Trajectory of Sleep, Depression, and Quality of Life in Pediatric HSCT Recipients.

Disrupted sleep is commonly reported during hematopoietic stem cell transplant. In this study, we use actigraphy to measure sleep parameters, and qualitative measures of quality of life, depression, and sleep in pediatric and young adult transplant recipients to describe their time course through transplant. Eight patients had evaluable actigraphy data, and 10 patients completed the surveys. The median age of the 6 male and 7 female participants was 13.94 years old. Sleep duration and efficiency measured by actigraphy were suboptimal prior to transplant, then declined to a nadir between Day +7 to +14. Self-reported sleep quality, depression, and quality of life were worst at Day +14 to +30 but improved by Day +100. Findings support efforts to improve sleep, which may improve recovery, mental health and quality of life.

An Updated Equitable Model of Readiness for Transition to Adult Care: Content Validation in Young People With Sickle Cell Disease.

Importance: Despite elevated health risks during young adulthood, many adolescents and young adults with serious health care needs face barriers during the transfer to an adult specialty practitioner, and health disparities may occur during the transition. Objective: To validate the content of an updated Social-Ecological Model of Adolescent and Young Adult Readiness for Transition to Promote Health Equity (SMART-E) in a group of adolescents and young adults with sickle cell disease (SCD) and their supports. Design, Setting, and Participants: Health equity framework components were reviewed. Systems of power (eg, institutional and practitioner bias) and environments or networks (eg, peer or school support) were added as SMART-E preexisting factors, and health literacy was included within readiness factors. Adolescents and young adults aged 16 to 29 years with SCD, caregivers, and practitioners participated in this convergent, mixed-methods study within Children's Hospital of Philadelphia between January and August 2022. Main Outcomes and Measures: Content validity was assessed through nominations of top 3 most important transition barriers prior to interviews and focus groups, ratings on importance of SMART-E factors (0-4 scale; ratings >2 support validity) after interviews and focus groups, nominations of 3 most important factors for transition and for health equity, and qualitative content analysis of interview transcripts. Results: The study enrolled 10 pediatric adolescents and young adults (mean [SD] age, 18.6 [2.9] years; 4 female and 6 male), 10 transferred adolescents and young adults (mean [SD] age, 22.9 [2.1] years; 8 female and 2 male), 9 caregivers (mean [SD] age, 49.8 [8.7] years; 5 female and 4 male), and 9 practitioners (mean [SD] age, 45.6 [10.5] years; 8 female and 1 male). Quantitative ratings supported the content validity of SMART-E and met established criteria for validity. Systems of power was the most endorsed transition barrier (14 of 38 participants) reported prior to interviews and focus groups. After the interview, participants endorsed all SMART-E factors as important for transition, with new factors systems of power and environments and networks rated at a mean (SD) 2.8 (1.23) and 3.1 (0.90), respectively, on a 0 to 4 scale of importance. The most important factors for transition and equity varied by participant group, with all factors being endorsed, supporting the comprehensiveness of SMART-E. Qualitative data corroborated quantitative findings, further supporting validity, and minor modifications were made to definitions. Conclusions and Relevance: SMART-E obtained initial content validation with inclusion of health equity factors for adolescents and young adults with SCD, caregivers, and practitioners. The model should be evaluated in other populations of adolescents and young adults with chronic disease.

Feasibility of Electronic Medication Monitoring Among Adolescents and Emerging Adults with Sickle Cell Disease.

Purpose: To examine the feasibility of using MEMS® bottles to assess adherence among adolescents and emerging adults with sickle cell disease. Patients and Methods: Eighteen non-Hispanic Black participants with HbSS (M = 17.8 years; 61% male) were given a MEMS® bottle to store hydroxyurea (n = 14) or deferasirox (n = 4). Results: One hundred percent initiated MEMS® use and 61% sustained use through the 18-week study; at follow-up, only 11% returned their bottle on time. Barriers to MEMS® use included medication changes and transition to adult care; facilitators included tip sheets and reminders. Conclusion: While MEMS® is acceptable to this population, ensuring sustained use and timely provision of bottles will require additional supports.

A feasibility randomized controlled trial of an mHealth app vs booklets for patient-facing guidelines in adults with SCD.

