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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.)

Background: PROSPERO is an international prospective register for systematic review protocols. Many of the registrations are the only available source of information about planned methods. This study investigated the extent to which records in PROSPERO contained the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P). Methods : A random sample of 439 single entry PROSPERO records of reviews of health interventions registered in 2018 was identified. Using a piloted list of 19 PRISMA-P items, divided into 63 elements, two researchers independently assessed the registration records. Where the information was present or not applicable to the review, a score of 1 was assigned. Overall scores were calculated and comparisons made by stage of review at registration, whether or not a meta-analysis was planned and whether or not funding/sponsorship was reported. Results : Some key methodological details, such as eligibility criteria, were relatively frequently reported, but much of the information recommended in PRISMA-P was not stated in PROSPERO registrations. Considering the 19 items, the mean score was 4.8 (SD 1.8; median 4; range 2-11) and across all the assessed records only 25% (2081/8227) of the items were scored as reported. Considering the 63 elements, the mean score was 33.4 (SD 5.8; median 33; range 18-47) and overall, 53% (14,469/27,279) of the elements were assessed as reported. Reporting was more frequent for items required in PROSPERO than optional items. The planned comparisons showed no meaningful differences between groups. Conclusions : PROSPERO provides reviewers with the opportunity to be transparent in their planned methods and demonstrate efforts to reduce bias. However, where the PROSPERO record is the only available source of a priori reporting, there is a significant shortfall in the items reported, compared to those recommended. This presents challenges in interpretation for those wishing to assess the validity of the final review., Competing Interests: Competing interests: AB led on the development of PROSPERO and is a group author of the PRISMA-P reporting guidelines papers. AB has not been involved in the management of PROSPERO since 2015. SC, SJ, SG, ASM, AM and CM declare they have no conflicts of interest., (Copyright: © 2020 Booth A et al.)

Objective: To obtain consensus on the content and delivery of an occupational advice intervention for patients undergoing primary hip and knee replacement surgery. The primary targets for the intervention were (1) patients, carers and employers through the provision of individualised support and information about returning to work and (2) hospital orthopaedic teams through the development of a framework and materials to enable this support and information to be delivered., Design: Modified Delphi study as part of a wider intervention development study (The Occupational advice for Patients undergoing Arthroplasty of the Lower limb (OPAL) study: Health Technology Assessment Reference 15/28/02) (ISRCTN27426982)., Setting: Five stakeholder groups (patients, employers, orthopaedic surgeons, general practitioners, allied health professionals and nurses) recruited from across the UK., Participants: Sixty-six participants., Methods: Statements for the Delphi process were developed relating to the content, format, delivery, timing and measurement of an occupational advice intervention. The statements were based on evidence gathered through the OPAL study that was processed using an intervention mapping framework. Intervention content was examined in round 1 and intervention format, delivery, timing and measurement were examined in round 2. In round 3, the developed intervention was presented to the stakeholder groups for comment., Consensus: For rounds 1 and 2, consensus was defined as 70% agreement or disagreement on a 4-point scale. Statements reaching consensus were ranked according to the distribution of responses to create a hierarchy of agreement. Round 3 comments were used to revise the final version of the developed occupational advice intervention., Results: Consensus was reached for 36 of 64 round 1 content statements (all agreement). In round 2, 13 questions were carried forward and an additional 81 statements were presented. Of these, 49 reached consensus (44 agreement/5 disagreement). Eleven respondents provided an appraisal of the intervention in round 3., Conclusions: The Delphi process informed the development of an occupational advice intervention as part of a wider intervention development study. Stakeholder agreement was achieved for a large number of intervention elements encompassing the content, format, delivery and timing of the intervention. The effectiveness and cost-effectiveness of the developed intervention will require evaluation in a randomised controlled trial., Trial Registration Number: International Standard Randomised Controlled Trials Number Trial ID: ISRCTN27426982., Competing Interests: Competing interests: AR is supported by the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC). CM is a member of the NIHR HTA and EME Editorial Boards., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)

Background: There are increasing numbers of total hip replacements (THR) and total knee replacements (TKR) being performed in patients of working age. Providing patients undergoing TKR and THR with return to work advice might facilitate return to work. The aim of this paper is to report on the process used to systematically develop an occupational advice intervention to be delivered in hospital for those undergoing arthroplasty., Methods: The six-step Intervention Mapping (IM) approach to development, implementation and evaluation of a theory and evidence-based interventions was followed. This paper reports on the development of the intervention covered by steps 1 to 4 of the IM process. Steps 1-3 gathered data on current practice and barriers to change using a mixed methods approach (cohort study of patients undergoing THR or TKR, stakeholder interviews, survey of practice, evidence synthesis) and provided a theoretical framework for intervention development. Step 4 used information from steps 1-3 in combination with a Delphi consensus process to develop the intervention and the associated tools and materials to facilitate its delivery., Results: The final intervention identified included a number of core principles including: early patient identification; delivery of key information to patients and their employers; assessment and support by a member of the orthopaedic team; procedures for escalation based on patient need; mechanisms to support communication; and training and support for the clinical teams delivering care. A total of 13 patient and 20 staff performance objectives as delivery requirements, were supported by a range of tools, roles and training resources. The intervention addressed outcomes based at the individual and interpersonal levels of the ecological model., Conclusions: Following the IM approach resulted in a structured and justified occupational intervention for delivery in secondary care for patients undergoing total hip and knee replacement. The feasibility of the intervention will subsequently be tested alongside further investigation to establish its effectiveness and cost-effectiveness.

Perioperative blood transfusion is associated with poorer postoperative outcomes following hip and knee replacement surgery. Evidence for the effectiveness of some measures aimed at reducing blood transfusions in this setting are limited and often rely on weak pre-post study designs. Quasi-experimental study designs such as interrupted time series (ITS) and regression discontinuity design (RDD) address many of the weaknesses of the pre-post study design. In addition, a priori publication of statistical analysis plans for such studies increases their transparency and likely validity, as readers are able to distinguish between pre-planned and exploratory analyses. As such, this article, written prospective of any analysis, provides the statistical analysis plan for an ITS and RDD study based on a data set of 20,772 primary elective hip and knee replacement patients in a single English NHS Trust. The primary aim is to evaluate the impact of a preoperative anaemia optimisation service on perioperative blood transfusion (within 7 days of surgery) using both ITS and RDD methods. A secondary aim is to evaluate the impact of a policy of increased tranexamic acid dose given at the time of surgery, using ITS methods., Competing Interests: Competing interests: No specific funding was received for this study. However, all authors are involved in a clinical trial which is partially funded by Vifor Pharma who market an IV iron preparation. This manuscript has no direct relevance, but the trial topic was related to anaemia management. The lead author (AS) is currently undertaking a PhD which is partially funded by the same trial grant. Vifor Pharma (or any other funding body) have had no input, involvement or influence in this manuscript, and have not seen the manuscript prior to submission. York Trials Unit acknowledge funding from the British Orthopaedic Association., (Copyright: © 2021 Scrimshire AB et al.)

Perioperative blood transfusion is associated with poorer postoperative outcomes following hip and knee replacement surgery. Evidence for the effectiveness of some measures aimed at reducing blood transfusions in this setting are limited and often rely on weak pre-post study designs. Quasi-experimental study designs such as interrupted time series (ITS) and regression discontinuity design (RDD) address many of the weaknesses of the pre-post study design. In addition, a priori publication of statistical analysis plans for such studies increases their transparency and likely validity, as readers are able to distinguish between pre-planned and exploratory analyses. As such, this article, written prospective of any analysis, provides the statistical analysis plan for an ITS and RDD study based on a data set of 20,772 primary elective hip and knee replacement patients in a single English NHS Trust. The primary aim is to evaluate the impact of a preoperative anaemia optimisation service on perioperative blood transfusion (within 7 days of surgery) using both ITS and RDD methods. A secondary aim is to evaluate the impact of a policy of increased tranexamic acid dose given at the time of surgery, using ITS methods., Competing Interests: Competing interests: No specific funding was received for this study. However, all authors are involved in a clinical trial which is partially funded by Vifor Pharma who market an IV iron preparation. This manuscript has no direct relevance, but the trial topic was related to anaemia management. The lead author (AS) is currently undertaking a PhD which is partially funded by the same trial grant. Vifor Pharma (or any other funding body) have had no input, involvement or influence in this manuscript, and have not seen the manuscript prior to submission. York Trials Unit acknowledge funding from the British Orthopaedic Association., (Copyright: © 2020 Scrimshire AB et al.)

