and the licensee is CPRD, not the wider DHSC nor the agency.
The Clinical Practice Research Datalink (CPRD) is a specialist health data research service provided by the Medicines and Healthcare products Regulatory Agency (the agency), an executive agency of the Department of Health and Social Care (DHSC). The agency regulates medicines, medical devices and blood components for transfusion in the UK and the agency acts as the Executive agency.
The Clinical Practice Research Datalink (CPRD) is a government not for profit research service delivered by the Medicines and Healthcare products Regulatory Agency (MHRA) with support from the National Institute of Health and Care Research (NIHR), that provides access to effectively anonymised health data for studies to safeguard and improve patient and public health. For more than 30 years, CPRD data have supported vital research into health care delivery, drug safety, effectiveness of medicines and risk factors for disease. The linked data supplied by NHS England and shared by CPRD under the NHS England sub-licence can only be used for public health research purposes in accordance with Article 6(1)(e) and Article 9(2)(j) or or drug safety and surveillance in accordance with Article 6(1)(e) and Article 9(2)(g) (reasons of substantial public interest).
Research using CPRD data has resulted in over 3,000 peer-reviewed publications, which have informed drug safety guidance and best clinical practice. Examples of research findings used in everyday NHS care include demonstrating the protective effect of whooping cough vaccination in pregnancy for infants and informing the National Institute of Health and Care Excellence (NICE) blood pressure targets for patients with diabetes. A searchable list of the users and uses of CPRD data is published on the CPRD website https://www.cprd.com/protocol-list. CPRD’s research and data services are based on a sharing data which are effectively anonymised once given to the researcher from longitudinal primary care records contributed by participating GP practices from the four UK nations. Approval to supply data for public health research is granted on an annual basis by the East Midlands - Derby Research Ethics Committee (Database REC reference 21/EM/0265).
CPRD provides researchers under sublicense agreements access to effectively anonymised primary care data linked to secondary health care datasets for both observational research and to supplement clinical trial data. Linked data greatly increases the scale, depth, completeness and value of data available for public health and clinical research. Linked data are also used to assess study feasibility and create lists of eligible patients who could potentially be included in clinical trials. In addition, linked data are used by CPRD to generate derived fields that improve the quality of the primary care data for e.g., ethnicity records. The outputs of such research based on linked data inform clinical guidance and best practice for patients in the UK. The CPRD Research Data Governance (RDG) review process includes lay reviewers. Applications that include non-standard elements that deviate from precedent will be assigned to lay reviewers. In addition, a sample of all applications is reviewed by the independent Central Advisory Committee (CAC) which includes lay representatives as part of CPRD’s assurance process.
Secondary healthcare datasets are provided by NHS England and these data are linked to the primary care data by NHS England. NHS England receives identifiers to enable them to carry out this linkage as described below in 5b processing activities. Continued support is given by Confidentiality Advisory Group (CAG) for the flow of identifiers to NHS England to enable linkage of CPRD primary care data to secondary datasets (CAG reference 21/CAG/0008).
The legal bases for processing the data provided by NHS England are:
o Gathering of GP patient data and collation with other datasets to produce datasets that have been anonymised:
o scientific research in the public interest under Articles 6(1)(e) and 9(2)(j) of the (UK) General Data Protection Regulation
o substantial public interest in relation to drug and device safety under Articles 6(1)(e) and 9(2)(g) of the General Data Protection Regulation.
NHS England has been providing and linking health-related datasets to CPRD primary care data for a number of years. Data linkage is carried out exclusively by NHS England as the Trusted Third Party (TTP) for this purpose. Linked datasets currently available include extracts from Civil Registration data; Hospital Episode Statistics (HES), which encompasses Admitted Patient Care, Critical Care, Outpatient and Accident & Emergency data; Diagnostic Imaging Dataset (DID); and Critical Care data (supplied as a separate dataset by NHS England but integrated with Admitted Patient Care). CPRD primary care data are also linked with the National Disease Registration Service National Cancer Registry data, the Second Generation Surveillance System (SGSS) data (specifically the COVID-19 test result data, including future serological testing as well as current antigen testing) and COVID-19 Hospitalisation in England Surveillance System (CHESS). NHS England also supply Lower Layer Super Output Area based on patient postcode, to enable linkage to deprivation data including Townsend Score and Index of Multiple Deprivation.
CPRD have historically received National Disease Registration Service (NDRS) data from Public Health England (PHE) until the service was transferred to NHS England. CPRD received this data under DARS-NIC-656848-T9J1Q. The data approved for dissemination under DARS-NIC-656848-T9J1Q has now been added to this agreement DARS-NIC-15625-T8K6L. The data disseminated includes:
~ Tumour table (represented by one of the NDRS Cancer Registration products) - this table contains information relating to the individual tumour and to the patient at the time of diagnosis of this tumour for e.g diagnosis date, stage, age at diagnosis, date of start of treatment. This dataset has one row per tumour
~ Treatment table (represented by one of the NDRS Cancer Registration products) – this table contains information about the treatments given for each tumour in the Tumour table. These could include surgeries, chemotherapies, radiotherapies and any other treatments. As multiple treatments are often given for a single tumour this dataset has multiple treatment rows for each tumour.
~ NDRS National Radiotherapy Dataset (RTDS) - RTDS data are linked to individual patients in the Cancer Registration datasets. RTDS is made up of 4 individual tables; RTDS Episodes, RTDS Prescriptions, RTDS Exposures and RTDS Procedures. Individual CPRD studies can request any of these tables.
~ NDRS Systemic Anti-Cancer Therapy Dataset (SACT) - SACT data are linked to individual tumours in the Cancer Registration datasets. SACT is made up of 6 tables; SACT Patient, SACT Tumour, SACT Regimen, SACT Cycle, SACT Drug Detail, SACT Outcome.
Both the RTDS and SACT datasets will be disseminated on an ad-hoc call off basis. Data will only be disseminated for these datasets when CPRD receive specific requests for them. All data files produced will be processed through POS at time of release.
Research using CPRD data and services informs clinical guidance and best practice related to drug safety, use of medicines, effectiveness of health policy, health care delivery and disease risk factors. Similarly, the primary care and linked HES data would permit research which would expand understanding about patient access to health services across the patient care pathway and the need for wider care of patients and vulnerable groups as a direct or indirect result of COVID-19 and the availability and capacity of those services or that care.
Patient and Public Involvement and Engagement (PPIE)
For all GP Practices who contribute primary care data to CPRD, CPRD regularly offers to present to their Practice Participation Groups (PPG's) on CPRD, followed by a question and answer session. Between January - July 2024, CPRD has presented at three different PPG's. CPRD hosts an annual PPIE workshop, open to all patients and members of the UK public. The last workshop was held in October 2023, and focused on the development of "Safe Outputs" in the CPRD Trusted Research Environment (TRE). The feedback from participants was incorporated into CPRD's development of the TRE. The next annual workshop is planned to take place at the end of 2024, and will focus on, among other topics, the flow of Confidential Patient Information without consent and outside of the direct care team.
TRUSTED THIRD PARTY DATA LINKAGE
NHS England have previously undertaken some data processing activities on behalf of CPRD, including linking CPRD patient identifiers to patients in the Intensive Care National Audit & Research Centre (ICNARC), data which are managed (collection and processing) by ICNARC, who is the data custodian (see https://cprd.com/cprd-linked-data). Recently NHS England have also linked data from University Hospitals Birmingham (UHB) to the CPRD cohort. These UHB Electronic Health Record data comprise data from a number of different clinical systems held within the Data Controllership of UHB, that are not routinely transferred to NHS England, including prescribing systems (PICS), laboratory systems (Telepath), health record noting (PICS/Clinical Portal/Medisoft) and patient administrative system, Imaging modalities (e.g. XRay: MRI: CT: OCT: Retinal photography) and clinically relevant parameters (ECG and EEG)- some data types will have features extracted and stored as structured data. This data provides a more comprehensive view of the provision of healthcare to patients with multiple long-term health conditions. This data contains more detailed data on patients diagnoses including severity of diseases and prescribing of medications only initiated in secondary care'. In both of these cases, data flowed under Section 251 of the Health and Social Care Act and no NHS England data was released. There will be no linkage to third party datasets with NHS England as a Trusted Third Party under this iteration of the agreement.
National Data Opt outs will be applied to the data prior to it being disseminated to CPRD.
Where individuals have opted out of disease registration by the National Disease Registration Service (NDRS), their data has been permanently removed from the registry and therefore will not be disseminated under this Data Sharing Agreement (DSA). https://digital.nhs.uk/ndrs/patients/opting-out
Expected output
Researchers using linked CPRD data will be producing research publications in peer-reviewed journals and presentations at scientific conferences on an ongoing basis. Target dates for expected outputs will vary by study but on average, publication of findings arising from approved research is expected between 3-4 years after data access. CPRD provides data to researchers in academic institutions, pharmaceutical companies, Governmental centres and research charities. While the typical output is publication in a peer-reviewed academic journal, other outputs may include reports submitted to medicines regulatory bodies or white papers. Some of the research findings may directly translate into clinical guidelines and public health policy.
A selection of recent publications resulting from use of CPRD linked data are presented below.
• Cohen, Alexander T., et al. "Comparison of Clinical Outcomes in Patients with Active Cancer Receiving Rivaroxaban or Low-Molecular-Weight Heparin: The OSCAR-UK Study." Thrombosis and Haemostasis (2024). DOI: 10.1055/a-2259-0662
• Berni, Thomas R., Christopher L. Morgan, and D. Aled Rees. "Rising incidence, health resource utilization, and costs of polycystic ovary syndrome in the United Kingdom." The Journal of Clinical Endocrinology & Metabolism (2024). DOI: 10.1210/clinem/dgae518
• Grønbæk, Lisbet, et al. "Smoking is a Risk Factor for Autoimmune Hepatitis: An English Registry-Based Case–Control Study." Clinical Epidemiology (2024): 23-30. DOI: 10.2147/clep.s439219
• Punyadasa, Dhanusha, et al. "Post-hospitalisation asthma management in primary care: a retrospective cohort study." British Journal of General Practice 74.743 (2024). DOI: 10.3399/bjgp.2023.0214
• Zheng, Bang, et al. "Dementia risk in patients with type 2 diabetes: Comparing metformin with no pharmacological treatment." Alzheimer's & Dementia 19.12 (2023). DOI: 10.1002/alz.13349
Outputs from the studies approved usually have research reports which are submitted to funders (such as the Medical Research Council). Some outputs may inform discussions with national programmes (such as NHS Cancer Screening Programmes and NHS Scotland), charities (such as Cancer Research UK) primary care professionals, policy makers and researchers. In many instances, the papers are also published and are available on Open Access journals. Many of the outputs are also presented at conferences (such as International Society for Pharmacoepidemiology). Many of the outputs have the capacity to not only influence the clinical community but also policy makers, for example clinical guidelines (see Oyinlola et al 2016, https://doi.org/10.1186/s12913-016-1562-8).
A comprehensive list of publications including those using linked data can be found at www.cprd.com/bibliography
Benefits reported
CPRD publish here https://cprd.com/approved-studies-using-cprd-data a register of all approved studies of which the detail on each study includes a lay and technical summary, the health outcomes to be measured and details on the organisations involved.
There are 3 case studies presented below highlighting how linked CPRD-NHS England data has supported public health research, especially in response to the COVID 19 effort in recent years. Research using linked CPRD data benefits patients in the UK indirectly by contributing to the evidence base for medicine and public health, which in turn informs public health policy, programmes and clinical guidelines.
Case study 1: Higher risks of flu and COVID-19 for cancer survivors (CPRD protocol 20_082).
Older individuals and people with certain health conditions are known to be at higher risk of severe illness if they contract viruses such as flu and COVID-19. This includes people who had certain cancers diagnosed recently and are receiving treatments like chemotherapy. In the UK there are more than two million cancer survivors. To investigate whether people who had cancer some time ago are also at higher risk from flu and COVID-19 a study was carried out using CPRD data. CPRD GOLD was linked to Hospital Episode Statistics Admitted Patient Care (HES APC) database, cancer registrations from the National Cancer Registration and Analysis Service (NCRAS), death registrations from the Office of National Statistics mortality database, and postcode-based index of Multiple Deprivation data. Researchers found that survivors from a wide range of cancers are more likely than people in the general population to be hospitalised or die from flu, even several years after their cancer diagnosis. The raised risks were most likely for blood cancer survivors. Because flu and COVID-19 are both respiratory viruses, this suggested that cancer survivors also have a higher risk of severe COVID-19. The study also showed that cancer survivors were more likely to have other diseases that are associated with increased risk of severe COVID-19, such as heart disease, diabetes, respiratory disease and kidney disease. The findings support the UK policy recommendation to include all blood cancer survivors as one of the priority groups to receive the COVID-19 vaccination. The study findings could also support any work by others to prioritise vaccinations and treatments for longer-term cancer survivors.
Reference 1: Carreira H, Strongman H, Peppa M, McDonald H, dos-Santos-Silva I, Stanway S, Smeeth L, Bhaskaran K. Prevalence of COVID-19-related risk factors and risk of severe influenza outcomes in cancer survivors: a matched cohort study using linked UK electronic health records data. EClinicalMedicine, Volume 29, 100656, December 2020. https://doi.org/10.1016/j.eclinm.2020.100656
https://cprd.com/protocol/covid-19-related-risks-cancer-survivors-matched-cohort-study-using-linked-uk-electronic
Case study 2: Vaccine uptake in pregnancy
Vaccination is an effective way to prevent infectious diseases. However, people with certain social characteristics – such as those living in more deprived areas – may be less likely to receive vaccination. Addressing inequalities in vaccine uptake to prevent infections is a key priority for public health. This cohort study examined the social factors that may be associated with lower uptake of flu vaccine and whooping cough vaccine by pregnant women. It considered a range of social determinants including maternal age, ethnicity, socioeconomic status, number of children in the household and region. The study used linkages between CPRD data, the CPRD GOLD Pregnancy Register, Hospital Episode Statistics (HES) and Office of National Statistics (ONS) small-area-level deprivation data.
The researchers concluded that more targeted campaigns have the potential to reduce vaccine-preventable disease among infants and pregnant women, and to reduce health inequalities. Identifying social factors that are associated with lower vaccination rates could help to design programmes to improve vaccine uptake for specific groups of individuals.
Reference 2: Walker et al. Social determinants of pertussis and influenza vaccine uptake in pregnancy: a national cohort study in England using electronic health records. BMJ Open 2021;11:e046545. https://doi.org/10.1136/bmjopen-2020-046545
https://cprd.com/protocol/social-determinants-uptake-maternal-influenza-and-pertussis-vaccine
Case study 3: Health of mothers of children with a life-limiting condition
More than 86,000 children and young people in England are now living with medical conditions that may ultimately shorten their life and cause death in childhood or young adulthood. Mothers of children with a severe health condition or whose child has died are more likely themselves to die earlier than other mothers.
The lack of studies quantifying the mental health of mothers of children with a life-limiting condition has been highlighted by the National Institute for Health and Care Excellence. In this first part of a larger research programme, researchers used CPRD data to investigate the types of physical and psychological health conditions diagnosed in mothers of children with a life-limiting condition. The CPRD GOLD Pregnancy Register was used to link mothers and their children's healthcare data. The study also used linkages to Hospital Episodes Statistics (HES), Mental Health Minimum Dataset (MHMDS) and Office for National Statistics (ONS) death certificate data.
The study concluded that mothers of children with life-limiting conditions have much higher rates of physical health problems, mental illness, and death. These findings were flagged as an ‘Alert’ for important research by the NIHR. Prior to this study, little research had explored the health of this group of women. Knowing more about the health problems that the women experience could help in the design of specific healthcare interventions.
Reference 3: Fraser et al. Health of mothers of children with a life-limiting condition: a comparative cohort study. Archives of Disease in Childhood 2021;106:987-993. http://dx.doi.org/10.1136/archdischild-2020-320655
https://cprd.com/protocol/life-limiting-conditions-health-children-and-their-mothers
NIHR Evidence - Mothers of children with life-limiting conditions are at risk of serious health problems - Informative and accessible health and care research https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fevidence.nihr.ac.uk%2Falert%2Fchildren-life-limiting-conditions-mothers-more-likely-to-die%2F%3Futm_source%3DNIHR%2Bmailing%2Blist%26utm_campaign%3Dc836e7227e-NEWS_RESEARCH_26_8_2021_COPY_01%26utm_medium%3Demail%26utm_term%3D0_570d86f9cb-c836e7227e-33120976&data=04%7C01%7CRhian.Hortin%40mhra.gov.uk%7Ceeaa93de1cb4421aafec08d9b0242f33%7Ce527ea5c62584cd2a27f8bd237ec4c26%7C0%7C0%7C637734491713613980%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=TKPdVHwcavrPA3jVYfUKdqC0ds9O2bgjo6GzYGJAk34%3D&reserved=0
CPRD have not received any updated data from NHS England for a significant number of months due to technical data production work which has delayed data dissemination as a result yielded benefits can only be provided on the use of the data which they have held historically.
DARS-NIC-15625-T8K6L-v13.4 23 November 2023 to 31 December 2024
- Title
- R23 - Clinical Practice Research Datalink (CPRD) Routine Linkages Application
- Commercial
- No
- Sublicensing
- Yes
- Datasets
- 28
- Files released
- 197
Datasets: Bridge file: Hospital Episode Statistics to Diagnostic Imaging Dataset; Bridge file: Hospital Episode Statistics to Mental Health Minimum Data Set; Civil Registrations of Death; COVID-19 Hospitalization in England Surveillance System; COVID-19 SGSS First Positives (Second Generation Surveillance System); CPRD Deprivation; CPRD/UHB linkage file (pseudonymised data only); Diagnostic Imaging Data Set (DID); Emergency Care Data Set (ECDS); HES-ID to MPS-ID HES Accident and Emergency; HES-ID to MPS-ID HES Admitted Patient Care; HES-ID to MPS-ID HES Outpatients; HES:Civil Registration (Deaths) bridge; Hospital Episode Statistics Accident and Emergency (HES A and E); Hospital Episode Statistics Admitted Patient Care (HES APC); Hospital Episode Statistics Critical Care (HES Critical Care); Hospital Episode Statistics Outpatients (HES OP); Maternity Services Data Set (MSDS) v2; Medicines dispensed in Primary Care (NHSBSA data); Mental Health and Learning Disabilities Data Set (MHLDDS); Mental Health Minimum Data Set (MHMDS); Mental Health Services Data Set (MHSDS); MRIS - Bespoke; NDRS Cancer Registrations; NDRS Cancer Registrations; NDRS National Radiotherapy Dataset (RTDS); NDRS Systemic Anti-Cancer Therapy Dataset (SACT); Patient Reported Outcome Measures (Linkable to HES)
What changed from DARS-NIC-15625-T8K6L-v12.6
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2023-11-23 | |
| End date | 2024-12-31 | |
| COVID-19 Hospitalization in England Surveillance System: legal basis | Health and Social Care Act 2012 - s261(5)(d) | |
| Civil Registrations of Death: legal basis | Health and Social Care Act 2012 - s261(5)(d) | |
| Emergency Care Data Set (ECDS): sensitivity | Sensitive | |
| MSDS (Maternity Services Data Set) v2.0: legal basis | Health and Social Care Act 2012 - s261(5)(d) | |
| Medicines dispensed in Primary Care (NHSBSA data): legal basis | Health and Social Care Act 2012 - s261(5)(d) |
Datasets: + CPRD Deprivation; + NDRS Cancer Registrations; + NDRS National Radiotherapy Dataset (RTDS); + NDRS Systemic Anti-Cancer Therapy Dataset (SACT)
Objective for processing
[2 paragraphs unchanged]
The Clinical Practice Research Datalink (CPRD) is a government not for profit
[60 words unchanged]
medicines and risk factors for disease. The linked data supplied by NHS
Digital
England
and shared by CPRD under the NHS
Digital
England
sub-licence can only be used for public health research purposes in accordance with Article 6(1)(e) and Article 9(2)(j).
[2 paragraphs unchanged]
Secondary healthcare datasets are provided by NHS
Digital
England
and these data are linked to the primary care data by NHS
Digital.
England.
NHS
Digital
England
receives identifiers to enable them to carry out this linkage as described
[9 words unchanged]
by Confidentiality Advisory Group (CAG) for the flow of identifiers to NHS
Digital
England
to enable linkage of CPRD primary care data to secondary datasets (CAG reference 21/CAG/0008).
The legal bases for processing the data provided by NHS
Digital
England
are:
[1 paragraph unchanged]
NHS
Digital
England
has been providing and linking health-related datasets to CPRD primary care data for a number of years. Data linkage is carried out exclusively by NHS
Digital
England
as the Trusted Third Party (TTP) for this purpose. Linked datasets currently
[27 words unchanged]
(DID); and Critical Care data (supplied as a separate dataset by NHS
Digital
England
but integrated with Admitted Patient Care). CPRD primary care data are also
[31 words unchanged]
current antigen testing) and COVID-19 Hospitalisation in England Surveillance System (CHESS). NHS
Digital
England
also supply Lower Layer Super Output Area based on patient postcode, to enable linkage to deprivation data including Townsend Score and Index of Multiple Deprivation.
CPRD have historically received National Disease Registration Service (NDRS) data from Public Health England (PHE) until the service was transferred to NHS England. CPRD received this data under DARS-NIC-656848-T9J1Q. The data approved for dissemination under DARS-NIC-656848-T9J1Q has now been added to this agreement DARS-NIC-15625-T8K6L. The data disseminated includes:
~ Tumour table (represented by one of the NDRS Cancer Registration products) - this table contains information relating to the individual tumour and to the patient at the time of diagnosis of this tumour for e.g diagnosis date, stage, age at diagnosis, date of start of treatment. This dataset has one row per tumour
~ Treatment table (represented by one of the NDRS Cancer Registration products) – this table contains information about the treatments given for each tumour in the Tumour table. These could include surgeries, chemotherapies, radiotherapies and any other treatments. As multiple treatments are often given for a single tumour this dataset has multiple treatment rows for each tumour.
~ NDRS National Radiotherapy Dataset (RTDS) - RTDS data are linked to individual patients in the Cancer Registration datasets. RTDS is made up of 4 individual tables; RTDS Episodes, RTDS Prescriptions, RTDS Exposures and RTDS Procedures. Individual CPRD studies can request any of these tables.
~ NDRS Systemic Anti-Cancer Therapy Dataset (SACT) - SACT data are linked to individual tumours in the Cancer Registration datasets. SACT is made up of 6 tables; SACT Patient, SACT Tumour, SACT Regimen, SACT Cycle, SACT Drug Detail, SACT Outcome.
Both the RTDS and SACT datasets will be disseminated on an ad-hoc call off basis. Data will only be disseminated for these datasets when CPRD receive specific requests for them. All data files produced will be processed through POS at time of release.
[2 paragraphs unchanged]
For all GP Practices who participate in the CPRD research CPRD reach
[11 words unchanged]
Primary Care Recruitment Team at CPRD attended and presented at two Public
Patient Group (PPG) meetings. One meeting covered a network of 8 practices in Liverpool area and the other was a practice PPG meeting in Kent and Medway area. Another three practice PPG meetings took place between Jan 2022 and April 2022 in Barking London, Sunderland and Bristol. Another PPIE workshop is planned to take place in late 2022.
Patient Group (PPG) meetings. One meeting covered a network of 8 practices in Liverpool area and the other was a practice PPG meeting in Kent and Medway area. Another three practice PPG meetings took place between Jan 2022 and April 2022 in Barking London, Sunderland and Bristol. Another PPIE workshop is planned to take place in late 2022.
[1 paragraph unchanged]
NHS
Digital
England
have previously undertaken some data processing activities on behalf of CPRD, including
[22 words unchanged]
processing) by ICNARC, who is the data custodian (see https://cprd.com/cprd-linked-data). Recently NHS
Digital
England
have also linked data from University Hospitals Birminham (UHB) to the CPRD
[18 words unchanged]
the Data Controllership of UHB, that are not routinely transferred to NHS
Digital,
England,
including prescribing systems (PICS), laboratory systems (Telepath), health record noting (PICS/Clinical Portal/Medisoft)
[81 words unchanged]
Section 251 of the Health and Social Care Act and no NHS
Digital
England
data was released. There will be no linkage as a Trusted Third Party under this iteration of the agreement.
National Data Opt outs will be applied to the data prior to it being disseminated to CPRD.
Where individuals have opted out of disease registration by the National Disease Registration Service (NDRS), their data has been permanently removed from the registry and therefore will not be disseminated under this Data Sharing Agreement (DSA). https://digital.nhs.uk/ndrs/patients/opting-out
Processing activities
[1 paragraph unchanged]
NHSD
NHS England
receive, process and link Identifiable data directly from participating General Practices (GPs) under the CAG section 251 approval
NHS England release Pseudonymised data to CPRD
NHSD release Pseudonymised data to CPRD
CPRD hold pseudonymised data CPRD release data to researchers and that data is rendered effectively anonymised
CPRD hold pseudonymised data
CPRD release data to researchers and that data is rendered effectively anonymised
[5 paragraphs unchanged]
In order to enable the linking of primary care records to other health related data, GP EHR suppliers provide certain patient identifiers directly to NHS
Digital.
England.
These are: NHS Number, full date of birth, postcode and gender. CPRD
[5 words unchanged]
not receive any of the other identifiers. The Trusted Third Party (NHS
Digital)
England)
provides the linkage service for CPRD.
[1 paragraph unchanged]
CPRD does not release the same linked data to external researchers that it receives from NHS
Digital.
England.
This is done to protect patient confidentiality, and also to better facilitate relevant research.
Transformation involves removing the provider codes supplied by NHS
Digital.
England.
Data provided by CPRD is matched to the Office for National Statistics
[43 words unchanged]
CPRD linked Hospital Episode Statistics Admitted Patient Care (HES APC) data involves:
(i) The encrypted HES_id (now MPS_tokenised_id) field provided to CPRD by NHS
Digital
England
is not released to customers. CPRD creates a pseudonym linked to a unique patient activity record in the HES data.
[1 paragraph unchanged]
(iii) Collating data across years, formatting date and diagnosis fields, and dropping
[7 words unchanged]
standard release of the data. The episode-level data files received by NHS
Digital
England
are transformed into a normalised data structure containing the following tables:
[10 paragraphs unchanged]
CPRD has agreed pseudonymisation processes with each GP EHR system provider as well as NHS
Digital
England
used for data linkage. The overarching process for patient data pseudonymisation comprises the following stages to protect patient confidentiality at all times:
[2 paragraphs unchanged]
(iii) Data linkage - undertaken by
NHSD,
NHS England,
all linked patient record data are pseudonymised by the TTP before release to CPRD.
[15 paragraphs unchanged]
d) Access to data provided by CPRD which is sub-licensed having been provided by NHS
Digital,
England,
is done under terms agreed with
NHSD
NHS England.
[3 paragraphs unchanged]
CPRD’s clinical trial services use pseudonymised CPRD primary care data to create
[104 words unchanged]
these instances, there is no need for the flow of identifiers to
NHSD
NHS England
for further linkage and CPRD will process the data using the standard
[46 words unchanged]
where patients have explicitly consented for the study team to access linked
NHSD
NHS England
data by name for the purpose of measuring clinical trial outcomes and adverse outcomes. Any scenarios involving the flow of identifiers to
NHSD
NHS England
for the purpose of further linkage are outside the scope of this agreement and will be subject to a separate study-specific DARS application.
[1 paragraph unchanged]
CPRD is part of the MHRA and conforms to the 10 National Data Guardian data security standards as well as to NHS
Digital
England
requirements. CPRD meets NHS
Digital
England
Data Security and Protection Toolkit standards, and details on standards and arrangements are set out in CPRD’s approved System Level Security Policy (SLSP).
[7 paragraphs unchanged]
Data destruction standards (currently, NHS
Digital
England
’Destruction and Disposal of Sensitive Data’ guidelines v3.2) have been implemented in
[44 words unchanged]
with industry standards and regulations, including International Organisation for Standardisation (ISO) 27001.
[6 paragraphs unchanged]
NHS
Digital
England
permits CPRD sub-licensees to share data with third parties subject to the
[14 words unchanged]
terms, checks and controls carried out by CPRD in relation to sub-licences.
[4 paragraphs unchanged]
The agreements by which CPRD shares NHS
Digital
England
data with a third-party organisations include all terms of the agreement between NHS
Digital
England
and CPRD. The agreements by which CPRD shares NHS
Digital
England
data with a third-party organisations include all terms of the agreement between NHS
Digital
England
and CPRD. Third-parties are typically, UK academic institutions (69%), research organisations (25%),
[29 words unchanged]
a total of 847 linked data releases in the financial year 21/22.
[1 paragraph unchanged]
CPRD ensures that NHS
Digital
England
retains direct rights for audit and/or requiring deletion of data in relation
[6 words unchanged]
whom data is shared by the sub-licensee; and CPRD ensures that NHS
Digital
England
may (under the licensing terms put in place by CPRD) require and enforce remedial action (whether in relation to this or other agreements between NHS
Digital
England
and the organisation) where appropriate. CPRD takes responsibility for the actions and
[11 words unchanged]
be regarded as breach of the Data Sharing Framework Contract with NHS
Digital.
England.
In the event of termination or expiry of the Data Sharing Framework Contract between NHS
Digital
England
and the CPRD, all sub-licence rights will be automatically terminated.
CPRD only releases NHS
Digital
England
data to third-parties which must have undergone the New Client Vetting process
[19 words unchanged]
appropriate data recipients) under sub-licence after an RDG approval for health-related research.
The GDPR legal basis for all current release is 6(1)(e) Public interest
[45 words unchanged]
re-identification of individuals by means reasonably likely to be used to low.
CPRD was subject to a remote data sharing audit by NHS Digital (NHSD) and the Office of National Statistics (ONS) between April and July 2022. CPRD was audited against the data sharing framework contract (DSFC) CON-325063-H0M5Y-v2.01 and the data sharing agreement (DSA) DARS-NIC-15625-T8K6L-v11.2. The audit did not identify any non-conformities, observations, or outstanding information, and categorised the risk of re-identification of individuals as “Low”; the lowest possible category.
CPRD has a searchable online register of all RDG approved studies data releases by CPRD including NHS
Digital
England
linked data. The register is online at www.cprd.com/protocol-list
In addition, CPRD sends a monthly data release report through to NHS
Digital,
England,
for review which details the data recipient organisation, purpose territory of use, and GDPR legal basis for release.
Expected measurable benefits
Studies using NHS
Digital
England
data linked to CPRD primary care database are expected and required to
[58 words unchanged]
examples of expected benefits included by researchers in recent RDG applications include:
[11 paragraphs unchanged]
Benefits reported
[1 paragraph unchanged]
There are 3 case studies presented below highlighting how linked
CPRD-NHSD
CPRD-NHS England
data has supported public health research, especially in response to the COVID
[26 words unchanged]
health, which in turn informs public health policy, programmes and clinical guidelines.
[16 paragraphs unchanged]
CPRD have not received any updated data from NHS England for a significant number of months due to technical data production work which has delayed data dissemination as a result yielded benefits can only be provided on the use of the data which they have held historically.
Unchanged: Expected output.
Objective for processing
The controller for GDPR purposes is the Department of Health and Social Care (DHSC); the legal signatory for this agreement (and for the overarching Data Sharing Framework Contract - DSFC) is the Secretary of State for Health and Social Care (acting as part of the Crown), acting through the Clinical Practice Research Datalink (hereinafter referred to as CPRD) within the Medicines and Healthcare products Regulatory Agency (MHRA) (the agency); and the licensee is CPRD, not the wider DHSC nor the agency.
The Clinical Practice Research Datalink (CPRD) is a specialist health data research service provided by the Medicines and Healthcare products Regulatory Agency (the agency), an executive agency of the Department of Health and Social Care (DHSC). The agency regulates medicines, medical devices and blood components for transfusion in the UK and the agency acts as the Executive agency.
The Clinical Practice Research Datalink (CPRD) is a government not for profit research service delivered by the Medicines and Healthcare products Regulatory Agency (MHRA) with support from the National Institute of Health and Care Research (NIHR), that provides access to pseudonymised health data for studies to safeguard and improve patient and public health. For more than 30 years, CPRD data have supported vital research into health care delivery, drug safety, effectiveness of medicines and risk factors for disease. The linked data supplied by NHS England and shared by CPRD under the NHS England sub-licence can only be used for public health research purposes in accordance with Article 6(1)(e) and Article 9(2)(j).
