Fatal Outcome Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 12500 |
Est. completion date | December 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - All deaths that have occurred in the last five years Exclusion Criteria: |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
India | HM Patel Center for Medical Care and Education | Karamsad | Gujarat |
India | International Institute of Population Sciences | Mumbai | Maharashtra |
India | Tata Memorial Centre | Mumbai | Maharashtra |
Lead Sponsor | Collaborator |
---|---|
Centre for Global Health Research, Toronto | HM Patel Center for Medical Care and Education, International Institute for Population Sciences, Tata Memorial Hospital |
India,
Desai N, Aleksandrowicz L, Miasnikof P, Lu Y, Leitao J, Byass P, Tollman S, Mee P, Alam D, Rathi SK, Singh A, Kumar R, Ram F, Jha P. Performance of four computer-coded verbal autopsy methods for cause of death assignment compared with physician coding on 24,000 deaths in low- and middle-income countries. BMC Med. 2014 Feb 4;12:20. doi: 10.1186/1741-7015-12-20. — View Citation
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. Review. — View Citation
Miasnikof P, Giannakeas V, Gomes M, Aleksandrowicz L, Shestopaloff AY, Alam D, Tollman S, Samarikhalaj A, Jha P. Naive Bayes classifiers for verbal autopsies: comparison to physician-based classification for 21,000 child and adult deaths. BMC Med. 2015 Nov 25;13:286. doi: 10.1186/s12916-015-0521-2. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | No |
Primary | 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 | No |
Secondary | 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 | 1 year | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
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