A realist evaluation of the implementation of a national tobacco control program and policy in India.

There is a growing interest in studying and unpacking implementation of policies and programmes as it provides an opportunity to reduce the policy translation time lag taken for research findings to translate to policies and get implemented and understand why policies may fail. Realist evaluation is a theory-driven approach that embraces complexity and helps to identify the mechanisms generating the observed policy outcomes in given context. We aimed to study facilitators and barriers while implementing the Cigarettes and Other Tobacco Products Act, 2003 (COTPA) a comprehensive national tobacco control policy, and the National Tobacco Control Programme (NTCP), 2008 using realist evaluation. We developed an initial program theory (IPT) based on a realist literature review of tobacco control policies in Low- and Middle-Income Countries (LMICs). Three diverse states -Kerala, West Bengal, and Arunachal Pradesh- with varying degree of implementation of tobacco control law and program were chosen as case studies. Within the three selected states, we conducted in-depth interviews with 48 state and district-level stakeholders and undertook non-participant observations to refine the IPT. Following this, we organized two regional consultations covering stakeholders from 20 Indian states for a second iteration to further refine the program theory. A total of 300 Intervention-Context-Actor-Mechanism-Outcome (ICAMO) configurations were developed from the interview data, which were later synthesized into state-specific narrative program theories for Kerala, West Bengal and Arunachal Pradesh. We identified five mechanisms: collective action, felt accountability, individual motivation, fear, and prioritization that were (or were not) triggered leading to diverse implementation outcomes. We identified facilitators and barriers to implementing the COTPA and the NTCP, which have important research and practical implications for furthering the implementation of these policies as well as implementation research in India. In the future, researchers could build on the refined program theory proposed in this study to develop a middle-range theory to explain tobacco control policy implementation in India and other LMICs.

Implementation Strategies for Maternal Near-Miss Case Reviews in LICs and LMICs: A scoping review protocol.

Background: Maternal mortality remains a persistent public health concern despite significant strides in reduction over the past few decades, with a global maternal mortality ratio (MMR) of 223 deaths per 100,000 live births in 2020, indicating a 34.3% decline over 20 years, with Low income countries (LICs) and Lower Middle-Income Countries (LMICs) bearing the major burden. Effective implementation of facility-based near-miss case reviews (NMCR), endorsed by the World Health Organization (WHO), faces challenges hindering progress, making exploring implementation strategies through a scoping review essential. This scoping review aims to identify and characterize implementation strategies employed in Low and Lower Middle- Income Countries to facilitate the implementation of facility-based NMCR. Methods: The scoping review will follow Arksey and O'Malley's methodological framework, involving five stages: identifying the research question, selecting relevant studies, selecting data, charting, and summarizing the results. Electronic databases like PubMed, Embase, Web of Science, EBSCOhost - CINAHL Ultimate, and Ovid MEDLINE will be searched, supplemented by citation tracking. Rayyan will be used to screen and remove duplicates, with data charting conducted using Google Sheets. Two independent reviewers will conduct blinded screening, eligibility assessment, and inclusion phases. Reviewers will conduct Systematic data extraction independently using piloted forms, with discrepancies resolved through team discussion and consensus. Results: The review will identify and characterize implementation strategies employed to facilitate the implementation of facility-based near-miss case reviews in LICs and LMICs. Conclusions: The findings of this review will contribute to the understanding of implementing strategies for facility-based NMCR in LICs and LMICs. The review can help in designing interventions/programs to reduce maternal mortality and knowledge products.

Shifting the gaze on implementation: examining the association between the implementation of tobacco control laws and prevalence of tobacco using data from a nationally representative survey.

