Unbiasing costs? An appraisal of economic assessment alongside randomized trials in neonatology.

Economic evaluations performed alongside randomized controlled trials benefit from the protections against bias inherent in randomization. In this systematic review, we assessed the frequency and quality of economic assessments alongside randomized controlled trials of interventions in neonates published between 1990 and 2016. Over that period, 58 economic assessments were published, corresponding to approximately 2% of RCTs. We noted significant methodological limitations of these studies, including limitation of included costs to the health sector or payer rather than broader categories such as family or community expenditures (81%), short time horizon for cost measurement (less than one year in 60%), lack of reporting of uncertainty (26%), and infrequent analysis of costs and effects in a single metric (combined in 45%). Strategies for improving the quality and frequency of economic evaluations in neonatology are discussed, including selection of appropriate trials, funding, and peer review.

Perspectives on fertility preservation and parenthood among transgender youth and their parents.

OBJECTIVE: The aim of this study was to investigate the views of young people (YP) with gender dysphoria and their parents concerning fertility preservation and reproductive and life priorities. DESIGN: A cross-sectional questionnaire-based study assessed knowledge of potential effects of treatments for gender dysphoria on fertility, current and future life priorities and preferences regarding future fertility/parenting options among YP and parents. RESULTS: A total of 79 YP (81% assigned female at birth [AFAB], 19% assigned male at birth [AMAB], aged 12-18 years, 68% between ages 16 years and 18 years) and 73 parents participated. The top current life priority for YP among eight options was being in good health; the least important priority was having children. Anticipated life priorities 10 years from now were ranked similarly. Parents' rankings paralleled the YP responses; however, parents ranked having children as a significantly higher priority for AFAB compared with AMAB YP in 10 years. The majority of YP (66% AFAB, 67% AMAB) want to be a parent in the future. However, most do not envision having a biological child. A large majority (72% AFAB, 80% AMAB) were open to adoption. None of the YP surveyed pursued fertility preservation. CONCLUSION: Fertility is a low current and future life priority for transgender YP. The majority of YP wish to become parents but are open to alternative strategies for building a family. These data may explain in part the reported low rates of fertility preservation among this population. Further studies are needed to assess if life priorities change over time.

Can the Mindful Awareness and Resilience Skills for Adolescents (MARS-A) Program Be Provided Online? Voices from the Youth.

Mindfulness-based interventions (MBIs) have been shown to improve health and well-being in adolescents with chronic illnesses. Because they are most often delivered in person in a group setting, there are several barriers that limit access to MBIs for youth with limited mobility or who cannot access in-person MBIs in their communities. The objective of this study was to determine if eHealth is a viable platform to increase accessibility to MBIs for teens with chronic illnesses. This study reports the qualitative results of a mixed method randomized trial describing the experience of the Mindful Awareness and Resilience Skills for Adolescents (MARS-A) program, an eight-week MBI, delivered either in person or via eHealth. Participants were adolescents between the ages of 13 and 18 with a chronic illness recruited at a tertiary pediatric hospital in Toronto, Canada. Individual semi-structured post-participation audio-video interviews were conducted by a research assistant. A multiple-pass inductive process was used to review interview transcripts and interpret emergent themes from the participants' lived experiences. Fifteen participants (8 online and 7 in person) completed post-participation interviews. Four distinct themes emerged from participants in both groups: Creation of a safe space, fostering peer support and connection, integration of mindfulness skills into daily life, and improved well-being through the application of mindfulness. Direct quotations representative of those four themes are reported. Results from this study suggest that eHealth delivery of an adapted MBI for adolescents with chronic illnesses may be an acceptable and feasible mode of delivery for MBIs in this population. EHealth should be considered in future studies of MBIs for adolescents with chronic illnesses as a promising avenue to increase access to MBIs for youth who might not be able to access in-person programs.

In-Person Versus eHealth Mindfulness-Based Intervention for Adolescents With Chronic Illness: Protocol for a Randomized Controlled Trial.

BACKGROUND: Eight-week mindfulness-based interventions (MBIs) have a beneficial impact on mental health and well-being in adolescents with chronic health conditions. Usually delivered in person in a group setting, these programs are difficult to access for teens with disabilities or who do not have in-person MBIs available in their communities. OBJECTIVE: This paper outlines the rationale, development, and design of a randomized controlled trial comparing the effects of an MBI delivered in person or via eHealth in adolescents with a chronic illness. Quantitative outcomes will include mindfulness skills acquisition (primary outcome), effects of the MBI on self-reported mood, anxiety, self-esteem, illness perception, and physiological stress (via salivary cortisol), and qualitative outcomes will include individual practice, participant appreciation, and adaptation of the MBI for eHealth. METHODS: This is a randomized noninferiority mixed methods study comparing 2 MBI arms: in-person and eHealth. Participants are eligible to participate if they are aged 13 to 18 years, have a diagnosis of chronic medical condition, live close enough to the recruitment hospital to participate in the in-person arm of the study, and are currently followed by a health care provider. Each participant will receive an adapted 8-week MBI delivered either in person at a tertiary pediatric hospital or via a secure audio-visual platform allowing group interactions in real time. Groups will be facilitated by 2 experienced mindfulness providers. Quantitative and qualitative data will be collected through standardized research questionnaires administered via a secure, youth-friendly online platform and through semistructured interviews, participant log books, facilitator log books, and salivary cortisol analysis. Qualitative data will be analyzed using a grounded theory model. RESULTS: Data collection is currently underway. Data analysis, manuscript writing, and additional publications are expected to be completed in the winter and spring of 2018. CONCLUSIONS: Based on previous results from in-person trials conducted in adolescents and eHealth trials conducted in adults, we anticipate that both modes of delivery will significantly improve mindfulness skills acquisition, mood, anxiety, self-esteem, illness perception, and stress and that the magnitude of the effects will be correlated to the level of home practice. We predict that participants in both arms will show similar levels of home practice and that both modes of delivery will have high levels of feasibility and acceptability. If successful, this study could provide evidence for the use of eHealth in the delivery of 8-week MBIs in clinical adolescent populations, potentially increasing availability to MBIs for a large group of youth with mobility issues or living away from large urban centers. TRIAL REGISTRATION: ClinicalTrials.org NCT03067207; https://clinicaltrials.gov/ct2/show/NCT03067207 (archived by WebCite at http://www.webcitation.org/6v4ZK8RBH).