Comparison · NCT04290975-sae
Task-shifted Epilepsy Care Arm (TSC) vs Enhanced Usual Epilepsy Care Arm (EUC): serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Task-shifted Epilepsy Care Arm (TSC) vs Enhanced Usual Epilepsy Care Arm (EUC): serious adverse events. Trial comparisons, record NCT04290975-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04290975-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.039 | 0.0279 | 0.0543 | wilson | |
| Risk in group 2 | 0.0303 | 0.0206 | 0.0443 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00874 | -0.00915 | 0.0268 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.29 | 0.773 | 2.15 | log | |
| Odds ratio, group 1 over group 2 | 1.3 | 0.766 | 2.21 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Task-shifted Epilepsy Care Arm (TSC) than on Enhanced Usual Epilepsy Care Arm (EUC) | 114 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Task-shifted Epilepsy Care Arm (TSC) | In the task-shifted arm composed of thirty clusters, each cluster being a primary healthcare center (PHC) serving a local community, all children who screened positive for untreated epilepsy underwent a diagnostic evaluation by an epilepsy-trained community health worker (CHW), supervised remotely by a physician with epilepsy expertise. Children who were diagnosed with untreated epilepsy after screening positive for epilepsy were prescribed anti-seizure medication (ASM) by the epilepsy-trained CHW according to a task-shifted protocol, and received follow-up care from an epilepsy-trained CHW, according to the specified task-shifted epilepsy protocol. These epilepsy-trained CHWs were supervised remotely by physicians with expertise in epilepsy, and were able to consult physicians with questions on an as-needed basis. | 33 | 846 | EG000 |
| Group 2 | Enhanced Usual Epilepsy Care Arm (EUC) | In the enhanced usual care arm composed of thirty clusters, each cluster being a primary healthcare center (PHC) serving a local community, all children who screened positive for epilepsy were referred to a physician according to standard medical practice at the PHC. The diagnostic evaluation was performed by the physician in the community. Children diagnosed by the physician as having epilepsy were prescribed anti-seizure medication (ASM) and received follow-up care from a physician.~In addition to the usual epilepsy care provided by the physician, each child in the EUC arm was followed by an epilepsy-trained CHW, who followed the child's progress, helped the family navigate the healthcare system (including finding a physician). The usual physician care of epilepsy was enhanced by the support of a CHW, but epilepsy diagnosis and treatment was provided by a physician, not by the epilepsy-trained CHW. | 25 | 826 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse event data were collection on study subjects from the time of enrollment until 1 month after completion of the 24-month follow-up visit for the cluster randomized clinical trial.
Source ClinicalTrials.gov
Trial
- Title
- Bridging the Childhood Epilepsy Treatment Gap in Africa
- NCT number
- NCT04290975
- Phases
- NA
- Conditions
- Epilepsy
- Interventions
- Task-shifting epilepsy care to epilepsy-trained community health workers (CHWs), Enhanced usual care for epilepsy (EUC)
- Lead sponsor
- Vanderbilt University Medical Center
- Results first posted
- 2026-02-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04290975?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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