Jonathan Lloyd Rees

Aims: Arthroplasty is a widely used surgery for end-stage arthritis, but venous thromboembolism (VTE) remains a major postoperative complication. Most previous studies have relied solely on hospital data; no study has examined the effect of national clinical guidelines on the rates of VTE in the UK. This study aimed to assess VTE trends after arthroplasty using linked primary and secondary care data, and the impact of the National Institute for Health and Care Excellence (NICE) guidelines in the UK on VTE rates after arthroplasty. Methods: We used the Clinical Practice Research Datalink (CPRD) Aurum version, the largest primary care database in the UK, and linked hospital and death data for patients undergoing knee, hip, or shoulder arthroplasty between October 2007 and September 2019. The outcome was VTE event within six months of surgery. Trends in VTE were assessed using the Cox-Stuart trend test, and the impact of seasonality and clinical guidelines introduced in 2010, 2012, and 2018 via logistic regression with a polynomial function. Results: A total of 476,620 arthroplasty records were included. The overall VTE incidence was 1.5% (knee (1.6%), hip (1.4%), and shoulder arthroplasty (1%)). More than 30% of the VTEs were found through the linked data. A decline in VTE rates was observed over time for hip (p = 0.004) and knee arthroplasty (p = 0.001). Introduction of NICE guidelines did not significantly change the VTE rate in knee and hip arthroplasty. In shoulder arthroplasty, VTE decreased by 9% after the introduction of the 2018 guidelines. Seasonal variation in the VTE risk differed by joint. Conclusion: Future research should investigate the factors driving the seasonal association in VTE rates, and determine why shoulder arthroplasty showed a unique response after 2018. Cite this article: Bone Joint J 2026;108-B(9):1138–1146.

Background: There is growing evidence that access to joint replacement surgery is being restricted based on body mass index (BMI) despite any formal recommendations. Our aim was to investigate the association between BMI and patient outcomes after elective primary shoulder replacement surgery to inform future commissioning and national guidance. Methods and findings: In this population-based cohort study, patients aged 18–100 years having elective primary shoulder replacement surgery were identified using linked national joint registry and hospital data from public and private hospitals in the United Kingdom (2018−22) and Denmark (2006−21). The main outcome measure was mortality within 365 days of surgery. Secondary outcome measures included mortality within 90 days, serious adverse events within 90 days, and revision surgery within 4.5 years of surgery. The association between BMI and patient outcomes was assessed using flexible parametric survival models and logistic regression models, adjusting for age, sex, deprivation, main surgical indication and American Society of Anaesthesiologists (ASA) score. 15,320 and 5,446 shoulder replacement procedures from within the United Kingdom and Denmark, respectively, met the inclusion criteria. In the United Kingdom, the average age was 72.2 years, 68.3% were female and the average BMI was 29.4 kg/m ² . In Denmark, the average age was 70.5 years, 65.3% were female and the average BMI was 28.0 kg/m ² . There was a decreased risk of 365-day mortality in obese (BMI 40 kg/m ² ) patients (hazard ratio (HR) 0.40 [95%CI 0.21, 0.73]) and an increased risk in underweight (BMI < 18.5 kg/m ² ) patients (HR 1.18 [95%CI 1.06, 1.32]), compared to patients with BMI 21.75 kg/m ² . Underweight patients had an increased risk of 90-day mortality (HR 1.69 [95%CI 1.14, 2.52]), 90-day serious adverse events (odds ratio 1.36 [95%CI 1.05, 1.77]) and revision surgery (HR 1.70 [95%CI 1.25, 2.33]). Increasing BMI was not associated with a significantly increased risk of any secondary outcome. The main limitation of this study was the high proportion of missing BMI data and the small case numbers for the underweight study population ( n = 131[UK], 70[Denmark]). Conclusions: Increasing BMI was associated with lower 365-day mortality, and no poorer outcomes after elective primary shoulder replacement surgery. This surgery is safe and effective in obese patients and access to shoulder replacements should not be restricted based on BMI alone. Clinicians and hospitals should be aware that underweight patients appear more at risk of mortality, serious adverse events and revision surgery after shoulder replacement.