Despite the increased number of evidence-based guidelines for sickle cell disease (SCD), dissemination of evidence-based guidelines in lay language for individuals or families with SCD has not been evaluated. We conducted a feasibility randomized controlled trial to determine the acceptability of a mobile health (mHealth) app with patient-facing guidelines to improve the knowledge of individuals with SCD about SCD-specific knowledge and reduce hospitalizations. Primary outcome measures include recruitment, retention, and adherence rates. Adults with SCD were enrolled at 2 sickle cell centers between 2018 and 2022. Participants were randomized to receive either an mHealth app + booklet with patient-facing guidelines or a booklet with the guidelines alone. Participants completed surveys at baseline and a final 6-month visit. Approximately 67 of 74 (91%) agreed to participate and were randomized, with 50 of 67 (75%) completing all the study components. All participants who completed the study in the treatment arm used the app. Our results demonstrated high recruitment, retention, and adherence rate for the first randomized trial for an mHealth app with patient-facing guidelines in adults with SCD. This clinical trial was registered at https://www.clinicaltrials.gov/ as #NCT03629678.

Partnering with Families and Communities to Improve Child Health and Health Equity.

Pediatricians and other pediatric health providers collaborate with families and communities, including schools, health departments, and other partners to advance pediatric health challenges and health equity. This article will discuss best practices and guiding principles to support engagement and effective partnership with families and communities. Models for engaging families and communities while promoting health equity will also be discussed. Case studies and examples will be shared, as well as how they may be applied by pediatric health providers to promote child health.

Evaluation of a Community COVID-19 Vaccine Ambassador Train-the-Trainer Program.

Racially minoritized groups are more likely to experience COVID-19 vaccine hesitancy and have lower vaccination rates.  As part of a multi-phase community-engaged project, we developed a train-the-trainer program in response to a needs assessment. "Community vaccine ambassadors" were trained to address COVID-19 vaccine hesitancy. We evaluated the program's feasibility, acceptability, and impact on participant confidence for COVID-19 vaccination conversations. Of the 33 ambassadors trained, 78.8% completed the initial evaluation; nearly all reported gaining knowledge (96.8%) and reported a high confidence with discussing COVID-19 vaccines (93.5%). At two-week follow-up, all respondents reported having a COVID-19 vaccination conversation with someone in their social network, reaching an estimated 134 people. A program that trains community vaccine ambassadors to deliver accurate information about COVID-19 vaccines may be an effective strategy for addressing vaccine hesitancy in racially minoritized communities.

Psychologists as leaders in equitable science: Applications of antiracism and community participatory strategies in a pediatric behavioral medicine clinical trial.

Psychologists have an ethical responsibility to advance health equity and can play a significant role in improving health care experiences for families racialized as Black, including those with sickle cell disease (SCD), a group of genetic blood disorders primarily affecting communities of color. Parents of children with SCD report experiences of stigma and discrimination due to racism in the health care system. The current commentary describes the application of antiracism and participatory strategies to the research design, implementation, and dissemination of a behavioral medicine clinical trial (Engage-HU; NCT03442114) of shared decision-making (SDM) for pediatric patients with SCD, including (a) the development of a research question to promote justice for racialized groups; (b) a focus on "redressing imbalances" through SDM and a multidisciplinary, inclusive research team led by a Black psychologist; (c) community participatory approaches through the integration of stakeholder feedback across the study; and (d) centering context by attending to structural realities in response to the COVID-19 and racism pandemics. With attention to the fact that most primary caregivers of children with SCD are Black women, an intersectionality lens was applied. Implications and considerations for psychologists working to advance health equity in medical settings are also discussed. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Virtual reality informs clinical observation tool.

