Patient outcomes and NHS costs following primary hip and knee replacement surgery

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

Objective for processing

[1 paragraph unchanged] The BHDG has originally received the linked data under a separate Data Sharing Agreement (ref: DARS-NIC-366845-Q1F0Q) for the purposes of two unrelated studies called STAR and ATLAS respectively. This data will was to be reused for two further studies called UKSAFE and UTMoST respectively. UTMoST. Although the Principal Investigators of the studies are different, the same individuals (statisticians and a health economist), all of whom are substantive employees of the University of Oxford, will undertake both the UK SAFE and UTMoST studies at the Botnar Research Centre at the Nuffield Department of Orthopaedic, Rheumatology & Musculoskeletal Science (NDORMS). The work on both the UK SAFE and UTMoST studies is being undertaken by individuals from the Big Health Data Group, of the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), at the University of Oxford. For both the UKSAFE and UTMOST studies, all of the statistical and health economic analyses have been completed. The final study report for UTMOST has been submitted and accepted. The final study report for UKSAFE has been written and submitted to the funder (NIHR Health Services & Delivery Research programme). Academic papers have been drafted and submitted for publication in academic journals for both UTMOST and UKSAFE. Although all of the statistical and health economic analyses have been completed, the final study report (UKSAFE only) and academic papers (both UTMOST and UKSAFE) are currently in submission with the funder and academic journals. Once external peer review of the outputs has been completed, any requested changes to the outputs will be completed before publication. The data is therefore still needed to facilitate these changes. UK SAFE- EVIDENCE BASED COST-EFFECTIVE HIP AND KNEE ARTHROPLASTY FOLLOW-UP CARE PATHWAYS The University of Oxford relies on GDPR Article 6(1)(e) and Artile 9(2)(j) as the lawful basis for processing data for this research. There is public interest from patients undergoing knee replacement surgery. Most people now understand the need for a cost-effective NHS but seek reassurance that this will not reduce the standard of care. This is particularly true of older people, who are the group most likely to be affected by this research. The UTMoST research will help by providing information on the comparative risks, benefit (patient-reported outcomes), and cost of partial / unicompartmental knee replacement (UKR) and total knee replacement (TKR) for patients with multiple co-morbid conditions. If, as expected, UKR is safer, as effective, less costly, and thus more cost-effective than TKR for this specific patient group, it might become the first line surgical solution for severe knee arthritis in multi-morbid patients. The BDHG would then inform NICE and the Medicine and Healthcare products Regulatory Authority (MHRA) of the findings with the aim to impact on future guidelines for the treatment of severe knee arthritis. Depending on the study results, the BDHG would –if relevant- produce UK guidance documents and information leaflets for patients and health care professionals in both primary and secondary care involved in this area. This The UKSAFE research project seeks to demonstrate that good aftercare is not necessarily expensive, in terms [22 words unchanged] potential problems in a timely fashion, to the benefit of all concerned. Total joint replacement provides considerable improvement in quality of life to people suffering with severe joint damage and in 2013 over 150,000 total hip and knee replacements were conducted. Due to increasing ageing and obesity in the UK population, this number is likely to increase each year. Sometimes, problems can develop with the replaced joint over time and a small percentage of people require further surgery. Because joint failure is not always associated with symptoms, follow-up care is provided to ensure that problems are identified as early as possible. This study looks at the routine data from the National Joint Registry on a large group of people admitted for revision surgery. Using PROMs data, the study looks at how people came to be admitted to hospital for revision surgery, their symptoms and previous hospital visits and then compare for those who needed emergency surgery, with those who have more timely revision surgery. This will help to understand when people are most likely to develop problems with their joint replacement and to identify whether some are more likely to develop problems than others. As described above there is significant public interest from patients undergoing joint replacement surgery and the scientific research project will therefore rely on article 9 (2)(j). Only the minimum data required for the project has been requested. Providing this care for everyone in the years after their surgery is extremely expensive and the NHS is under increasing pressure to reduce its costs. Many hospitals have dramatically reduced the amount of follow-up provided and some provide no follow-up at all. There is very little research