Introduction Musculoskeletal shoulder pain is a common reason for people to be treated in physiotherapy services, but diagnosis can be difficult and often does not guide treatment or predict outcome. People with shoulder pain cite a need for clear information, and timely, tailored consultations for their pain. This trial will evaluate the introduction of a personalised guided consultation to help physiotherapists manage care for individuals with shoulder pain. Methods and analysis This is a cluster randomised controlled trial to evaluate the clinical and cost-effectiveness of introducing a personalised guided consultation compared to usual UK NHS physiotherapy care. Physiotherapy services (n=16) will be randomised in a 1:1 ratio to either intervention (physiotherapy training package and personalised guided consultation incorporating a new prognostic tool) or control (usual care). 832 participants (416 in each arm) identified from participating physiotherapy service waiting lists aged 18 years or over with shoulder pain will be enrolled. Follow-up will occur at 3-time points: 6 weeks, 6 months and 12 months. The primary outcome will be the Shoulder Pain and Disability Index (SPADI) score over 12 months. Secondary outcomes include global perceived change of the shoulder condition, sleep, work absence and the impact of shoulder pain on work performance, healthcare utilisation and health-related quality of life (using the EQ-5D-5L). A multi-method process evaluation will investigate views and experiences of participants and physiotherapists, assess uptake, facilitators and barriers to delivery, and changes in factors assumed to explain intervention outcomes. Primary analysis of effectiveness will be by intention-to-treat, and a health economic evaluation will assess cost-utility of introducing the personalised consultation. Ethics and dissemination The trial received ethics approval from the Yorkshire & The Humber (South Yorkshire) Research Ethics Committee (REC reference: 23/YH/0070). Findings will be shared through journal publications, media outlets, and conference presentations. Supported by patient contributors and clinical advisors, we will communicate findings through a designated website, networks, newsletters, leaflets, and in the participating physiotherapy services. Trial registration ISRCTN: 45377604 STRENGTHS AND LIMITATIONS OF THIS STUDY This large cluster randomised controlled trial will evaluate the effects and costs of a new intervention, comprising a scalable physiotherapy training package and a personalised guided consultation that incorporates a new prognostic tool, to improve care for patients with shoulder pain in physiotherapy services. A multi-method process evaluation, informed by predefined logic model, will assess the uptake, acceptability and delivery the intervention. This approach will allow for a comprehensive understanding of the perspectives and experiences of both participants and physiotherapists. The first phase will be an internal pilot designed to strengthen the trial by assessing recruitment, retention, and intervention uptake, increasing the likelihood of successfully delivering the full trial. A potential limitation of the cluster trial design is the increased risk of participation bias related to differential recruitment between trial arms.

Objectives To answer a national research priority by comparing the risk-benefit and costs associated with reverse total shoulder replacement (RTSR) and anatomical total shoulder replacement (TSR) in patients having elective primary shoulder replacement for osteoarthritis. Design Population based cohort study using data from the National Joint Registry and Hospital Episode Statistics for England. Setting Public hospitals and publicly funded procedures at private hospitals in England, 2012-20. Participants Adults aged 60 years or older who underwent RTSR or TSR for osteoarthritis with intact rotator cuff tendons. Patients were identified from the National Joint Registry and linked to NHS Hospital Episode Statistics and civil registration mortality data. Propensity score matching and inverse probability of treatment weighting were used to balance the study groups. Main outcome measures The main outcome measure was revision surgery. Secondary outcome measures included serious adverse events within 90 days, reoperations within 12 months, prolonged hospital stay (more than three nights), change in Oxford Shoulder Score (preoperative to six month postoperative), and lifetime costs to the healthcare service. Results The propensity score matched population comprised 7124 RTSR or TSR procedures (126 were revised), and the inverse probability of treatment weighted population comprised 12 968 procedures (294 were revised) with a maximum follow-up of 8.75 years. RTSR had a reduced hazard ratio of revision in the first three years (hazard ratio local minimum 0.33, 95% confidence interval 0.18 to 0.59) with no clinically important difference in revision-free restricted mean survival time, and a reduced relative risk of reoperations at 12 months (odds ratio 0.45, 95% confidence interval 0.25 to 0.83) with an absolute risk difference of −0.51% (95% confidence interval −0.89 to −0.13). Serious adverse events and prolonged hospital stay risks, change in Oxford Shoulder Score, and modelled mean lifetime costs were similar. Outcomes remained consistent after weighting. Conclusions This study’s findings provide reassurance that RTSR is an acceptable alternative to TSR for patients aged 60 years or older with osteoarthritis and intact rotator cuff tendons. Despite a significant difference in the risk profiles of revision surgery over time, no statistically significant and clinically important differences between RTSR and TSR were found in terms of long term revision surgery, serious adverse events, reoperations, prolonged hospital stay, or lifetime healthcare costs.

