International trends in shoulder replacement: a meta-analysis from 11 public joint registers.

BACKGROUND AND PURPOSE: International variation exists in the types of shoulder replacement used for treatment of specific diseases. Implant choice continues to evolve without high-quality evidence. Our aim was to evaluate trends in incidence rates of shoulder replacement and assess any recent changes in practice between countries by using registry data. METHODS: Patient characteristics, indication and year of surgery, type of replacement, and collection methods of patient-reported outcomes (PROMs) was extracted from 11 public joint registries. Meta-analyses examined use of reverse total shoulder replacement (RTSR) for osteoarthritis, cuff tear arthropathy, and acute fracture; use of anatomical total shoulder replacement (TSR) for osteoarthritis; and use of humeral hemiarthroplasty for fracture. RESULTS: The annual growth rate of shoulder replacements performed is 6-15% (2011-2019). The use of RTSR has almost doubled (93%). RTSR is now universally performed for cuff tear arthropathy (97.3%, 95% confidence interval [CI] 96.0-98.1). Its use for avascular necrosis, trauma, and inflammatory arthropathy is increasing. The use of RTSR was similar (43.1%, CI 30.0-57.2) versus TSR (44.7%, CI 31.1-59.1) for osteoarthritis. The types of PROMs used, collection time points, and response rates lack standardization. COVID-19 had a varying inter-registry impact on incidence rates. CONCLUSION: The incidence of shoulder replacements has grown. Use of RTSR has increased for all disease indications despite limited high-quality evidence driving this change in indications outside of cuff arthropathy. Consequently, less variation is observed in international practice. Existing differences now relate to use of newer implant types and methodology of PROMs collection, which prevents international comparison and outcome analysis.

Shoulder replacement surgery's rising demand, inequality of provision, and variation in outcomes: cohort study using Hospital Episode Statistics for England.

BACKGROUND: The aim of this study was to forecast future patient demand for shoulder replacement surgery in England and investigate any geographic and socioeconomic inequalities in service provision and patient outcomes. METHODS: For this cohort study, all elective shoulder replacements carried out by NHS hospitals and NHS-funded care in England from 1999 to 2020 were identified using Hospital Episode Statistics data. Eligible patients were aged 18 years and older. Shoulder replacements for malignancy or acute trauma were excluded. Population estimates and projections were obtained from the Office for National Statistics. Standardised incidence rates and the risks of serious adverse events (SAEs) and revision surgery were calculated and stratified by geographical region, socioeconomic deprivation, sex, and age band. Hospital costs for each admission were calculated using Healthcare Resource Group codes and NHS Reference Costs based on the National Reimbursement System. Projected rates and hospital costs were predicted until the year 2050 for two scenarios of future growth. RESULTS: A total of 77,613 elective primary and 5847 revision shoulder replacements were available for analysis. Between 1999 and 2020, the standardised incidence of primary shoulder replacements in England quadrupled from 2.6 to 10.4 per 100,000 population, increasing predominantly in patients aged over 65 years. As many as 1 in 6 patients needed to travel to a different region for their surgery indicating inequality of service provision. A temporal increase in SAEs was observed: the 30-day risk increased from 1.3 to 4.8% and the 90-day risk increased from 2.4 to 6.0%. Patients from the more deprived socioeconomic groups appeared to have a higher risk of SAEs and revision surgery. Shoulder replacements are forecast to increase by up to 234% by 2050 in England, reaching 20,912 procedures per year with an associated annual cost to hospitals of £235 million. CONCLUSIONS: This study reports a rising incidence of shoulder replacements, regional disparities in service provision, and an overall increasing risk of SAEs, especially in more deprived socioeconomic groups. These findings highlight the need for better healthcare planning to match local population demand, while more research is needed to understand and prevent the increase observed in SAEs.

Mapping the Oxford Shoulder Score onto the EQ-5D utility index.

