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
Intralobar resection
Multilobar resection
Hemispherotomy

Arm Details

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

Sample Characteristics

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

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
CategoricalEngel I (after first surgery, timepoint not provided)
  • All Participants
  • Baseline
CategoricalNeeded second surgery
  • All Participants
  • Baseline
CategoricalEngels outcome
  • All Participants
  • Baseline
CategoricalAdverse EventMortality
  • All Participants
  • Baseline
CategoricalAdverse EventVP shunt replacement
  • All Participants
  • Baseline
CategoricalAdverse EventAcute post surgical seizures
  • All Participants
  • Baseline
CategoricalAdverse EventEpidural hemorrhage requiring surgical revision
  • All Participants
  • Baseline
CategoricalAdverse EventPituitary failure (due to thalamic lesion)
  • All Participants
  • Baseline
CategoricalSurgical Mortality - Hemispherectomy
  • All Participants
  • Baseline
CategoricalMultilobar/Intralobar Resection
  • All Participants
  • Baseline
CategoricalIntra or multilobar resection seizure frequency
  • All Participants
  • Baseline
CategoricalIntralobar resection seizure frequency
  • All Participants
  • Baseline

Outcome Details

1. For RCTs: Generation of randomization sequence
Engel I (after first surgery, timepoint not provided)
Needed second surgery
Engels outcome
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Surgical Mortality - Hemispherectomy
Multilobar/Intralobar Resection
Intra or multilobar resection seizure frequency
Intralobar resection seizure frequency
2. For RCTs: Allocation concealment
Engel I (after first surgery, timepoint not provided)
Needed second surgery
Engels outcome
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Surgical Mortality - Hemispherectomy
Multilobar/Intralobar Resection
Intra or multilobar resection seizure frequency
Intralobar resection seizure frequency
3. For RCTs: Baseline imbalance
Engel I (after first surgery, timepoint not provided)
Needed second surgery
Engels outcome
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Surgical Mortality - Hemispherectomy
Multilobar/Intralobar Resection
Intra or multilobar resection seizure frequency
Intralobar resection seizure frequency
4. For RCTs: Patient blinded
Engel I (after first surgery, timepoint not provided)
Needed second surgery
Engels outcome
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Surgical Mortality - Hemispherectomy
Multilobar/Intralobar Resection
Intra or multilobar resection seizure frequency
Intralobar resection seizure frequency
5. For RCTs: Staff blinded
Engel I (after first surgery, timepoint not provided)
Needed second surgery
Engels outcome
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Surgical Mortality - Hemispherectomy
Multilobar/Intralobar Resection
Intra or multilobar resection seizure frequency
Intralobar resection seizure frequency
6. For RCTs: Differential ancillary treatments
Engel I (after first surgery, timepoint not provided)
Needed second surgery
Engels outcome
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Surgical Mortality - Hemispherectomy
Multilobar/Intralobar Resection
Intra or multilobar resection seizure frequency
Intralobar resection seizure frequency
7. For RCTs: Adherence
Engel I (after first surgery, timepoint not provided)
Needed second surgery
Engels outcome
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Surgical Mortality - Hemispherectomy
Multilobar/Intralobar Resection
Intra or multilobar resection seizure frequency
Intralobar resection seizure frequency
8. For RCTs: Analytic approach to address departures from intended intervention
Engel I (after first surgery, timepoint not provided)
Needed second surgery
Engels outcome
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Surgical Mortality - Hemispherectomy
Multilobar/Intralobar Resection
Intra or multilobar resection seizure frequency
Intralobar resection seizure frequency
9. For RCTs: Data on at least 80% of those enrolled
Engel I (after first surgery, timepoint not provided)
Needed second surgery
Engels outcome
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Surgical Mortality - Hemispherectomy
Multilobar/Intralobar Resection
Intra or multilobar resection seizure frequency
Intralobar resection seizure frequency
