Physician Versus Computer Coding of Verbal Autopsies | NCT02810366

NCT02810366

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
International Institute for Population Sciences	UNKNOWN
Tata Memorial Hospital	OTHER_GOV
HM Patel Center for Medical Care and Education	UNKNOWN

Oversight Module

Description Module

Detailed Description

BACKGROUND

Most deaths in low and middle-income countries occur out of hospital and without medical attention and certification at the time of death. Hence, information on causes of death (COD) is lacking. In these settings, verbal autopsies (VAs), typically involving lay non-medical interviews of living family members or close associates of the deceased about the details of death, with subsequent assignment of COD by physician, can be used to estimate COD patterns.

Although VA is being commonly used for acquiring community-based COD data, its application and mode of assignment of COD may vary. The choice of physician-certified verbal autopsy (PCVA) coding versus computer-coded verbal autopsy methods (CCVA) has been widely debated. Both these methods have limitations. While PCVA methods suffer from inter and intra-observer differences in coding in addition to physician time consumption and expense, the accuracy of CCVA methods which are faster and less expensive than PCVA have not been assessed in different settings. A literature search yielded only one study that have systematically assessed the performance of four computer-coded verbal autopsy methods for COD assignment compared with physician coding of VAs on 24,000 deaths in low and middle-income countries (Miasnikof et al. 2015).

Here the investigators propose the first ever randomised control trial assessing PCVA versus CCVA at the population level.

STUDY DESIGN

This randomised control trial will be conducted in three states of India; a total of 12,500 deaths that occurred in the last five years will be collected via VA. In each district (five districts across the three states - see below), 50% of deaths are randomly selected for PCVA and the rest for CCVA. The COD distribution for both groups are then compared within each district. If the performance of PCVA and CCVA are comparable, the attained distributions should be similar.

Study districts in India (x number of anticipated VAs to be collected from approx. y number of households):

Amravati, Maharashtra (2500 VAs from ~12,500 households)
Anand and Kheda districts, Gujarat (5000 VAs from ~25,000 households)
Sangrur and Mansa districts, Punjab (5000 VAs from ~25,000 households)

OBJECTIVES

Primary Objective: To assess physician versus computer coding of VAs at the population level - Do computer algorithms perform as well as physician coding of VAs when determining the COD distribution at the population level.
Secondary Objective: To assess the quality of physician versus lay surveyor VA data collection - Does the quality of symptom information collected or final COD assigned differ when a physician versus a lay person carries out the VA data collection.
Tertiary Objective: To assess household preference of short VA questionnaire with narrative versus a long questionnaire without a narrative - Which VA instrument do households prefer.

DATA COLLECTION

Data collection for the study will proceed in two phases.

Phase 1: Enumeration and VA (short questionnaire with narrative, and long questionnaire with narrative) by lay data collectors. VA questionnaires were designed based on World Health Organization (WHO) recommendations.
Phase 2: Physician re-sampling for 50% of the VAs to be used for PCVA The data will be collected using a laptop/tablet in an electronic format in the local language.

Quality control/Quality Assurance:

Random 2-5% of cases will be re-interviewed by surveyors with the Quality Control Survey
An audio recording of the entire data collection will be done for quality control and monitoring.

ANALYSIS PLAN

Primary Objective: COD for 50% of VAs will be assigned by trained physicians using the Million Death Study (MDS) physician coding system; this includes dual, independent coding of VA records, disagreements resolved by reconciliation, and remaining cases by adjudication by a third physician. The assignment of CODs will be in line with the international classification of disease version 10 (ICD-10). The remaining 50% of deaths will be independently assigned COD by five leading CCVA algorithms. If the performance of PCVA and CCVA are comparable, the attained COD distributions at the population level should be similar, this "similarity" will be assessed by calculating the Cause Specific Mortality Fraction (CSMF) Accuracy for each algorithm's COD assignment in each district against the CSMF of the PCVAs in the respective district.
Secondary Objective: Half of the PCVAs in each district will be re-interviewed by physicians, and CODs will be assigned to these re-interviewed VAs using the MDS physician coding system described above. To assess concordance of COD assignment between lay person and physician collected VAs, the CSMF Accuracy will be calculated to determine concordance at the population level, while Sensitivity and Partial Chance Corrected Concordance (PCCC) will be calculated to assess similarity of COD assignment at the individual level.
Tertiary Objective: Respondents cooperation with the short VA questionnaire with narrative versus the long questionnaire without a narrative will be assessed to determine which VA instrument households prefer. A focus group with surveyors to receive their feedback on using both instruments in the field will also be conducted.

