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
Hemispherectomy

Arm Details

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

Sample Characteristics

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

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
CategoricalEngel outcome
  • All Participants
  • 6 months
  • 1 year
CategoricalAdverse EventHydrocephalus
  • Anatomical hemispherectomy (n=6), Hemidecortication (n=1)
  • 2 Functional hemispherectomy; 1 functional + hemidecortication
  • Baseline
CategoricalAdverse EventInfection
  • Anatomical hemispherectomy (n=6), Hemidecortication (n=1)
  • 2 Functional hemispherectomy; 1 functional + hemidecortication
  • Baseline
CategoricalAdverse EventSubdural fluid collection
  • Anatomical hemispherectomy (n=6), Hemidecortication (n=1)
  • Baseline
CategoricalAdverse EventCerebrospinal Fluid Leakage
  • Anatomical hemispherectomy (n=6), Hemidecortication (n=1)
  • Baseline
CategoricalAdverse EventTransient fever
  • Anatomical hemispherectomy (n=6), Hemidecortication (n=1)
  • Baseline
CategoricalSeizure freedom
  • All Participants
  • 6 months
  • 1 year
CategoricalFavorable outcome (Engel I or II)
  • All Participants
  • 6 months
  • 1 year

Outcome Details

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

Risk of Bias Assessment

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

Results

Categorical


Engel outcome

All Participants
Descriptive StatisticsBetween Arm Comparisons
Hemispherectomy
6 months
Engel Ib
Odds Ratio (OR)
Engel IIb
95% CI low (OR)
Engel Ia
95% CI high (OR)
Engel IIIa
p value
Engel IIa
Total (N analyzed)
Events
Percentage
1 year
Engel Ib
Odds Ratio (OR)
Engel IIb
95% CI low (OR)
Engel Ia
95% CI high (OR)
Engel IIIa
p value
Engel IIa
Total (N analyzed)
Events
Percentage
Within Arm ComparisonsNet Comparisons
Hemispherectomy

Adverse Event (Hydrocephalus)

Anatomical hemispherectomy (n=6), Hemidecortication (n=1)
Descriptive StatisticsBetween Arm Comparisons
Hemispherectomy
Baseline
Engel I or Ia
Odds Ratio (OR)
Engel Ib
95% CI low (OR)
Engel IIb
95% CI high (OR)
Engel Ia
p value
Engel IIIa
Engel IIa
Total (N analyzed)
Events
Percentage
Within Arm ComparisonsNet Comparisons
Hemispherectomy
2 Functional hemispherectomy; 1 functional + hemidecortication
Descriptive StatisticsBetween Arm Comparisons
Hemispherectomy
Baseline
Engel I or Ia
Odds Ratio (OR)
Engel Ib
95% CI low (OR)
Engel IIb
95% CI high (OR)
Engel Ia
p value
Engel IIIa
Engel IIa
Total (N analyzed)
Events
Percentage
Within Arm ComparisonsNet Comparisons
Hemispherectomy

Adverse Event (Infection)

Anatomical hemispherectomy (n=6), Hemidecortication (n=1)
Descriptive StatisticsBetween Arm Comparisons
Hemispherectomy
Baseline
Engel I or Ia
Odds Ratio (OR)
Engel Ib
95% CI low (OR)
Engel IIb
95% CI high (OR)
Engel Ia
p value
Engel IIIa
Engel IIa
Total (N analyzed)
Events
Percentage
Within Arm ComparisonsNet Comparisons
Hemispherectomy
2 Functional hemispherectomy; 1 functional + hemidecortication
Descriptive StatisticsBetween Arm Comparisons
Hemispherectomy
Baseline
Engel I or Ia
Odds Ratio (OR)
Engel Ib
95% CI low (OR)
Engel IIb
95% CI high (OR)
Engel Ia
p value
Engel IIIa
Engel IIa
Total (N analyzed)
Events
Percentage
Within Arm ComparisonsNet Comparisons
Hemispherectomy

Adverse Event (Subdural fluid collection)

Anatomical hemispherectomy (n=6), Hemidecortication (n=1)
Descriptive StatisticsBetween Arm Comparisons
Hemispherectomy
Baseline
Engel I or Ia
Odds Ratio (OR)
Engel Ib
95% CI low (OR)
Engel IIb
95% CI high (OR)
Engel Ia
p value
Engel IIIa
Engel IIa
Total (N analyzed)
Events
Percentage
Within Arm ComparisonsNet Comparisons
Hemispherectomy

Adverse Event (Cerebrospinal Fluid Leakage)

Anatomical hemispherectomy (n=6), Hemidecortication (n=1)
Descriptive StatisticsBetween Arm Comparisons
Hemispherectomy
Baseline
Engel I or Ia
Odds Ratio (OR)
Engel Ib
95% CI low (OR)
Engel IIb
95% CI high (OR)
Engel Ia
p value
Engel IIIa
Engel IIa
Total (N analyzed)
Events
Percentage
Within Arm ComparisonsNet Comparisons
Hemispherectomy

Adverse Event (Transient fever)

Anatomical hemispherectomy (n=6), Hemidecortication (n=1)
Descriptive StatisticsBetween Arm Comparisons
Hemispherectomy
Baseline
Engel I or Ia
Odds Ratio (OR)
Engel Ib
95% CI low (OR)
Engel IIb
95% CI high (OR)
Engel Ia
p value
Engel IIIa
Engel IIa
Total (N analyzed)
Events
Percentage
Within Arm ComparisonsNet Comparisons
Hemispherectomy

Seizure freedom

All Participants
Descriptive StatisticsBetween Arm Comparisons
Hemispherectomy
6 months
Engel I or Ia
Odds Ratio (OR)
Engel Ib
95% CI low (OR)
Engel IIb
95% CI high (OR)
Engel Ia
p value
Engel IIIa
Engel IIa
Total (N analyzed)
Events
Percentage
1 year
Engel I or Ia
Odds Ratio (OR)
Engel Ib
95% CI low (OR)
Engel IIb
95% CI high (OR)
Engel Ia
p value
Engel IIIa
Engel IIa
Total (N analyzed)
Events
Percentage
Within Arm ComparisonsNet Comparisons
Hemispherectomy

Favorable outcome (Engel I or II)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Hemispherectomy
6 months
Engel I or Ia
Odds Ratio (OR)
Engel Ib
95% CI low (OR)
Engel IIb
95% CI high (OR)
Engel Ia
p value
Engel IIIa
Engel IIa
Total (N analyzed)
Events
Percentage
1 year
Engel I or Ia
Odds Ratio (OR)
Engel Ib
95% CI low (OR)
Engel IIb
95% CI high (OR)
Engel Ia
p value
Engel IIIa
Engel IIa
Total (N analyzed)
Events
Percentage
Within Arm ComparisonsNet Comparisons
Hemispherectomy