Research using CPRD data has resulted in over 3,000 peer-reviewed publications, which have informed drug safety guidance and best clinical practice. Examples of research findings used in everyday NHS care include demonstrating the protective effect of whooping cough vaccination in pregnancy for infants and informing the National Institute of Health and Care Excellence (NICE) blood pressure targets for patients with diabetes. A searchable list of the users and uses of CPRD data is published on the CPRD website https://www.cprd.com/protocol-list. CPRD’s research and data services are based on a sharing data which are effectively anonymised once given to the researcher from longitudinal primary care records contributed by participating GP practices from the four UK nations. Approval to supply data for public health research is granted on an annual basis by the East Midlands and Derby Research Ethics Committee (Database REC reference 21/EM/0265). the data held by CPRD
CPRD provides researchers under sublicense agreements access to effectively anonymised primary care data linked to secondary health care datasets for both observational research and to supplement clinical trial data. Linked data greatly increases the scale, depth, completeness and value of data available for public health and clinical research. Linked data are also used to assess study feasibility and create lists of eligible patients who could potentially be included in clinical trials. In addition, linked data are used by CPRD to generate derived fields that improve the quality of the primary care data for e.g., ethnicity records. The outputs of such research based on linked data inform clinical guidance and best practice for patients in the UK. The CPRD Research Data Governance (RDG) review process includes lay reviewers. Applications that include non-standard elements that deviate from precedent will be assigned to lay reviewers. In addition, a sample of all applications is reviewed by the independent Central Advisory Committee (CAC) which includes lay representatives as part of CPRD’s assurance process.
Secondary healthcare datasets are provided by NHS England and these data are linked to the primary care data by NHS England. NHS England receives identifiers to enable them to carry out this linkage as described below in 5b processing activities. Continued support is given by Confidentiality Advisory Group (CAG) for the flow of identifiers to NHS England to enable linkage of CPRD primary care data to secondary datasets (CAG reference 21/CAG/0008).
The legal bases for processing the data provided by NHS England are:
• Gathering of GP patient data and collation with other datasets to produce datasets that have been anonymised: medical research under Article 9(2)(j); drug and device safety under Article 9(2)(i) of the General Data Protection Regulation.
NHS England has been providing and linking health-related datasets to CPRD primary care data for a number of years. Data linkage is carried out exclusively by NHS England as the Trusted Third Party (TTP) for this purpose. Linked datasets currently available include extracts from Civil Registration data; Hospital Episode Statistics (HES), which encompasses Admitted Patient Care, Critical Care, Outpatient and Accident & Emergency data; Diagnostic Imaging Dataset (DID); and Critical Care data (supplied as a separate dataset by NHS England but integrated with Admitted Patient Care). CPRD primary care data are also linked with the National Disease Registration Service National Cancer Registry data, the Second Generation Surveillance System (SGSS) data (specifically the COVID-19 test result data, including future serological testing as well as current antigen testing) and COVID-19 Hospitalisation in England Surveillance System (CHESS). NHS England also supply Lower Layer Super Output Area based on patient postcode, to enable linkage to deprivation data including Townsend Score and Index of Multiple Deprivation.
CPRD have historically received National Disease Registration Service (NDRS) data from Public Health England (PHE) until the service was transferred to NHS England. CPRD received this data under DARS-NIC-656848-T9J1Q. The data approved for dissemination under DARS-NIC-656848-T9J1Q has now been added to this agreement DARS-NIC-15625-T8K6L. The data disseminated includes:
~ Tumour table (represented by one of the NDRS Cancer Registration products) - this table contains information relating to the individual tumour and to the patient at the time of diagnosis of this tumour for e.g diagnosis date, stage, age at diagnosis, date of start of treatment. This dataset has one row per tumour
~ Treatment table (represented by one of the NDRS Cancer Registration products) – this table contains information about the treatments given for each tumour in the Tumour table. These could include surgeries, chemotherapies, radiotherapies and any other treatments. As multiple treatments are often given for a single tumour this dataset has multiple treatment rows for each tumour.
~ NDRS National Radiotherapy Dataset (RTDS) - RTDS data are linked to individual patients in the Cancer Registration datasets. RTDS is made up of 4 individual tables; RTDS Episodes, RTDS Prescriptions, RTDS Exposures and RTDS Procedures. Individual CPRD studies can request any of these tables.
~ NDRS Systemic Anti-Cancer Therapy Dataset (SACT) - SACT data are linked to individual tumours in the Cancer Registration datasets. SACT is made up of 6 tables; SACT Patient, SACT Tumour, SACT Regimen, SACT Cycle, SACT Drug Detail, SACT Outcome.
Both the RTDS and SACT datasets will be disseminated on an ad-hoc call off basis. Data will only be disseminated for these datasets when CPRD receive specific requests for them. All data files produced will be processed through POS at time of release.
Research using CPRD data and services informs clinical guidance and best practice related to drug safety, use of medicines, effectiveness of health policy, health care delivery and disease risk factors. Similarly, the primary care and linked HES data would permit research which would expand understanding about patient access to health services across the patient care pathway and the need for wider care of patients and vulnerable groups as a direct or indirect result of COVID-19 and the availability and capacity of those services or that care.
Patient and Public Involvement and Engagement (PPIE)
For all GP Practices who participate in the CPRD research CPRD reach out to join the individual Practice PPIE groups. In 2021 The Primary Care Recruitment Team at CPRD attended and presented at two Public Patient Group (PPG) meetings. One meeting covered a network of 8 practices in Liverpool area and the other was a practice PPG meeting in Kent and Medway area. Another three practice PPG meetings took place between Jan 2022 and April 2022 in Barking London, Sunderland and Bristol. Another PPIE workshop is planned to take place in late 2022.
TRUSTED THIRD PARTY DATA LINKAGE
NHS England have previously undertaken some data processing activities on behalf of CPRD, including linking CPRD patient identifiers to patients in the Intensive Care National Audit & Research Centre (ICNARC), data which are managed (collection and processing) by ICNARC, who is the data custodian (see https://cprd.com/cprd-linked-data). Recently NHS England have also linked data from University Hospitals Birminham (UHB) to the CPRD cohort. These UHB Electronic Health Record data comprise data from a number of different clinical systems held within the Data Controllership of UHB, that are not routinely transferred to NHS England, including prescribing systems (PICS), laboratory systems (Telepath), health record noting (PICS/Clinical Portal/Medisoft) and patient administrative system, Imaging modalities (e.g. XRay: MRI: CT: OCT: Retinal photography) and clinically relevant parameters (ECG and EEG)- some data types will have features extracted and stored as structured data. This data provides a more comprehensive view of the provision of healthcare to patients with multiple long-term health conditions. This data contains more detailed data on patients diagnoses including severity of diseases and prescribing of medications only initiated in secondary care'. In both of these cases, data flowed under Section 251 of the Health and Social Care Act and no NHS England data was released. There will be no linkage as a Trusted Third Party under this iteration of the agreement.
National Data Opt outs will be applied to the data prior to it being disseminated to CPRD.
Where individuals have opted out of disease registration by the National Disease Registration Service (NDRS), their data has been permanently removed from the registry and therefore will not be disseminated under this Data Sharing Agreement (DSA). https://digital.nhs.uk/ndrs/patients/opting-out
Expected output
Researchers using linked CPRD data will be producing research publications in peer-reviewed journals and presentations at scientific conferences on an ongoing basis. Target dates for expected outputs will vary by study but on average, publication of findings arising from approved research is expected between 3-4 years after data access. CPRD provides data to researchers in academic institutions, pharmaceutical companies, Governmental centres and research charities. While the typical output is publication in a peer-reviewed academic journal, other outputs may include reports submitted to medicines regulatory bodies or white papers. Some of the research findings may directly translate into clinical guidelines and public health policy.
A selection of recent publications resulting from use of CPRD linked data are presented below.
Pearson-Stuttard J, Cheng YJ, Bennett J et al. Trends in leading causes of hospitalisation of adults with diabetes in England from 2003 to 2018: an epidemiological analysis of linked primary care records. The Lancet Diabetes & Endocrinology, Volume 10, Issue 1, 2022. https://doi.org/10.1016/S2213-8587(21)00288-6
Rishi Caleyachetty, Thomas M Barber, Nuredin Ibrahim Mohammed, Francesco P Cappuccio, Rebecca Hardy, Rohini Mathur, Amitava Banerjee, Paramjit Gill. Ethnicity-specific BMI cutoffs for obesity based on type 2 diabetes risk in England: a population-based cohort study. The Lancet Diabetes & Endocrinology,
Volume 9, Issue 7, 2021. https://doi.org/10.1016/S2213-8587(21)00088-7 .
Ferguson R, Prieto-Alhambra D, Peat G, et al. Influence of pre-existing multimorbidity on receiving a hip arthroplasty: cohort study of 28 025 elderly subjects from UK primary care. BMJ Open 2021;11:e046713.
https://doi.org/10.1136/bmjopen-2020-046713 .
Clarke CS, Williamson E, Denaxas S On behalf of the MACRO programme team, et al. Observational retrospective study calculating health service costs of patients receiving surgery for chronic rhinosinusitis in England, using linked patient-level primary and secondary care electronic data. BMJ Open 2022;12:e055603. https://doi.org/10.1136/bmjopen-2021-055603 .
Roalfe A, Lay-Flurrie SL, Ordonez-Mena JM et al. Long term trends in natriuretic peptide testing for heart failure in UK primary care: a cohort study. European Heart Journal, ehab781. https://doi.org/10.1093/eurheartj/ehab781
Cadogan SL, Powell E, Wing K et al. Anticoagulant prescribing for atrial fibrillation and risk of incident dementia. Heart 2021;107:1898-1904.
http://dx.doi.org/10.1136/heartjnl-2021-319672
Outputs from the studies approved usually have research reports which are submitted to funders (such as the Medical Research Council). Some outputs may inform discussions with national programmes (such as NHS Cancer Screening Programmes and NHS Scotland), charities (such as Cancer Research UK) primary care professionals, policy makers and researchers. In many instances, the papers are also published and are available on Open Access journals. Many of the outputs are also presented at conferences (such as International Society for Pharmacoepidemiology). Many of the outputs have the capacity to not only influence the clinical community but also policy makers, for example clinical guidelines (see Oyinlola et al 2016, https://doi.org/10.1186/s12913-016-1562-8).
A comprehensive list of publications including those using linked data can be found at www.cprd.com/bibliography
Benefits reported
CPRD publish here https://cprd.com/approved-studies-using-cprd-data a register of all approved studies of which the detail on each study includes a lay and technical summary, the health outcomes to be measured and details on the organisations involved.
There are 3 case studies presented below highlighting how linked CPRD-NHS England data has supported public health research, especially in response to the COVID 19 effort in recent years. Research using linked CPRD data benefits patients in the UK indirectly by contributing to the evidence base for medicine and public health, which in turn informs public health policy, programmes and clinical guidelines.
Case study 1: Higher risks of flu and COVID-19 for cancer survivors (CPRD protocol 20_082).
Older individuals and people with certain health conditions are known to be at higher risk of severe illness if they contract viruses such as flu and COVID-19. This includes people who had certain cancers diagnosed recently and are receiving treatments like chemotherapy. In the UK there are more than two million cancer survivors. To investigate whether people who had cancer some time ago are also at higher risk from flu and COVID-19 a study was carried out using CPRD data. CPRD GOLD was linked to Hospital Episode Statistics Admitted Patient Care (HES APC) database, cancer registrations from the National Cancer Registration and Analysis Service (NCRAS), death registrations from the Office of National Statistics mortality database, and postcode-based index of Multiple Deprivation data. Researchers found that survivors from a wide range of cancers are more likely than people in the general population to be hospitalised or die from flu, even several years after their cancer diagnosis. The raised risks were most likely for blood cancer survivors. Because flu and COVID-19 are both respiratory viruses, this suggested that cancer survivors also have a higher risk of severe COVID-19. The study also showed that cancer survivors were more likely to have other diseases that are associated with increased risk of severe COVID-19, such as heart disease, diabetes, respiratory disease and kidney disease. The findings support the UK policy recommendation to include all blood cancer survivors as one of the priority groups to receive the COVID-19 vaccination. The study findings could also support any work by others to prioritise vaccinations and treatments for longer-term cancer survivors.
Reference 1: Carreira H, Strongman H, Peppa M, McDonald H, dos-Santos-Silva I, Stanway S, Smeeth L, Bhaskaran K. Prevalence of COVID-19-related risk factors and risk of severe influenza outcomes in cancer survivors: a matched cohort study using linked UK electronic health records data. EClinicalMedicine, Volume 29, 100656, December 2020. https://doi.org/10.1016/j.eclinm.2020.100656
https://cprd.com/protocol/covid-19-related-risks-cancer-survivors-matched-cohort-study-using-linked-uk-electronic
Case study 2: Vaccine uptake in pregnancy
Vaccination is an effective way to prevent infectious diseases. However, people with certain social characteristics – such as those living in more deprived areas – may be less likely to receive vaccination. Addressing inequalities in vaccine uptake to prevent infections is a key priority for public health. This cohort study examined the social factors that may be associated with lower uptake of flu vaccine and whooping cough vaccine by pregnant women. It considered a range of social determinants including maternal age, ethnicity, socioeconomic status, number of children in the household and region. The study used linkages between CPRD data, the CPRD GOLD Pregnancy Register, Hospital Episode Statistics (HES) and Office of National Statistics (ONS) small-area-level deprivation data.
The researchers concluded that more targeted campaigns have the potential to reduce vaccine-preventable disease among infants and pregnant women, and to reduce health inequalities. Identifying social factors that are associated with lower vaccination rates could help to design programmes to improve vaccine uptake for specific groups of individuals.
Reference 2: Walker et al. Social determinants of pertussis and influenza vaccine uptake in pregnancy: a national cohort study in England using electronic health records. BMJ Open 2021;11:e046545. https://doi.org/10.1136/bmjopen-2020-046545
https://cprd.com/protocol/social-determinants-uptake-maternal-influenza-and-pertussis-vaccine
Case study 3: Health of mothers of children with a life-limiting condition
More than 86,000 children and young people in England are now living with medical conditions that may ultimately shorten their life and cause death in childhood or young adulthood. Mothers of children with a severe health condition or whose child has died are more likely themselves to die earlier than other mothers.
The lack of studies quantifying the mental health of mothers of children with a life-limiting condition has been highlighted by the National Institute for Health and Care Excellence. In this first part of a larger research programme, researchers used CPRD data to investigate the types of physical and psychological health conditions diagnosed in mothers of children with a life-limiting condition. The CPRD GOLD Pregnancy Register was used to link mothers and their children's healthcare data. The study also used linkages to Hospital Episodes Statistics (HES), Mental Health Minimum Dataset (MHMDS) and Office for National Statistics (ONS) death certificate data.
The study concluded that mothers of children with life-limiting conditions have much higher rates of physical health problems, mental illness, and death. These findings were flagged as an ‘Alert’ for important research by the NIHR. Prior to this study, little research had explored the health of this group of women. Knowing more about the health problems that the women experience could help in the design of specific healthcare interventions.
Reference 3: Fraser et al. Health of mothers of children with a life-limiting condition: a comparative cohort study. Archives of Disease in Childhood 2021;106:987-993. http://dx.doi.org/10.1136/archdischild-2020-320655
https://cprd.com/protocol/life-limiting-conditions-health-children-and-their-mothers
NIHR Evidence - Mothers of children with life-limiting conditions are at risk of serious health problems - Informative and accessible health and care research https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fevidence.nihr.ac.uk%2Falert%2Fchildren-life-limiting-conditions-mothers-more-likely-to-die%2F%3Futm_source%3DNIHR%2Bmailing%2Blist%26utm_campaign%3Dc836e7227e-NEWS_RESEARCH_26_8_2021_COPY_01%26utm_medium%3Demail%26utm_term%3D0_570d86f9cb-c836e7227e-33120976&data=04%7C01%7CRhian.Hortin%40mhra.gov.uk%7Ceeaa93de1cb4421aafec08d9b0242f33%7Ce527ea5c62584cd2a27f8bd237ec4c26%7C0%7C0%7C637734491713613980%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=TKPdVHwcavrPA3jVYfUKdqC0ds9O2bgjo6GzYGJAk34%3D&reserved=0
CPRD have not received any updated data from NHS England for a significant number of months due to technical data production work which has delayed data dissemination as a result yielded benefits can only be provided on the use of the data which they have held historically.
DARS-NIC-15625-T8K6L-v12.6 22 December 2022 to 31 December 2023
- Title
- R23 - Clinical Practice Research Datalink (CPRD) Routine Linkages Application
- Commercial
- No
- Sublicensing
- Yes
- Datasets
- 23
- Files released
- 0
Datasets: Bridge file: Hospital Episode Statistics to Diagnostic Imaging Dataset; Bridge file: Hospital Episode Statistics to Mental Health Minimum Data Set; Civil Registrations of Death; COVID-19 Hospitalization in England Surveillance System; COVID-19 SGSS First Positives (Second Generation Surveillance System); CPRD/UHB linkage file (pseudonymised data only); Diagnostic Imaging Data Set (DID); Emergency Care Data Set (ECDS); HES-ID to MPS-ID HES Accident and Emergency; HES-ID to MPS-ID HES Admitted Patient Care; HES-ID to MPS-ID HES Outpatients; HES:Civil Registration (Deaths) bridge; Hospital Episode Statistics Accident and Emergency (HES A and E); Hospital Episode Statistics Admitted Patient Care (HES APC); Hospital Episode Statistics Critical Care (HES Critical Care); Hospital Episode Statistics Outpatients (HES OP); Maternity Services Data Set (MSDS) v2; Medicines dispensed in Primary Care (NHSBSA data); Mental Health and Learning Disabilities Data Set (MHLDDS); Mental Health Minimum Data Set (MHMDS); Mental Health Services Data Set (MHSDS); MRIS - Bespoke; Patient Reported Outcome Measures (Linkable to HES)
What changed from DARS-NIC-15625-T8K6L-v11.2
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2022-12-22 | |
| End date | 2023-12-31 | |
| Bridge file: Hospital Episode Statistics to Diagnostic Imaging Dataset: legal basis | Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'. | |
| Bridge file: Hospital Episode Statistics to Mental Health Minimum Data Set: legal basis | Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'. | |
| COVID-19 Hospitalization in England Surveillance System: legal basis | Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'. | |
| COVID-19 SGSS First Positives (Second Generation Surveillance System): legal basis | Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'. | |
| CPRD/UHB linkage file (pseudonymised data only): legal basis | Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'. | |
| Diagnostic Imaging Data Set (DID): legal basis | Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'. | |
| Emergency Care Data Set (ECDS): legal basis | Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'. | |
| HES-ID to MPS-ID HES Accident and Emergency: legal basis | Health and Social Care Act 2012 - s261(5)(d) | |
| HES-ID to MPS-ID HES Admitted Patient Care: legal basis | Health and Social Care Act 2012 - s261(5)(d) | |
| HES-ID to MPS-ID HES Outpatients: legal basis | Health and Social Care Act 2012 - s261(5)(d) | |
| HES:Civil Registration (Deaths) bridge: legal basis | Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'. | |
| Hospital Episode Statistics Accident and Emergency (HES A and E): legal basis | Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'. | |
| Hospital Episode Statistics Admitted Patient Care (HES APC): legal basis | Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'. | |
| Hospital Episode Statistics Critical Care (HES Critical Care): legal basis | Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'. | |
| Hospital Episode Statistics Outpatients (HES OP): legal basis | Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'. | |
| MRIS - Bespoke: legal basis | Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'. | |
| Mental Health Minimum Data Set (MHMDS): legal basis | Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'. | |
| Mental Health Services Data Set (MHSDS): legal basis | Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'. | |
| Mental Health and Learning Disabilities Data Set (MHLDDS): legal basis | Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'. | |
| Patient Reported Outcome Measures (Linkable to HES): legal basis | Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'. |
Datasets:
+ Civil Registrations of Death; + MSDS (Maternity Services Data Set) v2.0; + Medicines dispensed in Primary Care (NHSBSA data) · − Civil Registrations of Death - Secondary Care Cut
Objective for processing
The controller for GDPR purposes is the Department of Health and Social Care (DHSC); the legal signatory for this agreement (and for the overarching
Data Sharing Framework Contract -
DSFC) is the Secretary of State for Health and Social Care (acting as part of the Crown), acting through the Clinical Practice Research Datalink
centre
(hereinafter referred to as CPRD) within the Medicines and Healthcare products Regulatory Agency
(MHRA)
(the agency); and the licensee is CPRD, not the wider DHSC nor the agency.
The Clinical Practice Research Datalink (CPRD) is a
centre of
specialist health data research service provided by
the Medicines and Healthcare products Regulatory Agency (the agency), an executive agency
[19 words unchanged]
transfusion in the UK and the agency acts as the Executive agency.
The Clinical Practice Research Datalink (CPRD) is a government not for profit research
organisation, jointly supported
service delivered
by the Medicines and Healthcare products Regulatory Agency (MHRA)
and
with support from
the National Institute of Health
and Care
Research (NIHR),
supplying anonymised
that provides access to pseudonymised
health data for studies to safeguard and improve patient and public health.
[14 words unchanged]
delivery, drug safety, effectiveness of medicines and risk factors for disease. The
linked
data supplied by NHS Digital and
released
shared
by CPRD under the NHS Digital sub-licence can only be used for public health research purposes in accordance with Article 6(1)(e) and Article 9(2)(j).
Research using CPRD data has resulted in over
2,400
3,000
peer-reviewed publications, which have informed drug safety guidance and best clinical practice.
[44 words unchanged]
the users and uses of CPRD data is published on the CPRD
website.
website https://www.cprd.com/protocol-list.
CPRD’s research and data services are based on a
database of de-identified
sharing data which are effectively anonymised once given to the researcher from
longitudinal primary care records contributed by participating GP practices from the four UK nations. Approval to supply
anonymised
data for public health research is granted on an annual basis by the East Midlands and Derby Research Ethics Committee
(REC).
(Database REC reference 21/EM/0265). the data held by CPRD
CPRD provides
researchers under sublicense agreements
access to
effectively
anonymised primary care data linked to secondary health care
datasets.
datasets for both observational research and to supplement clinical trial data.
Linked data greatly increases the scale, depth, completeness and value of data available for public health
and clinical
research.
Linked data are also used to assess study feasibility and create lists of eligible patients who could potentially be included in clinical trials. In addition, linked data are used by CPRD to generate derived fields that improve the quality of the primary care data for e.g., ethnicity records.
The outputs of such research based on linked data inform clinical guidance and best practice for patients in the UK.
The CPRD Research Data Governance (RDG) review process includes lay reviewers. Applications that include non-standard elements that deviate from precedent will be assigned to lay reviewers. In addition, a sample of all applications is reviewed by the independent Central Advisory Committee (CAC) which includes lay representatives as part of CPRD’s assurance process.
Secondary healthcare datasets are provided by NHS Digital
and other data custodians
and these data are linked to the primary care data by NHS
[5 words unchanged]
to enable them to carry out this linkage as described below in
section 3, according to the method described used for this linkage is described in the following paper: Padmanabhan S, Carty L, Cameron E, Ghosh RE, Williams R, Strongman H. Approach to record linkage of primary care data from Clinical Practice Research Datalink to other health-related patient data: overview and implications. Eur J Epidemiol, 15 Sep 2018, 34(1):91-99.
5b processing activities.
Continued support is given by Confidentiality Advisory Group (CAG) for the flow of identifiers to NHS Digital to enable linkage of CPRD primary care data to secondary
datasets.
datasets (CAG reference 21/CAG/0008).
[2 paragraphs unchanged]
NHS Digital has been providing and linking health-related datasets to CPRD primary
[40 words unchanged]
encompasses Admitted Patient Care, Critical Care, Outpatient and Accident & Emergency data;
Patient Reported Outcome Measures (PROMs);
Diagnostic Imaging Dataset (DID);
Mental Health data;
and Critical Care data (supplied as a separate dataset by NHS Digital but integrated with Admitted Patient Care). CPRD primary care data are also linked with the National Disease Registration Service
National Cancer
Registry; National Asthma
Registry data, the Second Generation Surveillance System (SGSS) data (specifically the COVID-19 test result data, including future serological testing as well as current antigen testing)
and
COPD Audit Programme (NACAP) audit data, Deprivation
COVID-19 Hospitalisation in England Surveillance System (CHESS). NHS Digital also supply Lower Layer Super Output Area based on patient postcode, to enable linkage to deprivation
data including Townsend Score and Index of Multiple Deprivation.
Critical care is supplied as a separate dataset by NHS Digital, but is integrated with Admitted Patient Care.
CPRD also link with the following datasets:
Research using CPRD data and services informs clinical guidance and best practice related to drug safety, use of medicines, effectiveness of health policy, health care delivery and disease risk factors. Similarly, the primary care and linked HES data would permit research which would expand understanding about patient access to health services across the patient care pathway and the need for wider care of patients and vulnerable groups as a direct or indirect result of COVID-19 and the availability and capacity of those services or that care.
1) PHE’s Second Generation Surveillance System (SGSS) data (specifically the COVID-19 test result data, including future serological testing as well as current antigen testing)
Patient and Public Involvement and Engagement (PPIE)
and
For all GP Practices who participate in the CPRD research CPRD reach out to join the individual Practice PPIE groups. In 2021 The Primary Care Recruitment Team at CPRD attended and presented at two Public
2) PHE’s COVID-19 Hospitalisation in England Surveillance System (CHESS); both datasets are already held by NHSD.
Patient Group (PPG) meetings. One meeting covered a network of 8 practices in Liverpool area and the other was a practice PPG meeting in Kent and Medway area. Another three practice PPG meetings took place between Jan 2022 and April 2022 in Barking London, Sunderland and Bristol. Another PPIE workshop is planned to take place in late 2022.
Research using CPRD data and services informs clinical guidance and best practice related to drug safety, use of medicines, effectiveness of health policy, health care delivery and disease risk factors. With respect to COVID-19, and as per Regulation 3(1) of the COVID-19 notice, research using the linked CPRD primary care and COVID-19 SGSS/CHESS data would enable researchers to understand COVID-19 and risks to public health, trends in COVID-19 and COVID-19 risk factors, to inform the control and prevention of the spread of COVID-19. Linkage of the COVID-19 testing data to patient medical histories available in CPRD primary care databases would facilitate the identification and understanding about patients or potential patients with, or at risk of COVID-19, about incidents of patient exposure to COVID-19 and the management of patients with or at risk of COVID-19, including real world monitoring of such patients, and longitudinal collection of information about efficacy of treatment, medical and social interventions and recovery from COVID-19.
TRUSTED THIRD PARTY DATA LINKAGE
Similarly, the primary care and routinely linked HES data would permit research which would expand CPRDs understanding about patient access to health services and the need for wider care of patients and vulnerable groups as a direct or indirect result of COVID-19 and the availability and capacity of those services or that care.
NHS Digital have previously undertaken some data processing activities on behalf of CPRD, including linking CPRD patient identifiers to patients in the Intensive Care National Audit & Research Centre (ICNARC), data which are managed (collection and processing) by ICNARC, who is the data custodian (see https://cprd.com/cprd-linked-data). Recently NHS Digital have also linked data from University Hospitals Birminham (UHB) to the CPRD cohort. These UHB Electronic Health Record data comprise data from a number of different clinical systems held within the Data Controllership of UHB, that are not routinely transferred to NHS Digital, including prescribing systems (PICS), laboratory systems (Telepath), health record noting (PICS/Clinical Portal/Medisoft) and patient administrative system, Imaging modalities (e.g. XRay: MRI: CT: OCT: Retinal photography) and clinically relevant parameters (ECG and EEG)- some data types will have features extracted and stored as structured data. This data provides a more comprehensive view of the provision of healthcare to patients with multiple long-term health conditions. This data contains more detailed data on patients diagnoses including severity of diseases and prescribing of medications only initiated in secondary care'. In both of these cases, data flowed under Section 251 of the Health and Social Care Act and no NHS Digital data was released. There will be no linkage as a Trusted Third Party under this iteration of the agreement.
The linkage has been permitted by PHE and should be conducted under the recent Coronavirus (COVID-19) notices under reg 3(4) of the Health Service Control of Patient Information Regulations 2002 which allows the regulation 3 surveillance data’s ‘confidential patient information to be processed… for a COVID-19 Purpose… in accordance with regulation 7’ for research purposes. The general COPI notice covers the provision and use of GP identifiers while the NHSD-specific COPI notice would cover the provision and use of the relevant identifiers from SGSS/CHESS for the linkage; the NHSD COPI notice would also cover the actual linkage process of the two streams of identifiers for the purposes of COVID-19 research – as is the case here. The release of the linker file and the associated anonymised clinical data to CPRD does not involve confidential patient information (CPI).
CPRD also links data with the ICNARC CMP data which are managed (collection and processing) by ICNARC, who is the data custodian.
The Intensive Care National Audit and Research Centre (ICNARC) Case Mix Programme (CMP) data has been added to CPRD’s master dataset list (support given by HRA CAG in June 2020) for linkage on an ongoing basis. ICNARC also have support to process confidential patient information for the Case Mix Programme.
This will include research questions that seek to study serious outcomes of disease involving admission to critical care or longer-term outcomes of interventions in intensive care. The linked data will allow studies which need information on risk factors, treatments or longer-term outcomes that are recorded in the primary care data as well as treatments and outcomes recorded in critical care. For instance, survival models can be developed to describe the association between key pre-morbid clinical factors (e.g. sociodemographics, comorbidities, prescribing, other clinical factors) and outcomes relating to critical care admission, critical care survival, and length of critical care stay.
AMENDMENT REQUEST
CPRD would like NHS Digital to act as a Trusted Third Party for data linkage to link GP System data (as supplied by CPRD) to the following datasets which will be sent to NHS Digital by University Hospital Birmingham NHS Foundation Trust (UHB):
• Secondary care data (including demographics, diagnoses, prescriptions, procedures and clinical investigations) for the Birmingham and Solihull Sustainability and Transformation Partnership (STP)
• Screening data from the Birmingham Solihull and Black Country Diabetic Eye Screening Service (BSBCDESS).
These UHB Electronic Health Record data comprise data from a number of different clinical systems held within the Data Controllership of UHB, that are not routinely transferred to NHS Digital, including prescribing systems (PICS), laboratory systems (Telepath), health record noting (PICS/Clinical Portal/Medisoft) and patient administrative system, Imaging modalities (e.g. XRay: MRI: CT: OCT: Retinal photography) and clinically relevant parameters (ECG and EEG)- some data types will have features extracted and stored as structured data. This data provides a more comprehensive view of the provision of healthcare to patients with multiple long-term health conditions. This data contains more detailed data on patients diagnoses including severity of diseases and prescribing of medications only initiated in secondary care.
Both data sources have been added to CPRD’s master dataset list (CAG Section 251 support given January 2019) for linkage on an ongoing call off basis. University Hospitals Birmingham NHS Foundation Trust (UHB) is the data custodian for these data sources.
Processing activities
In summary,
NHSD receive, process and link Identifiable data directly from participating General Practices (GPs) under the CAG section 251 approval
NHSD release Pseudonymised data to CPRD
CPRD hold pseudonymised data
CPRD release data to researchers and that data is rendered effectively anonymised
[1 paragraph unchanged]
Protecting patient confidentiality is paramount to CPRD. A number of processes and
[32 words unchanged]
and multiple pseudonymisation, and governance and scrutiny on approvals to use linked
data.
data .
The CPRD Policy for 'Anonymisation and Managing the Risk of Identification in
[18 words unchanged]
research purposes and complies with the Information Commissioner's Office (ICO) Code on
Anonymisation and with Office of National Statistics (ONS) requirements on use of death registration data (last reviewed in 2020).
Anonymisation:
1) Data
Collection
Linkage
[2 paragraphs unchanged]
Data collections are received by CPRD securely through an N3 link and standard secure File Transfer Protocol (SFTP). Data arrives as a series of incremental collections of data from practices that have agreed to share data with CPRD. Data collections, once received, are checked for content (data structure and format), completeness (presence of key and optional data files) and continuity. The collection is then archived. Details of each data collection are logged to an administrative database, and data is made available for processing.