evidence to determine whether not providing follow-up care may be causing harm to people by missing the opportunity to pick up a problem with a replaced joint before serious damage occurs. The moral and ethical issues include the processing of patient data without consent and the risk of breach of patient confidentiality processing of records. These issues have been addressed through CAG Section 251 support. UK SAFE is a wider program of research funded by the NIHR Health Services & Delivery Research (HS&DR) and managed by the Leeds Biomedical Research Centre that covers four work packages. The principal investigator for the UK SAFE study is at University of Leeds. The investigator at the University of Oxford was a co-applicant on the grant and is leading work package 2a which will be using data from the NJR-HES-PROMS. This work package is being completed solely by the team at University of Oxford and University of Oxford is the sole data controller. The University of Oxford has sole autonomy for work package 2a and, as co-applicant on the grant, independently determined the purpose for and the means of data processing. Leeds BRC cannot direct or instruct any purpose or means for processing the data. To minimise risk, the University of Oxford only has access to pseudonymised records and will also suppress data on small volume groups in dissemination of study results to prevent re-identification. This study will enable University of Oxford’s BHDG to look at the routine data from the National Joint Registry on a large group of people admitted for revision surgery. Using PROMs data, the study will look at how people came to be admitted to hospital for revision surgery, their symptoms and previous hospital visits and then compare for those who needed emergency surgery, with those who have more timely revision surgery. This will help to understand when people are most likely to develop problems with their joint replacement and to identify whether some are more likely to develop problems than others. Access to the data has allowed researchers to analyse outcomes of interest and provide important information on hip and knee replacement surgeries. The outcomes of interest are patient-reported outcome measures, quality of life measures, mortality, revisions, re-operations and healthcare resource utilisation. It is vital that a decision to stop providing follow-up is not made just to save costs to the NHS, but is based on precise evidence, which includes understanding potential benefit and harm to people. The UTMoST project will complement the results of the NIHR HTA-funded TOPKAT RCT, (Total or Partial Knee Arthroplasty Trial) where unicompartmental knee replacement (UKR) is compared to total knee replacement (TKR). The UTMoST project assesses the risks, benefits and costs of these two alternative surgical procedures amongst the NHS patients with multiple co-morbidities (the simultaneous presence of two or more diseases or medical conditions in a patient) who were not eligible for TOPKAT according to the listed inclusion/exclusion criteria. The study will have a clear impact on and benefits for the public and the NHS, as well as for clinical research funders including NIHR by providing information on the comparative risks, benefits (patient-reported outcomes), costs, and cost-effectiveness of partial and total knee replacement for patients with multiple co-morbid conditions. This NIHR funded project is designed to address how to improve productivity within NHS services; ensure that the right care is delivered in the right settings; develop new, innovative ways of developing health care and allocating spending more rationally. The areas of research that the study will address will help identify mechanisms to close the NHS funding gap whilst ensuring that the interests of patients remain protected and that the standard of service provision is not compromised as prioritised by Monitor. The University of Oxford’s BHDG will replicate TOPKAT by analysing the association between unicompartmental knee replacement (UKR) (compared to total knee replacement (TKR)) and post-operative patient reported outcomes (PROMs) and cost-effectiveness estimates amongst participants in the National Joint Registry (NJR) eligible for TOPKAT (ASA grade <3 - ASA is the physical status classification system for assessing the fitness of patients before surgery, where 1 is “fit and healthy” and 5 is “not expected to survive”) using different analytical methods and then test for a difference between the obtained estimates and TOPKAT. This was validated, and so the same methods were used to study the benefits (PROMs), risks (revision, complications), mortality, costs and cost-effectiveness of UKR (compared to TKR) amongst NJR participants not eligible for TOPKAT (ASA 3+). At the end of the study an expert panel, including individuals who have undergone joint replacement, will consider the results to develop guidelines about how follow-up should be conducted to ensure no harm is caused. UK SAFE (Towards UK Post Arthroplasty Follow-up Recommendations) is a wider program of research funded by the NIHR Health Services & Delivery Research (HS&DR) and managed by the Leeds Biomedical Research Centre that covers