Background: A thoracolumbar fracture is the most common fracture of the spinal column. Where the fracture is not obviously stable or unstable, the optimal management is uncertain. There are variations between surgeons, treating centres and within the evidence base as to whether surgical or non-surgical approaches should be used. In addition, the boundaries of this zone of uncertainty for stability are unclear.This study has been designed in response to an NIHR HTA commissioning brief to assess the feasibility of undertaking a large-scale trial to evaluate the effectiveness of surgical and non-surgical treatments for thoracolumbar fractures without neurological deficit., Methods: Assessment of feasibility will be addressed through three elements: a randomised external feasibility study, a national survey of surgeons and a qualitative study.The external feasibility study is a pragmatic, parallel-group, randomised controlled trial comparing surgical fixation (intervention) versus non-surgical management (control). Recruitment will take place in three secondary care centres in the UK.The primary outcome is recruitment rate, defined as the proportion of eligible participants who are randomised. Further outcomes related to recruitment, randomisation, drop-out, cross-over, loss to follow-up, completeness of outcome data, study processes and details of the interventions delivered will be collected.The survey of surgeons and qualitative study of clinicians, recruiting staff and patients will enhance the feasibility study, enabling a broad overview of current practice in the field in addition to perceived facilitators and barriers to running a full-scale trial., Discussion: PRESTO is a feasibility study which aims to inform methodology for a definitive trial comparing surgical fixation with non-surgical management for patients with stable thoracolumbar fractures., Trial Registration: The trial is registered with the International Standard Randomised Controlled Trial Register (ISRCTN12094890). Date of registration was 22/02/2018 (http://www.isrctn.com/ISRCTN12094890)., Competing Interests: Competing interestsThe authors declare that they have no conflicts of interest., (© The Author(s) 2020.)

Background: Academic dishonesty (AD) is an increasing challenge for universities worldwide. The rise of the Internet has further increased opportunities for students to cheat., Aims: In this study, we investigate the role of personality traits defined within Reinforcement Sensitivity Theory (RST) as potential determinants of AD. RST defines behaviour as resulting from approach (Reward Interest/reactivity, goal-drive, and Impulsivity) and avoidance (behavioural inhibition and Fight-Flight-Freeze) motivations. We further consider the role of deep, surface, or achieving study motivations in mediating/moderating the relationship between personality and AD., Sample: A sample of UK undergraduates (N = 240)., Method: All participants completed the RST Personality Questionnaire, a short-form version of the study process questionnaire and a measure of engagement in AD, its perceived prevalence, and seriousness., Results: Results showed that RST traits account for additional variance in AD. Mediation analysis suggested that GDP predicted dishonesty indirectly via a surface study approach while the indirect effect via deep study processes suggested dishonesty was not likely. Likelihood of engagement in AD was positively associated with personality traits reflecting Impulsivity and Fight-Flight-Freeze behaviours. Surface study motivation moderated the Impulsivity effect and achieving motivation the FFFS effect such that cheating was even more likely when high levels of these processes were used., Conclusions: The findings suggest that motivational personality traits defined within RST can explain variance in the likelihood of engaging in dishonest academic behaviours., (© 2019 The British Psychological Society.)

Background: Measures shown to improve outcomes for patients often fail to be adopted into routine practice in the NHS. The Institute for Health Improvement Breakthrough Series Collaborative (BSC) model is designed to support implementation at scale. This trial aims to assess the effectiveness and cost-effectiveness of quality improvement collaboratives (QICs) based on the BSC method for introducing service improvements at scale in the NHS., Methods: Forty Trusts will be randomised (1:1) to introduce one of two protocols already shown to improve outcomes in patients undergoing elective total hip and knee replacement surgery. The intervention is improvement collaboratives based on the BSC model, a learning system that brings together a large number of teams to seek improvement focussed on a proven intervention. Collaboratives aim to deliver at scale, maximise local engagement and leadership and are designed to build capacity, enable learning and prepare for sustainability. Collaboratives involve Learning Sessions, Action Periods, and a summative congress. Trusts will be supported to introduce either: decolonisation for Methicillin Sensitive Staphylococcus aureus (MSSA) to reduce post-operative infection (QIST: Infection), or an anaemia optimisation programme to reduce peri-operative blood transfusions (QIST: Anaemia). Trusts will continue with their usual practice for whichever protocol they are not introducing. Anonymised data related to both infection and anaemia outcomes for patients undergoing hip or knee arthroplasty at all sites will mean that the two groups act as controls for each other. The primary outcome for the QIST: Infection collaborative is deep MSSA surgical site infection within 90 days of surgery, and for the QIST: Anaemia collaborative is blood transfusion within 7 days of surgery. Patient-level secondary outcomes include length of hospital stay and readmission, which will also inform the economic costings. Qualitative interviews will evaluate the support provided to teams., Discussion: The scale of this trial brings considerable challenges and potential barriers to delivery. Anticipated challenges relate to recruiting and sustaining up to 40 organisations, each with its own culture and context. This complex project with multiple stakeholders across a large geographical area will be managed by experienced senior-level project leaders with a proven track record in advanced project management. The team should ensure effective project governance and communications., Trial Registration: ISRCTN, ISRCTN11085475. Prospectively registered on 15 February 2018.

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.)

Objectives: Adults with knee instability related to neuromuscular disorders or central nervous conditions often experience mobility problems and rely on orthoses to improve function and mobility. Patient views of device effectiveness and acceptability are underexplored. Our study aimed to elicit device users' perspectives regarding fitting, acceptability, effectiveness and use of orthoses, and identify important treatment outcomes., Design: Qualitative descriptive study using in-depth semistructured interviews. Interview transcriptions were coded and thematically analysed, using 'Framework'., Setting and Participants: A purposive sample of 24 adult users of orthotic devices. Nineteen patients were recruited across three National Health Service sites, and five people through charities/patient support groups in England. Half of the participants had been diagnosed with poliomyelitis, and the remainder with multiple sclerosis, Charcot-Marie-Tooth disease, spinal injury or spina bifida, and stroke. The median age of participants was 64.5 years (range 36-80 years)., Results: Patients' medical condition impacted significantly on daily life. Participants relied on orthotic devices to enable engagement in daily activities. Patient goals for mobility were linked to individual circumstances. Desired treatment outcomes included reduction in pain, trips and falls, with improved balance and stability. Effectiveness, reliability, comfort and durability were the most valued features of orthoses and associated with reported use. Obtaining suitable footwear alongside orthotic devices was a significant concern. Time pressures during device fitting were viewed negatively., Conclusions: Orthotic devices for knee instability play a crucial role in promoting, maintaining and enhancing physical and psychological health and well-being, enabling patients to work, engage in family life and enjoy social activities. Future research should consider how best to measure the impact of orthotic devices on patient quality of life and daily functioning outside the clinic setting, as well as device use and any adverse effects., Trial Registration Number: This qualitative study was retrospectively registered as Current Controlled Trials ISRCTN65240228., Competing Interests: Competing interests: During this study, SL was an employee of Opcare, a company that provides orthotic and prosthetic services to the UK NHS. This company does not manufacture orthotic devices, although a sister company ORTHO C FAB does., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.)

