Anant Bhan

Introduction: Research integrity (RI) is the cornerstone of trustworthy and reliable research conduct and findings across all domains, particularly in the sensitive field of healthcare research. Despite the existence of international and institutional frameworks, the development and implementation of RI policies remain inconsistent across healthcare research institutions. There are multilevel determinants like individual, organisational and system level barriers and facilitators of RI policies. Existing evidence regarding these determinants has not been systematically synthesised to inform policy and governance. This review aims to integrate qualitative and quantitative evidence on multilevel factors influencing RI policy development and implementation in healthcare research institutions. Methods and analysis: This systematic review will be conducted according to the Joanna Briggs Institute (JBI) methodology for mixed-methods systematic reviews of evidence. Qualitative, quantitative and mixed-methods records will be searched in MEDLINE (Ovid), Scopus, Cochrane CENTRAL, CINAHL (Ovid), Embase (Ovid), PsychINFO and Epistemonikos. Grey literature will be searched in ProQuest Dissertations and Theses Global (EBSCOhost), OAIster and Google Scholar. Methodological quality will be assessed using appropriate JBI critical appraisal tools. A convergent integrated approach will be employed. Depending on the nature of the extracted data, appropriate data transformation will be done to enable integration. Integrated findings will be synthesised thematically across individual, organisational and system levels. Confidence in the integrated findings will be assessed using an approach informed by Grading of Recommendations Assessment, Development and Evaluation (GRADE), GRADE-CERQual and JBI principles. Ethics and dissemination: This study does not involve human participants. This is a secondary data analysis. Ethical approval is not required as this study involves analysis of published and publicly available data. Findings will be disseminated through publication in a peer-reviewed journal and presented at scientific conferences. PROSPERO registration: CRD420261279317.

This commentary explores the invisible identity-based emotional labour carried out by LGBTQIA+ staff coordinating community-focused programmes within civil society organisations (CSOs) that increasingly supplement public health systems in low- and middle-income countries. Drawing on lived experience and observations from LGBTQIA + –led and LGBTQIA + –affirmative health systems work in India within CSOs, we examine how LGBTQIA+ staff navigate the demands of professionalism, representation, and funder expectations within rigid institutional hierarchies. We offer recommendations for organisations and funders to recognise emotional labour and move towards ethical partnerships and supportive workplace environments.

Background Research priority setting (RPS) aims to direct research resources towards optimal social benefits. Research on substance use disorders (SUDs) due to the use of alcohol, tobacco or other psychoactive substances currently receives limited funding, making RPS particularly important. RPS are not just a technical exercise but also have ethical dimensions. However, there is no systematic review of ethics of RPS on SUDs. Objectives 1) To examine the extent to which recent RPS exercises on substance use disorders (SUDs) adhere to current reporting guidelines for RPS and 2) discuss our findings in light of the existing ethics literature on RPS and SUDs, and see to what extent ethical dimensions in the literature map onto current practice. Methods We will search MEDLINE, Embase, CINAHL, and PsycINFO, screen reference lists and hand search websites from selected organisations (e.g., funders, professional societies) for RPS exercises on SUDs published between 2020 and 2025. Two review authors will independently screen records and extract data using a piloted data extraction form. Any discrepancy will be resolved through consensus with another author acting as an arbiter. To examine adherence to current reporting and ethical guidelines for RPS, we will map adherence to the 2019 REPRISE reporting checklist and the 2025 WHO guidelines on ethics of RPS (e.g., optimise social value, respect special obligations, assess risks, follow fair procedures). We will narratively synthesise data, providing descriptive statistics, where appropriate, and discuss our findings in light of relevant literature. Implications By describing and critically discussing the extent to which current RPS exercises on SUDs adhere to current reporting and ethical guidelines for RPS, we hope this systematic review will inform and strengthen future RPS exercises and help direct available resources to the most valuable research on SUDs.