BACKGROUND: Tobacco use and the associated health burden is a cause of concern in India and globally. Despite several tobacco control policies in place, their sub-optimal and variable implementation across Indian states has remained a concern. Studies evaluating the real-world implementation of policies such as Cigarettes and Other Tobacco Products (COTPA) or National Tobacco Control Program (NTCP) in India and its association with reductions in tobacco use are limited. In this paper, we analyse data from a nationally representative survey to examine how policy implementation is associated with the tobacco use prevalence in India. METHODS: We analysed data from the Global Adult Tobacco Survey (GATS 2016-17) India using multivariable logistic regression. The dependent variables were the use of smoked tobacco, smokeless tobacco, and tobacco in any form. The independent variables were proxies of implementation of the COTPA and the NTCP. We followed a step-wise backward elimination technique to reach the best fit models. RESULTS: People exposed to no-smoking signages had lower odds of using tobacco (OR = 0.70, p < 0.001). People exposed to second-hand smoke (OR = 1.51, p < 0.001) and tobacco product advertisements (OR = 1.23, p < 0.001) had greater odds of using tobacco. Exposure to tobacco advertisements was associated with higher odds of using smokeless tobacco (OR = 1.23, p < 0.001), and smoked (OR = 1.33, p < 0.001) forms of tobacco. CONCLUSION: We find significant association between the implementation of tobacco control laws/programs and tobacco use in India. Our findings highlight the potential that policy implementation holds in reducing population-level tobacco use thus drawing attention towards the implementation phase of policies. The findings have implications on prioritising enforcement of specific tobacco control measures such as smokefree laws, modifying COTPA signages to encompass all tobacco products including against smokeless tobacco use and strengthening indirect advertising restrictions. Future research could focus on developing and validating predictors specific to policy implementation to support policy evaluation efforts.

How does Indian news media report smokeless tobacco control? A content analysis of the gutka ban enforcement.

Smokeless tobacco (SLT) products like gutka and paan masala are a growing public health crisis in India. Despite enacting a ban-the highest form of regulation-little is known about implementation progress. The purpose of this study was to look at how enforcement of gutka ban is covered in Indian news media and if media is a reliable source of data. We conducted a content analysis of online news reports (n = 192) from 2011 to 2019. News characteristics such as name and type of publication, language, location, slant and beat coverage, visuals, and administrative focus were quantified. Similarly, news contents were inductively coded to examine dominant themes and the implementation landscape. We found that coverage was initially low but increased after 2016. Overall, news reports were in favor of the ban. Five leading English newspapers covered the majority of the ban enforcement reports. Prominent themes like consumption, health hazards, tobacco control responses, impact on livelihoods, and illicit trade were drawn from the textual analysis as the main arguments in relation to the ban. Gutka is largely seen as an issue of crime reflected by the contents, sources, and frequent use of pictures depicting law enforcement. The interconnected distribution channels of the gutka industry hindered enforcement, highlighting the need to study the complexities of regional and local SLT supply chains.

Health technology assessment implementation in WHO South-East Asia Region: a realist review protocol.

Background: A robust Health Technology Assessment (HTA) framework is crucial to address the rising burden of healthcare costs and to inform decision-making to promote high-quality health systems. This research aims to describe the HTA methods and mechanisms for the successful implementation of HTA in the WHO South-East Asia region, and contextualize the synthesized evidence relevant to Indian settings. Methods: Realist review involves developing a program theory by conducting a systematic search strategy, screening, study selection, data extraction, and data synthesis. A systematic search for literature will be conducted on PubMed (NCBI), EMBASE (Elsevier), Scopus (Elsevier), Web of Science (Clarivate), and ProQuest Central for identifying the methods used for HTA of health technology interventions. Stakeholder consultations will be conducted to develop a program theory following the Context-Mechanism-Outcome configurations (CMOcs) framework. Searches for primary evidence will be conducted iteratively. Data will be extracted and tested against the programme theory. The proposed realist review will be reported as per the Realist and MEta-narrative Evidence Syntheses: Evolving Standards [RAMESES II] guidelines. Conclusions: To our knowledge, there has been no comprehensive review conducted to understand the mechanisms of HTA methods in the WHO South-East Asia region. The findings from the realist review will help us understand the mechanisms through which the HTA could work in WHO South-East Asian countries. We will then contextualize the findings obtained from evidence to Indian settings, based on program theory development through stakeholder consultation. A framework will be developed that can be used by policymakers/HTA experts in India for effective implementation of the same.

