Barriers and facilitators of the return-to-school process affecting adolescent recipients of allogeneic hematopoietic cell transplantation: A qualitative interview study of caregivers.

BACKGROUND: Adolescent hematopoietic cell transplant (HCT) recipients remain out of school for a prolonged period of time; navigating their return to school after completion of therapy can be challenging for caregivers. METHODS: Between August 2020 and June 2021, we conducted individual semi-structured interviews of 19 caregivers of adolescent HCT recipients (10-18 years of age at HCT; 1-7 years post HCT) to understand the challenges faced at the time of their child's return to in-person school post HCT. Conventional content analysis was used to analyze interview transcripts, and thematic analysis was used to identify and organize emerging themes. RESULTS: Three themes emerged from the caregivers' experiences. First, caregivers reported facing several challenges related to lack of communication between their child's healthcare and school teams, which was burdensome for them. Second, some caregivers reported receiving support from school and healthcare professionals, as well as their child's peers, which helped reduce the burden of return to school. Caregivers also reported providing motivational, emotional, and spiritual support to patients. Lastly, caregivers made several recommendations regarding the need for better communication between family, healthcare professionals, and school professionals and availability of supportive care such as mental health counseling and neuropsychological testing. Notably, the need for a return-to-school navigator emerged as a key finding from our analysis. CONCLUSIONS: Caregivers of adolescent HCT recipients face several challenges supporting their children's return to school post HCT, which are related to lack of communication between patients' healthcare and school teams. While some reported receiving support from school and healthcare professionals and their child's peers, the need to coordinate the return-to-school process was burdensome for several caregivers. Additional work is needed to optimize support for HCT recipients and their caregivers during their return-to-school process to minimize burden. Our study findings have the potential to serve as a framework for developing and testing supportive care interventions to improve the return-to-school experience of HCT survivors and ultimately their quality of life.

Family-Reflections.com: Creating a parent-to-parent web-based tool regarding pediatric home ventilation.

BACKGROUND: The decision to initiate pediatric mechanical ventilation via tracheostomy ("home ventilation") is complex and parents often desire information from other parents who have faced this decision. However, parent-to-parent communication is challenging as it is difficult to connect new families to experienced families in ways that optimize informed, balanced decision-making. OBJECTIVE: Create a parent-to-parent web-based tool to support decision-making about pediatric home ventilation. PATIENT INVOLVEMENT: The tool was created based on interviews and feedback from parents. METHODS: We interviewed parents who previously chose for, or against, home ventilation for their child. Interview themes and family comments guided website development. Viewer feedback was solicited via an embedded survey in the tool. RESULTS: We created 6 composite character families to communicate 6 themes about home ventilation: 1) Considering treatment options, 2) Talking with medical team, 3) Impact on life at home, 4) Impact on relationships, 5) Experience for the child, and 6) If the child's life is short. Nine families who reviewed the draft tool felt it would have helped with their decision about home ventilation. Specifically, it supported families in thinking through what was "most important about their child's breathing problems" (7 of 9 parents) and feeling "more at peace with the decision" (8 of 9 parents). Between 6/1/20-12/31/22, nearly 5500 viewers have accessed the tool and 56 viewers completed the survey (including 13 families and 39 clinicians). Feedback from experienced families and clinicians reported the tool taught them something new. DISCUSSION: This novel parent-to-parent tool shows promise for expanding access to balanced, family-centered information about pediatric home ventilation. PRACTICAL VALUE: The diverse stories and decisions let parents access multiple family perspectives. The tool's focus is on family-centric information that parents reported was usually missing from clinician counseling. FUNDING: This work was supported by the National Palliative Care Research Center.

"What Would Give Her the Best Life?": Understanding Why Families Decline Pediatric Home Ventilation.

