Exploring family, community and healthcare provider perceptions and acceptability for minimal invasive tissue sampling to identify the cause of death in under-five deaths and stillbirths in North India: a qualitative study protocol

Abstract

BackgroundAround 5.4 million under-five deaths occur globally annually. Over 2.5 million neonatal deaths and an equivalent stillbirths also occur annually worldwide. India is largest contributor to these under-five deaths and stillbirths. To meet the National Health Policy goals aligned with sustainable development targets, adoption of specific strategy and interventions based on exact causes of death and stillbirths are essential. The current cause of death (CoD) labelling process is verbal autopsy based and subject to related limitations. In view of rare diagnostic autopsies, the minimally invasive tissue sampling (MITS) has emerged as a suitable alternate with comparable efficiency to determine CoD. But there is no experience on perception and acceptance for MITS in north Indian context. This formative research is exploring the perceptions and view of families, communities and healthcare providers regarding MITS to determine the acceptability and feasibility.MethodsThe cross-sectional study adopts exploratory qualitative research design. The study will be conducted in New Delhi linked to deaths and stillbirths occurring at a tertiary care hospital. The data from multiple stakeholders will be collected through 53–60 key-informant in-depth interviews (IDIs), 8 focus group discussions (FGDs) and 8–10 death or stillbirth event observations. The IDIs will be done with the parents, family members, community representatives, religious priests, burial site representatives and different health care providers. The FGDs will be conducted with the fathers, mothers, and elderly family members in the community. The data collection will focus on death, post-death rituals, religious practices, willingness to know CoD, acceptability of MITS and decision making dynamics. Data will be analysed following free listing, open coding, selective coding and theme identification. Subsequently 8–10 parents will be approached for consent to conduct MITS using the communication package to be developed using the findings.DiscussionThe study will provide in-depth understanding of the cultural, social, religious practices related to child death and stillbirth and factors that potentially determine acceptance of MITS. The findings will guide development of communication and counselling package and strategies for obtaining consent for MITS. The pilot experience on obtaining consent for MITS will inform suitable refinement and future practice.

A comparison of MITS counseling and informed consent processes in Pakistan, India, Bangladesh, Kenya, and Ethiopia

“…MITS is a needle-based postmortem examination that uses very fine needles to percutaneously collect body fluids and organ tissue samples that are then analyzed through histopathological and microbiological techniques. Unlike a complete diagnostic autopsy, MITS can be performed with limited infrastructure and by trained medical technicians such as histopathologist or mortuary assistants [ 3 ]. Compared with complete diagnostic autopsy, MITS is faster, less expensive, and markedly less invasive, and has demonstrated potential to support accurate cause of death determination in stillbirths and neonates [ 1 , 4 ].…”

“…The hypothetical acceptability of MITS has also recently been assessed across diverse geographic settings, including north India [ 3 ], Kenya [ 6 ], Mali [ 6 ], Mozambique [ 6 ], Pakistan [ 5 ], and the United Kingdom [ 7 ]. These studies have demonstrated a high theoretical acceptability of MITS across a range of participants, including parents, relatives of the deceased, healthcare providers, and religious and community leaders [ 3 , 5 – 7 ].…”

“…The hypothetical acceptability of MITS has also recently been assessed across diverse geographic settings, including north India [ 3 ], Kenya [ 6 ], Mali [ 6 ], Mozambique [ 6 ], Pakistan [ 5 ], and the United Kingdom [ 7 ]. These studies have demonstrated a high theoretical acceptability of MITS across a range of participants, including parents, relatives of the deceased, healthcare providers, and religious and community leaders [ 3 , 5 – 7 ]. However, these studies have also reported some perceived barriers in the acceptability of MITS, which include lack of knowledge about the procedure, lack of trust in health professionals, lack of rapport with patients, lack of sensitivity on the part of health professionals when discussing MITS and a sense of next of kin feeling rushed in their decision making [ 3 , 5 – 7 ].…”

“…These studies have demonstrated a high theoretical acceptability of MITS across a range of participants, including parents, relatives of the deceased, healthcare providers, and religious and community leaders [ 3 , 5 – 7 ]. However, these studies have also reported some perceived barriers in the acceptability of MITS, which include lack of knowledge about the procedure, lack of trust in health professionals, lack of rapport with patients, lack of sensitivity on the part of health professionals when discussing MITS and a sense of next of kin feeling rushed in their decision making [ 3 , 5 – 7 ]. Many of the barriers cited in recent publications have the potential to be addressed through the MITS counselling and consent processes.…”

Perceptions of the healthcare providers regarding acceptability and conduct of minimal invasive tissue sampling (MITS) to identify the cause of death in under-five deaths and stillbirths in North India: a qualitative study

“…A formative research was conducted to understand the perceptions, practices, contextual factors and barriers for acceptance and conduct of MITS. The study protocol has been published earlier [37].…”