Database creation or a build process is undertaken on a monthly basis by taking a snapshot of the fully processed data and organising it into a structure which enables tools to query and extract the data for use in observation and interventional research studies.
CPRD retains the data collected up to the point that a GP Practice withdraws from participation. This is to ensure that CPRD can create (if needed) datasets, say, for validation of previous research, or for longitudinal studies. Patient opt-outs remain respected from the point of notification to CPRD.
[1 paragraph unchanged]
CPRD does not release the same linked data to external researchers that it receives from NHS Digital.
The changes made in between data receipt and release are termed ‘data transformation’.
This is done to protect patient confidentiality, and also to better facilitate relevant research.
Transformation involves removing the provider codes
provided
supplied
by NHS Digital. Data provided by CPRD is matched to the
former Strategic Health Authority (SHA) boundaries. It is
Office for National Statistics (ONS) Region boundaries
based on matching the address of the GP practice to the
SHA.
ONS region.
This ‘blurs’ the link between hospital activity records and other potential identifiers
[5 words unchanged]
date of death and ethnicity). For example, transformation of the CPRD linked
HES
Hospital Episode Statistics
Admitted Patient Care
(APC)
(HES APC)
data involves:
(i) The encrypted HES_id
(now MPS_tokenised_id)
field provided to CPRD by NHS Digital is not released to customers. CPRD creates a pseudonym linked to a unique patient activity record in the HES data.
[10 paragraphs unchanged]
(iv) Transformation of the linked data to a common data model (CDM) format (for e.g., the Observational Medical Outcomes Partnership (OMOP) CDM or Sentinel CDM) for the purposes of data standardisation to enable federated analyses and the use of rapid analytics tools like the OMOP Atlas analytical tools.
[1 paragraph unchanged]
CPRD has agreed pseudonymisation processes with each GP EHR system provider as well as
the Trusted Third Party
NHS Digital
used for data linkage. The overarching process for patient data pseudonymisation comprises the following stages to protect patient confidentiality at all times:
(i) GP system provider - the provider replaces the patient identifiers
(e.g
(for e.g.,
NHS number) in each patient record with a system patient key before its secure transfer to CPRD.
(ii) CPRD - on collection of the patient EHR data, CPRD replaces the original data source patient and practice keys from the GP system provider with a CPRD
patient and practice
pseudonym.
(iii) Data linkage -
where this is
undertaken by
the Trusted Third Party (TTP) (using patient identifiers sent directly from GPs),
NHSD,
all linked patient record data are pseudonymised by the TTP before release to CPRD.
Similarly, where cancer registry data is received by CPRD from Public Health England (PHE) for linkage, PHE pseudonymises patient data before release to CPRD.
(iv) Data release
-
– a subset of
the linked data
(as appropriate for any given study)
is
cut
extracted
by CPRD to minimise data ultimately
released to
shared with
third-party researchers (under a sub-licence agreement), where the linked patient key may be replaced again by a different patient key at release where
required,
required (double pseudonymisation),
establishing yet another layer of separation.
[2 paragraphs unchanged]
4) Data
use
Governance
Researchers must gain approval for their study protocol requesting access to linked data, from the Independent Scientific Advisory Committee for MHRA Database Research (ISAC). ISAC's role is to determine whether a research proposal is of public health value, will be conducted by researchers with the appropriate level of expertise, highlight if an ethical or confidentiality issues may arise in the proposed research, and to consider the scientific merit of the proposed methods and overall study. Approved applications to ISAC are published on the CPRD website www.cprd.com/protocol-list
Researchers must gain approval for their study protocol requesting access to linked data, from CPRD Research Data Governance (RDG) process. CPRD’s data governance process except for the purpose of feasibility counts or cohort definitions which are conducted within CPRD’s Trusted Research Environment. The RDG process includes the following:
5) Data release
a) Review of research applications to ensure they meet research data governance requirements (for all relevant data controllers) including risks to confidentiality
b) Possible further re-pseudonymisation of the linked data to minimise the risk of disclosure
c) Follow-up with researchers to ensure the linked data are securely destroyed at the end of the study contract period unless covered by an appropriate dataset retention period extension approval
More information on governance can be found https://cprd.com/Data-access
5) Data release and Access Management
[1 paragraph unchanged]
6)
Release of patient level linked data to third-party researchers will only occur after:
a)
ISAC
RDG
approval has been obtained and any other approvals
(e.g
(e.g.,
Research ethics committee if required);
b) Data has been risk assessed in accordance with CPRD's Policy for 'Anonymisation and Managing the Risk of Identification in Observational
Research';
Research'
c) Additional requirements on anonymisation relating to Civil Registration data have been met (see below);
c) Researchers must sign a data licence agreement defining terms of use relating to secure access, retention and destruction of the data; and
d) Researchers are provided with robust contracts defining terms of use relating to secure access, retention and destruction of the data; and
d) Access to data provided by CPRD which is sub-licensed having been provided by NHS Digital, is done under terms agreed with NHSD
e) Access to data provided by CPRD which is sub-licensed having been provided by NHS Digital, the Office for National Statistics or by any other Data Controller or Custodian, is done so under terms compatible with the terms under which data is provided to CPRD.
With regard to release of Civil Registration data:
• Civil Registration data provided by NHS Digital is stored separately by CPRD and interrogated on a case by case basis to assess the scientific value of research applications;
• Sub-national geographic data are not provided to researchers without additional review and approvals from ISAC and where relevant, HRA CAG;
• As standard, CPRD matches each GP practice postcode to a larger geographical area aligned with the historical NHS Strategic Health Authority boundaries, ensuring an underlying population size of at least two million people. The GP practice postcode, hospital or other institutional identifier are not released;
• The ISAC review includes a risk assessment of patient re-identification. If appropriate, research applicants are required to outline risk mitigation plans;
• CPRD’s policy for 'Anonymisation and Managing the Risk of Identification in Observational Research' sets out CPRD’s policy for the release and publication of data relating to small cell counts;
• Restrictions on the number of stratified analyses are imposed in the case of research proposals investigating rare diseases or treatments, to minimise the risk of re-identification;
• ISAC approvals only allow exact dates of death where there is a clear benefit to public health from the proposed research;
• Researchers are also contractually bound to maintain patient anonymity and prevent inadvertent re-identification of patients.
In accordance with guidance from the Information Commissioner's Office (ICO), CPRD does not permit personal data to be processed outside its own servers, and hence any such data is retained within the EU.
6) Data Access Management
[1 paragraph unchanged]
Sungard/Crown Hosting Datacentres are
Microsoft Azure Cloud is
recorded as data storage addresses as for the purposes of this application.
Sungard
Microsoft Azure
is the primary data centre store and is considered to be the initial back-up and recovery.
They
Microsoft
are not involved in processing of the data in any way
(Sungard
(they only
provide a facilities management and site management service). CPRD has confirmed that
neither Crown Hosting nor Sungard
Microsoft do not
have access to the server (neither administrative nor user rights).
6) Provision of linked data to supplement clinical trial data
CPRD’s clinical trial services use pseudonymised CPRD primary care data to create lists of potentially eligible patients that meet approved trial protocol inclusion and exclusion criteria. These lists of pseudonymised patients (with the standard CPRD pseudonymised patient IDs removed) are screened by GPs who obtain consent and randomise patients into the trial. Consented patients are then followed up for a trial protocol specified period of time through the linkage of their Primary and /or linked data. At pre-specified time points (for example - 1 year after first patient is recruited and/or 3 years after the last patient is randomised) CPRD may be requested to provide linked data to supplement the specifically collected clinical trial data. In these instances, there is no need for the flow of identifiers to NHSD for further linkage and CPRD will process the data using the standard CPRD pseudonymised patient IDs to create a trial dataset containing trial information from IRSP, primary care and linked data variables needed for the trial. In these scenarios, linked data will only be provided for Health Research Authority (HRA) Research Ethics Committee (REC) approved, consented patient studies where patients have explicitly consented for the study team to access linked NHSD data by name for the purpose of measuring clinical trial outcomes and adverse outcomes. Any scenarios involving the flow of identifiers to NHSD for the purpose of further linkage are outside the scope of this agreement and will be subject to a separate study-specific DARS application.
[2 paragraphs unchanged]
CPRD operates to a high level to ensure that when data is transmitted and/or stored it is done so in a way that protects the data.
All
The
data
in
centres where
CPRD
data
is stored
in a 'Tier 3' data centre that
is compliant with Government standards to operate in a way that meets
[12 words unchanged]
are always under review and are subject to audit. Security measures include:
[6 paragraphs unchanged]
Data destruction standards (currently, NHS Digital ’Destruction and Disposal of Sensitive Data’ guidelines v3.2) have been implemented in MHRA
via use of a Blancco LUN Eraser tool, to guarantee that sensitive
whereby all
data is
properly erased
physically destroyed to National Insttitute of Standards
and
sanitised securely and permanently.
Technology (NIST) 800-88, so no media ever leaves the datacentre, each facility has its own crushing machine so all media is reduced to dust before leaving the datacenters.
This
tool
ensures compliance with industry standards and regulations, including
PCI DSS, HIPAA, SOX, ISO 27001 and the EU General Data Protection Regulation.
International Organisation for Standardisation (ISO) 27001.
[2 paragraphs unchanged]
The default minimum standard for encryption will be
AES
Advanced Encryption Standard (AES)
256 using a complex pass-phrase consisting of 8 characters and a mix of upper case, lower case, numeric and special characters.
[3 paragraphs unchanged]
NHS Digital permits CPRD sub-licensees to share data with third parties subject
[16 words unchanged]
terms, checks and controls carried out by CPRD in relation to sub-licences.
Details of such licences will be published and shared with NHS Digital.
[2 paragraphs unchanged]
Applicants must provide a detailed protocol for assessment and approval
by ISAC
through the RDG process
(as previously detailed). CPRD routinely checks new publications using CPRD data to ensure concordance with the
ISAC
RDG
approved
protocol. For
protocol for
example,
that
research team members accessing the data
were detailed
are named
in the Protocol (or noted in an amendment),
and
that the processing is within the scope of the aims and methodology
[8 words unchanged]
not been undertaken at locations other than those declared in the protocol.
To date there has been full alignment
There is also a CPRD client audit programme which aims to audit 6 clients per year to ensure compliance
with
the publication and the approved protocols for linked data supplied by NHS Digital .
licence terms.
12)
Sub-licence
CPRD onwardly shares data with third-parties potentially worldwide under sub-licence arrangements only where that data cannot be given directly to the third-party by NHS Digital. CPRD assesses the re-identification risk and applies data minimisation techniques as required to ensure re-identification is not possible by means reasonably likely to be used. Any requests for NHS Digital data only would be referred by CPRD directly to NHS Digital.
The agreements by which CPRD shares NHS Digital data with a third-party organisations include all terms of the agreement between NHS Digital and CPRD. The agreements by which CPRD shares NHS Digital data with a third-party organisations include all terms of the agreement between NHS Digital and CPRD. Third-parties are typically, UK academic institutions (69%), research organisations (25%), or life science companies (6%). Figures of releases from financial yesr (FY) 21/22 which also gave the geographical split as: UK (78%), EU/EEA (9%) Non UK/EU/EEA (13%) There were a total of 847 linked data releases in the financial year 21/22.
The agreements by which CPRD shares NHS Digital data with a third-party include all terms of the agreement between NHS Digital and CPRD. Third-parties are typically, academic institutions (73%), research organisations (12%), government departments involved in healthcare or medicines regulation (1%), or life science companies (15%). Figures from a sample based on releases in July 2018, which also gave the geographical split as: UK (71%), EU/EEA (12%), Overseas (17%).
Any organisation which is commercial in its nature or has a commercial purpose must demonstrate clearly to CPRD that their request is connected with the provision of health care or adult social care, or the promotion of health. No requests are approved for data where the purpose is for marketing purposes, including promoting or selling products or services, market research or advertising. Any commercial organisation who receives data from CPRD via Sublicense must demonstrate clearly that its commercial interests are proportionately balanced with the benefits to the health and social care system and to the interests of the data subjects.
[2 paragraphs unchanged]
CPRD only releases NHS Digital data to third-parties which must have undergone the New Client Vetting process
https://www.cprd.com/sites/default/files/CPRD%20New%20Client%20request%20form_V3_1.doc (or www.cprd.com/Data-access)
(see ‘New client or funder request for access to CPRD data’ on our webpage www.cprd.com/Data-access
to ensure they are appropriate data recipients) under sub-licence after an
Independent Scientific Advisory Committee (ISAC) review
RDG approval
for health-related research.
The GDPR legal basis for all current release is 6(1)(e) Public interest
[13 words unchanged]
12 months at a time and then extended if retention is justified.
All data
Data are
shared under
sub-licence arrangements are anonymised.
a sublicence agreement after they have been subject to anonymisation measures to mitigate the risk of re-identification of individuals by means reasonably likely to be used to low. CPRD was subject to a remote data sharing audit by NHS Digital (NHSD) and the Office of National Statistics (ONS) between April and July 2022. CPRD was audited against the data sharing framework contract (DSFC) CON-325063-H0M5Y-v2.01 and the data sharing agreement (DSA) DARS-NIC-15625-T8K6L-v11.2. The audit did not identify any non-conformities, observations, or outstanding information, and categorised the risk of re-identification of individuals as “Low”; the lowest possible category.
CPRD has a searchable online register of all
ISAC
RDG
approved studies data releases by CPRD including NHS Digital linked data. The register is online at www.cprd.com/protocol-list
[1 paragraph unchanged]
In response to the coronavirus outbreak, CPRD is expediting processing of protocols relating to COVID-19 research, with a turn-around for initial ISAC review of 3-5 working days. In keeping with European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) guidelines to support the sharing of information on performed or planned studies and increase the efficiency of research, all expedited ISAC protocols will include ‘COVID-19’ in the title, and transparencies related to COVID-19 applications are being published on the CPRD website within 72 hours of approval.
Only research which aligns with the objective for processing as described in the objectives for processing will be reviewed as relating to COVID-19 research, and only those securing ISAC approval will be able to receive the CPRD-linked COVID-19 SGSS/CHESS data via sub-licence.
AMENDMENT REQUEST
The linkage will be conducted as indicated in steps 1-10 as detailed above. Where NHSD will receive identifiers from UHB (Date of Birth, NHS Number and Study Key) for the Secondary care data and the screening data types and will link the identifiers it receives from GP system providers for CPRD data. NHSD will then provide a bridging file back to CPRD to enable linkage of de-identified coded data.
Expected output
CPRD customers
Researchers
using linked
CPRD
data
products
will be producing
(on an ongoing basis)
research publications in peer-reviewed journals and presentations at scientific
conferences.
conferences on an ongoing basis. Target dates for expected outputs will vary by study but on average, publication of findings arising from approved research is expected between 3-4 years after data access.
CPRD
customers include
provides data to researchers in
academic institutions, pharmaceutical companies, Governmental centres and research charities.
These all undertake medical
While the typical output is publication in a peer-reviewed academic journal, other outputs may include reports submitted to medicines regulatory bodies or white papers. Some of the research findings may directly translate into clinical guidelines
and
public
health
data research, which may result in formal publications.
policy.
All data included in such outputs by CPRD customers will be aggregated, with small numbers suppressed in line with the HES Analysis Guide (or dataset specific suppression controls).
A selection of recent publications resulting from use of CPRD linked data are presented below.
A selection of publications resulting from use of CPRD linked data are presented below.
Pearson-Stuttard J, Cheng YJ, Bennett J et al. Trends in leading causes of hospitalisation of adults with diabetes in England from 2003 to 2018: an epidemiological analysis of linked primary care records. The Lancet Diabetes & Endocrinology, Volume 10, Issue 1, 2022. https://doi.org/10.1016/S2213-8587(21)00288-6
Akyea RK, Kai J, Qureshi N, Iyen B, Weng SF. Sub-optimal cholesterol response to initiation of statins and future risk of cardiovascular disease. Heart, 2019; 105:975-981.
Rishi Caleyachetty, Thomas M Barber, Nuredin Ibrahim Mohammed, Francesco P Cappuccio, Rebecca Hardy, Rohini Mathur, Amitava Banerjee, Paramjit Gill. Ethnicity-specific BMI cutoffs for obesity based on type 2 diabetes risk in England: a population-based cohort study. The Lancet Diabetes & Endocrinology,
Abel KM, Hope H, Swift E, Parisi R, Ashcroft DM, Kosidou K, Osam CS, Dalman C, Pierce M. Prevalence of maternal mental illness among children and adolescents in the UK between 2005 and 2017: a national retrospective cohort analysis. Lancet Public Health, vol. 4, pp. e291-e300, 2019.
Volume 9, Issue 7, 2021. https://doi.org/10.1016/S2213-8587(21)00088-7 .
Crellin E, Mansfield KE, Leyrat C, Nitsch D, Douglas IJ, Root A, Williamson E, Smeeth L, Tomlinson LA. Trimethoprim use for urinary tract infection and risk of adverse outcomes in older patients: cohort study. BMJ. 2018 Feb 9;360:k341.
Ferguson R, Prieto-Alhambra D, Peat G, et al. Influence of pre-existing multimorbidity on receiving a hip arthroplasty: cohort study of 28 025 elderly subjects from UK primary care. BMJ Open 2021;11:e046713.
Morgan C, Webb RT, Carr MJ, Kontopantelis E, Green J, Chew-Graham CA, Kapur N, Ashcroft DM. Incidence, clinical management, and mortality risk following self harm among children and adolescents: cohort study in primary care. BMJ, Volume 359, p.j4351 (2017).
https://doi.org/10.1136/bmjopen-2020-046713 .
Outputs from the studies approved usually have research reports which are submitted to funders (such as the Medical Research Council). Some outputs will inform discussions with national programmes (such as NHS Cancer Screening Programmes and NHS Scotland), charities (such as Cancer Research UK) primary care professionals, policy makers and researchers,
Clarke CS, Williamson E, Denaxas S On behalf of the MACRO programme team, et al. Observational retrospective study calculating health service costs of patients receiving surgery for chronic rhinosinusitis in England, using linked patient-level primary and secondary care electronic data. BMJ Open 2022;12:e055603. https://doi.org/10.1136/bmjopen-2021-055603 .
In many instances, the papers are also published and are available on Open Access journals. Many of the outputs are also presented at conferences (such as International Society for Pharmacoepidemiology). Many of the outputs have the capacity to not only influence the clinical community but also policy makers, for example clinical guidelines (see Oyinlola et al 2016).
Roalfe A, Lay-Flurrie SL, Ordonez-Mena JM et al. Long term trends in natriuretic peptide testing for heart failure in UK primary care: a cohort study. European Heart Journal, ehab781. https://doi.org/10.1093/eurheartj/ehab781
Cadogan SL, Powell E, Wing K et al. Anticoagulant prescribing for atrial fibrillation and risk of incident dementia. Heart 2021;107:1898-1904.
http://dx.doi.org/10.1136/heartjnl-2021-319672
Outputs from the studies approved usually have research reports which are submitted to funders (such as the Medical Research Council). Some outputs may inform discussions with national programmes (such as NHS Cancer Screening Programmes and NHS Scotland), charities (such as Cancer Research UK) primary care professionals, policy makers and researchers. In many instances, the papers are also published and are available on Open Access journals. Many of the outputs are also presented at conferences (such as International Society for Pharmacoepidemiology). Many of the outputs have the capacity to not only influence the clinical community but also policy makers, for example clinical guidelines (see Oyinlola et al 2016, https://doi.org/10.1186/s12913-016-1562-8).
[1 paragraph unchanged]
AMENDMENT REQUEST
The first project (involving both CPRD and UHB) as an example will use the resultant data for a NIHR funded multimorbidity research study ‘OPTIMising therapies, disease trajectories, and AI assisted clinical management for patients Living with complex multimorbidity (OPTIMAL)’. The study aims to integrate multimodal primary care, secondary care, and prescribing data to develop an Artificial Intelligence tool with the aim of optimising clinical decision making in patients with complex multimorbidity (there will be no automated decision making or profiling, it will be used to create a tool and will not have a direct impact on clinical decisions). This will be done by analysing large, detailed health records of patients who attend GP services and hospitals. These include all diagnoses, disease severity, drugs, blood tests, readings such as blood pressure and specialist tests. Using artificial intelligence methods, model how the different mixes of diseases arise over time. The models may inform what drugs cause or prevent a new disease. This may show if a drug helps improve symptoms of a disease or make them worse. The model may also help predict who may get another disease.
Expected measurable benefits
Past and existing studies (on an ongoing basis) use
Studies using NHS Digital data
linked
data with the
to
CPRD primary care database
to generate research results. These studies
are expected
and required
to
produce
demonstrate likely
benefits
of
to patients in England which may be via informing better
clinical
importance to the UK public, and to be published in peer-reviewed journals and presented at scientific conferences.
care or public health policies.
Some
studies, particularly worldwide, the
study
results
and publications
may also be used
as
to support
regulatory
evidence in different countries, including
decision making both within and outside
the UK, directly affecting the approval or removal of drugs or devices (and hence their availability) or guidance as to their use.
Some examples of expected benefits included by researchers in recent RDG applications include:
Some recent examples and other relevant publications resulting from linked data research which resulted in clinical benefits are presented below.
• Estimates of prevalence, incidence and healthcare burden of specific types of psoriasis in England. This study may further the understanding of the burden of these rare diseases in the UK, particularly highlighting differences between the different presentations of psoriasis. (RDG reference: 21_000421, see: https://www.cprd.com/protocol/prevalence-incidence-and-healthcare-burden-generalised-pustular-psoriasis-palmoplantar
Case Study 1: The effectiveness of the influenza vaccine against hospital admissions and mortality in individuals with type 2 diabetes
• An understanding of the risks associated with COVID-19 infection in patients with congenital heart disease to inform better clinical management of these patients (RDG reference: 20_000161, see: https://cprd.com/protocol/identifying-clinical-risks-associated-covid-19-patients-congenital-heart-disease-and-0)
Seasonal influenza accounts for a significant proportion of excess winter mortality. Current policy in the UK and in many countries worldwide recommends annual flu vaccinations for patients with chronic conditions such as diabetes, though evidence to support such policies is limited.
• An understanding of potential risks associated with various medications prescribed during pregnancy to both mothers and their children, to inform prescribing decisions (RDG reference: 21_000362, see: https://cprd.com/protocol/maternal-prescriptive-drug-use-risks-and-benefits-mothers-and-neonates)
Imperial College London investigated the effectiveness of the influenza vaccine at reducing cardiovascular and respiratory hospital admissions and mortality in patients with type 2 diabetes. The study used linkages between CPRD GOLD primary care data, Hospital Episode Statistics (HES) and the Office for National Statistics (ONS) mortality data to look at admissions and death in 125,000 patients over a seven-year period. Influenza vaccination was associated with a reduction in the rate of hospital admissions for acute cardiovascular and respiratory disease and a reduction in all-cause mortality across the seven flu seasons.
• An understanding of the different presentations of Long Covid and risk factors associated with developing Long Covid among non-hospitalised COVID patients with the aim of developing supportive interventions and treatments (RDG reference: 21_000423, see: https://cprd.com/protocol/long-covid-non-hospitalised-individuals-symptoms-risk-factors-and-syndromes-0)
The study was widely reported within healthcare and mainstream media and supports current flu vaccination initiatives in the UK and beyond.
• Examining the effects of COVID-19 on primary care management following self-harm in the UK, concluding that despite the challenges experienced by primary healthcare teams during the initial COVID-19 wave, prescribing and consultation patterns following self-harm were broadly similar to pre-pandemic levels (RDG reference 20_001, see: https://cprd.com/protocol/impact-covid-19-primary-care-contact-referrals-follow-care-and-patient-outcomes-after)
Reference 1:
• Examples of how research using CPRD data benefits public health: https://cprd.com/examples-how-research-using-cprd-data-benefits-public-health
Vamos EP et al. Effectiveness of the influenza vaccine in preventing admission to hospital and death in people with type 2 diabetes. CMAJ. 2016 Oct 4;188(14):E342-E351.
Further examples and other relevant publications resulting from linked data research which have informed clinical practice or public health policy are presented below. Some of the studies referenced are older (published up to 5 years before) as it can take 4-5 years to translate some research findings into clinical guidance or public health policy.
Case Study 2: Risk associated with the prescription of long-acting β2-agonists (LABA), short-acting β2-agonists (SABA) or inhaled corticosteroids (ICS) for asthma in primary care.
Pearson-Stuttard J, Cheng YJ, Bennett J et al. Trends in leading causes of hospitalisation of adults with diabetes in England from 2003 to 2018: an epidemiological analysis of linked primary care records. The Lancet Diabetes & Endocrinology, Volume 10, Issue 1, 2022. https://doi.org/10.1016/S2213-8587(21)00288-6 November 2021. The number of people with diabetes in the UK has increased substantially over past decades to almost 4 million with increasing costs to the health service.
Omalizumab is an antibody-based treatment developed to help control moderate to severe allergic asthma, when symptom control with inhaled corticosteroids (ICS) is inadequate. ICS are frequently prescribed alongside long-acting β2-agonists (LABA). A 2010 study using CPRD data (then GPRD) linked with Hospital Episode Statistics investigated the risk of asthma-related death and hospitalisation among patients on ICS or LABA therapy. The study was important to establish the relative risk across commonly-prescribed asthma treatments and concluded that LABA exposure was not associated with an increased risk for all-cause mortality. This study was subsequently incorporated into NICE guidelines released in 2013 outlining evidence-based recommendations for omalizumab use in patients with severe persistent asthma.
This research will inform the provision of health services, management and prevention of diabetes and diabetes-related complications.
Reference 2:
Masoli JAH, Delgado J, Pilling L et al. Blood pressure in frail older adults: associations with cardiovascular outcomes and all-cause mortality. Age and Ageing, Volume 49, Issue 5, September 2020, Pages 807–813. https://doi.org/10.1093/ageing/afaa028. In a study of 415,980 people, including those often excluded from studies, researchers reported that there was no increased mortality risk with hypertension in adults above 75 years with moderate to severe frailty and all above 85 years. Research supports the move to raise the blood pressure target for frail older people. https://evidence.nihr.ac.uk/alert/new-research-supports-the-move-to-raise-the-blood-pressure-target-for-frail-older-people/
de Vries F, Setakis E, Zhang B, van Staa TP. Long-acting {beta}2-agonists in adult asthma and the pattern of risk of death and severe asthma outcomes: a study using the GPRD. Eur Respir J. 2010 Sep;36(3):494-502.
Sheng-Chia Chung, Reecha Sofat, Dionisio Acosta-Mena, Julie A Taylor, Pier D Lambiase, Juan P Casas, Rui Providencia. Atrial fibrillation epidemiology, disparity and healthcare contacts: a population-wide study of 5.6 million individuals. The Lancet Regional Health - Europe, Volume 7, 2021. https://doi.org/10.1016/j.lanepe.2021.100157. From the paper: The study provides comprehensive evidence for the AF burden on population health and healthcare utilisation. We found approximately two in five AF patients had three or more comorbidities at the time of diagnosis.
Case study 3:
Vaccine surveillance using electronic health records is important for the detection of safety signals and to protect public health. A study used CPRD data to establish a near real-time vaccine safety surveillance system for influenza and MMR vaccines. The system was able to exclude large increases in the risk of rare outcomes after seasonal influenza and lower increases in risk for more frequent outcomes such as febrile seizures following MMR immunisation. The study was important to establish a novel method of using CPRD data for the protection of public health.
Reference 3: Leite A, Thomas SL, Andrews NJ. Implementing near real-time vaccine safety surveillance using the Clinical Practice Research Datalink (CPRD). Vaccine. 2017 Dec 14;35(49 Pt B):6885-6892.
Additional references describing health benefits of CPRD and linked data.
Example Reference 3:
A review of patients with learning disabilities (LD) at the Winterbourne View private hospital was established for all aspects of care for this patient group. This study used three years of CPRD data alongside HES APC data to describe the level of GP prescribing of psychotropic medication to patients with LD, and explored whether a relevant diagnostic indication was recorded. The results of the study led NHS England to promise rapid and sustained action to tackle over-prescribing, and an urgent letter sent to professionals to urge they review their own prescribing.
Reference:
Glover, G, Williams R. 'Prescribing of psychotropic drugs to people with learning disabilities and/or autism by general practitioners in England'. Public Health England. June 2015.
Example Reference 4:
An article published in May 2019 provides an overview of how CPRD primary care and linked data can be used to support pharmacovigilance and specific advantages in the context of the ‘six Vs of big data’ including volume, velocity, variety, veracity, validity and value.
Reference:
Ghosh RE, Crellin E, Beatty S, Donegan K, Myles P, Williams R. How Clinical Practice Research Datalink data are used to support pharmacovigilance. Therapeutic Advances in Drug Safety, 2019.
Additional reference 5 - example of European use (using CPRD data only):
A publication based on a study by Utrecht University, in collaboration with Utrecht Medical Centre and CPRD evaluated the risk of all-cause mortality associated with non-vitamin K antagonist oral anticoagulants, vitamin K antagonists and aspirin in patients with atrial fibrillation.
The study concluded that non-vitamin K anticoagulants are associated with a higher risk of all-cause mortality, particularly in men and in patients with a higher stroke risk, and identified a need for more research into the underlying mechanisms for this finding, particularly for rivaroxaban. While most clearly applicable to UK populations, the results are also important to similar health economies where these drugs may be used.
Gieling, E., de Vries, F., Williams, R. et al. Mortality risk in atrial fibrillation: the role of aspirin, vitamin K and non-vitamin K antagonists. Int J Clin Pharm (2019) 41: 1536
Additional reference 6 - example of worldwide use (from linked data release in 2015):
A study conducted by Canadian researchers (Drori et al. 2019) using CPRD data investigated whether the use of androgen deprivation therapy (ADT) which is a mainstay treatment for prostate cancer, is associated with an increased risk of rheumatoid arthritis (RA). RA is a long-term condition that causes pain, swelling and stiffness in the joints, with periods of severe flare-ups that could result in long-term damage to the joints. RA has no cure and can only be managed symptomatically, with supportive treatment like physiotherapy and in case of joint damage, with surgery. Thus, there has been considerable concern amongst prostate cancer patients and their doctors, about ADT potentially leading to this debilitating condition as a side effect.
This study was able to demonstrate that the use of ADT was not associated with an increased risk of RA in men with prostate cancer. This finding provides reassurance to clinicians and prostate cancer patients in England that ADT therapy will not increase their risk of RA.
Reference: Klil-Drori, Adi J., Santella, Christina, Tascilar, Koray, Yin, Hui, Aprikian, Armen, Azoulay, Laurent: Androgen Deprivation Therapy for Prostate Cancer and the Risk of Rheumatoid Arthritis: A Population-Based Cohort Study. Drug Safety 2019
Benefit of CHESS/SGSS linkage:
The data linkage is in the public interest as it will permit health research in response to the coronavirus outbreak. COVID-19 related research is already being supported by CPRD, including studies on: risk factors [1] and pharmacological risk factors [2] for COVID-19 infection; the impact of angiotensin receptor blockers/enzyme inhibitors on COVID-19 risk and outcome [3]; COVID-19 related risks in cancer survivors [4]; and a rapid network study to inform management of COVID-19 [5]. Linkage to the SGSS COVID-19 specific test data and the CHESS data on COVID-19 Hospitalisations in England would enable CPRDs research community to undertake wide ranging research to support the development and implementation of appropriate and timely clinical guidance and contribute to the current public health effort, with associated benefit for patients in England.
Benefit of ICNARC CMP linkage:
The linkage is in the public interest as it will permit health research requiring details of intensive care admissions with the intention of improving treatments and clinical outcomes for patients. This is particularly of relevance in the context of the current COVID-19 pandemic where a key clinical need is to determine which patients in primary care are at highest risk of admission to critical care and which pre-morbid factors predict survival. A standard linkage between CPRD and ICNARC CMP data will enable the conduct of such studies proactively for other conditions as well and help inform better patient care pathways for e.g. intermediate care options, decisions regarding stepping down of care etc.
AMENDMENT REQUEST
The new linkage request may be in the public interest as it may provide a data resource spanning community screening, primary care and secondary care. Linking these datasets across the patient care pathway will hopefully better inform understanding of disease risk, diagnosis, treatment effectiveness and clinical outcomes within a specific patient population.