Background: Families who must decide about pediatric home ventilation rely on the clinicians who counsel them for guidance. Most studies about pediatric home ventilation decisions focus on families who opt for this intervention, leaving much unknown about the families who decline. Objective: To describe the rationales of families who decline home ventilation. Design: Semi-structured interview study. Setting/Subjects: We interviewed 16 families in hospitals across 3 U.S. states, identified by their clinicians as previously deciding to not pursue home ventilation via tracheostomy within the past five years. Measurements: Targeted content and narrative analyses were used to understand family intentions and reasons for declining. Results: The clinical and social context varied among the 16 families in this study. Families' intentions in saying "no" fell into two categories: (1) definitive "No": Families who stood firm on in their decision and (2) contingent "No": Families who may consider this in the future. Families described four reasons why their child did not receive home ventilation: (1) concern about medical impacts, (2) concern about physical and/or communication restrictions, (3) concern that there would be no clear health benefit, and (4) concern about no clear meaningful life. Most families mentioned all four reasons, but concern about no clear meaningful life predominated. Conclusions: Though these families did not see home ventilation as an appropriate option, each reported a complex interplay of intentions behind and reasons for declining. Clinicians who counsel families about home ventilation could share the reasons that families commonly decline this intervention to facilitate a balanced discussion.

Engaging Patient Advisory Committees to Inform a Genomic Cancer Risk Study: Lessons for Future Efforts.

Introduction The Cancer Health Assessments Reaching Many study seeks to reduce disparities in genomic care. Two patient advisory committees (PACs) were formed, 1 of English speakers and 1 of Spanish speakers, to vet study processes and materials. Stakeholder engagement in research is relatively new, and we know little about how stakeholders view their engagement. We wanted to learn how patient stakeholders viewed the process, to inform future patient engagement efforts. Methods Patients at 2 study sites were invited to serve on 2 PACs. We used an iterative engagement process to solicit and incorporate patient feedback. Much of the PAC feedback on study materials and processes was incorporated. Using surveys and exit interviews, we evaluated stakeholders' experiences as PAC members. Results Nearly all PAC members felt satisfied and included in the study decisions, but surveys and exit interviews suggested the need to improve communications. Discussion Although most believed their feedback was used, and most felt included in study decisions, some said they did not know whether their opinions were used to modify materials or approaches. This suggests the need to explain to patient stakeholders the extent to which their feedback was used and to inform them about the impact that other stakeholders, such as institutional review boards, have on decisions. Conclusion Our evaluation highlights the value of dedicating resources to stakeholder engagement. Although gathering patient feedback on study materials and processes introduced time constraints and complexity to our study, adaptations to materials and processes furthered study goals.

Assessment of Resilience Training for Hospital Employees in the Era of COVID-19.

Importance: Health care workers face serious mental health challenges as a result of ongoing work stress. The COVID-19 pandemic exacerbated that stress, resulting in high rates of anxiety, depression, and burnout. To date, few evidence-based programs targeting mental health outcomes in health care workers have been described. Objective: To assess the feasibility, acceptability, and preliminary outcomes of a skills-based coaching program designed to reduce stress and build resilience. Design, Setting, and Participants: A pilot cohort study was conducted between September 2020 and April 2021 using preprogram and postprogram assessments and a mixed-methods analysis. Duration of follow-up was 7 weeks. The coaching program was delivered via video conferencing. Participants were health care workers and staff from a large urban health system. Intervention: The Promoting Resilience in Stress Management (PRISM) program, a manualized, skills-based coaching program originally developed for adolescents and young adults with serious/chronic illness, was adapted to support health care workers and staff ("PRISM at Work"). It included 6 weekly 1-hour group sessions. Main Outcomes and Measures: Feasibility was defined a priori as 70% completion rates. Acceptability was defined quantitatively (satisfaction scores) and qualitatively (open-ended questions regarding experience with program). Preliminary outcomes were assessed with preprogram and post program assessments of self-reported resilience, stress, anxiety, and burnout using validated instruments. Descriptive statistics summarized demographic variables and feasibility and acceptability. Linear mixed effects regression models examined preliminary outcomes, controlling for relevant covariates. Results: A total of 153 participants (median [SD] age, 40.6 [10.1] years; 142 [92%] were female; 128 [84%] identified as having White race; 81 [53%] were in patient-facing roles) enrolled. Of the 132 health care workers who provided follow-up surveys, 120 (91%) had completed the program, and 116 (88%) reported being satisfied. Answers to open-ended questions suggested that participants wanted more PRISM either with longer or additional sessions. Participant-reported resilience (ß = 1.74; 95% CI, 1.00-2.48), stress (ß = -2.40; 95% CI, -3.28 to -1.51), anxiety (ß = -2.04; 95% CI, -2.74 to -1.34), and burnout-exhaustion (ß = -0.37; 95% CI, -0.56 to -0.18) improved after the program. Conclusions and Relevance: Results of this study suggest that PRISM at Work may have utility for health care workers and staff in that the program was found to be feasible, acceptable, and associated with improved outcomes.