PURPOSE: In order to enable cost-utility analysis of shoulder pain conditions and treatments, this study aimed to develop and evaluate mapping algorithms to estimate the EQ-5D health index from the Oxford Shoulder Score (OSS) when health outcomes are only assessed with the OSS. METHODS: 5437 paired OSS and EQ-5D questionnaire responses from four national multicentre randomised controlled trials investigating different shoulder pathologies and treatments were split into training and testing samples. Separate EQ-5D-3L and EQ-5D-5L analyses were undertaken. Transfer to utility (TTU) regression (univariate linear, polynomial, spline, multivariable linear, two-part logistic-linear, tobit and adjusted limited dependent variable mixture models) and response mapping (ordered logistic regression and seemingly unrelated regression (SUR)) models were developed on the training sample. These were internally validated, and their performance evaluated on the testing sample. Model performance was evaluated over 100-fold repeated training-testing sample splits. RESULTS: For the EQ-5D-3L analysis, the multivariable linear and splines models had the lowest mean square error (MSE) of 0.0415. The SUR model had the lowest mean absolute error (MAE) of 0.136. Model performance was greatest in the mid-range and best health states, and lowest in poor health states. For the EQ-5D-5L analyses, the multivariable linear and splines models had the lowest MSE (0.0241-0.0278) while the SUR models had the lowest MAE (0.105-0.113). CONCLUSION: The developed models now allow accurate estimation of the EQ-5D health index when only the OSS responses are available as a measure of patient-reported health outcome.

Remote assessment of surgical site infection (SSI) using patient-taken wound images: Development and evaluation of a method for research and routine practice.

BACKGROUND/AIM: Clinical assessment of wounds for surgical site infection (SSI) after hospital discharge is challenging and resource intensive. Remote assessment using digital images may be feasible and expedite SSI diagnosis. Acceptable and accurate methods for this process are needed. This study developed and evaluated the feasibility, acceptability and usability of a method for patients to capture standardised wound images for remote wound assessment to detect SSI. MATERIALS AND METHODS: The work was conducted in two phases. Phase I involved: i) a review of literature to identify key components of photography relevant to taking wound images, ii) development of wound photography instructions for patients and a secure process for transmission of images using electronic survey software and iii) pre-testing of the photography instructions and processing method with a sample of 16 patients using cognitive interviews and observations. Phase II involved a prospective cohort study of 89 patients to evaluate the feasibility, acceptability and usability of the remote method following discharge from hospital after surgery. Quality of the images was assessed by three independent clinical reviewers. RESULTS: Some 21 key components for photographing wounds were identified from 11 documents. Of these, 16 were relevant to include in instructions for patients to photograph their wounds. Pre-testing and subsequent iterations improved understanding and ease of use of the instructions and the process for transmitting images. Fifty-two of 89 (58.4%) patients testing the method remotely took an image of their wound(s) and 46/52 (88.5%) successfully transmitted images. When it was possible to ascertain a reason for not taking/transmitting images, this was primarily health problems (n = 7) or lack of time/poor engagement with the study (n = 4) rather than problems relating to technology/competency (n = 2) or practical issues relating to the wound itself (n = 2). Eighty-seven (85.3%) of the 102 images received were evaluated to be of high quality and sufficient to remotely assess SSI by at least two independent reviewers. CONCLUSION: A simple, standardised and acceptable method for patients to take and transmit wound images suitable for remote assessment of SSI has been developed and tested and is now available for use in routine clinical care and research.

How long does an elbow replacement last? A systematic review and meta-analysis of case-series and national registry reports with more than 10 years of follow-up.

BACKGROUND AND PURPOSE: This study aims to determine, for the first time, generalizable data on the longevity and long-term function of elbow replacements. METHODS: In this systematic review and meta-analysis, we searched MEDLINE and Embase for articles reporting 10-year or greater survival of total elbow replacements (TERs) and distal humeral hemiarthroplasty. Implant survival and patient reported outcome measures (PROMs) data were extracted. National joint replacement registries were also analyzed. We weighted each series and calculated a pooled survival estimate at 10, 15, and 20 years. For PROMs we pooled the standardized mean difference (SMD) at 10 years. FINDINGS: Despite its widespread use, we identified only 9 series reporting all-cause survival of 628 linked TERs and 610 unlinked TERs and no series for distal humeral hemiarthroplasty. The studied population was treated for rheumatoid arthritis in over 90% of cases. The estimated 10-year survival for linked TERs was 92% (95% CI 90-95) and unlinked TERs 84% (CI 81-88). 2 independent registries contributed 32 linked TERs and 530 unlinked TERs. The pooled registry 10-year survival for unlinked TERs was 86% (CI 83-89). Pooled 10-year PROMs from 164 TERs (33 linked and 131 unlinked), revealed a substantial improvement from baseline scores (SMD 2.7 [CI 1.6-3.8]). INTERPRETATION: Over 80% of all elbow replacements and over 90% of linked elbow replacements can last more than 10 years with sustained patient-reported benefits. This information is long overdue and will be particularly useful to patients as well as healthcare providers.

A systematic review of post-pancreatectomy haemorrhage management stratified according to ISGPS grading.

