Recruitment Strategies in the Integration of Mobile Health Into Sickle Cell Disease Care to Increase Hydroxyurea Utilization Study (meSH): Multicenter Survey Study.

BACKGROUND: Hydroxyurea is an evidence-based disease-modifying therapy for sickle cell disease (SCD) but is underutilized. The Integration of Mobile Health into Sickle Cell Disease Care to Increase Hydroxyurea Utilization (meSH) multicenter study leveraged mHealth to deliver targeted interventions to patients and providers. SCD studies often underenroll; and recruitment strategies in the SCD population are not widely studied. Unanticipated events can negatively impact enrollment, making it important to study strategies that ensure adequate study accrual. OBJECTIVE: The goal of this study was to evaluate enrollment barriers and the impact of modified recruitment strategies among patients and providers in the meSH study in response to a global emergency. METHODS: Recruitment was anticipated to last 2 months for providers and 6 months for patients. The recruitment strategies used with patients and providers, new recruitment strategies, and recruitment rates were captured and compared. To document recruitment adaptations and their reasons, study staff responsible for recruitment completed an open-ended 9-item questionnaire eliciting challenges to recruitment and strategies used. Themes were extrapolated using thematic content analysis. RESULTS: Total enrollment across the 7 sites included 89 providers and 293 patients. The study acceptance rate was 85.5% (382/447) for both patients and providers. The reasons patients declined participation were most frequently a lack of time and interest in research, while providers mostly declined because of self-perceived high levels of SCD expertise, believing they did not need the intervention. Initially, recruitment involved an in-person invitation to participate during clinic visits (patients), staff meetings (providers), or within the office (providers). We identified several important recruitment challenges, including (1) lack of interest in research, (2) lack of human resources, (3) unavailable physical space for recruitment activities, and (4) lack of documentation to verify eligibility. Adaptive strategies were crucial to alleviate enrollment disruptions due to the COVID-19 pandemic. These included remote approaching and consenting (eg, telehealth, email, and telephone) for patients and providers. Additionally, for patients, recruitment was enriched by simplification of enrollment procedures (eg, directly approaching patients without a referral from the provider) and a multitouch method (ie, warm introductions with flyers, texts, and patient portal messages). We found that patient recruitment rates were similar between in-person and adapted (virtual with multitouch) approaches (167/200, 83.5% and 126/143, 88.1%, respectively; P=.23). However, for providers, recruitment was significantly higher for in-person vs remote recruitment (48/50, 96% and 41/54, 76%, respectively, P<.001). CONCLUSIONS: We found that timely adaptation in recruitment strategies secured high recruitment rates using an assortment of enriched remote recruitment strategies. Flexibility in approach and reducing the burden of enrollment procedures for participants aided enrollment. It is important to continue identifying effective recruitment strategies in studies involving patients with SCD and their providers and the impact and navigation of recruitment challenges. TRIAL REGISTRATION: ClinicalTrials.Gov NCT03380351; https://clinicaltrials.gov/study/NCT03380351. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/16319.

Validation of a screening tool for labor and sex trafficking among emergency department patients.

OBJECTIVE: Patients with labor and sex trafficking experiences seek healthcare while and after being trafficked. Their trafficking experiences are often unrecognized by clinicians who lack a validated tool to systematically screen for trafficking. We aimed to derive and validate a brief, comprehensive trafficking screening tool for use in healthcare settings. METHODS: Patients were randomly selected to participate in this prospective study based on time of arrival. Data collectors administered 5 dichotomous index questions and a reference standard trafficking assessment tool that requires 30 to 60 minutes to administer. Data collection was from June 2016 to January 2021. Data from patients in 5 New York City (NYC) emergency departments (EDs) were used for tool psychometric derivation, and data from patients in a Fort Worth ED were used for external validation. Clinically stable ED adults (aged ≥18 years) were eligible to participate. Candidate questions were selected from the Trafficking Victim Identification Tool (TVIT). The study outcome measurement was a determination of a participant having a lifetime experience of labor and/or sex trafficking based on the interpretation of the reference standard interview, the TVIT. RESULTS: Overall, 4127 ED patients were enrolled. In the derivation group, the reference standard identified 36 (1.1%) as positive for a labor and/or sex trafficking experience. In the validation group, 12 (1.4%) were positive by the reference standard. Rapid Appraisal for Trafficking (RAFT) is a new 4-item trafficking screening tool: in the derivation group, RAFT was 89% sensitive (95% confidence interval [CI], 79%-99%) and 74% specific (95% CI, 73%-76%) and in the external validation group, RAFT was 100% sensitive (95% CI, 100%-100%) and 61% specific (95% CI, 56%-65%). CONCLUSIONS: The rapid, 4-item RAFT screening tool demonstrated good sensitivity compared with the existing, resource-intensive reference standard tool. RAFT may enhance the detection of human trafficking in EDs. Additional multicenter studies and research on RAFT's implementation are needed.

