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Renal Replacement Anticoagulant Management (RRAM)

Intensive Care National Audit & Research Centre (ICNARC) · Research

In term In term in the September 2026 edition: the latest version runs to 6 April 2031.

Reference
DARS-NIC-184951-D1G8R
Current version
v2.9
Term of current version
7 April 2023 to 6 April 2031
Start date
3 December 2018
Data controller
Sole Data Controller
Commercial purposes
No
Sublicensing
No
Files released to date
14

Why the data was released

Objective for processing

The aim and purpose of this Agreement is to extend and amend the existing data sharing agreement (DSA) with NHS Digital for the Renal Replacement Anticoagulation Management (RRAM) study.

The amendment is that Babble Cloud Limited have replaced Nasstar and will provide external desktop and network managed services, including end user and infrastructure support. This Agreement will also be amended to an archiving Agreement.

This Agreement does not permit any further processing that involves analysis or linkage other than for the purpose of verifying findings in line with the original objectives of the study by repeating previous analyses described in this Agreement.

Any request to share data from the RRAM study will be to share outputs that have already been produced in the form of aggregate data with small number suppressed.

The RRAM study is now complete.

No additional data will be requested from NHS Digital.

This Agreement permits processing of the data for the purpose of secure storage and back up.

Following publication of the study findings, it is possible that the findings will be questioned or challenged by third parties through direct contact with Intensive Care National Audit & Research Centre (ICNARC), contact via the publishing journal or an open letter. In such circumstances, ICNARC may re-run the previous analyses undertaken to verify that the published results were accurate and may write a response to be issued directly to the challenger or published.

This Agreement does not permit any further processing that involves analysis or linkage other than for the purpose of verifying findings in line with the original objectives of the study by repeating previous analyses described in this Agreement.

ICNARC may not undertake different analyses to those undertaken during the original analysis.

This Agreement does not permit any onward sharing of the data with the exception that the data may be viewed for the purpose of an audit.

This Agreement also permits the necessary processing of the Data for the purposes of permanently destroying, deleting or erasing the Data once it is no longer required for the purpose for which it was collected. Once destroyed/deleted or erased, ICNARC must confirm destruction to NHS Digital.

If any further data processing is required in addition to the above purposes or if the data needs to be moved to a different location/organisation ICNARC must submit an amendment request to NHS Digital before data is accessed.

Data from the following NHS Digital datasets will be retained under this Agreement:

• Hospital Episode Statistics Admitted Patient Care

• Civil Registration (Deaths) - Secondary Care Cut

The level of the data being retained will be:

• Pseudonymised data

Intensive Care National Audit & Research Centre (ICNARC) requires access to NHS Digital data for the purpose of the following observational study which is now complete:

RRAM is an observational study that was designed to utilise high quality routinely collected clinical data, in order to compare the clinical and cost-effectiveness of changing to citrate anticoagulation for continuous renal replacement therapy (CRRT) in adult intensive care units (ICU). The study successfully completed in February 2020, following submission of the final report detailing the results of the study to the funder. Following completion of the RRAM study and the data linkage conducted by NHS Digital to Hospital Episodes Statistics, Civil Registrations death records and the UK Renal Registry (NHS Digital acted as trusted third party to conduct linkage), ICNARC produced and hold a linked, pseudonymised study database which has been used to produce the analyses for the study. Under this Agreement, researchers will continue to process these pseudonymised data, already obtained from NHS Digital, to ensure that the results of the study are published and disseminated widely to ensure maximum impact.

Under the original Agreement, NHS Digital linked the cohort provided by Intensive Care National Audit & Research Centre (ICNARC) to Civil Registrations death data and HES Admitted Patient Care data and provided ICNARC with the requested data, pseudonymised using the study ID (no identifiable data were transferred from NHS Digital to ICNARC) including requesting patient status and date of death (where applicable) for all patients in the cohort to directly contribute to the clinical evaluation of the primary outcome (90-day all-cause mortality) and the requested HES Admitted Patient Care data to obtain health care usage for linked patients that will be used to calculate the incremental cost-effectiveness at 1 year (primary cost effectiveness outcome) and estimate lifetime cost effectiveness.

This research is important to patients and the NHS as there is currently a rapid change occurring within the NHS, whereby traditional heparin based anticoagulation for CRRT is being replaced by citrate based methods. This is being done without any evidence that citrate is superior to heparin in terms of clinical or cost-effectiveness. This study utilised an efficient design using available data to clarify the effect of changing to citrate-based anticoagulation on health and economic outcomes in normal clinical practice to help determine whether the change should be encouraged or stopped.

The RRAM study was initially funded by the National Institute for Health Research, Health Technology Assessment Programme (HTA 16/111/136), managed and sponsored by the Intensive Care National Audit & Research Centre (ICNARC) and includes data from approximately 85,000 patients that were admitted to an adult general ICU in England or Wales between 1 April 2009 and 31 March 2017.

The National Institute for Health Research were the funders for the RRAM study however, this funding has now expired. They did not have access to the data and did not determine the manner or purposes of processing, therefore are not considered a data controller.

Under a previous iteration of this Agreement, ICNARC provided NHS Digital with a cohort of patients who received CRRT in an adult general ICU in England or Wales between 1 April 2009 and 31 March 2017. Eligible patients were aged 16 and over; admitted to an adult or general ICU in England and Wales, which participates in the ICNARC case mix programme, between 01/04/2009 and 31/03/2017; and received CRRT for at least one calendar day during the ICU stay.

There was data linkage between UK Renal Registry (UKRR) and ICNARCs Case Mix Programme for this study. Data extracts provided separately by the UKRR and NHS Digital were combined with the relevant clinical data from the ICNARC CMP to create the final dataset. UKRR provided a study ID and a local ID to NHS Digital which was sent back to UKRR. This enabled UKRR to identify which participants of the registry to send to ICNARC. However, no NHS Digital data was provided to UKRR and as such UKRR are not considered a data processor. UKRR do not determine the manner or purposes of processing for this study, therefore are not considered a data controller.

The Intensive Care National Audit and Research Centre (ICNARC), as the sponsor for the study, are the sole data controller as they have sole control over why and how personal data are processed. Specifically, ICNARC in their role as sponsor solely decides; to collect personal data and the legal basis for doing so, which items of personal data are collected, the purpose and purposes the data are used for, whether to disclose the data, whether subject access and other individuals’ rights apply, any amendments to the data, and how long the data are retained. The Chief Investigator was from the University of Oxford and Oxford University NHS Trust/John Radcliffe Hospital. Their role and responsibilities were to co-ordinate the study and provide data for the health economics aspect of the study. This involved the survey of ICUs, micro costing the study (visiting hospitals) and overseeing/ensuring delivery according to the study timelines. This was completed separately to the data linkage and analysis described and approved in this Data Sharing Agreement, which took place at ICNARC only. The University of Oxford are not considered a data controller for this application as the chief investigator (and therefore the University of Oxford) does not have any power over the purposes for which and the manner in which personal data are, or are to be processed.

The Data Processors for the data being requested from NHS Digital are ICNARC, Babble Cloud (SUI) Limited and Exponential-E Ltd. Exponential-E Ltd manage ICNARC’s secure virtual data centre; and Babble Cloud (SUI) Limited provide ICNARC’s end user IT support.

ICNARC works with the Intensive Care Unit Support Teams for Ex-Patients (ICUsteps), the intensive care patient support charity, already collaborating on ICNARCs Family Reported Experiences Evaluation Study funded by the NIHR Health Services & Delivery Research Programme. The RRAM team at ICNARC will work with both Healthtalk and ICUSteps to ensure the results of the study are fed-back to patients. In addition, once the primary clinical- and cost-effectiveness results of the study have been published and are publicly available, the publication and a summary of the results will also be available to patients and the public via the study website (https://www.icnarc.org/Our-Research/Studies/Rram/About).

The “legitimate interests” relied upon are of healthcare research. This is because the data processing described here is to support scientific and statistical research.

The legal basis for processing data under this agreement are Section 6(1)(f) and Article 9(2)(j) legal basis from the General Data Protection Regulation.

ICNARC has conducted a legitimate interests assessment to confirm processing is necessary for the purposes of the legitimate interests. ICNARC have assessed this against the ICO’s checklist (https://ico.org.uk/for-organisations/guide-to-the-general-data-protection-regulation-gdpr/lawful-basis-for-processing/legitimate-interests/) and are content that the requirements are met and has been reviewed by NHS Digital.

Purpose Test: are you pursuing a legitimate interest? ICNARC is an independent charity committed to providing high quality information through their national clinical audits, where hospitals/critical care units use information from reports to help them improve care; through research, where data are collected to answer specific questions or to test theories.

Necessity Test: is the processing necessary for that purpose? Processing personal data is necessary for ICNARC's legitimate interests which are described in this application. The data to which access is requested are proportionate and necessary to achieve those interests.

Balancing Test: do the individual’s interests override the legitimate interest? ICNARC have completed a legitimate interests assessment (LIA) and are satisfied that the interests of the data subjects do not override our legitimate interests; that they would reasonably expect the processing and it would not cause unjustified harm. The data subjects’ interests and fundamental rights are protected through appropriate minimisation of fields and patient records being processed; pseudonymisation to minimise any risk of identifying individuals; protection of the data in a secure environment, and guaranteeing secure destruction at any stage at the request of NHS Digital or after a defined period on completion of the project. ICNARC have assessed this against the ICO’s checklist and are content that the requirements are met and has been reviewed by NHS Digital.

The primary outcome for the processing of NHS Digital data in this Agreement is to provide important outcome data for this study. The outcomes of the study are:

Primary outcomes:

• All cause mortality at 90 days (clinical effectiveness)

• Incremental net monetary benefit at 1 year (cost effectiveness)

Secondary outcomes:

• All-cause mortality at hospital discharge, 30 days and one year

• Days of renal, cardiovascular, and advanced respiratory support

• ICU and hospital length of stay

• New dialysis-dependent renal disease at one year

• Estimated lifetime incremental cost-effectiveness

Processing personal data is necessary for ICNARC's legitimate interests which are described in this Agreement. ICNARC is an independent charity committed to providing high quality information through their national clinical audits and portfolio of research studies.

Processing activities

This study is now completed and closed.

This agreement permits processing of the data for the purpose of secure storage.

This agreement does not permit any further processing that involves analysis or linkage other than for the purpose of verifying findings in line with the original objectives of the study by repeating previous analyses described in this Agreement.

This agreement does not permit any onward sharing of the data with the exception that the data may be viewed for the purpose of an audit by a regulator.

If any further data processing is required in addition to the above purposes or if the data needs to be moved to a different location/organisation the applicant must submit an amendment request to NHS England before data is accessed.

The study data (used for analysis and now to be archived) is stored on a secure server at ICNARC, for a minimum of 10 years following completion of the study (February 2020), which can only be accessed by a restricted number of personnel.

In the event that the data needs to be accessed for the purposes of an audit or to enable verification of previous findings, the dataset would be accessible only for as long as is required to enable verification of the analyses and to write a response as appropriate. Responses will adhere to the rules for small number suppression in the HES Analysis Guide.

The data may not be transferred to any other location and may only be accessed for the purposes described above.

