An individually-tailored multifactorial intervention program for older fallers in a middle-income developing country: Malaysian Falls Assessment and Intevention Trial (MyFAIT)

Background: In line with a rapidly ageing global population, the rise in the frequency of falls will lead to increased healthcare and social care costs. This study will be one of the few randomized controlled trials evaluating a multifaceted falls intervention in a low-middle income, culturally-diverse older Asian community. The primary objective of our paper is to evaluate whether individually tailored multifactorial interventions will successfully reduce the number of falls among older adults. Methods: Three hundred community-dwelling older Malaysian adults with a history of (i) two or more falls, or (ii) one injurious fall in the past 12 months will be recruited. Baseline assessment will include cardiovascular, frailty, fracture risk, psychological factors, gait and balance, activities of daily living and visual assessments. Fallers will be randomized into 2 groups: to receive tailored multifactorial interventions (intervention group); or given lifestyle advice with continued conventional care (control group). Multifactorial interventions will target 6 specific risk factors. All participants will be re-assessed after 12 months. The primary outcome measure will be fall recurrence, measured with monthly falls diaries. Secondary outcomes include falls risk factors; and psychological measures including fear of falling, and quality of life.Previous studies evaluating multifactorial interventions in falls have reported variable outcomes. Given likely cultural, personal, lifestyle and health service differences in Asian countries, it is vital that individually-tailored multifaceted interventions are evaluated in an Asian population to determine applicability of these interventions in our setting. If successful, these approaches have the potential for widespread application in geriatric healthcare services, will reduce the projected escalation of falls and fall-related injuries, and improve the quality of life of our older community

Research Ethics Committee decision-making in relation to an efficient neonatal trial

Objective Randomised controlled trials, a gold-standard approach to reduce uncertainties in clinical practice, are growing in cost and are often slow to recruit. We determined the acceptability to United Kingdom (UK) Research Ethics Committees (REC) of approaches to facilitate large, efficient clinical trials. Design We developed a protocol in collaboration with parents, for a comparative-effectiveness, randomised controlled trial comparing two widely used blood transfusion practices in preterm infants. We incorporated four approaches to improve recruitment and efficiency: i) point-of-care design using Electronic Patient Records for patient identification, randomisation and data acquisition, ii) short two-page information sheet; iii) explicit mention of possible inclusion benefit; iv) opt-out consent with enrollment as the default. With the support of the UK Health Research Authority, we submitted an identical protocol to 12 UK REC. Setting Research Ethics Committees in the UK Main outcome Number of REC granting favourable opinions. Results The use of Electronic Patient Records was acceptable to all REC; one REC raised concerns about the short parent information sheet, 10 about inclusion benefit and 9 about opt-out consent. Following responses to queries 9 REC granted a favourable final opinion; 3 rejected the application because they considered the opt-out consent process invalid. Conclusions A majority of REC in this study consider the use of Electronic Patient Record data, short information sheets, opt-out consent and mention of possible inclusion benefit to be acceptable in neonatal comparative-effectiveness research. We identified a need for guidance for REC in relation to opt-out consent processes. These methods provide opportunity to facilitate large randomised controlled trials