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.

Tobacco Use and Respiratory Symptoms Among Adults: Findings From the Longitudinal Population Assessment of Tobacco and Health (PATH) Study 2014-2016.

INTRODUCTION: We examined the relationship between current tobacco use and functionally important respiratory symptoms. METHODS: Longitudinal cohort study of 16 295 US adults without COPD in Waves 2-3 (W2-3, 2014-2016) of the Population Assessment of Tobacco and Health Study. Exposure-Ten mutually exclusive categories of tobacco use including single product, multiple product, former, and never use (reference). Outcome-Seven questions assessing wheezing/cough were summed to create a respiratory symptom index; cutoffs of ≥2 and ≥3 were associated with functional limitations and poorer health. Multivariable regressions examined both cutoffs cross-sectionally and change over approximately 12 months, adjusting for confounders. RESULTS: All tobacco use categories featuring cigarettes (>2/3's of users) were associated with higher risk (vs. never users) for functionally important respiratory symptoms at W2, for example, at symptom severity ≥ 3, risk ratio for exclusive cigarette use was 2.34 [95% CI, 1.92, 2.85] and for worsening symptoms at W3 was 2.80 [2.08, 3.76]. There was largely no increased symptom risk for exclusive use of cigars, smokeless tobacco, hookah, or e-cigarettes (adjustment for pack-years and marijuana attenuated the cross-sectional e-cigarette association from 1.53(95% CI 0.98, 2.40) to 1.05 (0.67, 1.63); RRs for these products were also significantly lower compared to exclusive use of cigarettes. The longitudinal e-cigarette-respiratory symptom association was sensitive to the respiratory index cutoff level; exclusive e-cigarette use was associated with worsening symptoms at an index cutoff ≥ 2 (RR = 1.63 [1.02, 2.59]) and with symptom improvement at an index cutoff of ≥ 3 (RR = 1.64 [1.04, 2.58]). CONCLUSIONS: Past and current cigarette smoking drove functionally important respiratory symptoms, while exclusive use of other tobacco products was largely not associated. However, the relationship between e-cigarette use and symptoms was sensitive to adjustment for pack-years and symptom severity. IMPLICATIONS: How noncigarette tobacco products affect respiratory symptoms is not clear; some studies implicate e-cigarettes. We examined functionally important respiratory symptoms (wheezing/nighttime cough) among US adults without COPD. The majority of adult tobacco users smoke cigarettes and have higher risk of respiratory symptoms and worsening of symptoms, regardless of other products used with them. Exclusive use of other tobacco products (e-cigarettes, cigars, smokeless, hookah) was largely not associated with functionally important respiratory symptoms and risks associated with their use was significantly lower than for cigarettes. The association for e-cigarettes was greatly attenuated by adjustment for cigarette pack-years and sensitive to how symptoms were defined.

Text Messages and Financial Incentives to Increase Physical Activity in Adolescents With Prediabetes and Type 2 Diabetes: Web-Based Group Interviews to Inform Intervention Design.

BACKGROUND: Physical activity is a major component of treatment for adolescents with obesity and prediabetes or type 2 diabetes; however, sedentary behavior remains pervasive. An SMS text message-based intervention paired with financial incentives may be an effective way to promote physical activity in this population. OBJECTIVE: This study aims to obtain end-user feedback on SMS text message content and assess the acceptability of a planned SMS text messaging intervention with financial incentives to motivate youth with prediabetes or type 2 diabetes to increase physical activity. METHODS: Adolescents with overweight or obesity and prediabetes or type 2 diabetes who attended a large academic pediatric endocrinology clinic were recruited to participate in group interviews (2-4/group) via videoconferencing. Participants were asked to share their thoughts on the use of SMS text messages and financial incentives to remind and motivate them to be more physically active. They rated and provided feedback on specific messages to be used in clinical trials. Participants were also asked about their personal experience with rewards to motivate behavior change and their anticipated reactions to rewards provided for goal attainment (gain-framing) versus those provided and then taken away if a goal was not met (loss-framing). The interviews were conducted by 2 trained interviewers and a note-taker. Content analysis was used to explore themes. RESULTS: Group interviews were completed with 20 participants (11/20, 55% women; 15/20, 75% with type 2 diabetes; 5/20, 25% with prediabetes) with a mean age of 15 (SD 1; range 12-18) years and a mean BMI of 41 (SD 5) kg/m2 (all >95th percentile for age and sex). Most participants were non-Hispanic Black (14/20, 70%) and 10% (2/20) were Hispanics. Participants frequently cited near-continuous smartphone use and agreed that SMS text messages would serve as good reminders to be physically active, but the consensus about the need for short messages was strong. Favorable content included references to what they were likely to be doing when messages were sent (eg, homework or watching television) and messages that were upbeat or informative. Specific physical activity suggestions were rated favorably. Attitudes toward financial incentives varied, with differing opinions about whether loss-framed incentives would be motivating or discouraging. Many participants highlighted the role of intrinsic, rather than extrinsic, motivation in achieving and sustaining behavior change. CONCLUSIONS: The engagement of adolescents with obesity and diabetes or prediabetes allowed for the refinement of SMS text messages for our planned intervention, with an emphasis on short, upbeat, relatable, and informative messages. Although an SMS text messaging intervention using financial incentives to motivate youth with prediabetes or type 2 diabetes to be more physically active is theoretically acceptable, the impact on actual activity levels in this population requires prospective evaluation in a clinical trial.