The following processing activities were untaken during the course of the RRAM study:

In summary ICNARC requested three data linkages:

1. Patient status/date of death via linkage to Civil Registration data for all patient in the Case Mix Programme (CMP). (ICNARC hold the Case Mix Programme (CMP) national clinical audit database, from which the study cohort were derived).

2. Linkage to the HES APC data for all patients in the CMP.

3. NHS England carried out third party linkage to the UKRR data for all patients who matched in the CMP. The study id only was returned to UKRR and UKRR sent the clinical data to ICNARC. ICNARC used the study ID to link the returned HES and Civil Registration data and UKRR data to the relevant clinical data from the CMP database to create a final dataset for analysis.

NHS England linked direct patient identifiers provided from the CMP by ICNARC to HES, Civil Registration and UKRR datasets.

The data linkage process was as follows:

1. ICNARC identified eligible patients from the CMP database between 1 April 2009 and 31 March 2017 and uploaded to NHS England a file containing a study ID (for identification in the CMP) and the following direct patient identifiers; NHS number, date of birth and postcode.

2. In parallel, UKRR provided NHS England with a file containing the same direct patient identifiers for patients in the UKRR between 1 April 2009 and 31 March 2017 plus a local UKRR ID. The local ID allowed for linkage back to the locally held audit data.

The transfer of direct patient identifiers from ICNARC and the UKRR to NHS England was covered by the Section 251 approval (18/CAG/0070) for the RRAM study.

3. NHS England matched direct patient identifiers from the CMP with those supplied from the UKRR and returned to ICNARC and the UKRR a linkage file containing the local ID (to the UKRR) and study ID (allowing for linkage across all the datasets) for all matched records. NHS England also performed linkage for all patients within the CMP to HES (containing information on hospitals admissions for all matched patients between CMP and HES datasets) and Civil Registration (deaths) (containing death data for all matched patients between the CMP and Civil Registration) datasets.

The local ID was used by the UKRR to identify the relevant records within their individual audit system when it was returned by NHS England along with a study ID. This means that the UKRR did not receive any data other than the two ID’s. For the ICNARC CMP, the study ID will act as the local ID.

4. The UKRR then provided a file to ICNARC containing the clinical fields (with no direct patient identifiers) required for the project along with the study ID for those patients identified in the CMP. In parallel, NHS England provided ICNARC a file containing agreed HES data (containing information on hospitals admissions for all matched patients between CMP and HES datasets) and Civil Registration (deaths) (containing mortality data or all matched patients between the CMP and Civil Registration dataset (deaths)) data together with the study ID for patients identified in the ICNARC CMP.

5. ICNARC used the study ID to link the data extracts provided by the UKRR and NHS England with the relevant clinical data from the ICNARC CMP to create the final dataset. Once the data was linked, ICNARC pseudonymised the dataset by replacing date of birth with age in years, replacing the date of admission to critical care unit with month and year, replacing all other dates in the dataset (including date of death) with the number of days relative to these index dates, replacing postcode with area level deprivation measures, and replacing hospital/critical care unit names with anonymous identifiers. Consequently, the final pseudonymised dataset will contain no patient identifiable data.

6. The final linked project dataset will be analysed by statisticians at ICNARC, all of whom are substantive employees. The analysis will follow interrupted time series analysis techniques to compare the clinical effectiveness of a change to citrate anticoagulation on; all-cause mortality at 90-days, 30-days, and one year; number of days receiving renal, cardiovascular, and advanced respiratory support; ICU length of stay; and development of new-dialysis renal disease at one year.

The data received from NHS England was incorporated into the RRAM study database and stored on secure servers.

The UKRR only supplied patient identifiers to NHS England for data linkage and did not receive any HES/Civil Registration death data for linked patients and therefore are not considered a Data Processor.

As part of a separate data linkage, ICNARC linked the study cohort to Patient Episode Database for Wales (PEDW).

Following receipt of the requested pseudonymised data from NHS England (Civil Registrations deaths and HES Admitted Patient Care data), the UKRR, and PEDW, ICNARC combined all data into a single pseudonymised RRAM study database using the study ID for analysis and is stored at ICNARC. No identifiable data were transferred from the data providers to ICNARC.

The CMP database is stored on servers at ICNARC with the patient identifiers stored separately from clinical audit data. Although the final linked RRAM study dataset is pseudonymised, the rich clinical data mean that it is likely that at least some records would be able to be reidentified by individuals with access to the study dataset and the CMP databases. Identifiable and clinical data held for the CMP are stored on separate servers to the pseudonymised RRAM study dataset. No attempt to reidentify participants will be made.

ICNARC’s Case Mix Programme (CMP) dataset includes patient identifiers. An extract of CMP data was created for the RRAM project, including patient identifiers and a “study_ID” pseudo-identifier that was created for the project, which were transferred to NHS England for linkage. NHS England returned only the study_ID and pseudonymised clinical data.

On 19 November 2021, ICNARC pseudonymised all data files associated with the project by

(i) creating copies that included new pseudo-identifiers, and

(ii) excluded all patient identifiers (NHS number, date of birth, postcode) and all record identifiers that would permit linkage back to the raw CMP records, and

(iii) permanently destroying the original files (see data destruction certificates previously provided).

Since this process was conducted, ICNARC have been unable to link to the project dataset with the raw CMP records that contain patient identifiers.

To produce a derived dataset for retention outside of any Data Sharing Agreement, the following additional steps have been taken: date of death (which is recorded in both CMP and NHS England records) has been converted into vital status at 90 and 365 days after admission to critical care, and patient pseudo-identifiers have again been replaced to further remove ICNARC’s ability to link the derived data back to the archived date of death field.

All processing of identifiable data took place by staff with substantive contracts with ICNARC. All ICNARC staff are required to undertake NHS England training in Data Security Awareness. At no stage will those processing the data have access to patient identifiers beyond those already recorded for the Case Mix Programme and National Cardiac Arrest Audit, and the additional clinical data received will make minimal difference to the identifiability of data.

All ICNARC employees are trained in data protection and confidentiality and have signed a contract, which incorporates a confidentiality clause and the consequences of breaching confidentiality are covered by disciplinary procedures.

The NHS England data along with all study data will be stored on secure servers, managed by Exponential-E Ltd, on behalf of ICNARC. Exponential-E Ltd is a contractor authorised by ICNARC. The data will be analysed by a remote desktop connection via a virtual private network from ICNARC owned equipment to the server at Exponential-E Ltd, with all data remaining on the server at all times and no data downloaded to local machines. Employees of Exponential-E Ltd will not access the data held under this agreement, but will provide storage/back-up, and as such, are listed as processors.

Babble Cloud (SUI) Limited will provide external desktop and network managed services, including end user and infrastructure support. Employees at Babble Cloud (SUI) Limited have the ability to access NHS England data for logistical reasons but will not access the data held under this agreement, however, they will have remote access to ICNARC servers (which are hosted by Exponential-E Ltd).

NHS England reminds all organisations party to this agreement of the need to 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.

Expected output

As the study has completed, the study team are now disseminating the results of the study. No further processing of the data will be carried out in order to produce any outputs. The existing and planned outputs of the project are as follows:

1. Prior to completion of the study, the RRAM study protocol and statistical analysis plan were published in the Journal of the Intensive Care Society. This publication was important for ensuring transparency and reproducibility of the research. Additionally, publishing the protocol and analysis plan has helped raise the profile of the study amongst the critical care community and will allow others to follow the methods employed for other, similar analyses.

2. A final report detailing the results of the RRAM study was submitted to the NIHR (the study funder) in February 2020 and has subsequently been published in the NIHR Health Technology Assessment (HTA) journal. Publication of the final report is a requirement of the NIHR as the journal’s Technology Assessment Reports inform National Institute for Health and Care Excellence (NICE) guidance. HTA research is also an important source of evidence for National Screening Committee (NSC) policy decisions. Outputs included in the HTA journal will contain only aggregate level data with small numbers suppressed in line with the HES analysis guidance.

3. The primary clinical- and cost-effectiveness results of the study will be published in a peer reviewed journal and will conform to the RECORD standards – an agreed set of ‘rules’ for reporting research studies based on routinely-collected data. The manuscript reporting the results has been submitted to a peer reviewed journal and is currently under consideration. The study team are aiming to publish in a journal with the highest possible impact with a critical care audience. This will hopefully allow the results to have the biggest chance of having an impact amongst those who will use the result to inform their practice. Given the large amount of work that went into creating the RRAM study database, within each area of the study, it may be appropriate to split the data into more than one article/publication. Again, the study team will aim to publish these in a journal with the highest possible impact (e.g. a publication focussing on the methodology/data linkage would be published in journal with a methodological audience). Outputs will contain only aggregate level data with small numbers suppressed in line with the HES analysis guidance.

4. Presentations at professional and scientific conferences – the RRAM study methodology was presented at the at the Annual Meeting of the Case Mix Programme (April 2019) as an example of using data linkage to report longer-term outcomes in critically ill patients. An abstract describing the RRAM methodology was submitted to the International Population Data Linkage Network Conference in and was accepted for presentation in October 2020. Unfortunately, due to COVID-19 workload, the abstract was withdrawn. Presenting the methodology behind the RRAM study meets the objective to establish efficient research techniques that, if successful, could be used to track the effects of any change in critical care practice (or other clinical practice) over a reasonably short time scale. Presentations of the results at clinical conferences with appropriate audiences, such as critical care and/or renal clinicians, are planned following publication of the results in a peer reviewed journal. Outputs will contain only aggregate level data with small numbers suppressed in line with the HES analysis guidance.

5. The results of the study will be made available to patients and the public through dissemination via existing networks and media channels. ICNARC has access to both patients and their families and close friends from its recent collaboration in two modules (http://www.healthtalk.org/intensive_care/) for the award-winning website Healthtalk (http://www.healthtalk.org/). In addition, ICNARC works with the Intensive Care Unit Support Teams for Ex-Patients (ICUsteps), the intensive care patient support charity, already collaborating on ICNARCs Family Reported Experiences Evaluation Study funded by the NIHR Health Services & Delivery Research Programme. The RRAM team at ICNARC will work with both Healthtalk and ICUSteps to ensure the results of the study are fed-back to patients. In addition, once the primary clinical- and cost-effectiveness results of the study have been published and are publicly available, the publication and a summary of the results will also be available to patients and the public via the study website (https://www.icnarc.org/Our-Research/Studies/Rram/About).

6. The final linked pseudonymised dataset will be retained and stored securely on ICNARC’s servers for a minimum of 10 years following completion of the study (February 2020). Any requests for additional analyses based on this dataset would be subject to an amendment to this agreement and approval by NHS England.

The above outputs contained aggregated data with small numbers suppressed in line with the relevant disclosure rules for the datasets processed under this Agreement from which the aggregated data was derived.

No new outputs will be produced using the data under this Agreement.

Expected measurable benefits

The RRAM study aimed to determine the clinical and cost-effectiveness of regional citrate anticoagulation (RCA) versus systemic heparin anticoagulation (SHA) for continuous renal replacement therapy (CRRT) in patients treated in an ICU. The rapid shift towards the use of RCA for CRRT amongst NHS hospitals, however occurred with little evidence that it is superior to SHA in terms of clinical outcomes and cost-effectiveness. The results from the RRAM study outcomes will help determine whether the change should be encouraged or stopped.

