Trials and tribulations of recruiting 2,000 older women onto a clinical trial investigating falls and fractures: Vital D study.

BMC Medical Research Methodology
Kerrie M SandersGeoffrey C Nicholson

Abstract

Randomised, placebo-controlled trials are needed to provide evidence demonstrating safe, effective interventions that reduce falls and fractures in the elderly. The quality of a clinical trial is dependent on successful recruitment of the target participant group. This paper documents the successes and failures of recruiting over 2,000 women aged at least 70 years and at higher risk of falls or fractures onto a placebo-controlled trial of six years duration. The characteristics of study participants at baseline are also described for this study. The Vital D Study recruited older women identified at high risk of fracture through the use of an eligibility algorithm, adapted from identified risk factors for hip fracture. Participants were randomised to orally receive either 500,000 IU vitamin D3 (cholecalciferol) or placebo every autumn for five consecutive years. A variety of recruitment strategies were employed to attract potential participants. Of the 2,317 participants randomised onto the study, 74% (n = 1716/2317) were consented onto the study in the last five months of recruiting. This was largely due to the success of a targeted mail-out. Prior to this only 541 women were consented in the 18 months of recruiting. A total of...Continue Reading

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Citations

Apr 29, 2011·The British Journal of Psychiatry : the Journal of Mental Science·Kerrie M SandersMichael Berk
Jun 19, 2013·Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research·Jenny GianoudisRobin M Daly
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Jul 21, 2017·Osteoporosis International : a Journal Established As Result of Cooperation Between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA·K M SandersL Busija

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