The access to and outcomes of elective joint replacement surgery for patients with long-term conditions: a study using PROMs and administrative data

Pseudonymised HES, Civil Registration and PROMS data was supplied to The Royal College of Surgeons of England by the Health and Social Care Information Centre (which has since become NHS Digital) for the purpose of a research study referred to as "The access to and outcomes of elective joint replacement surgery for patients with long-term conditions: a study using PROMs and administrative data "

This Data Sharing Agreement permits the retention of the data for an interim period but no other processing of the data is permitted.

Permission to retain the data for the interim period is a practical step to enable the study to comply with the necessary legal and ethical requirements. If, for any reason, it is not possible for the study to meet the necessary requirements, this Agreement will be terminated, and destruction of the data will be required.

The following information provides background information on the purpose of the original study. No new data will be released under this version of the agreement, and this agreement allows the applicant to hold and not otherwise process any further data that has already been disseminated.

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The objective for processing is to;

1. support a research study that aims to determine the access to and outcomes of elective hip and knee replacement surgery for patients with long-term conditions.

2. provide methodological analysis for use in the care of patients with long term conditions.

The Royal College of Surgeons of England (RCS) would like to investigate the access to and outcomes of elective hip and knee replacement surgery for patient with long-term conditions (LTC) who have participated in the PROMs programme using the PROMs, HES and ONS datasets.

PROMS data is only available for non-commercial purposes, such as academic research, or in connection with delivering services to the NHS.

There will be no attempts to re-link the data to identify participants in the study.

There will be no data linkage undertaken with NHS Digital data provided under this agreement that is not already noted in the agreement.

Data will only be accessed and processed by substantive employees of The Royal College of Surgeons of England and will not be accessed or processed by any other third parties not mentioned in this agreement.

There will be five work packages in this project;

1. the first will consist of a systematic review on the key topics of access to and outcomes of hip and knee replacement surgery.

2. Work package two consists of a qualitative study to understand the barriers and facilitators to accessing hip and knee replacement surgery for patients with long term conditions (LTCs)

3. Work package three will be to assess the validity of patient-reported LTCs against LTCs recorded in HES.

4. Work Package four will be to describe the variation in the access to and utilisation of hip and knee replacement surgery for patients with different LTCs.

5. The final work package will be to describe the variation in the outcomes of hip and knee replacement surgery for patients with different LTCS

For this study the RCS is requesting that NHS Digital link the PROMs datasets with the corresponding HES episode, historical HES episodes dating back to 2003 and mortality datasets. The data requested will be used in work packages 3,4 and 5 as described in the following;

PROMs data will be used for the validation work in work package 3 and for investigating variations in access and outcomes in packages 4 and 5. Historical HES data will allow the validation of the identification of long-term conditions in both PROMS and HES datasets and will lead to a better understanding of how reliably long-term conditions are recorded in HES (Work Package 3). This linkage will also allow the study of the patient outcomes after the hip and knee replacement surgery (Work Package 5). Lastly the linkage will also enable casemix adjustment for age, sex, ethnicity and socioeconomic status (Work Package 3-5). Linkage with mortality data will provide date of death and underlying cause of death for those patients in the PROMs dataset who were discharged from hospital alive (Work Package 5)

All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract ie: employees, agents and contractors of the Data Recipient who may have access to that data)” Under this Agreement, the data may be securely stored but not otherwise processed. No new data will be provided by NHS Digital under this Agreement.

Pseudonymised HES, Civil Registration and PROMS data was supplied to The Royal College of Surgeons of England by the Health and Social Care Information Centre (which has since become NHS Digital) for the purpose of a research study referred to as "The access to and outcomes of elective joint replacement surgery for patients with long-term conditions: a study using PROMs and administrative data "

This Data Sharing Agreement permits the retention of the data for an interim period but no other processing of the data is permitted.

Permission to retain the data for the interim period is a practical step to enable the study to comply with the necessary legal and ethical requirements. If, for any reason, it is not possible for the study to meet the necessary requirements, this Agreement will be terminated, and destruction of the data will be required.