Both patients and the NHS will benefit from identifying the best mode of anticoagulant treatment for CRRT in patients in the ICU as the results apply directly to 95% of intensive care units (ICUs) who use CRRT to treat patients who have AKI in England, Wales and Northern Ireland who between them treat approximately 17,000 patients per year for acute kidney injury with about 190,000 patient-days of continuous renal replacement therapy (CRRT) delivered at an estimated cost of £1000-£1200 per patient-day. If neither treatment is clinically superior, benefits will be gained by identifying which treatment is most cost-effective when considering hospitalisations.

The results will be disseminated widely and will help inform practice and ultimately result in improvements in the provision of critical care - for patients and for those who care for them. As an independent, not-for-profit, scientific organisation that facilitates improvement in critical care through audit and research, disseminating the results of the RRAM study is a legitimate interest of ICNARC.

ICNARC have now completed the study and are in the process of actively disseminating the results. The final report to the funder has been published in the NIHR Health Technology Assessment (HTA) journal and is now publicly available (DOI: 10.3310/ZXHI9396). The primary manuscript reporting the results of the RRAM study has also been submitted for publication in a peer reviewed journal and is currently under consideration. The study team anticipate that the manuscript will be published in the Spring of 2023. The study team will aim to publish in a journal with the highest possible impact with a critical care audience. This will allow the results to have the biggest chance of having an impact amongst those who will use the results to inform their practice. This will be an important part of the strategy for achieving benefits for patients and the NHS.

A number of approaches have been identified for disseminating the RRAM study results, including: involving stakeholders; providing evidence in an integrated and graded way; taking account of the context and identifying the elements relevant to decision making, e.g. benefits, harms and costs; making recommendations as specific as possible; and using a multifaceted approach.

Benefits reported so far

The RRAM study has now completed and is in the process of publishing the results and the initial report of the results to the funder has been published in the NIHR Health Technology Assessment.

The study met its objectives of investigating the short-term clinical benefits, risks, and costs of RCA compared to SHA, and comparing the long-term development of end-stage renal disease (ESRD). The results of the study showed that the introduction of regional citrate anticoagulation has not improved clinical outcomes for patients and is likely to have substantially increased costs for the NHS. Since the initial publication of the final report to the funder in the public domain, there has been substantial discussion on public platforms (e.g. Twitter) and directly with the investigator team about the implications of the results for the NHS and clinical practice and will result in hospitals reviewing their current anticoagulation practices and/or will provide information on the outcomes and costs associated with changing to RCA in hospitals that have not changed. The study team anticipate the impact of the results will continue to grow with the subsequent publication of the study results in appropriate scientific journals, which will ultimately help inform critical care delivery for patients and the NHS.

In addition to the clinical and cost-effectiveness results of the study, the study team have also demonstrated the feasibility of evaluating effects of changes in practice using routinely collected data, which was a specific objective of the RRAM study. This is important as the study will now serve as a template for future evaluations changes to clinical practice using routinely collected data.

There has been substantial discussion on public platforms (e.g. Twitter) and directly with the investigator team about the implications of the results for the NHS and clinical practice and hopes to result in hospitals reviewing their current anticoagulation practices and/or aims to provide information on the outcomes and costs associated with changing to RCA in hospitals that have not changed. The study (and its results) were also selected by the NIHR for inclusion as an NIHR Alert. NIHR Alerts are accessible summaries of research that ICNARC reviewers believe should inform practice, which are posted on NIHR Evidence. The impact of the results are expected to continue to grow with the subsequent publication of the study in a journal targeting a critical care audience.

Datasets on the current version

Legal basis for provision: Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.

Datasets approved under DARS-NIC-184951-D1G8R-v2.9
DatasetType of dataSensitivity FrequencyConfidential data
Civil Registrations of Death - Secondary Care Cut Anonymised - ICO Code Compliant 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

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.

Patient opt-outs were applied to all 14 files released under this agreement, across every version. About opt-outs

No files recorded as released under the current version. 14 were released under earlier versions, shown in the version history.

Version history

The register lists each renewal of this agreement as a separate row. This site has 3 versions.

DARS-NIC-184951-D1G8R-v2.9 7 April 2023 to 6 April 2031
Title
Renal Replacement Anticoagulant Management (RRAM)
Commercial
No
Sublicensing
No
Datasets
2
Files released
0

Datasets: Civil Registrations of Death - Secondary Care Cut; Hospital Episode Statistics Admitted Patient Care (HES APC)

What changed from DARS-NIC-184951-D1G8R-v1.5

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Fields changed from DARS-NIC-184951-D1G8R-v1.5
FieldWasBecame
Start date2021-12-202023-04-07
End date2022-12-192031-04-06
Civil Registrations of Death - Secondary Care Cut: legal basisHealth and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'.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 basisHealth and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'.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): type of dataIdentifiableAnonymised - ICO Code Compliant

Objective for processing

The aim and purpose of this application Agreement is to extend and amend the existing data sharing agreement (DSA) with NHS Digital for the Renal Replacement Anticoagulation Management (RRAM) study (DARS-NIC-184951-D1G8R-v0.10). study. RRAM is an observational study that was designed to utilise high quality routinely collected clinical data, in order to compare the clinical and cost-effectiveness of changing to citrate anticoagulation for continuous renal replacement therapy (CRRT) in adult intensive care units (ICU). The study successfully completed in February 2020, following submission of the final report detailing the results of the study to the funder. Following completion of the RRAM study and the data linkage conducted by NHS Digital to Hospital Episodes Statistics, Civil Registrations death records and the UK Renal Registry (NHS Digital acted as trusted third party to conduct linkage), ICNARC produced and hold a linked, pseudonymised study database which has been used to produce the analyses for the study. The purpose of extending the DSA is to allow processing of these pseudonymised data, already obtained from NHS Digital, to ensure that the results of the study are published and disseminated widely to ensure maximum impact. The amendment is that Babble Cloud Limited have replaced Nasstar and will provide external desktop and network managed services, including end user and infrastructure support. This Agreement will also be amended to an archiving Agreement. Under the original DSA, NHS Digital linked the cohort provided by ICNARC to Civil Registrations death data and HES Admitted Patient Care data and provided ICNARC with the requested data, pseudonymised using the study ID (no identifiable data were transferred from NHS Digital to ICNARC) including requesting patient status and date of death (where applicable) for all patients in the cohort to directly contribute to the clinical evaluation of the primary outcome (90-day all-cause mortality) and the requested HES Admitted Patient Care data to obtain health care usage for linked patients that will be used to calculate the incremental cost-effectiveness at 1 year (primary cost effectiveness outcome) and estimate lifetime cost effectiveness. This Agreement does not permit any further processing that involves analysis or linkage other than for the purpose of verifying findings in line with the original objectives of the study by repeating previous analyses described in this Agreement. Any request to share data from the RRAM study will be to share outputs that have already been produced in the form of aggregate data with small number suppressed. The RRAM study is now complete. No additional data will be requested from NHS Digital. This Agreement permits processing of the data for the purpose of secure storage and back up. Following publication of the study findings, it is possible that the findings will be questioned or challenged by third parties through direct contact with Intensive Care National Audit & Research Centre (ICNARC), contact via the publishing journal or an open letter. In such circumstances, ICNARC may re-run the previous analyses undertaken to verify that the published results were accurate and may write a response to be issued directly to the challenger or published. This Agreement does not permit any further processing that involves analysis or linkage other than for the purpose of verifying findings in line with the original objectives of the study by repeating previous analyses described in this Agreement. ICNARC may not undertake different analyses to those undertaken during the original analysis. This Agreement does not permit any onward sharing of the data with the exception that the data may be viewed for the purpose of an audit. This Agreement also permits the necessary processing of the Data for the purposes of permanently destroying, deleting or erasing the Data once it is no longer required for the purpose for which it was collected. Once destroyed/deleted or erased, ICNARC must confirm destruction to NHS Digital. If any further data processing is required in addition to the above purposes or if the data needs to be moved to a different location/organisation ICNARC must submit an amendment request to NHS Digital before data is accessed. Data from the following NHS Digital datasets will be retained under this Agreement: • Hospital Episode Statistics Admitted Patient Care • Civil Registration (Deaths) - Secondary Care Cut The level of the data being retained will be: • Pseudonymised data Intensive Care National Audit & Research Centre (ICNARC) requires access to NHS Digital data for the purpose of the following observational study which is now complete: RRAM is an observational study that was designed to utilise high quality routinely collected clinical data, in order to compare the clinical and cost-effectiveness of changing to citrate anticoagulation for continuous renal replacement therapy (CRRT) in adult intensive care units (ICU). The study successfully completed in February 2020, following submission of the final report detailing the results of the study to the funder. Following completion of the RRAM study and the data linkage conducted by NHS Digital to Hospital Episodes Statistics, Civil Registrations death records and the UK Renal Registry (NHS Digital acted as trusted third party to conduct linkage), ICNARC produced and hold a linked, pseudonymised study database which has been used to produce the analyses for the study. Under this Agreement, researchers will continue to process these pseudonymised data, already obtained from NHS Digital, to ensure that the results of the study are published and disseminated widely to ensure maximum impact. Under the original Agreement, NHS Digital linked the cohort provided by Intensive Care National Audit & Research Centre (ICNARC) to Civil Registrations death data and HES Admitted Patient Care data and provided ICNARC with the requested data, pseudonymised using the study ID (no identifiable data were transferred from NHS Digital to ICNARC) including requesting patient status and date of death (where applicable) for all patients in the cohort to directly contribute to the clinical evaluation of the primary outcome (90-day all-cause mortality) and the requested HES Admitted Patient Care data to obtain health care usage for linked patients that will be used to calculate the incremental cost-effectiveness at 1 year (primary cost effectiveness outcome) and estimate lifetime cost effectiveness. [1 paragraph unchanged] The RRAM study was initially funded by the National Institute for Health Research, Health Technology Assessment Programme [30 words unchanged] in England or Wales between 1 April 2009 and 31 March 2017. The Intensive Care National Audit and Research Centre (ICNARC) Sponsored the RRAM study and are the sole Data Controller. The Chief Investigator was from the University of Oxford and Oxford University NHS Trust/John Radcliffe Hospital. Their role and responsibilities were to co-ordinate the study and provide data for the health economics aspect of the study. This was completed separately to the data linkage and analysis described and approved in the previous data sharing agreement, which took place at ICNARC only. The National Institute for Health Research were the funders for the RRAM study however, this funding has now expired. They did not have access to the data and did not determine the manner or purposes of processing, therefore are not considered a data controller. Under a previous iteration of this Agreement, ICNARC provided NHS Digital with a cohort of patients who received CRRT in an adult general ICU in England or Wales between 1 April 2009 and 31 March 2017. Eligible patients were aged 16 and over; admitted to an adult or general ICU in England and Wales, which participates in the ICNARC case mix programme, between 01/04/2009 and 31/03/2017; and received CRRT for at least one calendar day during the ICU stay. There was data linkage between UK Renal Registry (UKRR) and ICNARCs Case Mix Programme for this study. Data extracts provided separately by the UKRR and NHS Digital were combined with the relevant clinical data from the ICNARC CMP to create the final dataset. UKRR provided a study ID and a local ID to NHS Digital which was sent back to UKRR. This enabled UKRR to identify which participants of the registry to send to ICNARC. However, no NHS Digital data was provided to UKRR and as such UKRR are not considered a data processor. UKRR do not determine the manner or purposes of processing for this study, therefore are not considered a data controller. The Intensive Care National Audit and Research Centre (ICNARC), as the sponsor for the study, are the sole data controller as they have sole control over why and how personal data are processed. Specifically, ICNARC in their role as sponsor solely decides; to collect personal data and the legal basis for doing so, which items of personal data are collected, the purpose and purposes the data are used for, whether to disclose the data, whether subject access and other individuals’ rights apply, any amendments to the data, and how long the data are retained. The Chief Investigator was from the University of Oxford and Oxford University NHS Trust/John Radcliffe Hospital. Their role and responsibilities were to co-ordinate the study and provide data for the health economics aspect of the study. This involved the survey of ICUs, micro costing the study (visiting hospitals) and overseeing/ensuring delivery according to the study timelines. This was completed separately to the data linkage and analysis described and approved in this Data Sharing Agreement, which took place at ICNARC only. The University of Oxford are not considered a data controller for this application as the chief investigator (and therefore the University of Oxford) does not have any power over the purposes for which and the manner in which personal data are, or are to be processed. The Data Processors for the data being requested from NHS Digital are ICNARC, Babble Cloud (SUI) Limited and Exponential-E Ltd. Exponential-E Ltd manage ICNARC’s secure virtual data centre; and Babble Cloud (SUI) Limited provide ICNARC’s end user IT support. ICNARC works with the Intensive Care Unit Support Teams for Ex-Patients (ICUsteps), the intensive care patient support charity, already collaborating on ICNARCs Family Reported Experiences Evaluation Study funded by the NIHR Health Services & Delivery Research Programme. The RRAM team at ICNARC will work with both Healthtalk and ICUSteps to ensure the results of the study are fed-back to patients. In addition, once the primary clinical- and cost-effectiveness results of the study have been published and are publicly available, the publication and a summary of the results will also be available to patients and the public via the study website (https://www.icnarc.org/Our-Research/Studies/Rram/About). [5 paragraphs unchanged] Balancing Test: do the individual’s interests override the legitimate interest? ICNARC have [90 words unchanged] completion of the project. ICNARC have assessed this against the ICO’s checklist (https://ico.org.uk/for-organisations/guide-to-the-general-data-protection-regulation-gdpr/lawful-basis-for-processing/legitimate-interests/) and are content that the requirements are met and has been reviewed by NHS Digital. The primary outcome for the processing of NHS Digital data in this application Agreement is to provide important outcome data for this study. The outcomes of the study are: [9 paragraphs unchanged] Processing personal data is necessary for ICNARC's legitimate interests which are described in this application. There are no alternative, less intrusive ways of achieving the purpose. Agreement. ICNARC is an independent charity committed to providing high quality information through their national clinical audits and portfolio of research studies. Under the original DSA, ICNARC provided NHS Digital with a cohort of patients who received CRRT in an adult general ICU in England or Wales between 1 April 2009 and 31 March 2017. Eligible patients were aged 16 and over; admitted to an adult or general ICU in England and Wales, which participates in the ICNARC case mix programme, between 01/04/2009 and 31/03/2017; and received CRRT for at least one calendar day during the ICU stay.

