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Physician Versus Computer Coding of Verbal Autopsies

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ClinicalTrials.gov Identifier: NCT02810366
Recruitment Status : Unknown
Verified June 2016 by Centre for Global Health Research, Toronto.
Recruitment status was:  Recruiting
First Posted : June 23, 2016
Last Update Posted : June 23, 2016
Sponsor:
Collaborators:
International Institute for Population Sciences
Tata Memorial Hospital
HM Patel Center for Medical Care and Education
Information provided by (Responsible Party):
Centre for Global Health Research, Toronto

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Fatal Outcome Other: Physician versus Computer Coded Verbal Autopsy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Physician Versus Computer Coding of Verbal Autopsies, a Randomised Control Trial
Study Start Date : September 2015
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : December 2016

Arm Intervention/treatment
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 Name: 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 Name: PCVA vs. CCVA




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All deaths that have occurred in the last five years

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02810366


Contacts
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Contact: Rehana Begum, MD +919945908671 BegumR@smh.ca
Contact: Prabhat Jha, MD, PhD +14168646042 prabhat.jha@utoronto.ca

Locations
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India
HM Patel Center for Medical Care and Education Recruiting
Karamsad, Gujarat, India, 388325
Contact: Dinesh Kumar, MD       drdineshkl@charutarhealth.org   
Tata Memorial Centre Recruiting
Mumbai, Maharashtra, India, 400 012
Contact: Atul Budukh, MD    +91-9920863064    atul.budukh@gmail.com   
International Institute of Population Sciences Completed
Mumbai, Maharashtra, India, 400 088
Sponsors and Collaborators
Centre for Global Health Research, Toronto
International Institute for Population Sciences
Tata Memorial Hospital
HM Patel Center for Medical Care and Education
Investigators
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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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre for Global Health Research, Toronto
ClinicalTrials.gov Identifier: NCT02810366    
Other Study ID Numbers: PCVA vs CCVA
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: June 23, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Personal identifiers within each collected verbal autopsy will be anonymized. This anonymized dataset will be made publically available.
Keywords provided by Centre for Global Health Research, Toronto:
Verbal Autopsy
Physician-coded verbal autopsy
Computer-coded verbal autopsy
InterVA
Naive Bayes Classifier (NBC)
Tariff
InSilicoVA
Randomised Control Trial
SmartVA
King-Lu