How do tobacco control policies work in low-income and middle-income countries? A realist synthesis.

BACKGROUND: The burden of tobacco use is disproportionately high in low- and middle-income countries (LMICs). There is scarce theorisation on what works with respect to implementation of tobacco control policies in these settings. Given the complex nature of tobacco control policy implementation, diversity in outcomes of widely implemented policies and the defining role of the context, we conducted a realist synthesis to examine tobacco control policy implementation in LMICs. METHODS: We conducted a systematic realist literature review to test an initial programme theory developed by the research team. We searched EBSCOHost and Web of Science, containing 19 databases. We included studies on implementation of government tobacco control policies in LMICs. RESULTS: We included 47 studies that described several contextual factors, mechanisms and outcomes related to implementing tobacco control policies to varying depth. Our initial programme theory identified three overarching strategies: awareness, enforcement, and review systems involved in implementation. The refined programme theory identifies the plausible mechanisms through which these strategies could work. We found 30 mechanisms that could lead to varying implementation outcomes including normalisation of smoking in public places, stigmatisation of the smoker, citizen participation in the programme, fear of public opposition, feeling of kinship among violators and the rest of the community, empowerment of authorised officials, friction among different agencies, group identity among staff, shared learning, manipulation, intimidation and feeling left out in the policy-making process. CONCLUSIONS: The synthesis provides an overview of the interplay of several contextual factors and mechanisms leading to varied implementation outcomes in LMICs. Decision-makers and other actors may benefit from examining the role of one or more of these mechanisms in their particular contexts to improve programme implementation. Further research into specific tobacco control policies and testing particular mechanisms will help deepen our understanding of tobacco control implementation in LMICs. PROSPERO REGISTRATION NUMBER: CRD42020191541.

Coproducing tobacco control knowledge: Using virtual platforms to strengthen implementation in India.

Tobacco control is complex and multidimensional. In India, 266.8 million adults use tobacco in some form, with local contextual factors shaping its consumption, production, and trade. Actors have a stake in tobacco represent different sectors; with varying priorities, responding to different ideas, and exerting varying levels of influence often make it difficult to work collaboratively on tobacco control-related issues. Through online networking platforms such as webinars, we emphasize how coproduction of tobacco control knowledge enables participation, prioritizes multisectoral strategies, and enhances tobacco control leadership among policymakers and implementers in their settings. Coproduction of knowledge between and across stakeholders with a focus on "how to" implement tobacco control policies can leverage in negotiating and supplementing the policy implementation process.

LifeFirst: Impact of a school-based tobacco and supari cessation intervention among adolescent students in Mumbai, India.

INTRODUCTION: The youth are a vulnerable population-group for tobacco-related harms. Schools are an excellent setting for health promotion; yet there is a dearth of school-based cessation interventions, rarely evaluated for their impact. Here, we assess the impact of the LifeFirst program: an ongoing tobacco and supari (areca nut) cessation intervention delivered to students from corporation schools in Mumbai city. METHODS: We used a prospective quasi-experimental design with an intervention and a control arm embedded within an ongoing LifeFirst program in select schools. We used a difference-in-difference analysis with baseline and end-line surveys to assess the program's impact on students' knowledge about harms, students' refusal skills, and prevalence of tobacco/supari use. We report our work using the TREND statement checklist. RESULTS: A total of 959 students registered in the LifeFirst program. In our analysis, we included 827 students who completed both the baseline and end-line surveys. Postintervention, we found both tobacco and supari use reduced substantially among the intervention group while tobacco use increased among the control group. The difference-in-difference estimates show a statistically significant reduction of 17.9 and 38.1 percentage points in the intervention group for tobacco and supari use respectively, beyond the reduction in the control group. CONCLUSIONS: The LifeFirst program was successful in reducing tobacco and supari use among the study participants and protected students in the intervention group against new uptake of tobacco. It helped improve knowledge score and refusal skills among students. Implementation and evaluation of similar school-based programs should be considered as part of a multi-strategy approach to reducing tobacco use among young people.