Processing activities

This study is now completed and closed. This agreement permits processing of the data for the purpose of secure storage. This agreement does not permit any further processing that involves analysis or linkage other than for the purpose of verifying findings in line with the original objectives of the study by repeating previous analyses described in this Agreement. This agreement does not permit any onward sharing of the data with the exception that the data may be viewed for the purpose of an audit by a regulator. If any further data processing is required in addition to the above purposes or if the data needs to be moved to a different location/organisation the applicant must submit an amendment request to NHS England before data is accessed. The study data (used for analysis and now to be archived) is stored on a secure server at ICNARC, for a minimum of 10 years following completion of the study (February 2020), which can only be accessed by a restricted number of personnel. In the event that the data needs to be accessed for the purposes of an audit or to enable verification of previous findings, the dataset would be accessible only for as long as is required to enable verification of the analyses and to write a response as appropriate. Responses will adhere to the rules for small number suppression in the HES Analysis Guide. The data may not be transferred to any other location and may only be accessed for the purposes described above. The following processing activities were untaken during the course of the RRAM study: [1 paragraph unchanged] 1. Patient status/date of death via linkage to Civil Registration data for all patient in the CMP. Case Mix Programme (CMP). (ICNARC hold the Case Mix Programme (CMP) national clinical audit database, from which the study cohort were derived). [1 paragraph unchanged] 3. NHS Digital England carried out third party linkage to the UKRR data for all patients [13 words unchanged] and UKRR sent the clinical data to ICNARC. ICNARC used the study id ID to link the returned HES and Civil Registration data and UKRR data to the relevant clinical data from the CMP database to create a final dataset for analysis. NHS Digital England linked direct patient identifiers provided from the CMP by ICNARC to HES, Civil Registration and UKRR datasets. [1 paragraph unchanged] 1. ICNARC identified eligible patients from the CMP database between 1 April 2009 and 31 March 2017 and uploaded to NHS Digital England a file containing a study ID (for identification in the CMP) and the following direct patient identifiers; NHS number, date of birth and postcode. 2. In parallel, UKRR provided NHS Digital England with a file containing the same direct patient identifiers for patients in [16 words unchanged] local ID allowed for linkage back to the locally held audit data. The transfer of direct patient identifiers from ICNARC and the UKRR to NHS Digital England was covered by the Section 251 approval (18/CAG/0070) for the RRAM study. 3. NHS Digital England matched direct patient identifiers from the CMP with those supplied from the [21 words unchanged] (allowing for linkage across all the datasets) for all matched records. NHS Digital England also performed linkage for all patients within the CMP to HES (containing [19 words unchanged] data for all matched patients between the CMP and Civil Registration) datasets. The local ID was used by the UKRR to identify the relevant records within their individual audit system when it was returned by NHS Digital England along with a study ID. This means that the UKRR did not [9 words unchanged] the ICNARC CMP, the study ID will act as the local ID. 4. The UKRR then provided a file to ICNARC containing the clinical [13 words unchanged] study ID for those patients identified in the CMP. In parallel, NHS Digital England provided ICNARC a file containing agreed HES data (containing information on hospitals [30 words unchanged] together with the study ID for patients identified in the ICNARC CMP. 5. ICNARC used the study ID to link the data extracts provided by the UKRR and NHS Digital England with the relevant clinical data from the ICNARC CMP to create the [69 words unchanged] identifiers. Consequently, the final pseudonymised dataset will contain no patient identifiable data. [1 paragraph unchanged] The data received from NHS Digital England was incorporated into the RRAM study database and stored on secure servers. ICNARC are the sole data controller who also process data. Exponential E Ltd and Nasstar are also data processors, although Exponential E Ltd only provide storage and do not access the data. Nasstar don’t process the data but they do have the ability to access the data therefore they have been listed as a Data Processor. The UKRR only supplied patient identifiers to NHS England for data linkage and did not receive any HES/Civil Registration death data for linked patients and therefore are not considered a Data Processor. The UKRR only supplied patient identifiers to NHS Digital for data linkage and did not receive any HES/Civil Registration death data for linked patients and therefore are not considered a Data Processor. [1 paragraph unchanged] Following receipt of the requested pseudonymised data from NHS Digital England (Civil Registrations deaths and HES Admitted Patient Care data), the UKRR, and [22 words unchanged] ICNARC. No identifiable data were transferred from the data providers to ICNARC. ICNARC hold the Case Mix Programme (CMP) national clinical audit database, from which the study cohort were derived. [1 paragraph unchanged] Nasstar employees have the ability to access NHS Digital data for logistical reasons however they will not access the data. Only authorised, substantive ICNARC employees will access NHS Digital data. All ICNARC employees are trained in data protection and confidentiality and have signed a contract, which incorporates a confidentiality clause and the consequences of breaching confidentiality are covered by disciplinary procedures. Data received from NHS Digital is stored on secure servers at ICNARC, hosted by Exponential-e with regular back-ups of the data. Exponential-e are compliant with ISO 9001; ISO 27001; ISO 14001; ISO 22301; ISO 50001; ISO 20000 and also hold a Health & Social Care Network Complaint certificate of compliance. Employees of Exponential-e will not access the data held under this agreement, but will provide storage/back-up, and as such, are listed as processors. ICNARC’s Case Mix Programme (CMP) dataset includes patient identifiers. An extract of CMP data was created for the RRAM project, including patient identifiers and a “study_ID” pseudo-identifier that was created for the project, which were transferred to NHS England for linkage. NHS England returned only the study_ID and pseudonymised clinical data. ICNARC also contract Nasstar (formerly GCI Managed Services Ltd.) who provide external desktop and network managed services, including end user and infrastructure support. Employees at Nasstar will not access the data held under this agreement, however, they do have remote access to ICNARC servers (which are hosted by Exponential-e) and so are considered a Data Processor. Nasstar are compliant with ISO 20000-1:2011; ISO 27001:2013; ISO 9001:2015; Cyber Essentials Plus; and hold a Health & Social Care Network Complaint certificate of compliance. On 19 November 2021, ICNARC pseudonymised all data files associated with the project by NHS Digital reminds all organisations party to this agreement of the need to 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 ie: employees, agents and contractors of the Data Recipient who may have access to that data. (i) creating copies that included new pseudo-identifiers, and (ii) excluded all patient identifiers (NHS number, date of birth, postcode) and all record identifiers that would permit linkage back to the raw CMP records, and (iii) permanently destroying the original files (see data destruction certificates previously provided). Since this process was conducted, ICNARC have been unable to link to the project dataset with the raw CMP records that contain patient identifiers. To produce a derived dataset for retention outside of any Data Sharing Agreement, the following additional steps have been taken: date of death (which is recorded in both CMP and NHS England records) has been converted into vital status at 90 and 365 days after admission to critical care, and patient pseudo-identifiers have again been replaced to further remove ICNARC’s ability to link the derived data back to the archived date of death field. All processing of identifiable data took place by staff with substantive contracts with ICNARC. All ICNARC staff are required to undertake NHS England training in Data Security Awareness. At no stage will those processing the data have access to patient identifiers beyond those already recorded for the Case Mix Programme and National Cardiac Arrest Audit, and the additional clinical data received will make minimal difference to the identifiability of data. All ICNARC employees are trained in data protection and confidentiality and have signed a contract, which incorporates a confidentiality clause and the consequences of breaching confidentiality are covered by disciplinary procedures. The NHS England data along with all study data will be stored on secure servers, managed by Exponential-E Ltd, on behalf of ICNARC. Exponential-E Ltd is a contractor authorised by ICNARC. The data will be analysed by a remote desktop connection via a virtual private network from ICNARC owned equipment to the server at Exponential-E Ltd, with all data remaining on the server at all times and no data downloaded to local machines. Employees of Exponential-E Ltd will not access the data held under this agreement, but will provide storage/back-up, and as such, are listed as processors. Babble Cloud (SUI) Limited will provide external desktop and network managed services, including end user and infrastructure support. Employees at Babble Cloud (SUI) Limited have the ability to access NHS England data for logistical reasons but will not access the data held under this agreement, however, they will have remote access to ICNARC servers (which are hosted by Exponential-E Ltd). NHS England reminds all organisations party to this agreement of the need to 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.