BACKGROUND: Morbidity and mortality from post-pancreatectomy haemorrhage (PPH) remains high. The International Study Group of Pancreatic Surgery (ISGPS) published guidelines to standardise definitions of PPH severity, management and reporting. This study aimed to i) identify the number of studies reporting PPH using ISGPS guidelines (Grade A, B or C) and ii) describe treatment modality success by grade. METHODS: A systematic literature review was performed, identifying studies reporting PPH by ISGPS Grade and their subsequent management. RESULTS: Of 62 studies reporting on PPH management, 17 (27.4%) stratified by ISGPS guidelines and included 608 incidences of PPH: 48 Grade A, 274 Grade B (62 early, 166 late, 46 unspecified) and 286 Grade C. 96% of Grade A PPH were treated conservatively. Of 62 early Grade B, 54.8% were managed conservatively and 37.1% surgically. Late Grade B were managed non-operatively in 25.3% (42/166), with successful endoscopy in 90.9% (10/11) and angiography in 90.3% (28/31). In Grade C, endoscopic treatment was successful in 64.4% (29/45) and angiography in 90.8% (108/119). Surgical intervention was required in 43.5% early Grade B, 7.8% late Grade B and 33.2% Grade C. CONCLUSION: PPH grading is underreported and despite guidelines, inconsistencies remain when using definitions and reporting of outcomes.

A Systematic Review of Minimally Invasive Trans-thoracic Liver Resection to Examine Intervention Description, Governance, and Outcome Reporting of an Innovative Technique.

INTRODUCTION: The number of laparoscopic liver resections undertaken has increased. However, lesions located postero-superiorly are difficult to access. This may be overcome by the novel use of trans-thoracic port(s). Methods for the safe and transparent introduction of new and modified surgical procedures are limited and a summary of these issues, for minimally invasive trans-thoracic liver resections (MITTLR), is lacking. This study aims to understand and summarize technique description, governance procedures, and reporting of outcomes for MITTLR. METHODS: A systematic literature search to identify primary studies of all designs describing MITTLR was undertaken. How patients were selected for the new technique was examined. The technical components of MITTLR were identified and summarized to understand technique development over time. Governance arrangements (eg, Institutional Review Board approval) and steps taken to mitigate harm were recorded. Finally, specific outcomes reported across studies were documented. RESULTS: Of 2067 screened articles, 16 were included reporting data from 145 patients and 6 countries. Selection criteria for patients was explicitly stated in 2 papers. No studies fully described the technique. Five papers reported ethical approval and 3 gave details of patient consent. No study reported on steps taken to mitigate harm.Technical outcomes were commonly reported, for example, blood loss (15/16 studies), operative time (15/16), and margin status (11/16). Information on patient-reported outcomes and costs were lacking. CONCLUSIONS: Technical details and governance procedures were poorly described. Outcomes focussed on short term details alone. Transparency is needed for reporting the introduction of new surgical techniques to allow their safe dissemination.

Low rate of subsequent surgery and serious complications following intra-articular steroid injection for base of thumb osteoarthritis: national cohort analysis.

OBJECTIVES: Intra-articular steroid injection is commonly used to treat base of thumb osteoarthritis (BTOA), despite a lack of large-scale data on safety and effectiveness. We estimate the incidence of serious complications and further procedures following BTOA injection, including the risk of post-operative serious surgical site infection for subsequent operative intervention. METHODS: Hospital Episode Statistics data linked to mortality records from 1 April 1998 to 31 March 2017 were used to identify all BTOA injections undertaken in adults in the National Health Service secondary care in England. Patients were followed up longitudinally until death or 31 March 2017. A multivariable regression with a Fine and Gray model adjusting for the competing risk of mortality in addition to age, sex and socioeconomic deprivation was used to identify factors associated with progression to further procedure. Secondary outcomes included serious complications after injection and subsequent surgical site infection. RESULTS: A total of 19 120 primary injections were performed during the 19-year period in 18 356 patients. Of these 76.5% were female; mean age 62 years (s.d. 10.6); 50.48% underwent further procedure; 22.40% underwent surgery. Median time to further intervention was 412 days (IQR 110-1945). Female sex was associated with increased risk of proceeding to surgery. Serious complication rate following injection was 0.04% (0.01-0.08) within 90 days. Of those proceeding to surgery 0.16% (0.06-0.34) presented with a wound infection within 30 days and 90 days, compared with an overall post-operative wound infection rate of 0.03% (0.02-0.05). CONCLUSIONS: Very low rates of serious complications were identified following BTOA injections performed in secondary care; only one in five patients proceeded to subsequent surgery. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov, https://www.clinicaltrials.gov, NCT03573765.

