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Aims: Lower limb reconstruction (LLR) has a profound impact on patients, affecting multiple areas of their lives. Many patient-reported outcome measures (PROMs) are employed to assess these impacts; however, there are concerns that they do not adequately capture all outcomes important to patients, and may lack content validity in this context. This review explored whether PROMs used with adults requiring, undergoing, or after undergoing LLR exhibited content validity and adequately captured outcomes considered relevant and important to patients., Methods: A total of 37 PROMs were identified. Systematic searches were performed to retrieve content validity studies in the adult LLR population, and hand-searches used to find PROM development studies. Content validity assessments for each measure were performed following Consensus-based Standards for the selection of health measurement Instruments (COSMIN) guidelines. A mapping exercise compared all PROMs to a conceptual framework previously developed by the study team ('the PROLLIT framework') to explore whether each PROM covered important and relevant concepts., Results: The systematic searches found 13 studies, while hand searches found 50 PROM development studies, and copies of all 37 measures. Although several studies discussed content validity, none were found which formally assessed this measurement property in the adult LLR population. Development of many PROMs was rated as inadequate, no PROM had sufficient content validity in the study population, and none covered all areas of the PROLLIT framework. The LIMB-Q was the most promising and comprehensive measure assessed, although further validation in a wider sample of LLR patients was recommended., Conclusion: Current PROMs used in adults requiring, undergoing, or after undergoing LLR lack content validity and do not assess all important and relevant outcomes. There is an urgent need for improved outcome measurement in this population. This can be achieved through development of a new PROM, or through validation of existing measures in representative samples., Competing Interests: C. McDaid, H. Leggett, and J. Lister report institutional funding for this project from Hull University Teaching Hospitals NHS Foundation Trust. C. McDaid also reports research grants from NIHR HTA and i4i panels, which are unrelated to this study. C. McDaid is also Co-Director of the NIHR RSS Hub, a member of the NIHR PGfAR Panel B, the NIHR Predoctoral Fellowship Panel, Orthopaedic Research UK Scientific Advisory Committee, the Royal College of Surgeons of England Surgical Trials Centre group, and the British Orthopaedic Association Trials Network, the NIHR Journals Library Senior Journal Editor, and participates on the data safety monitoring board or advisory board of the NIHR TSC Op-Non STOP TSC and NIHR SCIENCE trial TSC., (© 2024 Lister et al.)

Aims: A review of the literature on elbow replacement found no consistency in the clinical outcome measures which are used to assess the effectiveness of interventions. The aim of this study was to define core outcome domains for elbow replacement., Methods: A real-time Delphi survey was conducted over four weeks using outcomes from a scoping review of 362 studies on elbow replacement published between January 1990 and February 2021. A total of 583 outcome descriptors were rationalized to 139 unique outcomes. The survey consisted of 139 outcomes divided into 18 domains. The readability and clarity of the survey was determined by an advisory group including a patient representative. Participants were able to view aggregated responses from other participants in real time and to revisit their responses as many times as they wished during the study period. Participants were able to propose additional items for inclusion. A Patient and Public Inclusion and Engagement (PPIE) panel considered the consensus findings., Results: A total of 45 respondents completed the survey. Nine core mandatory domains were identified: 'return to work or normal daily role'; delivery of care was measured in the domains 'patient satisfaction with the outcome of surgery' and 'would the patient have the same operation again'; 'pain'; 'revision'; 'elbow function'; 'independence in activities of daily living'; 'health-related quality of life'; and 'adverse events'. 'Elbow range of motion' was identified as important by consensus but was felt to be less relevant by the PPIE panel. The PPIE panel unanimously stated that pain should be used as the primary outcome domain., Conclusion: This study defined core domains for the clinical outcomes of elbow replacement obtained by consensus from patients, carers, and healthcare professionals. Pain may be used as the primary outcome in future studies, where appropriate. Further work is required to define the instruments that should be used., Competing Interests: A. C. Watts reports grants or contracts from NIHR, Zimmer Biomet, TRB Chemedica, and Stryker, royalties or licenses and patents planned, issued or pending from Adler, and payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Xiros, Medartis, and Arthrex, all of which are unrelated to this study. C. McDaid reports grants or contracts from NIHR HTA and i4i panels, research funding from Hull Teaching Hospitals NHS Trust, and is the co-director of NIHR RSS, all of which are unrelated to this study., (© 2024 The British Editorial Society of Bone & Joint Surgery.)

