A Mixed-Method Study to Determine the Cause of Death in Stillbirths, Children Under Five, and Persons 60 Years and Above Using Minimal Invasive Tissue Sampling (MITS) and Verbal Autopsy (VA) in the Bono East Region of Ghana (Stillbirths, Children under-five and Adult Deaths Study (SCADS).

December 26, 2024| Ongoing Project | Reading time: 5 min

Introduction

KHRC is conducting this SCADS study to evaluate the use of Minimal Invasive Tissue Sampling (MITS), a method that collects small tissue and fluid samples for laboratory analysis, to determine the cause of death. This procedure offers a cost-effective, less complex alternative to Complete Diagnostic Autopsy (CDA) while maintaining accuracy. The study aims to improve the quality of mortality data, which is essential for guiding health policies, enhancing healthcare services, and reducing deaths. By integrating MITS into the Kintampo Health and Demographic Surveillance System (KHDSS), the research seeks to address current challenges in cause-of-death determination and strengthen mortality surveillance programs in the Bono East Region of Ghana and beyond.

Investigators

Dr Kwaku Poku Asante, Ms Grace Manu, Dr Samuel Ekow Harrison, Dr Dennis Adu-Gyasi, Dr Seyram Kaali, Dr Ernest Adjei, Mr. Charles Zandoh, Dr Abubakari Sulemana Watara.

Background

Accurate cause of death (COD) data is critical to inform health policy, improve healthcare delivery and reduce mortality. Civil Registration and Vital Statistics (CRVS) systems are the primary administrative structures for continuously collecting mortality data (1). However, this remains a major challenge in many low- and middle-income countries (LMICs). Complete Diagnostic Autopsy (CDA) remains the appropriate option for determining the cause of death. But it is not fully utilized in most LMICs due to resource constraints and cultural reasons.

Verbal Autopsy (VA) has been the alternative method of determining cause of deaths in most LMICs. But this is also limited by lack of objective diagnostic information, recall bias and difficulty in distinguishing diseases with similar clinical presentations. Minimal Invasive Tissue Sampling (MITS) procedures involve extracting tissue specimens for histopathological, microbiological, and molecular analysis to support cause of death determination. It has been proven to have comparable accuracy to the CDA, yet less resource-intensive. However, there is limited evidence on how the MITS approach can be integrated into existing mortality surveillance programs.

Objectives
The main aim of this study is to strengthen the KHDSS mortality surveillance program by integrating MITS as a standard tool to improve cause of death determination and data quality.

Specific Objectives include:

1.To explore the feasibility of integrating MITS into the KHDSS to improve the determination of the cause of death.

2.To determine the accuracy of the clinician-determined cause of death using MITS as a reference

3.To test the validity of the VA cause of death using the MITS as a reference.

4.To determine the acceptability or otherwise of the MITS program in the study area.

5.To determine the cost-effectiveness of incorporating MITS into the KHDSS.

6.To produce MITS cause of death data in the study area that could be used as a reference for future studies or comparing similar MITS CoD data.

Study Methodology
The study is being conducted in the Kintampo North Municipal, Kintampo South District, Techiman South Municipal, and Techiman North District, all in the Bono East Region of Ghana. Both quantitative and qualitative methods of data collection are used.

Quantitative Data Collection:
A total of 300 deceased persons (including stillbirths, under-fives, and adults 60 years and above) registered in the Kintampo Health and Demographic Surveillance System (KHDSS) are enrolled in the study. Tissues and fluid samples from the brain, liver, and other pre-defined organs are collected using biopsy needles for molecular, microbiological, and histopathological analyses. The samples are collected at the mortuary facilities of the Kintampo Municipal Hospital, the Jema District Hospital, and the Holy Family Hospital in Techiman. Available clinical histories are then extracted from hospital records of the deceased, and a verbal autopsy is conducted within three months of death. A panel of experts including a Pathologist, Pediatrician, Microbiologist, Family Health Physician and Epidemiologist to determine the cause of death based on laboratory results, clinical history, and VA open narratives.

Qualitative Data Collection:
For the qualitative aspect of the study, Focus Group Discussions (FGDs) and In-depth Interviews (IDIs) will be conducted to determine the acceptability or otherwise of the MITS procedures. This will be done among opinion leaders and relatives of deceased persons. The study has ethical approval from the Institutional Ethics Committee of the Kintampo Health Research Centre and the Ghana Health Service Ethics Review Committee.

Expected Outcomes
By the end of the study, we aim to achieve the following outcomes:

1.Train lower-level health personnel, including non-clinical pathologists, to competently perform MITS procedures.

2.Successfully incorporate MITS into the mortality surveillance program of the KHDSS.

3.Generate accurate cause-of-death data through MITS to support health planning and improve service delivery.

4.Position KHRC as a key partner for collaboration and data sharing with other MITS sites (countries and institutions conducting the MITS study), to ultimately contribute to informed health policy decisions.

Funder
Bill & Melinda Gates Foundation through the MITS Surveillance Alliance Secretariat, led by RTI International

Collaborators
Dr Abraham Oduro, Research and Development Division, Ghana Health Service, the Bono East Regional Health Directorate, ERNPHIL Laboratory Services Ltd- Kumasi.

Study Duration
Three (3) Years
Start Date
2023
End Date
2026

Conclusion
By successfully integrating MITS into our mortality surveillance data system, we aim to improve the accuracy of death records. This will provide better data for health research and policymaking, ultimately helping to save more lives.