Protocol of the study for Setting up of a system for "Medical Certification of Cause of Death" for non-institutional deaths in a selected area of a Taluk of Kolar District, Karnataka, India: feasibility and validity

Abstract

Rationale: The current coverage of “Medical Certification of Cause of Death” in India is only 22.5%. This is largely due to significant proportion of deaths occurring outside the hospitals (non-institutional deaths). The “cause of death” in such cases is unlikely to be certified by any doctor. The present study attempts to address this gap by developing a system of MCCD for “non-institutional deaths” in the country.   Novelty:  This is a first of its kind study attempting to address the gap of coverage as well as reliability of MCCD for “non-institutional deaths”.   Objectives: To assess the feasibility of “Physician derived Cause of death” approach for deducing “cause of death” in “non-institutional deaths” in a selected area of Kolar Taluk, Karnataka and to validate this approach   Methods: Doctors of selected major hospitals in Kolar taluk and PHC medical officers and private practitioners of 2 selected PHC areas of the taluk would be trained in arriving at “Cause of Death” in “non-institutional deaths” using the “PhyCoD” tool. The “cause of death” deduced by this approach would be validated against the ‘gold standard’ autopsy wherever possible. The approach will also be tested for “inter-rater reliability”.   Expected outcome:           Development of a tool for physicians for deducing “Cause of Death” in “non-institutional deaths” Increased coverage of MCCD for “non-institutional deaths” Improved accuracy in the reporting of “cause of death” for “non-institutional deaths” Reduced delay in the reporting of “cause of death” for “non-institutional deaths”

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

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Clinical Protocols

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Funding Statement

Yes

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

IEC clearance No: NCDIR/IEC/3073/2023, 21/02/2024 Name of the institution or relevant body that granted permission: ICMR-NCDIR Institutional Ethics Committee

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

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I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

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Data Availability

No datasets were generated or analysed during the current study. All relevant data from this study will be made available upon study completion

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