The reform study: a cohort multiple randomised controlled trial
نویسندگان
چکیده
Background Undertaking randomised controlled trials can be challenging. Many trials fail to recruit, there may be issues around consent, patient preferences and treatment comparisons. The patient preference and Zelen designs have attempted to address the issues around recruitment and patient preference. However the cohort multiple randomised controlled trial has been suggested as an alternative design. The REFORM study uses this design to evaluate the clinical and cost effectiveness of a multifaceted podiatry intervention consisting of an orthotic, foot and ankle exercises and footwear advice for the prevention of falls in the over 65.
منابع مشابه
The REFORM study protocol: a cohort randomised controlled trial of a multifaceted podiatry intervention for the prevention of falls in older people
INTRODUCTION Falls and fall-related injuries are a serious cause of morbidity and cost to society. Foot problems and inappropriate footwear may increase the risk of falls; therefore podiatric interventions may play a role in reducing falls. Two Cochrane systematic reviews identified only one study of a podiatry intervention aimed to reduce falls, which was undertaken in Australia. The REFORM tr...
متن کاملAn optimised patient information sheet did not significantly increase recruitment or retention in a falls prevention study: an embedded randomised recruitment trial
BACKGROUND Randomised controlled trials are generally regarded as the 'gold standard' experimental design to determine the effectiveness of an intervention. Unfortunately, many trials either fail to recruit sufficient numbers of participants, or recruitment takes longer than anticipated. The current embedded trial evaluates the effectiveness of optimised patient information sheets on recruitmen...
متن کاملP-78: A Randomised Placebo-Controlled Trial to Determine the Effect of Iron Supplementation on Neonatal Outcome in Pregnant Women with Normal Heamoglobin (Hb=11-13
Background: To study the effect of iran supplementation on neonal outcom in pregnant women with normal heamoglobin (Hb=11g/dl )13 g/dl Methods : two handrad pregnant women with Hb=11-13 g/dl in the early slage of pregmancy? Materials and Methods: Each woman look one tablet of 50 mg of ferrossalphate daily in the case group (n=100) and placebo group (n=100). Results: While no significant differe...
متن کاملImproving recruitment of older people to clinical trials: use of the cohort multiple randomised controlled trial design.
There is widespread evidence of under-recruitment of older people to research studies, notably randomised controlled trials of interventions. Study exclusion criteria, ethical dilemmas, patient preference, risk of bias and challenges for treatment comparisons are particular problems faced by researchers. This article describes how more widespread use of the cohort multiple randomised controlled...
متن کاملImproving recruitment of older people to clinical trials: use of the cohort multiple randomised controlled trial design
There is widespread evidence of under-recruitment of older people to research studies, notably randomised controlled trials of interventions. Study exclusion criteria, ethical dilemmas, patient preference, risk of bias and challenges for treatment comparisons are particular problems faced by researchers. This article describes how more widespread use of the cohort multiple randomised controlled...
متن کامل