Perioperative Quality Improvement Programme (PQIP)

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Objective for processing

This Data Sharing Agreement (DSA) permits continued retention of the Data only. The DSA does not permit any other processing of the data. *** [3 paragraphs unchanged] Primary Objective - - To measure the rate of postoperative complications and other adverse outcomes after major inpatient surgery in England and Wales. [2 paragraphs unchanged] (b) What is the relationship between short-term complications and longer-term health related quality of life (HRQOL), and can longer-term HRQOL be improved through reducing postoperative complications? and can longer-term HRQOL be improved through reducing postoperative complications? [11 paragraphs unchanged] • Limited to Annual Data refreshes, from 2016/17 to 2020/21 the expiry of the DSA. [6 paragraphs unchanged] The “legitimate interests” are of healthcare research. This is because the data [43 words unchanged] anaesthesia and related subjects, and to disseminate the useful results of that research.. research. University College London and RCoA's The lawful basis for processing special category data under the UK GDPR is: Article 9(2)(j) - Processing processing is necessary for reasons of public interest archiving purposes in the area of public health, such as protecting against serious cross-border threats to health interest, scientific or ensuring high standards of quality and safety of health care and of medicinal products historical research purposes or medical devices, statistical purposes in accordance with Article 89(1) based on the basis of Union or Member State law which provides shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and freedoms the interests of the data subject, in particular professional secrecy. subject. [5 paragraphs unchanged] • Individuals/PhD students Individuals holding an honorary contract under the supervision of a substantive employee of UCL and RCoA for the purposes described in this DSA only. UCL and RCoA must maintain records in a single location that cover the following details of each individual given access under an honorary contract: UCL and RCoA must maintain records in a single location that cover the following details of each individual given access under an honorary contract: [5 paragraphs unchanged] Any student working with the Data held under this Agreement must have completed relevant data protection and confidentiality training and are subject to UCL or RCoA policies on data protection and confidentiality. [1 paragraph unchanged]

Processing activities

This Data Sharing Agreement (DSA) permits continued retention of the data only. The DSA does not permit any other processing of the data. *** [26 paragraphs unchanged]

Unchanged: Expected output, Expected measurable benefits, Benefits reported.

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Objective for processing

Version 5 - This Data Sharing Agreement (DSA) permits continued retention of the data Data only. The DSA does not permit any other processing of the data. [21 paragraphs unchanged] • Limited to Annual Data refreshes, from 2016/17 to the expiry of the DSA. 2020/21 [14 paragraphs unchanged] Researchers, analysts and PhD students affiliated with UCL and the University of Southampton. Any student working with the Data held under this Agreement must have completed relevant data protection and confidentiality training and are subject to UCL or RCoA policies on data protection and confidentiality. Any students accessing the Data will do so under the supervision of a substantive employee of UCL or RCoA. UCL or RCoA would be responsible and liable for any work carried out by students. These students would only work on the Data for the purposes described in this Agreement. • Individuals/PhD students holding an honorary contract under the supervision of a substantive employee of UCL and RCoA for the purposes described in this DSA only. UCL and RCoA must maintain records in a single location that cover the following details of each individual given access under an honorary contract: o Their substantive employer; o Their role in respect of the purpose for the processing specified in the DSA; o The start date and end date of the duration in which the Data will be accessed by the individual under an honorary contract; o The necessity for the Data to be accessed by the person(s) holding an honorary contract, instead of a substantive employee of an organisation named as controller or a processor in this DSA; o Confirmation that an appropriate contract is in place which follows the relevant guidance and is countersigned by the substantive employer of the honorary contract holder. Any student working with the Data held under this Agreement must have completed relevant data protection and confidentiality training and are subject to UCL or RCoA policies on data protection and confidentiality. [1 paragraph unchanged]

Processing activities

Version 5 - This Data Sharing Agreement (DSA) permits continued retention of the data only. The DSA does not permit any other processing of the data. [27 paragraphs unchanged]

Expected output

[6 paragraphs unchanged] PHD - Completed Projects: 1. Evaluation of the use of quality data at hospital level: 2. Development and implementation of a system to report near real-time risk adjusted postoperative morbidity data PHD - Ongoing Projects: 1. Analysis of risk factors for adverse health-related quality of life outcomes after complex orthopaedic surgery 2. Analysis of trajectories of postoperative outcome from surgery and use of machine learning to predict these [21 paragraphs unchanged]

Expected measurable benefits

[18 paragraphs unchanged] 5.5 million people undergo surgery each year in England, of whom 1.5 [59 words unchanged] important, generalizable findings with the potential to have the influences listed above. The benefit will be to healthcare and to patients, and impact will be measured through publications, policy changes, guideline development and further evaluation. Benefits should be realised within 5 years. Improving understanding This is because it is the largest study of perioperative epidemiology, and developing targets to improve medium and longer-term outcome is a public health priority, particularly as its known that short-term complications inpatient major general surgery we are linked to reduced long-term survival. Furthermore, these analyses are expected to assist with the elective recovery challenge aware of in the NHS, by supporting UK. Some registries (e.g. national clinical audits such as the National Joint Registry or the National Bowel Cancer Audit) have enrolled more patients who are and linked with HES and ONS; however, none contain the detailed information about preoperative risk factors (including patient-reported health and health behaviours), processes of care, inpatient postoperative complications, patient-reported outcomes at higher risk of complications 6 and increased length of stay, and thereby increasing capacity for 12 months after surgery. The benefit will be to healthcare and to patients, and impact will be measured through publications, policy changes, guideline development and further evaluation. Benefits should be realised within 5 years. Improving understanding of perioperative epidemiology, and developing targets to improve medium and longer-term outcome is a public health priority, particularly as its known that short-term complications are linked to reduced long-term survival. Furthermore, these analyses are expected to assist with the elective recovery challenge in the NHS, by supporting patients who are at higher risk of complications and increased length of stay, and thereby increasing capacity for surgery. [11 paragraphs unchanged]