Frozen shoulder is a spontaneously self-resolving chronic inflammatory fibrotic human disease, which distinguishes the condition from most fibrotic diseases that are progressive and irreversible. Using single-cell analysis, we identify pro-inflammatory MERTK^lowCD48⁺ macrophages and MERTK + LYVE1 + MRC1+ macrophages enriched for negative regulators of inflammation which co-exist in frozen shoulder capsule tissues. Micro-cultures of patient-derived cells identify integrin-mediated cell-matrix interactions between MERTK+ macrophages and pro-resolving DKK3+ and POSTN+ fibroblasts, suggesting that matrix remodelling plays a role in frozen shoulder resolution. Cross-tissue analysis reveals a shared gene expression cassette between shoulder capsule MERTK+ macrophages and a respective population enriched in synovial tissues of rheumatoid arthritis patients in disease remission, supporting the concept that MERTK+ macrophages mediate resolution of inflammation and fibrosis. Single-cell transcriptomic profiling and spatial analysis of human foetal shoulder tissues identify MERTK + LYVE1 + MRC1+ macrophages and DKK3+ and POSTN+ fibroblast populations analogous to those in frozen shoulder, suggesting that the template to resolve fibrosis is established during shoulder development. Crosstalk between MerTK+ macrophages and pro-resolving DKK3+ and POSTN+ fibroblasts could facilitate resolution of frozen shoulder, providing a basis for potential therapeutic resolution of persistent fibrotic diseases.

The clinical and cost effectiveness of surgical repair of partial rotator cuff tears in patients with subacromial shoulder pain: a comparison of surgical repair versus surgery with no repair. Partial Rotator Cuff Repair Trial (PRoCuRe Trial) Jonathan Rees¹*, Andrew Carr¹, Jonathan Cook¹, Amar Rangan², Jean Millar, Danielle van der Windt³, Alison Hall³, Daniel Prieto-Alhambra¹, Rafael Pinedo-Villanueva¹, Anju Jaggi⁴, Cushla Cooper¹, Marcus Jepson⁵, Sarah Lamb⁶, Ava Lorenc⁵, Naomi Merritt¹, Mae Chester-Jones¹, Louise Appleton¹, Heidi Fletcher¹, Loretta Davies¹, David Beard¹ & the PRoCuRe Study Group Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford South Tees Hospitals NHS Foundation Trust Keele University Royal National Orthopaedic Hospital NHS Trust University of Bristol University of Exeter Study registration: ISRCTN: 60983694 Plain language summary Aims and objectives: To assess if surgical repair of partial rotator cuff tears is effective in patients with persistent shoulder pain despite physiotherapy and steroid injection. Background: Rotator cuff tears are shoulder tendon tears causing pain, weakness and loss of movement, leading to problems with daily activities, work, recreation and sleep. Tears can be full thickness (whole tendon) or partial. Patients who do not get better with non-operative treatments may choose surgery. Although rotator cuff tears cause pain and disability, it is not known which surgery is best or if repairing partial tears prevents full tears and worsening problems. Methods: We planned a randomised controlled trial across 20 UK NHS hospitals . Between July 2021 and August 2022 we aimed to recruit 376 patients over 18 years of age suffering persistent shoulder pain and partial rotator cuff tears . Eligible patients received arthroscopic (keyhole) surgery to either debride (shave away inflamed tissue, rough tear edges and bone spurs) and repair the tear, or debride only without repair. Patients were followed up using questionnaires. Key findings: This study of an elective surgical procedure was severely impacted by the COVID-19 pandemic, especially staff shortages, sickness and redeployment. Changes post pandemic to the patient pathway and national surgical prioritisation processes had a major impact on identifying eligible patients with partial tears. All these factors effected site set-up and patient recruitment. The study closed early due to slow recruitment. Only 10 patients from 9 NHS Trusts were randomised, precluding any meaningful analysis . Patient and public involvement: Patients were involved in the study design, set up and monitoring. Conclusions and future plans: The impact of the pandemic prevented trial progression and this research question is now likely to remain unanswered. Detailed post-pandemic feasibility work is needed before attempting a similar study. Keywords: Acromion, Arthroscopy, Debridement, Decompression, Randomised Controlled Trial, Rotator Cuff, Shoulder Pain, Steroids Summary of research findings Background. The rotator cuff tendons of the shoulder connect the muscle bellies of Subscapularis, Supraspinatus, Infraspinatus and Teres Minor to the proximal humerus. These muscles play a critical role in the stability and function of the shoulder. Degenerative rotator cuff tendon tears are highly prevalent with increasing age and although some tears can be present without any symptoms, they can lead to subacromial shoulder pain and disability. Degenerative tears usually start at the leading edge of the supraspinatus tendon above the glenohumeral joint and underneath the acromion. Many surgeons and patients believe that these tears start as partial thickness tears (PTTs) and then progress to