Social influence and advocacy pathways during a web-based program for adolescent smoking prevention.

Introduction: Exposure to smokers has been identified as a predictor of adolescent tobacco use. Conversely, adolescents who tend to be advocates against smoking may become less likely to initiate smoking themselves. Several digital tobacco prevention programs have been developed to include social strategies. This study aimed to identify (1) whether programs can motivate adolescents to become advocates against smoking, and (2) if being an advocate against smoking and exposure to friends who smoke can predict smoking while controlling for a program's effect. Methods: We conducted a non-prespecified secondary analysis using data from a randomized controlled trial (RCT) with 18-month follow-up. High schools were randomized to either receive ASPIRE or a tobacco education booklet. We conducted a cross-lagged linear path model to allow for reciprocal associations, estimating a two-time-points, three-variable panel model with logistic regression. Results: Receiving ASPIRE was associated with a lower likelihood of smoking, but it did not predict becoming an advocate against smoking or changing adolescents' proportion of friends who smoke. After controlling for the effect of ASPIRE, the study shows that adolescents who were advocates against smoking had a decreased risk of smoking by follow-up, and smoking at baseline significantly predicted having a higher proportion of friends who smoke at follow-up. Discussion: Being an advocate against smoking can be a key predictor of lower odds of smoking, even when controlling for an individual-based intervention. Future research can study the mechanisms and long-term effects of advocacy and incorporate social strategies that can leverage social networks for tobacco prevention.

Identifying adolescents' gaming preferences for a tobacco prevention social game: A qualitative study.

INTRODUCTION: Considering the dangers of adolescent tobacco use, the successful design of behavioral programs is crucial for tobacco prevention. According to preliminary research, social game interventions can improve adolescent tobacco outcomes. The current qualitative study aims to (1) uncover the gaming elements that adolescents deem important for a positive learning experience, and (2) confirm these gaming elements with adolescents who are presented with a tobacco prevention game concept that applies these elements. METHODS: Findings from this study are drawn from two phases. Phase 1 involved in-person focus group discussions (n = 15) and Phase 2 included three online focus groups and a paired interview with another set of adolescents (n = 15). The study was conducted under a project that aimed to design and test a social game-based tobacco prevention program for adolescents (Storm-Heroes). With open coding and thematic analysis, two research team members identified repeated topics and relevant quotes to organize them into themes. The themes evolved as new content was identified during the process. This process was repeated until thematic saturation was reached. RESULTS: Thematic analysis across Phase 1 and Phase 2 revealed four major themes: 1) Balance during gaming challenges, 2) Healthy social interaction, 3) Performance and creative freedom, and 4) Fictional world and game mechanics for tobacco prevention. CONCLUSION: This study identified specific intervention features that best fit the needs of adolescents in the context of a social game for tobacco prevention. For future research, we will use a participatory approach to allow adolescents to take part in the design process, improve Storm-Heroes, and develop health promotional messages that can be incorporated into the program. Ultimately, a board game for tobacco prevention is expected to bring adolescents together to create lasting memories that nudge them away from tobacco use and the harm it can cause.

Availability of Investigational Medicines Through the US Food and Drug Administration's Expanded Access and Compassionate Use Programs.

Importance: The Right to Try Act of 2017 allows patients with life-threatening conditions to access investigational medicines outside clinical trials without oversight from the US Food and Drug Administration (FDA). A better understanding of existing expanded access programs can inform the consideration and implementation of both the federal Right to Try Act and state right-to-try laws. Objective: To determine the timing and duration of expanded access programs for investigational medicines initiated prior to FDA approval. Design and Setting: This cross-sectional study examined expanded access and compassionate use programs registered through August 1, 2017, identified from ClinicalTrials.gov and publicly available FDA documents. Main Outcomes and Measures: Start date of each program and 3 key regulatory dates (investigational new drug application activation, initial new drug application submission, and FDA approval), and timing and duration of expanded access availability in relation to new drug application submission and FDA approval. Results: Through ClinicalTrials.gov, 92 FDA-approved drugs and biologics with associated expanded access programs initiated prior to FDA approval were identified. These programs were initiated between September 1996 and June 2017 for medicines that were most commonly used to treat cancer (n = 46 [50.0%]); metabolic, endocrine, and genetic diseases (n = 16 [17.4%]); and infectious diseases (n = 14 [15.2%]). The median (interquartile range) premarket expanded access availability was 10.0 (6.0-19.5) months, constituting a median (interquartile range) of 14% (7%-25%) of the premarket clinical development period (investigational new drug application activation to FDA approval). Of 92 expanded access programs, 64 (69.6%) were initiated just before or after new drug application submission: 24 (26.1%) were initiated during the 6-month period before, and 40 (43.5%) in the 6 months after. Conclusions and Relevance: Over the past 2 decades, expanded access programs have provided access to investigational medicines for which evidence of safety and effectiveness was established. For medicines that ultimately receive FDA approval, these findings suggest that the FDA and pharmaceutical industry have established a balance between investigational new drug access and protection of patients from therapies without established safety. This balance may be compromised by policy makers seeking to speed access to investigational medicines through the Right to Try Act.