This Viewpoint presents an overview of trials methodology research (TMR) and the case for investing in TMR in India. Randomised controlled trials and other types of clinical research inform ...evidence-based medicine, but this endeavour is dependent on the quality of such research. TMR is aimed at improving the way in which clinical trials are designed, conducted, analysed, and reported. The evolution of TMR in countries like the UK has been nurtured through dedicated funding support. Similar funding opportunities for TMR in India will help optimise the ethical and methodological rigour of the growing number of trials conducted in India. Such funding could help initiate an interdisciplinary network of key stakeholders in India to lead on TMR priority-setting exercises so that methodological questions of relevance to India are addressed. The establishment of trials methodology hubs will enhance initiatives such as the disease-specific clinical trials networks being set up as part of the National Biopharma Mission in India. We posit that promoting and establishing TMR as a distinct field of study in India will ensure the improvement of our health research ecosystem and call on national and international funding bodies to initiate consultation, consensus building and ringfenced funding for TMR in India.
In August 2020, India announced its vision for the National Digital Health Mission (NDHM), a federated national digital health exchange where digitised data generated by healthcare providers will be ...exported via application programme interfaces to the patient’s electronic personal health record. The NDHM architecture is initially expected to be a claims platform for the national health insurance programme ‘Ayushman Bharat’ that serves 500 million people. Such large-scale digitisation and mobility of health data will have significant ramifications on care delivery, population health planning, as well as on the rights and privacy of individuals. Traditional mechanisms that seek to protect individual autonomy through patient consent will be inadequate in a digitised ecosystem where processed data can travel near instantaneously across various nodes in the system and be combined, aggregated, or even re-identified.In this paper we explore the limitations of ‘informed’ consent that is sought either when data are collected or when they are ported across the system. We examine the merits and limitations of proposed alternatives like the fiduciary framework that imposes accountability on those that use the data; privacy by design principles that rely on technological safeguards against abuse; or regulations. Our recommendations combine complementary approaches in light of the evolving jurisprudence in India and provide a generalisable framework for health data exchange that balances individual rights with advances in data science.
Despite having a higher burden of health problems, transgender persons face challenges in accessing healthcare in India. Most studies on healthcare access of transgender persons in India focus only ...on HIV related care, mental healthcare, gender affirmative services or on the ethno-cultural communities or transgender women. This study fills this gap by focusing on diverse gender identities within the transgender community with a specific focus on experiences in accessing general or routine healthcare services. A qualitative descriptive approach was used in this study. 23 in-depth interviews and 6 focus group discussions were conducted virtually and in-person with a total of 63 transgender persons in different regions of India between May and September 2021. The study used a community-based participatory research approach and was informed by the intersectionality approach. Thematic analysis was conducted to analyze the data. Four key themes emerged: (i) intersectional challenges in accessing healthcare start outside of the health system, continue through cisgender-binary-normative health systems that exclude transgender persons; and at the interface with individuals such as health professionals, support staff and bystanders; (ii) the experiences negatively impact transgender persons at an individual level; (iii) in response, transgender persons navigate these challenges across each of the levels: individual, health system level and from outside of the health system. This is a first of its kind qualitative participatory study focusing on routine healthcare services of transgender persons in India. The findings indicate the need to move conversations on trans-inclusion in healthcare from HIV and gender affirmative services to routine comprehensive healthcare services considering the higher burden of health problems in the community and the impact of poor access on their lives and well-being.
There is widespread agreement that clinical trials should be registered in a public registry, preferably before the trial commences. It is also important that details of each trial in the public ...record are complete and accurate. In this study, we examined the trial sites and ethics committee (EC) data for 1359 recent Phase 2 or Phase 3 interventional trials registered with Clinical Trials Registry-India (CTRI), to identify categories of problems that prevent the clear identification of which EC approved a given site. We created an SQLite database that hosted the relevant CTRI records, and queried this database, as needed. We identified two broad categories of problems: those pertaining to the understanding of an individual trial and those to adopting a data analytics approach for a large number of trials. Overall, about 30 problems were identified, such as an EC not being listed; an uninformative name of the EC that precluded its clear identification; ambiguity in which EC supervised a particular site; repetition of a site or an EC; the use of a given acronym for different organizations; site name not clearly listed, etc. The large number of problems with the data in the EC or site field creates a challenge to link particular sites with particular ECs, especially if a programme is used to find the matches. We make a few suggestions on how the situation could be improved. Most importantly, list the EC registration number for each EC, merge the site and EC tables so that it is clear which EC is linked to which site; and implement logic rules that would prevent a trial from being registered unless certain conditions were met. This will raise user confidence in CTRI EC data, and enable data based public policy and inferences. This will also contribute to increased transparency, and trust, in clinical trials, and their oversight, in India.