full thickness tears (FTTs)¹. Surgical repair of FTTs is very common in the NHS with around 9,000 repairs/year at a cost of £6,628 per operation (£60 million in total) ^{2, 3}. We have already shown in the UKUFF Trial that many repairs of larger FTTs fail ⁽³⁾. Some patients who develop larger FTTs also end up needing more expensive, complex repairs. In recent years, a rapidly increasing number of shoulder replacements are being undertaken for extensive FTTs. These expose patients to greater risks and are of great cost to the NHS ⁴. Despite these realities, little has been done to investigate whether some PTTs have the potential to heal sufficiently without repair surgery, or whether surgery prevents FTTs. It is therefore important to know if repairing PTTs is worthwhile to patients in improving pain, function and also in preventing FTTs developing ⁵. Current Practice: Patients with a partial rotator cuff tear can present with shoulder pain and loss of function. Arthroscopic shoulder surgery is offered as an option if physiotherapy and injection treatments have failed to make any improvement ⁶. As diagnosis of partial rotator cuff tears can only be confirmed during arthroscopic surgery ⁷, shoulder arthroscopy is commonly performed in the NHS to both confirm the diagnosis and then perform a subsequent therapeutic procedure at the same time. This can include debridement of inflamed bursal tissue and any ragged tear edges, and/or bony decompression, and/or a rotator cuff repair procedure. Physiotherapy and rehabilitation routinely follow surgery. Current Evidence: There is limited evidence available on the effectiveness of repairing PTTs surgically. It is not currently known if this practice improves pain, function and prevents FTTs from developing. There is the possibility that debridement surgery alone might help, or that symptoms can improve without surgical intervention, but the evidence for best treatment, and the natural history of painful PTTs, remains uncertain ^{8, 9}. The only evidence that exists assessing outcomes from PTT surgical repair is from a multitude of surgical technique case studies and small cohort studies showing favourable outcomes for surgery ^{4, 5, 10}. Previous systematic reviews support surgery but unfortunately contain low quality studies ^{11, 12}. Other studies were not direct assessments of the surgical repair intervention, however these focused more on surgical technique. These also showed no difference in outcomes with different techniques and concluded that the best treatment method for this patient group is unknown ^13-16. To add further to complexity of the choice of treatment for PTTs, there is evidence indicating that imaging quality in diagnosis of rotator cuff problems is insufficient. A 2013 Cochrane Review by Lenza et al on the accuracy of shoulder imaging for rotator cuff problems reports the sensitivity and specificity of Magnetic Resonance Imaging (MRI) to be 74% and 93% respectively 7. Ultrasound scans also showed problematic sensitivity and specificity rates, with 52% and 93% respectively. Therefore, in most cases, confirmation of PTT diagnosis can only be confirmed during an arthroscopic procedure. This issue of diagnostic inaccuracy (outside of arthroscopy) also needs careful consideration in any formal evaluation of PTT surgical intervention. Evidence Based Surgery: The provision of any treatment of unknown efficacy or value is problematic for both individual patient wellbeing and the health service in general and this work fits with the current initiative (NHS England and RCS) to scrutinise and fully evaluate the efficacy of surgical procedures. As symptomatic FTTs requiring surgery are now highly prevalent in the UK ¹⁷ knowledge on the effectiveness of treatment in reducing pain and disability, and proof that PTTs progress to FTTs is needed. FTT’s cause a significant health burden and their prevention should be a priority ^{2, 13}. The 2015 James Lind Alliance Priority Setting Partnership on shoulder surgery highlighted this research question and priority ⁵. The limited work in this area highlights the uncertainty around whether there is a benefit to PTT repair. Responses from a survey of the shoulder surgeon community confirmed the existence of community equipoise and a willingness to engage in the provision of evidence-based practice. Given the lack of quality evidence and the potential effects of progression on NHS resources, a robust trial was required to address the issues surrounding PTTs and their management. The PRoCuRe Trial was developed to answer whether arthroscopic surgical repair of PTTs is clinically and cost effective by comparing it to arthroscopic debridement surgery with no repair. The study was designed to help provide evidence on this patient population in relation to the short-medium term effects on pain and disability, and the longer-term effects including preventing progression to symptomatic FTTs. Choice and Justification of Treatment Arms: In the NHS, surgeons treat PTTs with a variety of surgical options including cuff repair, debridement, subacromial decompression/acromioplasty, and any combination of these interventions. The primary research question surrounds