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Background: Manipulation under anaesthesia and arthroscopic capsular release are costly and invasive treatments for frozen shoulder, but their effectiveness remains uncertain. We compared these two surgical interventions with early structured physiotherapy plus steroid injection., Methods: In this multicentre, pragmatic, three-arm, superiority randomised trial, patients referred to secondary care for treatment of primary frozen shoulder were recruited from 35 hospital sites in the UK. Participants were adults (≥18 years) with unilateral frozen shoulder, characterised by restriction of passive external rotation (≥50%) in the affected shoulder. Participants were randomly assigned (2:2:1) to receive manipulation under anaesthesia, arthroscopic capsular release, or early structured physiotherapy. In manipulation under anaesthesia, the surgeon manipulated the affected shoulder to stretch and tear the tight capsule while the participant was under general anaesthesia, supplemented by a steroid injection. Arthroscopic capsular release, also done under general anaesthesia, involved surgically dividing the contracted anterior capsule in the rotator interval, followed by manipulation, with optional steroid injection. Both forms of surgery were followed by postprocedural physiotherapy. Early structured physiotherapy involved mobilisation techniques and a graduated home exercise programme supplemented by a steroid injection. Both early structured physiotherapy and postprocedural physiotherapy involved 12 sessions during up to 12 weeks. The primary outcome was the Oxford Shoulder Score (OSS; 0-48) at 12 months after randomisation, analysed by initial randomisation group. We sought a target difference of 5 OSS points between physiotherapy and either form of surgery, or 4 points between manipulation and capsular release. The trial registration is ISRCTN48804508., Findings: Between April 1, 2015, and Dec 31, 2017, we screened 914 patients, of whom 503 (55%) were randomly assigned. At 12 months, OSS data were available for 189 (94%) of 201 participants assigned to manipulation (mean estimate 38·3 points, 95% CI 36·9 to 39·7), 191 (94%) of 203 participants assigned to capsular release (40·3 points, 38·9 to 41·7), and 93 (94%) of 99 participants assigned to physiotherapy (37·2 points, 35·3 to 39·2). The mean group differences were 2·01 points (0·10 to 3·91) between the capsular release and manipulation groups, 3·06 points (0·71 to 5·41) between capsular release and physiotherapy, and 1·05 points (-1·28 to 3·39) between manipulation and physiotherapy. Eight serious adverse events were reported with capsular release and two with manipulation. At a willingness-to-pay threshold of £20 000 per quality-adjusted life-year, manipulation under anaesthesia had the highest probability of being cost-effective (0·8632, compared with 0·1366 for physiotherapy and 0·0002 for capsular release)., Interpretation: All mean differences on the assessment of shoulder pain and function (OSS) at the primary endpoint of 12 months were less than the target differences. Therefore, none of the three interventions were clinically superior. Arthoscopic capsular release carried higher risks, and manipulation under anaesthesia was the most cost-effective., Funding: The National Institute for Health Research Health Technology Assessment programme., (Copyright © 2020 The Author(s). Publishedx by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Introduction: A patient-relevant, focused Core Outcome Set (COS) is essential to the design of clinical trials dealing with chest wall trauma, in order to maximise quality of evidence regarding impact of interventions and to reduce research waste., Methods: Outcome measures were collated by way of systematic review and entered into a three round Delphi consensus completed anonymously online. Participants were international clinicians and allied health professionals (AHP) involved in the treatment of rib fractures as well as patients who had experienced severe chest trauma. Consensus thresholds for statements were defined a priori as a group rating of more than 70% or less than 15% for 'important' or 'not important'., Results: Sixty-five participants responded to the first round and the final round Final round consisted of five AHP, two patients and 16 clinicians from eight different countries. Twenty-three outcomes were regarded as important for the COS; eight adverse events, three mortality, five clinical or physiological outcomes, six life impact and one resource-related. Health related quality of life was rated highest of the life impact outcomes but participants thought it was also important to assess disability, physical function, quality of life, return to activities and return to work., Conclusion: Collecting serious adverse outcomes was important to all stakeholders as were life impact outcomes such as quality of life, physical function and return to activities. Resource use outcomes were considered less important. We recommend this Core Outcome Set, developed with multiple relevant stakeholders, for use in future clinical trials, following further work on the most appropriate methods and instruments for measurement., Competing Interests: Declaration of Competing Interest AR declares receiving research and educational grants from DePuy Ltd outside the submitted work. York Trials Unit receives funding from the British Orthopaedic Association (BOA) for the BOA Orthopaedic Surgery Research Centre (BOSRC)., (Copyright © 2019. Published by Elsevier Ltd.)

