Extraction form for project: Management of Infantile Epilepsies

Design Details

1. Study Design
2. Country
3. Total sample size
4. Intervention Type
5. Funding source

Arms

Arm NameArm Description
Topiramate

Arm Details

1. Sample size for arm
Topiramate
2. Inclusion Criteria
Topiramate
3. Exclusion Criteria
Topiramate
4. Treatment details
Topiramate

Sample Characteristics

1. Gender, number of male
Topiramate
2. Gender, percentage of male
Topiramate
3. Age at intervention (mean)
Topiramate
4. Age at intervention (SD)
Topiramate
5. Age at intervention (range)
Topiramate
6. Age at intervention (median)
Topiramate
7. Seizure types and/or etiology
Topiramate
8. Prior treatment
Topiramate
9. Comments
Topiramate

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
CategoricalSeizure freedom
  • All Participants
  • Baseline
CategoricalSeizure reduction/effective (>50% reduction)
  • All Participants
  • Baseline
CategoricalSeizure reduction/effective (<50% reduction)
  • All Participants
  • Baseline
CategoricalEither a doubling of seizure frequency OR the appearance of new types of seizures
  • All Participants
  • Baseline

Outcome Details

1. For RCTs: Generation of randomization sequence
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure reduction/effective (<50% reduction)
Either a doubling of seizure frequency OR the appearance of new types of seizures
2. For RCTs: Allocation concealment
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure reduction/effective (<50% reduction)
Either a doubling of seizure frequency OR the appearance of new types of seizures
3. For RCTs: Baseline imbalance
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure reduction/effective (<50% reduction)
Either a doubling of seizure frequency OR the appearance of new types of seizures
4. For RCTs: Patient blinded
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure reduction/effective (<50% reduction)
Either a doubling of seizure frequency OR the appearance of new types of seizures
5. For RCTs: Staff blinded
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure reduction/effective (<50% reduction)
Either a doubling of seizure frequency OR the appearance of new types of seizures
6. For RCTs: Differential ancillary treatments
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure reduction/effective (<50% reduction)
Either a doubling of seizure frequency OR the appearance of new types of seizures
7. For RCTs: Adherence
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure reduction/effective (<50% reduction)
Either a doubling of seizure frequency OR the appearance of new types of seizures
8. For RCTs: Analytic approach to address departures from intended intervention
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure reduction/effective (<50% reduction)
Either a doubling of seizure frequency OR the appearance of new types of seizures
9. For RCTs: Data on at least 80% of those enrolled
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure reduction/effective (<50% reduction)
Either a doubling of seizure frequency OR the appearance of new types of seizures
10. For RCTs: Differential dropout <=15%
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure reduction/effective (<50% reduction)
Either a doubling of seizure frequency OR the appearance of new types of seizures
11. For RCTs: Standard way to measure the outcome
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure reduction/effective (<50% reduction)
Either a doubling of seizure frequency OR the appearance of new types of seizures
12. For RCTs: Blinded outcome assessor
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure reduction/effective (<50% reduction)
Either a doubling of seizure frequency OR the appearance of new types of seizures
13. For RCTs: Bias in selection of reported results
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure reduction/effective (<50% reduction)
Either a doubling of seizure frequency OR the appearance of new types of seizures
14. For nonrandomized comparative studies: Confounding
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure reduction/effective (<50% reduction)
Either a doubling of seizure frequency OR the appearance of new types of seizures
15. For nonrandomized comparative studies: Selection into study
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure reduction/effective (<50% reduction)
Either a doubling of seizure frequency OR the appearance of new types of seizures
16. For nonrandomized comparative studies: Classification of interventions
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure reduction/effective (<50% reduction)
Either a doubling of seizure frequency OR the appearance of new types of seizures
17. For nonrandomized comparative studies: Differential ancillary treatments
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure reduction/effective (<50% reduction)
Either a doubling of seizure frequency OR the appearance of new types of seizures
18. For nonrandomized comparative studies: Adherence
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure reduction/effective (<50% reduction)
Either a doubling of seizure frequency OR the appearance of new types of seizures
19. For nonrandomized comparative studies: Data on at least 80% of those enrolled
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure reduction/effective (<50% reduction)
Either a doubling of seizure frequency OR the appearance of new types of seizures
20. For nonrandomized comparative studies: Differential dropout <=15%
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure reduction/effective (<50% reduction)
Either a doubling of seizure frequency OR the appearance of new types of seizures
21. For nonrandomized comparative studies: Standard way to measure the outcome
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure reduction/effective (<50% reduction)
Either a doubling of seizure frequency OR the appearance of new types of seizures
22. For nonrandomized comparative studies: Blinded outcome assessor
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure reduction/effective (<50% reduction)
Either a doubling of seizure frequency OR the appearance of new types of seizures
23. For nonrandomized comparative studies: Bias in selection of reported result
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure reduction/effective (<50% reduction)
Either a doubling of seizure frequency OR the appearance of new types of seizures
24. For single arm studies: Does the design or analysis control account for important confounding and modifying variables through matching, stratification, multivariable analysis, or other approaches?
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure reduction/effective (<50% reduction)
Either a doubling of seizure frequency OR the appearance of new types of seizures
25. For single arm studies: Did researchers rule out any impact from a concurrent intervention or an unintended exposure that might bias results?
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure reduction/effective (<50% reduction)
Either a doubling of seizure frequency OR the appearance of new types of seizures
26. For single arm studies: Did the study maintain fidelity to the intervention protocol?
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure reduction/effective (<50% reduction)
Either a doubling of seizure frequency OR the appearance of new types of seizures
27. For single arm studies: If attrition (overall or differential nonresponse, dropout, loss to follow-up, or exclusion of participants) was a concern, were missing data handled appropriately (e.g., intention-to-treat analysis and imputation)?
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure reduction/effective (<50% reduction)
Either a doubling of seizure frequency OR the appearance of new types of seizures
28. For single arm studies: Were the outcome assessors blinded to the intervention or exposure status of participants?
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure reduction/effective (<50% reduction)
Either a doubling of seizure frequency OR the appearance of new types of seizures
29. For single arm studies: Were interventions/exposures assessed/defined using valid and reliable measures, implemented consistently across all study participants?
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure reduction/effective (<50% reduction)
Either a doubling of seizure frequency OR the appearance of new types of seizures
30. For single arm studies: Were outcomes assessed/defined using valid and reliable measures, implemented consistently across all study participants?
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure reduction/effective (<50% reduction)
Either a doubling of seizure frequency OR the appearance of new types of seizures
31. For single arm studies: Were confounding variables assessed using valid and reliable measures, implemented consistently across all study participants?
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure reduction/effective (<50% reduction)
Either a doubling of seizure frequency OR the appearance of new types of seizures
32. For single arm studies: Were the potential outcomes prespecified by the researchers? Are all prespecified outcomes reported?
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure reduction/effective (<50% reduction)
Either a doubling of seizure frequency OR the appearance of new types of seizures

Risk of Bias Assessment

1. For Risk of Bias Assessment results, see Outcome Details section.

Results

Categorical


Seizure freedom

All Participants
Descriptive StatisticsBetween Arm Comparisons
Topiramate
Baseline
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Topiramate

Seizure reduction/effective (>50% reduction)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Topiramate
Baseline
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Topiramate

Seizure reduction/effective (<50% reduction)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Topiramate
Baseline
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Topiramate

Either a doubling of seizure frequency OR the appearance of new types of seizures

All Participants
Descriptive StatisticsBetween Arm Comparisons
Topiramate
Baseline
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Topiramate