Recruitment and Accrual of Women in a Placebo-Controlled Clinical Pilot Study on Manual Therapy☆
Received 3 February 2003; received in revised form 21 March 2003
Abstract
Objective
To investigate the accrual rates and recruitment processes among 3 Midwestern sites during a pilot study on manual therapy for chronic pelvic pain.
Design
Multisite pilot study for a randomized, placebo-controlled clinical trial.
Setting
Three chiropractic institutions in or near major metropolitan cities in the Midwestern United States.
Subjects
Thirty-nine women aged 18 to 45 with chronic pelvic pain of at least 6 months duration, diagnosed by a board certified gynecologist.
Main Outcome Measures
The method of recruitment was collected for each individual who responded to an advertisement and completed an interviewer-administered telephone screen. Participants who were willing and eligible after 3 baseline visits were entered into a randomized clinical trial. The number of responses and accrual rates were determined for the overall study, each of the 3 treatment sites, and each of the 5 recruitment efforts.
Results
In this study, 355 women were screened over the telephone and 39 were randomized, making the rate of randomization approximately 10%. The most effective recruitment methods leading to randomization were direct mail (38%) and radio advertisements (34%). However, success of the recruitment process differed by site.
Conclusions
Based on the accrual of this multisite pilot study, a full-scale trial would not be feasible using this study's parameters. However, useful information was gained on recruitment effectiveness, eligibility criteria, and screening protocols among the 3 metropolitan sites.
aResearch Department, National University of Health Sciences, Lombard, Ill, USA
bSenior Researcher, Parker Research Institute, Dallas, Tex, USA
cResearch Department, Northwestern Health Sciences University, Bloomington, Minn, USA
dPalmer Center for Chiropractic Research, Palmer College of Chiropractic, Davenport, Iowa, USA
Jerrilyn A. Cambron, DC, MPH, National University of Health Sciences, Research Department, 200 E Roosevelt Rd, Lombard, IL 60148
☆ This publication was made possible by Grant Number U01 AT001 70 from the National Center for Complementary and Alternative Medicine (NCCAM) of the National Institutes of Health (NIH). Additional funding was provided by the National Chiropractic Mutual Insurance Company (NCMIC). Its contents are solely the responsibility of the authors and do not necessarily represent the official view of NCCAM, NIH, or NCMIC.
ABSTRACT