Title: Maximising outcome for patients with shoulder pain: using optimal diagnostic and prognostic information to target treatment (PANDA-S)
Funder: Department of Health and Social Care

Abstract: Background: Annually, 4% of adults will consult general practice for shoulder pain, resulting in 1.5 million consultations. Outcomes are highly variable with 40% of patients reporting persistent pain 6 months after consulting healthcare. Requests for imaging (ultrasound scans) and surgery have risen sharply, despite lack of evidence for their effectiveness. Generating high quality evidence of the value of diagnostic and prognostic information for predicting treatment outcomes will provide opportunities for improving the primary care management of shoulder pain. Aim: Improve patient outcomes and healthcare resource use by developing and evaluating a stratified care intervention, which uses a screening and decision tool based on diagnostic and prognostic information to allow more effective targeting of treatments based on patients probability to respond to specific treatments. Workstream 1: Individual participant data (IPD) meta-analysis Objective: Synthesise IPD from randomised trials to test predictors (moderators) of response to shoulder pain treatments, such as exercise, injection, or surgery. Methods: Our developmental work has identified candidate treatment moderators. Eligible trials will be identified from updated systematic reviews, their risk of bias examined, and authors approached for data-sharing (provisionally agreed for 8 trials, n=1,481). Primary outcome will be shoulder pain/disability at 6 months. A two-stage IPD random-effects meta-analysis framework will be used, which will account for clustering of patients within trials and avoid aggregation bias. Advanced methods will be used to deal with missing values and make optimal use of repeated outcome data. Key outputs: Confirmatory evidence regarding treatment moderators; estimates of treatment effects for patient subgroups. Workstream 2: Prospective inception cohort of patients with shoulder pain Objectives: (i) Develop a prediction model using information from patient history, physical examination, ultrasound scans, and additional prognostic factors, (ii) define prognostic subgroups at low versus increased risk of poor outcome. Methods: A clinical inception cohort of consecutive adults (n=1000) consulting with shoulder pain in general practices or self-referral physiotherapy services, of whom an estimated 600 will attend a research clinic for assessment (history, examination, ultrasound scan). All participants will complete a baseline questionnaire to assess clinical, lifestyle, work-related, and psychosocial factors. Follow-up includes postal/online questionnaires and medical record review over 3 years to assess patient outcomes and healthcare use. Primary outcome will be shoulder pain and disability (SPADI) at 6 months. Multivariable regression will be used to investigate the prognostic value of diagnostic and prognostic information, and develop a brief screening tool to discriminate between prognostic subgroups. Key outputs: Prediction model to estimate individuals risk of poor outcome; defined prognostic subgroups; novel data on long-term patient outcomes linked to healthcare data. Workstream 3: Development of stratified care for shoulder pain Objective: Integrate results from Workstreams 1&2 to develop a screening and decision tool supporting optimal targeting of shoulder pain treatments. Methods: (a) Semi-structured interviews with approximately 15 patient-clinician dyads to investigate their perceptions of cause and prognosis of shoulder pain, uncertainty and communication around treatment and referral, and opinions regarding the potential of stratified care. Grounded theory and constant comparative method will be used to identify themes, investigating overlaps and contrasts between individuals in the dyad. (b) Nominal Group meetings, involving patients, GPs, physiotherapists, and secondary care specialists. Informed by interview results and evidence from Workstreams 1&2, they will agree: design and format of the tool; matched treatments for defined subgroups; type of training and information materials for clinicians and patients. Key outputs: Evidence-based screening & decision tool with matched treatments for subgroups (stratified care), and supporting materials for clinicians and patients. Workstream 4: Clinical and cost-effectiveness of stratified care Objectives: (i) Determine whether stratified care results in reduced pain and disability compared to usual care, (ii) estimate incremental cost-effectiveness and cost-utility. Methods: Multi-centre pragmatic randomised trial with health-economic and process evaluation, with an internal pilot phase of 6 months. Consecutive, eligible adults consulting with shoulder pain in general practice or self-referral physiotherapy services (estimated n=530) will be randomly allocated to usual care or stratified care. In the stratified care arm, prognosis will be estimated using the screening tool. Low-risk participants will receive a brief package of reassurance and supported self-management, while those at increased risk will receive treatment or referral matched to their likelihood to respond well. Primary outcome will be SPADI at 6-months; secondary outcomes include pain, sleep, work absence, and quality of life over 12 months. The primary (intention-to-treat) analysis will use a linear mixed model to compare outcomes between arms. A mixed-methods process evaluation will assess acceptability, fidelity, adherence, and processes assumed to explain observed outcomes. The economic evaluation will determine cost-effectiveness and cost-utility of stratified care versus usual care from an NHS and societal perspective, and model long-term cost-effectiveness. Key outputs: Evidence of clinical and cost-effectiveness of stratified care; screening & treatment decision tool, tested and ready to be implemented in NHS primary care.

Lay abstract: The problem: Shoulder problems affect 20% of adults and are often very painful, affecting sleep, work, and everyday life. In England, about 1.5 million people visit their GP for shoulder pain annually, of whom 40% experience on-going pain. Most patients receive treatment from GPs or physiotherapists, but 7 times more patients are having surgery compared with 10 years ago. There is no evidence that surgery provides better results than non-surgical treatments such as shoulder exercises. Aim: To develop and evaluate a better approach ( stratified care ) to assessing the likely cause (diagnosis) and future outcome (prognosis) of shoulder problems, so that clinicians can offer optimal treatments matched to patients characteristics. This research will benefit patients and the NHS by: improving information and advice for patients about the possible causes and best ways to assess and treat shoulder pain supporting clinicians to better advise patients which treatment is best for them improving targeting of treatment options, and reducing unnecessary investigations and treatments in those who don t need them reducing long-term pain, disability, and work loss due to shoulder pain Research plan: The plan includes 4 workstreams. Workstream 1: Use data from existing studies to identify characteristics of patients likely to benefit from specific treatments such as exercise, shoulder injection, or surgery. Workstream 2: Recruit 1000 patients consulting with shoulder pain to a follow-up study. Their GP or physiotherapist will continue to treat them in the way they feel is most appropriate. Willing participants will: receive a clinical assessment, including physical examination and ultrasound scan of the shoulder complete 6 questionnaires on pain, difficulties with everyday activities, treatments, and quality of life over 3 years, providing unique information about long-term outcomes. Workstream 3: Work with expert clinicians and patient representatives to combine findings from Workstreams 1 and 2 to develop a screening and decision tool. This tool would help clinicians to identify patients likely to recover quickly or experience long-lasting pain, and select optimal treatments based on patients characteristics ( stratified care ). Patients and their clinicians will be interviewed to obtain their views on the causes and long-term impact of shoulder pain, how they make decisions about treatment, and the feasibility of introducing the new stratified care approach. Workstream 4: Conduct a randomised trial including 530 patients with shoulder pain to test whether using stratified care leads to better patient outcomes and better use of NHS resources. PPIE: An advisory group of people with experience of shoulder pain will meet regularly to advise the research team regarding the design of patient-facing materials, recruitment and data collection processes, content of interviews, design of stratified care, interpretation of findings, and best ways of sharing the findings with the wider public.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: MUSCULOSKELETAL