Below is information provided by the applicant (The Royal College of Surgeons) on background to the study for details of previous disseminations, and also an insight into what is anticipated will happen once access to new data flows and permission to process data is granted in the future. As stated above - this version of the agreement permits retention of data only - permission is not granted to otherwise process the data at this stage until relevant documentation can be provided.

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There will be no data linkage undertaken with NHS Digital data provided under this agreement that is not already noted in the agreement.

Data will only be accessed and processed by substantive employees of The Royal College of Surgeons of England and will not be accessed or processed by any other third parties not mentioned in this agreement

The study data, including data provided by NHS Digital under previous agreements, are currently held by Royal College of Surgeons. Under this interim extension all devices containing data will be securely locked away in a locked cabinet at the The Royal College of Surgeons storage address specified in this Agreement.

The following provides background on the processing activities undertaken for the original study:

The Royal College of Surgeons of England (RCS) is requesting a bespoke data linkage of PROMs to corresponding HES episode, historical HES episodes dating back to 2003 and mortality data for patients who have participated in the PROMs programme and who underwent a hip or knee replacement surgery.

The process will involve:

1. NHS Digital provide the RCS a bespoke data extract of PROMs data linked to the corresponding HES episode, linked to historical HES admissions and subsequent HES admissions, and finally also linked to mortality data all linked by encrypted HESID.

2. Extract will be received by the RCS by file transfer and stored on the RCS secure server.

3. The historic HES records of patients will be used to locate patients with long-term conditions.

4. Subsequent HES episodes will be used to identify patient outcomes.

5. A single patient-level dataset for the PROMs cohort will be created including long-term conditions and outcomes. The main analysis will be on this patient-level dataset. No other data will be used or linked to the data provided by NHS Digital.

The data analysis will be completed at The Clinical Effectiveness Unit (https://www.rcseng.ac.uk/standards-and-research/research/clinical-effectiveness-unit/) at RCS by the three people listed in this document; these are the only people who will have access to the data.

The Clinical Effectiveness Unit at the Royal College of Surgeons of England is an academic collaboration with the Health Services Research & Policy department (formerly Health Services Research Unit) at London School of Hygiene and Tropical Medicine. Only substantive employees of the Royal College of Surgeons and one member of the team with honorary contract with the Royal College of Surgeons has access to the data and will only use it for the purposes described in this document. The data manager and controller, is substantively employed by the CEU at the Royal College of Surgeons. The data will be managed, controlled and analysed exclusively at the Royal College of Surgeons. The project as a whole is sponsored by the London School of Hygiene and Tropical Medicine. The project is funded by the National Institute of Health Research (NIHR) Collaborations for Leadership in Applied Health Research and Care (CLAHRC) North Thames.

The data will not be linked to any other dataset held at RCS.

After undertaking statistical analysis, outputs will be in the form of tables containing aggregated data with small numbers suppressed in line with the HES Analysis Guide.

Pseudonymised HES, Civil Registration and PROMS data was supplied to The Royal College of Surgeons of England by the Health and Social Care Information Centre (which has since become NHS Digital) for the purpose of a research study referred to as "The access to and outcomes of elective joint replacement surgery for patients with long-term conditions: a study using PROMs and administrative data "

This Data Sharing Agreement permits the retention of the data for an interim period but no other processing of the data is permitted.

Permission to retain the data for the interim period is a practical step to enable the study to comply with the necessary legal and ethical requirements. If, for any reason, it is not possible for the study to meet the necessary requirements, this Agreement will be terminated, and destruction of the data will be required.

No further outputs of the data are permitted to be created under this version of the agreement. Outputs will only be permitted to be created once a new agreement that meets all of NHS Digital's legal, ethical and security requirements is in place.

The below provides background on to what has already been produced, and what will be produced once data flow and permission to process resumes.

