Research priorities for the management of complex fractures: a UK priority setting partnership with the James Lind Alliance.

OBJECTIVE: To determine research priorities for the management of complex fractures, which represent the shared priorities of patients, their families, carers and healthcare professionals. DESIGN/SETTING: A national (UK) research priority setting partnership. PARTICIPANTS: People who have experienced a complex fracture, their carers and relatives, and relevant healthcare professionals and clinical academics involved in treating patients with complex fractures. The scope includes open fractures, fractures to joints broken into multiple pieces, multiple concomitant fractures and fractures involving the pelvis and acetabulum. METHODS: A multiphase priority setting exercise was conducted in partnership with the James Lind Alliance over 21 months (October 2019 to June 2021). A national survey asked respondents to submit their research uncertainties which were then combined into several indicative questions. The existing evidence was searched to ensure that the questions had not already been sufficiently answered. A second national survey asked respondents to prioritise the research questions. A final shortlist of 18 questions was taken to a stakeholder workshop, where a consensus was reached on the top 10 priorities. RESULTS: A total of 532 uncertainties, submitted by 158 respondents (including 33 patients/carers) were received during the initial survey. These were refined into 58 unique indicative questions, of which all 58 were judged to be true uncertainties after review of the existing evidence. 136 people (including 56 patients/carers) responded to the interim prioritisation survey and 18 questions were taken to a final consensus workshop between patients, carers and healthcare professionals. At the final workshop, a consensus was reached for the ranking of the top 10 questions. CONCLUSIONS: The top 10 research priorities for complex fracture include questions regarding rehabilitation, complications, psychological support and return to life-roles. These shared priorities will now be used to guide funders and teams wishing to research complex fractures over the coming decade.

Platelet rich plasma versus placebo for the management of Achilles tendinopathy: protocol for the UK study of Achilles tendinopathy management (ATM) multi-centre randomised trial.

INTRODUCTION: In the UK, 150 000 people every year experience mid-substance Achilles tendinopathy. Typically patients are offered a range of treatment options such as exercise, electrotherapy, injections and surgery. With large variations in current practice, there is a pressing need to establish which treatments are effective and which are not. This is the protocol for a multi-centre randomised trial of platelet rich plasma (PRP) versus placebo injection for patients with Achilles tendinopathy. METHODS AND ANALYSIS: Adult patients with mid-substance Achilles tendinopathy for longer than 3 months will be screened. Randomisation will be on a 1:1 basis, stratified by centre and bilateral presentation. Participants will be allocated to either a single PRP injection or placebo injection. A minimum of 240 patients will be recruited into the study; this number will provide 90% power to detect a difference of 12 points in Victorian Institute of Sport Assessment-Achilles score at 6 months. Quality of life, pain and complications data will be collected at baseline, 2-week, 3-month and 6-month post-randomisation. The differences between treatment groups will be assessed on an intention-to-treat basis. ETHICS, REGISTRATION AND DISSEMINATION: This trial was funded by Versus Arthritis and commenced on 1 September 2015 (Versus Arthritis 20831). National Research Ethic Committee approved this study on 30 October 2015 (15/WM/0359). It was registered on the International Standard Randomised Controlled Trial Number (ISRCTN) registry with reference number ISRCTN 13254422 on 28 October 2015. The first site opened to recruitment on 27 April 2016 and the trial was in active recruitment at the point of submitting the protocol paper. The results of this trial will be submitted to a peer-reviewed journal and will inform clinical practice with regard to the treatment of Achilles tendinopathy.

Patient experiences of an ankle fracture and the most important factors in their recovery: a qualitative interview study.