BACKGROUND: Assessing trainees' skills via workplace-based assessments is challenging given the lack of psychometrically valid instruments. Our team previously developed an observation instrument to assess residents' competencies in behavioral health anticipatory guidance (BHAG) and motivational interviewing (MI) though its reliable usage required expert raters (e.g., paediatric psychologists). Our purpose was to establish validity evidence for a modified tool for clinicians. APPROACH: This study utilised data from a prior educational trial of a virtual reality (VR)-based behavioural health curriculum for paediatric residents. First, group interviews were conducted with clinicians to modify the expert instrument. Next, recorded VR simulations (n = 10) were scored to assess interrater reliability between clinicians. Finally, a physician used the tool to assess its ability to discriminate between residents' skill levels (n = 55). EVALUATION: Modifications during group interviews included a change from frequency counts for items related to MI to the binary outcome of present/absent and the addition of an entrustment item. On interrater-reliability testing, the clinician tool demonstrated mostly substantial or near perfect agreement for items related to BHAG. MI items demonstrated a range of agreement. Using 55 recorded VR simulations, the clinician tool discriminated between trained versus untrained residents in BHAG skills (p = 0.002) and level of entrustment (p = 0.001). Differences between groups in MI adherence was not statistically significant (p = 0.095) as it was on the expert instrument. IMPLICATIONS: VR demonstrated potential as a novel approach for obtaining validity evidence for tool development to support workplace-based assessments. Further work assessing usage of the clinician tool in real-world settings is warranted.

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.

Overcoming Vaccine Hesitancy Using Community-Based Efforts.

Vaccine acceptance by parents and caregivers remains a public health challenge that can potentially be addressed via community-based strategies. Such strategies might augment current vaccine hesitancy interventions occurring within medical homes. This article reviews the key challenges and advantages of evidence-based community strategies for overcoming parent/caregiver vaccine hesitancy, specifically (1) community-participatory vaccine hesitancy measurement, (2) communication approaches, (3) reinforcement techniques (eg, incentives, mandates), and (4) community-engaged partnerships (eg, vaccine champion training, vaccination in community settings). This article also discusses important considerations when vaccinating children and adolescents in non-primary care settings (school-based health centers, pharmacies, community events).

A Virtual Reality Curriculum to Enhance Residents' Behavioral Health Anticipatory Guidance Skills: A Pilot Trial.

OBJECTIVE: Effective educational strategies to train and assess residents' skills in behavioral health competencies have been limited. We hypothesized that a training curriculum using virtual reality (VR) simulations would enhance residents' evidence-based skills related to behavioral health anticipatory guidance (BHAG) and motivational interviewing (MI). METHODS: We conducted a randomized controlled pilot trial of our curriculum within an urban academic clinic. Intervention and control groups received four 15-minute, monthly didactics on BHAG and MI followed by VR simulations to 1) deliberately practice delivering BHAG by verbally counseling avatars, who responded real-time (intervention group) or 2) assessing pediatric respiratory distress (control group). Two months post-VR training, all residents participated in a unique VR behavioral health scenario which was recorded and coded by pediatric psychologists via an observation instrument to assess residents' skills. Differences in BHAG and MI competencies were assessed via independent samples t tests for continuous variables and Fisher's exact tests for categorical variables. RESULTS: Sixty-six percent (n = 55) of eligible residents completed all study protocols comprising 35 intervention and 20 control participants. Intervention participants demonstrated an increase in BHAG skills (P = .002), percentage of open-ended questions asked (P = .04), and percentage of MI adherent behaviors (P = .04) when compared to the control group. CONCLUSIONS: VR may be an effective educational strategy for residents to acquire BHAG and MI skills though deliberate practice. Next steps will focus on assessing the generalizability of the VR curriculum as well as exploring the opportunities to enhance its scalability through artificial intelligence.

Diversity, Equity, and Inclusion within Pediatric Adherence Science.

Given the long-standing history of systemic racism in psychological science, diversity, equity, and inclusion (DEI) efforts are increasingly vital to the advancement and improvement of the field. This commentary extends the seminal work of the article Upending Racism in Psychological Science: Strategies to Change How Our Science is Conducted, Reported, Reviewed, and Disseminated (Buchanan et al., Am Psychol, https://doi.org/10.31234/osf.io/6nk4x , 2020) by providing tangible applications and recommendations to improve DEI integration into pediatric adherence science. Real-world adherence examples are discussed regarding the challenges faced in systematically integrating DEI principles, potential solutions to overcoming barriers, and the implications of these efforts on scientific advancement in an effort to address and dismantle research practices that perpetuate inequity and White supremacy. Specifically, we provide discourse and practical guidance related to the conduct, reporting, reviewing, and dissemination of pediatric adherence science to promote dialog and produce actionable change toward the promotion of health equity and social justice.