10. For RCTs: Differential dropout <=15%
Engel I (after first surgery, timepoint not provided)
Needed second surgery
Engels outcome
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Surgical Mortality - Hemispherectomy
Multilobar/Intralobar Resection
Intra or multilobar resection seizure frequency
Intralobar resection seizure frequency
11. For RCTs: Standard way to measure the outcome
Engel I (after first surgery, timepoint not provided)
Needed second surgery
Engels outcome
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Surgical Mortality - Hemispherectomy
Multilobar/Intralobar Resection
Intra or multilobar resection seizure frequency
Intralobar resection seizure frequency
12. For RCTs: Blinded outcome assessor
Engel I (after first surgery, timepoint not provided)
Needed second surgery
Engels outcome
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Surgical Mortality - Hemispherectomy
Multilobar/Intralobar Resection
Intra or multilobar resection seizure frequency
Intralobar resection seizure frequency
13. For RCTs: Bias in selection of reported results
Engel I (after first surgery, timepoint not provided)
Needed second surgery
Engels outcome
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Surgical Mortality - Hemispherectomy
Multilobar/Intralobar Resection
Intra or multilobar resection seizure frequency
Intralobar resection seizure frequency
14. For nonrandomized comparative studies: Confounding
Engel I (after first surgery, timepoint not provided)
Needed second surgery
Engels outcome
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Surgical Mortality - Hemispherectomy
Multilobar/Intralobar Resection
Intra or multilobar resection seizure frequency
Intralobar resection seizure frequency
15. For nonrandomized comparative studies: Selection into study
Engel I (after first surgery, timepoint not provided)
Needed second surgery
Engels outcome
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Surgical Mortality - Hemispherectomy
Multilobar/Intralobar Resection
Intra or multilobar resection seizure frequency
Intralobar resection seizure frequency
16. For nonrandomized comparative studies: Classification of interventions
Engel I (after first surgery, timepoint not provided)
Needed second surgery
Engels outcome
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Surgical Mortality - Hemispherectomy
Multilobar/Intralobar Resection
Intra or multilobar resection seizure frequency
Intralobar resection seizure frequency
17. For nonrandomized comparative studies: Differential ancillary treatments
Engel I (after first surgery, timepoint not provided)
Needed second surgery
Engels outcome
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Surgical Mortality - Hemispherectomy
Multilobar/Intralobar Resection
Intra or multilobar resection seizure frequency
Intralobar resection seizure frequency
18. For nonrandomized comparative studies: Adherence
Engel I (after first surgery, timepoint not provided)
Needed second surgery
Engels outcome
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Surgical Mortality - Hemispherectomy
Multilobar/Intralobar Resection
Intra or multilobar resection seizure frequency
Intralobar resection seizure frequency
19. For nonrandomized comparative studies: Data on at least 80% of those enrolled
Engel I (after first surgery, timepoint not provided)
Needed second surgery
Engels outcome
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Surgical Mortality - Hemispherectomy
Multilobar/Intralobar Resection
Intra or multilobar resection seizure frequency
Intralobar resection seizure frequency
20. For nonrandomized comparative studies: Differential dropout <=15%
Engel I (after first surgery, timepoint not provided)
Needed second surgery
Engels outcome
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Surgical Mortality - Hemispherectomy
Multilobar/Intralobar Resection
Intra or multilobar resection seizure frequency
Intralobar resection seizure frequency
21. For nonrandomized comparative studies: Standard way to measure the outcome
Engel I (after first surgery, timepoint not provided)
Needed second surgery
Engels outcome
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Surgical Mortality - Hemispherectomy
Multilobar/Intralobar Resection
Intra or multilobar resection seizure frequency
Intralobar resection seizure frequency
22. For nonrandomized comparative studies: Blinded outcome assessor
