Document Detail

Recruitment and accrual of women in a placebo-controlled clinical pilot study on manual therapy.
MedLine Citation:
PMID:  15195037     Owner:  NLM     Status:  MEDLINE    
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.
Jerrilyn A Cambron; Cheryl Hawk; Roni Evans; Cynthia R Long
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  Journal of manipulative and physiological therapeutics     Volume:  27     ISSN:  1532-6586     ISO Abbreviation:  J Manipulative Physiol Ther     Publication Date:  2004 Jun 
Date Detail:
Created Date:  2004-06-14     Completed Date:  2005-01-28     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  7807107     Medline TA:  J Manipulative Physiol Ther     Country:  United States    
Other Details:
Languages:  eng     Pagination:  299-305     Citation Subset:  IM    
Research Department, National University of Health Sciences, Lombard, Ill 60148, USA.
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MeSH Terms
Advertising as Topic
Cost-Benefit Analysis
Data Collection
Feasibility Studies
Manipulation, Chiropractic*
Middle Aged
Midwestern United States
Patient Selection*
Pelvic Pain / therapy*
Pilot Projects
Postal Service
Randomized Controlled Trials as Topic / economics,  methods*
Women* / psychology
Grant Support

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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