A systematic review of the real-world effectiveness and economic and humanistic outcomes of selected oral antipsychotics among patients with schizophrenia in the United States: Updating the evidence and gaps.

BACKGROUND: Schizophrenia is a chronic, relapsing, and burdensome psychiatric disorder affecting approximately 0.25%-0.6% of the US population. Oral antipsychotic treatment (OAT) remains the cornerstone for managing schizophrenia. However, nonadherence and high treatment failure lead to increased disease burden and medical spending. Cost-effective management of schizophrenia requires understanding the value of current therapies to facilitate better planning of management policies while addressing unmet needs. OBJECTIVE: To review existing evidence and gaps regarding real-world effectiveness and economic and humanistic outcomes of OATs, including asenapine, brexpiprazole, cariprazine, iloperidone, lumateperone, lurasidone, olanzapine/samidorphan, paliperidone, and quetiapine. METHODS: We conducted a literature search using PubMed, American Psychological Association PsycINFO (EBSCOhost), and the Cumulative Index of Nursing and Allied Health Literature from January 2010 to March 2022 as per Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. English-language articles describing adults with schizophrenia receiving at least 1 of the selected OATs and reporting real-world effectiveness, direct or indirect costs, humanistic outcomes, behavioral outcomes, adherence/persistence patterns, or product switching were identified. RESULTS: We identified 25 studies from a total of 24,190 articles. Real-world effectiveness, cost, and adherence/persistence outcomes were reported for most OATs that were selected. Humanistic outcomes and product switching were reported only for lurasidone. Behavioral outcomes (eg, interpersonal relations and suicide ideation) were not reported for any OAT. The key economic outcomes across studies were incremental cost-effectiveness ratios, cost per quality-adjusted life-years, and health care costs. In studies that compared long-acting injectables (LAIs) with OATs, LAIs had a higher pharmacy and lower medical costs, while total health care cost was similar between LAIs and OATs. Indirect costs associated with presenteeism, absenteeism, or work productivity were not reported for any of the selected OATs. Overall, patients had poor adherence to OATs, ranging between 20% and 61% across studies. Product switching did not impact the all-cause health care costs before and after treatment. CONCLUSIONS: Our findings showed considerable gaps exist for evidence on behavioral outcomes, humanistic outcomes, medication switching, and adherence/persistence across OATs. Our findings also suggest an unmet need regarding treatment nonadherence and lack of persistence among patients receiving OATs. We identified a need for research addressing OATs' behavioral and humanistic outcomes and evaluating the impact of product switching in adults with schizophrenia in the United States, which could assist clinicians in promoting patient-centered care and help payers understand the total value of new antipsychotic drugs.

Implementation of an evidence-based tobacco control intervention for school teachers in India: Evaluating the effects of a capacity-building strategy.

Background: Tobacco-Free Teachers, Tobacco-Free Society (TFT-TFS) is an evidence-based intervention that promotes tobacco use cessation among teachers and tobacco control policies among schools in India. This study tested an implementation model to build Bihar Department of Education (DOE) capacity to support and deliver TFT-TFS within schools, leveraging DOE training infrastructure. Method: We used a training-of-trainers (TOT) "cascade" implementation strategy to embed the TFT-TFS program into the Bihar DOE infrastructure. We trained 46 Cluster Coordinators to train and support Headmasters to implement TFT-TFS in their schools over one academic year. We selected three school districts, representing approximately 46 clusters and 219 schools. We used the RE-AIM framework to assess program adoption (Headmaster participation in at least one of six TFT-TFS trainings), implementation (of four core program components), and reach (teachers' participation in three or more group discussions). Using a non-inferiority design, we hypothesized that program adoption, implementation, and reach would not be inferior to the high standards demonstrated when TFT-TFS was originally tested in the Bihar School Teachers Study. We used self-reported checklists to measure outcomes and SPSS Version 25 to analyze data. Results: For adoption, 94% of Headmasters attended the first training, although participation declined by the sixth training. Among the 112 schools out of 219 with complete Headmaster checklist data, all met our minimum criteria for implementing TFT-TFS. Over 99% of schools posted a school tobacco control policy and distributed quit booklets. However, only 69% of schools met our criteria for program reach. Conclusions: This study outlines the processes for taking a tobacco control intervention to scale and implementing it through the Bihar DOE infrastructure. These findings provide a foundation for other Indian states and low- and middle-income countries to implement tobacco control and other health programs for schoolteachers. Trial registration: NCT05346991. Plain Language Summary: Each year in India, more than 1.2 million people die from tobacco-related causes, and India has the world's highest oral cancer burden. The world needs more evidence on how to bring cost-effective tobacco control interventions to scale, especially in low- and middle-income countries (LMICs). To address this gap, from 2017 to 2021, we examined the process of scaling up Tobacco-Free Teachers, Tobacco-Free Society (TFT-TFS), an evidence-based intervention promoting tobacco use cessation among teachers and tobacco control policies in schools. Our study tested an implementation model aimed at building the Bihar State Department of Education (DOE) capacity to support and deliver TFT-TFS. We used a training-of-trainers model to embed TFT-TFS into Bihar DOE infrastructure, training 46 Cluster Coordinators to in turn train and support Headmasters to implement TFT-TFS over one academic year. We hypothesized that program adoption, implementation, and reach would not be inferior to the high standards demonstrated when we originally tested TFT-TFS through the Bihar School Teachers Study (2013-2017). For adoption, 94% of Headmasters attended the first training, although participation declined by the sixth training. Of 112 schools (out of 219 with complete Headmaster checklist data), all met our minimum criteria for implementing TFT-TFS. Over 99% of schools posted a school tobacco control policy and distributed quit booklets. However, only 69% of schools met our criteria for program reach. Study findings offer other Indian states and LMICs lessons to implement tobacco control and other health programs for schoolteachers within educational systems.

