Comparing community and specialty provider-based recruitment in a randomized clinical trial: clinical trial in fecal incontinence.
Recruitment of participants to clinical trials remains a significant challenge, especially for research addressing topics of a sensitive nature such as fecal incontinence (FI). In the Fiber Study, a randomized controlled trial on symptom management for FI, we 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 inclusion of informal caregivers. There were no differential effects on enrollment, final eligibility, or completion of 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.
HealthPartners Research Foundation, Bloomington, MN 55425, USA.
Robin R
RR
Whitebird
Donna Zimmaro
DZ
Bliss
Kay
K
Savik
Ann
A
Lowry
Hans-Joachim G
HJ
Jung
D000047:Academies and Institutes; D000329:Advertising; D000368:Aged; D000704:Analysis of Variance; D016009:Chi-Square Distribution; D003107:Colorectal Surgery; D016208:Databases, Factual; D004043:Dietary Fiber / Q000627:therapeutic use; D005242:Fecal Incontinence / Q000517:prevention & control; D005260:Female; D005582:Foundations / Q000458:organization & administration*; D006279:Health Maintenance Organizations / Q000458:organization & administration*; D006801:Humans; D007373:Interinstitutional Relations; D008297:Male; D008875:Middle Aged; D008910:Minnesota; D015403:Nursing Evaluation Research / Q000379:methods; D017063:Outcome Assessment, Health Care; D018579:Patient Selection; D011331:Private Practice / Q000458:organization & administration*; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D012107:Research Design; D012579:Schools, Nursing; D016037:Single-Blind Method