Using the consolidated framework for implementation research to identify recruitment barriers and targeted strategies for a shared decision-making randomized clinical trial in pediatric sickle cell disease.

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.

Marijuana, e-cigarette, and tobacco product use in young adults who underwent pediatric bariatric surgery.

BACKGROUND: The postoperative course after pediatric metabolic and bariatric surgery (MBS) cuts across a developmental phase when substance-use behaviors emerge as significant public health concerns. OBJECTIVE: We examined use of marijuana, conventional cigarettes, and alternate tobacco products/devices (e.g., e-cigarettes, hookah, smokeless, dissolvable) in young adults (YA) to 6 years postsurgery. SETTING: Five academic medical centers. METHODS: In a prospective observational cohort series, 139 surgical (Mage = 16.9, Mbody mass index [BMI] = 51.5, 80% female, 66% white) and 83 nonsurgical comparisons (Mage = 16.1, MBMI = 44.9, 82% female, 54% white) completed assessments at presurgery/baseline and postsurgery years 2, 4, and 6 (year 6 [2014-2018]: surgical n = 123 [89%], Mage = 23.0, MBMI = 39.8; nonsurgical n = 63 [76%], Mage = 22.4, MBMI = 53.6). Lifetime and current (past 30 days) use were reported. RESULTS: Consistent with national YA trends (2014-2018), the most commonly used were (1) conventional cigarettes (30% surgical, 41% nonsurgical, nonsignificant [ns]); (2) marijuana (25% surgical, 27% nonsurgical, ns); and (3) e-cigarettes (12% surgical, 10% nonsurgical). A sizable minority (26% surgical, 18% nonsurgical) used one or more alternate tobacco product/device. Many YA reported persistent and/or heavy use (e.g., >50% marijuana at year 6 and year 2 or 4; ≈50% ≥.5 pack/d of cigarettes), suggesting more established (versus intermittent) health risk behaviors. For the surgical group at year 6, current tobacco product/device use was associated with lower BMI (P < .001) and greater percent weight loss (P = .002). CONCLUSIONS: Pediatric MBS demonstrates promise in lowering risks for adult chronic disease, which may be diminished by age-typical health risk behaviors. Developmentally salient and holistic pediatric postoperative care guidelines are needed.

Early COVID-19 Vaccine Hesitancy Characteristics in Mothers Following Bariatric Surgery.

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 (Mage = 39.3 years) who underwent bariatric surgery (Mtime 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.

Engaging Caregivers and Providers of Children With Sickle Cell Anemia in Shared Decision Making for Hydroxyurea: Protocol for a Multicenter Randomized Controlled Trial.

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/ß0 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.

Weight status and health behaviors of adolescents and young adults with sickle cell disease: The emerging risk for obesity.

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.

Improving self-management in adolescents with sickle cell disease.

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.

Patient Perspectives on Gene Transfer Therapy for Sickle Cell Disease.

INTRODUCTION: Sickle cell disease (SCD) is a chronic genetic disease with high morbidity and early mortality; it affects nearly 100,000 individuals in the USA. Bone marrow transplantation, the only curative treatment, is available to less than 20% of patients because of a number of access barriers. Gene transfer therapy (GTT) has been shown to be curative in animal models and is approved for use in humans for early-phase studies at a few centers. GTT would offer a more accessible treatment option available to all patients. It is important to understand patient perspectives on GTT to help ensure human clinical trial success. METHODS: Two focus groups were conducted with younger (18-30 years) and older (31 years and older) adults with SCD to obtain data on patient knowledge and beliefs about GTT. Data from these two focus groups was used to develop a GTT educational brochure. A third focus group was conducted to obtain participant feedback on acceptability and feasibility of education and the brochure. RESULTS: Most adults, especially young adults, had little knowledge about GTT and expressed fear and uncertainty about the side effects of chemotherapy (e.g., hair loss, infertility), use of a human immunodeficiency virus (HIV)-derived viral vector, and potential for cancer risk. Participants wanted full transparency in educational materials, but advised researchers not to share the vector's relation to HIV because of cultural stigma and no HIV virus is used for the GTT vector. CONCLUSION: Older adults had more desire to participate in human clinical GTT trials than younger participants. When recruiting for trials, researchers should develop GTT educational materials that address participant lack of trust in the healthcare system, cultural beliefs, fears related to side effects, and include visual illustrations. Use of such materials will provide adults with SCD the information they need to fully evaluate GTT.