Benefits reported

[3 paragraphs unchanged] 2. Development of a new system to support hospitals monitoring their risk-adjusted [11 words unchanged] 10 hospitals with a mixed methods evaluation of adoption and impact and will be was rolled out nationally in Spring 2023. [3 paragraphs unchanged] 6. Two completed PhD projects and several more in progress. 6. PQIP outputs have already had impact on national health policy: for example, manuscript (5) listed above was shared with NHS England prior to publication and led directly to the development of a CQUIN for 22/23 which has now been expanded and extended for 23/24 (https://www.england.nhs.uk/publication/cquin-2023-24-guidance/). 7. PQIP outputs have already had impact on national health policy: for example, manuscript (5) listed above was shared with NHS England prior to publication and led directly to the development of a CQUIN for 22/23 which has now been expanded and extended for 23/24 (https://www.england.nhs.uk/publication/cquin-2023-24-guidance/). 7. Ongoing improvement through feedback of this Data is leading to a reduction in the postoperative morbidity and mortality rates and thus an overall improvement in patient outcomes. Outcomes will be measured by ongoing data collection at hospital sites throughout the project duration and therefore regular 6-monthly data linkage would be required. Data already collected is demonstrating a continuous improvement in care. Since the start of PQIP inpatient Length of Stay has reduced by over a day across a variety of specialties as is post operative morbidity. Length of stay for whole PQIP population has reduced from 8.9 days to 8.0 days. Day 7 morbidity has fallen from 28% to 19%. 8. Ongoing improvement through feedback of this Data is leading to a reduction in the postoperative morbidity and mortality rates and thus an overall improvement in patient outcomes. Outcomes will be measured by ongoing data collection at hospital sites throughout the project duration and therefore regular 6-monthly data linkage would be required. Data already collected is demonstrating a continuous improvement in care. Since the start of PQIP inpatient Length of Stay has reduced by over a day across a variety of specialties as is post operative morbidity. Length of stay for whole PQIP population has reduced from 8.9 days to 8.0 days. Day 7 morbidity has fallen from 28% to 19%. [4 paragraphs unchanged] RCoA are collaborating with clinical trials teams to run embedded studies to further improve the evidence base for what RCoA do – the first of these, Volatile vs Total intravenous Anaesthesia for major non-cardiac surgery: A pragmatic randomised trial (VITAL), will compare IV and inhalational anaesthesia in patients having major surgery in at least 40 NHS hospitals and starts recruiting in November 2021. As data is being processed to fulfil a "legitimate interest" Article 6(1)(f); the following has been demonstrated: • Purpose – to improve care for patients undergoing major surgery across the NHS. Reduce complications, deaths, and improve efficiency within the NHS. • Necessity – NHS England data is needed in order to the aims of PQIP. The strain of direct data collection would risk the project failing to meet its aims and would not be feasible. • Balancing – the potential benefits of PQIP to the population of the UK are significant. Over 1.5 million major operations take place annually. PQIP is recruiting in over 100 hospitals. [1 paragraph unchanged]

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Data controllers: + UNIVERSITY COLLEGE LONDON (UCL)

Datasets: + HES-ID to MPS-ID HES Admitted Patient Care · − HES:Civil Registration (Deaths) bridge