Engel I (after first surgery, timepoint not provided)
Needed second surgery
Engels outcome
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Surgical Mortality - Hemispherectomy
Multilobar/Intralobar Resection
Intra or multilobar resection seizure frequency
Intralobar resection seizure frequency
23. For nonrandomized comparative studies: Bias in selection of reported result
Engel I (after first surgery, timepoint not provided)
Needed second surgery
Engels outcome
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Surgical Mortality - Hemispherectomy
Multilobar/Intralobar Resection
Intra or multilobar resection seizure frequency
Intralobar resection seizure frequency
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 I (after first surgery, timepoint not provided)
Needed second surgery
Engels outcome
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Surgical Mortality - Hemispherectomy
Multilobar/Intralobar Resection
Intra or multilobar resection seizure frequency
Intralobar resection seizure frequency
25. For single arm studies: Did researchers rule out any impact from a concurrent intervention or an unintended exposure that might bias results?
Engel I (after first surgery, timepoint not provided)
Needed second surgery
Engels outcome
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Surgical Mortality - Hemispherectomy
Multilobar/Intralobar Resection
Intra or multilobar resection seizure frequency
Intralobar resection seizure frequency
26. For single arm studies: Did the study maintain fidelity to the intervention protocol?
Engel I (after first surgery, timepoint not provided)
Needed second surgery
Engels outcome
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Surgical Mortality - Hemispherectomy
Multilobar/Intralobar Resection
Intra or multilobar resection seizure frequency
Intralobar resection seizure frequency
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 I (after first surgery, timepoint not provided)
Needed second surgery
Engels outcome
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Surgical Mortality - Hemispherectomy
Multilobar/Intralobar Resection
Intra or multilobar resection seizure frequency
Intralobar resection seizure frequency
28. For single arm studies: Were the outcome assessors blinded to the intervention or exposure status of participants?
Engel I (after first surgery, timepoint not provided)
Needed second surgery
Engels outcome
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Surgical Mortality - Hemispherectomy
Multilobar/Intralobar Resection
Intra or multilobar resection seizure frequency
Intralobar resection seizure frequency
29. For single arm studies: Were interventions/exposures assessed/defined using valid and reliable measures, implemented consistently across all study participants?
Engel I (after first surgery, timepoint not provided)
Needed second surgery
Engels outcome
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Surgical Mortality - Hemispherectomy
Multilobar/Intralobar Resection
Intra or multilobar resection seizure frequency
Intralobar resection seizure frequency
30. For single arm studies: Were outcomes assessed/defined using valid and reliable measures, implemented consistently across all study participants?
Engel I (after first surgery, timepoint not provided)
Needed second surgery
Engels outcome
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Surgical Mortality - Hemispherectomy
Multilobar/Intralobar Resection
Intra or multilobar resection seizure frequency
Intralobar resection seizure frequency
31. For single arm studies: Were confounding variables assessed using valid and reliable measures, implemented consistently across all study participants?
Engel I (after first surgery, timepoint not provided)
Needed second surgery
Engels outcome
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Surgical Mortality - Hemispherectomy
Multilobar/Intralobar Resection
Intra or multilobar resection seizure frequency
Intralobar resection seizure frequency
32. For single arm studies: Were the potential outcomes prespecified by the researchers? Are all prespecified outcomes reported?
Engel I (after first surgery, timepoint not provided)
Needed second surgery
Engels outcome
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Surgical Mortality - Hemispherectomy
Multilobar/Intralobar Resection
Intra or multilobar resection seizure frequency
Intralobar resection seizure frequency

