CONCLUSIONS In the absence of definitive regulatory guidance, this report provides a considered approach to compiling a comprehensive body of evidence to justify acceptance of mobile sensors for support of new drug applications. INTRODUCTION When the Centers for Medicare and Medicaid Services announced coverage for low dose CT lung cancer screening, they also mandated that imaging centers offer smoking cessation services. We designed the Optimizing Lung Screening (OaSiS) trial to evaluate strategies to implement the Public Health Service Guidelines for Treating Tobacco Use and Dependence during CT screening for lung cancer. METHODS AND DESIGN OaSiS was implemented using a pragmatic effectiveness-implementation hybrid design in 26 imaging clinics across the United States affiliated with the National Cancer Institute's National Community Oncology Research Program (NCORP). The 26 sites selected for participation in the OaSiS trial were randomized to receive either a compendium of implementation strategies to add or enhance smoking cessation services during lung screening or to usual care. Usual care sites were given the option to receive the full compendium of implementation strategies at the conclusion of data collection. We have evaluated both the effectiveness of the implementation strategies to improve smoking cessation at six months among patients undergoing LDCT screening as well as the adoption and sustainability of evidence-based tobacco cessation strategies in imaging clinics. DISCUSSION The OaSiS trial was designed to identify opportunities for implementing evidence-based smoking cessation into LDCT lung cancer screening imaging facilities and to establish the effectiveness of these services. We report our study design and evaluation, including strengths of the pragmatic design and the inclusion of a diverse range of screening programs. Establishing these tobacco cessation services will be critical to reducing smoking related morbidity and mortality. Anxiety disorders (generalized anxiety disorder, social anxiety disorder, panic disorder, and agoraphobia) are common, distressing, and impairing. While pharmacotherapy and psychotherapy are first-line treatment strategies for anxiety disorders, many patients are reluctant to take psychiatric medication, and many prefer to avoid any kind of mental health treatment due to stigma or distrust of traditional medical care. We present the trial protocol for the first study comparing first-line medication treatment with Mindfulness-Based Stress Reduction (MBSR), a popular mindfulness meditation training program, for the treatment of anxiety disorders. We will use a non-inferiority, comparative effectiveness trial design, in which individuals with diagnosed anxiety disorders will be randomized to either pharmacotherapy with escitalopram or MBSR for 8 weeks of treatment. Treatment outcome will be based on gold standard symptom severity measures assessed by trained independent evaluators blind to treatment allocation. Secondary outcomes will include key symptom and function measures, as well as tolerability and satisfaction with treatment. Findings will provide crucial information to inform decision making about the relative benefits of MBSR versus a first line medication for anxiety disorders by patients, medical care providers, healthcare insurers and other stakeholders. Diabetes prevalence has risen rapidly and has become a global health challenge. The Diabetes Prevention Program (DPP) has been shown to prevent or delay the development of diabetes among individuals with prediabetes. Yet, diabetes prevention studies within the Medicaid population are limited and results are mixed. This study aimed to evaluate the impact of different financial incentive strategies on the utilization of the DPP for Medicaid managed care adults in New York State. A four-arm randomized controlled trial was conducted among Medicaid managed care adult enrollees diagnosed with prediabetes and/or obesity. Study participants were offered a 16-week DPP with various incentive strategies based on class attendance and weight loss as follows Attendance-Only, Weight-Loss Only, and both Attendance and Weight-Loss. A control group was offered DPP with no incentives for attendance or weight loss. We evaluated the impact of incentives on achievement of the program completion and weight-loss milestone. Participants who received incentives for the Attendance-Only class were least likely to be lost to follow-up, more likely to complete the program, and had two times higher percentage of meeting the weight-loss milestone compared to the control group. Results for the other incentive cohorts were mixed. A strong positive association was observed for participants who attended 9 or more classes and weight-loss regardless of incentive strategies. Providing monetary incentives for DPP class attendance had a positive impact on program completion and achieving the weight-loss milestone. However, the results from this study indicate that participant enrollment and retention remained challenges despite the incentives. Published by Elsevier Inc.Alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) are two prevalent psychiatric conditions in the U.S. The co-occurrence of AUD and PTSD is also common, and associated with a more severe clinical presentation and worse treatment outcomes across the biopsychosocial spectrum (e.g., social and vocational functioning, physical health) as compared to either disorder alone.  https://www.selleckchem.com/products/tolebrutinib-sar442168.html  Despite the high co-occurrence and negative outcomes, research on effective medications for AUD/PTSD is sparse and there is little empirical evidence to guide treatment decisions. The study described in this paper addresses this knowledge gap by testing the efficacy of N-acetylcysteine (NAC) in reducing alcohol use and PTSD symptoms. Animal studies and prior clinical research suggest a role for NAC in the treatment of substance use disorders and PTSD via glutamate modulation. NAC is a cysteine pro-drug that stimulates the cystine-glutamate exchanger, normalizes glial glutamate transporters, and restores glutamatergic tone on presynaptic receptors in reward regions of the brain.