Objective for processing

Perioperative Quality Improvement Programme (PQIP) is a study run by the National Institute of Academic Anaesthesia, Health Services Research Centre (NIAA-HSRC), and the Royal College of Anaesthestists (RCoA), and the Health Foundation, with a planned initial duration of 5 years. Version 5 - This Data Sharing Agreement (DSA) permits continued retention of the data only. The DSA does not permit any other processing of the data. NIAA and NIAA Health Services Research Centre are departments within RCoA. University College London is the sponsor and the Health Foundation is funding the study. Neither the University College London nor the Health Foundation is acting as Data Controllers in relation to this application. University College London Hospitals NHS Foundation Trust is a joint data processor with RCoA. All processing of data is carried out at RCoA. *** PQIP will measure risk-adjusted morbidity and mortality, as well as process and patient-reported outcome data in patients undergoing major surgery. The dataset has been informed by previous systematic and structured reviews, and over 60 UK NHS hospitals have so far volunteered to take part. The Royal College of Anaesthetics (RCoA) requires access to NHS England Data for the purpose of the following research project: The Perioperative Quality Improvement Programme (PQIP) RCoA will collect objective risk, process and outcome data on patients during their inpatient stay. The PQIP database will only collect data for the primary admission when patients undergo their planned operation. By linking to Hospital Episode Statistics (HES) data and mortality data at record level RCoA will be able to analyse a more complete dataset. This is necessary to track adverse outcomes which occur after discharge from hospital (e.g. readmission within 30/90 days of surgery - from HES data; longer term mortality). PQIP measures risk-adjusted morbidity and mortality, as well as process patient-reported outcome data in patients undergoing major surgery. The PQIP dataset has been informed by previous systematic and structured reviews, and over 150 UK NHS hospitals have taken part in PQIP at some point during the study so far. [2 paragraphs unchanged] To measure the rate of postoperative complications and other adverse outcomes after major inpatient surgery in the UK England and how it varies between hospitals. RCoA primary analysis will measure risk-adjusted variation between providers (comparing observed: expected ratios) in morbidity, mortality and failure to rescue rates. Wales. Secondary Objectives include – (a) What is the failure to rescue rate percentage of patients who die after a complication in NHS hospitals and how does it vary? [3 paragraphs unchanged] Aggregated outcome data will be reported back to participating hospitals to inform of their outcomes (hospital length of stay data, mortality data), together with data collected within the PQIP dataset. The following NHS England Data will be accessed: In summary, the purpose of this request is to support a UK wide clinical study, involving quality improvement within hospitals, and research on methods to monitor surgical outcomes. Through measuring process and outcome measures for patients undergoing major surgery the aim is to improve the quality of care for patients throughout the UK. Hospital Episode Statistics (HES) Admitted Patient Care – necessary because it is required for hospital readmission, days alive and out of hospital and recovery trajectories. The NIAA-HSRC is a body which sits within the remit of the Royal College of Anaesthetists. UCL (University College London) are acting as sponsors for the study, with the joint research office (a partnership between UCL and UCLH). The Health Foundation have supplied grant funding for the project but have no involvement in the design, day to day running of the project, or the outputs created from the study. Hospital Episode Statistics (HES) Critical Care – necessary because it is required for recovery trajectories. The data processing described within this agreement is to support the organisations legitimate Interests of scientific and statistical research as set out in this section. The legal basis for processing personal data is: Civil Registration Deaths (Secondary Care Cut) – necessary because it is required for days alive and out of hospital, long-term survival and recovery trajectories. "Article 6.1 (f) Legitimate interests: (processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party except where such interests are overridden by the interests of fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child)." The level of the Data will be: The “legitimate interests” are of healthcare research. This is because the data processing described here is to support scientific and statistical research. For the particular focus of this application - Perioperative Quality Improvement Programme (PQIP) the processing is necessary. · Identifiable - necessary to enable linkage of the Data with the cohort data. Research – PQIP: The study will measure risk-adjusted morbidity and mortality in patients undergoing major surgery. The PQIP study is also investigating whether the quality of care for patients undergoing surgery in NHS Hospitals can be improved through the feedback of data to clinicians and managers, leading to improvements in post-operative complications and failure to rescue. The Data will be minimised as follows: The Royal College of Anaethetists (RCoA) is a Registered Charity with the Charities Commission (Reg Number: 1013887) and is subject to the Charities Act 2011. Chapter 1, Section 4 of the Charities Act establishes that the nature of a charity is to operate for the public benefit if it is for charitable purposes. The purpose of medical research is compatible with the purposes defined within Chapter 3, Section 1(d) of the Charities Act for the advancement of health or for the saving of lives, paragraph 3(b) states that this includes the prevention or relief sickness disease or human suffering (http://www.legislation.gov.uk/ukpga/2011/25/section/3). • Limited to Data for a study cohort of patients recruited to the PQIP study, who are all adult patients who are undergoing a major non-cardiac elective inpatient surgery. The cohort currently contains ~50,800 participants. Recruitment is ongoing and the cohort is expected to increase by 8,000 - 10,000 newly recruited participants per year. In further guidance from the Charities Commission in relation to purposes, Section 6 states that the purposes extend beyond the treatment or provision of care, and includes Health Research charities https://www.gov.uk/government/publications/charitable-purposes. • Limited to patients undergoing any of the included Operating Procedure Codes Supplement (OPCS) procedure codes. The Commission also states that the Charity must also clearly define its purposes within its governance documents or ‘objects’ and the charity must be registered with the Charities Commission and its registration can be checked on-line, the purposes of the charity are also defined within its registration. (https://www.gov.uk/government/collections/charitable-purposes-and-public-benefit). • 37% of the available HES APC fields have been selected, 60% of the available HES CC fields have been selected and, 29% of the available Civil Registration Deaths-Secondary Care Cut fields have been selected. The IGA GDPR guidance on lawful processing, Section 7 states that when relying on legitimate interests for medical research this should be compatible with the HRA guidance on lawful processing for research purposes https://digital.nhs.uk/binaries/content/assets/legacy/pdf/3/p/igagdprprocessing.pdf, the HRA GDPR guidance states that commercial organisations and charities should rely on legitimate interests under GDPR for medical research. • Limited to Annual Data refreshes, from 2016/17 to the expiry of the DSA. The RCoA state the following on their website about their purpose as an organisation: University College London as the research sponsor, and the Royal College of Anaesthetists as the main collaborator, are joint controllers as the organisations responsible for ensuring that the data will only be processed for the purpose described above. "The Royal College of Anaesthetists (RCoA) is the third largest Medical Royal College in the UK by membership. With a combined membership of 22,000 fellows and members, it represents and ensures the quality of patient care by safeguarding standards in the three specialties of anaesthesia, intensive care and pain medicine. PQIP is managed by the National Institute of Academic Anaesthesia, Health Services Research Centre (NIAA-HSRC). The NIAA-HSRC is a body which sits within the remit of the Royal College of Anaesthetists. The College is the professional body responsible for the specialty of anaesthesia throughout the UK at all stages of fellows and members careers. As anaesthetists, RCoA have overall responsibility for patients' wellbeing before, during and after surgery. RCoA are the lynchpin that holds secondary and tertiary care together and are the UK's largest hospital specialty. University College London’s lawful basis for processing personal data under the UK GDPR is: The College champions the diverse and critical work of anaesthetists, and the science that underpins their work. They recruit, train and examine anaesthetists to the most exacting standards. RCoA support their fellows and members throughout their careers irrelevant of age and region. RCoA fund research to ensure that anaesthesia continues to advance at a rapid rate. RCoA promote the sharing of knowledge and best practice, as well as working with government on crucial policies, and with other stakeholders in the UK and overseas to make sure that anaesthesia and anaesthetists play a central role in shaping and delivering the healthcare agenda. Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller The College is the home of the Faculty of Pain Medicine and one of the eight parent Colleges of the Faculty of Intensive Care Medicine. RCoA’s lawful basis for processing personal data under the UK GDPR is: RCoA are committed to supporting their combined membership of 22,000 fellows and members throughout their careers. The key areas of work include: Article 6(1)(f) - Processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party except where such interests are overridden by the interests of fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child. • setting high standards of clinical care to ensure the constant rise in quality of patient care and safety The “legitimate interests” are of healthcare research. This is because the data processing described here is to support scientific and statistical research. For the particular focus of this application - the Perioperative Quality Improvement Programme (PQIP) the processing is line with RCoA’s charitable objectives and to advance, promote and carry on study and research into anaesthesia and related subjects, and to disseminate the useful results of that research.. • establishing the standards and curriculum for the training of anaesthetists, including examinations University College London and RCoA's lawful basis for processing special category data under the UK GDPR is: •the continued medical education of all practising anaesthetists to ensure their skills remain up-to-date Article 9(2)(j) - Processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy. • working collaboratively, through the National Institute of Academic Anaesthesia’s (NIAA) Health Services Research Centre (HSRC) to advance, fund and promote research activity acting as the voice of the specialty on behalf of the membership This processing is in the public interest because the data is required for improvement and ensuring high standards an quality/safe care. •professional and personal development to support the development of fellows’ and members’ careers and practice. PQIP is funded by the Royal College of Anaesthetists. The chief Investigator and a number of the study team have also received support from the National Institute for Health Research via infrastructure grants such as the UCLH Biomedical Research Centre. Funding is in place until 2027. •RCoA promote the sharing of knowledge and best practice working with government and other stakeholders in the UK and overseas to make sure that anaesthesia and anaesthetists play a central role in shaping and delivering the healthcare agenda ANS Group Limited provide IT hosting services to the PQIP IT system and will store the Data as contracted by the RCOA. The RCoA has conducted a legitimate interests assessment to confirm processing is necessary for the purposes of the legitimate interests. The RCoA 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 RCoA have employed Bluesource Information Limited to provide secure Cloud based back-up storage of the Data. In turn Bluesource have contracted Harbor Solutions Limited to provide these services. The Data will be accessed by: Researchers, analysts and PhD students affiliated with UCL and the University of Southampton. Any student working with the Data held under this Agreement must have completed relevant data protection and confidentiality training and are subject to UCL or RCoA policies on data protection and confidentiality. Any students accessing the Data will do so under the supervision of a substantive employee of UCL or RCoA. UCL or RCoA would be responsible and liable for any work carried out by students. These students would only work on the Data for the purposes described in this Agreement. There have been two patient and public representatives on the study management team from inception. They have attended the majority of study management team meetings and have contributed to study materials such as the protocol, consent form and participant information leaflets, dataset design and research papers using the primary dataset. They have been co-authors on all manuscripts published so far and they will contribute to the analysis, interpretation, write-up and dissemination of the HES analyses.