Linkage between the CPRD primary care and UHB secondary care data may enable the formation of a dataset that represents a more holistic view of the patient experience of disease and their journey within the health and care system. Currently a major limitation to most health data analyses is that they only view part of the patient’s health (for example only secondary care, or only primary care), but the combined anonymised database may provide an important new resource to support research for patient benefit that reflects the whole patient journey. The whole pathway approach may enable improved ‘patient centred’ understanding of care pathways, and health service improvements.
Benefits reported
There are 3 case studies presented below highlighting how linked CPRD-NHSD data has supported public health research, especially in response to the COVID19 effort. These studies have contributed to the scientific understanding of COVID19 amongst other areas, which in turn will be helpful literature to further research. CPRD’s observational research do not have direct impact on patients but overall adds to the resource of innovative research proposals, which may influence policy or programmes. Observational research can help us understand more about causal associations between treatments and outcomes and more about the world in general. These non-interventional studies have become valuable tools in health because they offer broad ways to answer real-world clinical research and product usage questions.
CPRD publish here https://cprd.com/approved-studies-using-cprd-data a register of all approved studies of which the detail on each study includes a lay and technical summary, the health outcomes to be measured and details on the organisations involved.
Case study 1: Higher risks of flu and COVID-19 for cancer survivors.
There are 3 case studies presented below highlighting how linked CPRD-NHSD data has supported public health research, especially in response to the COVID 19 effort in recent years. Research using linked CPRD data benefits patients in the UK indirectly by contributing to the evidence base for medicine and public health, which in turn informs public health policy, programmes and clinical guidelines.
Older individuals and people with certain health conditions are known to be at higher risk of severe illness if they contract viruses such as flu and COVID-19. This includes people who had certain cancers diagnosed recently and are receiving treatments like chemotherapy.
Case study 1: Higher risks of flu and COVID-19 for cancer survivors (CPRD protocol 20_082).
Older individuals and people with certain health conditions are known to be at higher risk of severe illness if they contract viruses such as flu and COVID-19. This includes people who had certain cancers diagnosed recently and are receiving treatments like chemotherapy.
In the UK there are more than two million cancer survivors. To
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of National Statistics mortality database, and postcode-based index of Multiple Deprivation data.
Researchers found that survivors from a wide range of cancers are more likely than people in the general population to be hospitalised or die from flu, even several years after their cancer diagnosis. The raised risks were most likely for blood cancer survivors. Because flu and COVID-19 are both respiratory viruses, this suggested that cancer survivors also have a higher risk of severe COVID-19. The study also showed that cancer survivors were more likely to have other diseases that are associated with increased risk of severe COVID-19, such as heart disease, diabetes, respiratory disease and kidney disease. The findings support the UK policy recommendation to include all blood cancer survivors as one of the priority groups to receive the COVID-19 vaccination. The study findings could also support any work by others to prioritise vaccinations and treatments for longer-term cancer survivors.
Researchers found that survivors from a wide range of cancers are more likely than people in the general population to be hospitalised or die from flu, even several years after their cancer diagnosis. The raised risks were most likely for blood cancer survivors. Because flu and COVID-19 are both respiratory viruses, this suggested that cancer survivors also have a higher risk of severe COVID-19. The study also showed that cancer survivors were more likely to have other diseases that are associated with increased risk of severe COVID-19, such as heart disease, diabetes, respiratory disease and kidney disease.
The findings support the UK policy recommendation to include all blood cancer survivors as one of the priority groups to receive the COVID-19 vaccination. The study findings could also support any work by others to prioritise vaccinations and treatments for longer-term cancer survivors.
[1 paragraph unchanged]
https://cprd.com/protocol/covid-19-related-risks-cancer-survivors-matched-cohort-study-using-linked-uk-electronic
[1 paragraph unchanged]
Vaccination is an effective way to prevent infectious diseases. However, people with
[23 words unchanged]
vaccine uptake to prevent infections is a key priority for public health.
This cohort study examined the social factors that may be associated with lower uptake of flu vaccine and whooping cough vaccine by pregnant women. It considered a range of social determinants including maternal age, ethnicity, socioeconomic status, number of children in the household and region. The study used linkages between CPRD data, the CPRD GOLD Pregnancy Register, Hospital Episode Statistics (HES) and Office of National Statistics (ONS) small-area-level deprivation data.
This cohort study examined the social factors that may be associated with lower uptake of flu vaccine and whooping cough vaccine by pregnant women. It considered a range of social determinants including maternal age, ethnicity, socioeconomic status, number of children in the household and region.
The researchers concluded that more targeted campaigns have the potential to reduce vaccine-preventable disease among infants and pregnant women, and to reduce health inequalities. Identifying social factors that are associated with lower vaccination rates could help to design programmes to improve vaccine uptake for specific groups of individuals.
The study used linkages between CPRD data, the CPRD GOLD Pregnancy Register, Hospital Episode Statistics (HES) and Office of National Statistics (ONS) small-area-level deprivation data.
The researchers concluded that more targeted campaigns have the potential to reduce vaccine-preventable disease among infants and pregnant women, and to reduce health inequalities.
Identifying social factors that are associated with lower vaccination rates could help to design programmes to improve vaccine uptake for specific groups of individuals.
[1 paragraph unchanged]
https://cprd.com/protocol/social-determinants-uptake-maternal-influenza-and-pertussis-vaccine
[2 paragraphs unchanged]
The lack of studies quantifying the mental health of mothers of children with a life-limiting condition has been highlighted by the National Institute for Health and Care Excellence.
In this first part of a larger research programme, researchers used CPRD data to investigate the types of physical and psychological health conditions diagnosed in mothers of children with a life-limiting condition. The CPRD GOLD Pregnancy Register was used to link mothers and their children's healthcare data. The study also used linkages to Hospital Episodes Statistics (HES), Mental Health Minimum Dataset (MHMDS) and Office for National Statistics (ONS) death certificate data.
In this first part of a larger research programme, researchers used CPRD data to investigate the types of physical and psychological health conditions diagnosed in mothers of children with a life-limiting condition. The CPRD GOLD Pregnancy Register was used to link mothers and their children's healthcare data.
The study concluded that mothers of children with life-limiting conditions have much higher rates of physical health problems, mental illness, and death. These findings were flagged as an ‘Alert’ for important research by the NIHR. Prior to this study, little research had explored the health of this group of women. Knowing more about the health problems that the women experience could help in the design of specific healthcare interventions.
The study also used linkages to Hospital Episodes Statistics (HES), Mental Health Minimum Dataset (MHMDS) and Office for National Statistics (ONS) death certificate data.
The study concluded that mothers of children with life-limiting conditions have much higher rates of physical health problems, mental illness, and death.
These findings were flagged as an ‘Alert’ for important research by the NIHR. Prior to this study, little research had explored the health of this group of women. Knowing more about the health problems that the women experience could help in the design of specific healthcare interventions.
[1 paragraph unchanged]
• NIHR Evidence - Mothers of children with life-limiting conditions are at risk of serious health problems - Informative and accessible health and care research
https://cprd.com/protocol/life-limiting-conditions-health-children-and-their-mothers
NIHR Evidence - Mothers of children with life-limiting conditions are at risk of serious health problems - Informative and accessible health and care research https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fevidence.nihr.ac.uk%2Falert%2Fchildren-life-limiting-conditions-mothers-more-likely-to-die%2F%3Futm_source%3DNIHR%2Bmailing%2Blist%26utm_campaign%3Dc836e7227e-NEWS_RESEARCH_26_8_2021_COPY_01%26utm_medium%3Demail%26utm_term%3D0_570d86f9cb-c836e7227e-33120976&data=04%7C01%7CRhian.Hortin%40mhra.gov.uk%7Ceeaa93de1cb4421aafec08d9b0242f33%7Ce527ea5c62584cd2a27f8bd237ec4c26%7C0%7C0%7C637734491713613980%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=TKPdVHwcavrPA3jVYfUKdqC0ds9O2bgjo6GzYGJAk34%3D&reserved=0
Objective for processing
The controller for GDPR purposes is the Department of Health and Social Care (DHSC); the legal signatory for this agreement (and for the overarching Data Sharing Framework Contract - DSFC) is the Secretary of State for Health and Social Care (acting as part of the Crown), acting through the Clinical Practice Research Datalink (hereinafter referred to as CPRD) within the Medicines and Healthcare products Regulatory Agency (MHRA) (the agency); and the licensee is CPRD, not the wider DHSC nor the agency.
The Clinical Practice Research Datalink (CPRD) is a specialist health data research service provided by the Medicines and Healthcare products Regulatory Agency (the agency), an executive agency of the Department of Health and Social Care (DHSC). The agency regulates medicines, medical devices and blood components for transfusion in the UK and the agency acts as the Executive agency.
The Clinical Practice Research Datalink (CPRD) is a government not for profit research service delivered by the Medicines and Healthcare products Regulatory Agency (MHRA) with support from the National Institute of Health and Care Research (NIHR), that provides access to pseudonymised health data for studies to safeguard and improve patient and public health. For more than 30 years, CPRD data have supported vital research into health care delivery, drug safety, effectiveness of medicines and risk factors for disease. The linked data supplied by NHS Digital and shared by CPRD under the NHS Digital sub-licence can only be used for public health research purposes in accordance with Article 6(1)(e) and Article 9(2)(j).
Research using CPRD data has resulted in over 3,000 peer-reviewed publications, which have informed drug safety guidance and best clinical practice. Examples of research findings used in everyday NHS care include demonstrating the protective effect of whooping cough vaccination in pregnancy for infants and informing the National Institute of Health and Care Excellence (NICE) blood pressure targets for patients with diabetes. A searchable list of the users and uses of CPRD data is published on the CPRD website https://www.cprd.com/protocol-list. CPRD’s research and data services are based on a sharing data which are effectively anonymised once given to the researcher from longitudinal primary care records contributed by participating GP practices from the four UK nations. Approval to supply data for public health research is granted on an annual basis by the East Midlands and Derby Research Ethics Committee (Database REC reference 21/EM/0265). the data held by CPRD
CPRD provides researchers under sublicense agreements access to effectively anonymised primary care data linked to secondary health care datasets for both observational research and to supplement clinical trial data. Linked data greatly increases the scale, depth, completeness and value of data available for public health and clinical research. Linked data are also used to assess study feasibility and create lists of eligible patients who could potentially be included in clinical trials. In addition, linked data are used by CPRD to generate derived fields that improve the quality of the primary care data for e.g., ethnicity records. The outputs of such research based on linked data inform clinical guidance and best practice for patients in the UK. The CPRD Research Data Governance (RDG) review process includes lay reviewers. Applications that include non-standard elements that deviate from precedent will be assigned to lay reviewers. In addition, a sample of all applications is reviewed by the independent Central Advisory Committee (CAC) which includes lay representatives as part of CPRD’s assurance process.
Secondary healthcare datasets are provided by NHS Digital and these data are linked to the primary care data by NHS Digital. NHS Digital receives identifiers to enable them to carry out this linkage as described below in 5b processing activities. Continued support is given by Confidentiality Advisory Group (CAG) for the flow of identifiers to NHS Digital to enable linkage of CPRD primary care data to secondary datasets (CAG reference 21/CAG/0008).
The legal bases for processing the data provided by NHS Digital are:
• Gathering of GP patient data and collation with other datasets to produce datasets that have been anonymised: medical research under Article 9(2)(j); drug and device safety under Article 9(2)(i) of the General Data Protection Regulation.
NHS Digital has been providing and linking health-related datasets to CPRD primary care data for a number of years. Data linkage is carried out exclusively by NHS Digital as the Trusted Third Party (TTP) for this purpose. Linked datasets currently available include extracts from Civil Registration data; Hospital Episode Statistics (HES), which encompasses Admitted Patient Care, Critical Care, Outpatient and Accident & Emergency data; Diagnostic Imaging Dataset (DID); and Critical Care data (supplied as a separate dataset by NHS Digital but integrated with Admitted Patient Care). CPRD primary care data are also linked with the National Disease Registration Service National Cancer Registry data, the Second Generation Surveillance System (SGSS) data (specifically the COVID-19 test result data, including future serological testing as well as current antigen testing) and COVID-19 Hospitalisation in England Surveillance System (CHESS). NHS Digital also supply Lower Layer Super Output Area based on patient postcode, to enable linkage to deprivation data including Townsend Score and Index of Multiple Deprivation.
Research using CPRD data and services informs clinical guidance and best practice related to drug safety, use of medicines, effectiveness of health policy, health care delivery and disease risk factors. Similarly, the primary care and linked HES data would permit research which would expand understanding about patient access to health services across the patient care pathway and the need for wider care of patients and vulnerable groups as a direct or indirect result of COVID-19 and the availability and capacity of those services or that care.
Patient and Public Involvement and Engagement (PPIE)
For all GP Practices who participate in the CPRD research CPRD reach out to join the individual Practice PPIE groups. In 2021 The Primary Care Recruitment Team at CPRD attended and presented at two Public
Patient Group (PPG) meetings. One meeting covered a network of 8 practices in Liverpool area and the other was a practice PPG meeting in Kent and Medway area. Another three practice PPG meetings took place between Jan 2022 and April 2022 in Barking London, Sunderland and Bristol. Another PPIE workshop is planned to take place in late 2022.
TRUSTED THIRD PARTY DATA LINKAGE
NHS Digital have previously undertaken some data processing activities on behalf of CPRD, including linking CPRD patient identifiers to patients in the Intensive Care National Audit & Research Centre (ICNARC), data which are managed (collection and processing) by ICNARC, who is the data custodian (see https://cprd.com/cprd-linked-data). Recently NHS Digital have also linked data from University Hospitals Birminham (UHB) to the CPRD cohort. These UHB Electronic Health Record data comprise data from a number of different clinical systems held within the Data Controllership of UHB, that are not routinely transferred to NHS Digital, including prescribing systems (PICS), laboratory systems (Telepath), health record noting (PICS/Clinical Portal/Medisoft) and patient administrative system, Imaging modalities (e.g. XRay: MRI: CT: OCT: Retinal photography) and clinically relevant parameters (ECG and EEG)- some data types will have features extracted and stored as structured data. This data provides a more comprehensive view of the provision of healthcare to patients with multiple long-term health conditions. This data contains more detailed data on patients diagnoses including severity of diseases and prescribing of medications only initiated in secondary care'. In both of these cases, data flowed under Section 251 of the Health and Social Care Act and no NHS Digital data was released. There will be no linkage as a Trusted Third Party under this iteration of the agreement.
Expected output
Researchers using linked CPRD data will be producing research publications in peer-reviewed journals and presentations at scientific conferences on an ongoing basis. Target dates for expected outputs will vary by study but on average, publication of findings arising from approved research is expected between 3-4 years after data access. CPRD provides data to researchers in academic institutions, pharmaceutical companies, Governmental centres and research charities. While the typical output is publication in a peer-reviewed academic journal, other outputs may include reports submitted to medicines regulatory bodies or white papers. Some of the research findings may directly translate into clinical guidelines and public health policy.
A selection of recent publications resulting from use of CPRD linked data are presented below.
Pearson-Stuttard J, Cheng YJ, Bennett J et al. Trends in leading causes of hospitalisation of adults with diabetes in England from 2003 to 2018: an epidemiological analysis of linked primary care records. The Lancet Diabetes & Endocrinology, Volume 10, Issue 1, 2022. https://doi.org/10.1016/S2213-8587(21)00288-6
Rishi Caleyachetty, Thomas M Barber, Nuredin Ibrahim Mohammed, Francesco P Cappuccio, Rebecca Hardy, Rohini Mathur, Amitava Banerjee, Paramjit Gill. Ethnicity-specific BMI cutoffs for obesity based on type 2 diabetes risk in England: a population-based cohort study. The Lancet Diabetes & Endocrinology,
Volume 9, Issue 7, 2021. https://doi.org/10.1016/S2213-8587(21)00088-7 .
Ferguson R, Prieto-Alhambra D, Peat G, et al. Influence of pre-existing multimorbidity on receiving a hip arthroplasty: cohort study of 28 025 elderly subjects from UK primary care. BMJ Open 2021;11:e046713.
https://doi.org/10.1136/bmjopen-2020-046713 .
Clarke CS, Williamson E, Denaxas S On behalf of the MACRO programme team, et al. Observational retrospective study calculating health service costs of patients receiving surgery for chronic rhinosinusitis in England, using linked patient-level primary and secondary care electronic data. BMJ Open 2022;12:e055603. https://doi.org/10.1136/bmjopen-2021-055603 .
Roalfe A, Lay-Flurrie SL, Ordonez-Mena JM et al. Long term trends in natriuretic peptide testing for heart failure in UK primary care: a cohort study. European Heart Journal, ehab781. https://doi.org/10.1093/eurheartj/ehab781
Cadogan SL, Powell E, Wing K et al. Anticoagulant prescribing for atrial fibrillation and risk of incident dementia. Heart 2021;107:1898-1904.
http://dx.doi.org/10.1136/heartjnl-2021-319672
Outputs from the studies approved usually have research reports which are submitted to funders (such as the Medical Research Council). Some outputs may inform discussions with national programmes (such as NHS Cancer Screening Programmes and NHS Scotland), charities (such as Cancer Research UK) primary care professionals, policy makers and researchers. In many instances, the papers are also published and are available on Open Access journals. Many of the outputs are also presented at conferences (such as International Society for Pharmacoepidemiology). Many of the outputs have the capacity to not only influence the clinical community but also policy makers, for example clinical guidelines (see Oyinlola et al 2016, https://doi.org/10.1186/s12913-016-1562-8).
A comprehensive list of publications including those using linked data can be found at www.cprd.com/bibliography
Benefits reported
CPRD publish here https://cprd.com/approved-studies-using-cprd-data a register of all approved studies of which the detail on each study includes a lay and technical summary, the health outcomes to be measured and details on the organisations involved.
There are 3 case studies presented below highlighting how linked CPRD-NHSD data has supported public health research, especially in response to the COVID 19 effort in recent years. Research using linked CPRD data benefits patients in the UK indirectly by contributing to the evidence base for medicine and public health, which in turn informs public health policy, programmes and clinical guidelines.
Case study 1: Higher risks of flu and COVID-19 for cancer survivors (CPRD protocol 20_082).
Older individuals and people with certain health conditions are known to be at higher risk of severe illness if they contract viruses such as flu and COVID-19. This includes people who had certain cancers diagnosed recently and are receiving treatments like chemotherapy. In the UK there are more than two million cancer survivors. To investigate whether people who had cancer some time ago are also at higher risk from flu and COVID-19 a study was carried out using CPRD data. CPRD GOLD was linked to Hospital Episode Statistics Admitted Patient Care (HES APC) database, cancer registrations from the National Cancer Registration and Analysis Service (NCRAS), death registrations from the Office of National Statistics mortality database, and postcode-based index of Multiple Deprivation data. Researchers found that survivors from a wide range of cancers are more likely than people in the general population to be hospitalised or die from flu, even several years after their cancer diagnosis. The raised risks were most likely for blood cancer survivors. Because flu and COVID-19 are both respiratory viruses, this suggested that cancer survivors also have a higher risk of severe COVID-19. The study also showed that cancer survivors were more likely to have other diseases that are associated with increased risk of severe COVID-19, such as heart disease, diabetes, respiratory disease and kidney disease. The findings support the UK policy recommendation to include all blood cancer survivors as one of the priority groups to receive the COVID-19 vaccination. The study findings could also support any work by others to prioritise vaccinations and treatments for longer-term cancer survivors.
Reference 1: Carreira H, Strongman H, Peppa M, McDonald H, dos-Santos-Silva I, Stanway S, Smeeth L, Bhaskaran K. Prevalence of COVID-19-related risk factors and risk of severe influenza outcomes in cancer survivors: a matched cohort study using linked UK electronic health records data. EClinicalMedicine, Volume 29, 100656, December 2020. https://doi.org/10.1016/j.eclinm.2020.100656
https://cprd.com/protocol/covid-19-related-risks-cancer-survivors-matched-cohort-study-using-linked-uk-electronic
Case study 2: Vaccine uptake in pregnancy
Vaccination is an effective way to prevent infectious diseases. However, people with certain social characteristics – such as those living in more deprived areas – may be less likely to receive vaccination. Addressing inequalities in vaccine uptake to prevent infections is a key priority for public health. This cohort study examined the social factors that may be associated with lower uptake of flu vaccine and whooping cough vaccine by pregnant women. It considered a range of social determinants including maternal age, ethnicity, socioeconomic status, number of children in the household and region. The study used linkages between CPRD data, the CPRD GOLD Pregnancy Register, Hospital Episode Statistics (HES) and Office of National Statistics (ONS) small-area-level deprivation data.
The researchers concluded that more targeted campaigns have the potential to reduce vaccine-preventable disease among infants and pregnant women, and to reduce health inequalities. Identifying social factors that are associated with lower vaccination rates could help to design programmes to improve vaccine uptake for specific groups of individuals.
Reference 2: Walker et al. Social determinants of pertussis and influenza vaccine uptake in pregnancy: a national cohort study in England using electronic health records. BMJ Open 2021;11:e046545. https://doi.org/10.1136/bmjopen-2020-046545
https://cprd.com/protocol/social-determinants-uptake-maternal-influenza-and-pertussis-vaccine
Case study 3: Health of mothers of children with a life-limiting condition
More than 86,000 children and young people in England are now living with medical conditions that may ultimately shorten their life and cause death in childhood or young adulthood. Mothers of children with a severe health condition or whose child has died are more likely themselves to die earlier than other mothers.
The lack of studies quantifying the mental health of mothers of children with a life-limiting condition has been highlighted by the National Institute for Health and Care Excellence. In this first part of a larger research programme, researchers used CPRD data to investigate the types of physical and psychological health conditions diagnosed in mothers of children with a life-limiting condition. The CPRD GOLD Pregnancy Register was used to link mothers and their children's healthcare data. The study also used linkages to Hospital Episodes Statistics (HES), Mental Health Minimum Dataset (MHMDS) and Office for National Statistics (ONS) death certificate data.
The study concluded that mothers of children with life-limiting conditions have much higher rates of physical health problems, mental illness, and death. These findings were flagged as an ‘Alert’ for important research by the NIHR. Prior to this study, little research had explored the health of this group of women. Knowing more about the health problems that the women experience could help in the design of specific healthcare interventions.
Reference 3: Fraser et al. Health of mothers of children with a life-limiting condition: a comparative cohort study. Archives of Disease in Childhood 2021;106:987-993. http://dx.doi.org/10.1136/archdischild-2020-320655
https://cprd.com/protocol/life-limiting-conditions-health-children-and-their-mothers
NIHR Evidence - Mothers of children with life-limiting conditions are at risk of serious health problems - Informative and accessible health and care research https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fevidence.nihr.ac.uk%2Falert%2Fchildren-life-limiting-conditions-mothers-more-likely-to-die%2F%3Futm_source%3DNIHR%2Bmailing%2Blist%26utm_campaign%3Dc836e7227e-NEWS_RESEARCH_26_8_2021_COPY_01%26utm_medium%3Demail%26utm_term%3D0_570d86f9cb-c836e7227e-33120976&data=04%7C01%7CRhian.Hortin%40mhra.gov.uk%7Ceeaa93de1cb4421aafec08d9b0242f33%7Ce527ea5c62584cd2a27f8bd237ec4c26%7C0%7C0%7C637734491713613980%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=TKPdVHwcavrPA3jVYfUKdqC0ds9O2bgjo6GzYGJAk34%3D&reserved=0
DARS-NIC-15625-T8K6L-v11.2 9 May 2022 to 30 October 2022
- Title
- R23 - Clinical Practice Research Datalink (CPRD) Routine Linkages Application
- Commercial
- No
- Sublicensing
- Yes
- Datasets
- 21
- Files released
- 0
Datasets: Bridge file: Hospital Episode Statistics to Diagnostic Imaging Dataset; Bridge file: Hospital Episode Statistics to Mental Health Minimum Data Set; Civil Registrations of Death - Secondary Care Cut; COVID-19 Hospitalization in England Surveillance System; COVID-19 SGSS First Positives (Second Generation Surveillance System); CPRD/UHB linkage file (pseudonymised data only); Diagnostic Imaging Data Set (DID); Emergency Care Data Set (ECDS); HES-ID to MPS-ID HES Accident and Emergency; HES-ID to MPS-ID HES Admitted Patient Care; HES-ID to MPS-ID HES Outpatients; HES:Civil Registration (Deaths) bridge; Hospital Episode Statistics Accident and Emergency (HES A and E); Hospital Episode Statistics Admitted Patient Care (HES APC); Hospital Episode Statistics Critical Care (HES Critical Care); Hospital Episode Statistics Outpatients (HES OP); Mental Health and Learning Disabilities Data Set (MHLDDS); Mental Health Minimum Data Set (MHMDS); Mental Health Services Data Set (MHSDS); MRIS - Bespoke; Patient Reported Outcome Measures (Linkable to HES)
What changed from DARS-NIC-15625-T8K6L-v10.4
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2022-05-09 | |
| End date | 2022-10-30 |
Datasets: + CPRD/UHB linkage file (pseudonymised data only)
Objective for processing
[16 paragraphs unchanged]
CPRD are aware that the powers under the COVID-19 notices are time bound and are due to be reviewed on or before 30 September 2020, and, if not extended, will expire on 30 September 2020. To ensure continuity in terms of governance and approvals for access to the CPRD-linked COVID-19 SGSS/CHESS data, CPRD plan to submit an amendment to their CAG application to secure approval to receive the linked SGSS/CHESS data once the COPI notices expire.
The CPRD-linked COVID-19 SGSS/CHESS data shared under sub-licence will be required to be deleted within 30 days should the COPI notice expire and CAG approval having not been secured.
[3 paragraphs unchanged]
AMENDMENT REQUEST
CPRD would like NHS Digital to act as a Trusted Third Party for data linkage to link GP System data (as supplied by CPRD) to the following datasets which will be sent to NHS Digital by University Hospital Birmingham NHS Foundation Trust (UHB):
• Secondary care data (including demographics, diagnoses, prescriptions, procedures and clinical investigations) for the Birmingham and Solihull Sustainability and Transformation Partnership (STP)
• Screening data from the Birmingham Solihull and Black Country Diabetic Eye Screening Service (BSBCDESS).
These UHB Electronic Health Record data comprise data from a number of different clinical systems held within the Data Controllership of UHB, that are not routinely transferred to NHS Digital, including prescribing systems (PICS), laboratory systems (Telepath), health record noting (PICS/Clinical Portal/Medisoft) and patient administrative system, Imaging modalities (e.g. XRay: MRI: CT: OCT: Retinal photography) and clinically relevant parameters (ECG and EEG)- some data types will have features extracted and stored as structured data. This data provides a more comprehensive view of the provision of healthcare to patients with multiple long-term health conditions. This data contains more detailed data on patients diagnoses including severity of diseases and prescribing of medications only initiated in secondary care.
Both data sources have been added to CPRD’s master dataset list (CAG Section 251 support given January 2019) for linkage on an ongoing call off basis. University Hospitals Birmingham NHS Foundation Trust (UHB) is the data custodian for these data sources.
Processing activities
[2 paragraphs unchanged]
The CPRD Policy for 'Anonymisation and Managing the Risk of Identification in
[32 words unchanged]
with Office of National Statistics (ONS) requirements on use of death registration
data.
data (last reviewed in 2020).
[82 paragraphs unchanged]
AMENDMENT REQUEST
The linkage will be conducted as indicated in steps 1-10 as detailed above. Where NHSD will receive identifiers from UHB (Date of Birth, NHS Number and Study Key) for the Secondary care data and the screening data types and will link the identifiers it receives from GP system providers for CPRD data. NHSD will then provide a bridging file back to CPRD to enable linkage of de-identified coded data.
Expected output
[7 paragraphs unchanged]
Outputs from the studies approved usually have research reports which are submitted to funders (such as the Medical Research
Council) .
Council).
Some outputs will inform discussions with national programmes (such as NHS Cancer
[6 words unchanged]
(such as Cancer Research UK) primary care professionals, policy makers and researchers,
[2 paragraphs unchanged]
AMENDMENT REQUEST
The first project (involving both CPRD and UHB) as an example will use the resultant data for a NIHR funded multimorbidity research study ‘OPTIMising therapies, disease trajectories, and AI assisted clinical management for patients Living with complex multimorbidity (OPTIMAL)’. The study aims to integrate multimodal primary care, secondary care, and prescribing data to develop an Artificial Intelligence tool with the aim of optimising clinical decision making in patients with complex multimorbidity (there will be no automated decision making or profiling, it will be used to create a tool and will not have a direct impact on clinical decisions). This will be done by analysing large, detailed health records of patients who attend GP services and hospitals. These include all diagnoses, disease severity, drugs, blood tests, readings such as blood pressure and specialist tests. Using artificial intelligence methods, model how the different mixes of diseases arise over time. The models may inform what drugs cause or prevent a new disease. This may show if a drug helps improve symptoms of a disease or make them worse. The model may also help predict who may get another disease.
Expected measurable benefits
[36 paragraphs unchanged] AMENDMENT REQUEST The new linkage request may be in the public interest as it may provide a data resource spanning community screening, primary care and secondary care. Linking these datasets across the patient care pathway will hopefully better inform understanding of disease risk, diagnosis, treatment effectiveness and clinical outcomes within a specific patient population. Linkage between the CPRD primary care and UHB secondary care data may enable the formation of a dataset that represents a more holistic view of the patient experience of disease and their journey within the health and care system. Currently a major limitation to most health data analyses is that they only view part of the patient’s health (for example only secondary care, or only primary care), but the combined anonymised database may provide an important new resource to support research for patient benefit that reflects the whole patient journey. The whole pathway approach may enable improved ‘patient centred’ understanding of care pathways, and health service improvements.
Benefits reported
A systematic review (Oyinlola et al 2016) identified 43 CPRD studies that have been used in 25 medical guidance documents. The reviewers found that use of data from the CPRD to inform guidelines has increased in recent years and noted the importance of linking data to extend research to medical conditions that are treated in multiple settings (e.g. primary and secondary care).
There are 3 case studies presented below highlighting how linked CPRD-NHSD data has supported public health research, especially in response to the COVID19 effort. These studies have contributed to the scientific understanding of COVID19 amongst other areas, which in turn will be helpful literature to further research. CPRD’s observational research do not have direct impact on patients but overall adds to the resource of innovative research proposals, which may influence policy or programmes. Observational research can help us understand more about causal associations between treatments and outcomes and more about the world in general. These non-interventional studies have become valuable tools in health because they offer broad ways to answer real-world clinical research and product usage questions.
The study identified national guidelines or guidance published in England from 2000 onwards that referenced studies using data provided by CPRD. The CPRD studies provided evidence of disease epidemiology, incidence/prevalence, pharmacoepidemiology, pharmacovigilance and health utilisation. This also highlighted the increasing trend in the use of healthcare system data to inform clinical practice, especially using the real world evidence through clinical studies.
Case study 1: Higher risks of flu and COVID-19 for cancer survivors.
Reference:
Older individuals and people with certain health conditions are known to be at higher risk of severe illness if they contract viruses such as flu and COVID-19. This includes people who had certain cancers diagnosed recently and are receiving treatments like chemotherapy.
Oyinlola JO, Campbell J, Kousoulis AA. Is real world evidence influencing practice? A systematic review of CPRD research in NICE guidances. BMC Health Serv Res. 2016 Jul 26;16:299.
In the UK there are more than two million cancer survivors. To investigate whether people who had cancer some time ago are also at higher risk from flu and COVID-19 a study was carried out using CPRD data. CPRD GOLD was linked to Hospital Episode Statistics Admitted Patient Care (HES APC) database, cancer registrations from the National Cancer Registration and Analysis Service (NCRAS), death registrations from the Office of National Statistics mortality database, and postcode-based index of Multiple Deprivation data.
Researchers found that survivors from a wide range of cancers are more likely than people in the general population to be hospitalised or die from flu, even several years after their cancer diagnosis. The raised risks were most likely for blood cancer survivors. Because flu and COVID-19 are both respiratory viruses, this suggested that cancer survivors also have a higher risk of severe COVID-19. The study also showed that cancer survivors were more likely to have other diseases that are associated with increased risk of severe COVID-19, such as heart disease, diabetes, respiratory disease and kidney disease.