The results of this study will be presented as three separate trials (one trial per state). The results of the first trial will be used for hypothesis generation.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Physician Coded Verbal Autopsy	Active Comparator	Of the approximately 12,500 VAs collected, 50% in each district will be randomly collected using the "electronic Verbal Autopsy" (eVA) instrument. In addition to "general information" about the deceased (e.g. name, sex, age, etc.), this VA instrument contains a short checklist questionnaire to capture from the respondent the signs and symptoms noted during the final illness, followed by a free-text narrative. Cause of death for these VAs will be assigned by trained physicians using the MDS physician coding system; this includes dual, independent coding of VA records, disagreements resolved by reconciliation, and remaining cases by adjudication by a third physician. The assignment of cause of deaths will be in line with the international classification of disease version 10 (ICD-10).	Other: Physician versus Computer Coded Verbal Autopsy
Computer Coded Verbal Autopsy	Experimental	Of the approximately 12,500 VAs collected, 50% in each district will be randomly collected using the "Extended Symptom List" (ESL) VA instrument. In addition to "general information" about the deceased (e.g. name, sex, age, etc.), this VA instrument contains a long checklist questionnaire to capture from the respondent the signs and symptoms noted during the final illness. This VA instrument does not contain a free-text narrative. The cause of death for these VAs will be independently assigned by five leading computer-coding VA algorithms. The assignment of cause of deaths will be in line with 17 broad cause of death categories.	Other: Physician versus Computer Coded Verbal Autopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Physician versus Computer Coded Verbal Autopsy	Other	Comparing the performance of computer coded verbal autopsies (CCVA) to physician coded verbal autopsies (PCVA) at the population level.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Equivalence (CSMF Accuracy) of cause of death distribution between physician versus computer coded verbal autopsies	Use CSMF Accuracy to measure the equivalence of the cause of death distribution between the physician and computer coded VA arms of this study, in order to assess whether the performance of physician vs. computer coding of VAs are comparable at the population level	1 year

Secondary Outcomes

Measure	Description	Time Frame
Equivalence of cause of death assignment at the population (CSMF Accuracy) and individual (sensitivity) levels of physician versus lay surveyor collected verbal autopsies	For each of the deaths for which a VA was independently collected by a physician and a lay person, calculate the CSMF Accuracy and sensitivity of the causes of death assigned to these VAs, in order to assess if the final cause of death assigned differs when a physician versus a lay person conducts the VA data collection

Other Outcomes

Measure	Description	Time Frame
Number of households that responded "poorly" to the short verbal autopsy questionnaire with narrative versus a long questionnaire without a narrative, as reported by the surveyor	Household preference of short verbal autopsy questionnaire with narrative versus a long questionnaire without a narrative	1 year

Eligibility Module

Contacts/Locations Module

Name	Role	Phone	Extension	Email
Rehana Begum, MD	Contact	+919945908671		BegumR@smh.ca
Prabhat Jha, MD, PhD	Contact	+14168646042		prabhat.jha@utoronto.ca

Overall Officials

Name	Affiliation	Role
Abhishek Singh, PhD	Associate Professor, International Institute of Population Sciences	Principal Investigator
Atul Budukh, MD	Assistant Professor Epidemiology, Tata Memorial Centre	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
HM Patel Center for Medical Care and Education	Recruiting	Karamsad	Gujarat	388325	India

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24495312	Background	Leitao J, Desai N, Aleksandrowicz L, Byass P, Miasnikof P, Tollman S, Alam D, Lu Y, Rathi SK, Singh A, Suraweera W, Ram F, Jha P. Comparison of physician-certified verbal autopsy with computer-coded verbal autopsy for cause of death assignment in hospitalized patients in low- and middle-income countries: systematic review. BMC Med. 2014 Feb 4;12:22. doi: 10.1186/1741-7015-12-22.
24495855

IPD Sharing Statement Module