Processing activities

The RCoA are the main data processors for PQIP and manage the extraction of the records from the PQIP IT system (which is stored on UKFast servers). Version 5 - This Data Sharing Agreement (DSA) permits continued retention of the data only. The DSA does not permit any other processing of the data. The RCoA are requesting two separate linkages the first will include sending patient identifiers for the consented cohort to NHS Digital for linkage and the second request involves a linkage via OPCS procedure codes where no patient identifiers will be sent to NHS Digital and RCoA will receive back pseudonymised HES data. No patient identifiers will flow back to NHS Digital for this second linkage. *** For the first data linkage the RCoA will send the file of patient identifiers and the PQIP ID to NHS Digital for linkage to HES and mortality fields. The RCoA are requesting two separate data linkages with NHS England Data described below. Patients who RCoA supply identifiable data to NHS Digital for the linkage (those included in the PQIP study) have been consented. The second linkage (via OPCS procedure codes) will not have consented, this linkage does not involve identifiable data being shared or linked. No mortality data is being requested for this second linkage. Linkage One: The RCoA will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth, Postcode, and a Unique Person Identifier) for the cohort to be linked with NHS England Data. In order to allow this, a file (P) containing these patient identifiers only will be extracted from the full dataset hosted in the PQIP webtool, and will be sent securely to a trusted Data Linkage Service (TDLS). For mortality tracking data and HES data, this would be NHS Digital. File (P) will contain the following identifiers: Linkage Two: The RCoA will transfer a list of OPCS codes to NHS England. This will consist of OPCS procedure codes that are included with the PQIP study. • PQIP study identifier NHS England Data will provide the relevant records from the HES and Civil Registration Deaths datasets to the RCoA. The Data on the consented cohort will contain no direct identifying data items but will contain a unique person ID which can be used to link the Data with other record level data already held by the recipient. • NHS number The Data will not be transferred to any other location. • Date of Birth The Data will be stored on servers at ANS. • Sex RCoA stores Data on the Cloud provided by Bluesource Information Limited and Harbor Solutions Limited. No patient identifiable Data is stored on the back-up servers provided by Harbor Solutions Limited. • Postcode The Data will be accessed onsite at the premises of RCoA. For each patient in the file, NHS Digital will identify the matching mortality or HES ID. NHS Digital will then return to the Royal College of Anaesthetists a ‘look-up’ file (L) containing only the PQIP identifier and the HES or mortality ID identifiers, and a MATCH_RANK field which indicates the strength of the match. An extract of pseudonymised HES or mortality data will then be requested from NHS Digital for all the list of IDs contained in file (L). The Data will also be accessed by authorised personnel via remote access. The file (L) will be placed in the secure RCoA server accessible only to the project data manager. It will then be used to link the pseudonymised mortality or HES data to the pseudonymised PQIP data for analysis. The pseudonymised PQIP extract will not contain NHS number, postcode or date of birth. Patients will be labelled with the PQIP identifier only. The pseudonymised dataset is analysed to produce results for PQIP reports and other PQIP outputs. All outputs produced will be pseudonymised aggregated level data with small numbers suppressed in line with HES analysis guidelines. The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract. RCoA will also request a second linkage as part of the same data sharing agreement, this is separate to the consented cohort. This will be to enable the PQIP team to obtain denominator data for the PQIP patient cohort. This data will be used to ensure the sampling technique for PQIP is representative of the total population of patients undergoing major surgery across the UK. This second linkage will be done via OPCS procedure codes. The PQIP team will provide NHS Digital with a list of OPCS procedure codes that are included within the PQIP study. RCoA will then ask for pseudonymised, non-sensitive record level data for those patients including HES data such as hospital length of stay, 30-day readmission and 30-day/90-day mortality flags. For remote access: The pseudonymised data NHS Digital supply will be used by the PQIP research team (the PQIP research team consists of NIAA-HSRC employees who are substantive employees of the RCoA and also substantive employees of UCLH) to produce hospital reports and academic outputs. The only access to patient identifiable data held within the PQIP database will be from substantive employees from the RCoA and only for the purpose of completing the NHS Digital linkages. The pseudonymised data (only containing PQIP identifier) will be passed on to the PQIP research team for data analysis. - Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA; RCoA will not link the HES/mortality data with any other dataset other than the PQIP data. Linkage with any other datasets would be subject to a future application and would be supported by an appropriate legal basis. - Personnel are both prohibited and technically prevented from downloading or copying NHSE Data to local devices; RCoA also plan to link to PEDW in Wales, and to NHS Scotland. These other linkages will be performed separately to the NHS Digital linkage and will not involve the sharing of NHS Digital data with Wales or Scotland. The linkages to central NHS held data will only involve the transfer of data for patients recruited in those nations, so for example there will be no data transferred to NHS Digital for patients recruited in an NHS Scotland institution. NHS Digital data will not be disseminated to Wales or Scotland for the purpose of this data linkage. - Access controls granting users the minimum level of access required are in place; Once RCoA have received data from NHS Digital, this will be linked via PQIP patient study number to the data held within the PQIP webtool, and this will be exported (pseudonymised with only PQIP patient number, no other identifiable data) to the PQIP team who will be performing the data analysis. - Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data; The analysis of pseudonymised linked data will be conducted by the RCoA statisticians/fellows who form part of the PQIP research team. The PQIP data analysis/research team are either substantive employees of UCLH or the RCoA. - Multifactor authentication (MFA) is required for remote access; All outputs and publications contain only aggregated data with small numbers suppressed in line with the HES Analysis Guide. - Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access; - All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this agreement) and complies with the organisation’s remote access policy. The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose). The Data will not leave England/Wales at any time. Access to confidential patient identifiable Data is restricted to employees or agents of UCL and RCoA. All personnel accessing the Data have been appropriately trained in data protection and confidentiality. The Data will be linked at person record level with the cohort data. The Data will not be linked with any other data. The identifying details will be stored in a separate database to the linked dataset used for analysis. All analyses will use the pseudonymised dataset. There will be no requirement and no attempt to reidentify individuals. Analysts from the RCoA will analyse the Data for the purposes described above.

