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Background Adolescent-onset psychosis is associated with more severe symptoms and poorer outcomes than adult-onset psychosis. The National Institute for Clinical Excellence (NICE) recommend that adolescents with first episode psychosis (FEP) should be offered a combination of antipsychotic medication (APs), cognitive behavioural therapy (CBT) and family intervention (FI). The evidence for APs in treating...
Background A key step in the design of a RCT is the estimation of the number of participants needed in the study. The most common approach is to specify a target difference between the treatments for the primary outcome and then calculate the required sample size. The sample size is chosen to ensure that the trial will have a high probability (adequate statistical power) of detecting a target difference...
Background Urinary stone disease is very common with an estimated prevalence among the general population of 2–3%. Ureteric stones are associated with severe pain as they pass through the urinary tract and have significant impact on patients’ quality of life due to the detrimental effect on their ability to work and need for hospitalisation. Most ureteric stones can be expected to pass spontaneously...
Background Stress urinary incontinence (SUI) is a frequent adverse effect for men undergoing prostate surgery. A large proportion (around 8% after radical prostatectomy and 2% after transurethral resection of prostate (TURP)) are left with severe disabling incontinence which adversely effects their quality of life and many are reliant on containment measures such as pads (27% and 6% respectively)...
Background Non-retention of participants seriously affects the credibility of clinical trial results and significantly reduces the potential of a trial to influence clinical practice. Non-retention can be defined as instances where participants leave the study prematurely. Examples include withdrawal of consent and loss to follow-up and thus outcome data cannot be obtained. The majority of existing...
Table of contents I1 Introduction Mona Kanaan, Noreen Dadirai Mdege, Ada Keding O1 The HiSTORIC trial: a hybrid before-and-after and stepped wedge design RA Parker, N Mills, A Shah, F Strachan, C Keerie, CJ Weir O2 Stepped wedge trials with non-uniform correlation structure Andrew Forbes, Karla Hemming O3 Challenges and solutions for the operationalisation...
Background The decision to conduct a randomized controlled trial (RCT) in a field raises ethical as well as scientific issues. From the clinical equipoise literature, future trials are justifiable if there is ”honest, professional disagreement in the community of expert practitioners as to the preferred treatment”. Empirical data are sparse about how clinicians apply the principles of equipoise to...
Background Urethral stricture is a common cause of difficulty passing urine in men with prevalence of 0.5 %; about 62,000 men in the UK. The stricture is usually sited in the bulbar part of the urethra causing symptoms such as reduced urine flow. Initial treatment is typically by endoscopic urethrotomy but recurrence occurs in about 60 % of men within 2 years. The best treatment for men with recurrent...
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