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Sickle Cell Disease Studies Should Diversify Recruitment Strategies - MD Magazine

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When it comes to participant recruitment for multisite sickle cell disease (SCD) studies, using a combination of strategies—through clinics, affiliated sites, community events, and/or phone calls—can be useful to ensuring adequate patient participation.

Several barriers — ranging from distrust of research to transportation challenges—pose challenges for the recruitment process, and so adopting multiple strategies can allow the strengths of one to compensate for the weakness of another.

A recent study led by Rita Masese, MD, MSc, of Duke University School of Nursing, and colleagues assessed the recruitment strategies of and challenges faced by 8 participating centers of the SCD Implementation Consortium (SCDIC).

In addition to the 8 centers, the SCDIC included 1 data coordinating center.

Funded by the National Heart Lung and Blood Institute (NHLBI), the sites were tasked with each recruiting a minimum of 300 SCD individuals over 20 months for their longitudinal patient registry project.

The goal of the project, as noted by the NHLBI, was to improve the quality of SCD care and development. The registry would be a resource for conducting data queries and identifying gaps in research so as to tailor interventions towards addressing barriers to SCD care.

Thus, following the 20 months recruitment period, all sites met their quota and recruited a total of 2432 participants. The mean age of the population was 28.1 years. Of the total, 95.3% were African American.

The primary strategy used by the research coordinators was through in-person recruitment from adult and pediatric SCD clinicals. The investigators noted that this strategy accounted for 68.1% of all those recruited.

Eligible participants were identified and added to a patient list. The coordinators and clinic staff then worked together to ensure that healthcare providers were aware of which patients were eligible. The provider would introduce the study to the patient and then refer them to the research coordinators following their appointment.

Although this method proved to be an effective strategy, there were nonetheless challenges that were reported. For one, a major concern was disruption of workflow. Another challenge was the healthcare provider forgetting to introduce the study as well as a failure of eligible participants to show up to their clinic appointments, among others.

“Despite its high recruitment yield, in-clinic recruitment proved to be unsuccessful at capturing people who were lost to clinic follow-up, received most of their care in the emergency department, or were unaffiliated with the study site,” Masese and team wrote.

Secondary strategies included recruitment from affiliated sites, which were defined as community hospitals in the same state as the primary SCDIC study site. These specific centers were willing to refer eligible patients to the local SDCDIC site.

Thus, the success rate was 15.6% of the total recruited population, therefore making it the second most successful strategy.

However, the investigators did note that success was variable across the 8 sites. In fact, 1 of the sites recruited 55% of its patients from these affiliated centers, while 3 sites found it unsuccessful.

A great limitation with recruiting outside the primary site was the difficulty in obtaining SCD diagnosis confirmation. The back and forth communication, travel, and paperwork was considered especially time-consuming.

Further, targeted phone calls and opt-out letters accounted for 5.9% of the entire population, inpatient recruitment accounted for 5.8%, recruitment at community events accounted for 2.1%, and recruitment from pain/infusion centers and the emergency department accounted for 1.0% and 0.6% respectively.

Masese and colleagues acknowledged that their approach may not generalizable to other studies seeking to recruit from the general population. And yet, they considered the study to offer useful insights into recruiting strategies for other studies involving minority population.

“Effective recruitment of participants in multi-site SCD studies requires the adaptation of various strategies and a centralized recruitment management system in order to achieve target sample sizes,” they concluded.

The study, “Effective Recruitment Strategies for a Sickle Cell Patient Registry Across Sites from the Sickle Cell Disease Implementation Consortium (SCDIC),” was published online in Journal of Immigrant and Minority Health.

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