Expected output

The purpose of the NHS Digital linkage is to reduce the data collection burden of local sites with regards to readmission rates, allow RCoA to collect mortality data, and to validate their sampling strategy. The expected outputs of the processing will be: The NHS Digital linked data will be used to produce quarterly/annual reports and academic outputs. These will also be reported via conference presentations and online video presentations. · Quarterly reports are produced reporting type of surgery and hospital level processes and outcomes. These are targeted to specific groups involved within the PQIP research team (nurses, research team, anaesthetists, surgical team, and hospital managers). Quarterly reports are produced reporting type of surgery and hospital level outcomes. These are targeted to specific groups involved within the PQIP research team (nurses, research team, anaesthetists, surgical team, and hospital managers). A full PQIP report and executive summary are produced on an approximately annual basis. The following publications have been created: A full PQIP report and executive summary are to be produced on an annual basis. The following publications have been created: [1 paragraph unchanged] - Quarterly hospital reports provided to participants and available to download from the PQIP website (www.pqip.org.uk) All reports/results (that contain only aggregated data with small number suppression) will be published on this website and therefore participants will be able to access this. The most recent quarterly report was published in October 2022 and an example can be found here: https://pqip.org.uk/Content/home In addition, research manuscripts using PQIP data will be submitted to open access peer reviewed journals. Wider dissemination to the surgical and anaesthetic profession is being achieved using the resources of the RCoA and other stakeholder Royal Colleges and the NIAA-HSRC, including websites, press releases, written and electronic communications. Different resources will be used to disseminate information to different stakeholders, using a multi-media approach and lay representation to ensure effective communication to the public. All reports/results (that contain only aggregated Data with small number suppression) are published on the PQIP website and therefore participants will be able to access this. In addition, other dissemination includes: Academic outputs (peer-reviewed) - Online webinars In addition, research manuscripts using PQIP data will be submitted to open access peer reviewed journals. Wider dissemination to the surgical and anaesthetic profession is being achieved using the resources of the RCoA and other stakeholder Royal Colleges, including websites, press releases, written and electronic communications. Different resources will be used to disseminate information to different stakeholders, using a multi-media approach and lay representation to ensure effective communication to the public. - PQIP Collaborative event held in 2019 including presentations on the PQIP results and from local participants on their successes and challenges. In addition, other disseminations so far have included: - Conference presentations – Including at 2021 HSRC Conference where the recent PQIP report was launched - Multiple online webinars - PQIP abstract competition held at the RCoA’s annual conference (2019 & 2021) - Three face to face PQIP Collaborative events including presentations on the PQIP results and from local participants on their successes and challenges. - Dozens of Conference presentations - PQIP abstract competition held at the RCoA’s annual conference (2019, 2021 &2022) [3 paragraphs unchanged] RCoA will be submitting journals to Anaesthesia, British Journal of Anaesthesia, The New England Journal of Medicine, or The Lancet. There may also be publications to other journals that are produced using the PQIP data. Future outputs: PQIP will continue to publish quarterly reports and summary cohort reports every 18 months. PQIP will also continue their wider dissemination and communication plans including webinars, face to face meetings, presentations, infographics, etc. PQIP have a number of peer-reviewed manuscripts planned which will address the research questions in the protocol. For example: a. describing associations between socioeconomic deprivation, ethnicity and a suite of short and longer-term outcomes including postoperative complications, hospital readmissions; days alive and out of hospital up to 1 year after surgery; longer-term survival. b. developing/validating risk models for longer-term outcomes after surgery (most risk models currently only developed to predict inpatient or 30-day mortality) c. describing and evaluating failure to rescue after postoperative complications – overall incidence and variation according to patient characteristics including deprivation, region etc d. describing trajectories of recovery after major surgery: funding secured for these analyses from NIHR e. evaluating the longer-term impact of interventions which appear to have benefit in the short-term (e.g. by reducing immediate postoperative morbidity and mortality or hospital readmissions / overall length of stay) The data linkage requested in this application will facilitate all of these analyses and outputs by providing information required about patients’ health status and outcomes after discharge from their primary surgical admission.

Expected measurable benefits

The general landscape for patients having surgery in the NHS is even more challenging than ever before, because of waiting list growth and the risk of patients becoming more deconditioned while they wait for surgery. For this reason, there has never been a greater need for the type of improvements which PQIP is trying to promote. RCoA know the value of individualised risk assessment in shared decision making and perioperative planning, how DrEaMing within 24h is associated with reduced length of stay, and how really good pain management is associated with better processes and outcomes of care. The findings of this research study are expected to contribute to evidence-based decision-making for policy-makers, local decision-makers such as doctors, and patients to inform best practice to improve the care, treatment and experience of health care users relevant to the subject matter of the study. The use of the Data could: · help the system to better understand the health and care needs of populations. · lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience. · advance understanding of regional and national trends in health and social care needs. · advance understanding of the need for, or effectiveness of, preventative health and care measures for particular populations or conditions such as obesity and diabetes. · inform planning health services and programmes, for example to improve equity of access, experience and outcomes. · inform decisions on how to effectively allocate and evaluate funding according to health needs. · provide a mechanism for checking the quality of care. This could include identifying areas of good practice to learn from, or areas of poorer practice which need to be addressed. · support knowledge creation or exploratory research (and the innovations and developments that might result from that exploratory work). Specific benefits expected are as follows: 1. Reduction in postoperative complications and length of hospital stay: within 3 years 2. Improvement in compliance with evidence-based processes of care such as related to anaemia and diabetes management: within 3 years 3. Generation of new knowledge about health inequalities and surgical outcomes (particularly deprivation) (within 2 years) 4. Development and evaluation of interventions to address these inequalities (within 5 years) 5. Development and evaluation of interventions to reduce unplanned readmissions to hospital after a primary procedure discharge: within 5 years 6. Comparison of the PQIP population vs. the total population of patients undergoing similar procedures, to understand biases in our sampling, and support strategies to recruit “harder to reach” patient groups into research: within 5 years. Further information 5.5 million people undergo surgery each year in England, of whom 1.5 million have major surgery of the type which this study evaluates. Postoperative complication rates are around 25% and RCoA believe at least 10% of patients are readmitted as an emergency to hospital. The linkage of detailed inpatient Data of this type with HES and mortality Data has not been achieved on this scale before and is expected to yield important, generalizable findings with the potential to have the influences listed above. The benefit will be to healthcare and to patients, and impact will be measured through publications, policy changes, guideline development and further evaluation. Benefits should be realised within 5 years. Improving understanding of perioperative epidemiology, and developing targets to improve medium and longer-term outcome is a public health priority, particularly as its known that short-term complications are linked to reduced long-term survival. Furthermore, these analyses are expected to assist with the elective recovery challenge in the NHS, by supporting patients who are at higher risk of complications and increased length of stay, and thereby increasing capacity for surgery. The general landscape for patients having surgery in the NHS is even more challenging than ever before, because of waiting list growth and the risk of patients becoming more deconditioned while they wait for surgery. For this reason, there has never been a greater need for the type of improvements which PQIP is trying to promote. RCoA know the value of individualised risk assessment in shared decision making and perioperative planning, how drinking, eating and mobilising within 24h is associated with reduced length of stay, and how good pain management is associated with better processes and outcomes of care. [1 paragraph unchanged] Ongoing improvement through feedback of this data is leading to a reduction in the postoperative morbidity and mortality rates and thus an overall improvement in patient outcomes. Outcomes will be measured by ongoing data collection at hospital sites throughout the project duration and therefore regular 6-monthly data linkage would be required. Data already collected is demonstrating a continuous improvement in care. Since the start of PQIP inpatient Length of Stay has reduced by over a day across a variety of specialties as is post operative morbidity. Length of stay for whole PQIP population has reduced from 8.9 days to 8.0 days. Day 7 morbidity has fallen from 28% to 19%. [3 paragraphs unchanged] Reporting will identify identifies whether NHS trusts are meeting national guidance such as NICE recommendations and will identify variations in the provision of care. Trusts showing poor performance will be notified to allow for investigation into the cause; this can be attributable to either data quality issues or clinical practice. [2 paragraphs unchanged] Publishing in peer-reviewed journals will allow greater discussion of the strengths and weaknesses of the results, and will provide the benefit of peer-review of the work from third parties. It is anticipated that the reports produced as a result of the audit will contribute to clinical guidance and national policy. Continued improvement in hospital processes and outcomes based on the quarterly reports, and with comparison of national data is likely to continue to happen as a result of the outputs [1 paragraph unchanged] The findings will be used to identify targets for intervention, to support improved outcomes after major surgery. For example, RCoA hypothesize that more deprived patients will have worse outcomes for some months or years after surgery. Understanding the patterns of ill-health and trajectories of outcomes will support development of interventions (e.g closer surveillance and monitoring) at particular time-points after surgery. This will therefore improve the chances of a clinically and cost effective intervention being developed. There are numerous other examples of novel findings which RCoA analyses will yield; for example, long-term outcomes of patients who have specific perioperative interventions; longer-term trajectories of recovery for patients with different characteristics and short-term outcomes etc.