Patient Reported Outcome Measures for Major Lower Limb Amputation Caused by Peripheral Artery Disease or Diabetes: A Systematic Review.

OBJECTIVE: Most major lower limb amputations are related to peripheral artery disease (PAD) or diabetes. Just 40% of patients who undergo major lower limb amputation will use a prosthesis yet measures of surgical success commonly focus on prosthesis use. Patient reported outcome measures (PROMs) are valuable to comprehensively evaluate health related quality of life (HRQL) after surgery. This systematic review aimed to identify and describe PROMs available to assess HRQL in patients after amputation for PAD or diabetes. METHODS: A search was conducted based on the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) for systematic reviews of PROMs. Ovid MEDLINE, Ovid EMBASE, PsycINFO, CINAHL, and Cochrane CENTRAL were also searched from inception until August 2019. Included were articles describing the development, measurement properties, or evaluation of HRQL via a PROM in adult patients after amputation for PAD or diabetes. Studies of amputation exclusively for trauma or malignancy were excluded. Data were collected on study characteristics, PROM characteristics (generic/disease specific), and properties of amputation specific PROMs. RESULTS: Of 3 317 abstracts screened, 111 full text articles were assessed for eligibility and 64 included. Fifty-six studies evaluated HRQL, with 23 (46%) of these using an amputation specific PROM to do so. Eleven different amputation specific PROMs were identified, 10 (91%) of which were developed only for prosthesis users. One measure was suitable for use in all patients after amputation. This "Amputee single item mobility measure" includes a single item evaluating mobility. Nine studies reported some psychometric testing of an amputation specific PROM. CONCLUSION: A well tested, multidimensional PROM applicable to wheelchair and prosthetic users after amputation is lacking and urgently needed for studies in this field. Future work to develop an appropriate measure is required.

Treatment for Barrett's oesophagus.

This review has been withdrawn because it has been split into the following reviews: 'Pharmaceutical interventions for Barrett's oesophagus' and 'Endoscopic interventions for Barrett's oesophagus'.

Temporal Trends and Geographical Variation in Dupuytren Disease Surgery in England: A Population-Based Cohort Study.

BACKGROUND: Dupuytren disease (DD) is a common fibroproliferative disease of the palmar fascia. The mainstay of DD treatment in England is surgery with either percutaneous needle fasciotomy, limited fasciectomy, or dermofasciectomy. This study aimed to investigate the temporal trends and geographical variation of primary DD surgery in England. METHODS: A longitudinal population-based cohort study was perfomed using the Hospital Episode Statistics database from April 1, 2007, to March 31, 2017. Directly standarized rates were estimated over time (between financial years 2007-2008 and 2016-2017) and by geographic region (by clinical commissioning groups [CCGs]; financial years 2010-2011, 2013-2014, and 2016-2017). The Office for National Statistics midyear population estimates were used as the reference population. MAIN FINDINGS: Primary DD surgery was undertaken at a steadily increasing rate from financial year 2007 to 2008, to 2016 to 2017 in England. There was a striking 3.6-fold variation in the rates of primary DD surgery among National Health Service CCGs in England place of residence. CONCLUSIONS: This significant variation in DD surgical treatment in England suggests a need for the development of standardized surgical practice across all CCGs and National Health Service hospitals, promoting equality of access to cost-effective health care.

Understanding junior doctors' experiences of teaching on the acute take: a qualitative study.

BACKGROUND: New medical graduates are significantly unprepared to manage acutely unwell patients due to limited first-hand clinical exposure in the undergraduate curriculum. Supporting undergraduate learning in the acute setting can be challenging for junior doctors when balancing teaching and clinical responsibilities. Our aim was to explore junior doctors' first-hand experiences of supporting undergraduate education in the acute admissions environment(take). METHODS: Fourteen junior doctors in one teaching hospital in South West England took part in semi-structured focus groups (4-6 participants in each) which were audio-recorded, transcribed, and thematically analysed. RESULTS: Junior doctors described their educational role as comprising: teaching, demonstrating, coaching, and supervising. They perceived the acute take as a highly variable, unpredictable setting that offered a broad scope for learning. Tensions between doctors' clinical and educational roles were described, influenced by internal and external factors. Clinical work was prioritised over teaching and participants lacked confidence in supervisory and clinical skills. Doctors felt pressured to meet students' expectations and lacked understanding of their educational needs. Senior colleagues were highly influential in establishing an educational culture and were often a source of pressure to deliver timely clinical care. Organisations were perceived not to value teaching due to the lack of provision of dedicated teaching time and prioritisation of limited resources towards patient care. Participants managed tensions by attempting to formally separate roles, demoting students to passive observers, and they sought greater continuity in placements to better understand students' abilities and expectations. CONCLUSIONS: Educational opportunities for undergraduate students on the acute take are varied and highly valuable. This study provides insight into the provision of workplace education and its challenges from junior doctors' perspectives. We highlight areas for improvement of relevance to educational providers.

