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
Focal Resection

Arm Details

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

Sample Characteristics

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

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
CategoricalSeizure freedom
  • All Participants
  • Median 6 months
CategoricalSeizure Frequency (seizures per day)
  • All Participants
  • Median 6 months
CategoricalSeizure reduction/effective (>50% reduction)
  • All Participants
  • Median 6 months
CategoricalASM use
  • All Participants
  • Median 6 months
CategoricalAdverse Events
  • All Participants
  • Median 6 months
CategoricalSeizure freedom hemipsherectomy/hemispherotomy
  • All Participants
  • Median 6 months
CategoricalSeizure freedom focal cortical resection
  • All Participants
  • Median 6 months
CategoricalSeizure frequency hemispherectomy/hemispherotomy
  • All Participants
  • Median 6 months

Outcome Details

1. For RCTs: Generation of randomization sequence
Seizure freedom
Seizure Frequency (seizures per day)
Seizure reduction/effective (>50% reduction)
ASM use
Adverse Events
Seizure freedom hemipsherectomy/hemispherotomy
Seizure freedom focal cortical resection
Seizure frequency hemispherectomy/hemispherotomy
2. For RCTs: Allocation concealment
Seizure freedom
Seizure Frequency (seizures per day)
Seizure reduction/effective (>50% reduction)
ASM use
Adverse Events
Seizure freedom hemipsherectomy/hemispherotomy
Seizure freedom focal cortical resection
Seizure frequency hemispherectomy/hemispherotomy
3. For RCTs: Baseline imbalance
Seizure freedom
Seizure Frequency (seizures per day)
Seizure reduction/effective (>50% reduction)
ASM use
Adverse Events
Seizure freedom hemipsherectomy/hemispherotomy
Seizure freedom focal cortical resection
Seizure frequency hemispherectomy/hemispherotomy
4. For RCTs: Patient blinded
Seizure freedom
Seizure Frequency (seizures per day)
Seizure reduction/effective (>50% reduction)
ASM use
Adverse Events
Seizure freedom hemipsherectomy/hemispherotomy
Seizure freedom focal cortical resection
Seizure frequency hemispherectomy/hemispherotomy
5. For RCTs: Staff blinded
Seizure freedom
Seizure Frequency (seizures per day)
Seizure reduction/effective (>50% reduction)
ASM use
Adverse Events
Seizure freedom hemipsherectomy/hemispherotomy
Seizure freedom focal cortical resection
Seizure frequency hemispherectomy/hemispherotomy
6. For RCTs: Differential ancillary treatments
Seizure freedom
Seizure Frequency (seizures per day)
Seizure reduction/effective (>50% reduction)
ASM use
Adverse Events
Seizure freedom hemipsherectomy/hemispherotomy
Seizure freedom focal cortical resection
Seizure frequency hemispherectomy/hemispherotomy
7. For RCTs: Adherence
Seizure freedom
Seizure Frequency (seizures per day)
Seizure reduction/effective (>50% reduction)
ASM use
Adverse Events
Seizure freedom hemipsherectomy/hemispherotomy
Seizure freedom focal cortical resection
Seizure frequency hemispherectomy/hemispherotomy
8. For RCTs: Analytic approach to address departures from intended intervention
Seizure freedom
Seizure Frequency (seizures per day)
Seizure reduction/effective (>50% reduction)
ASM use
Adverse Events
Seizure freedom hemipsherectomy/hemispherotomy
Seizure freedom focal cortical resection
Seizure frequency hemispherectomy/hemispherotomy
9. For RCTs: Data on at least 80% of those enrolled
Seizure freedom
Seizure Frequency (seizures per day)
Seizure reduction/effective (>50% reduction)
ASM use
Adverse Events
Seizure freedom hemipsherectomy/hemispherotomy
Seizure freedom focal cortical resection
Seizure frequency hemispherectomy/hemispherotomy
10. For RCTs: Differential dropout <=15%
Seizure freedom
Seizure Frequency (seizures per day)
Seizure reduction/effective (>50% reduction)
ASM use
Adverse Events
Seizure freedom hemipsherectomy/hemispherotomy
Seizure freedom focal cortical resection
Seizure frequency hemispherectomy/hemispherotomy
11. For RCTs: Standard way to measure the outcome
Seizure freedom
Seizure Frequency (seizures per day)
Seizure reduction/effective (>50% reduction)
ASM use
Adverse Events
Seizure freedom hemipsherectomy/hemispherotomy
Seizure freedom focal cortical resection
Seizure frequency hemispherectomy/hemispherotomy
12. For RCTs: Blinded outcome assessor
Seizure freedom
Seizure Frequency (seizures per day)
Seizure reduction/effective (>50% reduction)
ASM use
Adverse Events
Seizure freedom hemipsherectomy/hemispherotomy
Seizure freedom focal cortical resection
Seizure frequency hemispherectomy/hemispherotomy
13. For RCTs: Bias in selection of reported results
Seizure freedom
Seizure Frequency (seizures per day)
Seizure reduction/effective (>50% reduction)
ASM use
Adverse Events
Seizure freedom hemipsherectomy/hemispherotomy
Seizure freedom focal cortical resection
Seizure frequency hemispherectomy/hemispherotomy
14. For nonrandomized comparative studies: Confounding
Seizure freedom
Seizure Frequency (seizures per day)
Seizure reduction/effective (>50% reduction)
ASM use
Adverse Events
Seizure freedom hemipsherectomy/hemispherotomy
Seizure freedom focal cortical resection
Seizure frequency hemispherectomy/hemispherotomy
15. For nonrandomized comparative studies: Selection into study
Seizure freedom
Seizure Frequency (seizures per day)
Seizure reduction/effective (>50% reduction)
ASM use
Adverse Events
Seizure freedom hemipsherectomy/hemispherotomy
Seizure freedom focal cortical resection
Seizure frequency hemispherectomy/hemispherotomy
16. For nonrandomized comparative studies: Classification of interventions
Seizure freedom
Seizure Frequency (seizures per day)
Seizure reduction/effective (>50% reduction)
ASM use
Adverse Events
Seizure freedom hemipsherectomy/hemispherotomy
