Team based collaborative care model, facilitated by mHealth enabled and trained nurses, for management of heart failure with reduced ejection fraction in India (TIME-HF): design and rationale of a parallel group, open label, multi-centric cluster randomised controlled trial.

Background: Heart failure (HF) is a debilitating condition associated with enormous public health burden. Management of HF is complex as it requires care-coordination with different cadres of health care providers. We propose to develop a team based collaborative care model (CCM), facilitated by trained nurses, for management of HF with the support of mHealth and evaluate its acceptability and effectiveness in Indian setting. Methods: The proposed study will use mixed-methods research. Formative qualitative research will identify barriers and facilitators for implementing CCM for the management of HF. Subsequently, a cluster randomised controlled trial (RCT) involving 22 centres (tertiary-care hospitals) and more than 1500 HF patients will be conducted to assess the efficacy of the CCM in improving the overall survival as well as days alive and out of hospital (DAOH) at two-years (CTRI/2021/11/037797). The DAOH will be calculated by subtracting days in hospital and days from death until end of study follow-up from the total follow-up time. Poisson regression with a robust variance estimate and an offset term to account for clustering will be employed in the analyses of DAOH. A rate ratio and its 95% confidence interval (CI) will be estimated. The scalability of the proposed intervention model will be assessed through economic analyses (cost-effectiveness) and the acceptability of the intervention at both the provider and patient level will be understood through both qualitative and quantitative process evaluation methods. Potential Impact: The TIME-HF trial will provide evidence on whether a CCM with mHealth support is effective in improving the clinical outcomes of HF with reduced ejection fraction in India. The findings may change the practice of management of HF in low and middle-income countries.

Infertility - an unfinished reproductive rights agenda in India.

Twenty-five years after the International Conference on Population and Development (ICPD) mandate in 1994, India has fallen far short of providing universal access to preventive and treatment services for infertility. This mandate was a call to "prioritize the reproductive health and rights of all people" (1), and reproductive health was defined as.

Dispelling hope and leaving couples in a state of "inbetweenness": Moral dilemmas in infertility research.

Infertility is a condition that has an inherent cultural significance. In India, married couples with infertility face the brunt of speculations and certain demeaning identities are assigned to the women. Care-seeking options for infertility are deeply gendered. The availability of technologically advanced treatments for infertility provides "hope" to couples, especially women, to resolve the demeaning identities assigned to them, related to infertility. The paper focuses on the moral dilemma faced by a medically trained public health professional while collecting data from women in Kerala who were unable to continue the suggested biomedical treatment. Infertility treatment is an entropic cycle of success and failure; thus, the women studied moved from one stage to another hoping for a resolution to their problem. They were also undergoing alternative treatments that were unlikely to succeed. The paper discusses the moral dilemma of choosing between explaining the poor likelihood of success and leaving them with "hope".

Maintaining confidentiality while gaining access to the community.

Qualitative research is used to enhance the understanding of many issues but this method poses certain unique difficulties and ethical dilemmas for the researcher. These tend to be magnified when researching sensitive topics.