Impact of SARS-CoV-2 pandemic on pancreatic cancer services and treatment pathways: United Kingdom experience.

INTRODUCTION: The SARS-CoV-2 pandemic presented healthcare providers with an extreme challenge to provide cancer services. The impact upon the diagnostic and treatment capacity to treat pancreatic cancer is unclear. This study aimed to identify national variation in treatment pathways during the pandemic. METHODS: A survey was distributed to all United Kingdom pancreatic specialist centres, to assess diagnostic, therapeutic and interventional services availability, and alterations in treatment pathways. A repeating methodology enabled assessment over time as the pandemic evolved. RESULTS: Responses were received from all 29 centres. Over the first six weeks of the pandemic, less than a quarter of centres had normal availability of diagnostic pathways and a fifth of centres had no capacity whatsoever to undertake surgery. As the pandemic progressed services have gradually improved though most centres remain constrained to some degree. One third of centres changed their standard resectable pathway from surgery-first to neoadjuvant chemotherapy. Elderly patients, and those with COPD were less likely to be offered treatment during the pandemic. CONCLUSION: The COVID-19 pandemic has affected the capacity of the NHS to provide diagnostic and staging investigations for pancreatic cancer. The impact of revised treatment pathways has yet to be realised.

TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls.

BACKGROUND: Placebo or sham controls are the standard against which the benefits and harms of many active interventions are measured. Whilst the components and the method of their delivery have been shown to affect study outcomes, placebo and sham controls are rarely reported and often not matched to those of the active comparator. This can influence how beneficial or harmful the active intervention appears to be. Without adequate descriptions of placebo or sham controls, it is difficult to interpret results about the benefits and harms of active interventions within placebo-controlled trials. To overcome this problem, we developed a checklist and guide for reporting placebo or sham interventions. METHODS AND FINDINGS: We developed an initial list of items for the checklist by surveying experts in placebo research (n = 14). Because of the diverse contexts in which placebo or sham treatments are used in clinical research, we consulted experts in trials of drugs, surgery, physiotherapy, acupuncture, and psychological interventions. We then used a multistage online Delphi process with 53 participants to determine which items were deemed to be essential. We next convened a group of experts and stakeholders (n = 16). Our main output was a modification of the existing Template for Intervention Description and Replication (TIDieR) checklist; this allows the key features of both active interventions and placebo or sham controls to be concisely summarised by researchers. The main differences between TIDieR-Placebo and the original TIDieR are the explicit requirement to describe the setting (i.e., features of the physical environment that go beyond geographic location), the need to report whether blinding was successful (when this was measured), and the need to present the description of placebo components alongside those of the active comparator. CONCLUSIONS: We encourage TIDieR-Placebo to be used alongside TIDieR to assist the reporting of placebo or sham components and the trials in which they are used.

Proresolving Mediators LXB4 and RvE1 Regulate Inflammation in Stromal Cells from Patients with Shoulder Tendon Tears.

Tendon stromal cells isolated from patients with chronic shoulder rotator cuff tendon tears have dysregulated resolution responses. Current therapies do not address the biological processes concerned with persistent tendon inflammation; therefore, new therapeutic approaches that target tendon stromal cells are required. We examined whether two specialized proresolving mediators (SPMs), lipoxin B4 (LXB4) and resolvin E1 (RvE1), modulate the bioactive lipid mediator profiles of IL-1ß-stimulated tendon cells derived from patients with shoulder tendon tears and healthy volunteers. We also examined whether LXB4 or RvE1 treatments moderated the proinflammatory phenotype of tendon tear stromal cells. Incubation of IL-1ß-treated patient-derived tendon cells in LXB4 or RvE1 up-regulated concentrations of SPMs. RvE1 treatment of diseased tendon stromal cells increased 15-epi-LXB4 and regulated postaglandin F2α. LXB4 or RvE1 also induced expression of the SPM biosynthetic enzymes 12-lipoxygenase and 15-lipoxygenase. RvE1 treatment up-regulated the proresolving receptor human resolvin E1 compared with vehicle-treated cells. Incubation in LXB4 or RvE1 moderated the proinflammatory phenotype of patient-derived tendon tear cells, regulating markers of tendon inflammation, including podoplanin, CD90, phosphorylated signal transducer and activator of transcription 1, and IL-6. LXB4 and RvE1 counterregulate inflammatory processes in tendon stromal cells, supporting the role of these molecules as potential therapeutics to resolve tendon inflammation.

