Randomised trial of a vibrating bladder stimulator -the time to pee study

This randomised, non-blinded study evaluated a vibrating bladder stimulator to facilitate collection of a urine sample from pre-continent children. The use of a bladder stimulator produced no significant time improvements in any of the analysed parameters (n = 97). We identify a population of patients who may benefit from some form of bladder stimulation

Cost-effectiveness and value of information analysis of a low-friction environment following skin graft in patients with burn injury

Background Patients with burn injuries may receive a skin graft to achieve healing in a timely manner. However, in around 7% of cases, the skin graft is lost (fails to attach to the wound site) and a re-grafting procedure is necessary. It has been hypothesised that low-friction (smooth, more slippery) bedding may reduce the risk of skin-graft loss. A before and after feasibility study comparing low-friction with standard bedding in skin-grafted patients was conducted in order to collect proof of concept data. The resulting relative risk on the primary outcome (number of patients with skin graft failure) for the non-randomised study provided no evidence of effect but had a large standard error. The aim of this study is to see if an appropriately powered randomised control trial would be worthwhile. Methods A probabilistic decision-analytic model was constructed to compare low-friction bedding to standard care in a population of burn patients who have undergone skin grafting. Results from the before and after study were used as model inputs. The sensitivity of results to bias in the relative risk of graft loss was conducted. Low-friction bedding is considered optimal if expected incremental net benefit (INB) is positive. Uncertainty is assessed using cost-effectiveness acceptability curves. Expected Value of Perfect Partial Information (EVPPI) provides an upper bound for the potential net health benefits of new research for given model input. Results At a willingness to pay threshold of £20,000 per QALY, INB = £151 (95% Credible Interval (CrI) −142 to 814), marginally favouring low-friction bedding but with high uncertainty (probability of being cost-effective 70.5%). Expected value of perfect information (EVPI) per patient was £20.29, which results in a population EVPI of £174,765 over a 10-year lifetime for the technology (based on 1000 patients per year who would benefit from the intervention). The parameter contributing most to the uncertainty was the inpatient care cost, i.e. information that could be obtained from the audit of practice and without an expensive trial. These findings were robust to a wide-range of assumptions about the potential bias due to the observational nature of the comparative evidence. Conclusions Our study results suggest that an RCT (randomised controlled trial) is unlikely to be worthwhile, but there may be value in a study to estimate the re-graft rates and associated costs in this population

Trial protocol: a multicentre randomised trial of first-line treatment pathways for newly diagnosed immune thrombocytopenia: standard steroid treatment versus combined steroid and mycophenolate. The FLIGHT trial

Introduction Immune thrombocytopenia (ITP) is an autoimmune condition that may cause thrombocytopenia-related bleeding. Current first-line ITP treatment is with high-dose corticosteroids but frequent side effects, heterogeneous responses and high relapse rates are significant problems with only 20% remaining in sustained remission with this approach. Mycophenolate mofetil (MMF) is often used as the next treatment with efficacy in 50%–80% of patients and good tolerability but can take up to 2 months to work. Objective To test the hypothesis that MMF combined with corticosteroid is a more effective first-line treatment for immune thrombocytopenia (ITP) than current standard of corticosteroid alone. Design Multicentre, UK-based, open-label, randomised controlled trial. Setting Haematology departments in secondary care. Participants We plan to recruit 120 patients >16 years old with a diagnosis of ITP and a platelet count <30x109/L who require first-line treatment. Patients will be followed up for a minimum of 12 months following randomisation. Primary outcome Time from randomisation to treatment failure defined as platelets <30x109/L and a need for second-line treatment. Secondary outcomes Side effects, bleeding events, remission rates, time to relapse, time to next therapy, cumulative corticosteroid dose, rescue therapy, splenectomy, socioeconomic costs, patient-reported outcomes (quality of life, fatigue, impact of bleeding, care costs). Analysis The sample size of 120 achieves a 91.5% power to detect a doubling of the median time to treatment failure from 5 to 10 months. This will be expressed as an HR with 95% CI, median time to event if more than 50% have had an event and illustrated with Kaplan-Meier curves. Cost-effectiveness will be based on the first 12 months from diagnosis

Acceptability of Lycra arm sleeve in people with sub-acute stroke: Patients', 1 carers' and clinicians' perspectives

BackgroundPrevious studies found that the Lycra sleeve has potential to reduce glenohumeral subluxation in people with stroke. The primary aim of this study was to explore the acceptability of the Lycra sleeve from patients’, carers’ and staff perceptive in the sub-acute phase of stroke.MethodStroke survivors over 18 years with hemiplegia and muscle strength of ≤3 (Medical Research Council scale) shoulder abduction, able to provide informed consent were recruited as soon as they were medically stable. Patients wore the Lycra sleeve for up to 10 hours/day for three months. A questionnaire was administered three months post-sleeve application to immediate and delayed groups and healthcare staff.ResultsTwenty-seven patients (immediate group (n=19), delayed group (n=8)), 23 carers/family-members and 36 healthcare staff (nurses (n=10), nursing assistants (n=5), physiotherapists (n=10), physiotherapy assistants (n=3) and occupational therapists (n=8) completed a questionnaire. Several staff reported for more than one patient resulting in up to 37 responses to some questions from nursing staff and 46 responses from therapy staff. Of 27 patients, all found the sleeve to be comfortable. The average time to apply the sleeve was between two and five minutes. The sleeve was reported as acceptable in daily life by patients (96%, n=24/25), carers/family-members (96%, n=21/22), by nurses (92%, n=34/37) and in routine clinical practice by therapists (91%, n=41/45).ConclusionWearing of Lycra sleeve was acceptable for patients during activities of daily living/rehabilitation. However, research is required on the effectiveness of the sleeve before this can be routinely used in clinical practice