Risk of Bias Assessment

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

Results

Categorical


Engel I (after first surgery, timepoint not provided)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intralobar resectionMultilobar resectionHemispherotomy
Baseline
Engel I
Odds Ratio (OR)
Engel II-IV
95% CI low (OR)
Total (N analyzed)
95% CI high (OR)
Events
p value
Percentage
Within Arm ComparisonsNet Comparisons
Intralobar resectionMultilobar resectionHemispherotomy

Needed second surgery

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intralobar resectionMultilobar resectionHemispherotomy
Baseline
Engel I
Odds Ratio (OR)
Engel II-IV
95% CI low (OR)
Total (N analyzed)
95% CI high (OR)
Events
p value
Percentage
Within Arm ComparisonsNet Comparisons
Intralobar resectionMultilobar resectionHemispherotomy

Engels outcome

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intralobar resectionMultilobar resectionHemispherotomy
Baseline
Engel I
Odds Ratio (OR)
Engel II-IV
95% CI low (OR)
Total (N analyzed)
95% CI high (OR)
Events
p value
Percentage
Within Arm ComparisonsNet Comparisons
Intralobar resectionMultilobar resectionHemispherotomy

Adverse Event (Mortality)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intralobar resectionMultilobar resectionHemispherotomy
Baseline
Engel I
Odds Ratio (OR)
Engel II-IV
95% CI low (OR)
Total (N analyzed)
95% CI high (OR)
Events
p value
Percentage
Within Arm ComparisonsNet Comparisons
Intralobar resectionMultilobar resectionHemispherotomy

Adverse Event (VP shunt replacement)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intralobar resectionMultilobar resectionHemispherotomy
Baseline
Engel I
Odds Ratio (OR)
Engel II-IV
95% CI low (OR)
Total (N analyzed)
95% CI high (OR)
Events
p value
Percentage
Within Arm ComparisonsNet Comparisons
Intralobar resectionMultilobar resectionHemispherotomy

Adverse Event (Acute post surgical seizures)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intralobar resectionMultilobar resectionHemispherotomy
Baseline
Engel I
Odds Ratio (OR)
Engel II-IV
95% CI low (OR)
Total (N analyzed)
95% CI high (OR)
Events
p value
Percentage
Within Arm ComparisonsNet Comparisons
Intralobar resectionMultilobar resectionHemispherotomy

Adverse Event (Epidural hemorrhage requiring surgical revision)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intralobar resectionMultilobar resectionHemispherotomy
Baseline
Engel I
Odds Ratio (OR)
Engel II-IV
95% CI low (OR)
Total (N analyzed)
95% CI high (OR)
Events
p value
Percentage
Within Arm ComparisonsNet Comparisons
Intralobar resectionMultilobar resectionHemispherotomy

Adverse Event (Pituitary failure (due to thalamic lesion))

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intralobar resectionMultilobar resectionHemispherotomy
Baseline
Engel I
Odds Ratio (OR)
Engel II-IV
95% CI low (OR)
Total (N analyzed)
95% CI high (OR)
Events
p value
Percentage
Within Arm ComparisonsNet Comparisons
Intralobar resectionMultilobar resectionHemispherotomy

Surgical Mortality - Hemispherectomy

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intralobar resectionMultilobar resectionHemispherotomy
Baseline
Engel I
Odds Ratio (OR)
Engel II-IV
95% CI low (OR)
Total (N analyzed)
95% CI high (OR)
Events
p value
Percentage
Within Arm ComparisonsNet Comparisons
Intralobar resectionMultilobar resectionHemispherotomy

Multilobar/Intralobar Resection

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intralobar resectionMultilobar resectionHemispherotomy
Baseline
Engel I
Odds Ratio (OR)
Engel II-IV
95% CI low (OR)
Total (N analyzed)
95% CI high (OR)
Events
p value
Percentage
Within Arm ComparisonsNet Comparisons
Intralobar resectionMultilobar resectionHemispherotomy

Intra or multilobar resection seizure frequency

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intralobar resectionMultilobar resectionHemispherotomy
Baseline
Engel I
Odds Ratio (OR)
Engel II-IV
95% CI low (OR)
Total (N analyzed)
95% CI high (OR)
Events
p value
Percentage
Within Arm ComparisonsNet Comparisons
Intralobar resectionMultilobar resectionHemispherotomy

Intralobar resection seizure frequency

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intralobar resectionMultilobar resectionHemispherotomy
Baseline
Engel I
Odds Ratio (OR)
Engel II-IV
95% CI low (OR)
Total (N analyzed)
95% CI high (OR)
Events
p value
Percentage
Within Arm ComparisonsNet Comparisons
Intralobar resectionMultilobar resectionHemispherotomy