Expected output

As the study has completed, the study team are now in the process of disseminating the results of the study. No further processing of the data will be carried out in order to produce any outputs. The existing and planned outputs of the project are as follows: 1. Prior to completion of the study, the RRAM study protocol and statistical analysis plan were published in the Journal of the Intensive Care Society (DOI: 10.1177/1751143720913417). Society. This publication was important for ensuring transparency and reproducibility of the research. [21 words unchanged] will allow others to follow the methods employed for other, similar analyses. 2. A final report detailing the results of the RRAM study was submitted to the NIHR (the study funder) in February 2020 and has subsequently been accepted for publication published in the NIHR Health Technology Assessment (HTA) journal (anticipated to be available early 2022). journal. Publication of the final report is a requirement of the NIHR as [42 words unchanged] data with small numbers suppressed in line with the HES analysis guidance. 3. The primary clinical- and cost-effectiveness results of the study will be [15 words unchanged] agreed set of ‘rules’ for reporting research studies based on routinely-collected data. Target date for submission of The manuscript reporting the publication results has been submitted to a peer reviewed journal and is November 2021. currently under consideration. The study team will aim are aiming to publish in a journal with the highest possible impact with a critical care audience. This will hopefully allow the results to have the biggest chance of having an impact [84 words unchanged] data with small numbers suppressed in line with the HES analysis guidance. [2 paragraphs unchanged] 6. The final linked pseudonymised dataset will be retained and stored securely [26 words unchanged] be subject to an amendment to this agreement and approval by NHS Digital. England. The above outputs contained aggregated data with small numbers suppressed in line with the relevant disclosure rules for the datasets processed under this Agreement from which the aggregated data was derived. No new outputs will be produced using the data under this Agreement.

Expected measurable benefits

[3 paragraphs unchanged] We ICNARC have now completed the study and are in the process of actively disseminating the results. The final report has been submitted to the funder and accepted for publication has been published in the NIHR Health Technology Assessment (HTA) journal (anticipated and is now publicly available (DOI: 10.3310/ZXHI9396). The primary manuscript reporting the results of the RRAM study has also been submitted for publication in a peer reviewed journal and is currently under consideration. The study team anticipate that the manuscript will be published in the Spring of 2023. The study team will aim to publish in a journal with the highest possible impact with a critical care audience. This will allow the results to have the biggest chance of having an impact amongst those who will use the results to inform their practice. This will be available early 2022). an important part of the strategy for achieving benefits for patients and the NHS. We are also in the process of submitting the results of the RRAM study to be published in a peer reviewed journal. The expected date for submission is November 2021. The study team will aim to publish in a journal with the highest possible impact with a critical care audience. This will allow the results to have the biggest chance of having an impact amongst those who will use the results to inform their practice. This will be an important part of this strategy for achieving benefits for patients and the NHS. [1 paragraph unchanged]

Benefits reported

The RRAM study has now completed and is in the process of publishing the results. As such, there have not yet been any yielded benefits. The study has, however, been accepted for publication in the NIHR Health Technology Assessment (HTA) journal and the results are anticipated to be available publicly early 2022. The study has met its objectives of also investigating the short-term benefits, risks, and costs of RCA compared to SHA, and comparing the long-term development of end-stage renal disease (ESRD) which will help inform critical care delivery for patients in the NHS. The study team have also demonstrated the feasibility of evaluating effects of changes in practice using routinely collected data. The RRAM study has now completed and is in the process of publishing the results and the initial report of the results to the funder has been published in the NIHR Health Technology Assessment. The study met its objectives of investigating the short-term clinical benefits, risks, and costs of RCA compared to SHA, and comparing the long-term development of end-stage renal disease (ESRD). The results of the study showed that the introduction of regional citrate anticoagulation has not improved clinical outcomes for patients and is likely to have substantially increased costs for the NHS. Since the initial publication of the final report to the funder in the public domain, there has been substantial discussion on public platforms (e.g. Twitter) and directly with the investigator team about the implications of the results for the NHS and clinical practice and will result in hospitals reviewing their current anticoagulation practices and/or will provide information on the outcomes and costs associated with changing to RCA in hospitals that have not changed. The study team anticipate the impact of the results will continue to grow with the subsequent publication of the study results in appropriate scientific journals, which will ultimately help inform critical care delivery for patients and the NHS. In addition to the clinical and cost-effectiveness results of the study, the study team have also demonstrated the feasibility of evaluating effects of changes in practice using routinely collected data, which was a specific objective of the RRAM study. This is important as the study will now serve as a template for future evaluations changes to clinical practice using routinely collected data. There has been substantial discussion on public platforms (e.g. Twitter) and directly with the investigator team about the implications of the results for the NHS and clinical practice and hopes to result in hospitals reviewing their current anticoagulation practices and/or aims to provide information on the outcomes and costs associated with changing to RCA in hospitals that have not changed. The study (and its results) were also selected by the NIHR for inclusion as an NIHR Alert. NIHR Alerts are accessible summaries of research that ICNARC reviewers believe should inform practice, which are posted on NIHR Evidence. The impact of the results are expected to continue to grow with the subsequent publication of the study in a journal targeting a critical care audience.

DARS-NIC-184951-D1G8R-v1.5 20 December 2021 to 19 December 2022
Title
Renal Replacement Anticoagulant Management (RRAM)
Commercial
No
Sublicensing
No
Datasets
2
Files released
0

Datasets: Civil Registrations of Death - Secondary Care Cut; Hospital Episode Statistics Admitted Patient Care (HES APC)

What changed from DARS-NIC-184951-D1G8R-v0.10

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Fields changed from DARS-NIC-184951-D1G8R-v0.10
FieldWasBecame
Start date2018-12-032021-12-20
End date2021-12-022022-12-19
Civil Registrations of Death - Secondary Care Cut: legal basisHealth and Social Care Act 2012 – s261(7)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: sensitivityNon-SensitiveSensitive
Hospital Episode Statistics Admitted Patient Care (HES APC): legal basisHealth and Social Care Act 2012 – s261(7)Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'.

Objective for processing

The Renal Replacement Anticoagulation Management (RRAM) study is an observational study that has been designed to utilise high quality routinely collected clinical data, in order to compare the clinical and cost-effectiveness of changing to citrate anticoagulation for continuous renal replacement therapy (CRRT) in adult intensive care units (ICU). The aim and purpose of this application is to extend the existing data sharing agreement (DSA) with NHS Digital for the Renal Replacement Anticoagulation Management (RRAM) study (DARS-NIC-184951-D1G8R-v0.10). This research is important to patients and the NHS as there is currently a rapid change occurring within the NHS, whereby traditional heparin based anticoagulation for CRRT is being replaced by citrate based methods. This is being done without any evidence that citrate is superior to heparin in terms of clinical or cost-effectiveness. This study will make the most of an efficient design using available data to clarify the effect of changing to citrate-based anticoagulation on health and economic outcomes in normal clinical practice to help determine whether the change should be encouraged or stopped. RRAM is an observational study that was designed to utilise high quality routinely collected clinical data, in order to compare the clinical and cost-effectiveness of changing to citrate anticoagulation for continuous renal replacement therapy (CRRT) in adult intensive care units (ICU). The study successfully completed in February 2020, following submission of the final report detailing the results of the study to the funder. Following completion of the RRAM study and the data linkage conducted by NHS Digital to Hospital Episodes Statistics, Civil Registrations death records and the UK Renal Registry (NHS Digital acted as trusted third party to conduct linkage), ICNARC produced and hold a linked, pseudonymised study database which has been used to produce the analyses for the study. The purpose of extending the DSA is to allow processing of these pseudonymised data, already obtained from NHS Digital, to ensure that the results of the study are published and disseminated widely to ensure maximum impact. The RRAM study is funded by the National Institute for Health Research, Health Technology Assessment Programme (HTA 16/111/136), is managed and sponsored by the Intensive Care National Audit & Research Centre (ICNARC) and will include data from approximately 85,000 patients that were admitted to an adult general ICU in England or Wales between 1 April 2009 and 31 March 2017. Under the original DSA, NHS Digital linked the cohort provided by ICNARC to Civil Registrations death data and HES Admitted Patient Care data and provided ICNARC with the requested data, pseudonymised using the study ID (no identifiable data were transferred from NHS Digital to ICNARC) including requesting patient status and date of death (where applicable) for all patients in the cohort to directly contribute to the clinical evaluation of the primary outcome (90-day all-cause mortality) and the requested HES Admitted Patient Care data to obtain health care usage for linked patients that will be used to calculate the incremental cost-effectiveness at 1 year (primary cost effectiveness outcome) and estimate lifetime cost effectiveness. The chief investigator for this NIHR funded study is from the University of Oxford and Oxford University NHS Trust/John Radcliffe Hospital. Their role and responsibilities are to co-ordinate the study and will be providing data for the health economics aspect of the study. This will be completed separately to the data linkage and analysis described in this application which will take place at ICNARC only. Oxford will not have access to data provided by NHS Digital data. This research is important to patients and the NHS as there is currently a rapid change occurring within the NHS, whereby traditional heparin based anticoagulation for CRRT is being replaced by citrate based methods. This is being done without any evidence that citrate is superior to heparin in terms of clinical or cost-effectiveness. This study utilised an efficient design using available data to clarify the effect of changing to citrate-based anticoagulation on health and economic outcomes in normal clinical practice to help determine whether the change should be encouraged or stopped. The RRAM study was funded by the National Institute for Health Research, Health Technology Assessment Programme (HTA 16/111/136), managed and sponsored by the Intensive Care National Audit & Research Centre (ICNARC) and includes data from approximately 85,000 patients that were admitted to an adult general ICU in England or Wales between 1 April 2009 and 31 March 2017. The Intensive Care National Audit and Research Centre (ICNARC) Sponsored the RRAM study and are the sole Data Controller. The Chief Investigator was from the University of Oxford and Oxford University NHS Trust/John Radcliffe Hospital. Their role and responsibilities were to co-ordinate the study and provide data for the health economics aspect of the study. This was completed separately to the data linkage and analysis described and approved in the previous data sharing agreement, which took place at ICNARC only. [1 paragraph unchanged] The legal basis for processing data under this agreement are Section 6(1)(f) and Article 9(2)(j) legal basis from the General Data Protection Regulation. [3 paragraphs unchanged] Balancing Test: do the individual’s interests override the legitimate interest? ICNARC have [26 words unchanged] expect the processing and it would not cause unjustified harm. The data subjects subjects’ interests and fundamental rights are protected through appropriate minimisation of fields and [31 words unchanged] NHS Digital or after a defined period on completion of the project. ICNARC have assessed this against the ICO’s checklist (https://ico.org.uk/for-organisations/guide-to-the-general-data-protection-regulation-gdpr/lawful-basis-for-processing/legitimate-interests/) and are content that the requirements are met and has been reviewed by NHS Digital. [10 paragraphs unchanged] ICNARC are requesting linked data for a cohort of patients who received CRRT in an adult general ICU in England or Wales between 1 April 2009 and 31 March 2017. Eligible patients will be identified using the following inclusion criteria: aged 16 and over; admitted to an adult or general ICU in England and Wales, which participates in the ICNARC case mix programme, between 01/04/2009 and 31/03/2017; and in receipt of CRRT for at least one calendar day during the ICU stay. It is estimated that 85,000 patients would be included within the project. Processing personal data is necessary for ICNARC's legitimate interests which are described in this application. There are no alternative, less intrusive ways of achieving the purpose. ICNARC is an independent charity committed to providing high quality information through their national clinical audits and portfolio of research studies. ICNARC are requesting patient status (i.e. dead, alive, unknown/unable to link) and date of death (where applicable) from NHS digital via linkage to Civil Registration death data for all patients in the cohort to directly contribute to the clinical evaluation of the primary outcome (90-day all-cause mortality) and the secondary outcomes of all-cause mortality at 30 days and one year. Under the original DSA, ICNARC provided NHS Digital with a cohort of patients who received CRRT in an adult general ICU in England or Wales between 1 April 2009 and 31 March 2017. Eligible patients were aged 16 and over; admitted to an adult or general ICU in England and Wales, which participates in the ICNARC case mix programme, between 01/04/2009 and 31/03/2017; and received CRRT for at least one calendar day during the ICU stay. In addition, ICNARC are requesting linkage to HES inpatient data to obtain health care usage for linked patients that will be used to calculate the incremental cost-effectiveness at 1 year (primary cost effectiveness outcome) and estimate lifetime cost effectiveness. NHS Digital will also perform third party linkage to the UK Renal Registry (UKRR) for all patients in the cohort to identify diagnosis of new dialysis-dependent renal disease. The UKRR are not considered a data processor as they are only supplying direct patient identifiers to NHS Digital for data linkage and will not receive any HES/Civil Registration death data for linked patients.

