The role of patient factors, surgical factors and hospital factors upon patient outcomes and NHS costs in the treatment of upper limb musculoskeletal conditions: spatial and longitudinal analysis of routine data.

Musculoskeletal conditions of the upper limb (arm) are a significant disease burden, affecting all age groups including the working population. Prevalence of conditions affecting the hand such as osteoarthritis and carpal tunnel syndrome are estimated at between 15-36% of the population, causing pain, numbness and loss of function. Shoulder osteoarthritis prevalence is estimated to be as high as 32% in those over 60 years, which stands to increase as the UK population ages. Research also has shown that approximately 20% of the population present to their GP to discuss a musculoskeletal condition each year, with NHS spending totalling over £5 billion annually on musculoskeletal conditions. There has been little research exploring national trends in treatment, outcome or access to care in upper limb musculoskeletal conditions in the UK, and Nuffield Department of Orthopaedic, Rheumatology & Musculoskeletal Science (NDORMS), at University of Oxford believe that research in this field is vital for patients, clinicians and the NHS alike in order to improve patient care, patient information and patient pathways.

Around 5300 shoulder replacement operations now take place each year in the UK and this number is expected to increase, including revision (re-do) surgery. Elbow replacement surgery is rarer with only a few hundred cases per year, but revision rates are thought to be potentially very high and the costs even higher. It is currently difficult to estimate the considerable number of surgeries undertaken for hand and wrist arthritis, as this data is not yet collected into any national database.

Some forms of upper limb arthritis can develop following joint dislocation or injury to the soft tissues. Shoulder rotator cuff tendon tears and joint instability following shoulder joint dislocation are common injuries that may contribute to the development of osteoarthritis. Surgery to repair rotator cuff muscles and to stabilize the shoulder following dislocation seems to be rapidly increasing in recent years. Investigation of the use of these new procedures, and whether they have an impact upon the development of arthritis in later life is not yet known.

In the hand, dupuytrens disease is disorder of the connective tissue (soft tissue) of the hand causing a progressive significant deformity and reduced ability to use the hand. There are a variety of treatment options, ranging from splinting the affected finger, to local injections to break down the abnormal tissue, to surgery to remove it. It is thought that availability of treatment options available varies across the UK. There is an increasing trend in patients being diagnosed with the condition.

Compression of nerves in the arm is very common, and this is called nerve entrapment conditions. Carpal tunnel syndrome and cubital tunnel syndrome being the most common and treatment remains varied, with some patients undergoing local steroid injection and splinting of the affected area, and others proceeding to surgery to stop compression of the nerve. Previous evidence has suggested some nerve entrapment conditions may be related to obesity and diabetes, and therefore the number of patients suffering with the condition is expected to increase. There are some links suggesting development of nerve compression during pregnancy. The interaction between surgery to treat arthritis, and the development of a nerve entrapment condition is not yet understood.

This study aims to investigate the impact of treatment for the most prevalent upper limb conditions and will include investigation of surgical treatment trends, revision surgery trends (in particular upper limb joint replacement surgery) and current resource demands in treating these common conditions. These conditions include osteo and rheumatoid arthritis of the upper limb joints, shoulder rotator cuff (muscle) tendinopathies and tears, Frozen shoulder, shoulder joint instability (joint dislocation), Dupuytren’s contracture of the hand, and nerve entrapment (nerve compression) syndromes.

The legal basis for processing personal data for this purpose at University of Oxford falls under Article 6(1)(e) of the General Data Protection Regulations (GDPR), i.e. “a task carried out in the public interest”. It also falls under Article 9(2)(j), “processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes”.

