Physician Versus Computer Coding of Verbal Autopsies

June 19, 2016 updated by: Centre for Global Health Research, Toronto

Physician Versus Computer Coding of Verbal Autopsies, a Randomised Control Trial

The objective of this study is to compare the performance of computer-coded verbal autopsies (CCVA) to physician-coded verbal autopsies (PCVA) at the population level. In order to do so a randomised control trial is being conducted in five districts of India. In each district, 50% of deaths are randomly selected for PCVA and the rest for CCVA. The cause of death 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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

  1. Random 2-5% of cases will be re-interviewed by surveyors with the Quality Control Survey
  2. 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Rehana Begum, MD
  • Phone Number: +919945908671
  • Email: BegumR@smh.ca

Study Contact Backup

Study Locations

  • India
    • Gujarat
      • Karamsad, Gujarat, India, 388325
    • Maharashtra
      • Mumbai, Maharashtra, India, 400 012
        • Recruiting
        • Tata Memorial Centre
        • Contact:
      • Mumbai, Maharashtra, India, 400 088
        • Completed
        • International Institute of Population Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All deaths that have occurred in the last five years

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Physician Coded Verbal Autopsy

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
Comparing the performance of computer coded verbal autopsies (CCVA) to physician coded verbal autopsies (PCVA) at the population level.
Other Names:
  • PCVA vs. CCVA
EXPERIMENTAL: Computer Coded Verbal Autopsy

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
Comparing the performance of computer coded verbal autopsies (CCVA) to physician coded verbal autopsies (PCVA) at the population level.
Other Names:
  • PCVA vs. CCVA

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Equivalence (CSMF Accuracy) of cause of death distribution between physician versus computer coded verbal autopsies
Time Frame: 1 year
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
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
Time Frame: 1 year
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
1 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
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
Time Frame: 1 year
Household preference of short verbal autopsy questionnaire with narrative versus a long questionnaire without a narrative
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre for Global Health Research, Toronto

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Tata Memorial Hospital
International Institute for Population Sciences
HM Patel Center for Medical Care and Education

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Abhishek Singh, PhD, Associate Professor, International Institute of Population Sciences
  • Principal Investigator: Atul Budukh, MD, Assistant Professor Epidemiology, Tata Memorial Centre
  • Principal Investigator: Dinesh Kumar, MD, Associate Professor, HM Patel Center for Medical Care and Education

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2015

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 23, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 23, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PCVA vs CCVA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Personal identifiers within each collected verbal autopsy will be anonymized. This anonymized dataset will be made publically available.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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