Extraction form for project: Management of Infantile Epilepsies

Design Details

1. Study Design
Single Choice
RCT
Nonrandomized comparative study
Pre/post observational study
2. Country
3. Total sample size
4. Intervention Type
Single Choice
Pharmacological
Dietary
Surgery
5. Funding source

Arm Details

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

Sample Characteristics

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

Outcome Details

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

Risk of Bias Assessment

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

Suggested Arms

NameDescription
Carbamazepine
Hemispherectomy/hemispherotomy
Ketogenic Diet
Lamotrigine
Levetiracetam
Modified Atkins Diet
Other resective surgery
Phenobarbital
Phenytoin
Rufinamide
Stiripentol
Topiramate
Total All Arms combined
Valproate
Valproate + Levetiracetam
Vigabatrin

Please see downloadable data for more

Suggested Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)
CategoricalAdverse Event
CategoricalPercent reduction in seizures from baseline
CategoricalSeizure freedom
CategoricalSeizure reduction/effective (50-90% reduction)
CategoricalSeizure reduction/effective (90-99% reduction)
CategoricalSeizure reduction/effective (<50% reduction)
CategoricalSeizure reduction/effective (>50% reduction)

Please see downloadable data for more