Research staff turnover and participant adherence in the Women's Health Initiative.

Maintaining participant adherence is a prerequisite for successful completion of randomized controlled trials requiring long-term follow-up. While patient characteristics influencing adherence are well studied, the influence of contact with clinical staff on this process has received almost no attention. To address this issue the authors evaluated the association of turnover in key clinical research staff with measures of participant adherence to protocol requirements at 40 clinical centers participating in the Women's Health Initiative (WHI), a large multicenter study. Key staff turnover in positions with potential influence on maintaining participant adherence in the Dietary Modification Clinical Trial (DM-CT) and the two Menopausal Hormone Therapy Clinical Trials (HT-CT) of the WHI was determined at each clinical center. Three prospectively established measures of participant adherence for the DM-CT and HT-CT were related to key staff turnover at each clinical center by staff category. More frequent turnover of the clinic practitioner, clinic manager, and principal investigator positions was significantly (p<0.05) associated with lower participant adherence in the HT-CT but was not associated with DM-CT participant adherence. More frequent turnover of the lead nutritionist was not associated with HT-CT participant adherence but was significantly (p<0.05) associated with one measure of decreased DM-CT participant adherence, as would be expected since the lead nutritionist did not typically see the HT-CT participants. These significant and plausible associations suggest that providing consistent contact with key staff in randomized, controlled clinical trials may facilitate long-term participant adherence. Further prospective study exploring process evaluation of the provider side of controlled trial conduct is indicated.