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
Hemispherotomy

Arm Details

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

Sample Characteristics

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

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
CategoricalEngel outcome
  • All Participants
  • Baseline
CategoricalAdverse EventMortality
  • All Participants
  • Baseline
CategoricalAdverse EventVP shunt placement
  • All Participants
  • Baseline

Outcome Details

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

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
Hemispherotomy
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
Hemispherotomy

Adverse Event (Mortality)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Hemispherotomy
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
Hemispherotomy

Adverse Event (VP shunt placement)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Hemispherotomy
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
Hemispherotomy