Background Responding to rapid developments in Artificial Intelligence and Machine Learning and the deployment of its applications in healthcare in India, the Indian Council of Medical Research (ICMR) published Guidelines on the Ethical Use of AI in Biomedical Research and Healthcare in March 2023. We conducted stakeholder engagements to understand the challenges inherent in putting guidelines and policy into practice. Methods Two stakeholder workshops were convened - one in-person, where 22 participants discussed the ethical dilemmas of applying AI to health and health research, using 6 case studies or real-life scenarios, and a virtual one with 27 participants that focussed on the future of bioethics and AI in health. Outcomes Key elements emerged from the deliberations, as core prerequisites to enable ethical AI in health research and healthcare in the Indian context. Not in an order of priority or importance, they were: 1. Better data systems, to strengthen data quality, fidelity, storage and oversight, 2. User participation in AI development from the start and strengthening of frontline workers to critically engage with AI, 3. Capacity building of (a) technology developers, computational scientists and other non-health collaborators in ethics and AI, (b) health professionals, (c) Ethics Committees and regulators, to critically engage with AI 4. Strengthen organizational values to centre equity and justice at all stages of AI application design and deployment, 5. Civic engagement in health, research, technology, and bioethics to help hold all players accountable and safeguard public interest. Conclusion Ethical and responsible AI in health and health research in the Indian context requires prioritizing and strengthening the ethics oversight capacity from academia to industry to regulatory bodies with constant communication, public engagement and transparency to ensure the lessons from practice are fed back into policy and governance systems.

Background: During the COVID-19 pandemic, transgender and gender-diverse (TGD) people and people with disabilities in India faced disproportionate barriers to accessing vaccination services. Building on previous studies, this study explored the experiences of COVID-19 vaccine access in these two marginalized communities, using the WHO Behavioral and Social Drivers (BeSD) framework. Methods: Keeping community-based participatory methods (CBPR) at heart, we conducted a survey adapted from the BeSD COVID-19 survey tool. The survey was adapted using insights from a prior study, a literature review, stakeholder consultations, and discussions with a community leadership group (CLG) and an advisory board (AdB). Participants were recruited through transgender, gender-diverse, and disability rights networks. Data were analyzed descriptively, using percent analysis, and psychometrically, using exploratory factor analysis on polychoric correlations. Results: The adapted BeSD survey tool showed a high 0.85 (p < 0.05) internal consistency and criterion validity. Moreover, it showed a high willingness to be vaccinated (for ease of access to other services and community responsibility); however, systemic barriers hindered vaccination access. TGD people and people with disabilities faced multiple barriers in being vaccinated. The TGD community reported documentation mismatches and mistrust in health systems. People with disabilities reported mobility challenges, escort dependence, financial challenges, and variable accessibility at vaccination sites. Both groups faced digital exclusion, received inadequate information that did not address their specific needs, and experienced inconsistent implementation of inclusive policies. Community-led facilitation led to more uptake. Conclusions: Vaccine willingness alone is insufficient to ensure that vaccines reach everyone. Addressing trust deficits, infrastructural barriers, and digital exclusions requires diligent attention and commitment from the government to mitigate broader challenges faced by TGD people and people with disabilities.

Background: Brief psychosocial interventions, such as the Healthy Activity Program (HAP), which are based on behavioral activation and delivered by nonspecialist providers (NSPs), have emerged as cost-effective solutions for the treatment of depression. HAP treatment outcomes are improved by the engagement of patients in activation-focused homework assignments and their adherence to these assignments during therapy. Currently, patients are expected to complete these homework assignments using a paper workbook. Objective: The aim of this study was to describe the user-centered development process of PracticePal, a chatbot designed to enhance patient engagement and homework adherence, and to evaluate its feasibility and acceptability as a therapy aid in India. Methods: We used a user-centered approach to co-develop PracticePal, incorporating conversational flows and video scripts in Hindi. The chatbot was piloted with 30 participants having depression who were receiving the HAP from 15 nonspecialist counselors in primary care in rural Madhya Pradesh, India. The feasibility and acceptability of PracticePal were assessed through engagement data, in-depth interviews with a subset of 6 participants, and focus group discussions with 11 counselors. Treatment completion rates and changes in depressive symptoms were explored as secondary outcomes. Results: Average patient engagement spanned 29 days (95% CI 24-34) during the 60-day treatment period. The engagement of patients with PracticePal increased as their treatment progressed, particularly after the third HAP session. Of the 30 patients, 20 (67%) accessed more than half of the multimedia content available on the chatbot. On average, there was a greater frequency of self-initiated engagement (1558 out of a total of 1835 times, 84.9%) across all sessions compared with reminder prompts (277 out of 1835 times, 15.1%). All 30 patients completed treatment and experienced a reduction in the mean Patient Health Questionnaire-9 score from 13 (95% CI 12.6-13.6; signifying moderate severity) to 4 (95% CI 2.9-4.7; signifying none/minimal severity). Patients found the chatbot’s reminders for activities, mood tracking, and video messages helpful and observed that it could help others in their social network. NSPs also reported improved participation of patients in the homework tasks compared with the paper workbook. A few patients faced challenges with low internet bandwidth, and those with limited literacy suggested increasing the amount of video content for easier accessibility. Conclusions: The PracticePal chatbot is a feasible and acceptable therapy aid to complement a psychological treatment, with promising potential to enhance the effectiveness of NSP-delivered psychosocial interventions in low-resource settings. Future steps include conducting a fully powered randomized controlled trial to assess its effectiveness in improving mental health outcomes.