Neighbourhood tobacco retail access and tobacco use susceptibility in young adolescents in urban India.

BACKGROUND: Neighbourhood tobacco retail access may influence adolescent tobacco use. In India, we examined the association between neighbourhood tobacco retail access and cognitive risks for tobacco use during early adolescence. METHODS: In 2019-2020, a population-based sample (n=1759) of adolescents aged 13-15 years was surveyed from 52 neighbourhoods in Mumbai and Kolkata. Neighbourhood tobacco retail access was measured as the frequency of visits to tobacco retailers, mapped tobacco retailer density and perceived tobacco retailer density. We estimated associations between neighbourhood tobacco retail access and cognitive risks for tobacco use (perceived ease of access to tobacco, perceived peer tobacco use and intention to use tobacco). RESULTS: There was high neighbourhood tobacco retail access. Tobacco retailer density was higher in lower income neighbourhoods (p<0.001). Adolescent frequency of tobacco retailer visits was positively associated with cognitive tobacco use risks. Mapped tobacco retailer density was associated with perceived ease of access in Kolkata but not in Mumbai, and it was not associated with perceived peer tobacco use nor intention. Perceived tobacco retailer density was associated with perceived ease of access and perceived peer use, but not with intention. In Kolkata, higher perceived retailer density and frequency of tobacco retailer visits were negatively associated with perceived ease of access. CONCLUSIONS: Efforts to reduce neighbourhood tobacco retail access in India may reduce cognitive tobacco use risk factors in young adolescents. The frequency of tobacco retailer visits and perceived tobacco retailer density increased cognitive risks, though there were some exceptions in Kolkata that further research may explain.

Key Drivers to Implement an Evidence-based Tobacco Control Programme in Schools of India: A Mixed-Methods Study.

BACKGROUND: Adolescence is an influential stage in students' lives when lifelong behaviours such as tobacco use are formed. During these years, school teachers are important role models for tobacco control among students. A study was conducted among school personnel and administrators to understand the key drivers for implementing an evidence-based school tobacco control program. METHODOLOGY: A cross-sectional, mixed-method study was conducted in five districts of Assam, India. The quantitative study was conducted among 565 school personnel across 40 Government-aided schools. Data was collected by means of an anonymous, self-administered questionnaire. Qualitative data was generated from 15 focus group discussions (FGDs) among 146 participants - District Program Officers, Block Education Officers, Cluster Coordinators, Headmasters and Teachers. RESULTS: While the prevalence of smoked tobacco was low (3%), the use of smokeless tobacco was higher (40%), and the prevalence of use of areca nut without tobacco (65%) was still higher among school personnel. They were aware of the school policies prohibiting the use of tobacco among students within or outside school buildings or during school-sponsored activities (81%); they had rather limited knowledge about policy for themselves (58%). There was lack of access to training materials about prevention of tobacco use among youth. The FGDs amongst school personnel resulted in several constructive suggestions on tobacco control in schools mainly in training school teachers, monitoring the program and incentives for execution of the program. However, there was a reluctance to implement a smokeless tobacco control programme since many were current users of smokeless tobacco and areca nut. CONCLUSION: Tobacco control policies as well as training school personnel in schools need to improve and further measures must be taken to prohibit use of areca nut, which contains carcinogens. The existing system of the education department can be utilised to implement tobacco control programmes effectively.

Observed Circumvention of the Gutka Smokeless Tobacco Ban in Mumbai, India.