Introduction: The majority of older patients with a transtibial amputation are prescribed a standard (more rigid, not self-aligning) prosthesis. These are mostly suitable for level walking, and cannot adjust to different sloped surfaces. This makes walking more difficult and less energy efficient, possibly leading to longer term disuse. A Cochrane Review concluded that there was insufficient evidence to recommend any individual type of prosthetic ankle-foot mechanism. This trial will establish the feasibility of conducting a large-scale trial to assess the effectiveness and cost-effectiveness of a self-aligning prosthesis for older patients with vascular-related amputations and other health issues compared with a standard prosthesis., Methods and Analysis: This feasibility trial is a pragmatic, parallel group, randomised controlled trial (RCT) comparing standard treatment with a more rigid prosthesis versus a self-aligning prosthesis. The target sample size is 90 patients, who are aged 50 years and over, and have a transtibial amputation, where amputation aetiology is mostly vascular-related or non-traumatic. Feasibility will be measured by consent and retention rates, a plausible future sample size over a 24-month recruitment period and completeness of outcome measures. Qualitative interviews will be carried out with trial participants to explore issues around study processes and acceptability of the intervention. Focus groups with staff at prosthetics centres will explore barriers to successful delivery of the trial. Findings from the qualitative work will be integrated with the feasibility trial outcomes in order to inform the design of a full-scale RCT., Ethics and Dissemination: Ethical approval was granted by Yorkshire and the Humber-Leeds West Research Ethics Committee on 4 May 2018. The findings will be disseminated via peer-reviewed research publications, articles in relevant newsletters, presentations at relevant conferences and the patient advisory group., Trial Registration Number: ISRCTN15043643., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.)

Aim: To evaluate the effectiveness of pharmacological interventions for managing non-respiratory sleep disturbances in children with neurodisabilities., Method: We performed a systematic review and meta-analyses of randomized controlled trials (RCTs). We searched 16 databases, grey literature, and reference lists of included papers up to February 2017. Data were extracted and assessed for quality by two researchers (B.B., C.M., G.S., A.S., A.P.)., Results: Thirteen trials were included, all evaluating oral melatonin. All except one were at high or unclear risk of bias. There was a statistically significant increase in diary-reported total sleep time for melatonin compared with placebo (pooled mean difference 29.6min, 95% confidence interval [CI] 6.9-52.4, p=0.01). Statistical heterogeneity was high (97%). For the single RCT with low risk of bias, the unadjusted mean difference in total sleep time was 13.2 minutes (95% CI -13.3 to 39.7) favouring melatonin, while the mean difference adjusted for baseline total sleep time was statistically significant (22.4min, 95% CI 0.5-44.3, p=0.04). Adverse event profile suggested that melatonin was well-tolerated., Interpretation: There is a paucity of evidence on managing sleep disturbances in children with neurodisabilities, and it is mostly of limited scope and poor quality. There is evidence of the benefit and safety of melatonin compared with placebo, although the extent of this benefit is unclear., What This Paper Adds: Melatonin for the management of non-respiratory sleep disturbances in children with neurodisabilities was well tolerated with minimal adverse effects. The extent of benefit and which children might benefit most from melatonin use is uncertain. Benefit may be greatest in those with autism spectrum disorder; however, this finding should be interpreted with caution., (© 2019 The Authors. Developmental Medicine & Child Neurology published by John Wiley & Sons Ltd on behalf of Mac Keith Press.)

Recruitment remains an issue when conducting randomised controlled trials (RCTs) with a significant proportion of studies failing to reach their target sample size. Studies evaluating interventions to improve recruitment aimed specifically at recruiters to the trial are limited in number. This factorial RCT will evaluate the effectiveness of an educational intervention to trainee principal investigators and a positive reinforcement intervention via an email nudge on increasing recruitment. The targeted recruiters will be in 20 centres nationally recruiting to one large orthopaedic randomised controlled trial, WHiTE 8 COPAL. Centres will be randomised via minimisation to one of four groups. The primary outcome is recruitment rate in the first six months that a centre is actively recruiting, with data being analysed via a Poisson regression model. Results will be presented as adjusted incidence rate ratios with 95% confidence intervals. Secondary outcomes relate to the feasibility and logistics of running the interventions.  We will also collect feedback regarding the educational programme set out for the trainee principal investigators. The study started in August 2018 with the anticipation of the primary objective endpoint by October 2019. The results of this study will be used to inform the design of future RCTs, particularly in orthopaedics in the UK, where the role of Trainee Principal Investigators is now a consistent one across different trials. Trial registration: 11600053, ISRCTN, 20/08/2018; SWAT 67, Northern Ireland Hub for Trials Methodology Research SWAT repository, 01/10/2017., Competing Interests: No competing interests were disclosed.

Objectives: To assess whether a core outcome set is required for studies evaluating the effectiveness of interventions for non-respiratory sleep disturbances in children with neurodisabilities., Design: Survey of outcome measures used in primary studies identified by a systematic review., Data Sources: ASSIA, CENTRAL, Cochrane Database of Systematic Reviews, Conference Proceedings Citation Index, CINAHL, DARE, Embase, HMIC, MEDLINE, MEDLINE In-Process, PsycINFO, Science Citation Index, Social Care Online, Social Policy & Practice, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform and the UK Clinical Trials Gateway were searched up to February 2017., Eligibility Criteria: Studies evaluating pharmacological or non-pharmacological interventions for children (≤18 years old) with a neurodisability and experiencing non-respiratory sleep disturbance., Data Extraction and Synthesis: Outcome measures were listed from each study and categorised into domains., Results: Thirty-nine studies assessed five core outcome areas: child sleep, other child outcomes, parent outcomes, adverse events and process measures. There were 54 different measures of child sleep across five domains: global measures; sleep initiation; maintenance; scheduling; and other outcomes. Fifteen non-pharmacological (58%) and four pharmacological studies (31%) reported child outcomes other than sleep using 29 different measures.One pharmacological and 14 non-pharmacological (54%) studies reported parent outcomes (17 different measures). Eleven melatonin studies (85%) recorded adverse events, with variation in how data were collected and reported. One non-pharmacological study reported an explicit method of collecting on adverse events. Several process measures were reported, related to adherence, feasibility of delivery, acceptability and experiences of receiving the intervention., Conclusions: There is a lack of consistency between studies in the outcome measures used to assess the effectiveness of interventions for non-respiratory sleep disturbances in children with neurodisabilities. A minimum core outcome set, with international consensus, should be developed in consultation with parents, children and young people, and those involved in supporting families., Prospero Registration Number: CRD42016034067., Competing Interests: Competing interests: BB and MT were authors of studies included in the review, but were not involved in data extraction or quality assessment of these studies. CM is a member of the NIHR HTA & EME Editorial Board. CH is a member of HTA Commissioning Board, (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.)