Seizure freedom focal cortical resection
Seizure frequency hemispherectomy/hemispherotomy
17. For nonrandomized comparative studies: Differential ancillary treatments
Seizure freedom
Seizure Frequency (seizures per day)
Seizure reduction/effective (>50% reduction)
ASM use
Adverse Events
Seizure freedom hemipsherectomy/hemispherotomy
Seizure freedom focal cortical resection
Seizure frequency hemispherectomy/hemispherotomy
18. For nonrandomized comparative studies: Adherence
Seizure freedom
Seizure Frequency (seizures per day)
Seizure reduction/effective (>50% reduction)
ASM use
Adverse Events
Seizure freedom hemipsherectomy/hemispherotomy
Seizure freedom focal cortical resection
Seizure frequency hemispherectomy/hemispherotomy
19. For nonrandomized comparative studies: Data on at least 80% of those enrolled
Seizure freedom
Seizure Frequency (seizures per day)
Seizure reduction/effective (>50% reduction)
ASM use
Adverse Events
Seizure freedom hemipsherectomy/hemispherotomy
Seizure freedom focal cortical resection
Seizure frequency hemispherectomy/hemispherotomy
20. For nonrandomized comparative studies: Differential dropout <=15%
Seizure freedom
Seizure Frequency (seizures per day)
Seizure reduction/effective (>50% reduction)
ASM use
Adverse Events
Seizure freedom hemipsherectomy/hemispherotomy
Seizure freedom focal cortical resection
Seizure frequency hemispherectomy/hemispherotomy
21. For nonrandomized comparative studies: Standard way to measure the outcome
Seizure freedom
Seizure Frequency (seizures per day)
Seizure reduction/effective (>50% reduction)
ASM use
Adverse Events
Seizure freedom hemipsherectomy/hemispherotomy
Seizure freedom focal cortical resection
Seizure frequency hemispherectomy/hemispherotomy
22. For nonrandomized comparative studies: Blinded outcome assessor
Seizure freedom
Seizure Frequency (seizures per day)
Seizure reduction/effective (>50% reduction)
ASM use
Adverse Events
Seizure freedom hemipsherectomy/hemispherotomy
Seizure freedom focal cortical resection
Seizure frequency hemispherectomy/hemispherotomy
23. For nonrandomized comparative studies: Bias in selection of reported result
Seizure freedom
Seizure Frequency (seizures per day)
Seizure reduction/effective (>50% reduction)
ASM use
Adverse Events
Seizure freedom hemipsherectomy/hemispherotomy
Seizure freedom focal cortical resection
Seizure frequency hemispherectomy/hemispherotomy
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?
Seizure freedom
Seizure Frequency (seizures per day)
Seizure reduction/effective (>50% reduction)
ASM use
Adverse Events
Seizure freedom hemipsherectomy/hemispherotomy
Seizure freedom focal cortical resection
Seizure frequency hemispherectomy/hemispherotomy
25. For single arm studies: Did researchers rule out any impact from a concurrent intervention or an unintended exposure that might bias results?
Seizure freedom
Seizure Frequency (seizures per day)
Seizure reduction/effective (>50% reduction)
ASM use
Adverse Events
Seizure freedom hemipsherectomy/hemispherotomy
Seizure freedom focal cortical resection
Seizure frequency hemispherectomy/hemispherotomy
26. For single arm studies: Did the study maintain fidelity to the intervention protocol?
Seizure freedom
Seizure Frequency (seizures per day)
Seizure reduction/effective (>50% reduction)
ASM use
Adverse Events
Seizure freedom hemipsherectomy/hemispherotomy
Seizure freedom focal cortical resection
Seizure frequency hemispherectomy/hemispherotomy
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)?
Seizure freedom
Seizure Frequency (seizures per day)
Seizure reduction/effective (>50% reduction)
ASM use
Adverse Events
Seizure freedom hemipsherectomy/hemispherotomy
Seizure freedom focal cortical resection
Seizure frequency hemispherectomy/hemispherotomy
28. For single arm studies: Were the outcome assessors blinded to the intervention or exposure status of participants?
Seizure freedom
Seizure Frequency (seizures per day)
Seizure reduction/effective (>50% reduction)
ASM use
Adverse Events
Seizure freedom hemipsherectomy/hemispherotomy
Seizure freedom focal cortical resection
Seizure frequency hemispherectomy/hemispherotomy
29. For single arm studies: Were interventions/exposures assessed/defined using valid and reliable measures, implemented consistently across all study participants?
Seizure freedom
Seizure Frequency (seizures per day)
Seizure reduction/effective (>50% reduction)
ASM use
Adverse Events
Seizure freedom hemipsherectomy/hemispherotomy
Seizure freedom focal cortical resection
Seizure frequency hemispherectomy/hemispherotomy
30. For single arm studies: Were outcomes assessed/defined using valid and reliable measures, implemented consistently across all study participants?
Seizure freedom
Seizure Frequency (seizures per day)
Seizure reduction/effective (>50% reduction)
ASM use
Adverse Events
Seizure freedom hemipsherectomy/hemispherotomy
Seizure freedom focal cortical resection
Seizure frequency hemispherectomy/hemispherotomy
31. For single arm studies: Were confounding variables assessed using valid and reliable measures, implemented consistently across all study participants?
Seizure freedom
Seizure Frequency (seizures per day)
Seizure reduction/effective (>50% reduction)
ASM use
Adverse Events
Seizure freedom hemipsherectomy/hemispherotomy
Seizure freedom focal cortical resection
Seizure frequency hemispherectomy/hemispherotomy
32. For single arm studies: Were the potential outcomes prespecified by the researchers? Are all prespecified outcomes reported?
Seizure freedom
Seizure Frequency (seizures per day)
Seizure reduction/effective (>50% reduction)
ASM use
Adverse Events
Seizure freedom hemipsherectomy/hemispherotomy
Seizure freedom focal cortical resection
Seizure frequency hemispherectomy/hemispherotomy

