Streamlining the institutional review board process in pragmatic randomized clinical trials: challenges and lessons learned from the Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE) trial.

BACKGROUND: New considerations during the ethical review processes may emerge from innovative, yet unfamiliar operational methods enabled in pragmatic randomized controlled trials (RCT), potentially making institutional review board (IRB) evaluation more complex. In this manuscript, key components of the pragmatic "Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE)" randomized trial that required a reappraisal of the IRB submission, review, and approval processes are discussed. MAIN TEXT: ADAPTABLE is a pragmatic, multicenter, open-label RCT evaluating the comparative effectiveness of two doses of aspirin widely used for secondary prevention (81 mg and 325 mg) in 15,000 patients with an established history of atherosclerotic cardiovascular disease. The electronic informed consent form is completed online by the participants at the time of enrollment, and endpoint ascertainment is conducted through queries of electronic health records. IRB challenges encountered regarding centralized IRB evaluation, electronic informed consent, patient engagement, and risk determination in ADAPTABLE are described in this manuscript. The experience of ADAPTABLE encapsulates how pragmatic protocol components intended to facilitate the study conduct have been tempered by unexpected, yet justified concerns raised by local IRBs. How the lessons learned can be applied to future similar pragmatic trials is delineated. CONCLUSION: Development of engaging communication channels between IRB and study personnel in pragmatic randomized trials as early as at the time of protocol design allows to reduce issues with IRB approval. Integrations of the lessons learned in ADAPTABLE regarding the IRB process for centralized IRBs, informed consent, patient engagement, and risk determination can be emulated and will be instrumental in future pragmatic studies.

Engaging Stakeholders to Develop a Patient-centered Research Agenda: Lessons Learned From the Research Action for Health Network (REACHnet).

BACKGROUND: Patient-centered research requires a focus on the needs and priorities of patients. Because patient engagement can result in the discovery of important topics not currently prioritized by research programs, topic generation, and prioritization activities conducted with patients, caregivers, and other stakeholders are essential. To develop patient-centered research agendas for obesity and diabetes, the Research Action for Health Network conducted topic generation and prioritization activities with multistakeholder research advisory groups. OBJECTIVES: The purpose of this case study was to demonstrate how methods for engaging patients in topic generation and prioritization can be implemented in practice for the development of a patient-centered research agenda. RESEARCH DESIGN: Four multistakeholder groups comprising patients, clinicians, and researchers met 4-5 times between November 2014 and July 2015 to generate and prioritize topics for obesity and diabetes research. Topics were prioritized using an iterative engagement process, in which themes were identified and resulting topics were refined and ranked over multiple meetings. PARTICIPANTS: Sixty-four patients, clinicians, and researchers participated in 2 obesity and 2 diabetes advisory groups. The majority of participants (64.0%) were patients, followed by clinicians (23.4%), researchers (9.4%), and parents of children with diabetes (3.1%). RESULTS: Ten and 12 priority topics were identified for obesity and diabetes, respectively. The resulting research agendas were disseminated to patients, researchers, and clinicians. CONCLUSIONS: Patient engagement has the potential to enrich our understanding of patient priorities for research. The results from this process suggest that convening in-person multistakeholder groups can be an effective way to generate research topics that reflect patients' priorities. Engagement strategies should be focused not only on the development of patient-centered research topics but also on the implementation of these topics into research studies.

School Lunch Consumption Among 3 Food Service Providers in New Orleans.

BACKGROUND: Louisiana has one of the highest rates of overweight and obese children in the United States. The Healthy School Food Collaborative (HSFC) was created to allow New Orleans's schools to select their own healthy school Food Service Provider (FSP) with requirements for higher nutritional standards than traditional options. The goal of this cross-sectional study was to examine whether HSFC membership was associated with lunch consumption rates in elementary school children. METHODS: An 8-week plate waste study examining 18,070 trays of food among fourth and fifth graders was conducted. Participants included 7 schools and the 3 FSPs (2 HSFC and 1 non-HSFC member) that serviced them. Mixed models analysis examined whether consumption rates of food items differed among FSPs. RESULTS: On average, students consumed 307 cal during lunch. Analyses showed significant differences in consumption rates of entrée, vegetables, fruit, and milk between the 3 FSPs (p < .01). The highest consumption rate was among entrées at 65%. One HSFC provider had consumption levels consistent with the non-HSFC FSP. CONCLUSIONS: Overall, students consumed less than 60% of the US Department of Agriculture recommended calories for school lunch. While overall caloric consumption was higher among the non-HSFC schools, interventions to increase lunch consumption across all schools are needed.

Tobacco Policies in Louisiana: Recommendations for Future Tobacco Control Investment from SimSmoke, a Policy Simulation Model.

Despite the presence of tobacco control policies, Louisiana continues to experience a high smoking burden and elevated smoking-attributable deaths. The SimSmoke model provides projections of these health outcomes in the face of existing and expanded (simulated) tobacco control polices. The SimSmoke model utilizes population data, smoking rates, and various tobacco control policy measures from Louisiana to predict smoking prevalence and smoking-attributable deaths. The model begins in 1993 and estimates are projected through 2054. The model is validated against existing Louisiana smoking prevalence data. The most powerful individual policy measure for reducing smoking prevalence is cigarette excise tax. However, a comprehensive cessation treatment policy is predicted to save the most lives. A combination of tobacco control policies provides the greatest reduction in smoking prevalence and smoking-attributable deaths. The existing Louisiana excise tax ranks as one of the lowest in the country and the legislature is against further increases. Alternative policy measures aimed at lowering prevalence and attributable deaths are: cessation treatments, comprehensive smoke-free policies, and limiting youth access. These three policies have a substantial effect on smoking prevalence and attributable deaths and are likely to encounter more favor in the Louisiana legislature than increasing the state excise tax.