Objectives: To undertake a systematic review of the evidence base for the effectiveness of surgical fixation of lateral compression (LC-1) fragility fractures of the pelvis compared with non-surgical approaches., Searches: MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and two international trials registers were searched up to January 2017 (MEDLINE to February 2019) for studies of internal or external fixation of fragility fractures of the pelvis., Participants: Patients with lateral compression pelvic fractures, sustained as the result of a low-energy mechanism, defined as a fall from standing height or less., Interventions: Surgery using either external or internal fixation devices. Conservative non-surgical treatment was the defined comparator., Outcome Measures: Outcomes of interest were patient mobility and function, pain, quality of life, fracture union, mortality, hospital length of stay and complications (additional operative procedures, number and type of adverse events and serious adverse events)., Quality Assessment and Synthesis: The Joanna Briggs Institute Checklist for Case Series was used to assess the included studies. Results were presented in a narrative synthesis., Results: Of 3421 records identified, four retrospective case series met the inclusion criteria. Fixation types were not consistent between studies or within studies and most patients had more than one type of pelvic fixation. Where reported, mobility and function improved post-surgery, and a reduction in pain was recorded. Length of hospital stay ranged from 4 days to 54 days for surgical fixation of any type. Reported complications and adverse outcomes included: infections, implant loosening, pneumonia and thrombosis. Use of analgesia was not reported., Conclusions: There is insufficient evidence to support guidance on the most effective treatment for patients who fail to mobilise after sustaining an LC-1 fragility fracture., Trial Registration Number: CRD42017055872., Competing Interests: Competing interests: HMAI, MN, EC, MH, IK, CH declare they have no conflicts of interest. Since starting this review, AB, JK, PB and CM have received funding for a trial of surgical fixation compared to non-surgical treatment in a LC1 FFP population., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Multiple systematic reviews have reported on the impact of rib fracture fixation in the presence of flail chest and multiple rib fractures, however this practice remains controversial. Our aim is to synthesise the effectiveness of surgical rib fracture fixation as evidenced by systematic reviews., Design: A systematic search identified systematic reviews comparing effectiveness of rib fracture fixation with non-operative management of adults with flail chest or unifocal non-flail rib fractures. MEDLINE, EMBASE, Cochrane Database of Systematic Reviews and Science Citation Index were last searched 17 March 2017. Risk of bias was assessed using the Risk Of Bias In Systematic reviews (ROBIS) tool. The primary outcome was duration of mechanical ventilation., Results: Twelve systematic reviews were included, consisting of 3 unique randomised controlled trials and 19 non-randomised studies. Length of mechanical ventilation was shorter in the fixation group compared with the non-operative group in flail chest; pooled estimates ranged from -4.52 days, 95% CI (-5.54 to -3.5) to -7.5 days, 95% CI (-9.9 to -5.5). Pneumonia, length of hospital and intensive care unit stay all showed a statistically significant improvement in favour of fixation for flail chest; however, all outcomes in favour of fixation had substantial heterogeneity. There was no statistically significant difference between groups in mortality. Two systematic reviews included one non-randomised studies of unifocal non-flail rib fracture population; due to limited evidence the benefits with surgery are uncertain., Conclusions: Synthesis of the reviews has shown some potential improvement in patient outcomes with flail chest after fixation. For future review updates, meta-analysis for effectiveness may need to take into account indications and timing of surgery as a subgroup analysis to address clinical heterogeneity between primary studies. Further robust evidence is required before conclusions can be drawn of the effectiveness of surgical fixation for flail chest and in particular, unifocal non-flail rib fractures., Prospero Registration Number: CRD42016053494., Competing Interests: Competing interests: AR declares receiving research grants from NIHR; research and educational grants from DePuy Ltd outside the submitted work., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Aim: To describe existing evidence on non-pharmacological interventions to manage sleep disturbance in children with neurodisabilities., Method: We systematically reviewed non-pharmacological interventions aimed at improving non-respiratory sleep disturbance in children with neurodisability. Sixteen databases, grey literature, and reference lists of included papers were searched up to February 2017. Two researchers (B.B., C.M., G.S., A.S., A.P.) undertook screening, data extraction, and quality appraisal., Results: Twenty-five studies were included: 11 randomized controlled trials and 14 before-and-after studies. All studies were at high or unclear risk of bias. Parent-directed interventions were categorized as comprehensive tailored interventions (n=9), comprehensive non-tailored interventions (n=8), and non-comprehensive interventions (n=2). Six 'other' non-pharmacological interventions were included. Seventy-one child and parent sleep-related outcomes were measured across the included studies. We report the two most commonly measured outcomes: the Child Sleep Habits Questionnaire and sleep onset latency. Five studies reported significant improvements on at least one of these outcomes., Interpretation: Various types of non-pharmacological intervention for managing sleep disturbance have been evaluated. Clinical heterogeneity and poor study quality meant we could not draw definitive conclusions on the effectiveness of these interventions. Current clinical guidance recommends parent-directed interventions as the first approach to managing sleep disturbance; prioritizing research in this area is recommended., What This Paper Adds: Existing evidence on non-pharmacological interventions to manage sleep disturbance in children with neurodisabilities is predominately of poor quality. Most included studies evaluated parent-directed interventions of varying content and intensity. There was very little consistency between studies in the outcome measures used. There is some evidence that parent-directed interventions may improve child outcomes., (© 2018 The Authors. Developmental Medicine & Child Neurology published by John Wiley & Sons Ltd on behalf of Mac Keith Press.)

Background: Venous leg ulcers (VLUs) are the most common cause of leg ulceration, affecting 1 in 100 adults. VLUs may take many months to heal (25% fail to heal). Estimated prevalence is between 1% and 3% of the elderly population. Compression is the mainstay of treatment and few additional therapies exist to improve healing. Two previous trials have indicated that low-dose aspirin, as an adjunct to standard care, may improve healing time, but these trials were insufficiently robust. Aspirin is an inexpensive, widely used medication but its safety and efficacy in the treatment of VLUs remains to be established., Objectives: Primary objective - to assess the effects of 300 mg of aspirin (daily) versus placebo on the time to healing of the reference VLU. Secondary objectives - to assess the feasibility of leading into a larger pragmatic Phase III trial and the safety of aspirin in this population., Design: A multicentred, pilot, Phase II randomised double-blind, parallel-group, placebo-controlled efficacy trial., Setting: Community leg ulcer clinics or services, hospital outpatient clinics, leg ulcer clinics, tissue viability clinics and wound clinics in England, Wales and Scotland., Participants: Patients aged ≥ 18 years with a chronic VLU (i.e. the VLU is > 6 weeks in duration or the patient has a history of VLU) and who are not regularly taking aspirin., Interventions: 300 mg of daily oral aspirin versus placebo. All patients were offered care in accordance with Scottish Intercollegiate Guidelines Network (SIGN) guidance with multicomponent compression therapy aiming to deliver 40 mmHg at the ankle when possible., Randomisation: Participants were allocated in a 1 : 1 (aspirin : placebo) ratio by the Research Pharmacy, St George's University Hospitals NHS Foundation Trust, using a randomisation schedule generated in advance by the investigational medicinal product manufacturer. Randomisation was stratified according to ulcer size (≤ 5cm 2 or > 5cm 2 )., Main Outcome Measure: The primary outcome was time to healing of the largest eligible ulcer (reference ulcer)., Feasibility Results – Recruitment: 27 patients were recruited from eight sites over a period of 8 months. The target of 100 patients was not achieved and two sites did not recruit. Barriers to recruitment included a short recruitment window and a large proportion of participants failing to meet the eligibility criteria., Results: The average age of the 27 randomised participants (placebo, n  = 13; aspirin, n  = 14) was 62 years (standard deviation 13 years), and two-thirds were male ( n  = 18). Participants had their reference ulcer for a median of 15 months, and the median size of ulcer was 17.1 cm 2 . There was no evidence of a difference in time to healing of the reference ulcer between groups in an adjusted analysis for log-ulcer area and duration (hazard ratio 0.58, 95% confidence interval 0.18 to 1.85; p  = 0.357). One expected, related serious adverse event was recorded for a participant in the aspirin group., Limitations: The trial under-recruited because many patients did not meet the eligibility criteria., Conclusions: There was no evidence that aspirin was efficacious in hastening the healing of chronic VLUs. It can be concluded that a larger Phase III (effectiveness) trial would not be feasible., Trial Registration: Clinical Trials.gov NCT02333123; European Clinical Trials Database (EudraCT) 2014-003979-39., Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 22, No. 55. See the NIHR Journals Library website for further project information., Competing Interests: Catriona McDaid is a member of the National Institute for Health Research Health Technology Assessment and Efficacy and Mechanism Evaluation Editorial Board. Christine Moffatt has received grant funding from 3M UK PLC and Smith and Nephew, two health science-based technology companies, outside the submitted work.

