Applied Nursing Research 23 (2010) 227 – 232 www.elsevier.com/locate/apnr
A multistep recruitment strategy to a participant-intensive clinical trial Kim Dupree Jones, PhD, RNCa,⁎, Ann C. Reiner, RN, MN, OCN®b a
Oregon Health & Science University, Schools of Nursing and Medicine, Portland, OR 97239-2941, USA b Oregon Health & Science University, School of Nursing, Portland, OR, USA Received 25 June 2008; revised 28 August 2008; accepted 2 September 2008
Adequate access to well-informed study participants is key to rapid recruitment and retention to randomized controlled clinical trials (RCTs). We describe a novel seven-step recruitment process for enrolling participants in a recently completed drug and exercise RCT in fibromyalgia. The majority decided not to participate during the screening process. Approximately 7% dropped out after beginning the intervention. All participants were enrolled within 14 months, which was 21 months ahead of the projected timeline. We suggest that this strategy ultimately decreased costs, made efficient use of research staff, and provided a consistent message to participants about the RCT. © 2010 Elsevier Inc. All rights reserved.
Efficient recruitment to randomized controlled clinical trials (RCTs) is essential in managing study resources, primarily staff time. Ease of recruitment depends on many factors: adequate access to the population, the length and rigor of the study protocol, and the protocol's budget (Maurer et al., 1995). Slow recruitment not only costs money but also potentially introduces multiple threats to internal validity, such as history, maturation, differential selection, and differential attrition (Woods & Catanzaro, 1988). Slowed recruitment may also cause investigators to alter inclusion and exclusion criteria, which potentially reduces the validity of the findings (Adams, Silverman, Musa, & Peele, 1997). The purpose of this article is to describe a multistep recruitment process employed in a recently completed complex 6-month drug and exercise RCT in participants with fibromyalgia (FM). We conclude that recruitment is enhanced—and attrition may be minimized— when participants fully understand the risks and responsibilities of enrolling in an RCT by completing a multiple-step process before enrolling.
1. Background 1.1. Randomized clinical trials Randomized clinical trials are considered a powerful design because of their prospective nature and their random assignment to equally distribute variance and to control or manipulate independent variables. These strengths, however, pose obstacles related to recruitment. Parallel designs, compared with cross-over, often require large samples, particularly if the design includes more than two arms. In addition, an even larger sample is needed if one uses multiple stratification variables in a randomized block design. Large samples pose challenges for recruitment, and a number of major barriers to participation in RCTs have been identified: Randomization to receive a placebo was the most often identified barrier followed by reluctance to be randomized to a nonpreferred treatment, the burden of the study protocol, and concerns about protocol information and consent (Ross et al., 1999; Verheggen, Nieman, & Jonkers, 1998). Other reported barriers to participation include scheduling conflicts, side effect risks, or anticipated discomfort from the intervention (Cunny & Miller, 1994). 1.2. Historical strategies of recruitment to FM studies The site of this research project has a three-decade history in conducting FM studies, with investigators initially
The authors acknowledge the National Institutes of Health/National Institute of Nursing Research R01 NR008150 (Kim Dupree Jones, principal investigator) and in part by NIH Grant 5 M01 RR000334. ⁎ Corresponding author. Tel.: +1 503 494 3837; fax: +1 503 418 0903. E-mail address: email@example.com (K.D. Jones)....