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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. 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. 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 availa

1472-6963, Background: Though new technologies like Magnetic Resonance Imaging (MRI) may be accurate, they often diffuse into practice before thorough assessment of their value in diagnosis and management, and of their effects on patient outcome and costs. MRI of the knee is a common investigation despite concern that it is not always appropriate. There is wide variation in general practitioners (GPs) access to, and use of MRI, and in the associated costs. The objective of this study was to resolve uncertainty whether GPs should refer patients with suspected internal derangement of the knee for MRI or to an orthopaedic specialist in secondary care. Methods/Design: The design consisted of a pragmatic multi-centre randomised trial with two parallel groups and concomitant economic evaluation. Patients presenting in general practice with suspected internal derangement of the knee and for whom their GP was considering referral to an orthopaedic specialist in secondary care were eligible for inclusion. Within practices, GPs or practice nurses randomised eligible and consenting participants to the local radiology department for an MRI examination, or for consultation with an orthopaedic specialist. To ensure that the waiting time from GP consultation to orthopaedic appointment was similar for both trial arms, GPs made a provisional referral to orthopaedics when requesting the MRI examination. Thus we evaluated the more appropriate sequence of events independent of variations in waiting times. Follow up of participants was by postal questionnaires at six, twelve and 24 months after randomisation. This was to ensure that the evaluation covered all events up to and including arthroscopy. Discussion: The DAMASK trial should make a major contribution to the development of evidence-based partnerships between primary and secondary care professionals and inform the debate when MRI should enter the diagnostic pathway.

1471-2288, Background: Poor response rates to postal questionnaires can introduce bias and reduce the statistical power of a study. To improve response rates in our trial in primary care we tested the effect of introducing an unconditional direct payment of £5 for the completion of postal questionnaires. Methods: We recruited patients in general practice with knee problems from sites across the United Kingdom. An evidence-based strategy was used to follow-up patients at twelve months with postal questionnaires. This included an unconditional direct payment of £5 to patients for the completion and return of questionnaires. The first 105 patients did not receive the £5 incentive, but the subsequent 442 patients did. We used logistic regression to analyse the effect of introducing a monetary incentive to increase the response to postal questionnaires. Results: The response rate following reminders for the historical controls was 78.1% (82 of 105) compared with 88.0% (389 of 442) for those patients who received the £5 payment (diff = 9.9%, 95% CI 2.3% to 19.1%). Direct payments significantly increased the odds of response (adjusted odds ratio = 2.2, 95% CI 1.2 to 4.0, P = 0.009) with only 12 of 442 patients declining the payment. The incentive did not save costs to the trial – the extra cost per additional respondent was almost £50.Conclusion: The direct payment of £5 significantly increased the completion of postal questionnaires at negligible increase in cost for an adequately powered study.

Objective To explore stakeholder perspectives upon participant retention in clinical trials, and to generate strategies to support retention in a surgical, clinical trial. Study Design & Setting The SWIFFT trial is a multi-centre study comparing treatments for the fracture of the waist of the scaphoid bone in adults. Here we report upon a multi-stage, iterative consultative process with SWIFFT stakeholders, these include workshops with members of the public, with nurses involved in data collection, and with consultant clinicians. Structured discussions were digitally recorded and transcribed, data were handled and analysed following a framework approach to qualitative data analysis. Results Removing practical barriers were identified as important factors in supporting retention. Stakeholders also identified that i) how well a study is understood and ii) how much it is valued are important factors in an individual’s willingness to maintain their involvement. A number of strategies resulted from this consultation, these include: in-clinic data collection, co-ordinated clinical and research appointments, a SWIFFT website and newsletter. Conclusion A participatory approach to trial retention might engage all relevant stakeholders in the delivery of a clinical trial, it might also support the generation of specific and contextually relevant solutions to the challenge of participant retention.

Objective To explore stakeholder perspectives upon participant retention in clinical trials, and to generate strategies to support retention in a surgical, clinical trial. Study Design & Setting The SWIFFT trial is a multi-centre study comparing treatments for the fracture of the waist of the scaphoid bone in adults. Here we report upon a multi-stage, iterative consultative process with SWIFFT stakeholders, these include workshops with members of the public, with nurses involved in data collection, and with consultant clinicians. Structured discussions were digitally recorded and transcribed, data were handled and analysed following a framework approach to qualitative data analysis. Results Removing practical barriers were identified as important factors in supporting retention. Stakeholders also identified that i) how well a study is understood and ii) how much it is valued are important factors in an individual’s willingness to maintain their involvement. A number of strategies resulted from this consultation, these include: in-clinic data collection, co-ordinated clinical and research appointments, a SWIFFT website and newsletter. Conclusion A participatory approach to trial retention might engage all relevant stakeholders in the delivery of a clinical trial, it might also support the generation of specific and contextually relevant solutions to the challenge of participant retention.

Objective To explore stakeholder perspectives upon participant retention in clinical trials, and to generate strategies to support retention in a surgical, clinical trial. Study Design & Setting The SWIFFT trial is a multi-centre study comparing treatments for the fracture of the waist of the scaphoid bone in adults. Here we report upon a multi-stage, iterative consultative process with SWIFFT stakeholders, these include workshops with members of the public, with nurses involved in data collection, and with consultant clinicians. Structured discussions were digitally recorded and transcribed, data were handled and analysed following a framework approach to qualitative data analysis. Results Removing practical barriers were identified as important factors in supporting retention. Stakeholders also identified that i) how well a study is understood and ii) how much it is valued are important factors in an individual’s willingness to maintain their involvement. A number of strategies resulted from this consultation, these include: in-clinic data collection, co-ordinated clinical and research appointments, a SWIFFT website and newsletter. Conclusion A participatory approach to trial retention might engage all relevant stakeholders in the delivery of a clinical trial, it might also support the generation of specific and contextually relevant solutions to the challenge of participant retention.

Objective To explore stakeholder perspectives upon participant retention in clinical trials, and to generate strategies to support retention in a surgical, clinical trial. Study Design & Setting The SWIFFT trial is a multi-centre study comparing treatments for the fracture of the waist of the scaphoid bone in adults. Here we report upon a multi-stage, iterative consultative process with SWIFFT stakeholders, these include workshops with members of the public, with nurses involved in data collection, and with consultant clinicians. Structured discussions were digitally recorded and transcribed, data were handled and analysed following a framework approach to qualitative data analysis. Results Removing practical barriers were identified as important factors in supporting retention. Stakeholders also identified that i) how well a study is understood and ii) how much it is valued are important factors in an individual’s willingness to maintain their involvement. A number of strategies resulted from this consultation, these include: in-clinic data collection, co-ordinated clinical and research appointments, a SWIFFT website and newsletter. Conclusion A participatory approach to trial retention might engage all relevant stakeholders in the delivery of a clinical trial, it might also support the generation of specific and contextually relevant solutions to the challenge of participant retention.