Implementation research for taking tobacco control policies to scale in India: a realist evaluation study protocol.

INTRODUCTION: There are ongoing policies and programs to reduce tobacco use and minimise the associated health burden in India. However, there are several challenges in practice leading to different outcomes across Indian states. Inadequate understanding of how national tobacco control policies achieve their results under varied circumstances obstruct the implementation and scaling up of effective strategies. This study is a realist evaluation using largely qualitative methods to understand the implementation process of India's tobacco control policies. It will do so by evaluating India's Cigarettes and Other Tobacco Products Act (COTPA) and the National Tobacco Control Program (NTCP). The study aims to examine how, why, for whom and under which circumstances COTPA and NTCP are implemented in India. METHODS AND ANALYSIS: A realist synthesis on implementation of tobacco control policies in low-income and middle-income countries is conducted. This is followed by qualitative data collection and analysis in three Indian states selected based on data from two rounds of the Global Adult Tobacco Survey. The study comprises of three steps (1): development of initial programme theories, (2) testing and refinement of initial programme theories and (3) testing and validation of refined programme theories. We will interview policy-makers, programme managers and implementers to identify facilitators and barriers of implementation. The purpose is to identify context-specific evidence-based strategies to gain insights into the implementation process of COTPA and NTCP. Further we aim to contribute to tobacco control research by establishing communities of practice to engage with cross-cutting issues. ETHICS AND DISSEMINATION: The Institutional Ethics Committee, at the Institute of Public Health (Bengaluru), has approved the protocol. Written informed consent forms will be obtained from all the participants. Dissemination has been planned for researchers, policy-makers and implementers as well as the public through peer-reviewed publications, conference presentation, webinars and social media updates. PROSPERO REGISTRATION NUMBER: CRD42020191541.

Healthcare delivery in India amid the Covid-19 pandemic: Challenges and opportunities.

In India, the Covid-19 pandemic has thrown open challenges on multiple fronts: (a) the reconfiguration of care in hospitals, in response to Covid-19, has led to many patients suffering non-Covid conditions having to delay their treatment, and (b) the lockdown which though necessary has affected people unequally, some being much worse-off than others. This article unpacks the impact of Covid-19 on healthcare systems in India by raising moral and ethical questions about the plight of patients with other medical conditions while accessing care. This article also proposes a set of actions by which healthcare systems can address Covid and non-Covid related healthcare needs.

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Affirmative action, minorities, and public services in India: Charting a future research and practice agenda.

The National Health Policy in India mentions equity as a key policy principle and emphasises the role of affirmative action in achieving health equity for a range of excluded groups. We conducted a scoping review of literature and three multi-stakeholder workshops to better understand the available evidence on the impact of affirmative action policies in enhancing the inclusion of ethnic and religious minorities in health, education and governance in India. We consider these public services an important mechanism to enhance the social inclusion of many excluded groups. On the whole, the available empirical evidence regarding the uptake and impact of affirmative action policies is limited. Reservation policies in higher education and electoral constituencies have had a limited positive impact in enhancing the access and representation of minorities. However, reservations in government jobs remain poorly implemented. In general, class, gender and location intersect, creating inter- and intra-group differentials in the impact of these policies. Several government initiatives aimed at enhancing the access of religious minorities to public services/institutions remain poorly evaluated. Future research and practice need to focus on neglected but relevant research themes such as the role of private sector providers in supporting the inclusion of minorities, the political aspects of policy development and implementation, and the role of social mobilisation and movements. Evidence gaps also need to be filled in relation to information systems for monitoring and assessment of social disadvantage, implementation and evaluative research on inclusive policies and understanding how the pathways to inequities can be effectively addressed.

From Policy to Practice: Lessons from Karnataka about Implementation of Tobacco Control Laws.