Background: There is uncertainty about the most appropriate ways to manage non-respiratory sleep disturbances in children with neurodisabilities (NDs)., Objective: To assess the clinical effectiveness and safety of NHS-relevant pharmacological and non-pharmacological interventions to manage sleep disturbance in children and young people with NDs, who have non-respiratory sleep disturbance., Data Sources: Sixteen databases, including The Cochrane Central Register of Controlled Trials, EMBASE and MEDLINE, were searched up to February 2017, and grey literature searches and hand-searches were conducted., Review Methods: For pharmacological interventions, only randomised controlled trials (RCTs) were included. For non-pharmacological interventions, RCTs, non-randomised controlled studies and before-and-after studies were included. Data were extracted and quality assessed by two researchers. Meta-analysis and narrative synthesis were undertaken. Data on parents' and children's experiences of receiving a sleep disturbance intervention were collated into themes and reported narratively., Results: Thirty-nine studies were included. Sample sizes ranged from 5 to 244 participants. Thirteen RCTs evaluated oral melatonin. Twenty-six studies (12 RCTs and 14 before-and-after studies) evaluated non-pharmacological interventions, including comprehensive parent-directed tailored ( n  = 9) and non-tailored ( n  = 8) interventions, non-comprehensive parent-directed interventions ( n  = 2) and other non-pharmacological interventions ( n  = 7). All but one study were reported as having a high or unclear risk of bias, and studies were generally poorly reported. There was a statistically significant increase in diary-reported total sleep time (TST), which was the most commonly reported outcome for melatonin compared with placebo [pooled mean difference 29.6 minutes, 95% confidence interval (CI) 6.9 to 52.4 minutes; p  = 0.01]; however, statistical heterogeneity was extremely high (97%). For the single melatonin study that was rated as having a low risk of bias, the mean increase in TST was 13.2 minutes and the lower CI included the possibility of reduced sleep time (95% CI -13.3 to 39.7 minutes). There was mixed evidence about the clinical effectiveness of the non-pharmacological interventions. Sixteen studies included interventions that investigated the feasibility, acceptability and/or parent or clinician views of sleep disturbance interventions. The majority of these studies reported the 'family experience' of non-pharmacological interventions., Limitations: Planned subgroup analysis was possible in only a small number of melatonin trials., Conclusions: There is some evidence of benefit for melatonin compared with placebo, but the degree of benefit is uncertain. There are various types of non-pharmacological interventions for managing sleep disturbance; however, clinical and methodological heterogeneity, few RCTs, a lack of standardised outcome measures and risk of bias means that it is not possible to draw conclusions with regard to their effectiveness. Future work should include the development of a core outcome, further evaluation of the clinical effectiveness and cost-effectiveness of pharmacological and non-pharmacological interventions and research exploring the prevention of, and methods for identifying, sleep disturbance. Research mapping current practices and exploring families' understanding of sleep disturbance and their experiences of obtaining help may facilitate service provision development., Study Registration: This study is registered as PROSPERO CRD42016034067., Funding: The National Institute for Health Research Health Technology Assessment programme., Competing Interests: Bryony Beresford and Megan Thomas were authors of primary studies that are included in this review. Catriona McDaid is a member of the National Institute for Health Research Health Technology Assessment (HTA) and Efficacy and Mechanism Evaluation Editorial Board. Catherine Hewitt is a member of the HTA Commissioning Board.

Background: There are an increasing number of patients of working age undergoing hip and knee replacements. Currently there is variation in the advice and support given about sickness absence, recovery to usual activities and return to work after these procedures. Earlier, sustainable, return to work improves the health of patients and benefits their employers and society. An intervention that encourages and supports early recovery to usual activities, including work, has the potential to reduce the health and socioeconomic burden of hip and knee replacements., Methods/design: A two-phase research programme delivered over 27 months will be used to develop and subsequently test the feasibility of an occupational advice intervention to facilitate return to work and usual activities in patients undergoing lower limb arthroplasty. The 2 phases will incorporate a six-stage intervention mapping process: Phase 1: Intervention mapping stages 1-3: 1 Needs assessment (including rapid evidence synthesis, prospective cohort analysis and structured stakeholder interviews) 2 Identification of intended outcomes and performance objectives 3 Selection of theory-based methods and practical strategies Phase 2: Intervention mapping stages 4-6: 4 Development of components and materials for the occupational advice intervention using a modified Delphi process 5 Adoption and implementation of the intervention 6 Evaluation and feasibility testing The study will be undertaken in four National Health Service (NHS) hospitals in the United Kingdom and two Higher Education Institutions., Discussion: OPAL (Occupational advice for Patients undergoing Arthroplasty of the Lower limb) aims to develop an occupational advice intervention to support early recovery to usual activities including work, which is tailored to the requirements of patients undergoing hip and knee replacements. The developed intervention will then be assessed with a specific focus on evaluating its feasibility as a potential trial intervention to improve speed of recovery to usual activities including work., Trial Registration: The study was registered retrospectively with the International Standard Randomised Controlled Trials Number (ISRCTN): 27426982 (Date 20/12/2016) and the International prospective register of systematic reviews (PROSPERO): CRD42016045235 (Date 04/08/2016).

Introduction: Given the prevalence of mental health problems globally, there is an increasing need for the police and other non-mental health trained professionals to identify and manage situations involving individuals with mental health problems. The review aimed to identify and explore qualitative evidence on views and experiences of non-mental health professionals receiving mental health training and the barriers and facilitators to training delivery and implementation., Methods: A meta-synthesis of qualitative evidence on the barriers, facilitators and perceived impact of mental health training programmes for non-mental health trained professionals. Systematic literature searches were undertaken of the following databases: Criminal Justice Abstracts (CJA); MEDLINE; Embase; PsycINFO; ASSIA; CENTRAL; SSCI; ERIC; Campbell Library; Social Care Online and EPOC from 1995 to 2016. Records were independently screened for eligibility by two researchers, data extraction and quality appraisal of studies was also undertaken independently by two researchers. The CASP tool was used to quality appraise included studies. Included studies were synthesised using a meta-ethnographic approach as outlined by Noblit and Hare., Results: 10,282 records were identified and eight qualitative studies were included. A range of barriers and facilitators to training were identified and related to the delivery and content of training; the use of additional resources; and staff willingness to engage with training and organisational factors. The perceived impact of training was also discussed in terms of how it affects trainees; perceptions of mental health; self-perception; responses to situations involving mental health and the potential of training to reduce injury or physical harm in situations involving mental health. The value of training and how to measure its impact were also discussed., Conclusion: Findings from this review have implications for those designing, implementing and evaluating mental health training programmes. It is recommended that research evaluating mental health training includes a qualitative component to ensure that the barriers and facilitators to training and its impact on trainees' perceptions of mental health are understood., Protocol Registration Number: PROSPERO: CRD42015015981., Competing Interests: The authors have declared that no competing interests exist.

Objective: To identify existing evidence on interagency collaboration between law enforcement, emergency services, statutory services and third sector agencies regarding people with mental ill health., Design: Systematic scoping review. Scoping reviews map particular research areas to identify research gaps., Data Sources and Eligibility: ASSIA, CENTRAL, the Cochrane Library databases, Criminal Justice Abstracts, ERIC, Embase, MEDLINE, PsycINFO, PROSPERO and Social Care Online and Social Sciences Citation Index were searched up to 2017, as were grey literature and hand searches. Eligible articles were empirical evaluations or descriptions of models of interagency collaboration between the police and other agencies., Study Appraisal and Synthesis: Screening and data extraction were undertaken independently by two researchers. Arksey's framework was used to collate and map included studies., Results: One hundred and twenty-five studies were included. The majority of articles were of descriptions of models (28%), mixed methods evaluations of models (18%) and single service evaluations (14%). The most frequently reported outcomes (52%) were 'organisational or service level outcomes' (eg, arrest rates). Most articles (53%) focused on adults with mental ill health, whereas others focused on adult offenders with mental ill health (17.4%). Thirteen models of interagency collaboration were described, each involving between 2 and 13 agencies. Frequently reported models were 'prearrest diversion' of people with mental ill health (34%), 'coresponse' involving joint response by police officers paired with mental health professionals (28.6%) and 'jail diversion' following arrest (23.8%)., Conclusions: We identified 13 different interagency collaboration models catering for a range of mental health-related interactions. All but one of these models involved the police and mental health services or professionals. Several models have sufficient literature to warrant full systematic reviews of their effectiveness, whereas others need robust evaluation, by randomised controlled trial where appropriate. Future evaluations should focus on health-related outcomes and the impact on key stakeholders., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Background: There has been an increased drive towards Evidence Based Policing in recent years. Unlike in other public sector services, such as health and education, randomised controlled trials in the police setting are relatively rare. This paper discusses some of the methodological and practical challenges of conducting a randomised controlled trial in the police setting in the UK, based on our experience of the Connect trial. This pragmatic, cluster-randomised controlled trial investigated the effectiveness of a face-to-face training intervention for frontline officers in comparison to routine training. The primary outcome was the number of incidents which resulted in a police response reported to North Yorkshire Police control room in a 1-month period up to 6 months after delivery of training., Main Text: The methodological and practical challenges that we experienced whilst conducting the Connect trial are discussed under six headings: establishing the unit of randomisation; population of interest and sample size; co-production of evidence; time frame; outcomes; and organisational issues., Conclusion: Recommendations on the conduct of future randomised controlled trials in the police setting are made. To understand the context in which research is undertaken, collaboration between police and academia is needed and police officers should be embedded within trial management groups. Engagement with police data analysts to understand what data is available and facilitate obtaining trial data is also recommended. Police forces may wish to review their IT systems and recording practices. Pragmatic trials are encouraged and time frames need to allow for trial set-up and obtaining relevant ethical approvals., Trial Registration: ISRCTN Registry, ID: ISRCTN11685602 . Retrospectively registered on 13 May 2016.

