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
Anatomic hemispherectomy, Functional hemispherectomy, Peri-insular hemispherectomy

Arm Details

1. Sample size for arm
Anatomic hemispherectomy, Functional hemispherectomy, Peri-insular hemispherectomy
2. Inclusion Criteria
Anatomic hemispherectomy, Functional hemispherectomy, Peri-insular hemispherectomy
3. Exclusion Criteria
Anatomic hemispherectomy, Functional hemispherectomy, Peri-insular hemispherectomy
4. Treatment details
Anatomic hemispherectomy, Functional hemispherectomy, Peri-insular hemispherectomy

Sample Characteristics

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

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
CategoricalEngel Outcomes
  • All Participants
  • Baseline
CategoricalSeizure freedom
  • All Participants
  • Baseline
CategoricalFavorable outcome (Engel 1 or II)
  • All Participants
  • Baseline
CategoricalAdverse EventVP shunt
  • 10 Anatomic hemispherectomy
  • 4 Functional hemispherectomy, 1 Peri-insular hemispherectomy
  • Baseline

Outcome Details

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

Risk of Bias Assessment

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

Results

Categorical


Engel Outcomes

All Participants
Descriptive StatisticsBetween Arm Comparisons
Anatomic hemispherectomy, Functional hemispherectomy, Peri-insular hemispherectomy
Baseline
Engel Ia
Odds Ratio (OR)
Engel I
95% CI low (OR)
Engel II
95% CI high (OR)
Engel III or IIIa
p value
Engel IV
Total (N analyzed)
Events
Percentage
Within Arm ComparisonsNet Comparisons
Anatomic hemispherectomy, Functional hemispherectomy, Peri-insular hemispherectomy

Seizure freedom

All Participants
Descriptive StatisticsBetween Arm Comparisons
Anatomic hemispherectomy, Functional hemispherectomy, Peri-insular hemispherectomy
Baseline
Engel Ia
Odds Ratio (OR)
Engel I
95% CI low (OR)
Engel II
95% CI high (OR)
Engel III or IIIa
p value
Engel IV
Total (N analyzed)
Events
Percentage
Within Arm ComparisonsNet Comparisons
Anatomic hemispherectomy, Functional hemispherectomy, Peri-insular hemispherectomy

Favorable outcome (Engel 1 or II)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Anatomic hemispherectomy, Functional hemispherectomy, Peri-insular hemispherectomy
Baseline
Engel Ia
Odds Ratio (OR)
Engel I
95% CI low (OR)
Engel II
95% CI high (OR)
Engel III or IIIa
p value
Engel IV
Total (N analyzed)
Events
Percentage
Within Arm ComparisonsNet Comparisons
Anatomic hemispherectomy, Functional hemispherectomy, Peri-insular hemispherectomy

Adverse Event (VP shunt)

10 Anatomic hemispherectomy
Descriptive StatisticsBetween Arm Comparisons
Anatomic hemispherectomy, Functional hemispherectomy, Peri-insular hemispherectomy
Baseline
Engel Ia
Odds Ratio (OR)
Engel I
95% CI low (OR)
Engel II
95% CI high (OR)
Engel III or IIIa
p value
Engel IV
Total (N analyzed)
Events
Percentage
Within Arm ComparisonsNet Comparisons
Anatomic hemispherectomy, Functional hemispherectomy, Peri-insular hemispherectomy
4 Functional hemispherectomy, 1 Peri-insular hemispherectomy
Descriptive StatisticsBetween Arm Comparisons
Anatomic hemispherectomy, Functional hemispherectomy, Peri-insular hemispherectomy
Baseline
Engel Ia
Odds Ratio (OR)
Engel I
95% CI low (OR)
Engel II
95% CI high (OR)
Engel III or IIIa
p value
Engel IV
Total (N analyzed)
Events
Percentage
Within Arm ComparisonsNet Comparisons
Anatomic hemispherectomy, Functional hemispherectomy, Peri-insular hemispherectomy