Abstract
BackgroundRecruitment of fibromyalgia populations into long-term clinical trials involving exercise interventions is a challenge. We evaluated the cost and randomization yields of various recruitment methods used for a fibromyalgia trial in an urban setting. We also investigated differences in participant characteristics and exercise intervention adherence based on recruitment source.MethodsWe recruited individuals with fibromyalgia in the greater Boston area to a randomized controlled trial (RCT) using six recruitment strategies: newspaper advertisements, web advertisements, flyers, clinic referrals, direct mailing to patients in a clinic database, and word of mouth. We used the American College of Rheumatology 1990 and 2010 diagnostic criteria to screen and enroll participants. During an initial phone call to an interested participant, the study staff asked how they heard about the study. In this study, we compared the cost and yield of the six recruitment strategies as well as baseline characteristics, adherence, and attendance rates of participants across strategies.ResultsOur recruitment resulted in 651 prescreens, 272 screening visits, and 226 randomized participants. Advertisements in a local commuter newspaper were most effective, providing 113 of 226 randomizations, albeit high cost ($212 per randomized participant). Low-cost recruitment strategies included clinical referrals and web advertisements, but they only provided 32 and 16 randomizations. Community-based strategies including advertisement and flyers recruited a more racially diverse participant sample than clinic referrals and mailing or calling patients. There was no evidence of difference in adherence among participants recruited from various strategies.ConclusionsNewspaper advertisement was the most effective and most expensive method per randomized participant for recruiting large numbers of individuals with fibromyalgia in an urban setting. Community-based strategies recruited a more racially diverse cohort than clinic-based strategies.Trial registrationClinicalTrials.gov NCT01420640. Registered on 19 August 2011.
Highlights
Recruitment of fibromyalgia populations into long-term clinical trials involving exercise interventions is a challenge
We report our successful recruitment strategies from a comparative effectiveness randomized controlled trial (RCT) examining the effects of Tai Chi and aerobic exercise for fibromyalgia [11, 12]
There was no information about the recruitment method for 64 participants who were prescreened (9.8% total prescreened), 14 participants who attended a screening visit (5.2% total attended screening visit), and 13 participants who were randomized into the study (5.8% total randomized to study)
Summary
Recruitment of fibromyalgia populations into long-term clinical trials involving exercise interventions is a challenge. Other recruitment methods rely on clinicians’ referral of patients to relevant clinical trials as well as print and online advertisements [5] These strategies may not yield adequate numbers of participants for trials in certain populations, such as individuals with fibromyalgia. Many patients seek care from various other healthcare providers (e.g., physical therapists, massage therapists, and complementary and integrative medicine care providers) This makes it challenging to recruit a large sample size from a specific clinical setting. This population is often more accessible through community-based recruitment than clinic-based recruitment [10] Despite these challenges, effective recruitment strategies resulting in successfully completed clinical trials are vital to patients with fibromyalgia, as this population urgently needs effective treatment approaches to improve quality of life and reduce disability
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