Background: Frozen shoulder (also known as adhesive capsulitis) occurs when the capsule, or the soft tissue envelope around the ball and socket shoulder joint, becomes scarred and contracted, making the shoulder tight, painful and stiff. It affects around 1 in 12 men and 1 in 10 women of working age. Although this condition can settle with time (typically taking 1 to 3 years), for some people it causes severe symptoms and needs referral to hospital. Our aim is to evaluate the clinical and cost-effectiveness of two invasive and costly surgical interventions that are commonly used in secondary care in the National Health Service (NHS) compared with a non-surgical comparator of Early Structured Physiotherapy., Methods: We will conduct a randomised controlled trial (RCT) of 500 adult patients with a clinical diagnosis of frozen shoulder, and who have radiographs that exclude other pathology. Early Structured Physiotherapy with an intra-articular steroid injection will be compared with manipulation under anaesthesia with a steroid injection or arthroscopic (keyhole) capsular release followed by manipulation. Both surgical interventions will be followed with a programme of post-procedural physiotherapy. These treatments will be undertaken in NHS hospitals across the United Kingdom. The primary outcome and endpoint will be the Oxford Shoulder Score (a patient self-reported assessment of shoulder function) at 12 months. This will also be measured at baseline, 3 and 6 months after randomisation; and on the day that treatment starts and 6 months later. Secondary outcomes include the Disabilities of Arm Shoulder and Hand (QuickDASH) score, the EQ-5D-5 L score, pain, extent of recovery and complications. We will explore the acceptability of the different treatments to patients and health care professionals using qualitative methods., Discussion: The three treatments being compared are the most frequently used in secondary care in the NHS, but there is uncertainty about which one works best and at what cost. UK FROST is a rigorously designed and adequately powered study to inform clinical decisions for the treatment of this common condition in adults., Trial Registration: International Standard Randomised Controlled Trial Register, ID: ISRCTN48804508 . Registered on 25 July 2014.

Introduction: Police officers frequently come into contact with individuals with mental health problems. Specialist training in this area for police officers may improve how they respond to individuals with mental health problems; however, evidence to support this is sparse. This study evaluated the effectiveness of one bespoke mental health training package for frontline police officers relative to routine training., Design: Pragmatic, two-armed cluster randomised controlled trial in one police force in England. Police stations in North Yorkshire were randomised with frontline police officers receiving either a bespoke mental health training package or routine training. The primary outcome was the number of incidents which resulted in a police response reported to the North Yorkshire Police control room up to six months after delivery of training. Secondary outcomes included: likelihood of incidents using Section 136 of the Mental Health Act; likelihood of incidents having a mental health tag applied; and number of individuals with a mental health warning marker involved in incidents. The appropriateness of mental health tags applied to a random sample of incidents was checked by an independent mental health professional. Routinely collected data were used., Results: Twelve police stations were recruited and randomised (Intervention group n = 6; Control group n = 6), and 249 officers received the bespoke mental health training intervention. At follow-up, a median of 397 incidents were assigned to trial stations in the intervention group, and 498 in the control group. There was no evidence of a difference in the number of incidents with a police response (adjusted incidence rate ratio (IRR) 0.92, 95% CI 0.61 to 1.38, p = 0.69), or in the number of people with mental health warning markers involved in incidents (adjusted IRR 1.39, 95% CI 0.91 to 2.10, p = 0.13) between the intervention and control groups up to six months following the intervention; however, incidents assigned to stations in the intervention group were more likely to have a mental health tag applied to them than incidents assigned to control stations (adjusted odds ratio 1.41, 95% CI 1.16 to 1.71, p = 0.001). The review of 100 incidents suggests that there may be incidents involving individuals with mental health issues that are not being recorded as such (Kappa coefficient 0.65). There was no statistically significant difference in the likelihood of Section 136 of the Mental Health Act being applied to an incident., Conclusions: The bespoke one day mental health training delivered to frontline officers by mental health professionals did not reduce the number of incidents reported to the police control room up to six months after its delivery; however training may have a positive effect on how the police record incidents involving individuals with mental health problems. Our trial has shown that conducting pragmatic trials within the police setting is feasible and acceptable. There is a wealth of routinely collected police data that can be utilised for research and further collaboration between police forces and academia is encouraged., Trial Registration: ISRCTN (ISRCTN11685602). The authors confirm that all ongoing and related trials for this drug/intervention are registered.

Objectives: To assess the effectiveness of orthotic devices for the management of instability of the knee in adults with a neuromuscular disorder or central nervous system disorder., Design: A systematic review of primary studies., Setting: Community., Participants: Adults with a neuromuscular disorder or central nervous system disorder and impaired walking ability due to instability of the knee., Interventions: Orthoses with the clinical aim of controlling knee instability, for example, knee-ankle-foot orthoses, ankle-foot orthoses and knee orthoses or mixed design with no restrictions in design or material., Primary and Secondary Outcome Measures: Condition-specific or generic patient-reported outcome measures assessing function, disability, independence, activities of daily living, quality of life or psychosocial outcomes; pain; walking ability; functional assessments; biomechanical analysis; adverse effects; usage; patient satisfaction and the acceptability of a device; and resource utilisation data., Results: Twenty-one studies including 478 patients were included. Orthotic devices were evaluated in patients with postpolio syndrome, poststroke syndrome, inclusion body myositis and spinal cord injury. The review included 2 randomised controlled trials (RCTs), 3 non-randomised controlled studies and 16 case series. Most were small, single-centre studies with only 6 of 21 following patients for 1 year or longer. They met between one and five of nine quality criteria and reported methods and results poorly. They mainly assessed outcomes related to gait analysis and energy consumption with limited use of standardised, validated, patient-reported outcome measures. There was an absence of evidence on outcomes of direct importance to patients such as reduction in pain and falls., Conclusions: There is a need for high-quality research, particularly RCTs, of orthotic devices for knee instability related to neuromuscular and central nervous system conditions. This research should address outcomes important to patients. There may also be value in developing a national registry., Registration Number Systematic Review: PROSPERO (CRD42014010180)., Competing Interests: Competing interests: During this study, SL was an employee of Opcare, a company that provides orthotic and prosthetic services to the UK NHS. This company does not manufacture orthotic devices, although a sister company ORTHO C FAB does. CPI is a member of the National Institute for Health and Care Excellence Medical Technologies Assessment Committee and member of the European Clinical Research Infrastructure Network., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Objective: To examine whether the timing of delivery of intravenous antibiotics following open limb fractures has an effect on deep infection rates and other outcomes., Design: We published an a priori study protocol in PROSPERO. Our search strategy combined terms for antibiotics, timing of administration and fractures. Two independent reviewers screened, selected, assessed quality and extracted data from identified studies., Data Sources: We searched five electronic databases with no limits and performed grey literature searches., Eligibility Criteria for Selecting Studies: Randomised and non-randomised controlled studies, prospective and retrospective observational studies in which the effect of the timing of delivery of antibiotics on the outcome of deep infection in open fractures was considered were included., Results: Eight studies were included according to the above criteria. There were no randomised or non-randomised controlled trials. None of the included studies provided data on patient reported or health-related quality of life. The overall deep infection rate ranged from 5% to 17.5%. All of the studies were at substantial risk of bias. One study reported a reduced infection rate with the delivery of antibiotics within 66 min of injury and seven studies reporting no effect., Conclusions: Sufficiently robust evidence is not available currently to determine whether the timing of delivery of intravenous antibiotics has an effect on the risk of deep infection or other outcomes following open limb fractures. There is therefore a need for a randomised controlled trial in this area before policy changes should be instigated., Trial Registration Number: PROSPERO (CRD42015016729)., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

