Background
Methods
Data collection activities in the BetterBirth Trial
Design of the DQMIS
Accuracy | Data are correct and reflect the truth |
Reliability | Data are consistently collected and entered in a standard way across data collectors |
Timeliness | Data are current due to routine data entry and available for near real-time reporting |
Completeness | There are no missing essential data elements |
Precision | Data have necessary detail to address research questions and management requirements |
Integrity | Data are secure and protected from bias or manipulation |
Dimensions of data quality | ||||||
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Functional components of the DQMIS | Accuracy | Reliability | Timeliness | Completeness | Precision | Integrity |
M&E team to support data management and quality | X | X | X | X | X | X |
SOPs and tools for data collection | X | X | X | X | X | |
Training for data quality | X | X | X | X | ||
Electronic data collection and reporting system | X | X | X | X | X | X |
DQA protocol, including data collection audits, rapid data feedback, and supportive supervision | X | X |
Functional components of the DQMIS
Data source | Data collection process | Audit process | Intensive phase target and duration | Monitoring phase target and frequency |
---|---|---|---|---|
Accuracy of observation of birth attendant practices
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Birth practices performed by birth attendant during deliveries | Direct observation of deliveries with data entry into paper-based checklist by facility-based observers | Simultaneous observation by supervisor | 100% accuracy on three consecutive simultaneous observations of each of four observation points (OPs); first 4 weeks after hire | 100% accuracy on three consecutive simultaneous observations at each OP (OP1, OP2, OP3, OP4); every 3 months |
Accuracy of data entry
| ||||
Observation checklist of birth attendant practices | Data entry of paper-based delivery observation data into electronic data-entry app by facility-based observers | Double data entry by supervisors | 100% accuracy on two sets of 10 sequentially entered forms; first 4 weeks after hire | 100% accuracy on one set of 10 sequentially entered forms; every 3 months |
Facility registers | Extraction of patient data from paper-based facility registers into paper-based study register by facility-based data collectors | Cross verification of extracted data with facility-based register data by supervisors | No intensive phase | 100% accuracy on a consecutive set of 10 patients’ extracted register information; monthly |
Study register | Data entry of patient data from paper-based study register to electronic data entry app by facility-based data collectors | Double data entry by supervisors | No intensive phase | 100% accuracy on a consecutive set of 10 patients’ register information; monthly |
Accuracy of patient-reported outcomes
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Patient-reported outcomes | Call center staff contact patients to assess maternal and neonatal mortality and seven maternal morbidities using standardized data collection tool | Recorded call review and double data entry into electronic data entry app by supervisor | 100% accuracy on four sets of 10 sequentially reviewed calls; first 4 weeks after hire | 100% accuracy on four sets of 10 sequentially reviewed calls; every 3 months |
Data analysis
Results
Completeness, precision, and integrity
Timeliness and reliability
Proportion and accuracy of trial data audited
Data collection activity | Total forms (N) | Forms audited (n) | Proportion of total forms audited (%) | Forms audited with total accuracy (n) | Proportion of forms audited with total accuracy (%) |
---|---|---|---|---|---|
Observation of birth attendant practices | |||||
OP1: On admission | 4886 | 436 | 8.92% | 431 | 98.85% |
OP2: Just before delivery | 5000 | 479 | 9.58% | 445 | 92.90% |
OP3: Within 1 min after delivery | 4998 | 461 | 9.22% | 454 | 98.48% |
OP4: Within 1 h after delivery | 4854 | 465 | 9.58% | 451 | 96.99% |
Data entry of observation checklist | 5933 | 2333 | 39.32% | 2141 | 91.77% |
Data extraction of patient data from facility register to study register | 136,057 | 10,341 | 7.60% | 10,290 | 99.51% |
Data entry of patient data from study register to app | 136,057 | 8221 | 6.04% | 8155 | 99.20% |
Patient-reported outcomes | 110,475 | 2400 | 2.17% | 2350 | 97.92% |
Overall | 408,260 | 25,136 | 6.16% | 24,717 | 98.33% |
Accuracy of trial data over time
Accuracy of data collectors over time
Data collection activity | RR (95% CI) |
p value |
---|---|---|
Observation of birth-attendant practices | ||
OP1: On admission | 1.0003 (0.9995-1.0011) | 0.4140 |
OP2: Just before delivery | 1.0043 (1.0006-1.0081) | 0.0242 |
OP3: Within 1 min after delivery | 1.0015 (1.0003-1.0027) | 0.0119 |
OP4: Within 1 h after delivery | 1.0019 (0.9999-1.0039) | 0.0679 |
Data entry of observation checklist | 1.0006 (1.0000-1.0012) | 0.0366 |
Data extraction of patient data from facility register to study register | 1.0000 (1.0000-1.0001) | 0.7218 |
Data entry of patient data from study register to app | 1.0000 (1.0000-1.0001) | 0.0473 |
Patient-reported outcomes | 1.0003 (1.0000-1.0005) | 0.0304 |
Total combined trend in accuracy | 1.0001 (1.0000-1.0002) | 0.0004 |