OBJECTIVE: The objective of this qualitative research study is to explore patient experiences of ankle fracture and the factors most important to them in recovery. DESIGN: Semistructured interviews exploring patient experiences of ankle fracture recovery at 16-23 weeks following injury. Interviews followed a topic guide and were recorded with an encrypted audio recorder and then transcribed verbatim. Thematic content analysis was used to identify themes in the data. SETTING: Individuals were recruited from a sample of participants of a UK-based clinical trial of immobilisation methods for ankle fracture (ISRCTN15537280 at the pre-results stage at time of writing). Interviews were conducted at the participants' own homes or on a university campus setting. PARTICIPANTS: A purposive sample was used to account for key variables of age, gender and fracture management. Participants recruited from the clinical trial sample were adults aged 18 years or over with a closed ankle fracture. RESULTS: Ten participants were interviewed, five of whom were female and six of whom needed an operation to fix their ankle fracture. The age range of participants was 21-75 years with a mean of 51.6 years. Eight themes emerged from the data during analysis; mobility, loss of independence, healthcare, psychological effects, social and family life, ankle symptoms, sleep disturbance and fatigue, and activities of daily living. Factors of importance to participants included regaining their independence, sleep quality and quantity, ability to drive, ability to walk without walking aids or weight-bearing restrictions, and radiological union. CONCLUSIONS: The results of this research demonstrates the extensive impact of ankle fracture on individuals' lives, including social and family life, sleep, their sense of independence and psychological well-being. The results of this study will enable an increased understanding of the factors of relevance to individuals with ankle fracture, allowing collection of appropriate outcomes in clinical studies for this condition. Ultimately these results will help formulate appropriate patient-centred rehabilitation plans for these patients. TRIAL REGISTRATION NUMBER: ISRCTN15537280; Pre-results.

Acute Rehabilitation following Traumatic anterior shoulder dISlocAtioN (ARTISAN): protocol for a multicentre randomised controlled trial.

INTRODUCTION: First-time traumatic anterior shoulder dislocation (TASD) is predominantly managed non-operatively. People sustaining TASD have ongoing pain, disability and future risk of redislocation. There are no published randomised controlled trials (RCTs) comparing different non-operative rehabilitation strategies to ascertain the optimum clinically effective approach after TASD. METHODS AND ANALYSIS: In this multicentre adaptive RCT, with internal pilot, adults with a radiologically confirmed first time TASD treated non-surgically will be screened at a minimum of 30 sites. People with neurovascular complications, bilateral dislocations or are unable to attend physiotherapy will be excluded.Randomisation will be on a 1:1 treatment allocation, stratified by age, hand dominance and site. Participants will receive a single session of advice; or a single session of advice plus offer of further physiotherapy (maximum 4 months). The primary analysis will be the difference in Oxford Shoulder Instability Score at 6 months. A sample size of a minimum of 478 participants will allow us to show a four point difference with 90% power.An embedded qualitative study will explore the participants' experiences of the trial interventions. ETHICS, REGISTRATION AND DISSEMINATION: Funded by NIHR HTA (16/167/56), 1 June 2018; National Research Ethic Committee approved (18/WA/0236), 26 July 2018. First site opened 5 November 2018 and final results will be updated on trial registries and submitted to a peer-reviewed journal and will inform rehabilitation strategies after a TASD. Study Within A Trial (SWAT) funded by MRC (MR/R013748/1), 1 May 2019; registered on the MRC-HTMR All-Ireland Hub (reference number SWAT 121). TRIAL REGISTRATION NUMBER: ISRCTN63184243. (Trial stage: Pre-results).

Cast versus functional brace in the rehabilitation of patients treated for an ankle fracture: protocol for the UK study of ankle injury rehabilitation (AIR) multicentre randomised trial.

INTRODUCTION: Each year in the UK over 120 000 people fracture their ankle. It is not known what the best rehabilitation strategy is for these people. Traditionally standard care has involved immobilisation in a plaster cast but an alternative is a functional brace, which can be removed to allow early movement. This paper details the protocol for a multicentre randomised trial of plaster cast immobilisation versus functional bracing for patients with an ankle fracture. METHODS AND ANALYSIS: We will recruit adults with a fractured ankle, for which the treating clinician would consider plaster cast to be a reasonable management option. Randomisation will be on a 1:1 basis, stratified by centre, operative or non-operative management and age. Participants will be allocated to either plaster cast or a functional brace, both treatments are widely used. To have 90% power to detect a difference of 10 points on the primary outcome (Olerud and Molander Ankle Score) at the primary outcome time point (16 weeks), we need to randomise a minimum of 478 people. Quality of life and resource use will be collected at 6, 10, 16, 24 weeks and 12, 18, 24 months. The differences between treatment groups will be assessed on an intention-to-treat basis. The economic evaluation will adhere to the recommendations of the National Institute for Health and Care Excellence reference case. ETHICS, REGISTRATION AND DISSEMINATION: National Research Ethic Committee approved this study on 4 July 2017 (17/WM/0239). The first site opened to recruitment 9 October 2017. The results of this trial will be submitted to a peer-reviewed journal and will inform clinical practice. TRIAL REGISTRATION NUMBER: ISRCTN15537280; Pre-results.