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
TopiramateTopiramate dosing started at 1 mg/kg/d for the first week, then titrated over two-week intervals to a maximum of 5 mg/kg/d. Of the full patient group (N=151), 52 were on topiramate monotherapy and 99 on polytherapy

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
CategoricalAdverse EventHypohydrosis
  • All Participants
  • Average 13.4 months

Outcome Details

1. For RCTs: Generation of randomization sequence
Adverse Event
2. For RCTs: Allocation concealment
Adverse Event
3. For RCTs: Baseline imbalance
Adverse Event
4. For RCTs: Patient blinded
Adverse Event
5. For RCTs: Staff blinded
Adverse Event
6. For RCTs: Differential ancillary treatments
Adverse Event
7. For RCTs: Adherence
Adverse Event
8. For RCTs: Analytic approach to address departures from intended intervention
Adverse Event
9. For RCTs: Data on at least 80% of those enrolled
Adverse Event
10. For RCTs: Differential dropout <=15%
Adverse Event
11. For RCTs: Standard way to measure the outcome
Adverse Event
12. For RCTs: Blinded outcome assessor
Adverse Event
13. For RCTs: Bias in selection of reported results
Adverse Event
14. For nonrandomized comparative studies: Confounding
Adverse Event
15. For nonrandomized comparative studies: Selection into study
Adverse Event
16. For nonrandomized comparative studies: Classification of interventions
Adverse Event
17. For nonrandomized comparative studies: Differential ancillary treatments
Adverse Event
18. For nonrandomized comparative studies: Adherence
Adverse Event
19. For nonrandomized comparative studies: Data on at least 80% of those enrolled
Adverse Event
20. For nonrandomized comparative studies: Differential dropout <=15%
Adverse Event
21. For nonrandomized comparative studies: Standard way to measure the outcome
Adverse Event
22. For nonrandomized comparative studies: Blinded outcome assessor
Adverse Event
23. For nonrandomized comparative studies: Bias in selection of reported result
Adverse Event
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?
Adverse Event
25. For single arm studies: Did researchers rule out any impact from a concurrent intervention or an unintended exposure that might bias results?
Adverse Event
26. For single arm studies: Did the study maintain fidelity to the intervention protocol?
Adverse Event
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)?
Adverse Event
28. For single arm studies: Were the outcome assessors blinded to the intervention or exposure status of participants?
Adverse Event
29. For single arm studies: Were interventions/exposures assessed/defined using valid and reliable measures, implemented consistently across all study participants?
Adverse Event
30. For single arm studies: Were outcomes assessed/defined using valid and reliable measures, implemented consistently across all study participants?
Adverse Event
31. For single arm studies: Were confounding variables assessed using valid and reliable measures, implemented consistently across all study participants?
Adverse Event
32. For single arm studies: Were the potential outcomes prespecified by the researchers? Are all prespecified outcomes reported?
Adverse Event

Risk of Bias Assessment

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

Results

Categorical


Adverse Event (Hypohydrosis)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Topiramate
Average 13.4 months
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Topiramate