four work packages. The principal investigator for the UK SAFE study is at the University of Leeds. The investigator at the University of Oxford was a co-applicant on the grant and is leading work package 2a which will be using data from the NJR-HES-PROMS. This work package is being completed solely by the team at University of Oxford and University of Oxford is the sole data controller. The University of Oxford has sole autonomy for work package 2a and, as co-applicant on the grant, independently determined the purpose for and the means of data processing. Leeds BRC cannot direct or instruct any purpose or means for processing the data. UTMoST- RISK-BENEFIT AND COSTS OF UNICOMPARTMENTAL (COMPARED TO TOTAL) KNEE REPLACEMENT FOR PATIENTS WITH MULTIPLE CO-MORBIDITIES: A NON-RANDOMISED STUDY, AND DIFFERENT NOVEL APPROACHES TO MINIMISE CONFOUNDING This study will enable University of Oxford’s BHDG to look at the routine data from the NJR on a large group of people admitted for revision surgery. Using PROMs data, the study looks at how people came to be admitted to hospital for revision surgery, their symptoms and previous hospital visits and then compare for those who needed emergency surgery, with those who have more timely revision surgery. This will help to understand when people are most likely to develop problems with their joint replacement and to identify whether some are more likely to develop problems than others. Surgical randomised controlled trials (RCTs) are the gold standard in research methodology. However, despite recent evidence suggesting that surgical RCTs are both safe and useful, they remain uncommon for a number of reasons, including costs, time, ethical concerns, surgeon equipoise, and feasibility. The cohort consists of all patients over 18 years of age receiving primary elective hip or knee replacement surgery. Patients are included if they had primary total hip (THR) or knee (TKR) replacement, primary hip resurfacing (MoMHR), or uni-compartmental knee replacement (UKR). Non-randomised studies relying on routinely collected data, could offer an efficient alternative for the comparative assessment of surgical interventions in the National Health Service (NHS). In addition, these studies offer results which are potentially generalizable to the whole population of real world NHS patients (regardless of comorbidities or age) including patients who would have been excluded in RCTs, and they can be conducted at a much lower cost as well as within a shorter time. However, observational studies are limited by confounding and related bias due to the non-random allocation of treatment alternatives. The UTMOST project assesses the risks, benefits, costs, and cost-effectiveness of unicompartmental (UKR) in comparison to total knee replacement (TKR) amongst NHS patients with multiple co-morbidities using different analytical methods and then test for a difference between the obtained estimates and TOPKAT. As previously stated the same methods were used to study the benefits (PROMs), risks (revision, complications), mortality, costs and cost-effectiveness of UKR (compared to TKR) amongst NJR participants not eligible for TOPKAT (ASA 3+). The University of Oxford is currently running a larger and very expansive randomised controlled trial called TOPKAT. This NIHR HTA-funded RCT is a multi-centre randomised trial to measure the clinical effectiveness and cost effectiveness of total and partial knee replacement for medial compartmental osteoarthritis. Because of its restrictive eligibility criteria, the TOPKAT RCT involves comparatively healthier participants rather than patients with more severe comorbidities. For this reason, it is unclear whether the findings of TOPKAT will have external validity to the large number of patients with multiple co-morbidities (1 in 6 according to National Joint Registry data). The UKSAFE project uses data to identify people who have had hip and knee replacement surgery and uses PROMs data to look at how they came to be admitted to hospital for revision surgery, their symptoms and previous hospital visits and then compare for those who needed emergency surgery, with those who have more timely revision surgery. This will help to understand when people are most likely to develop problems with their joint replacement and to identify whether some are more likely to develop problems than others. The University of Oxfords BHDG will replicate TOPKAT by analysing the association between unicompartmental knee replacement (UKR) (compared to total knee replacement (TKR)) and post-operative patient reported outcomes (PROMs) amongst participants in the National Joint Registry (NJR) eligible for TOPKAT (ASA grade <3 - ASA is the physical status classification system for assessing the fitness of patients before surgery) using different analytical methods and then test for a difference between the obtained estimates and TOPKAT. If validated, the same method will be used to study the benefits (PROMs), risks (revision, complications), mortality, costs and cost-effectiveness of UKR (compared to TKR) amongst NJR participants not eligible for TOPKAT (ASA 3+). The University of Oxford requires Hospital Episode Statistics (HES) and Patient Reported