Systemic and Individual Factors That Shape Mental Health Service Usage Among Visible Minority Immigrants and Refugees in Canada: A Scoping Review.

There exists considerable research which reports that mental health disparities persist among visible minority immigrants and refugees within Canada. Accessing mental health care services becomes a concern which contributes to this, as visible minority migrants are regarded as an at-risk group that are clinically underserved. Thus, the purpose of this review is to explore the following research question: "what are the barriers and facilitators for accessing mental health care services among visible immigrants and refugees in Canada?". A scoping review following guidelines proposed by Arksey and O'Malley (International Journal of Social Research Methodology 8(1): 19-32, 2005) was conducted. A total of 45 articles published from 2000 to 2020 were selected through the review process, and data from the retrieved articles was thematically analyzed. Wide range of barriers and facilitators were identified at both the systemic and individual levels. Unique differences rooted within landing and legal statuses were also highlighted within the findings to provide nuance amongst immigrants and refugees. With the main layered identity of being a considered a visible minority, this yielded unique challenges patterned by other identities and statuses. The interplay of structural issues rooted in Canadian health policies and immigration laws coupled with individual factors produce complex barriers and facilitators when seeking mental health services. Through employing a combined and multifaceted approach which address the identified factors, the findings also provide suggestions for mental health care providers, resettlement agencies, policy recommendations, and future directions for research are discussed as actionable points of departure.

Acceptability, Feasibility, and Quality of Telehealth for Adolescent Health Care Delivery During the COVID-19 Pandemic: Cross-sectional Study of Patient and Family Experiences.

BACKGROUND: Data regarding the acceptability, feasibility, and quality of telehealth among adolescents and young adults (AYA) and their parents and caregivers (caregivers) are lacking. OBJECTIVE: The aim of this study was to assess the noninferiority of telehealth versus in-person visits by comparing acceptability with respect to efficiency, effectiveness, equity, patient-centeredness, and confidentiality. METHODS: Cross-sectional web-based surveys were sent to caregivers and AYA following video visits within an Adolescent Medicine subspecialty clinic in May-July 2020. Proportions of AYA and caregivers who rated telehealth as noninferior were compared using chi-squared tests. Feasibility was assessed via items measuring technical difficulties. Deductive thematic analysis using the Institute of Medicine dimensions of health care quality was used to code open-ended question responses. RESULTS: Survey response rates were 20.5% (55/268) for AYA and 21.8% (123/563) for caregivers. The majority of the respondents were White cisgender females. Most AYA and caregivers rated telehealth as noninferior to in-person visits with respect to confidentiality, communication, medication management, and mental health care. A higher proportion of AYA compared to caregivers found telehealth inferior with respect to confidentiality (11/51, 22% vs 3/118, 2.5%, P<.001). One-quarter (14/55) of the AYA patients and 31.7% (39/123) of the caregivers reported technical difficulties. The dominant themes in the qualitative data included advantages of telehealth for efficiency and equity of health care delivery. However, respondents' concerns included reduced safety and effectiveness of care, particularly for patients with eating disorders, owing to lack of hands-on examinations, collection of vital signs, and laboratory testing. CONCLUSIONS: Telehealth was highly acceptable among AYA and caregivers. Future optimization should include improving privacy, ameliorating technical difficulties, and standardizing at-home methods of obtaining patient data to assure patient safety.

