Heather Strong

Background/Aims: Recruitment is often a barrier in clinical trials that include minoritized populations, such as individuals with sickle cell disease. In the United States, the majority of people with sickle cell disease identify as Black or African American. In sickle cell disease, 57% of the United States trials that ended early did so due to low enrollment. Thus, there is a need for interventions that improve trial enrollment in this population. After lower-than-expected recruitment during the first 6 months of the Engaging Parents of Children with Sickle Cell Anemia and their Providers in Shared-Decision-Making for Hydroxyurea trial, a multi-site study for young children with sickle cell disease, we collected data to understand barriers and used the Consolidated Framework for Implementation Research to categorize them and guide the development of targeted strategies. Methods: Study staff used screening logs and coordinator and principal investigator calls to identify recruitment barriers that were then mapped onto Consolidated Framework for Implementation Research constructs. Targeted strategies were implemented during Months 7–13. Recruitment and enrollment data were summarized before (Months 1–6) and during the implementation period (Months 7–13). Results: During the first 13 months, 60 caregivers ( M = 30.65 years; SD = 6.35) enrolled in the trial. Most caregivers primarily self-identified as female ( n = 54, 95%) and African American or Black ( n = 51, 90%). Recruitment barriers mapped onto three Consolidated Framework for Implementation Research constructs: (1) Process barriers (i.e. no identified “site champion” and poor recruitment planning at several sites); (2) Inner setting barriers (i.e. limited communication, low relative study priority at several sites); and (3) Outer setting barriers (i.e. poor patient attendance at clinic appointments). Targeted strategies to improve recruitment included (1) principal investigator site visits and retraining on recruitment procedures to address process barriers; (2) increased frequency of communication through all coordinator, site principal investigator, and individual site calls to address inner setting barriers; and (3) development and implementation of no-show procedures for clinic appointments to address outer setting barriers. After implementation of the recruitment strategies, the number of caregivers identified for pre-screening increased from 54 to 164, and enrollment more than tripled from 14 to 46 caregiver participants. Conclusion: Consolidated Framework for Implementation Research constructs guided the development of targeted strategies that increased enrollment. This reflective process reframes recruitment challenges as the responsibility of the research team rather than characterizing minoritized populations as “difficult” or “hard to reach.” Future trials including patients with sickle cell disease and minoritized populations may benefit from this approach.

Background Obesity has played a central role in heightened coronavirus disease 2019 (COVID-19) risk and vaccine response. COVID-19 vaccine intention among those with a history of severe obesity, specifically those who have undergone bariatric surgery, has not been described. This study aims to examine early COVID-19 vaccine intention among mothers with a history of severe obesity who underwent bariatric surgery. Methods Sixty-four mothers (M_age = 39.3 years) who underwent bariatric surgery (M_{time since surgery} = 19.6 months) completed surveys online (November 2020–February 2021). Information obtained included their COVID-19 vaccine intention (vaccine ready, undecided, vaccine opposed). Analyses examined group differences in demographics, body mass index (BMI = kg/m²), knowledge of obesity-related COVID-19 risk, flu vaccination history, general beliefs about vaccine safety/effectiveness, and factors increasing confidence/motivation to obtain a COVID-19 vaccine. Results Thirty-six (56.3%) mothers had severe obesity (≥ Class II [BMI = ≥ 35 kg/m²]). The majority were vaccine hesitant (undecided [n = 28; 43.8%]; vaccine opposed [n = 15; 23.4%]). Compared to the vaccine-ready group, vaccine-hesitant groups were younger (p < .05). For the vaccine opposed, recent flu vaccination rates (p = .012) and general belief that vaccines are safe (p = .028) were lower than expected. Among hesitant participants, no reported side effects and the health of self and others were endorsed as top factors increasing vaccine confidence and motivation respectively. Conclusions While preliminary, the prominence of early vaccine hesitancy in this sample of mothers who have undergone bariatric surgery, with most persisting with severe obesity, indicates a subgroup at high risk. Factors to address through targeted messaging and intervention were identified. Graphical abstract

Background: Sickle cell anemia (SCA) is a genetic blood disorder that puts children at a risk of serious medical complications, early morbidity and mortality, and high health care utilization. Until recently, hydroxyurea was the only disease-modifying treatment for this life-threatening disease and has remained the only option for children younger than 5 years. Evidence-based guidelines recommend using a shared decision-making (SDM) approach for offering hydroxyurea to children with SCA (HbSS or HbS/β0 thalassemia) aged as early as 9 months. However, the uptake remains suboptimal, likely because caregivers lack information about hydroxyurea and have concerns about its safety and potential long-term side effects. Moreover, clinicians do not routinely receive training or tools, especially those that provide medical evidence and consider caregivers’ preferences and values, to facilitate a shared discussion with caregivers. Objective: The aim of this study is to understand how best to help parents of young children with sickle cell disease and their clinicians have a shared discussion about hydroxyurea (one that considers medical evidence and parent values and preferences). Methods: We designed our study to compare the effectiveness of two methods for disseminating hydroxyurea guidelines to facilitate SDM: a clinician pocket guide (ie, usual care) and a clinician hydroxyurea SDM toolkit (H-SDM toolkit). Our primary outcomes are caregiver reports of decisional uncertainty and knowledge of hydroxyurea. The study also assesses the number of children (aged 0-5 years) who were offered and prescribed hydroxyurea and the resultant health outcomes. Results: The Ethics Committee of the Cincinnati Children’s Hospital Medical Center approved this study in November 2017. As of February 2021, we have enrolled 120 caregiver participants. Conclusions: The long-term objective of this study is to improve the quality of care for children with SCA. Using multicomponent dissemination methods developed in partnership with key stakeholders and designed to address barriers to high-quality care, caregivers of patients with SCA can make informed and shared decisions about their health. Trial Registration: ClinicalTrials.gov NCT03442114; https://clinicaltrials.gov/ct2/show/NCT03442114 International Registered Report Identifier (IRRID): DERR1-10.2196/27650