This project aims to be in the public interest by improving understanding work undertaken by NHS in treating upper limb conditions, better appreciation of the trends over time in disease and management, and also the overall rate of complications sustained. The project aims to directly feed back into healthcare decision making by providing information about the risks associated with undergoing intervention for upper limb conditions. With regards ethical issues with the analysis detailed in this project, if anything, there are ethical issues in not undertaking the work. There is a public interest in understanding the manner in which the NHS is working and the overall risks associated with undergoing surgery for upper limb conditions. From the perspective of the clinician, this work is also aligned with the Montgomery principles of enabling patients to be fully informed. The risk of potential harm is aimed to be minimised at all times but only undertaking analysis that is vital for the project, using pseudonymised data that is aggregated to prevent secondary disclosure or identification of individuals. The aim of the project is to prevent further harm to specific patient groups who may be identified as having greater risk associated with intervention that would otherwise not be known in the national NHS population. This project aims to meets requirements of GDPR through only using the minimal fields necessary, within the number of years of data that gives the optimum answer to the research question, and by using pseudonymised data. The project only uses the minimum datasets of HES Admitted Patient Care and mortality in order to accurately undertake long term follow up after surgery (censoring for those who have died). The data will be held for the minimum time possible prior to be destroyed in accordance with NHS Digital regulations.

University of Oxford is the sole Data Controller who process the data for the purpose outlined in this agreement. There are no funders or commissioners involved in this project.

AIMS

The main aims of this study are:

1. Investigation of the variation in surgical treatments, revision rates and mortality rates in upper limb conditions

A large variety of new surgical techniques coupled with a rapid expansion of surgical implants mean that many different options exist in the surgical treatment of upper limb conditions. Newer innovative surgical options might enable patients to undergo less invasive surgery with reduced recovery time and improved return of function. Some new techniques aim to prevent disease recurrence or progression. NDORMS wish to investigate these surgical techniques, and the impact upon the need for further interventions following these procedures.

2. Geographical and temporal trends in management and outcome

Having identified the types of surgical intervention undertaken, NDORMS will investigate whether there are temporal or geographical trends associated with intervention type, compared to geographical and temporal trends in disease prevalence. NDORMS will investigate this comparing patient demographics within regions and over time, and produce maps highlighting these trends. NDORMS will also produce maps highlighting variation in length of stay, readmission complication and revision rates across the country as proxy measurements for patient outcome.

3. Assessment of access to care & care costs

Statistical analysis of national data from the Hospital Episode Statistics (HES) admissions database will allow identification of hospital organisation and surgical factors that may explain geographical variations in patient outcomes of surgery, after adjustment for patient level case-mix. This study aims to identify whether the different ways that hospitals organise services for patients presenting with upper limb conditions can lead to improved patient outcomes, and postulate reasons why outcomes may vary between hospitals or regions. NDORMS will investigate whether these differences cause a variation in access to care, due to disease prevalence, or due to variation in management and how these factors influence the cost of patient care. Greater understanding of trends in how these interventions are being used and the outcomes following them will enable NDORMS to propose changes that will influence health service provision and workforce planning.

This dataset has the unique and exciting opportunity of exploring the changes that have occurred in disease presentation, development, treatment and outcome over an extensive time period. Studies that have follow up of this duration have not been previously undertaken in this country, and undertaking research using routinely collected NHS data will enable a better understanding of how to care for patients with upper limb conditions. Long term follow up of surgical interventions allows evaluation of the impact of new techniques and devices, and especially the effect of new implants upon implants failure rates. Analysis of long-term outcomes are vital in order to determine which implants and interventions should continue to be used; evidence that is not available elsewhere.

Patient focused priorities for research

NDORMS have recently run a successful James Lind Alliance Priority Setting Partnership (non-profit making initiative to identify and prioritise uncertainties and questions about the effects of treatments) for “Surgery for Common Shoulder Conditions” which brought together patients, carers and clinicians to set the ongoing treatment uncertainties with regards to surgery for common shoulder conditions. These results are now published and highlight research questions that are important for UK patients. This application will help address some of these questions Including; Which shoulder replacement type operation should be undertaken in different patient groups. Due to the short term National Joint Registry (NJR) data this is currently not answerable but HES data over a longer period of time will allow for a separate and much more detailed data interrogation, potentially answering this question and negating the need for an expensive national surgical trial.