Processing activities

In summary ICNARC are requesting requested three data linkages: [2 paragraphs unchanged] 3. NHS Digital to carry carried out third party linkage to the UKRR data for all patients who match matched in the CMP. The study id only will be was returned to UKRR and UKRR will send sent the clinical data to ICNARC. ICNARC will used the study id to link the returned HES and Civil Registration [8 words unchanged] data from the CMP database to create a final dataset for analysis. NHS Digital will link linked direct patient identifiers provided from the CMP by ICNARC to HES, Civil Registration and UKRR datasets. The data linkage will process was as follows: 1. ICNARC will identify identified eligible patients from the CMP database between 1 April 2009 and 31 March 2017 and will upload uploaded to NHS Digital a file containing a study ID (for identification in the CMP) and the following direct patient identifiers; NHS number, date of birth and postcode. 2. In parallel, UKRR will provide provided NHS Digital with a file containing the same direct patient identifiers for [8 words unchanged] and 31 March 2017 plus a local UKRR ID. The local ID will allow allowed for linkage back to the locally held audit data. The transfer of direct patient identifiers from ICNARC and the UKRR to NHS Digital is was covered by the Section 251 approval (18/CAG/0070) for the RRAM study. 3. NHS Digital will match matched direct patient identifiers from the CMP with those supplied from the UKRR and return returned to ICNARC and the UKRR a linkage file containing the local ID [7 words unchanged] for linkage across all the datasets) for all matched records. NHS Digital will also perform performed linkage for all patients within the CMP to HES (containing information on [17 words unchanged] data for all matched patients between the CMP and Civil Registration) datasets. The local ID will be was used by the UKRR to identify the relevant records within their individual audit system when it is was returned by NHS Digital along with a study ID. This means that the UKRR will did not receive any data other than the two ID’s. For the ICNARC CMP, the study ID will act as the local ID. 4. The UKRR will then provide ICNARC provided a file to ICNARC containing the clinical fields (with no direct patient identifiers) required for the [5 words unchanged] ID for those patients identified in the CMP. In parallel, NHS Digital will provide provided ICNARC a file containing agreed HES data (containing information on hospitals admissions for all matched patients between CMP and [22 words unchanged] together with the study ID for patients identified in the ICNARC CMP. 5. ICNARC will use used the study ID to link the data extracts provided by the UKRR [8 words unchanged] from the ICNARC CMP to create the final dataset. Once the data are was linked, ICNARC will pseudonymise pseudonymised the dataset by replacing date of birth with age in years, replacing [48 words unchanged] identifiers. Consequently, the final pseudonymised dataset will contain no patient identifiable data. [1 paragraph unchanged] In summary ICNARC are requesting three data linkages: The data received from NHS Digital was incorporated into the RRAM study database and stored on secure servers. 1. Patient status/date of death via linkage to Civil Registration data for all patient in the CMP. ICNARC are the sole data controller who also process data. Exponential E Ltd and Nasstar are also data processors, although Exponential E Ltd only provide storage and do not access the data. Nasstar don’t process the data but they do have the ability to access the data therefore they have been listed as a Data Processor. 2. Linkage to the HES APC data for all patients in the CMP. The UKRR only supplied patient identifiers to NHS Digital for data linkage and did not receive any HES/Civil Registration death data for linked patients and therefore are not considered a Data Processor. 3. NHS Digital to carry out third party linkage to the UKRR data for all patients who match in the CMP. The study id only will be returned to UKRR and UKRR will send the clinical data to ICNARC. ICNARC will used the study id to link the returned HES and Civil Registration data and UKRR data to the relevant clinical data from the CMP database to create a final dataset for analysis. As part of a separate data linkage, ICNARC linked the study cohort to Patient Episode Database for Wales (PEDW). The data received from NHS Digital will be incorporated into the RRAM study database, stored on secure servers, managed by Red Technology Ltd, on behalf of ICNARC. In addition, ICNARC will regularly back-up the data through Disaster Recovery Service Ltd (DRS). Both Red Technology Ltd and DRS are contractors authorised by ICNARC and whom both have sufficient security assurances in place. Following receipt of the requested pseudonymised data from NHS Digital (Civil Registrations deaths and HES Admitted Patient Care data), the UKRR, and PEDW, ICNARC combined all data into a single pseudonymised RRAM study database using the study ID for analysis and is stored at ICNARC. No identifiable data were transferred from the data providers to ICNARC. Future linkage to the Patient Episode Database for Wales (PEDW) will take place in order to obtain inpatient data for patients treated in Welsh hospitals. This linkage will be performed separately to the NHS Digital linkage described above. This linkage will not involve the transfer of UKRR or NHS Digital data away from ICNARC. ICNARC hold the Case Mix Programme (CMP) national clinical audit database, from which the study cohort were derived. NHS Digital reminds all organisations party to this agreement of the need to 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 ie: employees, agents and contractors of the Data Recipient who may have access to that data). The CMP database is stored on servers at ICNARC with the patient identifiers stored separately from clinical audit data. Although the final linked RRAM study dataset is pseudonymised, the rich clinical data mean that it is likely that at least some records would be able to be reidentified by individuals with access to the study dataset and the CMP databases. Identifiable and clinical data held for the CMP are stored on separate servers to the pseudonymised RRAM study dataset. No attempt to reidentify participants will be made. Nasstar employees have the ability to access NHS Digital data for logistical reasons however they will not access the data. Only authorised, substantive ICNARC employees will access NHS Digital data. All ICNARC employees are trained in data protection and confidentiality and have signed a contract, which incorporates a confidentiality clause and the consequences of breaching confidentiality are covered by disciplinary procedures. Data received from NHS Digital is stored on secure servers at ICNARC, hosted by Exponential-e with regular back-ups of the data. Exponential-e are compliant with ISO 9001; ISO 27001; ISO 14001; ISO 22301; ISO 50001; ISO 20000 and also hold a Health & Social Care Network Complaint certificate of compliance. Employees of Exponential-e will not access the data held under this agreement, but will provide storage/back-up, and as such, are listed as processors. ICNARC also contract Nasstar (formerly GCI Managed Services Ltd.) who provide external desktop and network managed services, including end user and infrastructure support. Employees at Nasstar will not access the data held under this agreement, however, they do have remote access to ICNARC servers (which are hosted by Exponential-e) and so are considered a Data Processor. Nasstar are compliant with ISO 20000-1:2011; ISO 27001:2013; ISO 9001:2015; Cyber Essentials Plus; and hold a Health & Social Care Network Complaint certificate of compliance. NHS Digital reminds all organisations party to this agreement of the need to 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 ie: employees, agents and contractors of the Data Recipient who may have access to that data.

Expected output

As the study has completed, the study team are now in the process of disseminating the results of the study. The existing and planned outputs of the project are as follows: 1. A final report on the entire project to be published as a monograph in the NIHR journal, Health Technology Assessment programme. Target date for submission is 30/06/2019. Outputs will contain only aggregate level data with small numbers suppressed in line with the HES analysis guidance. 1. Prior to completion of the study, the RRAM study protocol and statistical analysis plan were published in the Journal of the Intensive Care Society (DOI: 10.1177/1751143720913417). This publication was important for ensuring transparency and reproducibility of the research. Additionally, publishing the protocol and analysis plan has helped raise the profile of the study amongst the critical care community and will allow others to follow the methods employed for other, similar analyses. 2. The A final report detailing the results of the RRAM study will be published in a peer reviewed journal and will conform was submitted to the RECORD standards – an agreed set of ‘rules’ NIHR (the study funder) in February 2020 and has subsequently been accepted for reporting research studies based on routinely-collected data. Target date for submission: September 2019. However, given publication in the large amount of work planned within each area NIHR Health Technology Assessment (HTA) journal (anticipated to be available early 2022). Publication of the study it may be appropriate to split final report is a requirement of the data into more than one article. NIHR as the journal’s Technology Assessment Reports inform National Institute for Health and Care Excellence (NICE) guidance. HTA research is also an important source of evidence for National Screening Committee (NSC) policy decisions. Outputs included in the HTA journal will contain only aggregate level data with small numbers suppressed in line with the HES analysis guidance. 3. Presentations at professional and scientific conferences, including the Annual Meeting of the Case Mix Programme (April 2019), the annual UK Kidney Week meet meeting (May 2019), and the UK Intensive Care Society (ICS) State of the Art Meeting (December 2019). Outputs will contain only aggregate level data with small numbers suppressed in line with the HES analysis guidance. 3. The primary clinical- and cost-effectiveness results of the study will be published in a peer reviewed journal and will conform to the RECORD standards – an agreed set of ‘rules’ for reporting research studies based on routinely-collected data. Target date for submission of the publication is November 2021. The study team will aim to publish in a journal with the highest possible impact with a critical care audience. This will allow the results to have the biggest chance of having an impact amongst those who will use the result to inform their practice. Given the large amount of work that went into creating the RRAM study database, within each area of the study, it may be appropriate to split the data into more than one article/publication. Again, the study team will aim to publish these in a journal with the highest possible impact (e.g. a publication focussing on the methodology/data linkage would be published in journal with a methodological audience). Outputs will contain only aggregate level data with small numbers suppressed in line with the HES analysis guidance. 4. The final linked pseudonymised dataset will be retained and stored securely on ICNARC’s servers for 5 years. Any requests for additional analyses based on this dataset would be subject to an amendment to this agreement and approval by NHS Digital. 4. Presentations at professional and scientific conferences – the RRAM study methodology was presented at the at the Annual Meeting of the Case Mix Programme (April 2019) as an example of using data linkage to report longer-term outcomes in critically ill patients. An abstract describing the RRAM methodology was submitted to the International Population Data Linkage Network Conference in and was accepted for presentation in October 2020. Unfortunately, due to COVID-19 workload, the abstract was withdrawn. Presenting the methodology behind the RRAM study meets the objective to establish efficient research techniques that, if successful, could be used to track the effects of any change in critical care practice (or other clinical practice) over a reasonably short time scale. Presentations of the results at clinical conferences with appropriate audiences, such as critical care and/or renal clinicians, are planned following publication of the results in a peer reviewed journal. Outputs will contain only aggregate level data with small numbers suppressed in line with the HES analysis guidance. 5. The results of the study will be made available to patients and the public through dissemination via existing networks and media channels. ICNARC has access to both patients and their families and close friends [25 words unchanged] for Ex-Patients (ICUsteps), the intensive care patient support charity, already collaborating on our ICNARCs Family Reported Experiences Evaluation Study funded by the NIHR Health Services & [16 words unchanged] ensure the results of the study are fed-back to patients. In addition, once the primary clinical- and cost-effectiveness results of the study have been published and are publicly available, the publication and a summary of the results will also be available to patients and the public via the ICNARC study website (www.icnarc.org). (https://www.icnarc.org/Our-Research/Studies/Rram/About). 6. The final linked pseudonymised dataset will be retained and stored securely on ICNARC’s servers for a minimum of 10 years following completion of the study (February 2020). Any requests for additional analyses based on this dataset would be subject to an amendment to this agreement and approval by NHS Digital.