the efficacy and cost effectiveness of arthroscopic repair of PTT. The treatment arms for the study were: Intervention = Arthroscopic Debridement and Arthroscopic Repair (ADAR) Comparator = Arthroscopic Debridement Only (No Repair) (ADO) The treatment chosen for comparison against surgical repair (arthroscopy and debridement only - ADO) is a routine surgical procedure that some surgeons perform for PTT. It consists of all elements of the definitive repair intervention, but without the “critical surgical element” of that procedure, the repair itself. This high-fidelity treatment control is also useful from a design point of view as it will confirm or refute the theoretical mechanism for benefit by accounting for any placebo effects of surgery ¹⁸. The previously outlined issue of diagnostic inaccuracy for PTTs without undergoing arthroscopy means that a non-operative arm is neither appropriate or possible ⁷. Any comparison study employing a non-surgical intervention would be compromised by inclusion of incorrectly diagnosed PTTs. Moreover, previous experience in surgical versus non-surgical treatment trials using similar populations (and recent patient involvement work), indicate a non-surgical intervention would be difficult to recruit to and therefore not feasible ³. Conducting a two-arm surgical trial in which both groups undergo arthroscopic surgery allows for essential confirmation of diagnosis, secure patient blinding and represents the most efficient design to assess efficacy of repairing PTTs. A QuinteT (Qualitative Research Integrated in Trials) Recruitment Intervention (QRI)¹⁹ was included to support recruitment. Aims and Objectives The aim of the PRoCuRe trial was to determine the clinical and cost effectiveness of surgical repair of partial rotator cuff tears in patients with subacromial shoulder pain, with the primary objective of answering the question, ‘In patients with suspected PTT listed for arthroscopic surgery, is ADAR more beneficial than ADO as measured by pain reduction and functional restoration at 24 months post operation?’ The secondary objectives of the PRoCuRe trial were to assess and compare: early patient reported pain and function outcome (Baseline 6, 12 and 24 months) patients’ quality of life patient resource use. patient satisfaction and perceptions tear progression long term health care usage, complications, further surgery, patient reported pain and function and quality of life for randomised patients. The study also had exploratory objectives to: optimise the accuracy of MRI and USS imaging in diagnosing PTTs assess the long-term health care usage, complications, further surgery, for the non-randomised patients Methods Study design: The PRoCuRe trial (Ethics Ref: 21/LO/0081) was designed to be a multicentre superiority randomised controlled trial (ISRCTN60983694) using a two-arm parallel group design with 1:1 allocation ratio as outlined in Figure 1. The trial had an internal pilot phase leading to the definitive trial and a Quintet Recruitment Intervention (QRI) with two iterative stages: Stage I: To develop a detailed understanding of the recruitment process leading to, Stage II: The use of tailored interventions to improve recruitment. The trial was designed so that participants would be blinded to the randomised allocation i.e. as to whether they had their PTT repaired or not. Due to the nature of the interventions, it was not possible to blind theatre staff nor the surgeon. Participants were recruited to the study in NHS hospitals across England. The study overall was modelled on participation from 20 centres, with additional sites to be included depending on recruitment rates in the 6-month pilot phase. Participants (patients) were expected to be enrolled in the study for up to 5 years. During this time, they would complete questionnaires at baseline, 6-, 12- and 24-months post randomisation. They would also be asked to have an MRI scan two years after their surgery. Routine healthcare data would be collected up to five years to assess for any longer- term shoulder diagnoses and healthcare resource use following the repair. Participants would have received a short questionnaire at 5 years to assess patient reported outcomes, so that long-term clinical and cost effectiveness could be estimated. Pilot phase: An internal pilot was planned that would progress to the definitive trial if predefined evaluation criteria regarding recruitment rate, randomisation process and adherence to allocated treatment were met. The pilot trial was to mirror the procedures and logistics to be undertaken in the main definitive trial. We planned for the data that were collected in the pilot trial to contribute to the final analysis. The pilot aimed to randomise 30 patients or more over a 6-month period from at least 6 sites with staggered initiation, with a target recruitment rate of one patient per site per month. If any issues were identified, it was proposed that they be discussed with the TSC; any changes required for the definitive trial were to be discussed with the funder and submitted as amendments for approval. The QRI is a well-established intervention involving rapid data collection and analysis, to