Understanding Adolescent and Young Adult 6-Mercaptopurine Adherence and mHealth Engagement During Cancer Treatment: Protocol for Ecological Momentary Assessment.

BACKGROUND: Adolescents and young adults (AYAs) with cancer demonstrate suboptimal oral chemotherapy adherence, increasing their risk of cancer relapse. It is unclear how everyday time-varying contextual factors (eg, mood) affect their adherence, stalling the development of personalized mobile health (mHealth) interventions. Poor engagement is also a challenge across mHealth trials; an effective adherence intervention must be engaging to promote uptake. OBJECTIVE: This protocol aims to determine the temporal associations between daily contextual factors and 6-mercaptopurine (6-MP) adherence and explore the proximal impact of various engagement strategies on ecological momentary assessment survey completion. METHODS: At the Children's Hospital of Philadelphia, AYAs with acute lymphoblastic leukemia or lymphoma who are prescribed prolonged maintenance chemotherapy that includes daily oral 6-MP are eligible, along with their matched caregivers. Participants will use an ecological momentary assessment app called ADAPTS (Adherence Assessments and Personalized Timely Support)-a version of an open-source app that was modified for AYAs with cancer through a user-centered process-and complete surveys in bursts over 6 months. Theory-informed engagement strategies will be microrandomized to estimate the causal effects on proximal survey completion. RESULTS: With funding from the National Cancer Institute and institutional review board approval, of the proposed 30 AYA-caregiver dyads, 60% (18/30) have been enrolled; of the 18 enrolled, 15 (83%) have completed the study so far. CONCLUSIONS: This protocol represents an important first step toward prescreening tailoring variables and engagement components for a just-in-time adaptive intervention designed to promote both 6-MP adherence and mHealth engagement. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/32789.

Validation of an Index for Functionally Important Respiratory Symptoms among Adults in the Nationally Representative Population Assessment of Tobacco and Health Study, 2014-2016.

The purpose of this study is to validate the seven-item wheezing module from the International Study of Asthma and Allergies in Children (ISAAC) in the nationally representative Population Assessment of Tobacco and Health Study. Adult participants with complete Wave 2-3 data were selected, including those with asthma but excluding those with COPD and other respiratory diseases (n = 16,295). We created a nine-point respiratory symptom index from the ISAAC questions, assessed the reliability of the index, and examined associations with self-reported asthma diagnosis. Threshold values were assessed for association with functional outcomes. The weighted prevalence for one or more respiratory symptom was 18.0% (SE = 0.5) for adults without asthma, 70.1% (SE = 1.3) for those with lifetime asthma, 75.7% (SE = 3.7) for adults with past-year asthma not on medications, and 92.6% (SE = 1.6) for those on medications. Cronbach's alpha for the respiratory symptom index was 0.86. Index scores of ≥2 or ≥3 yielded functionally important respiratory symptom prevalence of 7-10%, adequate sensitivity and specificity for identifying asthma, and consistent independent associations with all functional outcomes and tobacco use variables. Respiratory symptom index scores of ≥2 or ≥3 are indicative of functionally important respiratory symptoms and could be used to assess the relationship between tobacco use and respiratory health.

Associations of health services utilization by prescription drug coverage and immigration category in Ontario, Canada.

Canada is the only high-income country with a universal healthcare system that does not provide prescription drug coverage for all its residents. This study examines whether Canadians' prescription drug coverage status is associated with their health services use and how this association differs by gender across non-migrants and three categories of migrants: economic immigrants, family-class immigrants, and refugees. Very few studies have examined differences across these migrant groups, and there is a need to do so as they experience varying health disparities. This study contributes to the prescription drug coverage, migration and health literature by employing an intersectional lens to analyze a sample of Ontario working-aged residents (n=39,792) generated from linking the Canadian Community Health Survey (2005, 2008, 2013, 2014) and Longitudinal Immigrant Database. Predicted probabilities and average marginal effects from multivariable logistic regression models were generated, and interaction effects between prescription drug coverage and immigrant status were examined. The study reveals important differences in the use of health services across prescription drug coverage groups by immigration status. As the general debate about universal pharmacare in Canada is ongoing, this study reveals that drug insurance is positively associated with health services use of most migrants and non-migrants, however, some immigrant women may still experience barriers to access general practitioner services. If pharmacare is introduced, ongoing evaluation is needed to ensure that its implementation produces equitable outcomes for all.