Home mechanical ventilation for children with severe neurological impairment: Parents' perspectives on clinician counselling.

AIM: To retrospectively explore the perspectives of parents of children with severe neurological impairment (SNI), such as those with severe cerebral palsy, epilepsy syndromes, and structural brain differences, on clinician counseling regarding home mechanical ventilation (HMV). METHOD: Inductive thematic analysis was performed on data from telephone interviews with parents who chose for and against HMV for their child with SNI at three academic children's hospitals across the USA. RESULTS: Twenty-six parents/legal guardians of 24 children were interviewed. Fourteen children had static encephalopathy, 11 received HMV, and 20 were alive at the time of parent interviews. Themes included how HMV related to the child's prognosis, risk of death, and integration with goals of care. Although clinicians voiced uncertainty about how HMV would impact their child, parents felt this was coupled with prescriptive/intimidating examples about the child's end of life and judgments about the child's quality of life. INTERPRETATION: While prognositc uncertainty exists, this study suggests that parents of children with SNI seek clinician counseling about HMV that considers their goals of care and views on their child's quality of life.

Perceived Utility of Genomic Sequencing: Qualitative Analysis and Synthesis of a Conceptual Model to Inform Patient-Centered Instrument Development.

BACKGROUND AND OBJECTIVES: Successful clinical integration of genomic sequencing (GS) requires evidence of its utility. While GS potentially has benefits (utilities) or harms (disutilities) across multiple domains of life for both patients and their families, there is as yet no empirically informed conceptual model of these effects. Our objective was to develop an empirically informed conceptual model of perceived utility of GS that captures utilities and disutilities for patients and their families across diverse backgrounds. METHODS: We took a patient-centered approach, in which we began with a review of existing literature followed by collection of primary interview data. We conducted semi-structured interviews to explore types of utility in a clinically and sociopolitically diverse sample of 60 adults from seven Clinical Sequencing Evidence-Generating Research (CSER) consortium projects. Interviewees had either personally received, or were parents of a child who had received, GS results. Qualitative data were analyzed using thematic analysis. Findings from interviews were integrated with existing literature on clinical and personal utility to form the basis of an initial conceptual model that was refined based on expert review and feedback. RESULTS: Five key utility types that have been previously identified in qualitative literature held up as primary domains of utility and disutility in our diverse sample. Interview data were used to specify and organize subdomains of an initial conceptual model. After expert refinement, the five primary domains included in the final model are clinical, emotional, behavioral, cognitive, and social, and several subdomains are specified within each. CONCLUSION: We present an empirically informed conceptual model of perceived utility of GS. This model can be used to guide development of instruments for patient-centered outcome measurement that capture the range of relevant utilities and disutilities and inform clinical implementation of GS.

Parent perspectives on facilitating decision-making around pediatric home ventilation.

RATIONALE: Deciding about pediatric home ventilation is exceptionally challenging for parents. Understanding the decision-making needs of parents who made different choices for their children could inform clinician counseling that better supports parents' diverse values and goals. OBJECTIVES: To determine how clinicians can meet the decisional needs of parents considering home ventilation using a balanced sample of families who chose for or against intervention. METHODS: We conducted semi-structured interviews of parents who chose for or against home ventilation for their child within the previous 5 years. Parents were recruited from three academic centers across the United States. Interviews focused on parent-clinician communication during decision-making and how clinicians made the process easier or more difficult. Qualitative analysis was used to generate themes and identify key results. RESULTS: Thirty-eight parents were interviewed; 20 chose for and 18 chose against home ventilation. Five themes described their perspectives on how clinicians can facilitate high-quality decision-making: demonstrating dedication to families, effectively managing the medical team, introducing the concept of home ventilation with intention, facilitating meaningful conversation about the treatment options, and supporting and respecting the family's decision. CONCLUSIONS: High-quality decision-making around home ventilation depends on individual clinician actions and the complex operations of large academic settings. Strong working relationships with parents, collaborative alliances with colleagues, and appropriate delivery of key content can help meet the needs of parents considering invasive breathing supports for their children.

