Muralidhar Madhusudan, Rangamani Sukanya, Kulothungan Vaitheeswaran, Das Priyanka, Vishwakarma Monesh B, Mathur Prashant
ICMR-National Centre for Disease Informatics and Research, Bengaluru Rural District, India.
JMIR Res Protoc. 2025 Aug 18;14:e72330. doi: 10.2196/72330.
Medical Certification of Cause of Death (MCCD) coverage in India is only 22.5%, largely due to a significant proportion of deaths occurring outside hospitals (noninstitutional deaths). The cause of death (CoD) in such cases is unlikely to be certified by any doctor. This study attempts to address this gap by developing an MCCD system for noninstitutional deaths in India.
This study will assess the feasibility of a physician-derived cause of death (PhyCoD) approach for deducing CoD in noninstitutional deaths in a selected area of Kolar Taluk, Karnataka, and validate this approach.
This population-based feasibility and validation study will be conducted in 4 selected hospitals and 2 Primary Health Centre (PHC) areas in Kolar taluk, Kolar district, Karnataka, India. We developed 4 PhyCoD questionnaires: maternal, neonatal, child, and adult. Institutional deaths that occurred over the previous 10 months in these selected hospitals with detailed case records available were selected as "gold standard" cases. Trained investigators abstracted the history from these case records into the questionnaires and deduced the CoD sequence of events. The investigators then elicited the history from the deceased's relatives using the PhyCoD questionnaire and deduced the CoD sequence of events. This will be compared with the gold standard CoD sequence of events deduced from medical records. The extent of agreement will be measured. The tool will be revised based on the pilot phase experiences. For all brought dead cases to the 4 hospitals and home deaths in the 2 PHC areas over a 3-month period, doctors in these hospitals and PHC medical officers, respectively, will elicit the history from the deceased's kin using the PhyCoD questionnaires and arrive at a CoD sequence of events. This CoD sequence of events will be validated against the gold standard autopsy whenever possible (in brought dead cases). The PhyCoD approach will also be tested for inter-rater reliability by independent investigators on a random sample of noninstitutional deaths.
Institutional ethics committee clearance (January 2024), recruitment and training of project staff (January 2024-January 2025), preparation of questionnaires and application (August 2024-February 2025), pilot phase data collection (48 cases; August 2024-December 2024), and training of the doctors in the participating hospitals and PHC medical officers (December 2024) are complete. A total of 48 cases (32 adult, 7 child, 3 maternal, and 6 neonatal) were included in the pilot phase. Data review and analysis of the pilot phase data are underway.
The study is expected to provide information about the validity and feasibility of the PhyCoD approach. Depending on the study's outcomes, the tool may be adopted by more states, leading to increased coverage of noninstitutional deaths under MCCD, improved accuracy, and reduced delay of CoD reporting for noninstitutional deaths.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/72330.
印度的死因医学证明（MCCD）覆盖率仅为22.5%，这主要是因为很大一部分死亡发生在医院之外（非机构性死亡）。在这种情况下，死亡原因不太可能由任何医生进行证明。本研究试图通过为印度的非机构性死亡开发一个MCCD系统来解决这一差距。
本研究将评估在卡纳塔克邦科拉尔县科拉尔乡选定区域，采用医生推导死因（PhyCoD）方法推断非机构性死亡死因的可行性，并验证该方法。
这项基于人群的可行性和验证性研究将在印度卡纳塔克邦科拉尔县科拉尔乡选定的4家医院和2个初级卫生保健中心（PHC）地区进行。我们编制了4份PhyCoD问卷：孕产妇、新生儿、儿童和成人问卷。将这些选定医院过去10个月内发生的有详细病例记录的机构性死亡病例选为“金标准”病例。经过培训的调查人员从这些病例记录中提取病史信息填入问卷，并推导死亡事件的死因顺序。然后，调查人员使用PhyCoD问卷从死者亲属那里获取病史信息，并推导死亡事件的死因顺序。这将与从医疗记录中推导的金标准死因顺序进行比较。将测量一致性程度。将根据试点阶段的经验对工具进行修订。在3个月的时间里，对于所有送至这4家医院的死亡病例以及2个PHC地区的家中死亡病例，这些医院的医生和PHC医务人员将分别使用PhyCoD问卷从死者亲属那里获取病史信息，并得出死亡事件的死因顺序。只要有可能（在送来的死亡病例中），这个死亡事件的死因顺序将与金标准尸检结果进行验证。独立调查人员还将对非机构性死亡的随机样本进行测试，以检验PhyCoD方法的评分者间信度。
机构伦理委员会批准（2024年1月）、项目工作人员的招募和培训（2024年1月至2025年1月）、问卷编制和应用（2024年8月至2025年2月）、试点阶段数据收集（48例；2024年8月至2024年12月）以及参与医院的医生和PHC医务人员培训（2024年12月）均已完成。试点阶段共纳入48例病例（32例成人、7例儿童、3例孕产妇和6例新生儿）。试点阶段数据的审查和分析正在进行中。
该研究有望提供有关PhyCoD方法有效性和可行性的信息。根据研究结果，该工具可能会被更多邦采用，从而提高MCCD下非机构性死亡的覆盖率，提高准确性，并减少非机构性死亡死因报告的延迟。
国际注册报告识别号（IRRID）：DERR1-10.2196/72330。