Benefits reported

The project has continued to adapt adapt, and is the study team are pleased with how participation has held up and restarted as the affects effects of Covid subside. Benefits so far include: 1. Validation of a new approach to ‘enhanced recovery’ after surgery, which is associated with fewer postoperative complications and reduced length of hospital stay. On the basis of PQIP research data and recommendations, this has been adopted by NHSE as a Commissioning for Quality and Innovation (CQUIN) financial target for Trusts (launched 22/23 and is being expanded in 23/24). 2. Development of a new system to support hospitals monitoring their risk-adjusted outcomes from colorectal surgery in near real-time. This was piloted in 10 hospitals with a mixed methods evaluation of adoption and impact and will be rolled out nationally in Spring 2023. 3. Development and validation of a new risk prediction tool for severe postoperative pain which can be adopted to support better patient care 4. Publication of multiple hospital level and annual reports which support quality improvement at local level, on wide ranging topics such as pain management, perioperative blood and anaemia management, preoperative diabetes management 5. Two NIHR funded collaborations with clinical trials teams to run embedded studies to further improve the evidence base for what RCoA do – the first of these, Volatile vs Total intravenous Anaesthesia for major non-cardiac surgery: A pragmatic randomised trial (VITAL), will compare IV and inhalational anaesthesia in patients having major surgery in at least 40 NHS hospitals and started recruiting in November 2021 – so far almost 700 patients have been recruited from 36 hospitals. 6. Two completed PhD projects and several more in progress. 7. PQIP outputs have already had impact on national health policy: for example, manuscript (5) listed above was shared with NHS England prior to publication and led directly to the development of a CQUIN for 22/23 which has now been expanded and extended for 23/24 (https://www.england.nhs.uk/publication/cquin-2023-24-guidance/). 8. Ongoing improvement through feedback of this Data is leading to a reduction in the postoperative morbidity and mortality rates and thus an overall improvement in patient outcomes. Outcomes will be measured by ongoing data collection at hospital sites throughout the project duration and therefore regular 6-monthly data linkage would be required. Data already collected is demonstrating a continuous improvement in care. Since the start of PQIP inpatient Length of Stay has reduced by over a day across a variety of specialties as is post operative morbidity. Length of stay for whole PQIP population has reduced from 8.9 days to 8.0 days. Day 7 morbidity has fallen from 28% to 19%. [3 paragraphs unchanged] Outputs from PQIP have helped increase the knowledge and understanding of outcomes [45 words unchanged] feedback of data. Annual reports provide an overview and national picture. NHS Digital England data has supported the RCoA to produce national risk-adjusted mortality outcomes. [1 paragraph unchanged] As data is being processed to fulfill fulfil a "legitimate interest "Article interest" Article 6(1)(f); the following has been demonstrated: [1 paragraph unchanged] • Necessity – NHS Digital England data is needed in order to the aims of PQIP. The strain [6 words unchanged] the project failing to meet its aims and would not be feasible. [1 paragraph unchanged] It is not possible to collect the level of data present in the critical care and hospital episode statistics database using local data collectors. Follow-up mortality outcomes would also not be possible due to the strain on resources. Without this information PQIP would not be able to meet its stated aims and objectives. The NHS Digital data dissemination has supported PQIP in meeting these aims. Some of the analyses will be undertaken in support of PhD / postgraduate research fellow studies Continued benefits include: • Local quality improvement – improvement in processes and outcomes at a local level. Produced by regular quarterly feedback of hospital level data to NHS trusts taking part in PQIP. Two annual collaborative events were held in 2018 and another in 2019. • Supporting the development of local quality improvement collaboratives. • Dissemination o Hospital levels reports (produced every 3 months) o Annual reports – produced in 2018, 2019 and 2021 o Publications in medical literature 1.5 million patients undergo major surgery each year. By reducing complication and hospital length of stay there are potential benefits to the whole of the NHS. Cost savings by reducing length of stay by 1 day for only 100,000 patients (<10% of those eligible) would amount to £40 million per year. The benefit will to individual NHS trusts and to the NHS as a whole. Outputs have supported the increase in NHS trusts taking part in PQIP. The study now has over 150 hospitals taking part, having recruited almost 32,000 patients to date.

