# 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 Name | Arm 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

- All Participants
- Baseline
- All Participants
- Baseline
- All Participants
- Baseline
- All Participants
- Baseline

Type | Domain | Specific measurement (i.e., tool/definition/specific outcome) | Populations | Timepoints |
---|---|---|---|---|

Categorical | Seizure freedom | |||

Categorical | Seizure reduction/effective (>50% reduction) | |||

Categorical | Seizure reduction/effective (<50% reduction) | |||

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

# 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

Descriptive Statistics | Between Arm Comparisons | |||
---|---|---|---|---|

Topiramate | ||||

Baseline | ||||

Total (N analyzed) | Odds Ratio (OR) | |||

Events | 95% CI low (OR) | |||

Percentage | 95% CI high (OR) | |||

p value | ||||

Within Arm Comparisons | Net Comparisons | |||

Topiramate |

## Seizure reduction/effective (>50% reduction)

Descriptive Statistics | Between Arm Comparisons | |||
---|---|---|---|---|

Topiramate | ||||

Baseline | ||||

Total (N analyzed) | Odds Ratio (OR) | |||

Events | 95% CI low (OR) | |||

Percentage | 95% CI high (OR) | |||

p value | ||||

Within Arm Comparisons | Net Comparisons | |||

Topiramate |

## Seizure reduction/effective (<50% reduction)

Descriptive Statistics | Between Arm Comparisons | |||
---|---|---|---|---|

Topiramate | ||||

Baseline | ||||

Total (N analyzed) | Odds Ratio (OR) | |||

Events | 95% CI low (OR) | |||

Percentage | 95% CI high (OR) | |||

p value | ||||

Within Arm Comparisons | Net Comparisons | |||

Topiramate |

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

Descriptive Statistics | Between Arm Comparisons | |||
---|---|---|---|---|

Topiramate | ||||

Baseline | ||||

Total (N analyzed) | Odds Ratio (OR) | |||

Events | 95% CI low (OR) | |||

Percentage | 95% CI high (OR) | |||

p value | ||||

Within Arm Comparisons | Net Comparisons | |||

Topiramate |