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All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide

The main forms of dissemination will be through the publication of research articles in academic journals. Results will also be disseminated by presentation at relevant conferences. Outputs will also be disseminated through the NIHR CLAHRC North Thames. The CLAHRC as part of the National Institute for Health Research, use the skills, knowledge and expertise of researchers, health and social care professionals, managers, commissioners and patients to conduct high quality research projects to find new ways of improving healthcare. Its' aim is to ensure the results of the research are translated quickly and effectively into benefits for patients, the wider NHS and social care. Outputs will also be made freely accessible to the general public.

Academic articles:

1. Assessing the agreement between patient-reported and HES recorded comorbidity. (Published in 2019)

2. Publication of a paper describing the findings from the analysis of the severity of symptoms and duration of symptoms at time of surgery for patients with different long-term conditions. (January 2020)

3. Publication of a paper describing the findings from the analysis of outcomes for patients with different long-term conditions (January 2020)

4. Publication of a paper assessing the validity of patient-reported long-term conditions (December 2020)

5. Publication of a paper assessing the prevalence of multi-morbidity and the impact on preoperative severity (September 2020)

6. Publication of a paper assessing the impact of multi-morbidity on outcomes (September 2020)

This research provides methodological output for the 'methodological innovations ' which is one of the 5 broad research themes of the CLAHRC North Thames. This is research investigating novel ways of carrying out research to improve the way in which researchers work, for the benefit of patients, the public and the NHS. By addressing known methodological limitations in the way applied health research is currently carried out, this theme works to develop and test novel methods to enhance the efficiency, timeliness and usefulness of applied health research.

In summary, the findings will be presented to academic bodies through attending academic and clinical conferences and through academic publications to engage with other academics, orthopaedic surgeons, physiotherapists and General Practitioners. In addition the findings will be disseminated through the NIHR CLAHRC North Thames, the funders of this study, and whose key priority is to translate applied health research into direct impact on the health of patients with long term conditions and on the health of the public. This involves regularly presenting to healthcare professionals, patients and the public in the NIHR CLAHRC North Thames geography (including a patient and public involvement research advisory panel). A poster on this study has already been presented at the last NIHR CLAHRC North Thames Showcase. The findings will also be shared with NHS England and other commissioners as this will directly inform current challenges relating to access to elective joint replacement surgery in the NHS as reported in the media (e.g. http://www.bbc.co.uk/news/uk-england-hereford-worcester-38770046). Lastly, the findings will be published on the NIHR CLAHRC North Thames, London School of Hygiene and Tropical Medicine and the Royal College of Surgeons of England website.

A PhD thesis has also been an output.

Pseudonymised HES, Civil Registration and PROMS data was supplied to The Royal College of Surgeons of England by the Health and Social Care Information Centre (which has since become NHS Digital) for the purpose of a research study referred to as "The access to and outcomes of elective joint replacement surgery for patients with long-term conditions: a study using PROMs and administrative data "

This Data Sharing Agreement permits the retention of the data for an interim period but no other processing of the data is permitted.

Permission to retain the data for the interim period is a practical step to enable the study to comply with the necessary legal and ethical requirements. If, for any reason, it is not possible for the study to meet the necessary requirements, this Agreement will be terminated, and destruction of the data will be required.

No further outputs of the data are permitted to be created under this version of the agreement. Outputs will only be permitted to be created once a new agreement that meets all of NHS Digital's legal, ethical and security requirements is in place.

The following information provides background information on the benefits of the original dissemination. No new data will be released under this version of the agreement, and this agreement allows the applicant to hold and not otherwise process any further data that has already been disseminated.

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This project investigates the impact of long-term conditions and multimorbidity on access and outcomes of joint replacement as an example of elective surgery. The research is funded by the NIHR CLAHRC North Thames and forms part of the NIHR CLAHRC North Thames’s Methodological Innovation Theme where multimorbidity is a priority as it is increasingly prevalent given the ageing of the population.

The methodological theme has five strategic priorities and this project addresses two of them: using data sources from patients to investigate outcomes and using linkage of data to enable research relevant to the increasingly complex pathways for patients within the NHS.

The project has a number of key objectives. First, this study will for the first time validate an instrument identifying comorbidities reported by patients against administrative hospital data. Several patient-reported comorbidity instruments exist but no instrument has been validated. Therefore this validation study will be a key methodological achievement as it will provide a robust approach for studies addressing the issues of multimorbidity.