Differences in Patient-Reported Outcomes That Are Most Frequently Detected in Randomized Controlled Trials in Patients With Solid Tumors: A Pooled Analysis of 229 Trials.

OBJECTIVES: Patient-reported outcome (PRO) measurements used in cancer research can assess a number of health domains. Our primary objective was to investigate which broad types of PRO domains (namely, functional health, symptoms, and global quality of life [QoL]) most frequently yielded significant differences between treatments in randomized controlled trials (RCTs). METHODS: A total of 229 RCTs published between January 2004 and February 2019, conducted on patients diagnosed with the most common solid malignancies and assessed using the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30, were considered. Studies were identified systematically using literature searches in key electronic databases. Unlike other PRO measurements typically used in RCTs, the scoring algorithm of the multidimensional EORTC QLQ-C30 allowed us to clearly distinguish the 3 broad types of PRO domains. RESULTS: In total, 134 RCTs (58.5%) reported statistically significant differences between treatment arms for at least 1 of the QLQ-C30 domains. Most frequently, differences were reported for 2 or all 3 broad types of PRO domains (78 of 134 trials; 58.2%). In particular, 35 trials (26.1%) found significant differences for symptoms, functional health, and global QoL, 24 trials (17.9%) for symptoms and functional health, 11 trials (8.2%) for functional health and global QoL, and 8 trials (6.0%) for symptoms and global QoL. The likelihood of finding a statistically significant difference between treatment arms was not associated with key study characteristics, such as study design (ie, open-label vs blinded trials) and industry support. CONCLUSIONS: Our findings emphasize the importance of a multidimensional PRO assessment to most comprehensively capture the overall burden of therapy from the patients' standpoint.

Shoulder replacement surgery for osteoarthritis and rotator cuff tear arthropathy.

BACKGROUND: Shoulder replacement surgery is an established treatment for patients with end-stage glenohumeral osteoarthritis or rotator cuff tear arthropathy who have not improved with non-operative treatment. Different types of shoulder replacement are commonly used, but their relative benefits and risks compared versus one another and versus other treatments are uncertain. This expanded scope review is an update of a Cochrane Review first published in 2010. OBJECTIVES: To determine the benefits and harms of shoulder replacement surgery in adults with osteoarthritis (OA) of the shoulder, including rotator cuff tear arthropathy (RCTA). SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, CINAHL, SportDiscus, and Web of Science up to January 2019. We also searched clinical trial registers, conference proceedings, and reference lists from previous systematic reviews and included studies. SELECTION CRITERIA: We included randomised studies comparing any type of shoulder replacement surgery versus any other surgical or non-surgical treatment, no treatment, or placebo. We also included randomised studies comparing any type of shoulder replacement or technique versus another. Study participants were adults with osteoarthritis of the glenohumeral joint or rotator cuff tear arthropathy. We assessed the following major outcomes: pain, function, participant-rated global assessment of treatment success, quality of life, adverse events, serious adverse events, and risk of revision or re-operation or treatment failure. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and extracted data. We collected trial data on benefits and harms. MAIN RESULTS: We included 20 studies involving 1083 participants (1105 shoulders). We found five studies comparing one type of shoulder replacement surgery to another type of shoulder replacement surgery, including three studies comparing conventional stemmed total shoulder replacement (TSR) surgery to stemmed humeral hemiarthroplasty. The remaining 15 studies compared one type of shoulder replacement to the same type of replacement performed with a technical modification or a different prosthetic component. We found no studies comparing shoulder replacement surgery to any other type of surgical treatment or to any type of non-surgical treatment. We found no studies comparing reverse total shoulder replacement surgery to any other type of treatment or to any type of replacement. Trial size varied from 16 to 161 participants. Participant mean age ranged from 63 to 81 years. 47% of participants were male. Sixteen trials reported participants with a diagnosis of osteoarthritis and intact rotator cuff tendons. Four trials reported patients with osteoarthritis and a rotator cuff tear or rotator cuff tear arthropathy. All studies were at unclear or high risk of bias for at least two domains, and only one study was free from high risk of bias (included in the main comparison). The most common sources of bias were lack of blinding of participants and assessors, attrition, and major baseline imbalance. Three studies allowed a comparison of conventional stemmed TSR surgery versus stemmed humeral hemiarthroplasty in people with osteoarthritis. At two years, low-quality evidence from two trials (downgraded for bias and imprecision) suggested there may be a small but clinically uncertain improvement in pain and function. On a scale of 0 to 10 (0 is no pain), mean pain was 2.78 points after stemmed humeral hemiarthroplasty and 1.49 points lower (0.1 lower to 2.88 lower) after conventional stemmed TSR. On a scale of 0 to 100 (100 = normal function), the mean function score was 72.8 points after stemmed humeral hemiarthroplasty and 10.57 points higher (2.11 higher to 19.02 higher) after conventional stemmed TSR. There may be no difference in quality of life based on low-quality evidence, downgraded for risk of bias and imprecision. On a scale of 0 to 100 (100 = normal), mean mental quality of life was rated as 57.4 points after stemmed humeral hemiarthroplasty and 1.0 point higher (5.1 lower to 7.1 higher) after conventional stemmed TSR. We are uncertain whether there is any difference in the rate of adverse events or the rate of revision, re-operation, or treatment failure based on very low-quality evidence (downgraded three levels for risk of bias and serious imprecision). The rate of any adverse event following stemmed humeral hemiarthroplasty was 286 per 1000, and following conventional stemmed TSR 143 per 1000, for an absolute difference of 14% fewer events (25% fewer to 21% more). Adverse events included fractures, dislocations, infections, and rotator cuff failure. The rate of revision, re-operation, or treatment failure was 103 per 1000, and following conventional stemmed TSR 77 per 1000, for an absolute difference of 2.6% fewer events (8% fewer to 15% more). Participant-rated global assessment of treatment success was not reported. AUTHORS' CONCLUSIONS: Although it is an established procedure, no high-quality randomised trials have been conducted to determine whether shoulder replacement might be more effective than other treatments for osteoarthritis or rotator cuff tear arthropathy of the shoulder. We remain uncertain about which type or technique of shoulder replacement surgery is most effective in different situations. When humeral hemiarthroplasty was compared to TSR surgery for osteoarthritis, low-quality evidence led to uncertainty about whether there is a clinically important benefit for patient-reported pain or function and suggested there may be little or no difference in quality of life. Evidence is insufficient to show whether TSR is associated with greater or less risk of harm than humeral hemiarthroplasty. Available randomised studies did not provide sufficient data to reliably inform conclusions about adverse events and harm. Although reverse TSR is now the most commonly performed type of shoulder replacement, we found no studies comparing reverse TSR to any other type of treatment.