The findings support the UK policy recommendation to include all blood cancer survivors as one of the priority groups to receive the COVID-19 vaccination. The study findings could also support any work by others to prioritise vaccinations and treatments for longer-term cancer survivors.
Reference 1: Carreira H, Strongman H, Peppa M, McDonald H, dos-Santos-Silva I, Stanway S, Smeeth L, Bhaskaran K. Prevalence of COVID-19-related risk factors and risk of severe influenza outcomes in cancer survivors: a matched cohort study using linked UK electronic health records data. EClinicalMedicine, Volume 29, 100656, December 2020. https://doi.org/10.1016/j.eclinm.2020.100656
Case study 2: Vaccine uptake in pregnancy
Vaccination is an effective way to prevent infectious diseases. However, people with certain social characteristics – such as those living in more deprived areas – may be less likely to receive vaccination. Addressing inequalities in vaccine uptake to prevent infections is a key priority for public health.
This cohort study examined the social factors that may be associated with lower uptake of flu vaccine and whooping cough vaccine by pregnant women. It considered a range of social determinants including maternal age, ethnicity, socioeconomic status, number of children in the household and region.
The study used linkages between CPRD data, the CPRD GOLD Pregnancy Register, Hospital Episode Statistics (HES) and Office of National Statistics (ONS) small-area-level deprivation data.
The researchers concluded that more targeted campaigns have the potential to reduce vaccine-preventable disease among infants and pregnant women, and to reduce health inequalities.
Identifying social factors that are associated with lower vaccination rates could help to design programmes to improve vaccine uptake for specific groups of individuals.
Reference 2: Walker et al. Social determinants of pertussis and influenza vaccine uptake in pregnancy: a national cohort study in England using electronic health records. BMJ Open 2021;11:e046545. https://doi.org/10.1136/bmjopen-2020-046545
Case study 3: Health of mothers of children with a life-limiting condition
More than 86,000 children and young people in England are now living with medical conditions that may ultimately shorten their life and cause death in childhood or young adulthood. Mothers of children with a severe health condition or whose child has died are more likely themselves to die earlier than other mothers.
The lack of studies quantifying the mental health of mothers of children with a life-limiting condition has been highlighted by the National Institute for Health and Care Excellence.
In this first part of a larger research programme, researchers used CPRD data to investigate the types of physical and psychological health conditions diagnosed in mothers of children with a life-limiting condition. The CPRD GOLD Pregnancy Register was used to link mothers and their children's healthcare data.
The study also used linkages to Hospital Episodes Statistics (HES), Mental Health Minimum Dataset (MHMDS) and Office for National Statistics (ONS) death certificate data.
The study concluded that mothers of children with life-limiting conditions have much higher rates of physical health problems, mental illness, and death.
These findings were flagged as an ‘Alert’ for important research by the NIHR. Prior to this study, little research had explored the health of this group of women. Knowing more about the health problems that the women experience could help in the design of specific healthcare interventions.
Reference 3: Fraser et al. Health of mothers of children with a life-limiting condition: a comparative cohort study. Archives of Disease in Childhood 2021;106:987-993. http://dx.doi.org/10.1136/archdischild-2020-320655
• NIHR Evidence - Mothers of children with life-limiting conditions are at risk of serious health problems - Informative and accessible health and care research
Objective for processing
The controller for GDPR purposes is the Department of Health and Social Care (DHSC); the legal signatory for this agreement (and for the overarching DSFC) is the Secretary of State for Health and Social Care (acting as part of the Crown), acting through the Clinical Practice Research Datalink centre (hereinafter referred to as CPRD) within the Medicines and Healthcare products Regulatory Agency (the agency); and the licensee is CPRD, not the wider DHSC nor the agency.
The Clinical Practice Research Datalink (CPRD) is a centre of the Medicines and Healthcare products Regulatory Agency (the agency), an executive agency of the Department of Health and Social Care (DHSC). The agency regulates medicines, medical devices and blood components for transfusion in the UK and the agency acts as the Executive agency.
The Clinical Practice Research Datalink (CPRD) is a government not for profit research organisation, jointly supported by the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute of Health Research (NIHR), supplying anonymised health data for studies to safeguard and improve patient and public health. For more than 30 years, CPRD data have supported vital research into health care delivery, drug safety, effectiveness of medicines and risk factors for disease. The data supplied by NHS Digital and released by CPRD under the NHS Digital sub-licence can only be used for public health research purposes in accordance with Article 6(1)(e) and Article 9(2)(j).
Research using CPRD data has resulted in over 2,400 peer-reviewed publications, which have informed drug safety guidance and best clinical practice. Examples of research findings used in everyday NHS care include demonstrating the protective effect of whooping cough vaccination in pregnancy for infants and informing the National Institute of Health and Care Excellence (NICE) blood pressure targets for patients with diabetes. A searchable list of the users and uses of CPRD data is published on the CPRD website. CPRD’s research and data services are based on a database of de-identified longitudinal primary care records contributed by participating GP practices from the four UK nations. Approval to supply anonymised data for public health research is granted on an annual basis by the East Midlands and Derby Research Ethics Committee (REC).
CPRD provides access to anonymised primary care data linked to secondary health care datasets. Linked data greatly increases the scale, depth, completeness and value of data available for public health research. The outputs of such research based on linked data inform clinical guidance and best practice for patients in the UK.
Secondary healthcare datasets are provided by NHS Digital and other data custodians and these data are linked to the primary care data by NHS Digital. NHS Digital receives identifiers to enable them to carry out this linkage as described below in section 3, according to the method described used for this linkage is described in the following paper: Padmanabhan S, Carty L, Cameron E, Ghosh RE, Williams R, Strongman H. Approach to record linkage of primary care data from Clinical Practice Research Datalink to other health-related patient data: overview and implications. Eur J Epidemiol, 15 Sep 2018, 34(1):91-99. Continued support is given by Confidentiality Advisory Group (CAG) for the flow of identifiers to NHS Digital to enable linkage of CPRD primary care data to secondary datasets.
The legal bases for processing the data provided by NHS Digital are:
• Gathering of GP patient data and collation with other datasets to produce datasets that have been anonymised: medical research under Article 9(2)(j); drug and device safety under Article 9(2)(i) of the General Data Protection Regulation.
NHS Digital has been providing and linking health-related datasets to CPRD primary care data for a number of years. Data linkage is carried out exclusively by NHS Digital as the Trusted Third Party (TTP) for this purpose. Linked datasets currently available include extracts from Civil Registration data; Hospital Episode Statistics (HES), which encompasses Admitted Patient Care, Critical Care, Outpatient and Accident & Emergency data; Patient Reported Outcome Measures (PROMs); Diagnostic Imaging Dataset (DID); Mental Health data; National Cancer Registry; National Asthma and COPD Audit Programme (NACAP) audit data, Deprivation data including Townsend Score and Index of Multiple Deprivation. Critical care is supplied as a separate dataset by NHS Digital, but is integrated with Admitted Patient Care.
CPRD also link with the following datasets:
1) PHE’s Second Generation Surveillance System (SGSS) data (specifically the COVID-19 test result data, including future serological testing as well as current antigen testing)
and
2) PHE’s COVID-19 Hospitalisation in England Surveillance System (CHESS); both datasets are already held by NHSD.
Research using CPRD data and services informs clinical guidance and best practice related to drug safety, use of medicines, effectiveness of health policy, health care delivery and disease risk factors. With respect to COVID-19, and as per Regulation 3(1) of the COVID-19 notice, research using the linked CPRD primary care and COVID-19 SGSS/CHESS data would enable researchers to understand COVID-19 and risks to public health, trends in COVID-19 and COVID-19 risk factors, to inform the control and prevention of the spread of COVID-19. Linkage of the COVID-19 testing data to patient medical histories available in CPRD primary care databases would facilitate the identification and understanding about patients or potential patients with, or at risk of COVID-19, about incidents of patient exposure to COVID-19 and the management of patients with or at risk of COVID-19, including real world monitoring of such patients, and longitudinal collection of information about efficacy of treatment, medical and social interventions and recovery from COVID-19.
Similarly, the primary care and routinely linked HES data would permit research which would expand CPRDs understanding about patient access to health services and the need for wider care of patients and vulnerable groups as a direct or indirect result of COVID-19 and the availability and capacity of those services or that care.
The linkage has been permitted by PHE and should be conducted under the recent Coronavirus (COVID-19) notices under reg 3(4) of the Health Service Control of Patient Information Regulations 2002 which allows the regulation 3 surveillance data’s ‘confidential patient information to be processed… for a COVID-19 Purpose… in accordance with regulation 7’ for research purposes. The general COPI notice covers the provision and use of GP identifiers while the NHSD-specific COPI notice would cover the provision and use of the relevant identifiers from SGSS/CHESS for the linkage; the NHSD COPI notice would also cover the actual linkage process of the two streams of identifiers for the purposes of COVID-19 research – as is the case here. The release of the linker file and the associated anonymised clinical data to CPRD does not involve confidential patient information (CPI).
CPRD also links data with the ICNARC CMP data which are managed (collection and processing) by ICNARC, who is the data custodian.
The Intensive Care National Audit and Research Centre (ICNARC) Case Mix Programme (CMP) data has been added to CPRD’s master dataset list (support given by HRA CAG in June 2020) for linkage on an ongoing basis. ICNARC also have support to process confidential patient information for the Case Mix Programme.
This will include research questions that seek to study serious outcomes of disease involving admission to critical care or longer-term outcomes of interventions in intensive care. The linked data will allow studies which need information on risk factors, treatments or longer-term outcomes that are recorded in the primary care data as well as treatments and outcomes recorded in critical care. For instance, survival models can be developed to describe the association between key pre-morbid clinical factors (e.g. sociodemographics, comorbidities, prescribing, other clinical factors) and outcomes relating to critical care admission, critical care survival, and length of critical care stay.
AMENDMENT REQUEST
CPRD would like NHS Digital to act as a Trusted Third Party for data linkage to link GP System data (as supplied by CPRD) to the following datasets which will be sent to NHS Digital by University Hospital Birmingham NHS Foundation Trust (UHB):
• Secondary care data (including demographics, diagnoses, prescriptions, procedures and clinical investigations) for the Birmingham and Solihull Sustainability and Transformation Partnership (STP)
• Screening data from the Birmingham Solihull and Black Country Diabetic Eye Screening Service (BSBCDESS).
These UHB Electronic Health Record data comprise data from a number of different clinical systems held within the Data Controllership of UHB, that are not routinely transferred to NHS Digital, including prescribing systems (PICS), laboratory systems (Telepath), health record noting (PICS/Clinical Portal/Medisoft) and patient administrative system, Imaging modalities (e.g. XRay: MRI: CT: OCT: Retinal photography) and clinically relevant parameters (ECG and EEG)- some data types will have features extracted and stored as structured data. This data provides a more comprehensive view of the provision of healthcare to patients with multiple long-term health conditions. This data contains more detailed data on patients diagnoses including severity of diseases and prescribing of medications only initiated in secondary care.
Both data sources have been added to CPRD’s master dataset list (CAG Section 251 support given January 2019) for linkage on an ongoing call off basis. University Hospitals Birmingham NHS Foundation Trust (UHB) is the data custodian for these data sources.
Expected output
CPRD customers using linked data products will be producing (on an ongoing basis) research publications in peer-reviewed journals and presentations at scientific conferences. CPRD customers include academic institutions, pharmaceutical companies, Governmental centres and research charities. These all undertake medical and health data research, which may result in formal publications.
All data included in such outputs by CPRD customers will be aggregated, with small numbers suppressed in line with the HES Analysis Guide (or dataset specific suppression controls).
A selection of publications resulting from use of CPRD linked data are presented below.
Akyea RK, Kai J, Qureshi N, Iyen B, Weng SF. Sub-optimal cholesterol response to initiation of statins and future risk of cardiovascular disease. Heart, 2019; 105:975-981.
Abel KM, Hope H, Swift E, Parisi R, Ashcroft DM, Kosidou K, Osam CS, Dalman C, Pierce M. Prevalence of maternal mental illness among children and adolescents in the UK between 2005 and 2017: a national retrospective cohort analysis. Lancet Public Health, vol. 4, pp. e291-e300, 2019.
Crellin E, Mansfield KE, Leyrat C, Nitsch D, Douglas IJ, Root A, Williamson E, Smeeth L, Tomlinson LA. Trimethoprim use for urinary tract infection and risk of adverse outcomes in older patients: cohort study. BMJ. 2018 Feb 9;360:k341.
Morgan C, Webb RT, Carr MJ, Kontopantelis E, Green J, Chew-Graham CA, Kapur N, Ashcroft DM. Incidence, clinical management, and mortality risk following self harm among children and adolescents: cohort study in primary care. BMJ, Volume 359, p.j4351 (2017).
Outputs from the studies approved usually have research reports which are submitted to funders (such as the Medical Research Council). Some outputs will inform discussions with national programmes (such as NHS Cancer Screening Programmes and NHS Scotland), charities (such as Cancer Research UK) primary care professionals, policy makers and researchers,
In many instances, the papers are also published and are available on Open Access journals. Many of the outputs are also presented at conferences (such as International Society for Pharmacoepidemiology). Many of the outputs have the capacity to not only influence the clinical community but also policy makers, for example clinical guidelines (see Oyinlola et al 2016).
A comprehensive list of publications including those using linked data can be found at www.cprd.com/bibliography
AMENDMENT REQUEST
The first project (involving both CPRD and UHB) as an example will use the resultant data for a NIHR funded multimorbidity research study ‘OPTIMising therapies, disease trajectories, and AI assisted clinical management for patients Living with complex multimorbidity (OPTIMAL)’. The study aims to integrate multimodal primary care, secondary care, and prescribing data to develop an Artificial Intelligence tool with the aim of optimising clinical decision making in patients with complex multimorbidity (there will be no automated decision making or profiling, it will be used to create a tool and will not have a direct impact on clinical decisions). This will be done by analysing large, detailed health records of patients who attend GP services and hospitals. These include all diagnoses, disease severity, drugs, blood tests, readings such as blood pressure and specialist tests. Using artificial intelligence methods, model how the different mixes of diseases arise over time. The models may inform what drugs cause or prevent a new disease. This may show if a drug helps improve symptoms of a disease or make them worse. The model may also help predict who may get another disease.
Benefits reported
There are 3 case studies presented below highlighting how linked CPRD-NHSD data has supported public health research, especially in response to the COVID19 effort. These studies have contributed to the scientific understanding of COVID19 amongst other areas, which in turn will be helpful literature to further research. CPRD’s observational research do not have direct impact on patients but overall adds to the resource of innovative research proposals, which may influence policy or programmes. Observational research can help us understand more about causal associations between treatments and outcomes and more about the world in general. These non-interventional studies have become valuable tools in health because they offer broad ways to answer real-world clinical research and product usage questions.
Case study 1: Higher risks of flu and COVID-19 for cancer survivors.
Older individuals and people with certain health conditions are known to be at higher risk of severe illness if they contract viruses such as flu and COVID-19. This includes people who had certain cancers diagnosed recently and are receiving treatments like chemotherapy.
In the UK there are more than two million cancer survivors. To investigate whether people who had cancer some time ago are also at higher risk from flu and COVID-19 a study was carried out using CPRD data. CPRD GOLD was linked to Hospital Episode Statistics Admitted Patient Care (HES APC) database, cancer registrations from the National Cancer Registration and Analysis Service (NCRAS), death registrations from the Office of National Statistics mortality database, and postcode-based index of Multiple Deprivation data.
Researchers found that survivors from a wide range of cancers are more likely than people in the general population to be hospitalised or die from flu, even several years after their cancer diagnosis. The raised risks were most likely for blood cancer survivors. Because flu and COVID-19 are both respiratory viruses, this suggested that cancer survivors also have a higher risk of severe COVID-19. The study also showed that cancer survivors were more likely to have other diseases that are associated with increased risk of severe COVID-19, such as heart disease, diabetes, respiratory disease and kidney disease.
The findings support the UK policy recommendation to include all blood cancer survivors as one of the priority groups to receive the COVID-19 vaccination. The study findings could also support any work by others to prioritise vaccinations and treatments for longer-term cancer survivors.
Reference 1: Carreira H, Strongman H, Peppa M, McDonald H, dos-Santos-Silva I, Stanway S, Smeeth L, Bhaskaran K. Prevalence of COVID-19-related risk factors and risk of severe influenza outcomes in cancer survivors: a matched cohort study using linked UK electronic health records data. EClinicalMedicine, Volume 29, 100656, December 2020. https://doi.org/10.1016/j.eclinm.2020.100656
Case study 2: Vaccine uptake in pregnancy
Vaccination is an effective way to prevent infectious diseases. However, people with certain social characteristics – such as those living in more deprived areas – may be less likely to receive vaccination. Addressing inequalities in vaccine uptake to prevent infections is a key priority for public health.
This cohort study examined the social factors that may be associated with lower uptake of flu vaccine and whooping cough vaccine by pregnant women. It considered a range of social determinants including maternal age, ethnicity, socioeconomic status, number of children in the household and region.
The study used linkages between CPRD data, the CPRD GOLD Pregnancy Register, Hospital Episode Statistics (HES) and Office of National Statistics (ONS) small-area-level deprivation data.
The researchers concluded that more targeted campaigns have the potential to reduce vaccine-preventable disease among infants and pregnant women, and to reduce health inequalities.
Identifying social factors that are associated with lower vaccination rates could help to design programmes to improve vaccine uptake for specific groups of individuals.
Reference 2: Walker et al. Social determinants of pertussis and influenza vaccine uptake in pregnancy: a national cohort study in England using electronic health records. BMJ Open 2021;11:e046545. https://doi.org/10.1136/bmjopen-2020-046545
Case study 3: Health of mothers of children with a life-limiting condition
More than 86,000 children and young people in England are now living with medical conditions that may ultimately shorten their life and cause death in childhood or young adulthood. Mothers of children with a severe health condition or whose child has died are more likely themselves to die earlier than other mothers.
The lack of studies quantifying the mental health of mothers of children with a life-limiting condition has been highlighted by the National Institute for Health and Care Excellence.
In this first part of a larger research programme, researchers used CPRD data to investigate the types of physical and psychological health conditions diagnosed in mothers of children with a life-limiting condition. The CPRD GOLD Pregnancy Register was used to link mothers and their children's healthcare data.
The study also used linkages to Hospital Episodes Statistics (HES), Mental Health Minimum Dataset (MHMDS) and Office for National Statistics (ONS) death certificate data.
The study concluded that mothers of children with life-limiting conditions have much higher rates of physical health problems, mental illness, and death.
These findings were flagged as an ‘Alert’ for important research by the NIHR. Prior to this study, little research had explored the health of this group of women. Knowing more about the health problems that the women experience could help in the design of specific healthcare interventions.
Reference 3: Fraser et al. Health of mothers of children with a life-limiting condition: a comparative cohort study. Archives of Disease in Childhood 2021;106:987-993. http://dx.doi.org/10.1136/archdischild-2020-320655
• NIHR Evidence - Mothers of children with life-limiting conditions are at risk of serious health problems - Informative and accessible health and care research
DARS-NIC-15625-T8K6L-v10.4 1 May 2021 to 30 April 2022
- Title
- R23 - Clinical Practice Research Datalink (CPRD) Routine Linkages Application
- Commercial
- No
- Sublicensing
- Yes
- Datasets
- 20
- Files released
- 284
Datasets: Bridge file: Hospital Episode Statistics to Diagnostic Imaging Dataset; Bridge file: Hospital Episode Statistics to Mental Health Minimum Data Set; Civil Registrations of Death - Secondary Care Cut; COVID-19 Hospitalization in England Surveillance System; COVID-19 SGSS First Positives (Second Generation Surveillance System); Diagnostic Imaging Data Set (DID); Emergency Care Data Set (ECDS); HES-ID to MPS-ID HES Accident and Emergency; HES-ID to MPS-ID HES Admitted Patient Care; HES-ID to MPS-ID HES Outpatients; HES:Civil Registration (Deaths) bridge; Hospital Episode Statistics Accident and Emergency (HES A and E); Hospital Episode Statistics Admitted Patient Care (HES APC); Hospital Episode Statistics Critical Care (HES Critical Care); Hospital Episode Statistics Outpatients (HES OP); Mental Health and Learning Disabilities Data Set (MHLDDS); Mental Health Minimum Data Set (MHMDS); Mental Health Services Data Set (MHSDS); MRIS - Bespoke; Patient Reported Outcome Measures (Linkable to HES)
What changed from DARS-NIC-15625-T8K6L-v9.2
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2021-05-01 | |
| End date | 2022-04-30 | |
| Emergency Care Data Set (ECDS): sensitivity | Non-Sensitive |
Datasets: + HES-ID to MPS-ID HES Accident and Emergency; + HES-ID to MPS-ID HES Admitted Patient Care; + HES-ID to MPS-ID HES Outpatients
Unchanged: Objective for processing, Processing activities, Expected output, Expected measurable benefits, Benefits reported.
Objective for processing
The controller for GDPR purposes is the Department of Health and Social Care (DHSC); the legal signatory for this agreement (and for the overarching DSFC) is the Secretary of State for Health and Social Care (acting as part of the Crown), acting through the Clinical Practice Research Datalink centre (hereinafter referred to as CPRD) within the Medicines and Healthcare products Regulatory Agency (the agency); and the licensee is CPRD, not the wider DHSC nor the agency.
The Clinical Practice Research Datalink (CPRD) is a centre of the Medicines and Healthcare products Regulatory Agency (the agency), an executive agency of the Department of Health and Social Care (DHSC). The agency regulates medicines, medical devices and blood components for transfusion in the UK and the agency acts as the Executive agency.
The Clinical Practice Research Datalink (CPRD) is a government not for profit research organisation, jointly supported by the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute of Health Research (NIHR), supplying anonymised health data for studies to safeguard and improve patient and public health. For more than 30 years, CPRD data have supported vital research into health care delivery, drug safety, effectiveness of medicines and risk factors for disease. The data supplied by NHS Digital and released by CPRD under the NHS Digital sub-licence can only be used for public health research purposes in accordance with Article 6(1)(e) and Article 9(2)(j).
Research using CPRD data has resulted in over 2,400 peer-reviewed publications, which have informed drug safety guidance and best clinical practice. Examples of research findings used in everyday NHS care include demonstrating the protective effect of whooping cough vaccination in pregnancy for infants and informing the National Institute of Health and Care Excellence (NICE) blood pressure targets for patients with diabetes. A searchable list of the users and uses of CPRD data is published on the CPRD website. CPRD’s research and data services are based on a database of de-identified longitudinal primary care records contributed by participating GP practices from the four UK nations. Approval to supply anonymised data for public health research is granted on an annual basis by the East Midlands and Derby Research Ethics Committee (REC).
CPRD provides access to anonymised primary care data linked to secondary health care datasets. Linked data greatly increases the scale, depth, completeness and value of data available for public health research. The outputs of such research based on linked data inform clinical guidance and best practice for patients in the UK.
Secondary healthcare datasets are provided by NHS Digital and other data custodians and these data are linked to the primary care data by NHS Digital. NHS Digital receives identifiers to enable them to carry out this linkage as described below in section 3, according to the method described used for this linkage is described in the following paper: Padmanabhan S, Carty L, Cameron E, Ghosh RE, Williams R, Strongman H. Approach to record linkage of primary care data from Clinical Practice Research Datalink to other health-related patient data: overview and implications. Eur J Epidemiol, 15 Sep 2018, 34(1):91-99. Continued support is given by Confidentiality Advisory Group (CAG) for the flow of identifiers to NHS Digital to enable linkage of CPRD primary care data to secondary datasets.
The legal bases for processing the data provided by NHS Digital are:
• Gathering of GP patient data and collation with other datasets to produce datasets that have been anonymised: medical research under Article 9(2)(j); drug and device safety under Article 9(2)(i) of the General Data Protection Regulation.
NHS Digital has been providing and linking health-related datasets to CPRD primary care data for a number of years. Data linkage is carried out exclusively by NHS Digital as the Trusted Third Party (TTP) for this purpose. Linked datasets currently available include extracts from Civil Registration data; Hospital Episode Statistics (HES), which encompasses Admitted Patient Care, Critical Care, Outpatient and Accident & Emergency data; Patient Reported Outcome Measures (PROMs); Diagnostic Imaging Dataset (DID); Mental Health data; National Cancer Registry; National Asthma and COPD Audit Programme (NACAP) audit data, Deprivation data including Townsend Score and Index of Multiple Deprivation. Critical care is supplied as a separate dataset by NHS Digital, but is integrated with Admitted Patient Care.
CPRD also link with the following datasets:
1) PHE’s Second Generation Surveillance System (SGSS) data (specifically the COVID-19 test result data, including future serological testing as well as current antigen testing)
and
2) PHE’s COVID-19 Hospitalisation in England Surveillance System (CHESS); both datasets are already held by NHSD.
Research using CPRD data and services informs clinical guidance and best practice related to drug safety, use of medicines, effectiveness of health policy, health care delivery and disease risk factors. With respect to COVID-19, and as per Regulation 3(1) of the COVID-19 notice, research using the linked CPRD primary care and COVID-19 SGSS/CHESS data would enable researchers to understand COVID-19 and risks to public health, trends in COVID-19 and COVID-19 risk factors, to inform the control and prevention of the spread of COVID-19. Linkage of the COVID-19 testing data to patient medical histories available in CPRD primary care databases would facilitate the identification and understanding about patients or potential patients with, or at risk of COVID-19, about incidents of patient exposure to COVID-19 and the management of patients with or at risk of COVID-19, including real world monitoring of such patients, and longitudinal collection of information about efficacy of treatment, medical and social interventions and recovery from COVID-19.
Similarly, the primary care and routinely linked HES data would permit research which would expand CPRDs understanding about patient access to health services and the need for wider care of patients and vulnerable groups as a direct or indirect result of COVID-19 and the availability and capacity of those services or that care.
The linkage has been permitted by PHE and should be conducted under the recent Coronavirus (COVID-19) notices under reg 3(4) of the Health Service Control of Patient Information Regulations 2002 which allows the regulation 3 surveillance data’s ‘confidential patient information to be processed… for a COVID-19 Purpose… in accordance with regulation 7’ for research purposes. The general COPI notice covers the provision and use of GP identifiers while the NHSD-specific COPI notice would cover the provision and use of the relevant identifiers from SGSS/CHESS for the linkage; the NHSD COPI notice would also cover the actual linkage process of the two streams of identifiers for the purposes of COVID-19 research – as is the case here. The release of the linker file and the associated anonymised clinical data to CPRD does not involve confidential patient information (CPI).
CPRD are aware that the powers under the COVID-19 notices are time bound and are due to be reviewed on or before 30 September 2020, and, if not extended, will expire on 30 September 2020. To ensure continuity in terms of governance and approvals for access to the CPRD-linked COVID-19 SGSS/CHESS data, CPRD plan to submit an amendment to their CAG application to secure approval to receive the linked SGSS/CHESS data once the COPI notices expire.
The CPRD-linked COVID-19 SGSS/CHESS data shared under sub-licence will be required to be deleted within 30 days should the COPI notice expire and CAG approval having not been secured.
CPRD also links data with the ICNARC CMP data which are managed (collection and processing) by ICNARC, who is the data custodian.
The Intensive Care National Audit and Research Centre (ICNARC) Case Mix Programme (CMP) data has been added to CPRD’s master dataset list (support given by HRA CAG in June 2020) for linkage on an ongoing basis. ICNARC also have support to process confidential patient information for the Case Mix Programme.
This will include research questions that seek to study serious outcomes of disease involving admission to critical care or longer-term outcomes of interventions in intensive care. The linked data will allow studies which need information on risk factors, treatments or longer-term outcomes that are recorded in the primary care data as well as treatments and outcomes recorded in critical care. For instance, survival models can be developed to describe the association between key pre-morbid clinical factors (e.g. sociodemographics, comorbidities, prescribing, other clinical factors) and outcomes relating to critical care admission, critical care survival, and length of critical care stay.
Expected output
CPRD customers using linked data products will be producing (on an ongoing basis) research publications in peer-reviewed journals and presentations at scientific conferences. CPRD customers include academic institutions, pharmaceutical companies, Governmental centres and research charities. These all undertake medical and health data research, which may result in formal publications.
All data included in such outputs by CPRD customers will be aggregated, with small numbers suppressed in line with the HES Analysis Guide (or dataset specific suppression controls).
A selection of publications resulting from use of CPRD linked data are presented below.
Akyea RK, Kai J, Qureshi N, Iyen B, Weng SF. Sub-optimal cholesterol response to initiation of statins and future risk of cardiovascular disease. Heart, 2019; 105:975-981.
Abel KM, Hope H, Swift E, Parisi R, Ashcroft DM, Kosidou K, Osam CS, Dalman C, Pierce M. Prevalence of maternal mental illness among children and adolescents in the UK between 2005 and 2017: a national retrospective cohort analysis. Lancet Public Health, vol. 4, pp. e291-e300, 2019.
Crellin E, Mansfield KE, Leyrat C, Nitsch D, Douglas IJ, Root A, Williamson E, Smeeth L, Tomlinson LA. Trimethoprim use for urinary tract infection and risk of adverse outcomes in older patients: cohort study. BMJ. 2018 Feb 9;360:k341.
Morgan C, Webb RT, Carr MJ, Kontopantelis E, Green J, Chew-Graham CA, Kapur N, Ashcroft DM. Incidence, clinical management, and mortality risk following self harm among children and adolescents: cohort study in primary care. BMJ, Volume 359, p.j4351 (2017).
Outputs from the studies approved usually have research reports which are submitted to funders (such as the Medical Research Council) . Some outputs will inform discussions with national programmes (such as NHS Cancer Screening Programmes and NHS Scotland), charities (such as Cancer Research UK) primary care professionals, policy makers and researchers,
In many instances, the papers are also published and are available on Open Access journals. Many of the outputs are also presented at conferences (such as International Society for Pharmacoepidemiology). Many of the outputs have the capacity to not only influence the clinical community but also policy makers, for example clinical guidelines (see Oyinlola et al 2016).
A comprehensive list of publications including those using linked data can be found at www.cprd.com/bibliography
Benefits reported
A systematic review (Oyinlola et al 2016) identified 43 CPRD studies that have been used in 25 medical guidance documents. The reviewers found that use of data from the CPRD to inform guidelines has increased in recent years and noted the importance of linking data to extend research to medical conditions that are treated in multiple settings (e.g. primary and secondary care).
The study identified national guidelines or guidance published in England from 2000 onwards that referenced studies using data provided by CPRD. The CPRD studies provided evidence of disease epidemiology, incidence/prevalence, pharmacoepidemiology, pharmacovigilance and health utilisation. This also highlighted the increasing trend in the use of healthcare system data to inform clinical practice, especially using the real world evidence through clinical studies.
Reference:
Oyinlola JO, Campbell J, Kousoulis AA. Is real world evidence influencing practice? A systematic review of CPRD research in NICE guidances. BMC Health Serv Res. 2016 Jul 26;16:299.