Motivations and concerns of patients considering participation in an implementation study of a hereditary cancer risk assessment program in diverse primary care settings.

PURPOSE: Understanding the motivations and concerns of patients from diverse populations regarding participation in implementation research provides the needed evidence about how to design and conduct studies for facilitating access to genetics services. Within a hereditary cancer screening study assessing a multifaceted intervention, we examined primary care patients' motivations and concerns about participation. METHODS: We surveyed and interviewed study participants after they enrolled, surveyed those who did not complete enrollment, and used descriptive qualitative and quantitative methods to identify motivations and concerns regarding participation. RESULTS: Survey respondents' most common motivations included a desire to learn about their future risk (81%), receiving information that may help family (58%), and a desire to advance research (34%). Interviews revealed 3 additional important factors: affordability of testing, convenience of participation, and clinical relationships supporting research decision-making. Survey data of those who declined enrollment showed that the reasons for declining included concerns about privacy (38%), burdens of the research (19%), and their fear of not being able to cope with the genetic information (19%). CONCLUSION: Understanding the facilitating factors and concerns that contribute to decisions about research may reveal ways to improve equity in access to care and research that could lead to greater uptake of genomic medicine across diverse primary care patient populations.

Life with pediatric home ventilation: Expectations versus experience.

OBJECTIVES: To explore the family experience of home ventilation through a comparison of anticipated home life changes with subsequent experiences. STUDY DESIGN: Guided interviews with parents across three states who chose home ventilation for their child within the last 5 years. PATIENT-SUBJECT SELECTION: Purposive sampling of parents who chose home ventilation for their child within the last 5 years. METHODS: Interviews were transcribed for qualitative analysis and analyzed for thematic saturation and prevalence of codes. RESULTS: Twenty families were interviewed. Families generally reported not considering potential home life changes when facing the decision about home ventilation; instead, they worried most about medical management. These concerns reversed in importance later. Families learned medical management quickly but felt largely unprepared for the extensive changes to their home life, including isolation, altered relationships with extended family and community, effects on siblings, financial strain, and need for physical changes to their house. Families had not anticipated how much they would be affected by home healthcare as a new part of their life. CONCLUSIONS: The priorities that families consider during decisions about pediatric home ventilation may not be aligned with the actual home experience of this technology. Given that the success of home ventilation largely rests with the family's care, family expectations for home life adaptations must be augmented, as should postdischarge supports for families with complex home care experiences.

Parents Are the Experts: A Qualitative Study of the Experiences of Parents of Children With Severe Neurological Impairment During Decision-Making.

CONTEXT: Parents of children with severe neurologic impairment (SNI) often face high-stakes medical decisions when their child is hospitalized. These decisions involve technology and/or surgery, goals of care and/or advance care planning, or transitions of care. OBJECTIVES: This study describes the experiences of parents of children with SNI during decision-making. METHODS: Eligible participants were parents facing a decision for a child with SNI admitted to acute or intensive care units at a single tertiary pediatric center. Parents completed 1:1 semi-structured interviews and brief surveys between August 2019 and February 2020. Demographic information was extracted from the child's electronic health record. A team of palliative and complex care researchers with expertise in qualitative methods used thematic content analysis to formulate results. RESULTS: 25 parents participated. The majority had children with congenital/chromosomal SNI conditions (n = 13, 65%), >5 subspecialists (n = 14, 61%), and chronic technology assistance (n = 25, 100%). 68% (n = 17) were mothers and 100% identified as being their child's primary decision-maker. Responses from parents included 3 major themes: 1) our roles and actions; 2) our stresses and challenges; and 3) our meaning and purpose. Responses highlighted the pervasiveness of parental decision-making efforts and parents' advocacy and vigilance regarding their child's needs. Despite this, parents often felt unheard and undervalued in the hospital. CONCLUSION: During hospitalizations, when parents of children with SNI often face high-stakes medical decisions, interventions are needed to support parents and ensure they feel heard and valued as they navigate their child's medical needs and system challenges.