BACKGROUND: Tobacco use accounts for eight to nine lakh adult deaths annually in India. India enacted a national legislation "Cigarettes and Other Tobacco Products Act, 2003" (COTPA) to protect health of non-smokers and reduce tobacco consumption. However, even a decade after enacting this law, its implementation remains suboptimal and variable across the Indian states. Karnataka has shown leadership on this front by enacting a state law and implementing COTPA at (sub-) district levels. We, therefore, aim to analyze COTPA implementation processes in Karnataka to understand how COTPA can be effectively implemented. METHODS: We developed a case study of COTPA implementation in Karnataka using reports from health, police, education, and transport departments as well as government orders and media reports related to COTPA. We analyzed these data to map and understand the role played by the government agencies in COTPA implementation. We used the proportion of the districts reporting COTPA violations, the number of COTPA violations cases reported, and the proportion of schools reporting compliance with COTPA as proxy measures for COTPA implementation. RESULTS: We found that five government agencies (police, education, health, transport, and urban development) played a major role in COTPA implementation. All the police districts reported COTPA violations with 59,594 cases in a year (April 2013-March 2014). Three of the district anti-tobacco cells and two of the transport divisions reported 1130 and 14,543 cases of COTPA violations, respectively, in the same year. In addition, 84.7% of schools complied with signage requirements of COTPA. COTPA reporting was made part of the reporting systems within health, police, and education departments. The health department created awareness on tobacco harms and COTPA. CONCLUSIONS: COTPA implementation in Karnataka was made possible through integrating COTPA implementation within structure/functions of five government agencies.

Aloe vera as cure for lichen planus.

Oral lichen planus is a difficult condition to treat because of its chronic nature. Various treatment modalities have resulted in partial regression of symptoms but not a complete cure. Aloe vera, a product with minimal adverse effects, can be tried to treat this disorder. A 38-year-old male patient diagnosed with lichen planus of the skin and the oral mucosa was suffering from severe pain and a burning sensation intraorally and pruritus of the skin lesions. Considering the extensive involvement, an herbal alternative was considered. The patient was prescribed aloe vera juice and gel application for two months. At the nine-month follow-up, the patient was symptom-free and totally cured of the intraoral and skin lesions.

Mycological and histological associations of Candida in oral mucosal lesions.

The present study aimed to assess the presence and level of colonization of Candida in patients with oral mucosal lesions, to determine the presence or absence of candidal hyphae in biopsy specimens and to correlate the degree of epithelial dysplasia with the number of colony-forming units of Candida. We performed a prospective study including 50 patients diagnosed as having oral potentially malignant and malignant disorders. These patients had lesions such as leukoplakia, lichen planus, lichenoid reaction, verrucous carcinoma and oral squamous cell carcinoma. An oral swish with 10 mL of normal saline was performed, and this was collected in a sterile plastic container. Candidal colony-forming units were assessed in the specimen. This was followed by a biopsy of the lesion, which was sent for histopathologic examination for dysplasia and severity, and to assess the presence or absence of candidal hyphae. The results of the present study revealed a correlation between higher Candida colonization and increasing severity of dysplasia. An effort was made to correlate Candida by histologic and mycologic means with epithelial dysplasia. If such a correlation is strongly established, then the importance of antimycotic therapy can be emphasized to avoid deterioration.

Prevalence and correlation of oral lesions among tobacco smokers, tobacco chewers, areca nut and alcohol users.

INTRODUCTION: The incidence of oral premalignant and malignant lesions is on the rise due to an increased number of people taking in tobacco and alcohol related habits. MATERIAL AND METHODS: 1028 patients with tobacco, alcohol and areca nut habits attending our Department of Oral Medicine and Radiology formed the study sample. An interviewer based questionnaire was used to record the habit details. All the patients were then examined clinically for the presence of lesions. Chi square and Fisher exact tests were used to assess the statistical significance of the study parameters. RESULTS: Males had a higher prevalence and comprised 87.9% of the sample. The commonest habit in this study sample was smoking (39.2%) followed by smokeless tobacco use (28.1%). Out of the 1028 patients with habits 40% had no clinically detectable changes in their mucosa. Of the mucosal changes leukoplakia (14%) was the commonest. CONCLUSIONS: This study provided information about the habit trends in the patients visiting this institution. The study may serve as a useful tool in educating the patients about the deleterious effects of oral tobacco, alcohol and betel exposure.