Outcome Measures (PROMs) linked to data from the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man. The UTMoST project will complement the results of the NIHR HTA-funded TOPKAT RCT, where unicompartmental (UKR) is compared to total knee replacement (TKR). The UTMoST will assess the risks, benefits and costs of these two alternative surgical procedures amongst the NHS patients with multiple co-morbidities who were not eligible for TOPKAT according to the listed inclusion/exclusion criteria. The study will have a clear impact on and benefits for the public and the NHS, as well as for clinical research funders including NIHR by providing information on the comparative risks, benefits (patient-reported outcomes), and cost of partial and total knee replacement for patients with multiple co-morbid conditions. -HES is required to identify hip and knee replacement procedures, and provide data on both outcomes and predictors -PROMS is required to identify patient-reported outcomes and predictors for outcome. The data requested is pseudonymised, patient-level data and is required in order to support statistical analyses to identify associations to outcomes and for reference after external review of submitted publications. Starting in 2003, the National Joint Registry (NJR) collects information on all hip and knee replacements performed each year in both public and private hospitals in England, Wales, Northern Ireland and the Isle of Man. Since April 2008, Patient-Reported Outcome Measures (PROM) data have been collected on hip and knee replacements performed in public hospitals in England. University of Oxford are therefore restricting the years of data requested to be from April 2008 until December 2016, to only include data for which there are liked PROMS outcomes. The primary outcome for the UKSAFE study is the Oxford Knee Score (part of the PROMS data collection) and hence University of Oxford require data for all years PROMS data have been collected. For the UKSAFE study, the primary outcome of interest is mid-late term revision (defined as more than 5 years post primary surgery) and hence data up till end of 2016 is needed to ensure sufficient follow up of patients and obtain data on these longer term outcomes. Both projects are interested in national practices to ensure there is generalisability of the study findings to all patients across England. If data had been restricted to a specific local area, policy makers may deem that the findings were not generalisable across other areas of the country, and hence limit the potential impact and public benefit of the studies' findings. Record level data is needed in order to conduct the statistical analyses for the UTMOST and UKSAFE studies. For the UTMOST study, regression modelling is used to adjust the analyses for patient case-mix and confounding variables, and this require the use of record level data. For the UKSAFE study, regression modelling is used to identify variables that are predictive of mid-late term revision outcomes, and these analyses require record level data. It would not be possible to achieve the aims of the UTMOST and UKSAFE studies with tabulated data. To confirm, this analysis is complete but may need to be reviewed after external peer review that is currently taking place. Data have been minimised to only include patients receiving primary hip and knee replacement surgery. Data have been further minimised by only requesting data for the years 2008 to 2016. The data only includes patients aged 18 years or over. The work is being undertaken by individuals from the Big Health Data Group, of the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, at the University of Oxford. This work requires HES and PROMS data which is controlled by NHS Digital to be linked to National Joint Registry (NJR) data - for which Healthcare Quality Improvement Partnership (HQIP) is the data controller - and is supplied by HQIP's data processor, Northgate Information Solutions. All data accessible to the team at the University of Oxford is pseudonymised. Northgate Information Solutions will have no access to NHS Digital data under this Agreement. UTMOST project will complement the results of the NIHR HTA-funded TOPKAT RCT, where unicompartmental knee replacement (UKR) is compared to total knee replacement (TKR) but the TOPKAT team have no involvement in the project. UK SAFE is funded by the NIHR Health Services & Delivery Research. UTMoST is funded by NIHR Health Technology Assessment Efficient Study Designs Programme. The University of Oxford has now completed all of statistical and health economic analyses for both the UTMOST and UKSAFE studies. However, the final study report and academic papers are currently in submission with the funder and academic journals. The University of Oxford requires continued data access to be able to make any changes to the analyses following external peer review. This is vital to enable the University of Oxford to fully publish the findings from these studies. Extending this Data Sharing Agreement will allow sufficient time for external peer review of the outputs of this study, for publication in academic journals, and publication of the final study report in the NIHR journal.