Background: The police and others in occupations where they come into close contact with people experiencing/with mental ill health, often have to manage difficult and complex situations. Training is needed to equip them to recognise and assist when someone has a mental health issue or learning/intellectual disability. We undertook a systematic review of the effectiveness of training programmes aimed at increasing knowledge, changing behaviour and/or attitudes of the trainees with regard to mental ill health, mental vulnerability, and learning disabilities., Methods: Databases searched from 1995 onwards included: ASSIA, Cochrane Central Register of Controlled Clinical Trials (CENTRAL), Criminal Justice Abstracts, Embase, ERIC, MEDLINE, PsycINFO, Social Science Citation Index. Courses, training, or learning packages aimed at helping police officers and others who interact with the public in a similar way to deal with people with mental health problems were included. Primary outcomes were change in practice and change in outcomes for the groups of people the trainees come into contact with. Systematic reviews, randomised controlled trials (RCTs) and non- randomised controlled trials (non-RCTs) were included and quality assessed. In addition non-comparative evaluations of training for police in England were included., Results: From 8578 search results, 19 studies met the inclusion criteria: one systematic review, 12 RCTs, three prospective non-RCTs, and three non-comparative studies. The training interventions identified included broad mental health awareness training and packages addressing a variety of specific mental health issues or conditions. Trainees included police officers, teachers and other public sector workers. Some short term positive changes in behaviour were identified for trainees, but for the people the trainees came into contact with there was little or no evidence of benefit., Conclusions: A variety of training programmes exist for non-mental health professionals who come into contact with people who have mental health issues. There may be some short term change in behaviour for the trainees, but longer term follow up is needed. Research evaluating training for UK police officers is needed in which a number of methodological issues need to be addressed., Trial Registration: Protocol registration number: PROSPERO: CRD42015015981 .

Background: Patients who have knee instability that is associated with neuromuscular disease (NMD) and central nervous system (CNS) conditions can be treated using orthoses, such as knee-ankle-foot orthoses (KAFOs)., Objectives: To assess existing evidence on the effectiveness of orthoses; patient perspectives; types of orthotic devices prescribed in the UK NHS; and associated costs., Methods: Qualitative study of views of orthoses users - a qualitative in-depth interview study was undertaken. Data were analysed for thematic content. A coding scheme was developed and an inductive approach was used to identify themes. Systematic review - 18 databases were searched up to November 2014: MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, Cumulative Index to Nursing and Allied Health, EMBASE, PASCAL, Scopus, Science Citation Index, BIOSIS Previews, Physiotherapy Evidence Database, Recal Legacy, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, Health Technology Assessment database, Cochrane Central Register of Controlled Trials, Conference Proceedings Citation Index: Science, Health Management Consortium, ClinicalTrials.gov, International Clinical Trials Registry Platform and National Technical Information Service. Studies of adults using an orthosis for instability of the knee related to NMD or a CNS disorder were included. Data were extracted and quality was assessed by two researchers. Narrative synthesis was undertaken. Survey and costing analysis - a web survey of orthotists, physiotherapists and rehabilitation medicine physicians was undertaken. Telephone interviews with orthotists informed a costing analysis., Results: Qualitative study - a total of 24 people participated. Potential for engagement in daily activities was of vital importance to patients; the extent to which their device enabled this was the yardstick by which it was measured. Patients' prime desired outcome was a reduction in pain, falls or trips, with improved balance and stability. Effectiveness, reliability, comfort and durability were the most valued features of orthoses. Many expressed frustration with perceived deficiencies in service provision relating to appointment and administrative systems and referral pathways. Systematic review - a total of 21 studies (478 participants) were included of people who had post-polio syndrome, inclusion body myositis, were post stroke or had spinal cord injury. The studies evaluated KAFOs (mainly carbon fibre), stance control KAFO and hip KAFOs. All of the studies were at risk of bias and, in general, were poorly reported. Survey and costing analysis - in total, 238 health-care professionals responded. A range of orthoses is prescribed for knee instability that is related to NMD or CNS conditions, approximately half being custom-made. At least 50% of respondents thought that comfort and confidence in mobility were extremely important treatment outcomes. The cost of individual KAFOs was highly variable, ranging from £73 to £3553., Conclusions: Various types of orthoses are used in the NHS to manage patients with NMD/CNS conditions and knee instability, both custom-made and prefabricated, of variable cost. Evidence on the effectiveness of the orthoses is limited, especially in relation to the outcomes that are important to orthoses users., Limitations: The population included was broad, limiting any in-depth consideration of specific conditions. The response rate to the survey was low, and the costing analysis was based on some assumptions that may not reflect the true costs of providing KAFOs., Future Work: Future work should include high-quality research on the effectiveness and cost-effectiveness of orthoses; development of a core set of outcome measures; further exploration of the views and experiences of patients; and the best models of service delivery., Study Registration: This study is registered as PROSPERO CRD42014010180. The qualitative study is registered as Current Controlled Trials ISRCTN65240228., Funding: The National Institute for Health Research Health Technology Assessment programme.

Background: Venous leg ulcers (VLUs) are the commonest cause of leg ulceration, affecting 1 in 100 adults. There is a significant health burden associated with VLUs - it is estimated that the cost of treatment for 1 ulcer is up to £1300 per year in the NHS. The mainstay of treatment is with graduated compression bandaging; however, treatment is often prolonged and up to one quarter of venous leg ulcers do not heal despite standard care. Two previous trials have suggested that low-dose aspirin, as an adjunct to standard care, may hasten healing, but these trials were small and of poor quality. Aspirin is an inexpensive, widely used medication but its safety and efficacy in the treatment of VLUs remains to be established., Methods/design: AVURT is a phase II randomised double blind, parallel-group, placebo-controlled efficacy trial. The primary objective is to examine whether aspirin, in addition to standard care, is effective in patients with chronic VLUs (i.e. over 6 weeks in duration or a history of VLU). Secondary objectives include feasibility and safety of aspirin in this population. A target of 100 participants, identified from community leg ulcer clinics and hospital clinics, will be randomised to receive either 300 mg of aspirin once daily or placebo. All participants will receive standard care with compression therapy. The primary outcome will be time to healing of the reference ulcer. Follow-up will occur for a maximum of 27 weeks. The primary analysis will use a Cox proportional hazards model to compare time to healing using the principles of intention-to-treat. Secondary outcomes will include ulcer size, pain evaluation, compliance and adverse events., Discussion: The AVURT trial will investigate the efficacy and safety of aspirin as a treatment for VLU and will inform on the feasibility of proceeding to a larger phase III study. This study will address the paucity of information currently available regarding aspirin therapy to treat VLU., Trial Registration: The study is registered on a public database with clinicaltrials.gov ( NCT02333123 ; registered on 5 November 2014).

Purpose: In our study we explored the need to define a core outcome set for primary frozen shoulder., Methods: We investigated the outcomes used by studies included in a systematic review of the management of primary frozen shoulder; surveyed which primary outcome measures health care professionals considered important; and re-examined papers previously obtained for a systematic review of patients' views of interventions for frozen shoulder to investigate their views on outcomes., Results: Thirty-one studies investigated the outcomes range of movement (28 studies), pain (22), function and disability (22), adverse events (13), quality of life (7) and other outcomes (5). Many different types of pain and ranges of movement were measured. Function and disability was measured using fifteen instruments, the content of which varied considerably. Function and disability, pain and range of movement (132, 108 and 104 respondents, respectively) were most often cited by health care professionals as the primary outcome measure that should be used. Searches identified one paper that included patients' views. Outcomes of importance to patients were pain at night, general pain, reduced mobility (resulting in modification of activities) and the emotional impact of frozen shoulder., Conclusions: We identified a diverse range of outcomes that have been used or are considered to be important. The development of a core outcome set would improve the design and reporting of studies and availability of data for evidence synthesis. Methods used to develop a core outcome set should be robust, transparent and reflect the views of all stakeholders.

