Physician Versus Computer Coding of Verbal Autopsies, a Randomised Control Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 12,500
- 试验地点
- 3
- 主要终点
- Equivalence (CSMF Accuracy) of cause of death distribution between physician versus computer coded verbal autopsies
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All deaths that have occurred in the last five years
排除标准
- 未提供
研究组 & 干预措施
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).
干预措施: Physician versus Computer Coded Verbal Autopsy (Other)
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.
干预措施: Physician versus Computer Coded Verbal Autopsy (Other)
结局指标
主要结局
Equivalence (CSMF Accuracy) of cause of death distribution between physician versus computer coded verbal autopsies
时间窗: 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
次要结局
- Equivalence of cause of death assignment at the population (CSMF Accuracy) and individual (sensitivity) levels of physician versus lay surveyor collected verbal autopsies(1 year)