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
Hemispheric Surgeries
Lesionectomies ± cortical resections
Cortical resections

Arm Details

1. Sample size for arm
Hemispheric Surgeries
Lesionectomies ± cortical resections
Cortical resections
2. Inclusion Criteria
Hemispheric Surgeries
Lesionectomies ± cortical resections
Cortical resections
3. Exclusion Criteria
Hemispheric Surgeries
Lesionectomies ± cortical resections
Cortical resections
4. Treatment details
Hemispheric Surgeries
Lesionectomies ± cortical resections
Cortical resections

Sample Characteristics

1. Gender, number of male
Hemispheric Surgeries
Lesionectomies ± cortical resections
Cortical resections
Total
2. Gender, percentage of male
Hemispheric Surgeries
Lesionectomies ± cortical resections
Cortical resections
Total
3. Age at intervention (mean)
Hemispheric Surgeries
Lesionectomies ± cortical resections
Cortical resections
Total
4. Age at intervention (SD)
Hemispheric Surgeries
Lesionectomies ± cortical resections
Cortical resections
Total
5. Age at intervention (range)
Hemispheric Surgeries
Lesionectomies ± cortical resections
Cortical resections
Total
6. Age at intervention (median)
Hemispheric Surgeries
Lesionectomies ± cortical resections
Cortical resections
Total
7. Seizure types and/or etiology
Hemispheric Surgeries
Lesionectomies ± cortical resections
Cortical resections
Total
8. Prior treatment
Hemispheric Surgeries
Lesionectomies ± cortical resections
Cortical resections
Total
9. Comments
Hemispheric Surgeries
Lesionectomies ± cortical resections
Cortical resections
Total

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
CategoricalEngel outcome
  • All Participants
  • 1 year after surgery
CategoricalAdverse EventMortality
  • All Participants
  • ≥1 year after surgery
CategoricalAdverse EventBlood transfusion
  • All Participants
  • During operation
CategoricalAdverse EventAseptic meningitis
  • All Participants
  • Peri-operative
CategoricalSeizure frequency hemispherectomy/hemisphotomy
  • All Participants
  • Baseline
CategoricalSeizure frequency lesionectomy/cortical resection
  • All Participants
  • Baseline

Outcome Details

1. For RCTs: Generation of randomization sequence
Engel outcome
Adverse Event
Adverse Event
Adverse Event
Seizure frequency hemispherectomy/hemisphotomy
Seizure frequency lesionectomy/cortical resection
2. For RCTs: Allocation concealment
Engel outcome
Adverse Event
Adverse Event
Adverse Event
Seizure frequency hemispherectomy/hemisphotomy
Seizure frequency lesionectomy/cortical resection
3. For RCTs: Baseline imbalance
Engel outcome
Adverse Event
Adverse Event
Adverse Event
Seizure frequency hemispherectomy/hemisphotomy
Seizure frequency lesionectomy/cortical resection
4. For RCTs: Patient blinded
Engel outcome
Adverse Event
Adverse Event
Adverse Event
Seizure frequency hemispherectomy/hemisphotomy
Seizure frequency lesionectomy/cortical resection
5. For RCTs: Staff blinded
Engel outcome
Adverse Event
Adverse Event
Adverse Event
Seizure frequency hemispherectomy/hemisphotomy
Seizure frequency lesionectomy/cortical resection
6. For RCTs: Differential ancillary treatments
Engel outcome
Adverse Event
Adverse Event
Adverse Event
Seizure frequency hemispherectomy/hemisphotomy
Seizure frequency lesionectomy/cortical resection
7. For RCTs: Adherence
Engel outcome
Adverse Event
Adverse Event
Adverse Event
Seizure frequency hemispherectomy/hemisphotomy
Seizure frequency lesionectomy/cortical resection
8. For RCTs: Analytic approach to address departures from intended intervention
Engel outcome
Adverse Event
Adverse Event
Adverse Event
Seizure frequency hemispherectomy/hemisphotomy
Seizure frequency lesionectomy/cortical resection
9. For RCTs: Data on at least 80% of those enrolled
Engel outcome
Adverse Event
Adverse Event
Adverse Event
Seizure frequency hemispherectomy/hemisphotomy
Seizure frequency lesionectomy/cortical resection
10. For RCTs: Differential dropout <=15%
Engel outcome
Adverse Event
Adverse Event
Adverse Event
Seizure frequency hemispherectomy/hemisphotomy
Seizure frequency lesionectomy/cortical resection
11. For RCTs: Standard way to measure the outcome
Engel outcome
Adverse Event
Adverse Event
Adverse Event
Seizure frequency hemispherectomy/hemisphotomy
Seizure frequency lesionectomy/cortical resection
12. For RCTs: Blinded outcome assessor
Engel outcome
Adverse Event
Adverse Event
Adverse Event
Seizure frequency hemispherectomy/hemisphotomy
Seizure frequency lesionectomy/cortical resection
13. For RCTs: Bias in selection of reported results
Engel outcome
Adverse Event
Adverse Event
Adverse Event
Seizure frequency hemispherectomy/hemisphotomy
Seizure frequency lesionectomy/cortical resection
14. For nonrandomized comparative studies: Confounding
Engel outcome
Adverse Event
Adverse Event
Adverse Event
Seizure frequency hemispherectomy/hemisphotomy
Seizure frequency lesionectomy/cortical resection
15. For nonrandomized comparative studies: Selection into study
Engel outcome
Adverse Event
Adverse Event
Adverse Event
Seizure frequency hemispherectomy/hemisphotomy
Seizure frequency lesionectomy/cortical resection
16. For nonrandomized comparative studies: Classification of interventions
Engel outcome
Adverse Event
Adverse Event
Adverse Event
Seizure frequency hemispherectomy/hemisphotomy
Seizure frequency lesionectomy/cortical resection
17. For nonrandomized comparative studies: Differential ancillary treatments
Engel outcome
Adverse Event
Adverse Event
Adverse Event
Seizure frequency hemispherectomy/hemisphotomy
Seizure frequency lesionectomy/cortical resection
18. For nonrandomized comparative studies: Adherence
Engel outcome
Adverse Event
Adverse Event
Adverse Event
Seizure frequency hemispherectomy/hemisphotomy
Seizure frequency lesionectomy/cortical resection
19. For nonrandomized comparative studies: Data on at least 80% of those enrolled
Engel outcome
Adverse Event
Adverse Event
Adverse Event
Seizure frequency hemispherectomy/hemisphotomy
Seizure frequency lesionectomy/cortical resection
20. For nonrandomized comparative studies: Differential dropout <=15%
Engel outcome
Adverse Event
Adverse Event
Adverse Event
Seizure frequency hemispherectomy/hemisphotomy
Seizure frequency lesionectomy/cortical resection
21. For nonrandomized comparative studies: Standard way to measure the outcome
Engel outcome
Adverse Event
Adverse Event
Adverse Event
Seizure frequency hemispherectomy/hemisphotomy
Seizure frequency lesionectomy/cortical resection
22. For nonrandomized comparative studies: Blinded outcome assessor
Engel outcome
Adverse Event
Adverse Event
Adverse Event
Seizure frequency hemispherectomy/hemisphotomy
Seizure frequency lesionectomy/cortical resection
23. For nonrandomized comparative studies: Bias in selection of reported result
Engel outcome
Adverse Event
Adverse Event
Adverse Event
Seizure frequency hemispherectomy/hemisphotomy
Seizure frequency lesionectomy/cortical resection
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
Seizure frequency hemispherectomy/hemisphotomy
Seizure frequency lesionectomy/cortical resection
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
Seizure frequency hemispherectomy/hemisphotomy
Seizure frequency lesionectomy/cortical resection
26. For single arm studies: Did the study maintain fidelity to the intervention protocol?
Engel outcome
Adverse Event
Adverse Event
Adverse Event
Seizure frequency hemispherectomy/hemisphotomy
Seizure frequency lesionectomy/cortical resection
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
Seizure frequency hemispherectomy/hemisphotomy
Seizure frequency lesionectomy/cortical resection
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
Seizure frequency hemispherectomy/hemisphotomy
Seizure frequency lesionectomy/cortical resection
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
Seizure frequency hemispherectomy/hemisphotomy
Seizure frequency lesionectomy/cortical resection
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
Seizure frequency hemispherectomy/hemisphotomy
Seizure frequency lesionectomy/cortical resection
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
Seizure frequency hemispherectomy/hemisphotomy
Seizure frequency lesionectomy/cortical resection
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
Seizure frequency hemispherectomy/hemisphotomy
Seizure frequency lesionectomy/cortical resection