Appreciating that the James Lind Alliance Priority Setting Partnership for “Common Hand conditions” is currently underway in the UK but has not yet reported, NDORMS have lead a regional patient and public engagement project in hand surgery. This study has emphasized that improving patient selection for surgery, timing of surgery and type of surgical management undertaken is seen as a priority. NDORMS study will help answer or contribute further important information to those trying to answer these treatment uncertainties.

Alignment with NHS agenda

In the NHS, patients can choose which hospital they want to have their surgery in. Information on access to treatments and the outcomes of surgery between different hospitals would help patients in making their decision. Outcomes of surgery may vary across different regions and hospitals. Any such differences might be explained by a hospital treating more complex and sicker patients but could also be explained by the surgical techniques employed in different centres, or centralization of care into specialist high volume hospitals. Knowledge of this would inform dashboards and aid NHS managers and clinicians in changing and optimising service organisation to reduce any variations in outcomes.

The national audit into the orthopaedic surgical procedures called Getting It Right First Time (GIRFT) was launched in 2013. Initial results released in March 2015 found large variations in practice and have called for better research into the timing and types of procedures undertaken. Better understanding of regional and temporal variations in procedures, and which surgical procedures have the best outcomes would improve the quality of patient care in the UK, reduce costs for the NHS and more importantly provide better patient information to inform shared treatment decision making.

This dataset has the unique and exciting opportunity of exploring the changes that have occurred in disease presentation, development, treatment and outcome over an extensive time period. Studies that have follow up of this duration have not been previously undertaken in this country, and undertaking research using routinely collected NHS data will enable the study to better understand how to care for patients with upper limb conditions. Long term follow up of surgical interventions allows evaluation of the impact of new techniques and devices, and especially the effect of new implants upon implants failure rates. Analysis of long-term outcomes are vital in order to determine which implants and interventions should continue to be used; evidence that is not available elsewhere.

The predominant method of limiting the data requested is through the study of selected upper limb conditions only, and through only selecting certain procedures. Due to the lack of existing evidence surrounding the role of comorbidities in this research area, it is not advantageous or appropriate to further select a subgroup of patients with certain co-morbidities.

The National Joint Registry (NJR) data for shoulder replacement only began in 2012, and the elbow data began in 2017. There is no other source available to evaluate implants and procedures used for hand and wrist conditions. Over the time that HES data has been collected, there has been a rapid evolution of the implants available for these procedures, which have yet to be evaluated. The importance of long-term data has been shown in other areas of orthopaedics, especially in hip surgical research where metal on metal hip replacements have since been shown to have higher long term failure rate than other implants. A lack of long-term data surrounding complications associated with these new implants to treat hip osteoarthritis led to patients undergoing procedures that have since been withdrawn due to excess morbidity associated with their use. This work aims to identify implants and procedures with higher rates of complications using the long-term data available in HES Admitted Patient Care, to optimise future patient care and prevent harm. This data will not be available in other sources for many years, and therefore this emphasises the real value of the long-term data available through using HES to prevent future harm, and why this dataset has been specifically chosen for use in this work.

The hand, wrist and elbow procedures that this study wish to look at have been in use for well over 20 years, and as such the study would like to look specifically at the changes over time in their usage, for example in response to key papers, guidelines, changes in policy. Releasing less data than this would limit the usefulness of the study and the results that could inform future patient care.

No data will flow from the data controller to NHS Digital.

HES APC data linked to mortality data is disseminated by NHS Digital to the data controller. This data does not include any identifying fields.

Upon receiving the data from NHS Digital, a senior data manager with experience in managing HES datasets, will process the raw data into smaller extracts. Smaller extracts will be made available for analysis based upon disease pathology and surgical intervention undertaken. This will enable the separate research questions defined by the aims of the study to be answered.

