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1.  MIDSHIPS: Multicentre Intervention Designed for Self-Harm using Interpersonal Problem-Solving: protocol for a randomised controlled feasibility study 
Trials  2014;15:163.
Background
Around 150,000 people each year attend hospitals in England due to self-harm, many of them more than once. Over 5,000 people die by suicide each year in the UK, a quarter of them having attended hospital in the previous year because of self-harm. Self-harm is a major identifiable risk factor for suicide. People receive variable care at hospital; many are not assessed for their psychological needs and little psychological therapy is offered. Despite its frequent occurrence, we have no clear research evidence about how to reduce the repetition of self-harm. Some people who have self-harmed show less active ways of solving problems, and brief problem-solving therapies are considered the most promising psychological treatments.
Methods/Design
This is a pragmatic, individually randomised, controlled, feasibility study comparing interpersonal problem-solving therapy plus treatment-as-usual with treatment-as-usual alone, for adults attending a general hospital following self-harm. A total of 60 participants will be randomised equally between the treatment arms, which will be balanced with respect to the type of most recent self-harm event, number of previous self-harm events, gender and age. Feasibility objectives are as follows: a) To establish and field test procedures for implementing the problem-solving intervention; b) To determine the feasibility and best method of participant recruitment and follow up; c) To assess therapeutic delivery; d) To assess the feasibility of obtaining the definitive trial’s primary and secondary outcomes; e) To assess the perceived burden and acceptability of obtaining the trial’s self-reported outcome data; f) To inform the sample size calculation for the definitive trial.
Discussion
The results of this feasibility study will be used to determine the appropriateness of proceeding to a definitive trial and will allow us to design an achievable trial of interpersonal problem-solving therapy for adults who self-harm.
Trial registration
Current Controlled Trials (ISRCTN54036115)
doi:10.1186/1745-6215-15-163
PMCID: PMC4020387  PMID: 24886683
Self-harm; Problem-solving therapy; Suicide; Self-poisoning; Self-injury
2.  The STAR trial protocol: a randomised multi-stage phase II/III study of Sunitinib comparing temporary cessation with allowing continuation, at the time of maximal radiological response, in the first-line treatment of locally advanced/metastatic Renal Cancer 
BMC Cancer  2012;12:598.
Background
Over recent years a number of novel therapies have shown promise in advanced renal cell carcinoma (RCC). Internationally the standard of care of first-line therapy is sunitinib™, after a clear survival benefit was demonstrated over interferon-α. Convention dictates that sunitinib is continued until evidence of disease progression, assuming tolerability, although there is no evidence that this approach is superior to intermittent periods of treatment. The purpose of the STAR trial is to compare the standard treatment strategy (conventional continuation strategy, CCS) with a novel drug free interval strategy (DFIS) which includes planned treatment breaks.
Methods/Design
The STAR trial is an NIHR HTA-funded UK pragmatic randomised phase II/III clinical trial in the first-line treatment of advanced RCC. Participants will be randomised (1:1) to either a sunitinib CCS or a DFIS. The overall aim of the trial is to determine whether a DFIS is non-inferior, in terms of 2-year overall survival (OS) and quality adjusted life years (QALY) (averaged over treatment and follow up), compared to a CCS. The QALY primary endpoint was selected to assess whether any detriment in terms of OS could be balanced with improvements in quality of life (QoL). This is a complex trial with a number of design challenges, and to address these issues a feasibility stage is incorporated into the trial design. Predetermined recruitment (stage A) and efficacy (stage B) intermediary endpoints must be met to allow continuation to the overall phase III trial (stage C). An integral qualitative patient preference and understanding study will occur alongside the feasibility stage to investigate patients’ feelings regarding participation or non-participation in the trial.
Discussion
The optimal duration of continuing sunitinib in advanced RCC is unknown. Novel targeted therapies do not always have the same constraints to treatment duration as standard chemotherapeutic agents and currently there are no randomised data comparing different treatment durations. Incorporating planned treatment breaks has the potential to improve QoL and cost effectiveness, hopefully without significant detriment on OS, as has been demonstrated in other cancer types with other treatments.