Introduction: Chest wall trauma is commonly seen in patients admitted with both high and low-energy transfer injury. Whilst often associated with other injuries, it is also seen in isolation following simple falls in the older patient. Fixation of the chest wall grows in popularity as part of optimising patient care, particularly in terms of critical care stay. There is currently no description of the epidemiology of these injuries at a national level; nor has there been identification of factors that predict which of these patients undergoes surgery., Methods: The United Kingdom Trauma Audit & Research Network (TARN) database was analysed for the period April 2016 to 30th May 2017 for all adult patients presenting with a rib or sternal fracture. Characteristics of the population were described and a binary logistic regression model constructed to explore the influences of several explanatory variables on whether fixation was performed., Results: Of 16,638 patients with chest wall trauma, 402 underwent fixation. Most chest wall injury patients were admitted under three specialties (orthopaedics (19.1%), emergency medicine (16.6%) and general surgery (17.7%)). The odds of fixation in unilateral flail chest was 107.51 (p <0.0001), in bilateral flail or combined complexsternal fracture 47.63 (p = 0.007) and in 3 or more non-flail ribs 15.62 (p<0.0001) when compared to less than three non-flail rib fractures. The odds of fixation was higher in an MTC (p<0.0001) compared to a non-specialist hospital. The odds of fixation was higher in older patients (1.02, p<0.0001) and the more severely injured (1.02, p<0.0001)., Conclusion: There is considerable variation nationally in the management of chest wall trauma. Injury type, patient age and care setting contribute to decision making in fracture fixation. This unique national dataset characterises for the first time the nature of contemporary chest wall trauma management and should help inform the design of future research on this topic., Competing Interests: Declaration of Competing Interest AR declares receiving research and educational grants from DePuy Ltd outside the submitted work. York Trials Unit receives funding from the BOA for the BOA Orthopaedic Surgery Research Centre (BOSRC), (Copyright © 2019. Published by Elsevier Ltd.)

Non-opioid analgesics, paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs), or cyclo-oxygenase 2 (COX-2) inhibitors are often given along with morphine as part of multimodal analgesia after major surgery. We have undertaken a systematic review and a mixed treatment comparison (MTC) analysis in order to determine explicitly which class of non-opioid analgesic, paracetamol, NSAIDs, or COX-2 inhibitors is the most effective in reducing morphine consumption and morphine-related adverse effects. Sixty relevant studies were identified. The MTC found that when paracetamol, NSAIDs, or COX-2 inhibitors were added to patient-controlled analgesia (PCA) morphine, there was a statistically significant reduction in morphine consumption: paracetamol [mean difference (MD) -6.34 mg; 95% credibility interval (CrI) -9.02, -3.65], NSAIDs (MD -10.18; 95% CrI -11.65, -8.72), and COX-2 inhibitors (MD -10.92; 95% CrI -12.77, -9.08). There was a significant reduction in nausea and postoperative nausea and vomiting with NSAIDs compared with placebo (odds ratio 0.70; 95% CrI 0.53, 0.88) but not for paracetamol or COX-2 inhibitors, nor for NSAIDs compared with paracetamol or COX-2 inhibitors. There was no statistically significant difference in sedation between any intervention and comparator. On the basis of six trials (n=695), 2.4% of participants receiving an NSAID experienced surgical-related bleeding compared with 0.4% with placebo. The MTC found that there is a decrease in 24 h morphine consumption when paracetamol, NSAID, or COX-2 inhibitors are given in addition to PCA morphine after surgery, with no clear difference between them. Similarly, the benefits in terms of reduction in morphine-related adverse effects do not strongly favour one of the three non-opioid analgesics.

Objective: To investigate the barriers, modifiers, and benefits involved in participating in randomized controlled trials of cancer therapies as perceived by health care providers and patients., Study Design and Setting: We conducted a systematic review of the literature to identify published and unpublished studies in any language using electronic databases searched from 1996 to 2004, contact with experts, and reference lists. All study designs were acceptable provided relevant data were reported. Two reviewers were involved in the selection of studies, data extraction, and quality assessment processes. Studies were combined in a narrative synthesis., Results: Fifty-six studies met the inclusion criteria and represented the perspective of the patient or the health care provider or both. Although a range of barriers to trial participation were identified, a number of threats to the internal and external validity of the included studies limited interpretation of the evidence., Conclusion: The limitations within the evidence base do not permit a clear interpretation of the barriers, moderators, and benefits involved in participation in cancer trials. We recommend that trialists prospectively identify the issues relevant to a particular trial using the current research as a starting point. We report checklists to guide this process.