Evidence-Based Decision Making 3: Health Technology Assessment.

This chapter begins with a brief introduction to health technology assessment (HTA). HTA is concerned with the systematic evaluation of the consequences of the adoption and use of new health technologies and to improve the evidence on existing technologies. The objective of mainstream HTA is to support evidence-based decision- and policy-making that encourage the uptake of efficient and effective health-care technologies. This chapter provides a basic framework for conducting an HTA, as well as some fundamental concepts and challenges in assessing health technologies. Whether HTA is beneficial-supporting timely access to needed technologies-or detrimental depends on three critical issues: when the assessment is performed; how it is performed; and how the findings are used.

An institutional ethnographic analysis of public and patient engagement activities at a national health technology assessment agency.

OBJECTIVE: The practice of public and patient engagement (PPE) in health technology assessment (HTA) has spread worldwide, yet gaps in knowledge remain. We carried out an institutional ethnography of the Canadian Agency for Drugs and Technologies in Health (CADTH) public and patient involvement in HTA. METHODS: The research took place over 15 months and included observational work in the institutional settings, text review, and interviews with individuals working for or involved with the agency. RESULTS: We found that despite demonstrated commitment to PPE, organizational history, governance structure, and practices were impediments to a unified approach to PPE. Unclear role descriptions for committee members and differences in philosophy and priority given to PPE across the organization presented challenges to effective participation. The high degree of value given to evidence-based principles at times conflicted with meaningful integration of patient input. A lack of clear goals and processes, roles, and differential treatment of evidence in PPE served to minimize the importance of patient experiences and to displace their validity. An acknowledgment of conflicts between multiple epistemic traditions at work within HTA activities may strengthen organizational approaches to PPE. CONCLUSION: HTA organizations can learn from this study by reflecting on the challenges described and the recommendations offered to address them. We suggest solidifying CADTH's commitment to PPE with clear agency-wide roles and direction, values, and outcomes, a comprehensive framework, and policy and procedures. An acknowledgment of diverse epistemic traditions, as well as leadership and expertise in PPE, will strengthen CADTH's PPE activities and sustain its leadership position in the HTA field.

Psychosocial Correlates and Consequences of Adolescents' Self-Generated Academic Goals and Appraisals.

The current study examined whether characteristics of adolescents (i.e., externalizing problems) and their environments (i.e., social support, adverse childhood experiences) relate to academic goal setting, appraisals, and outcomes. Adolescents (n = 99; 87% Black/African American) 13-16 years old completed baseline interviews, and 80% also completed follow-up interviews. Adolescents with more externalizing problems set fewer academic goals, and youth with social networks characterized by greater support (and less strain) appraised their academic goals as more supported and achievable. Adolescents' appraisals of their academic goals, but not how many academic goals they had, predicted grades at follow-up. Increasing social support (and reducing social strain) may foster adolescents' positive appraisals of their academic goals, which may promote academic achievement.

GRADE Guidelines 30: the GRADE approach to assessing the certainty of modeled evidence-An overview in the context of health decision-making.

OBJECTIVES: The objective of the study is to present the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) conceptual approach to the assessment of certainty of evidence from modeling studies (i.e., certainty associated with model outputs). STUDY DESIGN AND SETTING: Expert consultations and an international multidisciplinary workshop informed development of a conceptual approach to assessing the certainty of evidence from models within the context of systematic reviews, health technology assessments, and health care decisions. The discussions also clarified selected concepts and terminology used in the GRADE approach and by the modeling community. Feedback from experts in a broad range of modeling and health care disciplines addressed the content validity of the approach. RESULTS: Workshop participants agreed that the domains determining the certainty of evidence previously identified in the GRADE approach (risk of bias, indirectness, inconsistency, imprecision, reporting bias, magnitude of an effect, dose-response relation, and the direction of residual confounding) also apply when assessing the certainty of evidence from models. The assessment depends on the nature of model inputs and the model itself and on whether one is evaluating evidence from a single model or multiple models. We propose a framework for selecting the best available evidence from models: 1) developing de novo, a model specific to the situation of interest, 2) identifying an existing model, the outputs of which provide the highest certainty evidence for the situation of interest, either "off-the-shelf" or after adaptation, and 3) using outputs from multiple models. We also present a summary of preferred terminology to facilitate communication among modeling and health care disciplines. CONCLUSION: This conceptual GRADE approach provides a framework for using evidence from models in health decision-making and the assessment of certainty of evidence from a model or models. The GRADE Working Group and the modeling community are currently developing the detailed methods and related guidance for assessing specific domains determining the certainty of evidence from models across health care-related disciplines (e.g., therapeutic decision-making, toxicology, environmental health, and health economics).