Biomedical perspectives, high-tech solutions and ‘disciplinary supremacy’ where randomised controlled trials are held as the highest form of evidence in global health research can undermine the ...integrative and social determinants perspectives of public health. Involving a broad range of perspectives beyond academia increases the impact potential of research, with evidence showing such research is relevant, facilitates adoption of innovations, drives change, reduces waste of resources and improves recruitment of participants.9 The value of coproduced knowledge, validation against local needs and community-led research agenda setting, implementation and translation has been identified over and over in diverse low-income and high-income settings;5 10 11 it is commended by ethics guidelines and experts, and often required by funders.12 As researchers and practitioners working primarily with organisations that are not tertiary academic institutions, but who publish in peer-reviewed academic journals, we have faced several challenges which are illustrated in the case study in box 1. Academic conventions purporting to promote accountability can further limit communities and CBOs from joining the global conversation.7 While prior registration for clinical (not public health) trials may be required, registries which include global health research should allow for retrospective registration on the basis of a valid rationale for such registration being provided, with full fee waivers for authors from CBOs and LMICs.Box 1 Case study of CBO attempts to retrospectively register a public health intervention trial In a recent example, one of us conducted research within the communities where we work. ...there are multiple ways for researchers to be held accountable.
Transgender persons in India, who are one of the most vulnerable groups, were particularly impacted by the COVID-19 pandemic. Increased risk of COVID-19, challenges with continuing livelihood, ...uncertainty, and anxiety around the pandemic over pre-existing social discrimination and exclusion pose risk of a mental health impact as well. To investigate this further, this component of a larger study on experiences in healthcare of transgender persons in India during COVID-19 and looks into the question "How did the COVID-19 pandemic impact the mental health of transgender persons in India".
22 In-depth interviews (IDI) and 6 focus group discussions (FGD) were conducted virtually and in-person with persons self-identifying as transgender or belonging to ethnocultural transgender communities from different parts of India. Community based participatory research approach was used by ensuring representation from the community in the research team and through a series of consultative workshops. Purposive sampling with snowballing was used. The IDIs and FGDs were recorded, transcribed verbatim and analyzed using an inductive thematic analysis.
Mental health of transgender persons were affected in the following ways. Firstly, COVID-19, its associated fear and suffering combined with pre-existing inaccessibility of healthcare and reduced access to mental health care affected their mental health. Secondly, unique social support needs of transgender persons were disrupted by pandemic linked restrictions. Thirdly, pre-existing vulnerabilities such as precarious employment and underlying stigma were exacerbated. Finally, gender dysphoria was a key mediating factor in the impact of COVID-19 on mental health with a negative and positive impact.
The study reiterates the need to make systemic changes to make mental healthcare and general healthcare services trans-inclusive while also recognizing the essential nature of gender affirmative services and the need to continue them even during emergencies and disaster situations. While this brings out how public health emergencies can exacerbate vulnerabilities, it also shows how the lived mental health experience of transgender person is intricately linked to the way work, travel and housing is structured in our society and therefore points to the structural nature of the linkage between mental health and gender.
Measurement-based peer supervision is one strategy to assure the quality of psychological treatments delivered by non-mental health specialist providers. In this formative study, we aimed to 1) ...describe the development and 2) examine the acceptability and feasibility of PEERS (Promoting Effective mental healthcare through peER Supervision)—a novel smartphone app that aims to facilitate registering and scheduling patients, collecting patient outcomes, rating therapy quality and assessing supervision quality—among frontline treatment providers delivering behavioral activation treatment for depression. The PEERS prototype was developed and tested in 2021, and version 1 was launched in 2022. To date, 215 treatment providers (98% female; ages 30–35) in Madhya Pradesh and Goa, India, have been trained to use PEERS and 65.58% have completed the supplemental, virtual PEERS course. Focus group discussions with 98 providers were examined according to four themes—training and education, app effectiveness, user experience and adherence and data privacy and safety. This yielded commonly endorsed facilitators (e.g., collaborative learning through group supervision, the convenience of consolidated patient data), barriers (e.g., difficulties with new technologies) and suggested changes (e.g., esthetic improvements, suicide risk assessment prompt). The PEERS app has the potential to scale measurement-based peer supervision to facilitate quality assurance of psychological treatments across contexts.
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