While various treatment options for primary snoring are available, evidence-based recommendations to determine the optimal intervention remain unestablished. To inform future directions of research to guide clinical decision-making, this scoping review was conducted to map the existing evidence on interventions for primary snoring, the outcomes and instruments used to assess their clinical effects in adults. The feasibility of conducting further systematic reviews and comparing outcomes across these therapies using network meta-analysis was also assessed. Of the 1673 records identified, 38 interventional studies met the inclusion criteria with three-fifths of them being before-after studies. The most common reason for study exclusion was results being reported for patients with primary snoring and obstructive sleep apnoea (OSA) combined. Interventions were surgical (73 %), behavioural and the use of devices/medications. Twenty-six common outcomes were identified and categorised into six domains. Fifty-nine instruments were used to assess the outcomes and based mainly on non-validated questionnaires. Our findings indicated (1) the need for randomised controlled trials with strict discrimination between patients with primary snoring and OSA, (2) further network meta-analyses using some outcomes is feasible, and (3) a core outcome set to inform standardised reporting for future research should be developed., Competing Interests: Declaration of competing interest The authors declare no conflicts of interest., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Background: In the UK, one in four patients are in work at the time of their hip or knee replacement surgery. These patients receive little support about their return to work (RTW). There is a need for an occupational support intervention that encourages safe and sustained RTW which can be integrated into National Health Service practice. We developed a two-arm intervention trial, based on a feasibility study, to assess whether an occupational support intervention (the OPAL (Occupational support for Patients undergoing Arthroplasty of the Lower limb) intervention) is effective in supporting a reduced time to full, sustained RTW compared with usual care in patients undergoing hip and knee replacement., Methods and Analysis: This is a multicentre, individually randomised controlled superiority trial comparing the OPAL intervention to usual care. 742 working adults listed for elective primary hip or knee replacement, who intend to RTW, will be randomised to the OPAL intervention or usual care. The intervention comprises: (1) multimedia information resources; and (2) support from a designated RTW coordinator. The primary outcome is time until 'full' sustained RTW without sick leave for a consecutive 4-week period. Secondary outcomes are: time to any RTW, measures of functional recovery, number of 'sick days' between surgery and 'full' sustained RTW and the use of workplace modifications to facilitate their return. A health economic evaluation and a mixed methods process evaluation will assess cost-effectiveness and the implementation, fidelity and acceptability of the intervention, respectively. Outcomes will be collected at baseline, 3, 6, 9 and 12-month follow-up time points, as well as a monthly RTW questionnaire., Ethics and Dissemination: Dissemination will focus on supporting the wider adoption and implementation of the intervention (if effective) and will target groups for whom the results will be relevant. This trial was approved by West Midlands-Edgbaston REC 23/WM/0013., Trial Registration Number: ISRCTN13694911., Competing Interests: Competing interests: Professor Catriona McDaid is a Senior Journal Editor at NIHR Journals Library. All the other authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Background: There is strong evidence that those recruited into studies are not always representative of the population for whom the research is most relevant. Development of the study design and funding decisions are points in the research process where considerations about inclusion of under-served populations may usefully be made. Current practical guidance focuses on designing and modifying participant recruitment and retention approaches but an area that has not been addressed is recruitment site selection., Methods: We present case studies of three NIHR funded trials to demonstrate how publicly available UK population datasets can be used to facilitate the identification of under-served communities for inclusion in trials. The trials have different designs, address different needs and demonstrate recruitment planning across Trauma centres, NHS Trusts and special educational settings.We describe our use of national freely available datasets, such as those provided by NHS Digital and the Office for National Statistics, to identify potential recruitment sites with consideration of health status, socio-economic status and ethnicity as well as clinical and risk factors to support inclusivity.For all three studies, we produced lists of potential recruitment sites in excess of the number anticipated as necessary to meet the recruitment targets., Discussion: We reflect on the challenges to our approach and some potential future developments. The datasets used are all free to use but each has their limitations. Agreeing search parameters, acceptable proxies and identifying the appropriate datasets, then cross referencing between datasets takes considerable time and particular expertise. The case studies are trials, but the methods are generalisable for various other study types., Conclusion: Through these exemplars, we aim to build on the NIHR INCLUDE project, by providing trialists with a much needed practical approach to embedding EDI into trial design at the grant application stage., Competing Interests: No competing interests were disclosed., (Copyright: © 2024 Booth A et al.)