Family-centered communication in pediatric sickle cell disease.

BACKGROUND: Individuals with sickle cell disease (SCD) experience systemic barriers in accessing high-quality care. Research suggests that patient/family-provider relationships are an important indicator of healthcare quality and can influence disease self-management and outcomes. The Patient Centered Communication (PCC) framework holds that patient/family-centered communication (e.g., eliciting, understanding, and validating patients' perspectives within their unique psychosocial contexts) contributes to improved family-provider relationships, as well as self-efficacy for disease management, adherence, and health outcomes. While the PCC framework has been useful in guiding the evaluation of patient/family-provider communication in other pediatric populations, it has not yet been applied in the context of pediatric SCD. This study aimed to use this framework to examine patient and family perceptions of communication with pediatric SCD healthcare providers. PROCEDURE: Total 17 caregivers (82% mothers, 94% Black/African American) and eight patients (62% female, aged 13-19 years, M = 16.50) completed semi-structured interviews. The PCC framework informed the development of a preliminary codebook. Thematic content analysis summarized family perspectives regarding communication with providers. RESULTS: For youth with SCD and their caregivers, specific themes related to family-centered communication included: reducing patient/family distress, supporting disease self-management efforts, facilitating information exchange and decision-making, and fostering positive and trusting relationships with providers. CONCLUSIONS: This study helps to address gaps in the literature related to patient/family-provider communication within pediatric SCD. Results underscore the importance of patient- and family-centered communication across pediatric SCD care. These findings can inform future research and clinical care initiatives to improve patient/family-provider interactions and health outcomes for this underserved population.

Partnering With Faith-Based Organizations to Offer Flu Vaccination and Other Preventive Services.

In 2019, just one-half of Americans received their influenza vaccine, despite it being safe, effective, and important in preventing serious infection, hospitalization, and death. Black children receive fewer influenza vaccines than their White counterparts. Vaccine hesitancy can hinder influenza vaccine uptake and is partially fueled by ongoing systemic racism and historical abuse leading to medical mistrust in communities of color. Building trust may enhance the transfer of reliable vaccine information and may move people along the spectrum of vaccine intention. We sought to partner with faith-based organizations through a community influenza vaccination event to increase vaccination rates. By leveraging the reach and expertise of trusted voices, such as church "first ladies" and local community leaders, we were able to administer 600 pediatric influenza vaccines between 2016 and 2019. In addition, this event served as a platform to assess whether youth attendees had a place for regular medical care ("medical home") (>80% did in each year assessed) and to conduct preventive screenings. Most children, as reported by their caregivers, had recent medical check-ups (85% in 2016, 84% in 2017, and 82% in 2018). Of the children screened, more than one-third had an abnormal body mass index and one-half had abnormal dentition. By partnering with organizations that are well-embedded in the local community, such as faith-based organizations, health care groups may be able to maximize the impact of their health promotion campaigns.

Considerations for Selecting Cognitive Endpoints and Psychological Patient-Reported Outcomes for Clinical Trials in Pediatric Patients With Sickle Cell Disease.

Pediatric patients with sickle cell disease (SCD) experience a range of medical complications that result in significant morbidity and mortality. Recent advances in prophylactic and curative treatment approaches have highlighted the need for sensitive and clinically-meaningful trial endpoints. The detrimental effects of cognitive and psychological difficulties on social and economic mobility are well described. Although numerous reviews have assessed cognitive outcomes in other rare genetic disorders, SCD has not received the same focus. This review describes the cognitive (i.e., executive function and processing speed) and psychological domains (i.e., depression and anxiety) that are consistently associated with SCD pathology and, therefore, may be of particular interest as clinical trial endpoints. We then discuss corresponding well-validated and reliable cognitive tests and patient-reported outcomes (PROs) that may be appropriate for clinical trials given their robust psychometric properties, ease of administration, and previous use in the SCD population. Further, we provide a discussion of potential pitfalls and considerations to guide endpoint selection. In line with the move toward patient-centered medicine, we identify specific tests (e.g., NIH Toolbox Cognition Module, Wechsler Cancellation Test) and psychological PROs (e.g., PROMIS depression and anxiety scales) that are sensitive to SCD morbidity and have the potential to capture changes that are clinically meaningful in the context of patients' day to day lives. In particularly vulnerable cognitive domains, such as executive function, we highlight the advantages of composite over single-test scores within the context of trials. We also identify general (i.e., practice effects, disease heterogeneity) and SCD-specific considerations (i.e., genotype, treatment course, and disease course, including degree of neurologic, pain, and sleep morbidity) for trial measures. Executive function composites hold particular promise as trial endpoints that are clinically meaningful, amenable to change, relatively easy to collect, and can be incorporated into the routine care of patients with SCD in various settings and countries.