ICON 2019-International Scientific Tendinopathy Symposium Consensus: There are nine core health-related domains for tendinopathy (CORE DOMAINS): Delphi study of healthcare professionals and patients.

BACKGROUND: The absence of any agreed-upon tendon health-related domains hampers advances in clinical tendinopathy research. This void means that researchers report a very wide range of outcome measures inconsistently. As a result, substantial synthesis/meta-analysis of tendon research findings is almost futile despite researchers publishing busily. We aimed to determine options for, and then define, core health-related domains for tendinopathy. METHODS: We conducted a Delphi study of healthcare professionals (HCP) and patients in a three-stage process. In stage 1, we extracted candidate domains from clinical trial reports and developed an online survey. Survey items took the form: 'The 'candidate domain' is important enough to be included as a core health-related domain of tendinopathy'; response options were: agree, disagree, or unsure. In stage 2, we administered the online survey and reported the findings. Stage 3 consisted of discussions of the findings of the survey at the ICON (International Scientific Tendinopathy Symposium Consensus) meeting. We set 70% participant agreement as the level required for a domain to be considered 'core'; similarly, 70% agreement was required for a domain to be relegated to 'not core' (see Results next). RESULTS: Twenty-eight HCP (92% of whom had >10 years of tendinopathy experience, 71% consulted >10 cases per month) and 32 patients completed the online survey. Fifteen HCP and two patients attended the consensus meeting. Of an original set of 24 candidate domains, the ICON group deemed nine domains to be core. These were: (1) patient rating of condition, (2) participation in life activities (day to day, work, sport), (3) pain on activity/loading, (4) function, (5) psychological factors, (6) physical function capacity, (7) disability, (8) quality of life and (9) pain over a specified time. Two of these (2, 6) were an amalgamation of five candidate domains. We agreed that seven other candidate domains were not core domains: range of motion, pain on clinician applied test, clinical examination, palpation, drop out, sensory modality pain and pain without other specification. We were undecided on the other five candidate domains of physical activity, structure, medication use, adverse effects and economic impact. CONCLUSION: Nine core domains for tendon research should guide reporting of outcomes in clinical trials. Further research should determine the best outcome measures for each specific tendinopathy (ie, core outcome sets).