Historically, youth with sickle cell disease (SCD) were at risk for being underweight, but recent data suggests this population is replicating obesity trends of youth in the United States. The current observational study assessed the weight status and health behaviors of 44 adolescents and young adults with SCD via a self-report survey and chart review. Using height and weight data closest to survey completion date, 27% of participants were either overweight or obese. With respect to obesogenic risk behaviors, 77% ate fast food 1-3 times per week, 25% had no fruits/vegetables with any of their meals, 11% drank no water, and 57% watched 4 or more hours of television per day. Though more research is needed, this preliminary study adds to the SCD literature suggesting an emerging shift toward obesity in this population. As such, adolescents with SCD may benefit from interventions to decrease obesity risk factors as being overweight or obese has the potential to worsen SCD-related symptoms and complications.

Background: Sickle cell disease (SCD) is associated with significant medical challenges that often worsen in adolescence when caregivers are beginning to transfer responsibility for disease management. Behavioral activation (BA) is an important precedent to improvements in self‐management and ultimately health outcomes; however, few interventions targeting BA have been developed for the SCD population. The goal of the present study was to evaluate a technology‐enhanced self‐management intervention for adolescents and young adults (AYA) with SCD targeting BA domains (ie, disease knowledge, self‐efficacy, motivation, and self‐management skills).Design/methods: Participants were randomized to one of two study arms. SCThrive participants (N = 26) completed six weekly group sessions, an in‐person booster session, and used a companion app (iManage) to record symptoms, progress on goals, and connect with other group members. Each SCHealthEd participant (N = 27) received six weekly phone calls on SCD‐related and general health education topics. All AYA completed questionnaires assessing BA at baseline and posttreatment.Results: Separate mixed ANOVA analyses to assess for the effects of group (SCThrive/SCHealthEd), time (baseline/posttreatment), and group × time interaction indicated that there was a clinically meaningful improvement (8‐point change) in self‐efficacy, with a medium effect size, P = .09, η² = .06, and there was statistically significant improvement in one self‐management skill (tracking health), P = .001, d = .71, among SCThrive participants.Conclusions: The results support the potential for a self‐management intervention to improve self‐efficacy in AYA with SCD. Health care providers are encouraged to target BA skills to support self‐management of AYA with SCD.

Objective: In the United States, sickle cell disease (SCD) is the most prevalent genetic disorder affecting African American and Hispanic youth. Disparities in care have been reported for this population with adolescents and young adults (AYA) with SCD at increased risk for poor health outcomes. It is essential that AYA with SCD receive high-quality care and have access to disease-modifying therapies, yet engaging them in their care and clinical research studies to discover new treatments remains a challenge. Method: Our team developed an innovative approach to engage AYA with SCD in clinical care and research: the SCD Teen Symposium, which uses motivational interviewing strategies to educate AYA with SCD, their family members, and friends while providing concurrent opportunities for research participation. Results: Over a 6-year period, 81 AYA with SCD (47% male; M _age = 14.58, SD = 2.9) and 162 family and friends (48% male; M _age = 13.37, SD = 2.1) participated. Participants rated the symposium as acceptable ( M _rating = 1.74, SD = 0.85) on a scale from 1 ( excellent ) to 5 ( poor ), and 72% reported they would recommend it to others. Research was rated as very important ( M _rating = 1.21, SD = 0.46) by 81% of attendees on a scale from 1 ( very important ) to 4 ( not important ), and 82% reported increased trust in research. AYA suggested improvements including separate programming for younger and older teens. Conclusions: Results support the feasibility of the Teen Symposium as a model for increasing trust and potentially increasing participation in research. Future studies will determine whether it can be disseminated by other SCD clinics. Implications for Impact Statement: This study describes a 1-day research and education event for adolescents and young adults with sickle cell disease, the Teen Symposium. After attending the symposium, teens reported more trust in research and that they would participate in research studies in the future.

A Photovoice pilot was conducted with youth living with sickle cell disease (SCD), in order to further understand their lived experience and examine the acceptability, feasibility, and utility of this method in this population. SCD is an inherited genetic condition whose primary symptom is severe pain. Youth were able to reflect on their experiences with SCD using Photovoice and the adapted SHOWeD method. Parents and youth found Photovoice to be valuable for children and adolescents with SCD. Emerging themes included the impact of SCD, the importance of everyday activities and interests, and the importance of family and support.