DARS-NIC-15625-T8K6L-v9.2 1 February 2021 to 30 April 2021
- Title
- R23 - Clinical Practice Research Datalink (CPRD) Routine Linkages Application
- Commercial
- No
- Sublicensing
- Yes
- Datasets
- 17
- Files released
- 2
Datasets: Bridge file: Hospital Episode Statistics to Diagnostic Imaging Dataset; Bridge file: Hospital Episode Statistics to Mental Health Minimum Data Set; Civil Registrations of Death - Secondary Care Cut; COVID-19 Hospitalization in England Surveillance System; COVID-19 SGSS First Positives (Second Generation Surveillance System); Diagnostic Imaging Data Set (DID); Emergency Care Data Set (ECDS); HES:Civil Registration (Deaths) bridge; Hospital Episode Statistics Accident and Emergency (HES A and E); Hospital Episode Statistics Admitted Patient Care (HES APC); Hospital Episode Statistics Critical Care (HES Critical Care); Hospital Episode Statistics Outpatients (HES OP); Mental Health and Learning Disabilities Data Set (MHLDDS); Mental Health Minimum Data Set (MHMDS); Mental Health Services Data Set (MHSDS); MRIS - Bespoke; Patient Reported Outcome Measures (Linkable to HES)
What changed from DARS-NIC-15625-T8K6L-v8.2
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2021-02-01 | |
| End date | 2021-04-30 | |
| Bridge file: Hospital Episode Statistics to Diagnostic Imaging Dataset: legal basis | Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'. | |
| Bridge file: Hospital Episode Statistics to Mental Health Minimum Data Set: legal basis | Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'. | |
| Civil Registrations of Death - Secondary Care Cut: legal basis | Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'. | |
| Diagnostic Imaging Data Set (DID): legal basis | Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'. | |
| Emergency Care Data Set (ECDS): legal basis | Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'. | |
| HES:Civil Registration (Deaths) bridge: legal basis | Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'. | |
| Hospital Episode Statistics Accident and Emergency (HES A and E): legal basis | Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'. | |
| Hospital Episode Statistics Admitted Patient Care (HES APC): legal basis | Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'. | |
| Hospital Episode Statistics Critical Care (HES Critical Care): legal basis | Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'. | |
| Hospital Episode Statistics Outpatients (HES OP): legal basis | Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'. | |
| MRIS - Bespoke: legal basis | Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'. | |
| Mental Health Minimum Data Set (MHMDS): legal basis | Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'. | |
| Mental Health Services Data Set (MHSDS): legal basis | Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'. | |
| Mental Health and Learning Disabilities Data Set (MHLDDS): legal basis | Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'. | |
| Patient Reported Outcome Measures (Linkable to HES): legal basis | Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'. |
Objective for processing
[18 paragraphs unchanged]
Amendment Request
CPRD also links data with the ICNARC CMP data which are managed (collection and processing) by ICNARC, who is the data custodian.
CPRD would like to extend its current DSA approval to include linkage with the ICNARC CMP data which are managed (collection and processing) by ICNARC, who is the data custodian.
[2 paragraphs unchanged]
Processing activities
[28 paragraphs unchanged]
(iv) Data release - the linked data is cut by CPRD to
[22 words unchanged]
different patient key at release where required, establishing yet another layer of
seperation.
separation.
[34 paragraphs unchanged]
Data destruction standards (currently, NHS Digital ’Destruction and Disposal of Sensitive Data’
[38 words unchanged]
PCI DSS, HIPAA, SOX, ISO 27001 and the EU General Data Protection
Regulation including ISO27001.
Regulation.
[10 paragraphs unchanged]
12) Addition of new data linkage
The linkage will be conducted as indicated in steps 1-10. By linking patient records from ICNARC CMP with records in the CPRD database. This linkage is expected to occur using in the same method as other linkages for which NHSD is a Trusted Third-Party data processor. ICNARC will send Identifiers (NHS number, Date of Birth, gender and postcode) plus an ICNARC CMP pseudonym to NHSD for patients. NHSD will then link to CPRD identifiers (NHS number, Date of Birth, gender and postcode) plus GP system pseudonyms and provide CPRD will the bridging file, which contains the ICNARC pseudonyms, GP system pseudonyms and match rank.
[11 paragraphs unchanged]
Expected measurable benefits
[34 paragraphs unchanged]
Amendment Request:
Benefit of ICNARC CMP linkage:
The
amendment
linkage
is in the public interest as it will permit health research requiring
[86 words unchanged]
for e.g. intermediate care options, decisions regarding stepping down of care etc.
Unchanged: Expected output, Benefits reported.
Objective for processing
The controller for GDPR purposes is the Department of Health and Social Care (DHSC); the legal signatory for this agreement (and for the overarching DSFC) is the Secretary of State for Health and Social Care (acting as part of the Crown), acting through the Clinical Practice Research Datalink centre (hereinafter referred to as CPRD) within the Medicines and Healthcare products Regulatory Agency (the agency); and the licensee is CPRD, not the wider DHSC nor the agency.
The Clinical Practice Research Datalink (CPRD) is a centre of the Medicines and Healthcare products Regulatory Agency (the agency), an executive agency of the Department of Health and Social Care (DHSC). The agency regulates medicines, medical devices and blood components for transfusion in the UK and the agency acts as the Executive agency.
The Clinical Practice Research Datalink (CPRD) is a government not for profit research organisation, jointly supported by the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute of Health Research (NIHR), supplying anonymised health data for studies to safeguard and improve patient and public health. For more than 30 years, CPRD data have supported vital research into health care delivery, drug safety, effectiveness of medicines and risk factors for disease. The data supplied by NHS Digital and released by CPRD under the NHS Digital sub-licence can only be used for public health research purposes in accordance with Article 6(1)(e) and Article 9(2)(j).
Research using CPRD data has resulted in over 2,400 peer-reviewed publications, which have informed drug safety guidance and best clinical practice. Examples of research findings used in everyday NHS care include demonstrating the protective effect of whooping cough vaccination in pregnancy for infants and informing the National Institute of Health and Care Excellence (NICE) blood pressure targets for patients with diabetes. A searchable list of the users and uses of CPRD data is published on the CPRD website. CPRD’s research and data services are based on a database of de-identified longitudinal primary care records contributed by participating GP practices from the four UK nations. Approval to supply anonymised data for public health research is granted on an annual basis by the East Midlands and Derby Research Ethics Committee (REC).
CPRD provides access to anonymised primary care data linked to secondary health care datasets. Linked data greatly increases the scale, depth, completeness and value of data available for public health research. The outputs of such research based on linked data inform clinical guidance and best practice for patients in the UK.
Secondary healthcare datasets are provided by NHS Digital and other data custodians and these data are linked to the primary care data by NHS Digital. NHS Digital receives identifiers to enable them to carry out this linkage as described below in section 3, according to the method described used for this linkage is described in the following paper: Padmanabhan S, Carty L, Cameron E, Ghosh RE, Williams R, Strongman H. Approach to record linkage of primary care data from Clinical Practice Research Datalink to other health-related patient data: overview and implications. Eur J Epidemiol, 15 Sep 2018, 34(1):91-99. Continued support is given by Confidentiality Advisory Group (CAG) for the flow of identifiers to NHS Digital to enable linkage of CPRD primary care data to secondary datasets.
The legal bases for processing the data provided by NHS Digital are:
• Gathering of GP patient data and collation with other datasets to produce datasets that have been anonymised: medical research under Article 9(2)(j); drug and device safety under Article 9(2)(i) of the General Data Protection Regulation.
NHS Digital has been providing and linking health-related datasets to CPRD primary care data for a number of years. Data linkage is carried out exclusively by NHS Digital as the Trusted Third Party (TTP) for this purpose. Linked datasets currently available include extracts from Civil Registration data; Hospital Episode Statistics (HES), which encompasses Admitted Patient Care, Critical Care, Outpatient and Accident & Emergency data; Patient Reported Outcome Measures (PROMs); Diagnostic Imaging Dataset (DID); Mental Health data; National Cancer Registry; National Asthma and COPD Audit Programme (NACAP) audit data, Deprivation data including Townsend Score and Index of Multiple Deprivation. Critical care is supplied as a separate dataset by NHS Digital, but is integrated with Admitted Patient Care.
CPRD also link with the following datasets:
1) PHE’s Second Generation Surveillance System (SGSS) data (specifically the COVID-19 test result data, including future serological testing as well as current antigen testing)
and
2) PHE’s COVID-19 Hospitalisation in England Surveillance System (CHESS); both datasets are already held by NHSD.
Research using CPRD data and services informs clinical guidance and best practice related to drug safety, use of medicines, effectiveness of health policy, health care delivery and disease risk factors. With respect to COVID-19, and as per Regulation 3(1) of the COVID-19 notice, research using the linked CPRD primary care and COVID-19 SGSS/CHESS data would enable researchers to understand COVID-19 and risks to public health, trends in COVID-19 and COVID-19 risk factors, to inform the control and prevention of the spread of COVID-19. Linkage of the COVID-19 testing data to patient medical histories available in CPRD primary care databases would facilitate the identification and understanding about patients or potential patients with, or at risk of COVID-19, about incidents of patient exposure to COVID-19 and the management of patients with or at risk of COVID-19, including real world monitoring of such patients, and longitudinal collection of information about efficacy of treatment, medical and social interventions and recovery from COVID-19.
Similarly, the primary care and routinely linked HES data would permit research which would expand CPRDs understanding about patient access to health services and the need for wider care of patients and vulnerable groups as a direct or indirect result of COVID-19 and the availability and capacity of those services or that care.
The linkage has been permitted by PHE and should be conducted under the recent Coronavirus (COVID-19) notices under reg 3(4) of the Health Service Control of Patient Information Regulations 2002 which allows the regulation 3 surveillance data’s ‘confidential patient information to be processed… for a COVID-19 Purpose… in accordance with regulation 7’ for research purposes. The general COPI notice covers the provision and use of GP identifiers while the NHSD-specific COPI notice would cover the provision and use of the relevant identifiers from SGSS/CHESS for the linkage; the NHSD COPI notice would also cover the actual linkage process of the two streams of identifiers for the purposes of COVID-19 research – as is the case here. The release of the linker file and the associated anonymised clinical data to CPRD does not involve confidential patient information (CPI).
CPRD are aware that the powers under the COVID-19 notices are time bound and are due to be reviewed on or before 30 September 2020, and, if not extended, will expire on 30 September 2020. To ensure continuity in terms of governance and approvals for access to the CPRD-linked COVID-19 SGSS/CHESS data, CPRD plan to submit an amendment to their CAG application to secure approval to receive the linked SGSS/CHESS data once the COPI notices expire.
The CPRD-linked COVID-19 SGSS/CHESS data shared under sub-licence will be required to be deleted within 30 days should the COPI notice expire and CAG approval having not been secured.
CPRD also links data with the ICNARC CMP data which are managed (collection and processing) by ICNARC, who is the data custodian.
The Intensive Care National Audit and Research Centre (ICNARC) Case Mix Programme (CMP) data has been added to CPRD’s master dataset list (support given by HRA CAG in June 2020) for linkage on an ongoing basis. ICNARC also have support to process confidential patient information for the Case Mix Programme.
This will include research questions that seek to study serious outcomes of disease involving admission to critical care or longer-term outcomes of interventions in intensive care. The linked data will allow studies which need information on risk factors, treatments or longer-term outcomes that are recorded in the primary care data as well as treatments and outcomes recorded in critical care. For instance, survival models can be developed to describe the association between key pre-morbid clinical factors (e.g. sociodemographics, comorbidities, prescribing, other clinical factors) and outcomes relating to critical care admission, critical care survival, and length of critical care stay.
Expected output
CPRD customers using linked data products will be producing (on an ongoing basis) research publications in peer-reviewed journals and presentations at scientific conferences. CPRD customers include academic institutions, pharmaceutical companies, Governmental centres and research charities. These all undertake medical and health data research, which may result in formal publications.
All data included in such outputs by CPRD customers will be aggregated, with small numbers suppressed in line with the HES Analysis Guide (or dataset specific suppression controls).
A selection of publications resulting from use of CPRD linked data are presented below.
Akyea RK, Kai J, Qureshi N, Iyen B, Weng SF. Sub-optimal cholesterol response to initiation of statins and future risk of cardiovascular disease. Heart, 2019; 105:975-981.
Abel KM, Hope H, Swift E, Parisi R, Ashcroft DM, Kosidou K, Osam CS, Dalman C, Pierce M. Prevalence of maternal mental illness among children and adolescents in the UK between 2005 and 2017: a national retrospective cohort analysis. Lancet Public Health, vol. 4, pp. e291-e300, 2019.
Crellin E, Mansfield KE, Leyrat C, Nitsch D, Douglas IJ, Root A, Williamson E, Smeeth L, Tomlinson LA. Trimethoprim use for urinary tract infection and risk of adverse outcomes in older patients: cohort study. BMJ. 2018 Feb 9;360:k341.
Morgan C, Webb RT, Carr MJ, Kontopantelis E, Green J, Chew-Graham CA, Kapur N, Ashcroft DM. Incidence, clinical management, and mortality risk following self harm among children and adolescents: cohort study in primary care. BMJ, Volume 359, p.j4351 (2017).
Outputs from the studies approved usually have research reports which are submitted to funders (such as the Medical Research Council) . Some outputs will inform discussions with national programmes (such as NHS Cancer Screening Programmes and NHS Scotland), charities (such as Cancer Research UK) primary care professionals, policy makers and researchers,
In many instances, the papers are also published and are available on Open Access journals. Many of the outputs are also presented at conferences (such as International Society for Pharmacoepidemiology). Many of the outputs have the capacity to not only influence the clinical community but also policy makers, for example clinical guidelines (see Oyinlola et al 2016).
A comprehensive list of publications including those using linked data can be found at www.cprd.com/bibliography
Benefits reported
A systematic review (Oyinlola et al 2016) identified 43 CPRD studies that have been used in 25 medical guidance documents. The reviewers found that use of data from the CPRD to inform guidelines has increased in recent years and noted the importance of linking data to extend research to medical conditions that are treated in multiple settings (e.g. primary and secondary care).
The study identified national guidelines or guidance published in England from 2000 onwards that referenced studies using data provided by CPRD. The CPRD studies provided evidence of disease epidemiology, incidence/prevalence, pharmacoepidemiology, pharmacovigilance and health utilisation. This also highlighted the increasing trend in the use of healthcare system data to inform clinical practice, especially using the real world evidence through clinical studies.
Reference:
Oyinlola JO, Campbell J, Kousoulis AA. Is real world evidence influencing practice? A systematic review of CPRD research in NICE guidances. BMC Health Serv Res. 2016 Jul 26;16:299.
DARS-NIC-15625-T8K6L-v8.2 13 July 2020 to 31 January 2021
- Title
- R23 - Clinical Practice Research Datalink (CPRD) Routine Linkages Application
- Commercial
- No
- Sublicensing
- Yes
- Datasets
- 17
- Files released
- 442
Datasets: Bridge file: Hospital Episode Statistics to Diagnostic Imaging Dataset; Bridge file: Hospital Episode Statistics to Mental Health Minimum Data Set; Civil Registrations of Death - Secondary Care Cut; COVID-19 Hospitalization in England Surveillance System; COVID-19 SGSS First Positives (Second Generation Surveillance System); Diagnostic Imaging Data Set (DID); Emergency Care Data Set (ECDS); HES:Civil Registration (Deaths) bridge; Hospital Episode Statistics Accident and Emergency (HES A and E); Hospital Episode Statistics Admitted Patient Care (HES APC); Hospital Episode Statistics Critical Care (HES Critical Care); Hospital Episode Statistics Outpatients (HES OP); Mental Health and Learning Disabilities Data Set (MHLDDS); Mental Health Minimum Data Set (MHMDS); Mental Health Services Data Set (MHSDS); MRIS - Bespoke; Patient Reported Outcome Measures (Linkable to HES)
What changed from DARS-NIC-15625-T8K6L-v7.1
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2020-07-13 | |
| End date | 2021-01-31 |
Objective for processing
[3 paragraphs unchanged]
Research using CPRD data has resulted in over 2,400 peer-reviewed publications, which
[72 words unchanged]
based on a database of de-identified longitudinal primary care records contributed by
consenting
participating
GP practices from the four UK nations. Approval to supply anonymised data
[8 words unchanged]
annual basis by the East Midlands and Derby Research Ethics Committee (REC).
[5 paragraphs unchanged]
Amendment Request
CPRD also link with the following datasets:
CPRD would like to include linkage with the following datasets:
[8 paragraphs unchanged]
Amendment Request
CPRD would like to extend its current DSA approval to include linkage with the ICNARC CMP data which are managed (collection and processing) by ICNARC, who is the data custodian.
The Intensive Care National Audit and Research Centre (ICNARC) Case Mix Programme (CMP) data has been added to CPRD’s master dataset list (support given by HRA CAG in June 2020) for linkage on an ongoing basis. ICNARC also have support to process confidential patient information for the Case Mix Programme.
This will include research questions that seek to study serious outcomes of disease involving admission to critical care or longer-term outcomes of interventions in intensive care. The linked data will allow studies which need information on risk factors, treatments or longer-term outcomes that are recorded in the primary care data as well as treatments and outcomes recorded in critical care. For instance, survival models can be developed to describe the association between key pre-morbid clinical factors (e.g. sociodemographics, comorbidities, prescribing, other clinical factors) and outcomes relating to critical care admission, critical care survival, and length of critical care stay.
Processing activities
[74 paragraphs unchanged]
12) Addition of new data linkage
The linkage will be conducted as indicated in steps 1-10. By linking patient records from ICNARC CMP with records in the CPRD database. This linkage is expected to occur using in the same method as other linkages for which NHSD is a Trusted Third-Party data processor. ICNARC will send Identifiers (NHS number, Date of Birth, gender and postcode) plus an ICNARC CMP pseudonym to NHSD for patients. NHSD will then link to CPRD identifiers (NHS number, Date of Birth, gender and postcode) plus GP system pseudonyms and provide CPRD will the bridging file, which contains the ICNARC pseudonyms, GP system pseudonyms and match rank.
[9 paragraphs unchanged]
Amendment request:
The linkage will be conducted as indicated in steps 1-10 of the processing activities.
[2 paragraphs unchanged]
Expected measurable benefits
[32 paragraphs unchanged]
Benefit of CHESS/SGSS linkage:
The data linkage is in the public interest as it will permit health research in response to the coronavirus outbreak. COVID-19 related research is already being supported by CPRD, including studies on: risk factors [1] and pharmacological risk factors [2] for COVID-19 infection; the impact of angiotensin receptor blockers/enzyme inhibitors on COVID-19 risk and outcome [3]; COVID-19 related risks in cancer survivors [4]; and a rapid network study to inform management of COVID-19 [5]. Linkage to the SGSS COVID-19 specific test data and the CHESS data on COVID-19 Hospitalisations in England would enable CPRDs research community to undertake wide ranging research to support the development and implementation of appropriate and timely clinical guidance and contribute to the current public health effort, with associated benefit for patients in England.
[1 paragraph unchanged]
The amendment to allow the additional data linkage is in the public interest as it will permit health research in response to the coronavirus outbreak. COVID-19 related research is already being supported by CPRD, including studies on: risk factors [1] and pharmacological risk factors [2] for COVID-19 infection; the impact of angiotensin receptor blockers/enzyme inhibitors on COVID-19 risk and outcome [3]; COVID-19 related risks in cancer survivors [4]; and a rapid network study to inform management of COVID-19 [5]. Linkage to the SGSS COVID-19 specific test data and the CHESS data on COVID-19 Hospitalisations in England would enable CPRDs research community to undertake wide ranging research to support the development and implementation of appropriate and timely clinical guidance and contribute to the current public health effort, with associated benefit for patients in England.
The amendment is in the public interest as it will permit health research requiring details of intensive care admissions with the intention of improving treatments and clinical outcomes for patients. This is particularly of relevance in the context of the current COVID-19 pandemic where a key clinical need is to determine which patients in primary care are at highest risk of admission to critical care and which pre-morbid factors predict survival. A standard linkage between CPRD and ICNARC CMP data will enable the conduct of such studies proactively for other conditions as well and help inform better patient care pathways for e.g. intermediate care options, decisions regarding stepping down of care etc.
Unchanged: Expected output, Benefits reported.
Objective for processing
The controller for GDPR purposes is the Department of Health and Social Care (DHSC); the legal signatory for this agreement (and for the overarching DSFC) is the Secretary of State for Health and Social Care (acting as part of the Crown), acting through the Clinical Practice Research Datalink centre (hereinafter referred to as CPRD) within the Medicines and Healthcare products Regulatory Agency (the agency); and the licensee is CPRD, not the wider DHSC nor the agency.
The Clinical Practice Research Datalink (CPRD) is a centre of the Medicines and Healthcare products Regulatory Agency (the agency), an executive agency of the Department of Health and Social Care (DHSC). The agency regulates medicines, medical devices and blood components for transfusion in the UK and the agency acts as the Executive agency.
The Clinical Practice Research Datalink (CPRD) is a government not for profit research organisation, jointly supported by the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute of Health Research (NIHR), supplying anonymised health data for studies to safeguard and improve patient and public health. For more than 30 years, CPRD data have supported vital research into health care delivery, drug safety, effectiveness of medicines and risk factors for disease. The data supplied by NHS Digital and released by CPRD under the NHS Digital sub-licence can only be used for public health research purposes in accordance with Article 6(1)(e) and Article 9(2)(j).
Research using CPRD data has resulted in over 2,400 peer-reviewed publications, which have informed drug safety guidance and best clinical practice. Examples of research findings used in everyday NHS care include demonstrating the protective effect of whooping cough vaccination in pregnancy for infants and informing the National Institute of Health and Care Excellence (NICE) blood pressure targets for patients with diabetes. A searchable list of the users and uses of CPRD data is published on the CPRD website. CPRD’s research and data services are based on a database of de-identified longitudinal primary care records contributed by participating GP practices from the four UK nations. Approval to supply anonymised data for public health research is granted on an annual basis by the East Midlands and Derby Research Ethics Committee (REC).
CPRD provides access to anonymised primary care data linked to secondary health care datasets. Linked data greatly increases the scale, depth, completeness and value of data available for public health research. The outputs of such research based on linked data inform clinical guidance and best practice for patients in the UK.
Secondary healthcare datasets are provided by NHS Digital and other data custodians and these data are linked to the primary care data by NHS Digital. NHS Digital receives identifiers to enable them to carry out this linkage as described below in section 3, according to the method described used for this linkage is described in the following paper: Padmanabhan S, Carty L, Cameron E, Ghosh RE, Williams R, Strongman H. Approach to record linkage of primary care data from Clinical Practice Research Datalink to other health-related patient data: overview and implications. Eur J Epidemiol, 15 Sep 2018, 34(1):91-99. Continued support is given by Confidentiality Advisory Group (CAG) for the flow of identifiers to NHS Digital to enable linkage of CPRD primary care data to secondary datasets.
The legal bases for processing the data provided by NHS Digital are:
• Gathering of GP patient data and collation with other datasets to produce datasets that have been anonymised: medical research under Article 9(2)(j); drug and device safety under Article 9(2)(i) of the General Data Protection Regulation.
NHS Digital has been providing and linking health-related datasets to CPRD primary care data for a number of years. Data linkage is carried out exclusively by NHS Digital as the Trusted Third Party (TTP) for this purpose. Linked datasets currently available include extracts from Civil Registration data; Hospital Episode Statistics (HES), which encompasses Admitted Patient Care, Critical Care, Outpatient and Accident & Emergency data; Patient Reported Outcome Measures (PROMs); Diagnostic Imaging Dataset (DID); Mental Health data; National Cancer Registry; National Asthma and COPD Audit Programme (NACAP) audit data, Deprivation data including Townsend Score and Index of Multiple Deprivation. Critical care is supplied as a separate dataset by NHS Digital, but is integrated with Admitted Patient Care.
CPRD also link with the following datasets:
1) PHE’s Second Generation Surveillance System (SGSS) data (specifically the COVID-19 test result data, including future serological testing as well as current antigen testing)
and
2) PHE’s COVID-19 Hospitalisation in England Surveillance System (CHESS); both datasets are already held by NHSD.
Research using CPRD data and services informs clinical guidance and best practice related to drug safety, use of medicines, effectiveness of health policy, health care delivery and disease risk factors. With respect to COVID-19, and as per Regulation 3(1) of the COVID-19 notice, research using the linked CPRD primary care and COVID-19 SGSS/CHESS data would enable researchers to understand COVID-19 and risks to public health, trends in COVID-19 and COVID-19 risk factors, to inform the control and prevention of the spread of COVID-19. Linkage of the COVID-19 testing data to patient medical histories available in CPRD primary care databases would facilitate the identification and understanding about patients or potential patients with, or at risk of COVID-19, about incidents of patient exposure to COVID-19 and the management of patients with or at risk of COVID-19, including real world monitoring of such patients, and longitudinal collection of information about efficacy of treatment, medical and social interventions and recovery from COVID-19.
Similarly, the primary care and routinely linked HES data would permit research which would expand CPRDs understanding about patient access to health services and the need for wider care of patients and vulnerable groups as a direct or indirect result of COVID-19 and the availability and capacity of those services or that care.
The linkage has been permitted by PHE and should be conducted under the recent Coronavirus (COVID-19) notices under reg 3(4) of the Health Service Control of Patient Information Regulations 2002 which allows the regulation 3 surveillance data’s ‘confidential patient information to be processed… for a COVID-19 Purpose… in accordance with regulation 7’ for research purposes. The general COPI notice covers the provision and use of GP identifiers while the NHSD-specific COPI notice would cover the provision and use of the relevant identifiers from SGSS/CHESS for the linkage; the NHSD COPI notice would also cover the actual linkage process of the two streams of identifiers for the purposes of COVID-19 research – as is the case here. The release of the linker file and the associated anonymised clinical data to CPRD does not involve confidential patient information (CPI).
CPRD are aware that the powers under the COVID-19 notices are time bound and are due to be reviewed on or before 30 September 2020, and, if not extended, will expire on 30 September 2020. To ensure continuity in terms of governance and approvals for access to the CPRD-linked COVID-19 SGSS/CHESS data, CPRD plan to submit an amendment to their CAG application to secure approval to receive the linked SGSS/CHESS data once the COPI notices expire.
The CPRD-linked COVID-19 SGSS/CHESS data shared under sub-licence will be required to be deleted within 30 days should the COPI notice expire and CAG approval having not been secured.
Amendment Request
CPRD would like to extend its current DSA approval to include linkage with the ICNARC CMP data which are managed (collection and processing) by ICNARC, who is the data custodian.
The Intensive Care National Audit and Research Centre (ICNARC) Case Mix Programme (CMP) data has been added to CPRD’s master dataset list (support given by HRA CAG in June 2020) for linkage on an ongoing basis. ICNARC also have support to process confidential patient information for the Case Mix Programme.
This will include research questions that seek to study serious outcomes of disease involving admission to critical care or longer-term outcomes of interventions in intensive care. The linked data will allow studies which need information on risk factors, treatments or longer-term outcomes that are recorded in the primary care data as well as treatments and outcomes recorded in critical care. For instance, survival models can be developed to describe the association between key pre-morbid clinical factors (e.g. sociodemographics, comorbidities, prescribing, other clinical factors) and outcomes relating to critical care admission, critical care survival, and length of critical care stay.
Expected output
CPRD customers using linked data products will be producing (on an ongoing basis) research publications in peer-reviewed journals and presentations at scientific conferences. CPRD customers include academic institutions, pharmaceutical companies, Governmental centres and research charities. These all undertake medical and health data research, which may result in formal publications.
All data included in such outputs by CPRD customers will be aggregated, with small numbers suppressed in line with the HES Analysis Guide (or dataset specific suppression controls).
A selection of publications resulting from use of CPRD linked data are presented below.
Akyea RK, Kai J, Qureshi N, Iyen B, Weng SF. Sub-optimal cholesterol response to initiation of statins and future risk of cardiovascular disease. Heart, 2019; 105:975-981.
Abel KM, Hope H, Swift E, Parisi R, Ashcroft DM, Kosidou K, Osam CS, Dalman C, Pierce M. Prevalence of maternal mental illness among children and adolescents in the UK between 2005 and 2017: a national retrospective cohort analysis. Lancet Public Health, vol. 4, pp. e291-e300, 2019.
Crellin E, Mansfield KE, Leyrat C, Nitsch D, Douglas IJ, Root A, Williamson E, Smeeth L, Tomlinson LA. Trimethoprim use for urinary tract infection and risk of adverse outcomes in older patients: cohort study. BMJ. 2018 Feb 9;360:k341.
Morgan C, Webb RT, Carr MJ, Kontopantelis E, Green J, Chew-Graham CA, Kapur N, Ashcroft DM. Incidence, clinical management, and mortality risk following self harm among children and adolescents: cohort study in primary care. BMJ, Volume 359, p.j4351 (2017).
Outputs from the studies approved usually have research reports which are submitted to funders (such as the Medical Research Council) . Some outputs will inform discussions with national programmes (such as NHS Cancer Screening Programmes and NHS Scotland), charities (such as Cancer Research UK) primary care professionals, policy makers and researchers,
In many instances, the papers are also published and are available on Open Access journals. Many of the outputs are also presented at conferences (such as International Society for Pharmacoepidemiology). Many of the outputs have the capacity to not only influence the clinical community but also policy makers, for example clinical guidelines (see Oyinlola et al 2016).
A comprehensive list of publications including those using linked data can be found at www.cprd.com/bibliography
Benefits reported
A systematic review (Oyinlola et al 2016) identified 43 CPRD studies that have been used in 25 medical guidance documents. The reviewers found that use of data from the CPRD to inform guidelines has increased in recent years and noted the importance of linking data to extend research to medical conditions that are treated in multiple settings (e.g. primary and secondary care).
The study identified national guidelines or guidance published in England from 2000 onwards that referenced studies using data provided by CPRD. The CPRD studies provided evidence of disease epidemiology, incidence/prevalence, pharmacoepidemiology, pharmacovigilance and health utilisation. This also highlighted the increasing trend in the use of healthcare system data to inform clinical practice, especially using the real world evidence through clinical studies.
Reference:
Oyinlola JO, Campbell J, Kousoulis AA. Is real world evidence influencing practice? A systematic review of CPRD research in NICE guidances. BMC Health Serv Res. 2016 Jul 26;16:299.
DARS-NIC-15625-T8K6L-v7.1 19 May 2020 to 21 October 2020
- Title
- R23 - Clinical Practice Research Datalink (CPRD) Routine Linkages Application
- Commercial
- No
- Sublicensing
- Yes
- Datasets
- 17
- Files released
- 222
Datasets: Bridge file: Hospital Episode Statistics to Diagnostic Imaging Dataset; Bridge file: Hospital Episode Statistics to Mental Health Minimum Data Set; Civil Registrations of Death - Secondary Care Cut; COVID-19 Hospitalization in England Surveillance System; COVID-19 SGSS First Positives (Second Generation Surveillance System); Diagnostic Imaging Data Set (DID); Emergency Care Data Set (ECDS); HES:Civil Registration (Deaths) bridge; Hospital Episode Statistics Accident and Emergency (HES A and E); Hospital Episode Statistics Admitted Patient Care (HES APC); Hospital Episode Statistics Critical Care (HES Critical Care); Hospital Episode Statistics Outpatients (HES OP); Mental Health and Learning Disabilities Data Set (MHLDDS); Mental Health Minimum Data Set (MHMDS); Mental Health Services Data Set (MHSDS); MRIS - Bespoke; Patient Reported Outcome Measures (Linkable to HES)
What changed from DARS-NIC-15625-T8K6L-v6.4
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Title | R23 - Clinical Practice Research Datalink (CPRD) Routine Linkages Application | |
| Start date | 2020-05-19 |
Datasets: + COVID-19 Hospitalization in England Surveillance System; + COVID-19 SGSS First Positives (Second Generation Surveillance System)
Objective for processing
[9 paragraphs unchanged] Amendment Request CPRD would like to include linkage with the following datasets: 1) PHE’s Second Generation Surveillance System (SGSS) data (specifically the COVID-19 test result data, including future serological testing as well as current antigen testing) and 2) PHE’s COVID-19 Hospitalisation in England Surveillance System (CHESS); both datasets are already held by NHSD. Research using CPRD data and services informs clinical guidance and best practice related to drug safety, use of medicines, effectiveness of health policy, health care delivery and disease risk factors. With respect to COVID-19, and as per Regulation 3(1) of the COVID-19 notice, research using the linked CPRD primary care and COVID-19 SGSS/CHESS data would enable researchers to understand COVID-19 and risks to public health, trends in COVID-19 and COVID-19 risk factors, to inform the control and prevention of the spread of COVID-19. Linkage of the COVID-19 testing data to patient medical histories available in CPRD primary care databases would facilitate the identification and understanding about patients or potential patients with, or at risk of COVID-19, about incidents of patient exposure to COVID-19 and the management of patients with or at risk of COVID-19, including real world monitoring of such patients, and longitudinal collection of information about efficacy of treatment, medical and social interventions and recovery from COVID-19. Similarly, the primary care and routinely linked HES data would permit research which would expand CPRDs understanding about patient access to health services and the need for wider care of patients and vulnerable groups as a direct or indirect result of COVID-19 and the availability and capacity of those services or that care. The linkage has been permitted by PHE and should be conducted under the recent Coronavirus (COVID-19) notices under reg 3(4) of the Health Service Control of Patient Information Regulations 2002 which allows the regulation 3 surveillance data’s ‘confidential patient information to be processed… for a COVID-19 Purpose… in accordance with regulation 7’ for research purposes. The general COPI notice covers the provision and use of GP identifiers while the NHSD-specific COPI notice would cover the provision and use of the relevant identifiers from SGSS/CHESS for the linkage; the NHSD COPI notice would also cover the actual linkage process of the two streams of identifiers for the purposes of COVID-19 research – as is the case here. The release of the linker file and the associated anonymised clinical data to CPRD does not involve confidential patient information (CPI). CPRD are aware that the powers under the COVID-19 notices are time bound and are due to be reviewed on or before 30 September 2020, and, if not extended, will expire on 30 September 2020. To ensure continuity in terms of governance and approvals for access to the CPRD-linked COVID-19 SGSS/CHESS data, CPRD plan to submit an amendment to their CAG application to secure approval to receive the linked SGSS/CHESS data once the COPI notices expire. The CPRD-linked COVID-19 SGSS/CHESS data shared under sub-licence will be required to be deleted within 30 days should the COPI notice expire and CAG approval having not been secured.