NDORMS will provide data at the small area level presented as maps to describe variation in outcomes, before and after accounting for these organisational and surgical factors. All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide. Mortality data has previously been supplied by the Office for National Statistics (ONS), the responsibility for disseminating this dataset is now with NHS Digital and is known as Civil Registration Mortality. NDORMS will also focus on variation in outcomes of specific patient groups (old and frail with co-morbidities and obese) and present evidence as to whether the introduction of new surgical innovations (e.g. minimally invasive surgery), and centralisation of services, has led to improved patient outcomes. Civil Registration Mortality data for the patients selected will enable analysis of associations between surgery and death rates. Investigation of spatial and longitudinal trends in mortality will also be studied.

Multilevel regression modelling of HES data will assess the association of surgical factors on patient outcomes of surgery, adjusting for patient case-mix. Random intercept models will explore geographical variation in outcomes across hospital trusts and Clinical Commissioning Groups. Geographical Information Systems will be used to produce maps depicting variation in outcomes, and graphically display the influence these factors have on explaining such variation.

NDORMS will then use a natural experimental study design to specifically examine the impact that the new treatments have had on NHS resource use, NHS costs and patient outcomes (based upon length of stay, complications, readmission, further surgical intervention including revision surgery). Interrupted time series analysis will examine changes in secular trends in outcomes and NHS costs before and after the introduction of the new treatments. There will be a focus on the benefit of the new treatments to specific patient groups such as frail older people with complex co-morbid conditions. An economic evaluation will describe the hospital NHS costs, patient health related quality of life and cost effectiveness that reflect the new treatments for upper limb conditions. The predominant method of limiting the data requested is through the study of selected upper limb conditions only, and through only selecting certain procedures. Due to the lack of existing evidence surrounding the role of comorbidities in this research area, it is not advantageous or appropriate to further select a subgroup of patients with certain co-morbidities.

A cost-effectiveness analysis will be performed to estimate the economic burden of conservative and surgical care in relation to trends in outcome, adjusting for socioeconomic status and case-mix. This is largely unexplored to date and essential for further studies potentially exploring the cost-effectiveness of the surgical intervention.

Once data has been disseminated to the study;

- The HES and Civil Registration Mortality datasets will be held on a password protected University Computer on an encrypted drive at the Botnar Research Centre, Nuffield Department of Orthopaedic, Rheumatology & Musculoskeletal Science (NDORMS).

- The data will be managed by a named researcher based at the Botnar Research Centre Nuffield Department of Orthopaedic, Rheumatology & Musculoskeletal Science (NDORMS) University of Oxford.

- The data will be used exclusively for the purpose of this project

- At the end of the study, the data will be safely held in a password protected University Computer at the Botnar Research Centre, for further 36 months, and assessed only to answer questions arising from the publication and other publicity.

All data will be processed only by substantive employees of University of Oxford.

Data will not be linked to any other record level data, no attempts will be made to identify any individual from the data being supplied, and there will be no onward disclosure of record level data.

DISSEMINATION PLANS

Throughout all stages of this project, NDORMS will engage with key stakeholders including NHS managers, healthcare professionals, patients and the public for interpretation, dissemination and direct communication of the main findings. This will be facilitated through collaboration with the James Lind Alliance, support of specialist societies, and Patient and Public Involvement (PPI) representation. A Professor of Orthopaedic Surgery at the University of Oxford and a Professor of Plastic Surgery at Oxford University Hospitals NHS trust are named co-applicants on this study and will assist in interpreting and the national dissemination of findings. This project has also been informed by results from the recent James Lind Alliance (JLA) Priority Setting Partnership (PSP) for surgery for common shoulder conditions, carried out within the Oxford NIHR Musculoskeletal BRU and supported by the British Shoulder and Elbow Society (BESS) and the British Orthopaedic Association (BOA). NDORMS shoulder and elbow, and hand and wrist applicants both have national roles and collaborations that provide excellent access and influence to disseminate the study findings nationally and internationally through the following societies and funded research centres:

1. British Elbow and Shoulder Society (BESS) – Dissemination to all British shoulder surgeons and shoulder physiotherapists. Presentation at the National Congress.