OBJECTIVES: Gutka is industrially manufactured in India and some Indian states have instituted bans on the sale of manufactured gutka as a public health initiative. We explored whether gutka was still available for purchase after the ban and also sought to observe methods of ban circumvention. METHODS: We visited 5 different markets at different locations separated by at least 15-20 km around the Mumbai Metropolitan Region (MMR) area, consisting of Mumbai and its satellite towns in Maharashtra, India during August- September, 2019. In each location, purveyors were queried as to the availability of gutka. RESULTS: Tobacco purchases were made in 5 locations/sections of MMR. At all markets, banned gutka was not displayed , and could only be purchased after requesting from the shopkeeper. Three methods of ban circumvention were observed: (1) packages marked 'export only'; (2) use of twin packaging in which pan masala and tobacco are sold together for immediate mixing to create gutka; and, (3) non-descript packaging without mention of 'gutka'. CONCLUSIONS: Although not readily displayed in shops, gutka is readily available in MMR, despite a statewide ban in Maharashtra. Marketers have used multiple methods to circumvent the statewide gutka ban.

Longitudinal study of adolescent tobacco use and tobacco control policies in India.

BACKGROUND: This project will use a multilevel longitudinal cohort study design to assess whether changes in Community Tobacco Environmental (CTE) factors, measured as community compliance with tobacco control policies and community density of tobacco vendors and tobacco advertisements, are associated with adolescent tobacco use in urban India. India's tobacco control policies regulate secondhand smoke exposure, access to tobacco products and exposure to tobacco marketing. Research data about the association between community level compliance with tobacco control policies and youth tobacco use are largely unavailable, and are needed to inform policy enforcement, implementation and development. METHODS: The geographic scope will include Mumbai and Kolkata, India. The study protocol calls for an annual comprehensive longitudinal population-based tobacco use risk and protective factors survey in a cohort of 1820 adolescents ages 12-14 years (and their parent) from baseline (Wave 1) to 36-month follow-up (Wave 4). Geographic Information Systems data collection will be used to map tobacco vendors, tobacco advertisements, availability of e-cigarettes, COTPA defined public places, and compliance with tobacco sale, point-of-sale and smoke-free laws. Finally, we will estimate the longitudinal associations between CTE factors and adolescent tobacco use, and assess whether the associations are moderated by family level factors, and mediated by individual level factors. DISCUSSION: India experiences a high burden of disease and mortality from tobacco use. To address this burden, significant long-term prevention and control activities need to include the joint impact of policy, community and family factors on adolescent tobacco use onset. The findings from this study can be used to guide the development and implementation of future tobacco control policy designed to minimize adolescent tobacco use.

Comparison of charges and resource use associated with saxagliptin and sitagliptin.

OBJECTIVES: Saxagliptin and sitagliptin are two commonly used dipeptidyl peptidase-4 (DPP-4) inhibitors. Little is known about their comparative effectiveness in the real world, particularly their impact on cost and resources use. The objective of this study was to analyze charges and resource use associated with saxagliptin and sitagliptin to understand the impact of these DPP-4 inhibitor treatment options in a real-world setting. METHODS: This was a retrospective, new-user study approved by the Institutional Review Board at the University of Toledo. Data were collected from a US insurance claims dataset (OptumInsight) for patients newly initiating treatment with saxagliptin or sitagliptin between January 1, 2010 and December 31, 2011. ICD-9 code 250 was used to identify patients with T2D. Overall and diabetes-related medical and pharmacy charges were observed. Inpatient hospitalizations were also compared. Propensity score matching was used to balance the cohorts of patients prescribed saxagliptin and sitagliptin. Appropriate univariate statistical tests were applied to the propensity-matched sample to examine differences in resource utilization outcomes. Statistical significance was evaluated at P < 0.05. RESULT: After the propensity score matching, each cohort included 7711 patients. Saxagliptin treatment was associated with lower overall charges ($13,292 vs $14,032; P = 0.0023) and overall medical charges ($9,540 vs $10,296; P = 0.0024) during the 6-month follow-up period compared with sitagliptin treatment. No significant differences were observed in the overall pharmacy charges ($3,751 vs $3,753; P = 0.6937) and the diabetes-related charges ($5,141 vs $5,232; P = 0.2957). All-cause and diabetes-related inpatient hospitalization rates were significantly lower with saxagliptin treatment (p = 0.0001 and p = 0.0019, respectively). All-caused inpatient charges were also significantly lower with saxagliptin ($2,917.26 vs $3445.89; P < 0.0001). CONCLUSION: Compared with patients initiating sitagliptin treatment, patients initiating saxagliptin treatment reported lower overall and medical charges and lower overall and diabetes-related hospitalization rates. These findings may aid payers in managing patients with T2D.