Processing activities
[83 paragraphs unchanged] Amendment request: The linkage will be conducted as indicated in steps 1-10 of the processing activities. In response to the coronavirus outbreak, CPRD is expediting processing of protocols relating to COVID-19 research, with a turn-around for initial ISAC review of 3-5 working days. In keeping with European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) guidelines to support the sharing of information on performed or planned studies and increase the efficiency of research, all expedited ISAC protocols will include ‘COVID-19’ in the title, and transparencies related to COVID-19 applications are being published on the CPRD website within 72 hours of approval. Only research which aligns with the objective for processing as described in the objectives for processing will be reviewed as relating to COVID-19 research, and only those securing ISAC approval will be able to receive the CPRD-linked COVID-19 SGSS/CHESS data via sub-licence.
Expected measurable benefits
[32 paragraphs unchanged] Amendment request: The amendment to allow the additional data linkage is in the public interest as it will permit health research in response to the coronavirus outbreak. COVID-19 related research is already being supported by CPRD, including studies on: risk factors [1] and pharmacological risk factors [2] for COVID-19 infection; the impact of angiotensin receptor blockers/enzyme inhibitors on COVID-19 risk and outcome [3]; COVID-19 related risks in cancer survivors [4]; and a rapid network study to inform management of COVID-19 [5]. Linkage to the SGSS COVID-19 specific test data and the CHESS data on COVID-19 Hospitalisations in England would enable CPRDs research community to undertake wide ranging research to support the development and implementation of appropriate and timely clinical guidance and contribute to the current public health effort, with associated benefit for patients in England.
Unchanged: Expected output, Benefits reported.
Objective for processing
The controller for GDPR purposes is the Department of Health and Social Care (DHSC); the legal signatory for this agreement (and for the overarching DSFC) is the Secretary of State for Health and Social Care (acting as part of the Crown), acting through the Clinical Practice Research Datalink centre (hereinafter referred to as CPRD) within the Medicines and Healthcare products Regulatory Agency (the agency); and the licensee is CPRD, not the wider DHSC nor the agency.
The Clinical Practice Research Datalink (CPRD) is a centre of the Medicines and Healthcare products Regulatory Agency (the agency), an executive agency of the Department of Health and Social Care (DHSC). The agency regulates medicines, medical devices and blood components for transfusion in the UK and the agency acts as the Executive agency.
The Clinical Practice Research Datalink (CPRD) is a government not for profit research organisation, jointly supported by the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute of Health Research (NIHR), supplying anonymised health data for studies to safeguard and improve patient and public health. For more than 30 years, CPRD data have supported vital research into health care delivery, drug safety, effectiveness of medicines and risk factors for disease. The data supplied by NHS Digital and released by CPRD under the NHS Digital sub-licence can only be used for public health research purposes in accordance with Article 6(1)(e) and Article 9(2)(j).
Research using CPRD data has resulted in over 2,400 peer-reviewed publications, which have informed drug safety guidance and best clinical practice. Examples of research findings used in everyday NHS care include demonstrating the protective effect of whooping cough vaccination in pregnancy for infants and informing the National Institute of Health and Care Excellence (NICE) blood pressure targets for patients with diabetes. A searchable list of the users and uses of CPRD data is published on the CPRD website. CPRD’s research and data services are based on a database of de-identified longitudinal primary care records contributed by consenting GP practices from the four UK nations. Approval to supply anonymised data for public health research is granted on an annual basis by the East Midlands and Derby Research Ethics Committee (REC).
CPRD provides access to anonymised primary care data linked to secondary health care datasets. Linked data greatly increases the scale, depth, completeness and value of data available for public health research. The outputs of such research based on linked data inform clinical guidance and best practice for patients in the UK.
Secondary healthcare datasets are provided by NHS Digital and other data custodians and these data are linked to the primary care data by NHS Digital. NHS Digital receives identifiers to enable them to carry out this linkage as described below in section 3, according to the method described used for this linkage is described in the following paper: Padmanabhan S, Carty L, Cameron E, Ghosh RE, Williams R, Strongman H. Approach to record linkage of primary care data from Clinical Practice Research Datalink to other health-related patient data: overview and implications. Eur J Epidemiol, 15 Sep 2018, 34(1):91-99. Continued support is given by Confidentiality Advisory Group (CAG) for the flow of identifiers to NHS Digital to enable linkage of CPRD primary care data to secondary datasets.
The legal bases for processing the data provided by NHS Digital are:
• Gathering of GP patient data and collation with other datasets to produce datasets that have been anonymised: medical research under Article 9(2)(j); drug and device safety under Article 9(2)(i) of the General Data Protection Regulation.
NHS Digital has been providing and linking health-related datasets to CPRD primary care data for a number of years. Data linkage is carried out exclusively by NHS Digital as the Trusted Third Party (TTP) for this purpose. Linked datasets currently available include extracts from Civil Registration data; Hospital Episode Statistics (HES), which encompasses Admitted Patient Care, Critical Care, Outpatient and Accident & Emergency data; Patient Reported Outcome Measures (PROMs); Diagnostic Imaging Dataset (DID); Mental Health data; National Cancer Registry; National Asthma and COPD Audit Programme (NACAP) audit data, Deprivation data including Townsend Score and Index of Multiple Deprivation. Critical care is supplied as a separate dataset by NHS Digital, but is integrated with Admitted Patient Care.
Amendment Request
CPRD would like to include linkage with the following datasets:
1) PHE’s Second Generation Surveillance System (SGSS) data (specifically the COVID-19 test result data, including future serological testing as well as current antigen testing)
and
2) PHE’s COVID-19 Hospitalisation in England Surveillance System (CHESS); both datasets are already held by NHSD.
Research using CPRD data and services informs clinical guidance and best practice related to drug safety, use of medicines, effectiveness of health policy, health care delivery and disease risk factors. With respect to COVID-19, and as per Regulation 3(1) of the COVID-19 notice, research using the linked CPRD primary care and COVID-19 SGSS/CHESS data would enable researchers to understand COVID-19 and risks to public health, trends in COVID-19 and COVID-19 risk factors, to inform the control and prevention of the spread of COVID-19. Linkage of the COVID-19 testing data to patient medical histories available in CPRD primary care databases would facilitate the identification and understanding about patients or potential patients with, or at risk of COVID-19, about incidents of patient exposure to COVID-19 and the management of patients with or at risk of COVID-19, including real world monitoring of such patients, and longitudinal collection of information about efficacy of treatment, medical and social interventions and recovery from COVID-19.
Similarly, the primary care and routinely linked HES data would permit research which would expand CPRDs understanding about patient access to health services and the need for wider care of patients and vulnerable groups as a direct or indirect result of COVID-19 and the availability and capacity of those services or that care.
The linkage has been permitted by PHE and should be conducted under the recent Coronavirus (COVID-19) notices under reg 3(4) of the Health Service Control of Patient Information Regulations 2002 which allows the regulation 3 surveillance data’s ‘confidential patient information to be processed… for a COVID-19 Purpose… in accordance with regulation 7’ for research purposes. The general COPI notice covers the provision and use of GP identifiers while the NHSD-specific COPI notice would cover the provision and use of the relevant identifiers from SGSS/CHESS for the linkage; the NHSD COPI notice would also cover the actual linkage process of the two streams of identifiers for the purposes of COVID-19 research – as is the case here. The release of the linker file and the associated anonymised clinical data to CPRD does not involve confidential patient information (CPI).
CPRD are aware that the powers under the COVID-19 notices are time bound and are due to be reviewed on or before 30 September 2020, and, if not extended, will expire on 30 September 2020. To ensure continuity in terms of governance and approvals for access to the CPRD-linked COVID-19 SGSS/CHESS data, CPRD plan to submit an amendment to their CAG application to secure approval to receive the linked SGSS/CHESS data once the COPI notices expire.
The CPRD-linked COVID-19 SGSS/CHESS data shared under sub-licence will be required to be deleted within 30 days should the COPI notice expire and CAG approval having not been secured.
Expected output
CPRD customers using linked data products will be producing (on an ongoing basis) research publications in peer-reviewed journals and presentations at scientific conferences. CPRD customers include academic institutions, pharmaceutical companies, Governmental centres and research charities. These all undertake medical and health data research, which may result in formal publications.
All data included in such outputs by CPRD customers will be aggregated, with small numbers suppressed in line with the HES Analysis Guide (or dataset specific suppression controls).
A selection of publications resulting from use of CPRD linked data are presented below.
Akyea RK, Kai J, Qureshi N, Iyen B, Weng SF. Sub-optimal cholesterol response to initiation of statins and future risk of cardiovascular disease. Heart, 2019; 105:975-981.
Abel KM, Hope H, Swift E, Parisi R, Ashcroft DM, Kosidou K, Osam CS, Dalman C, Pierce M. Prevalence of maternal mental illness among children and adolescents in the UK between 2005 and 2017: a national retrospective cohort analysis. Lancet Public Health, vol. 4, pp. e291-e300, 2019.
Crellin E, Mansfield KE, Leyrat C, Nitsch D, Douglas IJ, Root A, Williamson E, Smeeth L, Tomlinson LA. Trimethoprim use for urinary tract infection and risk of adverse outcomes in older patients: cohort study. BMJ. 2018 Feb 9;360:k341.
Morgan C, Webb RT, Carr MJ, Kontopantelis E, Green J, Chew-Graham CA, Kapur N, Ashcroft DM. Incidence, clinical management, and mortality risk following self harm among children and adolescents: cohort study in primary care. BMJ, Volume 359, p.j4351 (2017).
Outputs from the studies approved usually have research reports which are submitted to funders (such as the Medical Research Council) . Some outputs will inform discussions with national programmes (such as NHS Cancer Screening Programmes and NHS Scotland), charities (such as Cancer Research UK) primary care professionals, policy makers and researchers,
In many instances, the papers are also published and are available on Open Access journals. Many of the outputs are also presented at conferences (such as International Society for Pharmacoepidemiology). Many of the outputs have the capacity to not only influence the clinical community but also policy makers, for example clinical guidelines (see Oyinlola et al 2016).
A comprehensive list of publications including those using linked data can be found at www.cprd.com/bibliography
Benefits reported
A systematic review (Oyinlola et al 2016) identified 43 CPRD studies that have been used in 25 medical guidance documents. The reviewers found that use of data from the CPRD to inform guidelines has increased in recent years and noted the importance of linking data to extend research to medical conditions that are treated in multiple settings (e.g. primary and secondary care).
The study identified national guidelines or guidance published in England from 2000 onwards that referenced studies using data provided by CPRD. The CPRD studies provided evidence of disease epidemiology, incidence/prevalence, pharmacoepidemiology, pharmacovigilance and health utilisation. This also highlighted the increasing trend in the use of healthcare system data to inform clinical practice, especially using the real world evidence through clinical studies.
Reference:
Oyinlola JO, Campbell J, Kousoulis AA. Is real world evidence influencing practice? A systematic review of CPRD research in NICE guidances. BMC Health Serv Res. 2016 Jul 26;16:299.
DARS-NIC-15625-T8K6L-v6.4 19 March 2020 to 21 October 2020
- Title
- Clinical Practice Research Datalink (CPRD) Routine Linkages Application
- Commercial
- No
- Sublicensing
- Yes
- Datasets
- 15
- Files released
- 213
Datasets: Bridge file: Hospital Episode Statistics to Diagnostic Imaging Dataset; Bridge file: Hospital Episode Statistics to Mental Health Minimum Data Set; Civil Registrations of Death - Secondary Care Cut; Diagnostic Imaging Data Set (DID); Emergency Care Data Set (ECDS); HES:Civil Registration (Deaths) bridge; Hospital Episode Statistics Accident and Emergency (HES A and E); Hospital Episode Statistics Admitted Patient Care (HES APC); Hospital Episode Statistics Critical Care (HES Critical Care); Hospital Episode Statistics Outpatients (HES OP); Mental Health and Learning Disabilities Data Set (MHLDDS); Mental Health Minimum Data Set (MHMDS); Mental Health Services Data Set (MHSDS); MRIS - Bespoke; Patient Reported Outcome Measures (Linkable to HES)
What changed from DARS-NIC-15625-T8K6L-v5.6
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2020-03-19 | |
| Commercial purposes | No |
Objective for processing
The
data
controller
for GDPR purposes
is
the
Department of Health and Social
Care, with
Care (DHSC); the legal signatory for this agreement (and for the overarching DSFC) is
the Secretary of State for Health and Social Care (acting as part
[9 words unchanged]
Datalink centre (hereinafter referred to as CPRD) within the Medicines and Healthcare
Products
products
Regulatory
Agency.
Agency (the agency); and the licensee is CPRD, not the wider DHSC nor the agency.
The Clinical Practice Research
Data-linkage
Datalink
(CPRD) is a centre of the Medicines and Healthcare products Regulatory Agency
(MHRA),
(the agency),
an executive agency of the Department of Health
&
and
Social Care (DHSC). The
MHRA
agency
regulates medicines, medical devices and blood components for transfusion in the UK and the
MHRA act
agency acts
as the Executive agency.
CPRD is the UK’s pre-eminent research service, providing access to primary care data (that has been anonymised) linked by NHS Digital to other similarly pseudonymised health data. This data is provided by NHS Digital and others for the purposes of public health research including the monitoring of drug safety. All such data is linked (in its identifiable form) by NHS Digital only. It is jointly funded by the MHRA and the National Institute for Health Research (NIHR).
The Clinical Practice Research Datalink (CPRD) is a government not for profit research organisation, jointly supported by the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute of Health Research (NIHR), supplying anonymised health data for studies to safeguard and improve patient and public health. For more than 30 years, CPRD data have supported vital research into health care delivery, drug safety, effectiveness of medicines and risk factors for disease. The data supplied by NHS Digital and released by CPRD under the NHS Digital sub-licence can only be used for public health research purposes in accordance with Article 6(1)(e) and Article 9(2)(j).
CPRD’s aims are to support vital public health research and to inform advances in patient safety in the delivery of patient care pathways. These depend on access to accurate, real-time representative patient data to produce reliable evidence based clinical and drug safety guidance. The legal bases for processing the data provided by NHS Digital are:
Research using CPRD data has resulted in over 2,400 peer-reviewed publications, which have informed drug safety guidance and best clinical practice. Examples of research findings used in everyday NHS care include demonstrating the protective effect of whooping cough vaccination in pregnancy for infants and informing the National Institute of Health and Care Excellence (NICE) blood pressure targets for patients with diabetes. A searchable list of the users and uses of CPRD data is published on the CPRD website. CPRD’s research and data services are based on a database of de-identified longitudinal primary care records contributed by consenting GP practices from the four UK nations. Approval to supply anonymised data for public health research is granted on an annual basis by the East Midlands and Derby Research Ethics Committee (REC).
• Gathering of GP patient data and collation with other data sets to produce data-sets that have been anonymised: medical research under Article 9(2)(j); drug and device safety under Article 9(2)(i) of the General Data Protection Regulation.
CPRD provides access to anonymised primary care data linked to secondary health care datasets. Linked data greatly increases the scale, depth, completeness and value of data available for public health research. The outputs of such research based on linked data inform clinical guidance and best practice for patients in the UK.
CPRD services are designed to maximise the way de-identified NHS clinical data can be used to improve and safeguard public health. For more than 20 years data provided by CPRD have been used in a range of drug safety and epidemiological studies that have impacted on health care, and resulted in over 2100 peer-reviewed publications. In addition to supporting high-quality observational research, CPRD is developing world-leading services based on using real world data to support clinical trials and intervention studies. The intention is to continue to link CPRD primary care data to NHS Digital’s secondary care and other datasets, as linkage greatly increases the scale, depth, completeness and therefore value of data available for public health research. The outputs of such research based on linked data in turn improve and protect patient care pathways/treatments and provide clinical benefits for the UK, supporting delivery of CPRD’s core objectives.
Secondary healthcare datasets are provided by NHS Digital and other data custodians and these data are linked to the primary care data by NHS Digital. NHS Digital receives identifiers to enable them to carry out this linkage as described below in section 3, according to the method described used for this linkage is described in the following paper: Padmanabhan S, Carty L, Cameron E, Ghosh RE, Williams R, Strongman H. Approach to record linkage of primary care data from Clinical Practice Research Datalink to other health-related patient data: overview and implications. Eur J Epidemiol, 15 Sep 2018, 34(1):91-99. Continued support is given by Confidentiality Advisory Group (CAG) for the flow of identifiers to NHS Digital to enable linkage of CPRD primary care data to secondary datasets.
CPRD’s research and data services are based on a database of de-identified longitudinal primary care records contributed by consenting GP practices from the four UK nations, and on the ability to link primary care data to secondary care data (and other data sets), from the NHS, Office of National Statistics (ONS) and Public Health England (PHE). One of CPRD’s main priorities is to increase the number of national data sets that are linked to primary care data and made available on a routine basis to the research community. Such collection and linkages occur under the appropriate permissions (ethical and s251), which have been granted to CPRD by the East Midlands & Derby Research Ethics Committee (REC), and the Health Research Authority (HRA).
The legal bases for processing the data provided by NHS Digital are:
NHS Digital has been providing secondary and other data for linkage with CPRD primary care data for a number of years. Data linkage is carried out exclusively by NHS Digital as the Trusted Third Party (TTP) for this purpose. Linked data sets currently available include extracts from Civil Registration data; Hospital Episode Statistics (HES), which encompasses Admitted Patient Care, Critical Care, Outpatient and Accident & Emergency data; Patient Reported Outcome Measures (PROMs); Diagnostic Imaging Dataset (DID); Mental Health data; National Cancer Registry; Deprivation data including Townsend Score and Index of Multiple Deprivation. Critical care is supplied as a separate dataset by NHS Digital, but is integrated with Admitted Patient Care.
• Gathering of GP patient data and collation with other datasets to produce datasets that have been anonymised: medical research under Article 9(2)(j); drug and device safety under Article 9(2)(i) of the General Data Protection Regulation.
The data released under the sub-licence can only be used for public health research purposes using Section 6(1)(e) and Section 9(2)(j), as recommended for approval by ISAC for MHRA database research. CPRD make the final decision on access, and ensure compliance with NHS Digital’s requirements within the data sharing agreement, e.g. security of the third party. Access to CPRD data and services will not be permitted in circumstances that may result in loss of public trust or for activities that may undermine the integrity of the CPRD database.
NHS Digital has been providing and linking health-related datasets to CPRD primary care data for a number of years. Data linkage is carried out exclusively by NHS Digital as the Trusted Third Party (TTP) for this purpose. Linked datasets currently available include extracts from Civil Registration data; Hospital Episode Statistics (HES), which encompasses Admitted Patient Care, Critical Care, Outpatient and Accident & Emergency data; Patient Reported Outcome Measures (PROMs); Diagnostic Imaging Dataset (DID); Mental Health data; National Cancer Registry; National Asthma and COPD Audit Programme (NACAP) audit data, Deprivation data including Townsend Score and Index of Multiple Deprivation. Critical care is supplied as a separate dataset by NHS Digital, but is integrated with Admitted Patient Care.
Additional Data Request
The National Asthma and COPD Audit Programme (NACAP) audit data which consists of the chronic obstructive pulmonary disease (COPD) and asthma (adult; children and young people) collection has been added to CPRD’s master dataset list (support given April 2019) for linkage on an ongoing basis. This request is for a one-off link of the data. It is envisaged that future iterations of this agreement would allow additional linkages. The National Asthma and Chronic Pulmonary (NACAP) Disease audit dataset is being requested within the CPRD master dataset list as the linkage to supplementary primary
care data would be valuable to those researchers undertaking research into asthma and COPD.
Processing activities
[2 paragraphs unchanged]
The CPRD Policy for
'Anonymisation and
Managing
Anonymisation and
the Risk of Identification in Observational
Research
Research'
sets out the management processes employed to ensure that CPRD appropriately anonymises
[19 words unchanged]
Office of National Statistics (ONS) requirements on use of death registration data.
[2 paragraphs unchanged]
In order to enable the linking of primary care records to other
[10 words unchanged]
directly to NHS Digital. These are: NHS Number, full date of birth,
post code
postcode
and gender. CPRD does receive gender but does not receive any of the other identifiers. The Trusted Third Party (NHS Digital) provides the linkage service for CPRD.
[2 paragraphs unchanged]
CPRD retains the data collected up to the point that a GP Practice withdraws from participation. This is to ensure that CPRD can create (if needed)
datasets
datasets, say,
for
(e.g.)
validation of previous research, or for longitudinal studies. Patient opt-outs remain respected from the point of notification to CPRD.
[2 paragraphs unchanged]
Transformation involves removing the provider codes provided by NHS Digital. Data provided
[10 words unchanged]
(SHA) boundaries. It is based on matching the address of the GP
Practice
practice
to the SHA. This ‘blurs’ the link between hospital activity records and other potential identifiers collected and provided
(Gender, Year
(gender, year-of-birth, date
of
Birth, Date of Death
death
and
Ethnicity).
ethnicity).
For example, transformation of the CPRD linked HES Admitted Patient Care (APC) data involves:
(i) The encrypted
”HES id"
HES_id
field provided to CPRD by NHS Digital is not released to customers. CPRD creates a pseudonym linked to a unique patient activity record in the HES data.
[11 paragraphs unchanged]
CPRD has agreed pseudonymisation processes with each GP EHR system provider as
[6 words unchanged]
used for data linkage. The overarching process for patient data pseudonymisation comprises
of
the following stages to protect patient confidentiality at all times:
(i) GP system provider - the provider replaces the patient identifiers
(NHS
(e.g NHS
number) in each patient record with a
system practice key and
system patient key before its secure transfer to CPRD.
[1 paragraph unchanged]
(iii) Data linkage - where this is undertaken by the Trusted Third Party
(TTP)
(using patient identifiers sent directly from GPs), all linked patient record data
[14 words unchanged]
is received by CPRD from Public Health England (PHE) for linkage, PHE
pseudonymise
pseudonymises
patient data before release to CPRD.
(iv) Data release - the linked data is cut by CPRD to minimise data ultimately released to
third party
third-party
researchers (under a sub-licence agreement),
with
where
the linked patient key
may be
replaced again by a
further
different
patient key at release
where required,
establishing yet another layer of
separation.
seperation.
Record level identifiers (such as epikey, attendkey, aekey) are additionally encoded such that the record level pseudonym differs in every
distinct
release of the linked data.
[2 paragraphs unchanged]
Access and use of the data is controlled. With the exception of interventional and clinical studies (which require separate Health Research Authority approval), researchers
Researchers
must gain approval for their study protocol
requesting access to linked data,
from the Independent Scientific Advisory Committee for MHRA Database Research (ISAC).
ISAC's role is to determine whether a research proposal is of public health value, will be conducted by researchers with the appropriate level of expertise, highlight if an ethical or confidentiality issues may arise in the proposed research, and to consider the scientific merit of the proposed methods and overall study.
Approved applications to ISAC are published on the CPRD website
https://www.cprd.com/ISAC/datause.asp.
www.cprd.com/protocol-list
CPRD may generate aggregate level linked data without ISAC approval to inform feasibility and design of external research (observational and interventional/clinical) and for assessment of ISAC protocols. CPRD will undertake such assessments on behalf of external researchers with no release of record level linked data permitted outside of CPRD.
ISAC therefore plays a key data governance role. Approval from ISAC is required if access to patient level data (that has been anonymised) is requested for observational research and there is an intention to publish results, or where the study depends on access to primary care data linked to other health related data. ISAC's role is to determine whether a research proposal is of public health value, will be conducted by researchers with the appropriate level of expertise, highlight if an ethical or confidentiality issues may arise in the proposed research, and to consider the scientific merit of the proposed methods and overall study.
[1 paragraph unchanged]
Release of patient level linked data to third party researchers will only occur after:
All organisations and researchers requesting or funding requests for data go through a due diligence process. Data are only released to bona fide researchers and organisations which comply with the data security standards as laid in CPRD licences and sub-licences as described in the CPRD Data Access policy.
a) All required approvals (including ISAC approval) have been obtained;
Release of patient level linked data to third-party researchers will only occur after:
b) Data has been anonymised as per CPRD's Policy for Managing Anonymisation and the Risk of Identification in Observational Research;
a) ISAC approval has been obtained and any other approvals (e.g Research ethics committee if required);
b) Data has been risk assessed in accordance with CPRD's Policy for 'Anonymisation and Managing the Risk of Identification in Observational Research';
[6 paragraphs unchanged]
• As standard, CPRD
match
matches
each GP practice postcode to a larger geographical area aligned with the historical NHS Strategic Health Authority boundaries, ensuring an underlying population size of at least
2
two
million
persons.
people.
The GP practice
post code, the
postcode,
hospital or other institutional identifier are not released;
• The ISAC review includes a risk assessment of patient
re-identification, and if appropriate
re-identification. If appropriate,
research applicants are required to outline risk mitigation plans;
• CPRD’s
Policy
policy
for
'Anonymisation and
Managing
Anonymisation and
the Risk of Identification in Observational
Research
Research'
sets out CPRD’s policy for the release
for
and
publication of data relating to small cell counts;
• Restrictions on the number of stratified analyses are imposed in the case of research proposals investigating rare diseases or
treatments
treatments,
to minimise the risk of re-identification;
• ISAC approvals only allow exact dates of death where there is a clear benefit to public health from the proposed
research
research;
• Researchers are also contractually bound to maintain patient anonymity and prevent inadvertent re-identification of
patients
patients.
[2 paragraphs unchanged]
CPRD processes patient data and makes it available internally to CPRD researchers. To control third-party access to linked data and minimise data released to
third parties,
third-parties,
the CPRD Observational Research Team
will
extract datasets for researchers against a query specification or primary care data
[7 words unchanged]
content will be agreed with the researcher prior to generation of the
data sets.
datasets.
This is the only process by which applicants to CPRD may access linked data.
Sungard/CrownHosting
Sungard/Crown Hosting
Datacentres are
captured
recorded
as data storage addresses as for the purposes of this
application,
application.
Sungard is the primary
datacentre
data centre
store and is considered to be the initial back-up and recovery. They
[9 words unchanged]
any way (Sungard provide a facilities management and site management service). CPRD
have
has
confirmed that
CrownHosting
neither Crown Hosting
nor Sungard have access to the server (neither administrative nor user rights).
[1 paragraph unchanged]
CPRD is part of
a wider Government agency (the MHRA)
the MHRA
and conforms to the 10 National Data Guardian data security standards as well as to NHS Digital requirements.
The MHRA
CPRD
meets NHS
Information Governance
Digital Data Security and Protection
Toolkit
standards on information security,
standards,
and details on standards and arrangements are set out in CPRD’s approved System Level Security Policy
(SLSP) .
(SLSP).
CPRD operates to a high level to ensure that when data is transmitted
and or
and/or
stored it is done so in a way that protects the data.
[37 words unchanged]
are always under review and are subject to audit. Security measures include:
[5 paragraphs unchanged]
8) Data destruction and disposal Data destruction standards (currently NHS Digital’ Destruction and Disposal of Sensitive Data’ guidelines v3.2) have been implemented in MHRA via use of a Blancco LUN Eraser tool , to guarantee that sensitive data is properly erased and sanitized securely and permanently. This tool ensures compliance with industry standards and regulations, including PCI DSS, HIPAA, SOX, ISO 27001 and the EU General Data Protection Regulation.
8) Data destruction and disposal
Data destruction standards (currently, NHS Digital ’Destruction and Disposal of Sensitive Data’ guidelines v3.2) have been implemented in MHRA via use of a Blancco LUN Eraser tool, to guarantee that sensitive data is properly erased and sanitised securely and permanently. This tool ensures compliance with industry standards and regulations, including PCI DSS, HIPAA, SOX, ISO 27001 and the EU General Data Protection Regulation including ISO27001.
[1 paragraph unchanged]
Encryption is used for data in transit between secure locations. This will
[5 words unchanged]
for linkage and clinical / research data. Although the clinical data is
pseudonymised,
anonymised,
there remains the residual risk of re-identification or the risk of inclusion
[8 words unchanged]
for processing by authorised recipients. Encryption mitigates the risk and provides assurance.
[5 paragraphs unchanged]
All organisations party to this agreement must comply with the Data Sharing
[11 words unchanged]
that use) by “Personnel” (as defined within the Data Sharing Framework Contract
ie:
i.e.:
employees, agents and contractors of the Data Recipient who may have access to that data).
11) CPRD auditing of study outputs and purposes
Applicants must provide a detailed protocol for assessment and approval by ISAC (as previously detailed). CPRD routinely checks new publications using CPRD data to ensure concordance with the ISAC approved protocol. For example, research team members accessing the data were detailed in the Protocol (or noted in an amendment), and that the processing is within the scope of the aims and methodology indicated in the protocol, and that it has not been undertaken at locations other than those declared in the protocol. To date there has been full alignment with the publication and the approved protocols for linked data supplied by NHS Digital .
[1 paragraph unchanged]
CPRD onwardly
share
shares
data with
3rd parties
third-parties potentially worldwide
under
sublicence
sub-licence
arrangements only where that data cannot be given directly to the
3rd party
third-party
by NHS Digital.
CPRD assesses the re-identification risk and applies data minimisation techniques as required to ensure re-identification is not possible by means reasonably likely to be used.
Any requests for NHS Digital data only would be referred by CPRD directly to NHS Digital.
The agreements by which CPRD shares data with a third party include all terms of the agreement between NHS Digital and CPRD. CPRD ensure that NHS Digital retain direct rights for audit and/or requiring deletion of data in relation to sub-licensee, and any organisation to whom data is shared by the sub-licensee; and CPRD ensure that NHS Digital may (under the licensing terms put in place by CPRD) require and enforce remedial action (whether in relation to this or other agreements between NHS Digital and the organisation) where appropriate. CPRD take responsibility for the actions and omissions of all sub licensees and breach of a sub licence would automatically be regarded as breach of the Data Sharing Framework Contract with CPRD.
The agreements by which CPRD shares NHS Digital data with a third-party include all terms of the agreement between NHS Digital and CPRD. Third-parties are typically, academic institutions (73%), research organisations (12%), government departments involved in healthcare or medicines regulation (1%), or life science companies (15%). Figures from a sample based on releases in July 2018, which also gave the geographical split as: UK (71%), EU/EEA (12%), Overseas (17%).
In the event of termination or expiry of the Data Sharing Framework Contract between NHSD and the CPRD, all sub licence rights will be automatically terminated.
CPRD ensures that NHS Digital retains direct rights for audit and/or requiring deletion of data in relation to sub-licensee, and any organisation to whom data is shared by the sub-licensee; and CPRD ensures that NHS Digital may (under the licensing terms put in place by CPRD) require and enforce remedial action (whether in relation to this or other agreements between NHS Digital and the organisation) where appropriate. CPRD takes responsibility for the actions and omissions of all sub-licensees and breach of a sub-licence would automatically be regarded as breach of the Data Sharing Framework Contract with NHS Digital.
CPRD only releases data to 3rd parties under sub licence after an Independent Scientific Advisory Committee (ISAC) review for health-related research.
In the event of termination or expiry of the Data Sharing Framework Contract between NHS Digital and the CPRD, all sub-licence rights will be automatically terminated.
The GDPR legal basis for all current release is 6(1)(e) Public interest and 9(2)(j) research. Agreements are in place for 12 months at a time and then extended if needed through the ISAC committee. All data shared under Sublicence arrangements are Pseudonymise and in line with the data sharing agreement the territory of use are restricted to England and Wales.