Processing activities

NDORMS will forward The Nuffield Department of Orthopaedic, Rheumatology & Musculoskeletal Science (NDORMS) previously forwarded to NHS Digital via a Secure Electronic File Transfer (SEFT) account from their current dataset and data NIC-366845-Q1F0Q. NHS Digital will reidentify then reidentified them, apply objections applied the latest national data opt-outs and return returned a cleaned list of HESIDs. NDORMS can then extract extracted only the data linked to those HESIDs HESIDs, thereby applying current patient objections. opt-outs to the datasets to be analysed under this Agreement. The linked NJR, HES and PROMS datasets are held on a password protected University Computer on an encrypted drive at the Botnar Research Centre, Nuffield Department of Orthopaedic, Rheumatology & Musculoskeletal Science (NDORMS). NDORMS. [1 paragraph unchanged] The BHDG has received pseudonymised HES and PROMS PROMs data under a separate Data Sharing Agreement (ref: DARS-NIC-366845-Q1F0Q) which are linked with pseudnoymised pseudonymised NJR data for the purposes of two unrelated studies called STAR and ATLAS respectively. The BHDG will was previously permitted to take copies of some of that data to reuse them for the purposes of the UK SAFE and UTMoST studies studies, respectively. The detailed process to do this is was as follows: 1. From the dataset that the University of Oxford is authorised to hold and process under the Data Sharing Agreement DARS-NIC-366845-Q1F0Q, the encrypted HESIDs will be was extracted and supplied to NHS Digital. 2. NHS Digital will decrypt decrypted those IDs to identify the individuals. 3. NHS Digital will apply applied national patient opt-outs to this list of patients. The data of any individual who has had registered a Type 2 objection/patient opt out since the data was supplied under DARS-NIC-366845-Q1F0Q will be was removed. 4. NHS Digital will remove removed all identifiers; re-encrypt re-encrypted the HESIDs using the same encryption key as for DARS-NIC-366845-Q1F0Q, and provide provided the list of HESIDs, as pseudo-anonymised data, to the University of Oxford. 5. The University of Oxford would extract extracted a copy of the linked HES, PROMS and NJR supplied under DARS-NIC-366845-Q1F0Q for all individuals whose data is was included in the output file from NHS Digital. The resulting dataset will be is stored separately from the dataset supplied under DARS-NIC-366845-Q1F0Q with access controls ensuring the two will not be linked or accessed together. The same fields of data are required for both studies and the knee replacement data will be has been used in both but the hip replacement data will has only be been used for UK SAFE. The data will be used exclusively for the [27 words unchanged] held in a password protected University Computer at the Botnar Research Centre, NDORMS for a further 5 years, and accessed only to answer questions arising from the publication and other publicity if required. Only individuals, substantively employed by the University of Oxford, will have access to the data. The processing of the requested data will be carried out in the course of its legitimate activities by a University of Oxford research team which has a longstanding experience in orthopaedic outcomes. There will be no linkage to any publicly available data. All outputs will be aggregated with small numbers suppressed in line with the HES analysis guide. No record level data falling under this agreement will be shared with any third-party. There will be no requirement or attempt to re-identify individuals. All organisations party to this Agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract – i.e. employees, agents and contractors of the Data Recipient who may have access to that data. Only individuals, substantively employed by the University of Oxford, will have access to the data. All researchers have completed mandatory, annual University of Oxford Information Security module which covers data protection and confidentiality. All researchers have completed induction to the secure data room with the NDORMS Information Governance Manager. The data will be stored in a secure data room at the Botnar Research Centre with strict access controls. Data are encrypted and stored in a safe. Data are accessed on non-networked computers.

Expected output

UK SAFE- EVIDENCE BASED COST-EFFECTIVE HIP AND KNEE ARTHROPLASTY FOLLOW-UP CARE PATHWAYS The UKSAFE project will deliver the first research-supported, best-for-patient, joint-specific, cost-effective recommendations for follow-up care, providing a gold standard for clinical excellence, and follow-up advice for patients, surgeons, purchasers and health services. Value is not limited to the UK, but has massive global potential. This project will deliver the first research-supported, best-for-patient, joint-specific, cost-effective recommendations for follow-up care, providing a gold standard for clinical excellence, and follow-up advice for patients, surgeons, purchasers and health services. Value is not limited to the UK, but has massive global potential. [3 paragraphs unchanged] Overall findings and findings from individual work-packages will be disseminated through a [39 words unchanged] present at the NIHR Methodology Conference and NHS Management conferences and events. Manuscripts will be submitted to appropriate peer-reviewed journals, including general medical, orthopaedic and management journals. Patient dissemination will be supported through the Leeds Musculoskeletal Biomedical Research Unit (LMBRU) PPI forum and website and the strong ties with Arthritis Care of the applicant within the University. The BDHG will hold a PPI conference at the end of the study. The BDHG will encourage their PPI representatives to be involved in presentations, with support from research staff, and they will help to ensure conference material is appropriate. Working with the lay representatives, the BDHG will write a lay summary for publication in a patient publication such as The Patient or Inspire. Manuscripts are currently in submission with appropriate peer-reviewed journals, including general medical, orthopaedic and management journals. The target date is 36 months following receipt of data. Patient dissemination will be supported through the Leeds Musculoskeletal Biomedical Research Unit (LMBRU) PPI forum and website and the strong ties with Arthritis Care of the applicant within the University. The BDHG will hold a PPI conference at the end of the study. The BDHG will encourage their PPI representatives to be involved in presentations, with support from research staff, and they will help to ensure conference material is appropriate. Working with the lay representatives, the BDHG will write a lay summary for publication in a patient publication such as The Patient or Inspire. The expected date of this dissemination is dependant on when the research gets published. UTMoST- RISK-BENEFIT AND COSTS OF UNICOMPARTMENTAL (COMPARED TO TOTAL) KNEE REPLACEMENT FOR PATIENTS WITH MULTIPLE CO-MORBIDITIES: A NON-RANDOMISED STUDY, AND DIFFERENT NOVEL APPROACHES TO MINIMISE CONFOUNDING The UTMOST project has now delivered a thorough report of the research to be included in the NIHR HTA Journal, which is currently under review. In addition, the University will publish at least two papers in national and/or international scientific journals to report key findings. This has also been submitted and is under review. In order to increase the impact and accessibility of the findings, they will be published in open access journal(s) when possible. At this time, the final study report and academic papers produced from the UTMOST and UKSAFE studies have been submitted and are currently under review. The data is still needed to make any changes required when these external peer reviews are completed. The University of Oxford will write a thorough report of the research at the end of the project to be included in the NIHR HTA Journal. In addition, the University will publish at least two papers in national and/or international scientific journals to report key findings. In order to increase the impact and accessibility of the findings, they will be published in open access journal(s) when possible. [2 paragraphs unchanged] Both UTMOST and UKSAFE have successfully produced numerous deliverables which were proposed in the previous application. FOR UTMOST, the NIHR report has been submitted and accepted and is currently in an embargo period. Additional conference posters/abstracts relating to UTMOST are listed below: • 2020 ICPE. Multi-level Propensity Scores In Comparative Effectiveness Research On Medical Devices: A Pragmatic Example Of Partial Vs Total Knee Replacement Using National Joint Registry Data Compared To RCT Findings • 2020 ICPE. The Risk Of Myocardial Infarction And Venous Thromboembolism After Partial Or Total Knee Arthroplasty: A Self Controlled Case Series • 2019 ICPE. The performance of preference-based instrumental variables to emulate a randomised clinical trial of comparative medical device effectiveness. • 2019 ICPE. Propensity scores and inverse probability weighting in device epidemiology: a comparison of different approaches to minimise confounding when emulating a surgical randomised clinical trial. • 2019 ISPOR. Hospital costs and outcomes of unicompartemental compared to total knee replacement for patients with multiple comorbidities: a population-based study. • 2019 ACPE. Comparative effectiveness of unicompartmental and total knee replacement for patients with comorbidities. • 2019 EUROCIM. Different approaches to minimise confounding when emulating a surgical randomised clinical trial: an application to partial vs total knee replacement. • 2019 ACPE. Comparative effectiveness of unicompartmental and total knee replacement for patients with comorbidities. For UKSAFE the NIHR report is to be submitted after an extension in December as a result of a Covid-19 associated delay. The study protocol and conference posters/abstracts relating to UKSAFE are listed below: Study protocol • Czoksi Murray CJ, et al. Towards UK poSt Arthroplasty Follow-up recommendations (UK SAFE): protocol for an evaluation of the requirements for arthroplasty follow-up, and the production of consensus-based recommendations. BMJ Open 2019;9:e031351. Conference posters/abstracts • 2020 IOF-WCO-ESCEO. Primary care consultations after long-term follow-up of unrevised hip and knee replacements: findings from routinely-collected healthcare records in the UK. • 2020 IOF-WCO-ESCEO. Impact of long-term follow-up on revision of knee and hip replacement surgery. • 2020 BOA. Patients self-present for revision arthroplasty: results from the UK SAFE study. [2 paragraphs unchanged] The target date is 36 months following access to data. All outputs will be aggregated with small numbers suppressed in line with the HES analysis guide. No record level data falling under this agreement will be shared with any third-party. As described above, both UKSAFE and UTMOST have extensive dissemination and communication plans for their findings.