Trial Registration
Controlled-trials.com ISRCTN 06473203
doi:10.1186/1471-2407-12-598
PMCID: PMC3583710  PMID: 23241439
Renal cancer; Sunitinib; Intermittent treatment; Quality of life; Quality adjusted life years; Health economics
3.  Cost-effectiveness of total hip arthroplasty versus resurfacing arthroplasty: economic evaluation alongside a clinical trial 
BMJ Open  2012;2(5):e001162.
Objective
To report on the relative cost-effectiveness of total hip arthroplasty and resurfacing arthroplasty (replacement of articular surface of femoral head only) in patients with severe arthritis suitable for hip joint resurfacing arthroplasty.
Design
Cost-effectiveness analysis on an intention-to-treat basis of a single-centre, single-blind randomised controlled trial of 126 adult patients within 12 months of treatment. Missing data were imputed using multiple imputations with differences in baseline quality of life and gender adjusted using regression techniques.
Setting
A large teaching hospital trust in the UK.
Participants
A total of 126 adult patients with severe arthritis of the hip joint suitable for a resurfacing arthroplasty of the hip.
Results
Data were received for 126 patients, 4 of whom did not provide any resource use data. For the remainder, data were imputed for costs or quality of life in at least one time point (baseline, 3, 6 months and 1 year) for 18 patients. Patients in the resurfacing arm had higher quality of life at 12 months (0.795 vs 0.727) and received 0.032 more QALYs within the first 12 months postoperation. At an additional cost of £564, resurfacing arthroplasty offers benefits at £17 451 per QALY within the first 12 months of treatment. When covariates are considered, the health economic case is stronger in men than in women.
Conclusions
Resurfacing arthroplasty appears to offer very short-term efficiency benefits over total hip arthroplasty within a selected patient group. The short-term follow-up in this trial should be noted, particularly in light of the concerns raised regarding adverse reactions to metal debris from metal-on-metal bearing surfaces in the longer term. Longer-term follow-up of resurfacing arthroplasty patients and decision analytic modelling is also advised.
Trial registration
Current controlled Trials ISRCTN33354155. UKCRN 4093.
doi:10.1136/bmjopen-2012-001162
PMCID: PMC3488749  PMID: 23065450
Orthopaedic & trauma surgery < SURGERY
5.  Percutaneous fixation with Kirschner wires versus volar locking plate fixation in adults with dorsally displaced fracture of distal radius: randomised controlled trial 
Objectives To compare the clinical effectiveness of Kirschner wire fixation with locking plate fixation for patients with a dorsally displaced fracture of the distal radius.
Design A multicentre two arm parallel group assessor blind randomised controlled trial with 1:1 treatment allocation.
Setting 18 trauma centres in the United Kingdom.
Participants 461 adults with a dorsally displaced fracture of the distal radius within 3 cm of the radiocarpal joint that required surgical fixation. Patients were excluded if the surgeon thought that the surface of the wrist joint was so badly displaced it required open reduction.
Interventions Kirschner wire fixation: wires are passed through the skin over the dorsal aspect of the distal radius and into the bone to hold the fracture in the correct anatomical position. Locking plate fixation: a locking plate is applied through an incision over the volar (palm) aspect of the wrist and secured to the bone with fixed angle locking screws.
Main outcome measures Primary outcome measure: validated patient rated wrist evaluation (PRWE). This rates wrist function in two (equally weighted) sections concerning the patient’s experience of pain and disability to give a score out of 100. Secondary outcomes: disabilities of arm, shoulder, and hand (DASH) score, the EuroQol (EQ-5D), and complications related to the surgery.
Results The baseline characteristics of the two groups were well balanced, and over 90% of patients completed follow-up. The wrist function of both groups of patients improved by 12 months. There was no clinically relevant difference in the patient rated wrist score at three, six, or 12 months (difference in favour of the plate group was −1.3, 95% confidence interval −4.5 to 1.8; P=0.40). Nor was there a clinically relevant difference in health related quality of life or the number of complications in each group.
Conclusions Contrary to the existing literature, and against the rapidly increasing use of locking plate fixation, this trial found no difference in functional outcome in patients with dorsally displaced fractures of the distal radius treated with Kirschner wires or volar locking plates. Kirschner wire fixation, however, is cheaper and quicker to perform.
Trial registration Current Controlled Trials ISCRTN 31379280. UKCRN 8956.
doi:10.1136/bmj.g4807
PMCID: PMC4122170  PMID: 25096595

Results 1-5 (5)