ICON PART-T 2019-International Scientific Tendinopathy Symposium Consensus: recommended standards for reporting participant characteristics in tendinopathy research (PART-T).

We aimed to establish consensus for reporting recommendations relating to participant characteristics in tendon research. A scoping literature review of tendinopathy studies (Achilles, patellar, hamstring, gluteal and elbow) was followed by an online survey and face-to-face consensus meeting with expert healthcare professionals (HCPs) at the International Scientific Tendon Symposium, Groningen 2018. We reviewed 263 papers to form statements for consensus and invited 30 HCPs from different disciplines and geographical locations; 28 completed the survey and 15 attended the meeting. There was consensus that the following data should be reported for cases and controls: sex, age, standing height, body mass, history of tendinopathy, whether imaging was used to confirm pathology, loading tests, pain location, symptom duration and severity, level of disability, comorbidities, physical activity level, recruitment source and strategies, and medication use history. Standardised reporting of participant characteristics aims to benefit patients and clinicians by guiding researchers in the conduct of their studies. We provide free resources to facilitate researchers adopting our recommendations.

Arthroscopic subacromial decompression for subacromial shoulder pain (CSAW): a multicentre, pragmatic, parallel group, placebo-controlled, three-group, randomised surgical trial.

BACKGROUND: Arthroscopic sub-acromial decompression (decompressing the sub-acromial space by removing bone spurs and soft tissue arthroscopically) is a common surgery for subacromial shoulder pain, but its effectiveness is uncertain. We did a study to assess its effectiveness and to investigate the mechanism for surgical decompression. METHODS: We did a multicentre, randomised, pragmatic, parallel group, placebo-controlled, three-group trial at 32 hospitals in the UK with 51 surgeons. Participants were patients who had subacromial pain for at least 3 months with intact rotator cuff tendons, were eligible for arthroscopic surgery, and had previously completed a non-operative management programme that included exercise therapy and at least one steroid injection. Exclusion criteria included a full-thickness torn rotator cuff. We randomly assigned participants (1:1:1) to arthroscopic subacromial decompression, investigational arthroscopy only, or no treatment (attendance of one reassessment appointment with a specialist shoulder clinician 3 months after study entry, but no intervention). Arthroscopy only was a placebo as the essential surgical element (bone and soft tissue removal) was omitted. We did the randomisation with a computer-generated minimisation system. In the surgical intervention groups, patients were not told which type of surgery they were receiving (to ensure masking). Patients were followed up at 6 months and 1 year after randomisation; surgeons coordinated their waiting lists to schedule surgeries as close as possible to randomisation. The primary outcome was the Oxford Shoulder Score (0 [worst] to 48 [best]) at 6 months, analysed by intention to treat. The sample size calculation was based upon a target difference of 4·5 points (SD 9·0). This trial has been registered at ClinicalTrials.gov, number NCT01623011. FINDINGS: Between Sept 14, 2012, and June 16, 2015, we randomly assigned 313 patients to treatment groups (106 to decompression surgery, 103 to arthroscopy only, and 104 to no treatment). 24 [23%], 43 [42%], and 12 [12%] of the decompression, arthroscopy only, and no treatment groups, respectively, did not receive their assigned treatment by 6 months. At 6 months, data for the Oxford Shoulder Score were available for 90 patients assigned to decompression, 94 to arthroscopy, and 90 to no treatment. Mean Oxford Shoulder Score did not differ between the two surgical groups at 6 months (decompression mean 32·7 points [SD 11·6] vs arthroscopy mean 34·2 points [9·2]; mean difference -1·3 points (95% CI -3·9 to 1·3, p=0·3141). Both surgical groups showed a small benefit over no treatment (mean 29·4 points [SD 11·9], mean difference vs decompression 2·8 points [95% CI 0·5-5·2], p=0·0186; mean difference vs arthroscopy 4·2 [1·8-6·6], p=0·0014) but these differences were not clinically important. There were six study-related complications that were all frozen shoulders (in two patients in each group). INTERPRETATION: Surgical groups had better outcomes for shoulder pain and function compared with no treatment but this difference was not clinically important. Additionally, surgical decompression appeared to offer no extra benefit over arthroscopy only. The difference between the surgical groups and no treatment might be the result of, for instance, a placebo effect or postoperative physiotherapy. The findings question the value of this operation for these indications, and this should be communicated to patients during the shared treatment decision-making process. FUNDING: Arthritis Research UK, the National Institute for Health Research Biomedical Research Centre, and the Royal College of Surgeons (England).