Expected measurable benefits

UK SAFE- EVIDENCE BASED COST-EFFECTIVE HIP AND KNEE ARTHROPLASTY FOLLOW-UP CARE PATHWAYS Upon completion, the UKSAFE research project will have major immediate effect on national NHS planning and budgeting and patient well-being. The outputs will be evidence-based support for timing of follow- up and identification of the most cost-effective follow-up model. This fits directly within the NHS framework for improving outcomes from elective procedures. Rationalising current diversity of follow-up practices should enable substantial savings for the NHS. Novel follow-up strategies, such as creating a rapid access pathway after joint replacement for symptomatic patients will be examined. It is envisaged outputs to be readily applicable to the wider NHS, not only hip and knee but also other joint replacements. Upon completion, this research will have major immediate effect on national NHS planning and budgeting and patient well-being. The outputs will be evidence-based support for timing of follow- up and identification of the most cost-effective follow-up model. This fits directly within the NHS framework for improving outcomes from elective procedures. Rationalising current diversity of follow-up practices should enable substantial savings for the NHS. Novel follow-up strategies, such as creating a rapid access pathway after joint replacement for symptomatic patients will be examined. It is envisaged outputs to be readily applicable to the wider NHS, not only hip and knee but also other joint replacements. Upon completion of the UTMOST study, results will have clear impact on and benefits for both the public and the NHS, as well as for clinical research funders including NIHR by providing information on the comparative risks, benefit (patient-reported outcomes), and cost of partial and total knee replacement for patients with multiple co-morbid conditions. It will also benefit the provision of health care by informing on the usefulness of efficient studies using routinely collected (non-randomised) data for the evaluation of surgical alternatives in the NHS to complement randomized studies. The impact will be to reduce the burden on patients and the NHS in terms of outpatient visits and clinical tests that do not add benefit, while optimising detection of potential problems. From an NHS perspective, this work will provide NHS managers with economic and clinical information on arthroplasty follow-up to inform service planning and delivery, and the role of arthroplasty practitioners in this service; provide orthopaedic surgeons with guidance on follow-up, including patient and economic considerations of factors involved; produce arthroplasty follow-up guidelines for adoption by the relevant specialist societies and inclusion with information for their members. From a patient perspective, this work will help to inform patients about follow-up practice and empower them to make choices about future healthcare relating to their joint arthroplasty. Dissemination of UKSAFE findings is in the public interest in order to: At the end of the project, a policy document will be created with support of the relevant societies, NHS England, CCGs and patient representation. It is anticipated that this will include a stratification algorithm to determine appropriate follow-up for an individual patient, taking into account, for example, implant type and patient factors, and that recommended follow-up pathways for hip may differ to those for knee. This advisory document will be disseminated to all stakeholders, including orthopaedic surgeons, arthroplasty surveillance professionals and NHS managers. With the committed support of these key organisations, the applicant anticipates that these guidelines will be positively received and that implementation will be widespread. It is the BDHG’s ambition that the recommended follow-up pathway/s defined by this programme of work will be adopted for all hip and knee replacement patients in the UK and internationally. - Better inform decision support for patients undergoing hip and knee arthroplasty; The target date is 36 months following receipt of data. - Support evidence-based commissioning and care provision within the NHS UTMoST- RISK-BENEFIT AND COSTS OF UNICOMPARTMENTAL (COMPARED TO TOTAL) KNEE REPLACEMENT FOR PATIENTS WITH MULTIPLE CO-MORBIDITIES: A NON-RANDOMISED STUDY, AND DIFFERENT NOVEL APPROACHES TO MINIMISE CONFOUNDING - Provide orthopaedic surgeons with guidance on the best patient follow-up in terms of cost effectiveness and patient outcomes This study will have clear impact on and benefits for both the public and the NHS, as well as for clinical research funders including NIHR by: Dissemination of UTMOST findings is in the public interest in order to: - Providing information on the comparative risks, benefit (patient-reported outcomes), and cost of partial and total knee replacement for patients with multiple co-morbid conditions. - Better inform decision support for patients with co-morbidities undergoing knee replacement; If, as expected, UKR is safer, as effective, less costly, and thus more cost-effective than TKR for this specific patient group, it might become the first line surgical solution for severe knee arthritis in multi-morbid patients. The BDHG would then inform NICE and the Medicine and Healthcare products Regulatory Authority (MHRA) of the findings with the aim to impact on future guidelines for the treatment of severe knee arthritis. Depending on the study results, the BDHG would –if relevant- produce UK guidance documents and information leaflets for patients and health care professionals in both primary and secondary care involved in this area. - Support