Expected measurable benefits

The RRAM study aims aimed to determine the clinical and cost-effectiveness of regional citrate anticoagulation (RCA) versus systemic heparin anticoagulation (SHA) for continuous renal replacement therapy (CRRT) in patients treated in an ICU. Currently there is a The rapid shift towards the use of RCA for CRRT amongst NHS hospitals, however there is occurred with little evidence that it is superior to SHA in terms of clinical outcomes and cost-effectiveness. The results from the RRAM study outcomes will help determine whether the change should be encouraged or stopped. The benefits to Both patients and the NHS may be very large. ICNARC estimate these will benefit from identifying the best mode of anticoagulant treatment for CRRT in patients in the ICU as the results will apply directly to 95% of UK intensive care units (ICUs) who use CRRT to treat patients who have AKI in England, Wales and Northern Ireland who between them treat approximately 17,000 patients per year for acute kidney injury with about 190,000 patient-days of continuous renal replacement therapy (CRRT) delivered at an estimated cost of £1000-£1200 per patient-day. If neither treatment is clinically superior, benefits will be gained by identifying which treatment is most cost-effective when considering hospitalisations. The study will provide the first accurate cost-effectiveness analysis of regional citrate anticoagulation (RCA) and systemic heparin anticoagulation (SHA) in the NHS. If the results show that RCA is less effective and more costly than SHA, curbing the spread of RCA will benefit both patients and NHS funds. In contrast, if RCA is more effective and less costly both patients and the NHS will benefit from a more effective, cheaper treatment. However, it is more likely RCA is either less effective and less costly, or more effective and more costly. In this case the benefits to the NHS budget and the patient benefit go in different directions and the overall benefit depends on willingness to pay for clinical benefit. The results will be disseminated widely and will help inform practice and ultimately result in improvements in the provision of critical care - for patients and for those who care for them. As an independent, not-for-profit, scientific organisation that facilitates improvement in critical care through audit and research, disseminating the results of the RRAM study is a legitimate interest of ICNARC. Both patients and the NHS will benefit from identifying the best mode of anticoagulant treatment for CRRT in patients in the ICU. If neither treatment is clinically superior, benefits will be gained by identifying which treatment is most cost-effective when considering hospitalisations. We have now completed the study and are in the process of actively disseminating the results. The final report has been submitted to the funder and accepted for publication in the NIHR Health Technology Assessment (HTA) journal (anticipated to be available early 2022). This will need an effective implementation strategy. Active and wide dissemination of the results of the RRAM study will be an important part of this strategy and will begin upon publication of the primary study results (estimated to be published around September 2019). A number of approaches have been identified, including: involving stakeholders; providing evidence in an integrated and graded way; taking account of the context and identifying the elements relevant to decision making, e.g. benefits, harms and costs; making recommendations as specific as possible; and using a multifaceted approach. We are also in the process of submitting the results of the RRAM study to be published in a peer reviewed journal. The expected date for submission is November 2021. The study team will aim to publish in a journal with the highest possible impact with a critical care audience. This will allow the results to have the biggest chance of having an impact amongst those who will use the results to inform their practice. This will be an important part of this strategy for achieving benefits for patients and the NHS. A number of approaches have been identified for disseminating the RRAM study results, including: involving stakeholders; providing evidence in an integrated and graded way; taking account of the context and identifying the elements relevant to decision making, e.g. benefits, harms and costs; making recommendations as specific as possible; and using a multifaceted approach.

Benefits reported

Yielded Benefits is not a requirement for new applications. The RRAM study has now completed and is in the process of publishing the results. As such, there have not yet been any yielded benefits. The study has, however, been accepted for publication in the NIHR Health Technology Assessment (HTA) journal and the results are anticipated to be available publicly early 2022. The study has met its objectives of also investigating the short-term benefits, risks, and costs of RCA compared to SHA, and comparing the long-term development of end-stage renal disease (ESRD) which will help inform critical care delivery for patients in the NHS. The study team have also demonstrated the feasibility of evaluating effects of changes in practice using routinely collected data.

Objective for processing

The aim and purpose of this application is to extend the existing data sharing agreement (DSA) with NHS Digital for the Renal Replacement Anticoagulation Management (RRAM) study (DARS-NIC-184951-D1G8R-v0.10).

RRAM is an observational study that was designed to utilise high quality routinely collected clinical data, in order to compare the clinical and cost-effectiveness of changing to citrate anticoagulation for continuous renal replacement therapy (CRRT) in adult intensive care units (ICU). The study successfully completed in February 2020, following submission of the final report detailing the results of the study to the funder. Following completion of the RRAM study and the data linkage conducted by NHS Digital to Hospital Episodes Statistics, Civil Registrations death records and the UK Renal Registry (NHS Digital acted as trusted third party to conduct linkage), ICNARC produced and hold a linked, pseudonymised study database which has been used to produce the analyses for the study. The purpose of extending the DSA is to allow processing of these pseudonymised data, already obtained from NHS Digital, to ensure that the results of the study are published and disseminated widely to ensure maximum impact.

Under the original DSA, NHS Digital linked the cohort provided by ICNARC to Civil Registrations death data and HES Admitted Patient Care data and provided ICNARC with the requested data, pseudonymised using the study ID (no identifiable data were transferred from NHS Digital to ICNARC) including requesting patient status and date of death (where applicable) for all patients in the cohort to directly contribute to the clinical evaluation of the primary outcome (90-day all-cause mortality) and the requested HES Admitted Patient Care data to obtain health care usage for linked patients that will be used to calculate the incremental cost-effectiveness at 1 year (primary cost effectiveness outcome) and estimate lifetime cost effectiveness.

This research is important to patients and the NHS as there is currently a rapid change occurring within the NHS, whereby traditional heparin based anticoagulation for CRRT is being replaced by citrate based methods. This is being done without any evidence that citrate is superior to heparin in terms of clinical or cost-effectiveness. This study utilised an efficient design using available data to clarify the effect of changing to citrate-based anticoagulation on health and economic outcomes in normal clinical practice to help determine whether the change should be encouraged or stopped.

The RRAM study was funded by the National Institute for Health Research, Health Technology Assessment Programme (HTA 16/111/136), managed and sponsored by the Intensive Care National Audit & Research Centre (ICNARC) and includes data from approximately 85,000 patients that were admitted to an adult general ICU in England or Wales between 1 April 2009 and 31 March 2017.

The Intensive Care National Audit and Research Centre (ICNARC) Sponsored the RRAM study and are the sole Data Controller. The Chief Investigator was from the University of Oxford and Oxford University NHS Trust/John Radcliffe Hospital. Their role and responsibilities were to co-ordinate the study and provide data for the health economics aspect of the study. This was completed separately to the data linkage and analysis described and approved in the previous data sharing agreement, which took place at ICNARC only.

The “legitimate interests” relied upon are of healthcare research. This is because the data processing described here is to support scientific and statistical research.

The legal basis for processing data under this agreement are Section 6(1)(f) and Article 9(2)(j) legal basis from the General Data Protection Regulation.

ICNARC has conducted a legitimate interests assessment to confirm processing is necessary for the purposes of the legitimate interests. ICNARC have assessed this against the ICO’s checklist (https://ico.org.uk/for-organisations/guide-to-the-general-data-protection-regulation-gdpr/lawful-basis-for-processing/legitimate-interests/) and are content that the requirements are met and has been reviewed by NHS Digital.

Purpose Test: are you pursuing a legitimate interest? ICNARC is an independent charity committed to providing high quality information through their national clinical audits, where hospitals/critical care units use information from reports to help them improve care; through research, where data are collected to answer specific questions or to test theories.

Necessity Test: is the processing necessary for that purpose? Processing personal data is necessary for ICNARC's legitimate interests which are described in this application. The data to which access is requested are proportionate and necessary to achieve those interests.

Balancing Test: do the individual’s interests override the legitimate interest? ICNARC have completed a legitimate interests assessment (LIA) and are satisfied that the interests of the data subjects do not override our legitimate interests; that they would reasonably expect the processing and it would not cause unjustified harm. The data subjects’ interests and fundamental rights are protected through appropriate minimisation of fields and patient records being processed; pseudonymisation to minimise any risk of identifying individuals; protection of the data in a secure environment, and guaranteeing secure destruction at any stage at the request of NHS Digital or after a defined period on completion of the project. ICNARC have assessed this against the ICO’s checklist (https://ico.org.uk/for-organisations/guide-to-the-general-data-protection-regulation-gdpr/lawful-basis-for-processing/legitimate-interests/) and are content that the requirements are met and has been reviewed by NHS Digital.

The primary outcome for the processing of NHS Digital data in this application is to provide important outcome data for this study. The outcomes of the study are:

Primary outcomes:

• All cause mortality at 90 days (clinical effectiveness)

• Incremental net monetary benefit at 1 year (cost effectiveness)

Secondary outcomes:

• All-cause mortality at hospital discharge, 30 days and one year

• Days of renal, cardiovascular, and advanced respiratory support

• ICU and hospital length of stay

• New dialysis-dependent renal disease at one year

• Estimated lifetime incremental cost-effectiveness

Processing personal data is necessary for ICNARC's legitimate interests which are described in this application. There are no alternative, less intrusive ways of achieving the purpose. ICNARC is an independent charity committed to providing high quality information through their national clinical audits and portfolio of research studies.

Under the original DSA, ICNARC provided NHS Digital with a cohort of patients who received CRRT in an adult general ICU in England or Wales between 1 April 2009 and 31 March 2017. Eligible patients were aged 16 and over; admitted to an adult or general ICU in England and Wales, which participates in the ICNARC case mix programme, between 01/04/2009 and 31/03/2017; and received CRRT for at least one calendar day during the ICU stay.