Second, the project will also produce outputs highlighting potential inequalities in access to elective surgery – partly by using the validated patient-reported morbidities. It is important to know to what extent general practitioners and surgeons are influenced by long-term conditions when they decide whether or not to recommend surgery for patients. This project will provide insight in current practice and in that way inform recommendation to ensure that all patients who have the capacity to benefit, irrespective of age and presence of long-term conditions, will be able to have access to elective surgical care.

Third, the project will also provide further insight into the impact of long-term conditions on the outcomes of orthopaedic surgery which will further help to refine recommendation for the indication of orthopaedic surgery in patients with long-term conditions and evaluate the risks and benefits of the surgery.

Fourth, the project is also a case study that would allow an investigation of the issues that need to be overcome when data from a number of different sources is linked at the patient level.

In summary, the outputs of the project will be of immediate benefit for patients in the NHS as it will strengthen the methodological approach to address the issues related to the care for patients with long-term conditions, and issues which is likely to be increasingly relevant in the years to come. The outputs will also be of immediate benefit for patients in the NHS as it will inform clinical guidelines on how to prepare patients with long-term conditions for joint replacement surgery. It will also inform clinical guidelines on clinical indication for joint replacement surgery for patients by exploring the risks and benefits of the surgery for individual comorbidities and multimorbidity in the UK thereby reducing clinical variation and improving access. Currently clinical guidelines for patients with long-term conditions undergoing joint replacement surgery is limited. Outputs of this project will also be used by other researchers within the NIHR CLAHRC North Thames, within the NHS and by other research groups abroad involved in health services research and service evaluation.

As the project is funded by the NIHR CLAHRC North Thames, the findings and recommendations have been disseminated through the CLAHRC North Thames network to enable commissioners and policy makers to raise standards of care for patients with long-term conditions in need of joint replacement surgery and will continue to be. The methodological findings in using the PROMS linked HES/Mortality data will also be of benefit to future use of the data in health research for the benefit of patients and the healthcare system.

Pseudonymised HES, Civil Registration and PROMS data was supplied to The Royal College of Surgeons of England by the Health and Social Care Information Centre (which has since become NHS Digital) for the purpose of a research study referred to as "The access to and outcomes of elective joint replacement surgery for patients with long-term conditions: a study using PROMs and administrative data "

This Data Sharing Agreement permits the retention of the data for an interim period but no other processing of the data is permitted.

Permission to retain the data for the interim period is a practical step to enable the study to comply with the necessary legal and ethical requirements. If, for any reason, it is not possible for the study to meet the necessary requirements, this Agreement will be terminated, and destruction of the data will be required.

No further outputs of the data are permitted to be created under this version of the agreement. Outputs will only be permitted to be created once a new agreement that meets all of NHS Digital's legal, ethical and security requirements is in place.

The following information provides background information on the benefits of the original dissemination. No new data will be released under this version of the agreement, and this agreement allows the applicant to hold and not otherwise process any further data that has already been disseminated.

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The yielded benefits to date are the following:

- Of the five planned papers, three have been published, two have been submitted, one has been drafted and two planned. Two of the published papers are preparatory work: A systematic review and a qualitative study that have informed the rest of the papers.

- A PhD thesis has been completed and published online in January 2019 on the LSHTM online and the British Library. https://doi.org/10.17037/PUBS.04653866

- Presentations at two conferences in 2017, 2018 and 2019: Health Service Research UK and Advances in Patient Reported Outcomes Research.

- Participation in the NICE scoping guidelines workshop for the updated guidelines on Hip, Knee and Shoulder joint replacement. The aim of the NICE scoping guidelines workshop was to decide on the topics that would be covered in the updated guideline. This study provided the evidence for the need for further guidance on clinical indication for hip and knee replacement surgery and generally on the clinical pathway to hip and knee replacement surgery from primary care to surgical consultation. Further guidance will ensure there is less variation in the access to care for patients in need of hip or knee replacement surgery.