evidence-based surgery that surgeons can use to change their practice; - Informing on the usefulness of efficient studies using routinely collected (non-randomised) data for the evaluation of surgical alternatives in the NHS to complement randomized studies. - Support evidence-based commissioning and care provision If some or all of the proposed pharmaco-epidemiological analytical methods are able to replicate the findings from an ongoing surgical RCT, these could be used in the future to provide information on the comparative risk-benefit and cost-effectiveness of surgical options for patients typically under-represented in (or even excluded from) randomized studies. This would typically include a growing proportion of the UK population: the elderly and multi-morbid patients. - Inform on the usefulness of efficient studies using routinely collected (non-randomised) data for the evaluation of surgical alternatives in the NHS to complement randomized studies. The target date is 48 months following access to data. Both UKSAFE and UTMOST are expected to yield results which will benefit patients, surgeons and NHS commissioners nationally which is why the projects have extensive plans for data dissemination is various forms. Dissemination benefits of UKSAFE findings will include: - Better informed decision support for patients undergoing hip and knee arthroplasty; - Support evidence-based commissioning and care provision within the NHS - Provide orthopaedic surgeons with guidance on the best patient follow-up in terms of cost effectiveness and patient outcomes Dissemination benefits of UTMOST findings will include: - Better inform decision support for patients with co-morbidities undergoing knee replacement; - Support evidence-based surgery that surgeons can use to change their practice; - Support evidence-based commissioning and care provision - Inform on the usefulness of efficient studies using routinely collected (non-randomised) data for the evaluation of surgical alternatives in the NHS to complement randomized studies. For the UKSAFE project, in 2013 over 150,000 total hip and knee replacements were conducted. Due to increasing ageing and obesity in the UK population, this number is likely to increase each year. Sometimes, problems can develop with the replaced joint over time and a small percentage of people require further surgery. Because joint failure is not always associated with symptoms, follow-up care is provided to ensure that problems are identified as early as possible. Providing this care for everyone in the years after their surgery is extremely expensive and the NHS is under increasing pressure to reduce its costs. Many hospitals have dramatically reduced the amount of follow-up provided and some provide no follow-up at all. There is very little research evidence to determine whether not providing follow-up care may be causing harm to people by missing the opportunity to pick up a problem with a replaced joint before serious damage occurs. This project could lead to cost savings for the NHS but also better patient outcomes where patients are given follow-up care at the most effective time. The UTMOST project is expected to benefit the public and the NHS, as well as for clinical research funders including NIHR by providing information on the comparative risks, benefits (patient-reported outcomes), and cost of partial and total knee replacement for patients with multiple co-morbid conditions. As described above the research projects are expected to deliver results and disseminate to decision makers in order to achieve benefits to patients and the NHS. The NHS routinely collects data on the patient perspective following revision hip and knee replacement as part of the NHS PROMs programme. If this proposal is successful and changes are implemented into practice, then improvement in PROMs would be expected over time. Other success criteria for this project include the number of high-quality outputs. The expectation is that benefits will be realised throughout the project as individual articles are published and begin to inform clinical practice. • For UKSAFE, the project has met the overarching aim of investigating aftercare in terms of benefits for patients and potential impact on the NHS and may inform decision making among stakeholders. A consensus meeting has been held during the BOA Annual Congress 2019 in Liverpool where preliminary findings were discussed. Disseminated research to date has found that longer-term follow up was associated with higher revision risk, and that primary care consultation costs for unrevised joint replacement patients were higher in those receiving long-term hospital outpatient follow-up. • For UTMoST, the project has met the overarching aim of investigating benefits of UKR for patients and impact on the NHS and may inform decision making among stakeholders. The research has shown that UKR may lead to improved quality of life and lower costs to the NHS in patients with multiple comorbidities (ASA 3+) not typically included in clinical trials. This application will support part of a DPhil for a student at the University of Oxford. The thesis is expected to be submitted by 2025 (graduate studies standards agreement form to follow).

Benefits reported

Yielded Benefits is not a requirement for new applications. Due to Covid-19, which stopped access to data for a period of time, and changes in staff, there have been interruptions to work which is why an extension has been requested. The research team are working to produce all deliverables described, and have now completed all analyses. However, until these outputs have been peer-reviewed and published, no benefits can be yielded.