Prepubertal Internalizing Symptoms and Timing of Puberty Onset in Girls.

Stressful environments have been associated with earlier menarche. We hypothesized that anxiety, and possibly other internalizing symptoms, are also associated with earlier puberty in girls. The Lessons in Epidemiology and Genetics of Adult Cancer From Youth (LEGACY) Girls Study (2011-2016) included 1,040 girls aged 6-13 years at recruitment whose growth and development were assessed every 6 months. Prepubertal maternal reports of daughter's internalizing symptoms were available for breast onset (n = 447), pubic hair onset (n = 456), and menarche (n = 681). Using Cox proportional hazard regression, we estimated prospective hazard ratios and 95% confidence intervals for the relationship between 1 standard deviation of the percentiles of prepubertal anxiety, depression, and somatization symptoms and the timing of each pubertal outcome. Multivariable models included age, race/ethnicity, study center, maternal education, body mass index percentile, and family history of breast cancer. Additional models included maternal self-reported anxiety. A 1-standard deviation increase in maternally reported anxiety in girls at baseline was associated with earlier subsequent onset of breast (hazard ratio (HR) = 1.22, 95% confidence interval (CI): 1.09, 1.36) and pubic hair (HR = 1.15, 95% CI: 1.01, 1.30) development, but not menarche (HR = 0.94, 95% CI: 0.83, 1.07). The association of anxiety with earlier breast development persisted after adjustment for maternal anxiety. Increased anxiety in young girls may indicate risk for earlier pubertal onset.

When are Pharmaceuticals Priced Fairly? An Alternative Risk-Sharing Model for Pharmaceutical Pricing.

The most common solutions to the problem of high pharmaceutical prices have taken the form of regulations, price negotiations, or changes in drug coverage by insurers. These measures for the most part transfer the burden of drug expenditures between pharmaceutical companies and payers or between payers. The aim of this study is to propose an alternative model for the relationship between the main stakeholders (the pharmaceutical companies, third party payers, and the public) involved in the price setting and purchasing of pharmaceuticals, one that encourages a more cooperative approach. We draw from principles of ethics and health economics and apply them to the context of the pharmaceutical industry. The model prioritises two objectives, (1) to make drugs financially accessible to the patients who need them, and (2) to keep pharmaceutical companies viable and profitable. It is centered around the sharing of financial risk between the main stakeholders, which we describe as 'enlightened risk sharing'. After establishing the foundations of this model, we expand on the type of policies that can follow these principles with current day examples.

Randomized Study of Providing Evidence Context to Mitigate Physician Misinterpretation Arising From Off-Label Drug Promotion.

BACKGROUND: Recent court decisions have thrown into question the Food and Drug Administration's rules limiting manufacturer promotion of prescription drugs for unapproved uses. We assessed how providing pro forma disclosures or more descriptive evidence context about the data supporting an off-label claim affected physicians' beliefs about drug efficacy. METHODS AND RESULTS: In online and mailed surveys, we randomized national samples of board-certified, clinically active cardiologists, internists, and endocrinologists to receive 1 of 3 information scenarios about a hypothetical drug derived verbatim from excerpts on the website for Vascepa, a prescription fish oil for which Food and Drug Administration specially permitted off-label promotion after a manufacturer lawsuit. The scenarios presented information about the approved on-label indication (severe hypertriglyceridemia), off-label claim + pro forma disclaimers (suggestive but not conclusive evidence for use as an add-on to a statin for patients reaching low-density lipoprotein goal but with persistent moderate hypertriglyceridemia), and off-label claim + evidence context (eg, reports on 3 trials failing to demonstrate cardiovascular benefit of other triglyceride-lowering drugs for such patients). Among 686 respondents (48% response rate), 29% reported receiving off-label information about Vascepa (ie, use as an add-on to a statin) from the manufacturer, and 16% had prescribed it off-label for this purpose. Off-label prescribing was 5 times higher among physicians who received such off-label information (38% versus 7%, P<0.001). For the hypothetical drug, the proportion of physicians endorsing the unproven claim that the drug reduced cardiovascular risk was similar among those randomized to the on-label and off-label claim + pro forma disclaimers scenarios (35% versus 37% [95% CI, -6% to 11%]), but substantially lower among those randomized to the off-label claim + evidence context scenario (21% [95% CI, -24% to 7%]). CONCLUSIONS: Physicians who received company information about the unapproved use of Vascepa were more likely to report prescribing it off-label. Supplementing off-label claims with evidence context improved the prescribers' knowledge and reduced enthusiasm for the unproven, off-label indication of reducing cardiovascular risk.

