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
PhenytoinOral treatment (N=33 had started on long-term oral administration after intravenous PHT, and the other N=22 had only received oral administration).

Arm Details

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

Sample Characteristics

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

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
CategoricalSeizure freedom
  • All Participants
  • 3 months
CategoricalSeizure reduction/effective (>50% reduction)
  • All Participants
  • 3 months
CategoricalAdverse EventAllergic reaction
  • All Participants
  • 3 months
CategoricalAdverse EventAnorexia
  • All Participants
  • 3 months
CategoricalAdverse EventAtaxia
  • All Participants
  • 3 months
CategoricalAdverse EventBehavior disturbances
  • All Participants
  • 3 months
CategoricalAdverse EventCognitive disturbances
  • All Participants
  • 3 months
CategoricalAdverse EventDrowsiness
  • All Participants
  • 3 months
CategoricalAdverse EventGingival hyperplasia
  • All Participants
  • 3 months
CategoricalAdverse EventHyperactivity
  • All Participants
  • 3 months
CategoricalAdverse EventLoss of weight
  • All Participants
  • 3 months
CategoricalAdverse EventMovement disorders
  • All Participants
  • 3 months
CategoricalAdverse EventSleep troubles
  • All Participants
  • 3 months
CategoricalAdverse EventVomiting
  • All Participants
  • 3 months

Outcome Details

1. For RCTs: Generation of randomization sequence
Seizure freedom
Seizure reduction/effective (>50% reduction)
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
2. For RCTs: Allocation concealment
Seizure freedom
Seizure reduction/effective (>50% reduction)
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
3. For RCTs: Baseline imbalance
Seizure freedom
Seizure reduction/effective (>50% reduction)
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
4. For RCTs: Patient blinded
Seizure freedom
Seizure reduction/effective (>50% reduction)
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
5. For RCTs: Staff blinded
Seizure freedom
Seizure reduction/effective (>50% reduction)
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
6. For RCTs: Differential ancillary treatments
Seizure freedom
Seizure reduction/effective (>50% reduction)
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
7. For RCTs: Adherence
Seizure freedom
Seizure reduction/effective (>50% reduction)
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
8. For RCTs: Analytic approach to address departures from intended intervention
Seizure freedom
Seizure reduction/effective (>50% reduction)
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
9. For RCTs: Data on at least 80% of those enrolled
Seizure freedom
Seizure reduction/effective (>50% reduction)
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
10. For RCTs: Differential dropout <=15%
Seizure freedom
Seizure reduction/effective (>50% reduction)
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
11. For RCTs: Standard way to measure the outcome
Seizure freedom
Seizure reduction/effective (>50% reduction)
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
12. For RCTs: Blinded outcome assessor
Seizure freedom
Seizure reduction/effective (>50% reduction)
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
13. For RCTs: Bias in selection of reported results
Seizure freedom
Seizure reduction/effective (>50% reduction)
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
14. For nonrandomized comparative studies: Confounding
Seizure freedom
Seizure reduction/effective (>50% reduction)
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
15. For nonrandomized comparative studies: Selection into study
Seizure freedom
Seizure reduction/effective (>50% reduction)
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
16. For nonrandomized comparative studies: Classification of interventions
Seizure freedom
Seizure reduction/effective (>50% reduction)
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
17. For nonrandomized comparative studies: Differential ancillary treatments
Seizure freedom
Seizure reduction/effective (>50% reduction)
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
18. For nonrandomized comparative studies: Adherence
Seizure freedom
Seizure reduction/effective (>50% reduction)
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
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
Seizure reduction/effective (>50% reduction)
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
20. For nonrandomized comparative studies: Differential dropout <=15%
Seizure freedom
Seizure reduction/effective (>50% reduction)
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
21. For nonrandomized comparative studies: Standard way to measure the outcome
Seizure freedom
Seizure reduction/effective (>50% reduction)
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
22. For nonrandomized comparative studies: Blinded outcome assessor
Seizure freedom
Seizure reduction/effective (>50% reduction)
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
23. For nonrandomized comparative studies: Bias in selection of reported result
Seizure freedom
Seizure reduction/effective (>50% reduction)
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
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
Seizure reduction/effective (>50% reduction)
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
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
Seizure reduction/effective (>50% reduction)
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
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
Seizure reduction/effective (>50% reduction)
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
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
Seizure reduction/effective (>50% reduction)
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
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
Seizure reduction/effective (>50% reduction)
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
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
Seizure reduction/effective (>50% reduction)
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
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
Seizure reduction/effective (>50% reduction)
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
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
Seizure reduction/effective (>50% reduction)
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
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
Seizure reduction/effective (>50% reduction)
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
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

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

Seizure reduction/effective (>50% reduction)

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

Adverse Event (Allergic reaction)

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

Adverse Event (Anorexia)

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

Adverse Event (Ataxia)

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

Adverse Event (Behavior disturbances)

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

Adverse Event (Cognitive disturbances)

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

Adverse Event (Drowsiness)

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

Adverse Event (Gingival hyperplasia)

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

Adverse Event (Hyperactivity)

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

Adverse Event (Loss of weight)

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

Adverse Event (Movement disorders)

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

Adverse Event (Sleep troubles)

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

Adverse Event (Vomiting)

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