Recruitment and accrual of women in a placebo-controlled clinical pilot study on manual therapy

Jerrilyn A. Cambron, Cheryl Hawk, Roni Evans, Cynthia R. Long

Research output: Contribution to journalArticlepeer-review

10 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)299-305
Number of pages7
JournalJournal of manipulative and physiological therapeutics
Volume27
Issue number5
DOIs
StatePublished - Jun 2004

Bibliographical note

Funding Information:
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.

Keywords

  • Chiropractic
  • Controlled Clinical Trials
  • Patient Selection
  • Randomized Controlled Trials

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