2. British Society for Surgery of the Hand (BSSH)- Dissemination to all British hand surgeons and hand therapists. Presentation at the biannual National Congress.

3. NIHR Oxford Biomedical Research Unit/Centre – Dissemination to all linked patient and local GP networks

4. ARUK Centre of Excellence (CoE) for Sports and Exercise Medicine – Dissemination to all patients and professional sporting bodies linked to this CoE.

5. Internationally NDORMS will disseminate through peer review publications and via presentations at the European Shoulder and Elbow Society (SECEC) and the Federation of European Societies for Surgery of the Hand (FESSH)

One of the NDORMS professors using this data has written national guidelines for NICE and the specialist societies on managing many shoulder conditions including authoring national commissioning guidelines. This study will allow evidence-based updating of these guidelines will be able to influence these as an Executive Council member of BESS and the BESS Quality Outcomes Lead.

A senior researcher on the study team is a member of the British Society for Surgery of the Hand (BSSH) Research Committee, and will use the aggregated, anonymised results generated from this study to influence practice nationwide. BSSH is in the process of gaining accreditation from NICE for guideline development and NDORMS anticipate this to be in place by the time the results of this work are published.

Working with and informing all stakeholders will remain an important part of NDORMS dissemination plans. NDORMS recognize the importance of meaningful PPI involvement and have worked collaboratively with the PPI Officer at NIHR Research Design Service (RDS) to identify individuals to become involved, and NDORMS Director of Patient Involvement at the Oxford NIHR BRC. NDORMS have identified three lay people who understand the needs and problems of upper limb conditions. Through their involvement and recommendations regarding the dissemination of findings, NDORMS will ensure results are readily available and interpretable to the wider patient and public community.

NDORMS shall disseminate findings in peer-reviewed journals, at national and international conferences, and inform learned societies that include the British Orthopaedic Association, The British Shoulder and Elbow Society (BESS), British Society for Surgery of the Hand (BSSH), Arthritis Research UK, rheumatology (British Society for Rheumatology), care of the elderly (British Society of Geriatrics). NDORMS will work alongside charities and learned societies to disseminate the findings of this study using established platforms that include social media such as Twitter and a study website, as more patients are now turning to these resources for information about planned surgery.

Based on the findings NDORMS will write scientific papers for submission to high quality peer-reviewed journals. NDORMS will also present findings to professionals at conferences and meetings, will develop Plain English summaries of findings for communication to patients and members of the public . All outputs will adhere to HES analysis guide so that data is only shown in aggregate form with small numbers supressed. NDORMS will publish a full and complete account of that research in the NIHR HS&DR Journal, ensuring the research is reported fully, and publicly available via the NIHR Journals Library website and Europe PubMed Central. A webpage will be developed within the NDORMS website specifically for this study in order to further transmit the results to the public. This study aims to capture the attention of patients and the public by presenting the long-term results of surgery for upper limb conditions in the UK not previously undertaken, and to also present the potential reasons why there may be variation in outcomes following surgery. Previous PPI work has shown that variation in disease progression, and outcome following intervention is of particular interest to patients and the public.

BENEFIT

The study will inform patients, NHS managers, commissioners and health professionals of the NHS costs and patient outcomes and cost-effectiveness associated with the treatment of upper limb conditions, and the key elements that are most clinically and cost effective. It will provide patients with information on variation in outcomes of surgery to inform patient choice and decision-making. NDORMS will work alongside charities and learned societies to disseminate the findings of this study using established platforms that include social media such as Twitter and a study website, as more patients are now turning to these resources for information about planned surgery. NDORMS will provide evidence of modifiable hospital organisational factors that can explain unwarranted geographical variation in patient outcomes of surgery. This can be used to inform healthcare organisations of factors identified as improving patient outcome and both local and national level, and can be used by clinicians and policy makers to inform healthcare policy.

