Recruitment and accrual of women in a placebo-controlled clinical pilot study on manual therapy.
OBJECTIVE
To investigate the accrual rates and recruitment processes among 3 Midwestern sites during a pilot study on manual therapy for chronic pelvic pain.


METHODS
Multisite pilot study for a randomized, placebo-controlled clinical trial.


METHODS
Three chiropractic institutions in or near major metropolitan cities in the Midwestern United States.


METHODS
Thirty-nine women aged 18 to 45 with chronic pelvic pain of at least 6 months duration, diagnosed by a board certified gynecologist.


METHODS
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.
Cambron
Jerrilyn A
JA
Research Department, National University of Health Sciences, Lombard, Ill 60148, USA. jcambron@nuhs.edu
Hawk
Cheryl
C
Evans
Roni
R
Long
Cynthia R
CR
D000293:Adolescent; D000328:Adult; D000329:Advertising; D003362:Cost-Benefit Analysis; D003625:Data Collection; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D026882:Manipulation, Chiropractic; D008875:Middle Aged; D015146:Midwestern United States; D018579:Patient Selection; D017699:Pelvic Pain / Q000628:therapy*; D010865:Pilot Projects; D011177:Postal Service; D011845:Radio; D016032:Randomized Controlled Trials as Topic / Q000191:economics / Q000379:methods*; D013689:Telephone; D014930:Women / Q000523:psychology