CPRD only releases NHS Digital data to third-parties which must have undergone the New Client Vetting process https://www.cprd.com/sites/default/files/CPRD%20New%20Client%20request%20form_V3_1.doc (or www.cprd.com/Data-access) to ensure they are appropriate data recipients) under sub-licence after an Independent Scientific Advisory Committee (ISAC) review for health-related research.
CPRD have a public facing release register which covers all data releases by them not just those which include NHS Digital data. There is a 2-month lag between data release and the study appearing on the register (though as the list is updated only monthly, so could be up to 3 months lag for a particular study).https://www.cprd.com/protocol-list
The GDPR legal basis for all current release is 6(1)(e) Public interest (in performing public health research) and 9(2)(j) research. Agreements are in place for 12 months at a time and then extended if retention is justified. All data shared under sub-licence arrangements are anonymised.
In addition, CPRD send a monthly data release report through to NHS Digital for review which details the data organisation purpose and GDPR legal basis for release.
CPRD has a searchable online register of all ISAC approved studies data releases by CPRD including NHS Digital linked data. The register is online at www.cprd.com/protocol-list
Additional data request
In addition, CPRD sends a monthly data release report through to NHS Digital, for review which details the data recipient organisation, purpose territory of use, and GDPR legal basis for release.
The linkage for the additional dataset will be conducted as indicated in steps 1-10 of the processing activities. By linking patient records from the NACAP Audit with records in the CPRD database, researchers will be able to examine treatments and clinical outcomes for patients with both COPD and asthma and undertake healthcare utilisation and public health research to improve outcomes for patients.
This linkage will occur using the same method as other linkages for which NHS Digital is a Trusted Third-Party data processor.
The National Asthma and Chronic Obstructive Pulmonary Disease (NACAP) audit data which is managed (collection and processing) by the Royal College of Physicians (RCP) and their subcontractors on behalf of HQIP, who is the data custodian.
Crown Informatics under the direction Royal College of Physicians (RCP) who is also under the direction of HQIP will send Identifiers (NHS number, Date of Birth, gender and postcode) plus HQIP pseudonym to NHS Digital for patients in both datasets (COPD and Asthma). NHS Digital will then link to CPRD identifiers (NHS number, Date of Birth, gender and postcode) plus GP system pseudonyms and provide CPRD will the bridging file, which contains the HQIP pseudonyms, GP system pseudonyms and match rank.
Expected output
[1 paragraph unchanged]
All data included in such outputs by CPRD customers will be aggregated,
with
small numbers suppressed in line with the HES Analysis Guide (or dataset specific suppression controls).
[3 paragraphs unchanged]
Abrahami D, Douros A, Yin H, Yu OHY, Renoux C, Bitton A, Azoulay L. Dipeptidyl peptidase-4 inhibitors and incidence of inflammatory bowel disease among patients with type 2 diabetes: population based cohort study. BMJ. 2018 Mar 21;360:k872.
[1 paragraph unchanged]
Bailey SE, Ukoumunne OC, Shephard EA, Hamilton W. Clinical relevance of thrombocytosis in primary care: a prospective cohort study of cancer incidence using English electronic medical records and cancer registry data. British Journal of General Practice 2017; 67 (659): e405-e413.
[1 paragraph unchanged]
Outputs from the studies approved usually have research reports which are submitted to funders (such as the Medical Research Council) . Some outputs will inform discussions with national programmes (such as NHS Cancer Screening Programmes and NHS Scotland), charities (such as Cancer Research UK) primary care professionals, policy makers and researchers,
In many instances, the papers are also published and are available on Open Access journals. Many of the outputs are also presented at conferences (such as International Society for Pharmacoepidemiology). Many of the outputs have the capacity to not only influence the clinical community but also policy makers, for example clinical guidelines (see Oyinlola et al 2016).
[1 paragraph unchanged]
Expected measurable benefits
Past and existing studies (on an ongoing basis) use linked data with
[24 words unchanged]
to be published in peer-reviewed journals and presented at scientific conferences. Some
recent examples
studies, particularly worldwide, the results
and
other relevant
publications
resulting from linked data research which resulted
may also be used as regulatory evidence
in
clinical benefits are presented below.
different countries, including the UK, directly affecting the approval or removal of drugs or devices (and hence their availability) or guidance as to their use.
Some recent examples and other relevant publications resulting from linked data research which resulted in clinical benefits are presented below.
[15 paragraphs unchanged]
The CPRD and the RCGP: building on research success by enhancing benefits for patients and practices.
Antonis A Kousoulis, Imran Rafi, Chair, and Simon de Lusignan
Br J Gen Pract. 2015 Feb; 65(631): 54–55. Available from:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4325440/?tool=pmcentrez
Example Reference 4:
Quality Improvement: prescribing and patient safety reports
https://www.rcgp.org.uk/clinical-and-research/our-programmes/quality-improvement/quality-improvement-prescribing-and-patient-safety-reports.aspx
RCGP and Clinical Practice Research Datalink (CPRD) have joined forces to produce innovative data reports focusing on prescribing and patient safety, which enable benchmarking and case-finding.
Example Reference 5:
A systematic review (Oyinlola et al 2016) identified 43 CPRD studies that have been used in 25 medical guidance documents. The reviewers found that use of data from the CPRD to inform guidelines has increased in recent years and noted the importance of linking data to extend research to medical conditions that are treated in multiple settings (e.g. primary and secondary care).
Reference:
Oyinlola JO, Campbell J, Kousoulis AA. Is real world evidence influencing practice? A systematic review of CPRD research in NICE guidances. BMC Health Serv Res. 2016 Jul 26;16:299.
Example Reference 6:
[3 paragraphs unchanged]
Example Reference
7:
4:
[3 paragraphs unchanged]
Additional data request
Additional reference 5 - example of European use (using CPRD data only):
The amendment is in the public interest as it will permit health research into two key respiratory areas (COPD and asthma) with the intention of improving treatments and clinical outcomes for patients. Unlinked CPRD primary care data have been used extensively for respiratory health research, but key gaps relating to acute admissions events in patients suffering from exacerbations have been identified in the data. NACAP audit data are not linked to any form of primary care data, preventing investigations of the patient pathways pre- and post- hospital admission. In terms of understanding and identifying factors that contribute to and thus, potentially allow mitigation of admissions and re-admissions, this linkage to primary care data is crucial. Given the health implications associated with acute exacerbations of COPD (AECOPD) and asthma, the number of clinically and public health policy-relevant research questions that can be answered using a linked dataset is high. Moreover, research using the linked data could also be used for care quality improvement in the NHS.
A publication based on a study by Utrecht University, in collaboration with Utrecht Medical Centre and CPRD evaluated the risk of all-cause mortality associated with non-vitamin K antagonist oral anticoagulants, vitamin K antagonists and aspirin in patients with atrial fibrillation.
The study concluded that non-vitamin K anticoagulants are associated with a higher risk of all-cause mortality, particularly in men and in patients with a higher stroke risk, and identified a need for more research into the underlying mechanisms for this finding, particularly for rivaroxaban. While most clearly applicable to UK populations, the results are also important to similar health economies where these drugs may be used.
Gieling, E., de Vries, F., Williams, R. et al. Mortality risk in atrial fibrillation: the role of aspirin, vitamin K and non-vitamin K antagonists. Int J Clin Pharm (2019) 41: 1536
Additional reference 6 - example of worldwide use (from linked data release in 2015):
A study conducted by Canadian researchers (Drori et al. 2019) using CPRD data investigated whether the use of androgen deprivation therapy (ADT) which is a mainstay treatment for prostate cancer, is associated with an increased risk of rheumatoid arthritis (RA). RA is a long-term condition that causes pain, swelling and stiffness in the joints, with periods of severe flare-ups that could result in long-term damage to the joints. RA has no cure and can only be managed symptomatically, with supportive treatment like physiotherapy and in case of joint damage, with surgery. Thus, there has been considerable concern amongst prostate cancer patients and their doctors, about ADT potentially leading to this debilitating condition as a side effect.
This study was able to demonstrate that the use of ADT was not associated with an increased risk of RA in men with prostate cancer. This finding provides reassurance to clinicians and prostate cancer patients in England that ADT therapy will not increase their risk of RA.
Reference: Klil-Drori, Adi J., Santella, Christina, Tascilar, Koray, Yin, Hui, Aprikian, Armen, Azoulay, Laurent: Androgen Deprivation Therapy for Prostate Cancer and the Risk of Rheumatoid Arthritis: A Population-Based Cohort Study. Drug Safety 2019
Benefits reported
The examples below demonstrate how CPRD data has been used in vital research to inform clinical practice.
A systematic review (Oyinlola et al 2016) identified 43 CPRD studies that have been used in 25 medical guidance documents. The reviewers found that use of data from the CPRD to inform guidelines has increased in recent years and noted the importance of linking data to extend research to medical conditions that are treated in multiple settings (e.g. primary and secondary care).
MMR and risk of autism
The study identified national guidelines or guidance published in England from 2000 onwards that referenced studies using data provided by CPRD. The CPRD studies provided evidence of disease epidemiology, incidence/prevalence, pharmacoepidemiology, pharmacovigilance and health utilisation. This also highlighted the increasing trend in the use of healthcare system data to inform clinical practice, especially using the real world evidence through clinical studies.
The Wakefield study in 1998 suggested a link between mumps-measles-rubella (MMR) vaccination and autism, based on an uncontrolled series of case studies of 12 children. Despite widespread criticism from the scientific community, the study generated media interest and led to a fall in MMR coverage in the UK.
Reference:
Researchers at the London School of Hygiene and Tropical Medicine used CPRD data to investigate the possibility of a link between the vaccine and incident autism. A case-control design was used to determine whether autistic children were more likely to have received the MMR vaccine. The study found no evidence of an association between being vaccinated against MMR and the risk of developing autism.
Oyinlola JO, Campbell J, Kousoulis AA. Is real world evidence influencing practice? A systematic review of CPRD research in NICE guidances. BMC Health Serv Res. 2016 Jul 26;16:299.
The study was published in the Lancet and was instrumental in restoring public opinion of the vaccine. The Wakefield study was fully retracted, and authors withdrew their association with the original publication.
Smeeth L, Cook C, Fombonne E, Heavey L, Rodrigues LC, Smith PG, Hall AJ. MMR vaccination and pervasive developmental disorders: a case-control study. Lancet, Volume 364, Number 9438, p.963-9 (2004).
Pertussis and pregnancy
Whooping cough can cause serious and fatal complications in new-born babies and young children. Babies are routinely vaccinated early, from two months of age, but can still be at risk if a mother catches whooping cough whilst pregnant.
After an outbreak of whooping cough in 2012, a national programme was introduced to give pregnant mothers a vaccine to protect their baby. Using the CPRD database, the MHRA took a proactive approach to pharmacovigilance, collecting data on a monthly basis from the start of the programme to identify a large cohort of vaccinated women. The study compared the vaccinated cohort to historical records. There was no evidence of an increased risk of adverse events in women who received the vaccine in the third trimester.
CPRD data was vital for checking the safety of the vaccine after the programme was introduced, in as near to real-time as possible. As a result of the research, all GPs and maternity services now routinely vaccinate all pregnant mothers from 20 weeks.
Donegan K, King B, Bryan P. Safety of pertussis vaccination in pregnant women in UK: observational study. BMJ. 2014;349:g4219.
Blood pressure treatment for diabetes
This study evaluated the dogma of ‘lower is better’ when managing hypertension among patients with diabetes. Results showed a greater than three-fold increase in mortality among hypertensive patients with newly-diagnosed diabetes when systolic blood pressure was reduced to levels below 110 mmHg. Risk was further increased in patients with diabetes and hypertension who had previously had a stroke or myocardial infarction. Subsequent guidelines from the European Society of Hypertension and the European Society of Cardiology (2013) now recommend lowering blood pressure to a goal of <140/90 mmHg.
Vamos EP, Harris M, Millett C, Pape UJ, Khunti K, Curcin V, Molokhia M, Majeed A. Association of systolic and diastolic blood pressure and all cause mortality in people with newly diagnosed type 2 diabetes: retrospective cohort study. BMJ. 2012 Aug 30;345:e5567.
Objective for processing
The controller for GDPR purposes is the Department of Health and Social Care (DHSC); the legal signatory for this agreement (and for the overarching DSFC) is the Secretary of State for Health and Social Care (acting as part of the Crown), acting through the Clinical Practice Research Datalink centre (hereinafter referred to as CPRD) within the Medicines and Healthcare products Regulatory Agency (the agency); and the licensee is CPRD, not the wider DHSC nor the agency.
The Clinical Practice Research Datalink (CPRD) is a centre of the Medicines and Healthcare products Regulatory Agency (the agency), an executive agency of the Department of Health and Social Care (DHSC). The agency regulates medicines, medical devices and blood components for transfusion in the UK and the agency acts as the Executive agency.
The Clinical Practice Research Datalink (CPRD) is a government not for profit research organisation, jointly supported by the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute of Health Research (NIHR), supplying anonymised health data for studies to safeguard and improve patient and public health. For more than 30 years, CPRD data have supported vital research into health care delivery, drug safety, effectiveness of medicines and risk factors for disease. The data supplied by NHS Digital and released by CPRD under the NHS Digital sub-licence can only be used for public health research purposes in accordance with Article 6(1)(e) and Article 9(2)(j).
Research using CPRD data has resulted in over 2,400 peer-reviewed publications, which have informed drug safety guidance and best clinical practice. Examples of research findings used in everyday NHS care include demonstrating the protective effect of whooping cough vaccination in pregnancy for infants and informing the National Institute of Health and Care Excellence (NICE) blood pressure targets for patients with diabetes. A searchable list of the users and uses of CPRD data is published on the CPRD website. CPRD’s research and data services are based on a database of de-identified longitudinal primary care records contributed by consenting GP practices from the four UK nations. Approval to supply anonymised data for public health research is granted on an annual basis by the East Midlands and Derby Research Ethics Committee (REC).
CPRD provides access to anonymised primary care data linked to secondary health care datasets. Linked data greatly increases the scale, depth, completeness and value of data available for public health research. The outputs of such research based on linked data inform clinical guidance and best practice for patients in the UK.
Secondary healthcare datasets are provided by NHS Digital and other data custodians and these data are linked to the primary care data by NHS Digital. NHS Digital receives identifiers to enable them to carry out this linkage as described below in section 3, according to the method described used for this linkage is described in the following paper: Padmanabhan S, Carty L, Cameron E, Ghosh RE, Williams R, Strongman H. Approach to record linkage of primary care data from Clinical Practice Research Datalink to other health-related patient data: overview and implications. Eur J Epidemiol, 15 Sep 2018, 34(1):91-99. Continued support is given by Confidentiality Advisory Group (CAG) for the flow of identifiers to NHS Digital to enable linkage of CPRD primary care data to secondary datasets.
The legal bases for processing the data provided by NHS Digital are:
• Gathering of GP patient data and collation with other datasets to produce datasets that have been anonymised: medical research under Article 9(2)(j); drug and device safety under Article 9(2)(i) of the General Data Protection Regulation.
NHS Digital has been providing and linking health-related datasets to CPRD primary care data for a number of years. Data linkage is carried out exclusively by NHS Digital as the Trusted Third Party (TTP) for this purpose. Linked datasets currently available include extracts from Civil Registration data; Hospital Episode Statistics (HES), which encompasses Admitted Patient Care, Critical Care, Outpatient and Accident & Emergency data; Patient Reported Outcome Measures (PROMs); Diagnostic Imaging Dataset (DID); Mental Health data; National Cancer Registry; National Asthma and COPD Audit Programme (NACAP) audit data, Deprivation data including Townsend Score and Index of Multiple Deprivation. Critical care is supplied as a separate dataset by NHS Digital, but is integrated with Admitted Patient Care.
Expected output
CPRD customers using linked data products will be producing (on an ongoing basis) research publications in peer-reviewed journals and presentations at scientific conferences. CPRD customers include academic institutions, pharmaceutical companies, Governmental centres and research charities. These all undertake medical and health data research, which may result in formal publications.
All data included in such outputs by CPRD customers will be aggregated, with small numbers suppressed in line with the HES Analysis Guide (or dataset specific suppression controls).
A selection of publications resulting from use of CPRD linked data are presented below.
Akyea RK, Kai J, Qureshi N, Iyen B, Weng SF. Sub-optimal cholesterol response to initiation of statins and future risk of cardiovascular disease. Heart, 2019; 105:975-981.
Abel KM, Hope H, Swift E, Parisi R, Ashcroft DM, Kosidou K, Osam CS, Dalman C, Pierce M. Prevalence of maternal mental illness among children and adolescents in the UK between 2005 and 2017: a national retrospective cohort analysis. Lancet Public Health, vol. 4, pp. e291-e300, 2019.
Crellin E, Mansfield KE, Leyrat C, Nitsch D, Douglas IJ, Root A, Williamson E, Smeeth L, Tomlinson LA. Trimethoprim use for urinary tract infection and risk of adverse outcomes in older patients: cohort study. BMJ. 2018 Feb 9;360:k341.
Morgan C, Webb RT, Carr MJ, Kontopantelis E, Green J, Chew-Graham CA, Kapur N, Ashcroft DM. Incidence, clinical management, and mortality risk following self harm among children and adolescents: cohort study in primary care. BMJ, Volume 359, p.j4351 (2017).
Outputs from the studies approved usually have research reports which are submitted to funders (such as the Medical Research Council) . Some outputs will inform discussions with national programmes (such as NHS Cancer Screening Programmes and NHS Scotland), charities (such as Cancer Research UK) primary care professionals, policy makers and researchers,
In many instances, the papers are also published and are available on Open Access journals. Many of the outputs are also presented at conferences (such as International Society for Pharmacoepidemiology). Many of the outputs have the capacity to not only influence the clinical community but also policy makers, for example clinical guidelines (see Oyinlola et al 2016).
A comprehensive list of publications including those using linked data can be found at www.cprd.com/bibliography
Benefits reported
A systematic review (Oyinlola et al 2016) identified 43 CPRD studies that have been used in 25 medical guidance documents. The reviewers found that use of data from the CPRD to inform guidelines has increased in recent years and noted the importance of linking data to extend research to medical conditions that are treated in multiple settings (e.g. primary and secondary care).
The study identified national guidelines or guidance published in England from 2000 onwards that referenced studies using data provided by CPRD. The CPRD studies provided evidence of disease epidemiology, incidence/prevalence, pharmacoepidemiology, pharmacovigilance and health utilisation. This also highlighted the increasing trend in the use of healthcare system data to inform clinical practice, especially using the real world evidence through clinical studies.
Reference:
Oyinlola JO, Campbell J, Kousoulis AA. Is real world evidence influencing practice? A systematic review of CPRD research in NICE guidances. BMC Health Serv Res. 2016 Jul 26;16:299.
DARS-NIC-15625-T8K6L-v5.6 22 October 2019 to 21 October 2020
- Title
- Clinical Practice Research Datalink (CPRD) Routine Linkages Application
- Commercial
- Yes
- Sublicensing
- Yes
- Datasets
- 15
- Files released
- 428
Datasets: Bridge file: Hospital Episode Statistics to Diagnostic Imaging Dataset; Bridge file: Hospital Episode Statistics to Mental Health Minimum Data Set; Civil Registrations of Death - Secondary Care Cut; Diagnostic Imaging Data Set (DID); Emergency Care Data Set (ECDS); HES:Civil Registration (Deaths) bridge; Hospital Episode Statistics Accident and Emergency (HES A and E); Hospital Episode Statistics Admitted Patient Care (HES APC); Hospital Episode Statistics Critical Care (HES Critical Care); Hospital Episode Statistics Outpatients (HES OP); Mental Health and Learning Disabilities Data Set (MHLDDS); Mental Health Minimum Data Set (MHMDS); Mental Health Services Data Set (MHSDS); MRIS - Bespoke; Patient Reported Outcome Measures (Linkable to HES)
Objective for processing
The data controller is Department of Health and Social Care, with the Secretary of State for Health and Social Care (acting as part of the Crown), acting through the Clinical Practice Research Datalink centre (hereinafter referred to as CPRD) within the Medicines and Healthcare Products Regulatory Agency.
The Clinical Practice Research Data-linkage (CPRD) is a centre of the Medicines and Healthcare products Regulatory Agency (MHRA), an executive agency of the Department of Health & Social Care (DHSC). The MHRA regulates medicines, medical devices and blood components for transfusion in the UK and the MHRA act as the Executive agency.
CPRD is the UK’s pre-eminent research service, providing access to primary care data (that has been anonymised) linked by NHS Digital to other similarly pseudonymised health data. This data is provided by NHS Digital and others for the purposes of public health research including the monitoring of drug safety. All such data is linked (in its identifiable form) by NHS Digital only. It is jointly funded by the MHRA and the National Institute for Health Research (NIHR).
CPRD’s aims are to support vital public health research and to inform advances in patient safety in the delivery of patient care pathways. These depend on access to accurate, real-time representative patient data to produce reliable evidence based clinical and drug safety guidance. The legal bases for processing the data provided by NHS Digital are:
• Gathering of GP patient data and collation with other data sets to produce data-sets that have been anonymised: medical research under Article 9(2)(j); drug and device safety under Article 9(2)(i) of the General Data Protection Regulation.
CPRD services are designed to maximise the way de-identified NHS clinical data can be used to improve and safeguard public health. For more than 20 years data provided by CPRD have been used in a range of drug safety and epidemiological studies that have impacted on health care, and resulted in over 2100 peer-reviewed publications. In addition to supporting high-quality observational research, CPRD is developing world-leading services based on using real world data to support clinical trials and intervention studies. The intention is to continue to link CPRD primary care data to NHS Digital’s secondary care and other datasets, as linkage greatly increases the scale, depth, completeness and therefore value of data available for public health research. The outputs of such research based on linked data in turn improve and protect patient care pathways/treatments and provide clinical benefits for the UK, supporting delivery of CPRD’s core objectives.
CPRD’s research and data services are based on a database of de-identified longitudinal primary care records contributed by consenting GP practices from the four UK nations, and on the ability to link primary care data to secondary care data (and other data sets), from the NHS, Office of National Statistics (ONS) and Public Health England (PHE). One of CPRD’s main priorities is to increase the number of national data sets that are linked to primary care data and made available on a routine basis to the research community. Such collection and linkages occur under the appropriate permissions (ethical and s251), which have been granted to CPRD by the East Midlands & Derby Research Ethics Committee (REC), and the Health Research Authority (HRA).
NHS Digital has been providing secondary and other data for linkage with CPRD primary care data for a number of years. Data linkage is carried out exclusively by NHS Digital as the Trusted Third Party (TTP) for this purpose. Linked data sets currently available include extracts from Civil Registration data; Hospital Episode Statistics (HES), which encompasses Admitted Patient Care, Critical Care, Outpatient and Accident & Emergency data; Patient Reported Outcome Measures (PROMs); Diagnostic Imaging Dataset (DID); Mental Health data; National Cancer Registry; Deprivation data including Townsend Score and Index of Multiple Deprivation. Critical care is supplied as a separate dataset by NHS Digital, but is integrated with Admitted Patient Care.
The data released under the sub-licence can only be used for public health research purposes using Section 6(1)(e) and Section 9(2)(j), as recommended for approval by ISAC for MHRA database research. CPRD make the final decision on access, and ensure compliance with NHS Digital’s requirements within the data sharing agreement, e.g. security of the third party. Access to CPRD data and services will not be permitted in circumstances that may result in loss of public trust or for activities that may undermine the integrity of the CPRD database.
Additional Data Request
The National Asthma and COPD Audit Programme (NACAP) audit data which consists of the chronic obstructive pulmonary disease (COPD) and asthma (adult; children and young people) collection has been added to CPRD’s master dataset list (support given April 2019) for linkage on an ongoing basis. This request is for a one-off link of the data. It is envisaged that future iterations of this agreement would allow additional linkages. The National Asthma and Chronic Pulmonary (NACAP) Disease audit dataset is being requested within the CPRD master dataset list as the linkage to supplementary primary
care data would be valuable to those researchers undertaking research into asthma and COPD.
Expected output
CPRD customers using linked data products will be producing (on an ongoing basis) research publications in peer-reviewed journals and presentations at scientific conferences. CPRD customers include academic institutions, pharmaceutical companies, Governmental centres and research charities. These all undertake medical and health data research, which may result in formal publications.
All data included in such outputs by CPRD customers will be aggregated, small numbers suppressed in line with the HES Analysis Guide (or dataset specific suppression controls).
A selection of publications resulting from use of CPRD linked data are presented below.
Akyea RK, Kai J, Qureshi N, Iyen B, Weng SF. Sub-optimal cholesterol response to initiation of statins and future risk of cardiovascular disease. Heart, 2019; 105:975-981.
Abel KM, Hope H, Swift E, Parisi R, Ashcroft DM, Kosidou K, Osam CS, Dalman C, Pierce M. Prevalence of maternal mental illness among children and adolescents in the UK between 2005 and 2017: a national retrospective cohort analysis. Lancet Public Health, vol. 4, pp. e291-e300, 2019.
Abrahami D, Douros A, Yin H, Yu OHY, Renoux C, Bitton A, Azoulay L. Dipeptidyl peptidase-4 inhibitors and incidence of inflammatory bowel disease among patients with type 2 diabetes: population based cohort study. BMJ. 2018 Mar 21;360:k872.
Crellin E, Mansfield KE, Leyrat C, Nitsch D, Douglas IJ, Root A, Williamson E, Smeeth L, Tomlinson LA. Trimethoprim use for urinary tract infection and risk of adverse outcomes in older patients: cohort study. BMJ. 2018 Feb 9;360:k341.
Bailey SE, Ukoumunne OC, Shephard EA, Hamilton W. Clinical relevance of thrombocytosis in primary care: a prospective cohort study of cancer incidence using English electronic medical records and cancer registry data. British Journal of General Practice 2017; 67 (659): e405-e413.
Morgan C, Webb RT, Carr MJ, Kontopantelis E, Green J, Chew-Graham CA, Kapur N, Ashcroft DM. Incidence, clinical management, and mortality risk following self harm among children and adolescents: cohort study in primary care. BMJ, Volume 359, p.j4351 (2017).
A comprehensive list of publications including those using linked data can be found at www.cprd.com/bibliography
Benefits reported
The examples below demonstrate how CPRD data has been used in vital research to inform clinical practice.
MMR and risk of autism
The Wakefield study in 1998 suggested a link between mumps-measles-rubella (MMR) vaccination and autism, based on an uncontrolled series of case studies of 12 children. Despite widespread criticism from the scientific community, the study generated media interest and led to a fall in MMR coverage in the UK.
Researchers at the London School of Hygiene and Tropical Medicine used CPRD data to investigate the possibility of a link between the vaccine and incident autism. A case-control design was used to determine whether autistic children were more likely to have received the MMR vaccine. The study found no evidence of an association between being vaccinated against MMR and the risk of developing autism.
The study was published in the Lancet and was instrumental in restoring public opinion of the vaccine. The Wakefield study was fully retracted, and authors withdrew their association with the original publication.
Smeeth L, Cook C, Fombonne E, Heavey L, Rodrigues LC, Smith PG, Hall AJ. MMR vaccination and pervasive developmental disorders: a case-control study. Lancet, Volume 364, Number 9438, p.963-9 (2004).
Pertussis and pregnancy
Whooping cough can cause serious and fatal complications in new-born babies and young children. Babies are routinely vaccinated early, from two months of age, but can still be at risk if a mother catches whooping cough whilst pregnant.
After an outbreak of whooping cough in 2012, a national programme was introduced to give pregnant mothers a vaccine to protect their baby. Using the CPRD database, the MHRA took a proactive approach to pharmacovigilance, collecting data on a monthly basis from the start of the programme to identify a large cohort of vaccinated women. The study compared the vaccinated cohort to historical records. There was no evidence of an increased risk of adverse events in women who received the vaccine in the third trimester.
CPRD data was vital for checking the safety of the vaccine after the programme was introduced, in as near to real-time as possible. As a result of the research, all GPs and maternity services now routinely vaccinate all pregnant mothers from 20 weeks.
Donegan K, King B, Bryan P. Safety of pertussis vaccination in pregnant women in UK: observational study. BMJ. 2014;349:g4219.
Blood pressure treatment for diabetes
This study evaluated the dogma of ‘lower is better’ when managing hypertension among patients with diabetes. Results showed a greater than three-fold increase in mortality among hypertensive patients with newly-diagnosed diabetes when systolic blood pressure was reduced to levels below 110 mmHg. Risk was further increased in patients with diabetes and hypertension who had previously had a stroke or myocardial infarction. Subsequent guidelines from the European Society of Hypertension and the European Society of Cardiology (2013) now recommend lowering blood pressure to a goal of <140/90 mmHg.
Vamos EP, Harris M, Millett C, Pape UJ, Khunti K, Curcin V, Molokhia M, Majeed A. Association of systolic and diastolic blood pressure and all cause mortality in people with newly diagnosed type 2 diabetes: retrospective cohort study. BMJ. 2012 Aug 30;345:e5567.
Register history
When this agreement appeared in, or was edited in, each monthly edition of the register. Built by comparing every edition this site holds, the earliest of which is July 2021.
-
July 2021 —
already listed in the earliest edition this site holds, so it may be older. 6 versions: DARS-NIC-15625-T8K6L-v10.4, DARS-NIC-15625-T8K6L-v5.6, DARS-NIC-15625-T8K6L-v6.4, DARS-NIC-15625-T8K6L-v7.1, DARS-NIC-15625-T8K6L-v8.2, DARS-NIC-15625-T8K6L-v9.2
-
October 2021
Amended DARS-NIC-15625-T8K6L-v10.4
- Datasets: + HES-ID to MPS-ID HES Accident and Emergency; + HES-ID to MPS-ID HES Admitted Patient Care; + HES-ID to MPS-ID HES Outpatients
-
June 2022
1 version added: DARS-NIC-15625-T8K6L-v11.2
-
January 2023
1 version added: DARS-NIC-15625-T8K6L-v12.6Amended DARS-NIC-15625-T8K6L-v10.4
- Datasets:
+ COVID-19 SGSS First Positives (Second Generation Surveillance System) ·
− COVID-19 Second Generation Surveillance System (SGSS)
Amended DARS-NIC-15625-T8K6L-v11.2- Datasets:
+ COVID-19 SGSS First Positives (Second Generation Surveillance System) ·
− COVID-19 Second Generation Surveillance System (SGSS)
Amended DARS-NIC-15625-T8K6L-v7.1- Datasets:
+ COVID-19 SGSS First Positives (Second Generation Surveillance System) ·
− COVID-19 Second Generation Surveillance System (SGSS)
Amended DARS-NIC-15625-T8K6L-v8.2- Datasets:
+ COVID-19 SGSS First Positives (Second Generation Surveillance System) ·
− COVID-19 Second Generation Surveillance System (SGSS)
Amended DARS-NIC-15625-T8K6L-v9.2- Datasets:
+ COVID-19 SGSS First Positives (Second Generation Surveillance System) ·
− COVID-19 Second Generation Surveillance System (SGSS)
- Datasets:
+ COVID-19 SGSS First Positives (Second Generation Surveillance System) ·
-
December 2023
1 version added: DARS-NIC-15625-T8K6L-v13.4
-
July 2024
Amended DARS-NIC-15625-T8K6L-v13.4
- Datasets: + CPRD Deprivation
-
June 2025
1 version added: DARS-NIC-15625-T8K6L-v14.2
-
March 2026
1 version added: DARS-NIC-15625-T8K6L-v15.3
"Amended in place" means NHS England changed the record without issuing a new version number. The register publishes no changelog for those edits; this site infers them by comparing editions. An edit is attributed to the edition it first appears in, not to the date it was made.
Cite this page
NHS England (2026) Data Uses Register, September 2026 edition, agreement DARS-NIC-15625-T8K6L, “R23 - Clinical Practice Research Datalink (CPRD) Routine Linkages Application”. Read via NHS Data Access Explorer (unofficial), https://healthdatauses.uk/agreements/dars-nic-15625-t8k6l/ (accessed [date]).
This address stays the same, but the page is rebuilt with each monthly edition, so the citation names the edition it shows. Every edition's data is kept in the facts store.
Source: datausesregister_september2026.xlsx, September 2026 edition of the NHS England Data Uses Register. Search that workbook for DARS-NIC-15625-T8K6L to see the original rows.