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
Hemispheric SurgeriesLesionectomies ± cortical resectionsCortical resections
1 year after surgery
Engel I
Odds Ratio (OR)
Engel II
95% CI low (OR)
Engel III
95% CI high (OR)
Engel IV
p value
Total (N analyzed)
Events
Percentage
Within Arm ComparisonsNet Comparisons
Hemispheric SurgeriesLesionectomies ± cortical resectionsCortical resections

Adverse Event (Mortality)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Hemispheric SurgeriesLesionectomies ± cortical resectionsCortical resections
≥1 year after surgery
Engel I
Odds Ratio (OR)
Engel II
95% CI low (OR)
Engel III
95% CI high (OR)
Engel IV
p value
Total (N analyzed)
Events
Percentage
Within Arm ComparisonsNet Comparisons
Hemispheric SurgeriesLesionectomies ± cortical resectionsCortical resections

Adverse Event (Blood transfusion)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Hemispheric SurgeriesLesionectomies ± cortical resectionsCortical resections
During operation
Engel I
Odds Ratio (OR)
Engel II
95% CI low (OR)
Engel III
95% CI high (OR)
Engel IV
p value
Total (N analyzed)
Events
Percentage
Within Arm ComparisonsNet Comparisons
Hemispheric SurgeriesLesionectomies ± cortical resectionsCortical resections

Adverse Event (Aseptic meningitis)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Hemispheric SurgeriesLesionectomies ± cortical resectionsCortical resections
Peri-operative
Engel I
Odds Ratio (OR)
Engel II
95% CI low (OR)
Engel III
95% CI high (OR)
Engel IV
p value
Total (N analyzed)
Events
Percentage
Within Arm ComparisonsNet Comparisons
Hemispheric SurgeriesLesionectomies ± cortical resectionsCortical resections

Seizure frequency hemispherectomy/hemisphotomy

All Participants
Descriptive StatisticsBetween Arm Comparisons
Hemispheric SurgeriesLesionectomies ± cortical resectionsCortical resections
Baseline
Engel I
Odds Ratio (OR)
Engel II
95% CI low (OR)
Engel III
95% CI high (OR)
Engel IV
p value
Total (N analyzed)
Events
Percentage
Within Arm ComparisonsNet Comparisons
Hemispheric SurgeriesLesionectomies ± cortical resectionsCortical resections

Seizure frequency lesionectomy/cortical resection

All Participants
Descriptive StatisticsBetween Arm Comparisons
Hemispheric SurgeriesLesionectomies ± cortical resectionsCortical resections
Baseline
Engel I
Odds Ratio (OR)
Engel II
95% CI low (OR)
Engel III
95% CI high (OR)
Engel IV
p value
Total (N analyzed)
Events
Percentage
Within Arm ComparisonsNet Comparisons
Hemispheric SurgeriesLesionectomies ± cortical resectionsCortical resections