Background: The utility of the suprascapular nerve block (SSNB) in the non-surgical management of shoulder pain continues to be explored, whilst its associated physical harms have not. This systematic review aims to report the physical harms associated with the SSNB in the non-surgical management of shoulder pain., Methods: A search was undertaken of AMED, CINAHL, Cochrane Library, EMBASE, Medline, Pubmed, and Scopus databases. Studies were included if they reported the presence or absence of harm following a SSNB intervention (injection, pulsed radiofrequency, ablation) in the non-surgical management of acute or chronic shoulder pain. Excluded studies were those which utilised SSNB for peri, intra, or post-surgical intervention. The McMaster tool for assessing quality of harms assessment and reporting was utilised., Results: A total of 111 studies were included in this review of which 168 episodes of harm were reported across 4142 participants. Harm severity ranged from pneumothorax (n = 5) to local pain and bruising (n = 50). The quality of harms assessment and reporting across all studies was poor., Discussion: Despite heterogeneity in SSNB intervention, and low-quality evidence, SSNB carries a low risk of physical harm. Further work is needed in addressing the poor quality of harms assessment and reporting in SSNB studies., Competing Interests: The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2024.)

Background: Lateral compression type-1 pelvic fractures are a common fragility fracture in older adults. Patients who do not mobilise due to ongoing pain are at greater risk of immobility-related complications. Standard treatment in the United Kingdom is provision of pain relief and early mobilisation, unlike fragility hip fractures, which are usually treated surgically based on evidence that early surgery is associated with better outcomes. Currently there is no evidence on whether patients with lateral compression type-1 fragility fractures would have a better recovery with surgery than non-surgical management., Objectives: To assess the clinical and cost effectiveness of surgical fixation with internal fixation device compared to non-surgical management of lateral compression type-1 fragility fractures in older adults., Design: Pragmatic, randomised controlled superiority trial, with 12-month internal pilot; target sample size was 600 participants. Participants were randomised between surgical and non-surgical management (1 : 1 allocation ratio). An economic evaluation was planned., Setting: UK Major Trauma Centres., Participants: Patients aged 60 years or older with a lateral compression type-1 pelvic fracture, arising from a low-energy fall and unable to mobilise independently to a distance of 3 m and back due to pelvic pain 72 hours after injury., Interventions: Internal fixation device surgical fixation and non-surgical management. Participants, surgeons and outcome assessors were not blinded to treatment allocation., Main Outcome Measures: Primary outcome - average patient health-related quality of life, over 6 months, assessed by the EuroQol-5 Dimensions, five-level version utility score. Secondary outcomes (over the 6 months following injury) - self-rated health, physical function, mental health, pain, delirium, displacement of pelvis, mortality, complications and adverse events, and resource use data for the economic evaluation., Results: The trial closed early, at the end of the internal pilot, due to low recruitment. The internal pilot was undertaken in two separate phases because of a pause in recruitment due to the coronavirus disease 2019 pandemic. The planned statistical and health economic analyses were not conducted. Outcome data were summarised descriptively. Eleven sites opened for recruitment for a combined total of 92 months. Three-hundred and sixteen patients were assessed for eligibility, of whom 43 were eligible (13.6%). The main reason for ineligibility was that the patient was able to mobilise independently to 3 m and back ( n  = 161). Of the 43 eligible participants, 36 (83.7%) were approached for consent, of whom 11 (30.6%) provided consent. The most common reason for eligible patients not consenting to take part was that they were unwilling to be randomised to a treatment ( n  = 10). There were 11 participants, 5 randomised to surgical management with internal fixation device and 6 to non-surgical management. The average age of participants was 83.0 years (interquartile range 76.0, 89.0) and the EuroQol-5 Dimensions, five-level version utility score at 6 months post randomisation ( n  = 8) was 0.32 (standard deviation 0.37). A limitation of the trial was that study objectives were not addressed due to poor recruitment., Conclusions: It was not feasible to recruit to this trial in the current context. Further research to understand the treatment and recovery pathways of this group of patients, along with their outcomes, would be needed prior to undertaking a future trial., Future Work: Exploration of equipoise across different healthcare professional groups. Investigate longer-term patient outcomes., Trial Registration: This trial is registered as ISRCTN16478561., Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/167/57) and is published in full in Health Technology Assessment ; Vol. 28, No. 15. See the NIHR Funding and Awards website for further award information.