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Title: Comparing community and specialty provider-based recruitment in a randomized clinical trial: clinical trial in fecal incontinence

Author
item WHITEBIRD, ROBIN - University Of Minnesota
item BLISS, DONNA - University Of Minnesota
item SAVIK, KAY - University Of Minnesota
item LOWRY, ANN - University Of Minnesota
item Jung, Hans Joachim

Submitted to: Research in Nursing and Health
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 9/9/2010
Publication Date: 12/1/2010
Citation: Whitebird, R.R., Bliss, D.Z., Savik, K., Lowry, A., Jung, H.G. 2010. Comparing community and specialty provider-based recruitment in a randomized clinical trial: clinical trial in fecal incontinence. Research in Nursing and Health. 33(6):500-511.

Interpretive Summary: Experiments on human health therapies require recruitment of a representative sample of people as subjects for the experiment. Various methods of subject recruitment have been utilized, but the potential bias in the subject pool for age, ethnicity, gender, and other characteristics that might result in a non-representative group of people from different recruitment methods has not been fully examined. For a study examining dietary fiber supplementation as a treatment for fecal incontinence, two methods of subject recruitment were used and the resulting subject groups compared for bias. Using both a community-based random recruitment method at an academic health center and recruiting through a specialty medical clinic, focused on health issues related to fecal incontinence, resulted in a more diverse set of subjects for the study than did either recruitment method alone. These results indicate that human subject recruitment for health therapy studies can be more successful at acquiring representative subject groups using a mix of recruitment methods.

Technical Abstract: Recruitment of participants to clinical trials remains a significant challenge, especially for research addressing topics of a sensitive nature such as fecal incontinence (FI). The Fiber Study, a randomized controlled trial on symptom management for FI, successfully enrolled 189 community-living adults through collaborations with specialty-based and community-based settings, each employing methods tailored to the organizational characteristics of their site. Results show that using the two settings increased racial and ethnic diversity of the sample and those who were informal caregivers for others. There were no differential effects on enrollment or completion of the protocol by site. Strategic collaborations with complementary sites can achieve sample recruitment goals for clinical trials on topics that are sensitive or known to be underreported.