Participant Reactions to a Literacy-Focused, Web-Based Informed Consent Approach for a Genomic Implementation Study.

BACKGROUND: Clinical genomic implementation studies pose challenges for informed consent. Consent forms often include complex language and concepts, which can be a barrier to diverse enrollment, and these studies often blur traditional research-clinical boundaries. There is a move toward self-directed, web-based research enrollment, but more evidence is needed about how these enrollment approaches work in practice. In this study, we developed and evaluated a literacy-focused, web-based consent approach to support enrollment of diverse participants in an ongoing clinical genomic implementation study. Methods: As part of the Cancer Health Assessments Reaching Many (CHARM) study, we developed a web-based consent approach that featured plain language, multimedia, and separate descriptions of clinical care and research activities. CHARM offered clinical exome sequencing to individuals at high risk of hereditary cancer. We interviewed CHARM participants about their reactions to the consent approach. We audio recorded, transcribed, and coded interviews using a deductively and inductively derived codebook. We reviewed coded excerpts as a team to identify overarching themes. Results: We conducted 32 interviews, including 12 (38%) in Spanish. Most (69%) enrolled without assistance from study staff, usually on a mobile phone. Those who completed enrollment in one day spent an average of 12 minutes on the consent portion. Interviewees found the information simple to read but comprehensive, were neutral to positive about the multimedia support, and identified increased access to testing in the study as the key difference from clinical care. Conclusions: This study showed that interviewees found our literacy-focused, web-based consent approach acceptable; did not distinguish the consent materials from other online study processes; and valued getting access to testing in the study. Overall, conducting empirical bioethics research in an ongoing clinical trial was useful to demonstrate the acceptability of our novel consent approach but posed practical challenges.

Exploring Ethical Concerns About Human Challenge Studies: A Qualitative Study of Controlled Human Malaria Infection Study Participants' Motivations and Attitudes.

Controlled human malaria infection (CHMI) studies deliberately infect healthy participants with malaria to test interventions faster and more efficiently. Some argue the study design and high payments offered raise ethical concerns about participants' understanding of risks and undue inducement. We conducted baseline and exit interviews with 16 CHMI study participants to explore these concerns. Participants described themes including decision-making tension with friends and family, mixed motivations for participating, low study risks but high burdens, fair compensation, sacrificing values, deceiving researchers, and perceived benefits. Our findings do not support concerns that high payments limit understanding of study risks, but suggest participants may lack appreciation of study burdens, withhold information or engage in deception, and experience conflict with others regarding study participation.

A Randomized Trial Evaluating the Prophylactic Activity of DSM265 Against Preerythrocytic Plasmodium falciparum Infection During Controlled Human Malarial Infection by Mosquito Bites and Direct Venous Inoculation.

Background: DSM265 is a selective inhibitor of Plasmodium dihydroorotate dehydrogenase that fully protected against controlled human malarial infection (CHMI) by direct venous inoculation of Plasmodium falciparum sporozoites when administered 1 day before challenge and provided partial protection when administered 7 days before challenge. Methods: A double-blinded, randomized, placebo-controlled trial was performed to assess safety, tolerability, pharmacokinetics, and efficacy of 1 oral dose of 400 mg of DSM265 before CHMI. Three cohorts were studied, with DSM265 administered 3 or 7 days before direct venous inoculation of sporozoites or 7 days before 5 bites from infected mosquitoes. Results: DSM265-related adverse events consisted of mild-to-moderate headache and gastrointestinal symptoms. DSM265 concentrations were consistent with pharmacokinetic models (mean area under the curve extrapolated to infinity, 1707 µg*h/mL). Placebo-treated participants became positive by quantitative reverse transcription-polymerase chain reaction (qRT-PCR) and were treated 7-10 days after CHMI. Among DSM265-treated subjects, 2 of 6 in each cohort were sterilely protected. DSM265-treated recipients had longer times to development of parasitemia than placebo-treated participants (P < .004). Conclusions: This was the first CHMI study of a novel antimalarial compound to compare direct venous inoculation of sporozoites and mosquito bites. Times to qRT-PCR positivity and treatment were comparable for both routes. DSM265 given 3 or 7 days before CHMI was safe and well tolerated but sterilely protected only one third of participants.