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
LevetiracetamInitially 10 mg/kg/day titrated up to 60 mg/kg/day. 26% ended at <30 mg/kg/day, 52% took 30-40 mg/kg/day, and the other 22% took >40 mg/kg/day.

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

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
CategoricalSeizure FreedomSeizure Freedom
  • All Participants
  • Baseline
CategoricalAdverse EventBehavioral side effects
  • All Participants
  • Median 12 months
CategoricalAdverse EventBiochemical side effects
  • All Participants
  • Median 12 months
CategoricalAdverse EventHematological side effects
  • All Participants
  • Median 12 months
CategoricalAdverse EventIrritability
  • All Participants
  • Median 12 months
CategoricalAdverse EventWithdrawal due to AE
  • All Participants
  • Median 12 months

Outcome Details

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

Risk of Bias Assessment

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

Results

Categorical


Seizure Freedom (Seizure Freedom)

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

Adverse Event (Behavioral side effects)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Levetiracetam
Median 12 months
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Levetiracetam

Adverse Event (Biochemical side effects)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Levetiracetam
Median 12 months
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Levetiracetam

Adverse Event (Hematological side effects)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Levetiracetam
Median 12 months
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Levetiracetam

Adverse Event (Irritability)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Levetiracetam
Median 12 months
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Levetiracetam

Adverse Event (Withdrawal due to AE)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Levetiracetam
Median 12 months
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Levetiracetam