identify and understand any challenges to recruitment, with feedback to the trial management team, the development of action plans and provision of tailored recruitment support and training. The pilot phase included close monitoring of discrepancies between suspected diagnosis from imaging and true diagnosis from operation. Any patterns in these errors and inaccuracies based on imaging type, imaging sequencing, content or seniority of reporting formed part of feedback to centres, and surgeons in order to make improvements during the full recruitment phase 20, 21. Adherence with protocol was assessed as part of the pilot. The Trial Management Group (TMG) and independent oversight committees monitored progress and success during the pilot phase using the following traffic light system for progression; green light for 30 recruited patients, no other action needed, trial continues. Amber light for between 15-30 recruits, actions to include; auditing of centres, analysis and implementation of QRI results, refresher training, amendment of study procedures. Red light for less than 15 recruits, next steps and measures would be discussed with the funder. Inclusion Criteria for potential recruitment into trial: Each participant in the trial were patients who had decided on surgical treatment based on ongoing subacromial shoulder pain and who: Had MRI or USS imaging suggesting a PTT diagnosis in Supraspinatus or any small FTT in Supraspinatus where there is radiologist or surgeon uncertainty between a PTT and small FTT and were: Over 18 years of age Willing and able to provide informed consent An understanding of the English language sufficient to receive written and verbal information about the trial, its consent process and complete study questionnaires Inclusion Criteria for randomisation in the operating theatre during surgery: PTT more than 50% tendon thickness confirmed in Supraspinatus during arthroscopy Exclusion Criteria. Individuals who met any of the following criteria were excluded from the trial: Patient has not had at least one steroid injection on the side to be operated Steroid injection within six weeks of planned surgery date on the side to be operated Inflammatory arthritis (e.g. rheumatoid) Established Glenohumeral Osteoarthritis (Grades II, III and IV) Current active malignancy of any kind Tears associated with acute fractures Tears associated with shoulder dislocations Upper limb neurological deficit on either side Cardiac Pacemaker (absolute contraindication for MRI) Unable to complete the written follow up questionnaires Screening and recruitment: Potential participants were recruited through routine shoulder services such as outpatient clinics, pre-op assessment clinics, surgical waiting lists; depending on local procedures and new ways of working post COVID pandemic, the format of this initial contact was face-to-face or virtual/remote. The clinical team identified potential participants and, if trained, discussed the trial before referring the patient to the research team for further information. At some centres QRI intervention(s) were used to support recruitment and training; clinical team members who had not received training would advise the patient of their potential eligibility for PRoCuRe and refer them on appropriately. In addition to verbal information, potential participants were given, or sent, written study information to read at home. They were informed that participation in the trial was optional and would not affect their medical or legal rights. All patients were made aware of the trial’s aims, anticipated benefits and potential risks. Patients were allowed a period of reflection adequate to their individual needs to decide whether they would like to consent to take part in the trial or not. No delay to surgery was incurred as a result of being invited to take part in the study i.e. patients with a surgery date that did not allow for the minimum reflection period needed were not consented. During their outpatient clinic appointment, a patient may decide to pursue surgical treatment; making them potentially eligible for PRoCuRe. All patients who decided on surgery were routinely added to the waiting list at this point. This included patients who expressed an interest in taking part in PRoCuRe, but they were not prioritised for surgery above those who were not participating. They proceeded through the standard clinical pathway as per routine care. The eligibility assessment formed a 2-stage process: Stage 1: Initial eligibility assessment; confirm patient as potentially eligible for randomisation  This initial stage of the assessment was conducted by an appropriately qualified member of the clinical team and depended on routine history, shoulder examination and interpretation of the MRI or USS imaging conducted as part of normal care (as per local hospital policy), to confirm the initial diagnosis and rule out any exclusion criteria. The PI/co-PI at each site would take overall responsibility for confirming patient eligibility but was able to delegate the eligibility assessment to a suitably qualified and experienced member of the clinical team. Details relating to the scan report such as reviewer staff...