Expected output

As the study has completed, the study team are now in the process of disseminating the results of the study. The existing and planned outputs of the project are as follows:

1. Prior to completion of the study, the RRAM study protocol and statistical analysis plan were published in the Journal of the Intensive Care Society (DOI: 10.1177/1751143720913417). This publication was important for ensuring transparency and reproducibility of the research. Additionally, publishing the protocol and analysis plan has helped raise the profile of the study amongst the critical care community and will allow others to follow the methods employed for other, similar analyses.

2. A final report detailing the results of the RRAM study was submitted to the NIHR (the study funder) in February 2020 and has subsequently been accepted for publication in the NIHR Health Technology Assessment (HTA) journal (anticipated to be available early 2022). Publication of the final report is a requirement of the NIHR as the journal’s Technology Assessment Reports inform National Institute for Health and Care Excellence (NICE) guidance. HTA research is also an important source of evidence for National Screening Committee (NSC) policy decisions. Outputs included in the HTA journal will contain only aggregate level data with small numbers suppressed in line with the HES analysis guidance.

3. The primary clinical- and cost-effectiveness results of the study will be published in a peer reviewed journal and will conform to the RECORD standards – an agreed set of ‘rules’ for reporting research studies based on routinely-collected data. Target date for submission of the publication is November 2021. The study team will aim to publish in a journal with the highest possible impact with a critical care audience. This will allow the results to have the biggest chance of having an impact amongst those who will use the result to inform their practice. Given the large amount of work that went into creating the RRAM study database, within each area of the study, it may be appropriate to split the data into more than one article/publication. Again, the study team will aim to publish these in a journal with the highest possible impact (e.g. a publication focussing on the methodology/data linkage would be published in journal with a methodological audience). Outputs will contain only aggregate level data with small numbers suppressed in line with the HES analysis guidance.

4. Presentations at professional and scientific conferences – the RRAM study methodology was presented at the at the Annual Meeting of the Case Mix Programme (April 2019) as an example of using data linkage to report longer-term outcomes in critically ill patients. An abstract describing the RRAM methodology was submitted to the International Population Data Linkage Network Conference in and was accepted for presentation in October 2020. Unfortunately, due to COVID-19 workload, the abstract was withdrawn. Presenting the methodology behind the RRAM study meets the objective to establish efficient research techniques that, if successful, could be used to track the effects of any change in critical care practice (or other clinical practice) over a reasonably short time scale. Presentations of the results at clinical conferences with appropriate audiences, such as critical care and/or renal clinicians, are planned following publication of the results in a peer reviewed journal. Outputs will contain only aggregate level data with small numbers suppressed in line with the HES analysis guidance.

5. The results of the study will be made available to patients and the public through dissemination via existing networks and media channels. ICNARC has access to both patients and their families and close friends from its recent collaboration in two modules (http://www.healthtalk.org/intensive_care/) for the award-winning website Healthtalk (http://www.healthtalk.org/). In addition, ICNARC works with the Intensive Care Unit Support Teams for Ex-Patients (ICUsteps), the intensive care patient support charity, already collaborating on ICNARCs Family Reported Experiences Evaluation Study funded by the NIHR Health Services & Delivery Research Programme. The RRAM team at ICNARC will work with both Healthtalk and ICUSteps to ensure the results of the study are fed-back to patients. In addition, once the primary clinical- and cost-effectiveness results of the study have been published and are publicly available, the publication and a summary of the results will also be available to patients and the public via the study website (https://www.icnarc.org/Our-Research/Studies/Rram/About).

6. The final linked pseudonymised dataset will be retained and stored securely on ICNARC’s servers for a minimum of 10 years following completion of the study (February 2020). Any requests for additional analyses based on this dataset would be subject to an amendment to this agreement and approval by NHS Digital.

Benefits reported

The RRAM study has now completed and is in the process of publishing the results. As such, there have not yet been any yielded benefits. The study has, however, been accepted for publication in the NIHR Health Technology Assessment (HTA) journal and the results are anticipated to be available publicly early 2022. The study has met its objectives of also investigating the short-term benefits, risks, and costs of RCA compared to SHA, and comparing the long-term development of end-stage renal disease (ESRD) which will help inform critical care delivery for patients in the NHS. The study team have also demonstrated the feasibility of evaluating effects of changes in practice using routinely collected data.

DARS-NIC-184951-D1G8R-v0.10 3 December 2018 to 2 December 2021
Title
Renal Replacement Anticoagulant Management (RRAM)
Commercial
No
Sublicensing
No
Datasets
2
Files released
14

Datasets: Civil Registrations of Death - Secondary Care Cut; Hospital Episode Statistics Admitted Patient Care (HES APC)

Objective for processing

The Renal Replacement Anticoagulation Management (RRAM) study is an observational study that has been designed to utilise high quality routinely collected clinical data, in order to compare the clinical and cost-effectiveness of changing to citrate anticoagulation for continuous renal replacement therapy (CRRT) in adult intensive care units (ICU).

This research is important to patients and the NHS as there is currently a rapid change occurring within the NHS, whereby traditional heparin based anticoagulation for CRRT is being replaced by citrate based methods. This is being done without any evidence that citrate is superior to heparin in terms of clinical or cost-effectiveness. This study will make the most of an efficient design using available data to clarify the effect of changing to citrate-based anticoagulation on health and economic outcomes in normal clinical practice to help determine whether the change should be encouraged or stopped.

The RRAM study is funded by the National Institute for Health Research, Health Technology Assessment Programme (HTA 16/111/136), is managed and sponsored by the Intensive Care National Audit & Research Centre (ICNARC) and will include data from approximately 85,000 patients that were admitted to an adult general ICU in England or Wales between 1 April 2009 and 31 March 2017.

The chief investigator for this NIHR funded study is from the University of Oxford and Oxford University NHS Trust/John Radcliffe Hospital. Their role and responsibilities are to co-ordinate the study and will be providing data for the health economics aspect of the study. This will be completed separately to the data linkage and analysis described in this application which will take place at ICNARC only. Oxford will not have access to data provided by NHS Digital data.

The “legitimate interests” relied upon are of healthcare research. This is because the data processing described here is to support scientific and statistical research.

ICNARC has conducted a legitimate interests assessment to confirm processing is necessary for the purposes of the legitimate interests. ICNARC have assessed this against the ICO’s checklist (https://ico.org.uk/for-organisations/guide-to-the-general-data-protection-regulation-gdpr/lawful-basis-for-processing/legitimate-interests/) and are content that the requirements are met and has been reviewed by NHS Digital.

Purpose Test: are you pursuing a legitimate interest? ICNARC is an independent charity committed to providing high quality information through their national clinical audits, where hospitals/critical care units use information from reports to help them improve care; through research, where data are collected to answer specific questions or to test theories.

Necessity Test: is the processing necessary for that purpose? Processing personal data is necessary for ICNARC's legitimate interests which are described in this application. The data to which access is requested are proportionate and necessary to achieve those interests.

Balancing Test: do the individual’s interests override the legitimate interest? ICNARC have completed a legitimate interests assessment (LIA) and are satisfied that the interests of the data subjects do not override our legitimate interests; that they would reasonably expect the processing and it would not cause unjustified harm. The data subjects interests and fundamental rights are protected through appropriate minimisation of fields and patient records being processed; pseudonymisation to minimise any risk of identifying individuals; protection of the data in a secure environment, and guaranteeing secure destruction at any stage at the request of NHS Digital or after a defined period on completion of the project.

The primary outcome for the processing of NHS Digital data in this application is to provide important outcome data for this study. The outcomes of the study are:

Primary outcomes:

• All cause mortality at 90 days (clinical effectiveness)

• Incremental net monetary benefit at 1 year (cost effectiveness)

Secondary outcomes:

• All-cause mortality at hospital discharge, 30 days and one year

• Days of renal, cardiovascular, and advanced respiratory support

• ICU and hospital length of stay

• New dialysis-dependent renal disease at one year

• Estimated lifetime incremental cost-effectiveness

ICNARC are requesting linked data for a cohort of patients who received CRRT in an adult general ICU in England or Wales between 1 April 2009 and 31 March 2017. Eligible patients will be identified using the following inclusion criteria: aged 16 and over; admitted to an adult or general ICU in England and Wales, which participates in the ICNARC case mix programme, between 01/04/2009 and 31/03/2017; and in receipt of CRRT for at least one calendar day during the ICU stay. It is estimated that 85,000 patients would be included within the project.

ICNARC are requesting patient status (i.e. dead, alive, unknown/unable to link) and date of death (where applicable) from NHS digital via linkage to Civil Registration death data for all patients in the cohort to directly contribute to the clinical evaluation of the primary outcome (90-day all-cause mortality) and the secondary outcomes of all-cause mortality at 30 days and one year.

In addition, ICNARC are requesting linkage to HES inpatient data to obtain health care usage for linked patients that will be used to calculate the incremental cost-effectiveness at 1 year (primary cost effectiveness outcome) and estimate lifetime cost effectiveness.

NHS Digital will also perform third party linkage to the UK Renal Registry (UKRR) for all patients in the cohort to identify diagnosis of new dialysis-dependent renal disease. The UKRR are not considered a data processor as they are only supplying direct patient identifiers to NHS Digital for data linkage and will not receive any HES/Civil Registration death data for linked patients.

Expected output

The planned outputs of the project are as follows:

1. A final report on the entire project to be published as a monograph in the NIHR journal, Health Technology Assessment programme. Target date for submission is 30/06/2019. Outputs will contain only aggregate level data with small numbers suppressed in line with the HES analysis guidance.

2. The results of the study will be published in a peer reviewed journal and will conform to the RECORD standards – an agreed set of ‘rules’ for reporting research studies based on routinely-collected data. Target date for submission: September 2019. However, given the large amount of work planned within each area of the study it may be appropriate to split the data into more than one article. Outputs will contain only aggregate level data with small numbers suppressed in line with the HES analysis guidance.

3. Presentations at professional and scientific conferences, including the Annual Meeting of the Case Mix Programme (April 2019), the annual UK Kidney Week meet meeting (May 2019), and the UK Intensive Care Society (ICS) State of the Art Meeting (December 2019). Outputs will contain only aggregate level data with small numbers suppressed in line with the HES analysis guidance.

4. The final linked pseudonymised dataset will be retained and stored securely on ICNARC’s servers for 5 years. Any requests for additional analyses based on this dataset would be subject to an amendment to this agreement and approval by NHS Digital.

5. ICNARC has access to both patients and their families and close friends from its recent collaboration in two modules (http://www.healthtalk.org/intensive_care/) for the award-winning website Healthtalk (http://www.healthtalk.org/). In addition, ICNARC works with the Intensive Care Unit Support Teams for Ex-Patients (ICUsteps), the intensive care patient support charity, already collaborating on our Family Reported Experiences Evaluation Study funded by the NIHR Health Services & Delivery Research Programme. The RRAM team at ICNARC will work with both Healthtalk and ICUSteps to ensure the results of the study are fed-back to patients. In addition, the results will also be available to patients and the public via the ICNARC website (www.icnarc.org).

Benefits reported

Yielded Benefits is not a requirement for new applications.

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.

Cite this page

NHS England (2026) Data Uses Register, September 2026 edition, agreement DARS-NIC-184951-D1G8R, “Renal Replacement Anticoagulant Management (RRAM)”. Read via NHS Data Access Explorer (unofficial), https://healthdatauses.uk/agreements/dars-nic-184951-d1g8r/ (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-184951-D1G8R to see the original rows.