Exception From Informed Consent: How IRB Reviewers Assess Community Consultation and Public Disclosure.

Exception from Informed Consent (EFIC) regulations detail specific circumstances in which Institutional Review Boards (IRB) can approve studies where obtaining informed consent is not possible prior to subject enrollment. To better understand how IRB members evaluate community consultation (CC) and public disclosure (PD) processes and results, semi-structured interviews of EFIC-experienced IRB members were conducted and analyzed using thematic analysis. Interviews with 11 IRB members revealed similar approaches to reviewing EFIC studies. Most use summaries of CC activities to determine community members' attitudes; none reported using specific criteria nor recalled any CC reviews that resulted in modifications to or denials of EFIC studies. Most interviewees thought metrics based on Community VOICES's domains (feasibility, participant selection, quality of communication, community perceptions, investigator/IRB perceptions) would be helpful. IRB members had similar experiences and concerns about reviewing EFIC studies. Development of metrics to assess CC processes may be useful to IRBs reviewing EFIC studies.

Effective Recruitment Strategies for a Sickle Cell Patient Registry Across Sites from the Sickle Cell Disease Implementation Consortium (SCDIC).

Sickle cell disease (SCD) is a genetic disorder predominantly affecting people of African descent and is associated with significant morbidity and mortality. To improve SCD outcomes, the National Heart Lung and Blood Institute funded eight centers to participate in the SCD Implementation Consortium. Sites were required to each recruit 300 individuals with SCD, over 20 months. We aim to describe recruitment strategies and challenges encountered. Participants aged 15-45 years with confirmed diagnosis of SCD were eligible. Descriptive statistics were used to analyze the effectiveness of each recruitment strategy. A total of 2432 participants were recruited. Majority (95.3%) were African American. Successful strategies were recruitment from clinics (68.1%) and affiliated sites (15.6%). Recruitment at community events, emergency departments and pain centers had the lowest yield. Challenges included saturation of strategies and time constraints. Effective recruitment of participants in multi-site studies requires multiple strategies to achieve adequate sample sizes.

Building RAFT: Trafficking Screening Tool Derivation and Validation Methods.

BACKGROUND: Labor and sex trafficking have long impacted the patients who seek care in emergency departments (ED) across the United States. Increasing social and legislative pressures have led to multiple calls for screening for trafficking in the clinical care setting, but adoption of unvalidated screening tools for trafficking recognition is unwise for individual patient care and population-level data. Development of a valid screening tool for a social malady that is largely "invisible" to most clinicians requires significant investments. Valid screening tool development is largely a poorly understood process in the antitrafficking field and among clinicians who would use the tools. METHODS: The authors describe the study design and procedures for reliable data collection and analysis in the development of RAFT (Rapid Appraisal for Trafficking). In a five-ED, randomized, prospective study, RAFT will be derived and validated as a labor and sex trafficking screening tool for use among adult ED patients. Using a novel method of ED patient-participant randomization, intensively trained data collectors use qualitative data to assess subjects for a lifetime experience of human trafficking. CONCLUSION: Study methodology transparency encourages investigative rigor and integrity and will allow other sites to reproduce and externally validate this study's findings.

A conceptual framework for improved analyses of 72-hour return cases.

For more than 25 years, emergency medicine researchers have examined 72-hour return visits as a marker for high-risk patient visits and as a surrogate measure for quality of care. Individual emergency departments frequently use 72-hour returns as a screening tool to identify deficits in care, although comprehensive departmental reviews of this nature may consume considerable resources. We discuss the lack of published data supporting the use of 72-hour return frequency as an overall performance measure and examine why this is not a valid use, describe a conceptual framework for reviewing 72-hour return cases as a screening tool, and call for future studies to test various models for conducting such quality assurance reviews of patients who return to the emergency department within 72 hours.