Objective To provide clinicians and patients with accurate risk estimates of serious adverse events after common elective shoulder arthroscopic procedures, including reoperation within one year. Design Population based cohort study. Setting Hospital Episode Statistics for NHS England, including civil registration mortality data from the Office for National Statistics. Participants 288 250 arthroscopic shoulder procedures performed in 261 248 patients aged ≥16 years between 1 April 2009 and 31 March 2017. Elective procedures were grouped into subacromial decompression, rotator cuff repair, acromioclavicular joint excision, glenohumeral stabilisation, and frozen shoulder release. Main outcome measures The primary outcomes were rates of serious adverse events (mortality, pulmonary embolism, pneumonia, myocardial infarction, acute kidney injury, stroke, and urinary tract infection) requiring inpatient care within 90 days post-surgery. Secondary outcomes were specific adverse event rates at 90 days, and reoperations (including for deep infection) within one year. Results The overall rate of complications within 90 days after arthroscopic shoulder surgery (including reoperation) was low at 1.2% (95% confidence interval 1.2% to 1.3%), with one in 81 patients at risk, and varied according to type of procedure, from 0.6% (0.5% to 0.8%) for glenohumeral stabilisation to 1.7% (1.5% to 1.8%) for frozen shoulder release. After adjustment for age, comorbidities, and sex, no effect of procedure type was observed. Pneumonia was the most common adverse event (0.3%, 0.3% to 0.4%), with one in 303 patients at risk. Pulmonary embolic events were rare, at 0.1% (0.1% to 0.1%), with one in 1428 patients at risk. At one year, the overall rate for reoperation was 3.8% (3.8% to 3.9%), with one in 26 patients at risk, ranging from 2.7% (2.5% to 3.0%) for glenohumeral stabilisation to 5.7% (5.4% to 6.1%) for frozen shoulder release. The overall rate of further surgery for deep infection was low, at 0.1% (0.1% to 0.1%), with one in 1111 patients at risk, but was higher after rotator cuff repair (0.2%, 0.2% to 0.2%), with one in 526 patients at risk. Over the study period the number of arthroscopic shoulder procedures increased, except for subacromial decompression, which decreased. Conclusions The findings of this study suggest that risks of serious adverse events associated with common shoulder arthroscopy procedures are low. Nevertheless, serious complications do occur, and include the risk of reoperation in one in 26 patients within one year. Study registration Clinical.Trials.gov NCT03573765.

Objectives: To examine temporal trends in incidence of arthroscopic subacromial decompression (ASAD) surgery internationally during conduct and after publication of placebo controlled trials finding no evidence of meaningful benefit of ASAD for shoulder impingement. Design: Observational study of incidence rates. Setting: Large routinely collected datasets were used: outpatient data from Belgium and UK, and insurance claims and outpatient data from US. UK data were from Clinical Practice Research Datalink and Belgium and US data were from IQVIA. US and UK data spanned 2005 – 2019 and Belgium data 2011 – 2019. Participants: Patients were eligible for inclusion in the study if they had at least one visit recorded in the database in a given year and cases were defined as patients undergoing ASAD for the first time in their records in a given year. Outcome measures: We calculated incidence of ASAD over time, overall and stratified by age and sex. Characteristics of patients undergoing ASAD were also assessed over time. Results: UK incidence has fallen since a peak of 4.7 per 10,000 person years in 2011 (when the CSAW trial began) to 1.8 in 2019. US incidence shows no clear pattern and remains consistently higher than the UK, at 11.5 per 100,000 person years in 2019. Changes in incidence patterns were similar across different age groups and sexes. The number of cases in Belgium was too small for meaningful conclusions. Conclusions: We found ASAD rates have fallen in the UK during conduct and after publication of two large surgical RCTs from the UK and Finland that questioned the effectiveness of ASAD for shoulder impingement. A similar impact on clinical practice has not been seen in US. Further work to understand the barriers or concerns preventing international uptake of high quality evidence into clinical practice is needed. Strengths and limitations of this study: This is the most comprehensive study of ASAD incidence we are aware of. Routinely collected datasets were used to assess proportions of the patients undergoing this procedure in several countries Standardised case definitions were used across databases to increase comparability of findings Temporal changes in database coverage and quality of reporting can influence findings. The observed variation in ASAD incidence may not be entirely attributable to changes in ASAD surgery rates.