IMPACT

The exploration of current trends in procedures undertaken, in temporal and geographical variation in operation numbers and type, mismatch of prevalence and surgery rates, and of outcomes will enable NDORMS to understand more about the current management of upper limb conditions and how to improve NHS services nationwide. NDORMS will explore variations found to identify whether differences in the way hospitals or regions organise their services, such as specialist surgeons, use of new surgical techniques, or centralising care into specialist hospitals, can explain any observed variations. Similarly, understanding the variation in outcomes following a range of procedures enables greater knowledge of which interventions should continue to be funded. Knowledge of these factors would inform changes that can be made to the way services are organized and provided, leading to better access for patients and helping to standardise evidenced based care and patient pathways across the UK.

To date 6 key papers to improve shared decision making between patients and clinicians have been directly generated as a result of this project and have been published within the peer review literature. These published articles generated from this data extract have been publicised within the orthopaedic community and are freely available for patients to review.

They have been used to feed directly into clinical practice to inform patients of their risk of sustaining complications or requiring further interventions after undergoing surgical procedures for upper limb conditions.

Update December 2021:

The 6 publications produced using the data under this Agreement as follows:

1. Serious adverse events and lifetime risk of reoperation after elective shoulder replacement: population based cohort study using hospital episode statistics for England.

Craig RS, Lane JCE, Carr AJ, Furniss D, Collins GS, Rees JL. BMJ 2019. Feb 20;364:I298. PMID: 30786996

2.Low rates of serious complications and further procedures following surgery for base of thumb osteoarthritis:

analysis of a national cohort of 43 076 surgeries.

Lane JCE Craig R, Rees JL, Gardiner M, Mikhail MM, Riley ND, Prieto-Alhambra D, Furniss D. BMJ Open. 2021;11:e045614 doi:10.1136/bmjopen-2020-045614

3.Serious postoperative complications and reoperation after carpal tunnel decompression surgery in England: a nationwide cohort analysis. Lane JCE, Craig RS, Rees JL, Gardiner MD, Green J, Prieto-Alhambra D, Furniss D. Lancet Rheumatology 2020 Sep 30;3(1):e49-e57. PMID: 33381769

4. Low rate of subsequent surgery and serious complications following intra-articular steroid injection for base of thumb osteoarthritis: national cohort analysis. Lane JCE, Craig RS, Rees JL, Gardiner MD, Shaw AV, Spiteri M, Kuo R, Dean BF, Green J, Prieto-Alhambra D, Furniss D. Rheumatology. 2021 Jan ;keaa925.PMID: 33410485

5. Serious complications and risk of re-operation after Dupuytren’s disease surgery: a population-based cohort study of 121,488 patients in England. Alser O, Craig RS, Lane JCE, Prats-Uribe A, Robinson DR, Rees JL, Prieto-Alhambra D, Furniss D. Scientific Reports 2020 Oct(5);10(1):16520. PMID: 33020582

6.Temporal trends and geographical variation in Dupuytren Disease surgery in England. A population based cohort study. Alser O, Abram SGF, Craig RS, Lane JCE, Shaw AV, Prats-Uribe A, Rees JL, Prieto-Alhambra D, Furniss D. Ann Plast Surg 2021 Sep 1;87(3):265-270. PMID: 34397515

Whilst some projects have now come to completion, there are projects still in progress that the study team would like to achieve with the current data extract, and therefore the data is required to held for a further 24 months.

Researchers have measured the magnitude by the direct use of evidence generated in policy produced by specialist orthopaedic societies, with the aim that these are generated within the 24 month window. This has been achieved by previous publications, and the study team would aim for the same impact from the outstanding projects.

Further details of yielded benefits will be included in any subsequent version of the Agreement.