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
Resective or disconnective surgery Focal resection, lobar / multilobar resection or disconnection, corpus callosotomy, or hemispheric surgery.

Arm Details

1. Sample size for arm
Resective or disconnective surgery
2. Inclusion Criteria
Resective or disconnective surgery
3. Exclusion Criteria
Resective or disconnective surgery
4. Treatment details
Resective or disconnective surgery

Sample Characteristics

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

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
CategoricalEngel outcome
  • All Participants
  • Baseline
CategoricalAdverse EventMortality
  • Anatomic hemispherectomy
  • Peri-insular and vertical functional hemispherotomies
  • Focal resections, Lobectomies
  • Perioperative
CategoricalAdverse EventHydrocephalus
  • Focal resections, Lobectomies
  • 25 periinsular, 12 vertical functional hemispherotomies, 10 anatomic hemispherectomies
  • NR specifically for hydrocephalus; however, follow up for hemispheric surgeries was median 51 months (IQR 27 to 126)
CategoricalSeizure frequency hemispherectomy/hemispherotomy
  • All Participants
  • Baseline
CategoricalSeizure frequency nonhemispheric procedure
  • All Participants
  • Baseline
CategoricalILAE outcome
  • Hemispherectomy/hemispherotomy
  • At median followup: 51 months (interquartile range 27 to 126)
CategoricalFavorable outcome (ILAE I to ILAE IV)
  • Hemisperectomy/hemispherotomy
  • At median followup: 51 months (interquartile range 27 to 126)

Outcome Details

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

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
Resective or disconnective surgery
Baseline
Engel I
Odds Ratio (OR)
Engel II
95% CI low (OR)
Engel III
95% CI high (OR)
Engel IV
p value
Engel V
ILAE I
ILAE II
ILAE III
ILAE IV
ILAE V
Total (N analyzed)
Events
Percentage
Within Arm ComparisonsNet Comparisons
Resective or disconnective surgery

Adverse Event (Mortality)

Anatomic hemispherectomy
Descriptive StatisticsBetween Arm Comparisons
Resective or disconnective surgery
Perioperative
Engel I
Odds Ratio (OR)
Engel II
95% CI low (OR)
Engel III
95% CI high (OR)
Engel IV
p value
Engel V
ILAE I
ILAE II
ILAE III
ILAE IV
ILAE V
Favorable outcome (ILAE I to IV)
Total (N analyzed)
Events
Percentage
Within Arm ComparisonsNet Comparisons
Resective or disconnective surgery
Peri-insular and vertical functional hemispherotomies
Descriptive StatisticsBetween Arm Comparisons
Resective or disconnective surgery
Perioperative
Engel I
Odds Ratio (OR)
Engel II
95% CI low (OR)
Engel III
95% CI high (OR)
Engel IV
p value
Engel V
ILAE I
ILAE II
ILAE III
ILAE IV
ILAE V
Favorable outcome (ILAE I to IV)
Total (N analyzed)
Events
Percentage
Within Arm ComparisonsNet Comparisons
Resective or disconnective surgery
Focal resections, Lobectomies
Descriptive StatisticsBetween Arm Comparisons
Resective or disconnective surgery
Perioperative
Engel I
Odds Ratio (OR)
Engel II
95% CI low (OR)
Engel III
95% CI high (OR)
Engel IV
p value
Engel V
ILAE I
ILAE II
ILAE III
ILAE IV
ILAE V
Favorable outcome (ILAE I to IV)
Total (N analyzed)
Events
Percentage
Within Arm ComparisonsNet Comparisons
Resective or disconnective surgery

Adverse Event (Hydrocephalus)

Focal resections, Lobectomies
Descriptive StatisticsBetween Arm Comparisons
Resective or disconnective surgery
NR specifically for hydrocephalus; however, follow up for hemispheric surgeries was median 51 months (IQR 27 to 126)
Engel I
Odds Ratio (OR)
Engel II
95% CI low (OR)
Engel III
95% CI high (OR)
Engel IV
p value
Engel V
ILAE I
ILAE II
ILAE III
ILAE IV
ILAE V
Favorable outcome (ILAE I to IV)
Total (N analyzed)
Events
Percentage
Within Arm ComparisonsNet Comparisons
Resective or disconnective surgery
25 periinsular, 12 vertical functional hemispherotomies, 10 anatomic hemispherectomies
Descriptive StatisticsBetween Arm Comparisons
Resective or disconnective surgery
NR specifically for hydrocephalus; however, follow up for hemispheric surgeries was median 51 months (IQR 27 to 126)
Engel I
Odds Ratio (OR)
Engel II
95% CI low (OR)
Engel III
95% CI high (OR)
Engel IV
p value
Engel V
ILAE I
ILAE II
ILAE III
ILAE IV
ILAE V
Favorable outcome (ILAE I to IV)
Total (N analyzed)
Events
Percentage
Within Arm ComparisonsNet Comparisons
Resective or disconnective surgery

Seizure frequency hemispherectomy/hemispherotomy

All Participants
Descriptive StatisticsBetween Arm Comparisons
Resective or disconnective surgery
Baseline
Engel I
Odds Ratio (OR)
Engel II
95% CI low (OR)
Engel III
95% CI high (OR)
Engel IV
p value
Engel V
ILAE I
ILAE II
ILAE III
ILAE IV
ILAE V
Favorable outcome (ILAE I to IV)
Total (N analyzed)
Events
Percentage
Within Arm ComparisonsNet Comparisons
Resective or disconnective surgery

Seizure frequency nonhemispheric procedure

All Participants
Descriptive StatisticsBetween Arm Comparisons
Resective or disconnective surgery
Baseline
Engel I
Odds Ratio (OR)
Engel II
95% CI low (OR)
Engel III
95% CI high (OR)
Engel IV
p value
Engel V
ILAE I
ILAE II
ILAE III
ILAE IV
ILAE V
Favorable outcome (ILAE I to IV)
Total (N analyzed)
Events
Percentage
Within Arm ComparisonsNet Comparisons
Resective or disconnective surgery

ILAE outcome

Hemispherectomy/hemispherotomy
Descriptive StatisticsBetween Arm Comparisons
Resective or disconnective surgery
At median followup: 51 months (interquartile range 27 to 126)
Engel I
Odds Ratio (OR)
Engel II
95% CI low (OR)
Engel III
95% CI high (OR)
Engel IV
p value
Engel V
ILAE I
ILAE II
ILAE III
ILAE IV
ILAE V
Favorable outcome (ILAE I to IV)
Total (N analyzed)
Events
Percentage
Within Arm ComparisonsNet Comparisons
Resective or disconnective surgery

Favorable outcome (ILAE I to ILAE IV)

Hemisperectomy/hemispherotomy
Descriptive StatisticsBetween Arm Comparisons
Resective or disconnective surgery
At median followup: 51 months (interquartile range 27 to 126)
Engel I
Odds Ratio (OR)
Engel II
95% CI low (OR)
Engel III
95% CI high (OR)
Engel IV
p value
Engel V
ILAE I
ILAE II
ILAE III
ILAE IV
ILAE V
Total (N analyzed)
Events
Percentage
Within Arm ComparisonsNet Comparisons
Resective or disconnective surgery