Risk of Bias Assessment

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

Results

Categorical


Seizure freedom

All Participants
Descriptive StatisticsBetween Arm Comparisons
HemispherectomyFocal Resection
Median 6 months
Before
Odds Ratio (OR)
After
95% CI low (OR)
Total (N analyzed)
95% CI high (OR)
Events
p value
Percentage
Within Arm ComparisonsNet Comparisons
HemispherectomyFocal Resection

Seizure Frequency (seizures per day)

All Participants
Descriptive StatisticsBetween Arm Comparisons
HemispherectomyFocal Resection
Median 6 months
Before
Odds Ratio (OR)
After
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
HemispherectomyFocal Resection

Seizure reduction/effective (>50% reduction)

All Participants
Descriptive StatisticsBetween Arm Comparisons
HemispherectomyFocal Resection
Median 6 months
Before
Odds Ratio (OR)
After
95% CI low (OR)
Total (N analyzed)
95% CI high (OR)
Events
p value
Percentage
Within Arm ComparisonsNet Comparisons
HemispherectomyFocal Resection

ASM use

All Participants
Descriptive StatisticsBetween Arm Comparisons
HemispherectomyFocal Resection
Median 6 months
Before
Odds Ratio (OR)
After
95% CI low (OR)
Total (N analyzed)
95% CI high (OR)
Events
p value
Percentage
Within Arm ComparisonsNet Comparisons
HemispherectomyFocal Resection

Adverse Events

All Participants
Descriptive StatisticsBetween Arm Comparisons
HemispherectomyFocal Resection
Median 6 months
Before
Odds Ratio (OR)
After
95% CI low (OR)
Total (N analyzed)
95% CI high (OR)
Events
p value
Percentage
Within Arm ComparisonsNet Comparisons
HemispherectomyFocal Resection

Seizure freedom hemipsherectomy/hemispherotomy

All Participants
Descriptive StatisticsBetween Arm Comparisons
HemispherectomyFocal Resection
Median 6 months
Before
Odds Ratio (OR)
After
95% CI low (OR)
Total (N analyzed)
95% CI high (OR)
Events
p value
Percentage
Within Arm ComparisonsNet Comparisons
HemispherectomyFocal Resection

Seizure freedom focal cortical resection

All Participants
Descriptive StatisticsBetween Arm Comparisons
HemispherectomyFocal Resection
Median 6 months
Before
Odds Ratio (OR)
After
95% CI low (OR)
Total (N analyzed)
95% CI high (OR)
Events
p value
Percentage
Within Arm ComparisonsNet Comparisons
HemispherectomyFocal Resection

Seizure frequency hemispherectomy/hemispherotomy

All Participants
Descriptive StatisticsBetween Arm Comparisons
HemispherectomyFocal Resection
Median 6 months
Before
Odds Ratio (OR)
After
95% CI low (OR)
Total (N analyzed)
95% CI high (OR)
Events
p value
Percentage
Within Arm ComparisonsNet Comparisons
HemispherectomyFocal Resection