Background: India has the world’s largest number of suicides, but there is little research on the trends in suicidal thoughts, especially for individuals with psychosis. More research is necessary to develop preventive interventions. Smartphone-based ecological momentary assessments (EMAs) can assess dynamic symptoms, but most EMA studies are conducted in higher income settings and have shorter (≤1 month) follow-up periods. Objective: This study aimed to examine the duration of onset to offset of suicidal ideation (SI) in tertiary hospital outpatients with psychosis in India. Methods: This study is an exploratory, secondary analysis of smartphone EMA data nested within the ongoing “Smartphone Health Assessment for Relapse Prevention (SHARP)” project. Tertiary hospital outpatients (n=50) with early course schizophrenia at 2 socioculturally different sites in India were recruited and given the “mindLAMP” app for monitoring mood through daily EMA surveys. The mood survey matched the 9-item Patient Health Questionnaire; the ninth item was used to define an instance of SI (score ≥1). A total of 14 patients with ≥1 SI instances who met the site-specific EMA survey use cutoff were included. We examined the between- and within-person variability in SI and computed the timescale of “episodic” SI (sequences of consecutive daily observations of SI score ≥1). Positive and Negative Syndrome Scale (PANSS) was used to assess changes in psychosis symptoms and its relationship with the temporality of SI. Results: Over approximately 11 (SD 2.1) months of EMA reporting on average, 3253 mood surveys were filled by the 14 participants (median 213, IQR 147‐256). A total of 521 instances of SI were reported. Monthly SI instances showed substantial within- and between-person variations. Timescale summary statistics revealed episodic SI patterns in 11 patients, with an average of 5.9 episodes (SD 4.4; range:1‐14; n=65) with an episode lasting on average 2.5 days (SD 1.5; range:1‐5.3; n=27). There was an average lag of approximately 59, 66, and 81 days between the time of the first drop in PANSS positive, negative, and general psychopathology scores, respectively, and the last reported SI instance. Results after imputation of missing data showed an average of 12.1 episodes and 228 days (average lag) between the first drop in PANSS scores and last reported SI. This indicated that SI was an enduring vulnerability subsequent to the beginning of clinical improvement in psychosis. Conclusions: Our study adds to the much-needed evidence base in India to measure the dynamics of suicidal thinking within an individual, for more targeted preventive interventions. Further steps in EMA research are highlighted such as the use of higher frequency “burst” surveys to assess the duration of an SI episode in hours or minutes, and inclusion of both active and passive SI markers to measure the timescale of suicidal thinking.

Processing payments (reimbursements or honoraria) to study participants by researchers working in institutional setups can raise ethical concerns, as the institute’s administration and finance departments control the procedural mandate of this issue. This commentary discusses this critical and often ignored aspect and provides suggestions that could help minimise the risk of violating research participants' anonymity.

A qualitative study was conducted during the RATIONS trial to explore the perceptions, experiences, and expectations of participants and stakeholders on the acceptability, benefits, and feasibility of the nutritional intervention to complement the trial findings for deeper exploration into why and how of these findings and other allied themes. Using purposive sampling, we recruited 58 individuals for 22 in-depth interviews (IDI) and four focus group discussions (FGDs) between January and June 2022. These included 12 patients with TB, six household contacts, and other stakeholders (18 trial members, 18 government community workers, and four National TB Elimination Program (NTEP) staff). All IDIs and FGDs were audio-recorded, transcribed, and translated. The codes were generated using an inductive process and categorized manually into themes, with direct quotes describing the themes. The intervention was found to be acceptable in terms of cultural compatibility, quality, quantity, and duration; considered beneficial in helping tolerate the adverse effects of medications, weight gain, and resuming work; and was considered life-saving by many during the COVID-19 pandemic. Other observations included food-sharing in the control arm, inability to regain pre-disease functional status despite weight gain, and preference for in-kind support. Community health workers expressed confidence in its feasibility and willingness to take responsibility for its implementation. The NTEP staff considered it feasible if necessary resources were provided. This qualitative inquiry reflected the perspectives and lived experiences of households experiencing poverty, food insecurity, TB and the stakeholders serving them. Their voices are relevant in framing policy and practice in the NTEP and future research in India and similar low-resource settings. The food-based intervention was perceived as acceptable, feasible, and beneficial for the recipients and the NTEP. Opinion on cash or support in kind was divided; many preferred in-kind support over cash, but others expressed a requirement for both.