School Performance and Disease Interference in Adolescents with Sickle Cell Disease.

Sickle cell disease (SCD) results in neuropsychological complications that place adolescents at higher risk for limited educational achievement. A first step to developing effective educational interventions is to understand the impact of SCD on school performance. The current study assessed perceptions of school performance, SCD interference and acceptability of educational support strategies in adolescents with SCD. To identify potential risk factors, the relationship between school performance, SCD interference and demographics were also examined. Thirty adolescents aged 12 to 20 completed demographics and SCD school performance questionnaires. Approximately 37% of participants reported receiving special education services, but more than 60% reported that SCD interfered with their school performance. Females reported that SCD impacted their schooling more than males (X2 (1, N = 30) = 5.00, p < .05). Study findings provide important insights into demographic risk factors and support the need for individualized health and educational plans for adolescents with SCD.

The effects of aerobic- versus strength-training on body image among young women with pre-existing body image concerns.

This experiment compared the effects of aerobic-training (AT) versus strength-training (ST) on body image among young women with pre-existing body image concerns. Theory-based correlates of body image change were also examined. Participants were 46 women (M age=21.5 years), randomly assigned to an 8-week AT or ST intervention consisting of supervised exercise 3 days/week. Multidimensional measures of body image were administered pre- and post-intervention, along with measures of physical fitness, perceived fitness, and exercise self-efficacy. Women in the AT condition reported greater reductions in social physique anxiety (p=.001) and tended to report greater improvements in appearance evaluation (p=.06) than women in the ST condition. Changes in perceived fatness, perceived aerobic endurance and aerobic self-efficacy were significantly correlated with body image change (ps<.003). Results provide direction for prescribing exercise to improve body image and advancing theory to account for the effects of exercise.

Understanding the experiences of youth living with sickle cell disease: a photovoice pilot.

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.

The effects of threatened social evaluation of the physique on cortisol activity.

Social self preservation theory asserts that situations high in social-evaluative threat elicit increases in cortisol, a hormone released by the hypothalamic-pituitary-adrenal axis. Most tests of the theory have examined threats associated with social evaluation of a performance. Two experiments examined the effects of threatened social evaluation of one's physique. In Experiments 1 (n = 50) and 2 (n = 40), participants allocated to an experimental (threat) condition had significantly higher post-manipulation cortisol than participants in a control (no threat) condition. In Experiment 1, perceptions of social-evaluative threat were significantly correlated with post-manipulation cortisol levels. These results suggest that the threatened social evaluation of one's body can activate the cortisol response. Women who frequently experience such threats may be at increased risk for a variety of health conditions associated with chronic cortisol exposure.

Construct validation of a state version of the Social Physique Anxiety Scale among young women.

This study examined the validity of a state version of the Social Physique Anxiety Scale (Hart, Leary & Rejeski, 1989) by conducting tests of concurrent and discriminative validation. Participants were four separate samples of young women (N=221) who exercised ≤ 2 days/week and who participated in various experiments examining body image and self-presentation. Participants' scores on the state SPAS (S-SPAS) were significantly correlated, in expected directions, with scores on both trait and state measures of body image and self-presentation, and with body mass index (BMI). In addition, S-SPAS scores discriminated between women who exercised in a mixed-sex versus a same-sex environment, but trait SPAS scores did not. Together, these results provide evidence of construct validity of a state version of the SPAS and demonstrate that social physique anxiety can be conceptualized and measured as a situational variable. The S-SPAS, rather than the trait SPAS, should be employed in experiments designed to detect differences in state social physique anxiety.

Self-presentational motives in eating disordered behavior: a known groups difference approach.

OBJECTIVE: This study investigated the role of self-presentation motivation across three groups with known differences in disordered eating behavior. METHODS: Female participants (N=131) were currently in-treatment for an eating disorder (n=39), deemed at-risk (n=46), or not-at-risk for an eating disorder (n=46). All participants completed general and physique-specific measures of self-presentation motivation. RESULTS: Results revealed significant moderate differences between groups. Those not-at-risk reported lower levels of self-presentation motivation across all measures compared to those in the other groups. Those at-risk reported significantly lower scores across global measures of self-presentation motivation, but not physique-specific motives, than those in-treatment. A discriminant function analysis demonstrated that self-presentation motivation correctly classified 63.4% of cases. DISCUSSION: Results suggest that self-presentation motives may be particularly salient for individuals at-risk or in-treatment for eating disordered behavior.