An Immersive Virtual Reality Curriculum for Pediatric Hematology Clinicians on Shared Decision-making for Hydroxyurea in Sickle Cell Anemia.

Although hydroxyurea (HU) is an effective treatment for sickle cell anemia, uptake remains low. Shared decision-making (SDM) is a recommended strategy for HU initiation to elicit family preferences; however, clinicians lack SDM training. We implemented an immersive virtual reality (VR) curriculum at 8 pediatric institutions to train clinicians on SDM that included counseling virtual patients. Clinicians' self-reported confidence significantly improved following the VR simulations on all communication skills assessed, including asking open-ended questions, eliciting specific concerns, and confirming understanding (Ps≤0.01 for all). VR may be an effective method for educating clinicians to engage in SDM for HU.

Factors Associated With Participation in Clinical Trials Among Patients With Lupus.

BACKGROUND/OBJECTIVE: Participation rates for clinical trials, including lupus trials, in the United States are low, but are even lower for underrepresented minorities. The impact of underrepresentation in trials can be far-reaching and is problematic because female subjects of color with lupus experience greater morbidity and mortality. As such, the overarching goal of this study was to characterize the factors that influence participation in lupus clinical trials. METHODS: The Lupus and Allied Diseases Association, the Lupus Foundation of America, and the Lupus Research Alliance collected data for their externally led Patient-Focused Drug Development Initiative-for the purpose of understanding and improving the rates of participation in lupus-related clinical trials. Participants completed a 46-question survey (in English or Spanish) electronically or on paper, which was distributed online or at lupus events. Logistic regression was used to test whether demographic and disease characteristics were associated with participation in past lupus trials. RESULTS: Data were available for 2220 respondents. Black respondents with lupus were more likely, than their White and Hispanic counterparts, to have participated in past clinical trials (p < 0.05). Although not statistically significant, Hispanic respondents were also more likely to have participated than their White counterparts (odds ratio, 1.40; 95% confidence interval, 0.96-2.11). Both demographic (ie, race/ethnicity) and medical (ie, disease severity defined as more organ involvement) factors seem to be important determinants of participation in clinical trials (p < 0.05). CONCLUSIONS: Combining the results from this study and prior research provides insight into recruitment strategies to increase participation rates of historically underrepresented minorities.

The influence of perceived racial bias and health-related stigma on quality of life among children with sickle cell disease.

Objectives: Individuals with sickle cell disease (SCD) experience significant health problems that may result in unpredictable pain episodes and frequent healthcare utilization. Disparities in clinical care may contribute to health-related stigma and racial bias for this majority African-American/Black population. There is less known about the influence of health-related stigma and racial bias on the health-related quality of life (HRQOL) of children with SCD. In the present study, we assessed these relationships and identified differences across demographic factors (i.e. age, gender).Design: Data was collected from African American children with SCD aged 8-16 years (57% male, 63% HbSS). Children completed the Childhood Stigma Scale (adapted for SCD), the Child Perceptions of Racism in Children and Youth scale, and the Pediatric Quality of Life Inventory Sickle Cell Disease Module. Caregivers provided demographic information.Results: In the first regression model, health-related stigma (p = .007) predicted HRQOL, but neither age nor gender were significant predictors. In the second regression model, age (p = .03) predicted HRQOL, but neither gender nor racial bias were significant predictors. Of interest, there was a significant interaction between age, gender, and racial bias (p = .02). Specifically, older girls who reported high levels of perceived racial bias had poorer HRQOL.Conclusions: Our study highlights the need for increased awareness about the effects of health-related stigma and racial bias on HRQOL for children with SCD, particularly for older girls who endorse racial bias. Our findings will guide future stigma and bias reduction interventions that may meet the needs of older girls with SCD.