Background: Eustachian tube dysfunction (ETD) is the inability of the Eustachian tube (ET) to adequately perform at least one of its functions: to protect the middle ear from sources of disease, to ventilate the middle ear, and to help drain secretions away from the middle ear. There are a number of treatment options for ETD, but there is little consensus about management., Objectives: To determine the clinical effectiveness of interventions for adult ETD and to identify gaps in the evidence to inform future research., Data Sources: Twelve databases were searched up to October 2012 for published and unpublished studies in English (e.g. MEDLINE from 1946, EMBASE from 1974, Biosis Previews from 1969 and Cumulative Index to Nursing and Allied Health Literature from inception). References of included studies, relevant systematic reviews and regulatory agency websites were checked., Review Methods: A systematic review was undertaken. Controlled studies evaluating prespecified treatments for adult patients diagnosed with ETD were eligible. Uncontrolled studies with at least 10 participants were included for interventions where no controlled studies were found. Outcomes included change in symptoms severity/frequency (primary outcome), quality of life, middle ear function, hearing, clearance of middle ear effusion, early ventilation tube extrusion, additional treatment, adverse events and complications. All aspects of the review process were performed using methods to reduce reviewer error and bias. Owing to heterogeneous data, a quantitative synthesis could not be performed, and results were reported in a narrative synthesis., Results: Nineteen studies were included: three randomised controlled trials (RCTs) and two non-RCTs evaluating pharmacological interventions or mechanical devices for middle ear pressure equalisation; and 13 case series and one retrospective controlled before-and-after study evaluating surgical interventions. None was conducted in the UK. All studies were small (11 to 108 participants). Most non-surgical studies reported including mixed populations of adults and children. All except two studies were at high risk of bias, and subject to multiple limitations. Based on a single RCT, nasal steroids showed no improvement in symptoms or middle ear function for patients with otitis media with effusion and/or negative middle ear pressure. Very short-term improvements in middle ear function were observed in patients receiving directly applied topical decongestants or a combination of antihistamine and ephedrine. Single trials found two pressure equalisation devices were each associated with significant short-term improvements in symptoms, middle ear function and/or hearing. Eustachian tuboplasty (seven case series) and balloon dilatation (three case series) were associated with improved outcomes. Positive results were also reported for myringotomy (two case series), directly applied topical steroids (one case series) and laser point coagulation (one controlled before-and-after study). High rates of co-interventions were documented. Minor complications of surgery and pharmacological treatments but no serious adverse effects were reported., Limitations: The evidence was limited in quantity and overall was of poor quality. No data were identified on several interventions despite extensive searches., Conclusions: It is not possible to draw conclusions regarding the effectiveness of any of the interventions for the treatment of adults with an ETD diagnosis, and there is insufficient evidence to recommend a trial of any particular intervention. Further research is needed to address lack of consensus on several issues, including the definition of ETD in adults, its relation to broader middle ear ventilation problems and clear diagnostic criteria., Study Registration: This study is registered as PROSPERO CRD42012003035., Funding: The National Institute for Health Research Health Technology Assessment programme.

Objective: To summarise evidence on the effectiveness of behaviour change interventions to encourage prescribing of generic forms of prescription drugs where clinically appropriate in the UK National Health Service (NHS) and similar settings., Design: Systematic review., Search Strategy: We conducted a rapid evidence synthesis in two stages: First, we searched databases, such as the Cochrane Database of Systematic Reviews (CDSR) and Database of Abstracts of Reviews of Effects (DARE), for systematic reviews of interventions that reported outcomes related to utilisation of generic drugs. In the second stage, we searched several databases including MEDLINE and EMBASE to identify primary studies of any interventions not covered by systematic reviews., Data Extraction and Quality Assessment: Data were extracted into a standardised data extraction form. Standardised quality assessment tools were used to assess study quality. Two reviewers were involved in data extraction and quality assessment., Results: 10 reviews were included for the initial evidence synthesis, but most were of limited usefulness to our focused review question. One review evaluated the effect of prescribing policies using financial incentives and showed an increase in generic prescribing. Thirteen primary studies of other interventions were included for the rapid review. Two studies showed an increase in percentage of overall generic prescribing with an educational intervention; two studies showed an improvement in generic prescribing rates when physicians collaborated with pharmacists, though in one study this was not statistically significant; two US studies showed improvements in generic prescribing with electronic prescribing. Five out of seven studies showed positive results with multifaceted interventions., Conclusions: The existing evidence remains insufficient to determine which behaviour change intervention or combination of interventions is most effective due to methodological weaknesses and conflicting results. Based on the evidence, financial incentives with educational intervention and audit/feedback look promising but decision-makers should take into account the practicality and costs of the interventions before implementation., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Background: Clearly the benefits of a treatment must not be outweighed by the adverse effects. If researchers fail to incorporate adverse effects adequately in models, this could limit the validity of the results obtained. In the worst case, interventions that are cost-effective may be shown not to be. The aim of this research was to review current practice when incorporating adverse effects in economic models., Methods: A survey of HTA reports commissioned by the National Institute for Health Research (NIHR) Health Technology Assessment programme, published between 2004 and 2007 was conducted. All reports which investigated the clinical and cost-effectiveness of a health technology using a systematic review and an economic model framework were included., Results: A total of eighty reports met the inclusion criteria. Of the models including adverse effects (43/80), 67 percent used a clinical adverse effects parameter, 79 percent a cost of adverse effects parameter, 86 percent used one of these, and 60 percent used both. Of the thirty-seven models that did not include adverse effects, eighteen justified this omission, most commonly lack of data; nineteen appeared to make no explicit consideration of adverse effects in the model., Conclusions: In many cases, poor reporting made it difficult to ascertain if there had been any consideration of adverse effects. We suggest that the findings of this survey support a call for much clearer and explicit reporting of adverse effects, or their exclusion, in decision models and for explicit recognition in future guidelines that "all relevant outcomes" should include some consideration of adverse events.

Objectives: The objective of this study is to assess the cost-effectiveness of enhanced external counterpulsation (EECP) compared with no treatment as additional therapy to usual care for the treatment of chronic stable angina from the perspective of the UK National Health Service., Methods: The study design was a systematic review of published evidence, use of expert clinical opinion, and decision analytic cost-effectiveness model. The systematic review was conducted and statistical methods used to synthesize the effectiveness evidence from randomized control trials. Formal methods were used to elicit opinion from clinical experts where no evidence was available. These provide informed "priors" on key model parameters. A decision analytic model was developed to assess the costs and health consequences associated with the primary outcome of the trials over a lifetime time horizon. The main outcome measures were costs from a health service perspective and outcomes measured as quality-adjusted life-years (QALYs)., Results: The incremental cost-effectiveness ratio of EECP was 18,643 pound sterling for each additional QALY, with a probability of being cost-effective of 0.44 and 0.70 at cost-effectiveness thresholds of 20,000 pound sterling and 30,000 pound sterling per QALY gained, respectively. Results were sensitive to the duration of health-related quality of life (HRQoL) benefits from treatment., Conclusions: The long-term maintenance of HRQoL benefits of EECP is central to the estimate of cost-effectiveness. The results from a single randomized control trial do not provide firm evidence of the clinical or cost-effectiveness of EECP in stable angina. Long-term follow-up trials assessing quality of life from EECP are required.

Background: Promoting the mental health of people bereaved through suicide is a key aim of the National Suicide Prevention Strategy., Aims: To evaluate the effects of interventions to support people bereaved through suicide., Method: We conducted a systematic review of data from controlled studies of interventions for people bereaved through suicide. Studies were identified using systematic searches, the methodological quality of included studies was assessed and narrative synthesis conducted., Results: Eight studies were identified. None was UK-based and all but one study had substantial methodological limitations. When compared with no intervention, there was evidence of some benefit from single studies of a cognitive-behavioural family intervention of four sessions with a psychiatric nurse; a psychologist-led 10-week bereavement group intervention for children; and 8-week group therapy for adults delivered by a mental health professional and volunteer. The findings from studies comparing two or more active interventions were more equivocal., Conclusions: Although there is evidence of some benefit from interventions for people bereaved by suicide, this is not robust. Further methodologically sound evidence is required to confirm whether interventions are helpful and, if so, for whom.

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.