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

Datasets: − HES-ID to MPS-ID HES Admitted Patient Care

Objective for processing

Perioperative Quality Improvement Programme (PQIP) is a new study run by the National Institute of Academic Anaesthesia, Health Services Research [9 words unchanged] and the Health Foundation, with a planned initial duration of 5 years. [2 paragraphs unchanged] RCoA will collect objective risk, process and outcome data on patients during [17 words unchanged] their planned operation. By linking to Hospital Episode Statistics (HES) data and Office of National Statistics (ONS) mortality data at record level RCoA will be able to analyse a [17 words unchanged] readmission within 30/90 days of surgery - from HES data; longer term mortality - from ONS). mortality). [11 paragraphs unchanged] The data processing described within this agreement is to support the organisations legitimate Interests of scientific and statistical research as set out in this section. The legal basis for processing personal data is: "Article 6.1 (f) Legitimate interests: (processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party except where such interests are overridden by the interests of fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child)." The “legitimate interests” are of healthcare research. This is because the data processing described here is to support scientific and statistical research. For the particular focus of this application - Perioperative Quality Improvement Programme (PQIP) the processing is necessary. Research – PQIP: The study will measure risk-adjusted morbidity and mortality in patients undergoing major surgery. The PQIP study is also investigating whether the quality of care for patients undergoing surgery in NHS Hospitals can be improved through the feedback of data to clinicians and managers, leading to improvements in post-operative complications and failure to rescue. The Royal College of Anaethetists (RCoA) is a Registered Charity with the Charities Commission (Reg Number: 1013887) and is subject to the Charities Act 2011. Chapter 1, Section 4 of the Charities Act establishes that the nature of a charity is to operate for the public benefit if it is for charitable purposes. The purpose of medical research is compatible with the purposes defined within Chapter 3, Section 1(d) of the Charities Act for the advancement of health or for the saving of lives, paragraph 3(b) states that this includes the prevention or relief sickness disease or human suffering (http://www.legislation.gov.uk/ukpga/2011/25/section/3). In further guidance from the Charities Commission in relation to purposes, Section 6 states that the purposes extend beyond the treatment or provision of care, and includes Health Research charities https://www.gov.uk/government/publications/charitable-purposes. The Commission also states that the Charity must also clearly define its purposes within its governance documents or ‘objects’ and the charity must be registered with the Charities Commission and its registration can be checked on-line, the purposes of the charity are also defined within its registration. (https://www.gov.uk/government/collections/charitable-purposes-and-public-benefit). The IGA GDPR guidance on lawful processing, Section 7 states that when relying on legitimate interests for medical research this should be compatible with the HRA guidance on lawful processing for research purposes https://digital.nhs.uk/binaries/content/assets/legacy/pdf/3/p/igagdprprocessing.pdf, the HRA GDPR guidance states that commercial organisations and charities should rely on legitimate interests under GDPR for medical research. The RCoA state the following on their website about their purpose as an organisation: "The Royal College of Anaesthetists (RCoA) is the third largest Medical Royal College in the UK by membership. With a combined membership of 22,000 fellows and members, it represents and ensures the quality of patient care by safeguarding standards in the three specialties of anaesthesia, intensive care and pain medicine. The College is the professional body responsible for the specialty of anaesthesia throughout the UK at all stages of fellows and members careers. As anaesthetists, RCoA have overall responsibility for patients' wellbeing before, during and after surgery. RCoA are the lynchpin that holds secondary and tertiary care together and are the UK's largest hospital specialty. The College champions the diverse and critical work of anaesthetists, and the science that underpins their work. They recruit, train and examine anaesthetists to the most exacting standards. RCoA support their fellows and members throughout their careers irrelevant of age and region. RCoA fund research to ensure that anaesthesia continues to advance at a rapid rate. RCoA promote the sharing of knowledge and best practice, as well as working with government on crucial policies, and with other stakeholders in the UK and overseas to make sure that anaesthesia and anaesthetists play a central role in shaping and delivering the healthcare agenda. The College is the home of the Faculty of Pain Medicine and one of the eight parent Colleges of the Faculty of Intensive Care Medicine. RCoA are committed to supporting their combined membership of 22,000 fellows and members throughout their careers. The key areas of work include: • setting high standards of clinical care to ensure the constant rise in quality of patient care and safety • establishing the standards and curriculum for the training of anaesthetists, including examinations •the continued medical education of all practising anaesthetists to ensure their skills remain up-to-date • working collaboratively, through the National Institute of Academic Anaesthesia’s (NIAA) Health Services Research Centre (HSRC) to advance, fund and promote research activity acting as the voice of the specialty on behalf of the membership •professional and personal development to support the development of fellows’ and members’ careers and practice. •RCoA promote the sharing of knowledge and best practice working with government and other stakeholders in the UK and overseas to make sure that anaesthesia and anaesthetists play a central role in shaping and delivering the healthcare agenda The RCoA has conducted a legitimate interests assessment to confirm processing is necessary for the purposes of the legitimate interests. The RCoA 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.

Processing activities

[2 paragraphs unchanged] For the first data linkage the RCoA will send the file of patient identifiers and the PQIP ID to NHS Digital for linkage to HES and ONS mortality fields. Patients who RCoA supply identifiable data to NHS Digital for the linkage [20 words unchanged] this linkage does not involve identifiable data being shared or linked. No ONS mortality data is being requested for this second linkage. [6 paragraphs unchanged] For each patient in the file, NHS Digital will identify the matching ONS mortality or HES ID. NHS Digital will then return to the Royal College of Anaesthetists a ‘look-up’ file (L) containing only the PQIP identifier and the HES or ONS mortality ID identifiers, and a MATCH_RANK field which indicates the strength of the match. An extract of pseudonymised HES or ONS mortality data will then be requested from NHS Digital for all the list of IDs contained in file (L). The file (L) will be placed in the secure RCoA server accessible only to the project data manager. It will then be used to link the pseudonymised ONS mortality or HES data to the pseudonymised PQIP data for analysis. The pseudonymised [43 words unchanged] level data with small numbers suppressed in line with HES analysis guidelines. [2 paragraphs unchanged] RCoA will not link the HES/ONS HES/mortality data with any other dataset other than the PQIP data. Linkage with [7 words unchanged] a future application and would be supported by an appropriate legal basis. [4 paragraphs unchanged]