Health Technology Agency insights: informing modification of a qualitative benefit risk framework for Health Technology Reassessment of prescription medications.

OBJECTIVES: This study's intent was to determine if a qualitative benefit risk framework could be used or modified to further enable Health Technology Reassessment (HTR) of prescription medicine recommendations. The purpose of this research was to understand Canadian Health Technology Agency assessors past experiences and insights to inform any modifications to the Universal Methodology for Benefit-Risk Assessment (UMBRA) qualitative framework. The UMBRA framework consists of an eight-step process, used during the assessment phase, to aid in decision making and dissemination. METHODS: A qualitative descriptive study was conducted and included a purposeful, criterion-based sample of eight assessors who had participated in Health Technology Assessment (HTA) or HTR for prescription medicines or in qualitative decision-making frameworks. RESULTS: Participant interviews lead to four common themes: "adoption of a qualitative benefit risk framework," "data (either too much or not enough)," "importance of incorporating stakeholder values," and "feasibility of the UMBRA framework." Methodological challenges with HTR were highlighted including the lack of clinical outcome data and the ability to compare clinically relevant meaningful differences. The implementation of a ranking or weighing process found within the UMBRA framework was not favored by half of the participants. CONCLUSIONS: Research participants did not consider all steps of the UMBRA framework to be transferable to the assessment phase of HTR given the need for simplicity, resource efficiency, and stakeholder input throughout the process. The assessor experiences and insights and the resultant key themes can be used in future research to aid in the development of a qualitative recommendation framework for HTR.

Ethical Challenges Related to Patient Involvement in Health Technology Assessment.

Including information and values from patients in HTA has the potential to improve both the process and outcomes of health technology policy decisions. Accordingly, funding and structural incentives to include patients in HTA activities have increased over the past several years. Unfortunately, these incentives have not yet been accompanied by a corresponding increase in resources, time, or commitment to responsiveness. In this Perspectives piece, we reflect on our collective experiences participating in, conducting, and overseeing patient engagement activities within HTA to highlight the ethical challenges associated with this area of activity. While we remain committed to the idea that patient engagement activities strengthen the findings, relevance, and legitimacy of health technology policy, we are deeply concerned about the potential for these activities to do ethical harm. We use this analysis to call for action to introduce strong protections against ethical violations that may harm patients participating in HTA engagement activities.

Transitional care practices, services, and delivery in childhood cancer survivor programs: A survey study of U.S. survivorship providers.

PURPOSE: There are limited reports describing transition of young adult childhood cancer survivors (CCS) from pediatric to adult-focused survivorship care. The purpose of this study was to characterize current transitional care practices in the United States. PROJECT DESCRIPTION: An online survey was sent to one preselected respondent at 163 Children's Oncology Group member institutions in the United States. Data were collected about (i) the availability and type of long-term follow-up services for adult CCS and (ii) policies and procedures for transitioning. Logistic regression was used to evaluate factors related to care for CCS. RESULTS: The response rate was 60% (97/163). Eighty-one respondents (84%) represented centers with specialized pediatric-focused CCS programs. Thirty-nine percent (38/97) of programs delivered specialized transitional care for adult CCS. Adult-centered care was delivered in both pediatric (39%, 15/38) and adult oncology clinics (39%, 15/38). The most common perceived transition barriers were lack of available partnering adult providers and adult providers' lack of knowledge regarding CCS. The larger the program in terms of new diagnoses, the more likely they were to offer formal transitional care (<50 vs >200: odds ratios [OR] 20.0; 95% CI 3.2, 100.0, P = 0.004). CONCLUSIONS: A variety of models are utilized for delivering care to adult CCS. Our results suggest that interventions to establish effective partnerships with adult providers on appropriate care of CCS may facilitate expanded availability of these services.