Subject Recruitment for Cancer Control Studies in an Adverse Environment

Abstract

Subject recruitment in an adverse environment prompted researchers to identify a novel method to gain a different perspective on the problem. Lewin's Model of Change was used in a post hoc examination of recruitment strategies from 5 cancer control studies of breast or prostate cancer. Based on this evaluation, driving and restraining forces in recruitment were identified. Lessons learned and recommendations are discussed based on this evaluation. Five categories of restrainers were identified from this evaluation and include sociocultural, institutional, individuals, budget, and study design. Conversely, only 3 categories of drivers were elucidated by the examination: sociocultural, institutional, and individuals. Lessons and recommendations ranged from addressing institutional barriers to capitalizing on public relations. Researchers entering a new environment for recruitment would benefit from using Lewin's force field analysis before writing a proposal or implementing a project. This approach better directs energy and resources and enhances the ability of the investigator to maintain a broad, less biased perspective.

Impact of the Health Insurance Portability and Accountability Act on Participant Recruitment and Retention

“…Although a patient is more likely to participate in a study if asked by his or her primary care provider or physician (Loftin et al, 2005), having a physician or other clinic or hospital staff member determine study eligibility and introduce the study to potential participants may be challenging given the patient care responsibilities in a busy clinic or hospital unit. In fact, researchers have indicated that the more work required of physicians, the greater the resistance to assist with a study (Heiney et al, 2006). A number of challenges to and strategies for obtaining gatekeeper buy-in have been identified by others (Northouse et al, 2006;Rose, 2000;Villarruel, Jemmott, Jemmott, & Eakin, 2006).…”

“…Our experience is consistent with reports from the Pew Internet and American Life Project indicating that the demographic characteristics of Internet users tend to be young, male, White, educated, and from a high socioeconomic status (Lenhart, Horrigon, & Fallows, 2004). When advertisements and flyers are a major mode of recruitment, researchers must keep their research office telephones staffed every day, respond as quickly as possible to all inquiries, and anticipate that a high portion of the calls will be from individuals who do not meet study criteria (Heiney et al, 2006;Loftin et al, 2005).…”

“…HIPAA affects the number, length, and complexity of the forms in the participant consent process, which can be a deterrent to the recruitment of potential participants (Heiney et al, 2006;Ness, 2005;Steinke, 2004). If the researcher is part of a covered or hybrid entity and is collecting PHI, he or she then faces three aspects to the consent process: provision of a copy of the institution's notice of privacy practices (NPP), obtaining informed consent, and obtaining a HIPAA authorization.…”

“…The proverbial disappearing sample is an all-too-common phenomenon experienced by many human participants researchers (Wilson-Barnett & Griffiths, 2002). A number of researchers have examined the challenges of participant recruitment and retention in specific patient populations across a number of different settings (Blanton et al, 2006;Heiney et al, 2006;Im & Chee, 2005;Loftin, Barnett, Bunn, & Sullivan, 2005;Northouse et al, 2006;Rose, 2000;Villarruel, Jemmott, Jemmott, & Eakin, 2006). Most of the recent work in this area includes little information regarding the Health Insurance Portability and Accountability Act (HIPAA) privacy rule.…”

“…Although the original intent of HIPAA had nothing to do with research, by the time that the regulations were enacted, they affected research directly. In the wake of the implementation of the HIPAA privacy rule, researchers have begun to document that HIPAA is hindering research by increasing researchers' administrative burden (Clause, Triller, Bornhorst, Hamilton, & Cosler, 2004;Lydon-Rochelle & Holt, 2004), delaying initial project approval (Heiney et al, 2006;O'Herrin, Fost, & Kudsk, 2004), impeding participant recruitment processes (Albert & Levine, 2005;Blanton et al, 2006;Heiney et al;Kaiser, 2004;Ness, 2005;Wolf & Bennett, 2006), escalating recruitment costs (Albert & Levine; Heiney et al), hampering medical record and registry research (Inglefinger & Drazen, 2004;Lydon-Rochelle & Holt;O'Herrin et al), and generating data sets that are less than adequate for good research (Clause et al;Inglefinger & Drazen;Maas, Kompanje, & Stocchetti, 2005).…”