Journal article
Trials and tribulations of recruiting 2,000 older women onto a clinical trial investigating falls and fractures: Vital D study
KM Sanders, AL Stuart, EN Merriman, ML Read, MA Kotowicz, D Young, R Taylor, I Blair-Holt, AG Mander, GC Nicholson
BMC Medical Research Methodology | Published : 2009
Abstract
Background. 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. Methods. The Vital D Study recruited older women identified at high risk of fracture through the use of an eligibility algorithm, adapte..
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Awarded by National Health and Medical Research Council
Funding Acknowledgements
The study has been funded through a 5-year project grant from the Australian National Health and Medical Research Council (NHMRC No. 251682). Additional funding aimed specifically at recruitment was granted through the Government Department of Health and Ageing. These funding bodies did not have any role in the study design, in the collection, analysis or interpretation of the data; in the writing of the manuscript; or in the decision to submit the manuscript for publication.