Expected output

[1 paragraph unchanged] The NHS Digital linked data will be used to produce quarterly/annual reports and academic outputs. These will also be reported via conference presentations and online video presentations. Quarterly reports will be are produced reporting type of surgery or and hospital level outcomes. These will be are targeted to specific groups involved within the PQIP research team (nurses, research team, anaesthetists, surgical team, and hospital managers). A full PQIP report and executive summary will be produced annually, with the first planned for March 2018 and subsequent releases annually. A full PQIP report and executive summary are to be produced on an annual basis. The following publications have been created: - Annual Report published in 2018, 2019 and 2021 (due to Covid the 2020 report was incorporated into the 2021 version) - Quarterly hospital reports provided to participants and available to download from the PQIP website [1 paragraph unchanged] In addition, research manuscripts using PQIP data will be submitted to open access peer reviewed journals. Wider dissemination to the surgical and anaesthetic profession will be is being achieved using the resources of the RCoA and other stakeholder Royal Colleges [24 words unchanged] multi-media approach and lay representation to ensure effective communication to the public. These include: - Publications in open access peer reviewed scientific journals In addition, other dissemination includes: - Face to face presentations - Online webinars - Live-action & animated video content on our own open-access Youtube - PQIP Collaborative event held in 2019 including presentations on the PQIP results and from local participants on their successes and challenges. channel - Conference presentations – Including at 2021 HSRC Conference where the recent PQIP report was launched - Social media - PQIP abstract competition held at the RCoA’s annual conference (2019 & 2021) - Conference presentations - Live-action & animated video content available to be viewed on the PQIP website - Professional literature e.g. Royal College of Anaesthetists’ literature - Quality Improvement information and tools available to be accessed on the PQIP website. Local participants are making use of this information and the PQIP data to develop their own local QI projects aimed at improving patient experience. RCoA will be submitting journals to Anaesthesia, British Journal of Anaesthesia, The New England Journal of Medicine, or The Lancet. There may also be publications to other journals that are produced using the PQIP data. The target dates for these publications will be in years 2-3 of the study onwards (November 2018-2019 onwards). - Sharing good practice by highlighting hospitals that have performed well across various PQIP measures. RCoA will be submitting journals to Anaesthesia, British Journal of Anaesthesia, The New England Journal of Medicine, or The Lancet. There may also be publications to other journals that are produced using the PQIP data.

Expected measurable benefits

PQIP will produce indicators that describe the standard of care for patients undergoing a variety of major surgical procedures throughout the UK. These indicators will identify NHS providers that are performing well and those needing to improve the quality of care provided to patients. The general landscape for patients having surgery in the NHS is even more challenging than ever before, because of waiting list growth and the risk of patients becoming more deconditioned while they wait for surgery. For this reason, there has never been a greater need for the type of improvements which PQIP is trying to promote. RCoA know the value of individualised risk assessment in shared decision making and perioperative planning, how DrEaMing within 24h is associated with reduced length of stay, and how really good pain management is associated with better processes and outcomes of care. Ongoing improvement through feedback of this data should lead to a reduction in the postoperative morbidity and mortality rates and thus an overall improvement in patient outcomes. Outcomes will be measured by ongoing data collection at hospital sites throughout the project duration and therefore regular 6-monthly data linkage would be required. It is hoped that the data collected will lead to steady, continuous improvement in care throughout the whole duration of PQIP, but within this period, a clear signal of improvement by the publication of the second annual report planned for March 2019 . PQIP produces indicators that describe the standard of care for patients undergoing a variety of major surgical procedures throughout the UK. These indicators will identify NHS providers that are performing well and those needing to improve the quality of care provided to patients. Ongoing improvement through feedback of this data is leading to a reduction in the postoperative morbidity and mortality rates and thus an overall improvement in patient outcomes. Outcomes will be measured by ongoing data collection at hospital sites throughout the project duration and therefore regular 6-monthly data linkage would be required. Data already collected is demonstrating a continuous improvement in care. Since the start of PQIP inpatient Length of Stay has reduced by over a day across a variety of specialties as is post operative morbidity. Length of stay for whole PQIP population has reduced from 8.9 days to 8.0 days. Day 7 morbidity has fallen from 28% to 19%. [2 paragraphs unchanged] PQIP has been designed as a quality improvement programme (based on work [76 words unchanged] against each other, instead choosing to look for continuous improvement from trusts. We RCoA will provide national references for metrics as that data becomes available. [1 paragraph unchanged] RCoA will report metrics PQIP have reported back to trusts, trusts improvement priorities and look for continuous improvement. As part of the qualitative research taking place within PQIP the study will assess quality improvement interventions undertaken by trusts, and offer provided local support for initiatives to improve quality. [1 paragraph unchanged] The initial planned quarterly reports will be made available to trusts taking part in PQIP. The format of larger annual reports is yet to be decided, but these are likely to be openly available. There is also a desire to make the quarterly reports openly available but RCoA are assessing the views of local teams. [1 paragraph unchanged] Continued improvement in hospital processes and outcomes based on the quarterly reports, and with comparison of national data is likely to continue to happen as a result of the outputs [1 paragraph unchanged]

Benefits reported

The project has continued to adapt and is pleased with how participation has held up and restarted as the affects of Covid subside. [4 paragraphs unchanged] RCoA are collaborating with clinical trials teams to run embedded studies to further improve the evidence base for what RCoA do – the first of these, Volatile vs Total intravenous Anaesthesia for major non-cardiac surgery: A pragmatic randomised trial (VITAL), will compare IV and inhalational anaesthesia in patients having major surgery in at least 40 NHS hospitals and starts recruiting in November 2021. [5 paragraphs unchanged] Future Potential Continued benefits include: • Local quality improvement – improvement in processes and outcomes at a [14 words unchanged] taking part in PQIP. Two annual collaborative events were held in 2018 with further planned for and another in 2019. [1 paragraph unchanged] • Dissemination – [1 paragraph unchanged] o Annual report reports – produced April 2018 (https://pqip.org.uk/FilesUploaded/PQIP%20Annual%20Report%202017-18.pdf) in 2018, 2019 and 2021 [2 paragraphs unchanged] The RCoA measure hospital processes and outcomes as part of the study. Hospital length of stay is directly collected, together with complication and mortality outcomes and all stated benefits will be achieved within the timescale of the PQIP study (planned to run until December 2021). Outputs have supported the increase in NHS trusts taking part in PQIP. The study now has over 150 hospitals taking part, having recruited almost 32,000 patients to date. Outputs have supported the increase in NHS trusts taking part in PQIP. The study now has over 100 hospitals taking part, having recruited over 15,000 patients to date. The annual report (https://pqip.org.uk/FilesUploaded/PQIP%20Annual%20Report%202017-18.pdf) gives and overview of national performance and quarterly hospital level reports provide rapid feedback on both process and outcomes to trusts and supports them in local QI work.