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
Ketogenic Diet (classic)Classic KD, unspecified.

Arm Details

1. Sample size for arm
Ketogenic Diet (classic)
2. Inclusion Criteria
Ketogenic Diet (classic)
3. Exclusion Criteria
Ketogenic Diet (classic)
4. Treatment details
Ketogenic Diet (classic)

Sample Characteristics

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

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
CategoricalSeizure reduction/effective (90-99% reduction)
  • All Participants
  • 3 months
  • 6 months
  • 12 months
CategoricalSeizure reduction/effective (50-90% reduction)
  • All Participants
  • 3 months
  • 6 months
  • 12 months
CategoricalSeizure reduction/effective (<50% reduction)
  • All Participants
  • 3 months
  • 6 months
  • 12 months
CategoricalAdverse EventReduction of Overweight/Obesity
  • All participants
  • Before study
  • After study

Outcome Details

1. For RCTs: Generation of randomization sequence
Seizure reduction/effective (90-99% reduction)
Seizure reduction/effective (50-90% reduction)
Seizure reduction/effective (<50% reduction)
Adverse Event
2. For RCTs: Allocation concealment
Seizure reduction/effective (90-99% reduction)
Seizure reduction/effective (50-90% reduction)
Seizure reduction/effective (<50% reduction)
Adverse Event
3. For RCTs: Baseline imbalance
Seizure reduction/effective (90-99% reduction)
Seizure reduction/effective (50-90% reduction)
Seizure reduction/effective (<50% reduction)
Adverse Event
4. For RCTs: Patient blinded
Seizure reduction/effective (90-99% reduction)
Seizure reduction/effective (50-90% reduction)
Seizure reduction/effective (<50% reduction)
Adverse Event
5. For RCTs: Staff blinded
Seizure reduction/effective (90-99% reduction)
Seizure reduction/effective (50-90% reduction)
Seizure reduction/effective (<50% reduction)
Adverse Event
6. For RCTs: Differential ancillary treatments
Seizure reduction/effective (90-99% reduction)
Seizure reduction/effective (50-90% reduction)
Seizure reduction/effective (<50% reduction)
Adverse Event
7. For RCTs: Adherence
Seizure reduction/effective (90-99% reduction)
Seizure reduction/effective (50-90% reduction)
Seizure reduction/effective (<50% reduction)
Adverse Event
8. For RCTs: Analytic approach to address departures from intended intervention
Seizure reduction/effective (90-99% reduction)
Seizure reduction/effective (50-90% reduction)
Seizure reduction/effective (<50% reduction)
Adverse Event
9. For RCTs: Data on at least 80% of those enrolled
Seizure reduction/effective (90-99% reduction)
Seizure reduction/effective (50-90% reduction)
Seizure reduction/effective (<50% reduction)
Adverse Event
10. For RCTs: Differential dropout <=15%
Seizure reduction/effective (90-99% reduction)
Seizure reduction/effective (50-90% reduction)
Seizure reduction/effective (<50% reduction)
Adverse Event
11. For RCTs: Standard way to measure the outcome
Seizure reduction/effective (90-99% reduction)
Seizure reduction/effective (50-90% reduction)
Seizure reduction/effective (<50% reduction)
Adverse Event
12. For RCTs: Blinded outcome assessor
Seizure reduction/effective (90-99% reduction)
Seizure reduction/effective (50-90% reduction)
Seizure reduction/effective (<50% reduction)
Adverse Event
13. For RCTs: Bias in selection of reported results
Seizure reduction/effective (90-99% reduction)
Seizure reduction/effective (50-90% reduction)
Seizure reduction/effective (<50% reduction)
Adverse Event
14. For nonrandomized comparative studies: Confounding
Seizure reduction/effective (90-99% reduction)
Seizure reduction/effective (50-90% reduction)
Seizure reduction/effective (<50% reduction)
Adverse Event
15. For nonrandomized comparative studies: Selection into study
Seizure reduction/effective (90-99% reduction)
Seizure reduction/effective (50-90% reduction)
Seizure reduction/effective (<50% reduction)
Adverse Event
16. For nonrandomized comparative studies: Classification of interventions
Seizure reduction/effective (90-99% reduction)
Seizure reduction/effective (50-90% reduction)
Seizure reduction/effective (<50% reduction)
Adverse Event
17. For nonrandomized comparative studies: Differential ancillary treatments
Seizure reduction/effective (90-99% reduction)
Seizure reduction/effective (50-90% reduction)
Seizure reduction/effective (<50% reduction)
Adverse Event
18. For nonrandomized comparative studies: Adherence
Seizure reduction/effective (90-99% reduction)
Seizure reduction/effective (50-90% reduction)
Seizure reduction/effective (<50% reduction)
Adverse Event
19. For nonrandomized comparative studies: Data on at least 80% of those enrolled
Seizure reduction/effective (90-99% reduction)
Seizure reduction/effective (50-90% reduction)
Seizure reduction/effective (<50% reduction)
Adverse Event
20. For nonrandomized comparative studies: Differential dropout <=15%
Seizure reduction/effective (90-99% reduction)
Seizure reduction/effective (50-90% reduction)
Seizure reduction/effective (<50% reduction)
Adverse Event
21. For nonrandomized comparative studies: Standard way to measure the outcome
Seizure reduction/effective (90-99% reduction)
Seizure reduction/effective (50-90% reduction)
Seizure reduction/effective (<50% reduction)
Adverse Event
22. For nonrandomized comparative studies: Blinded outcome assessor
Seizure reduction/effective (90-99% reduction)
Seizure reduction/effective (50-90% reduction)
Seizure reduction/effective (<50% reduction)
Adverse Event
23. For nonrandomized comparative studies: Bias in selection of reported result
Seizure reduction/effective (90-99% reduction)
Seizure reduction/effective (50-90% reduction)
Seizure reduction/effective (<50% reduction)
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?
Seizure reduction/effective (90-99% reduction)
Seizure reduction/effective (50-90% reduction)
Seizure reduction/effective (<50% reduction)
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?
Seizure reduction/effective (90-99% reduction)
Seizure reduction/effective (50-90% reduction)
Seizure reduction/effective (<50% reduction)
Adverse Event
26. For single arm studies: Did the study maintain fidelity to the intervention protocol?
Seizure reduction/effective (90-99% reduction)
Seizure reduction/effective (50-90% reduction)
Seizure reduction/effective (<50% reduction)
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)?
Seizure reduction/effective (90-99% reduction)
Seizure reduction/effective (50-90% reduction)
Seizure reduction/effective (<50% reduction)
Adverse Event
28. For single arm studies: Were the outcome assessors blinded to the intervention or exposure status of participants?
Seizure reduction/effective (90-99% reduction)
Seizure reduction/effective (50-90% reduction)
Seizure reduction/effective (<50% reduction)
Adverse Event
29. For single arm studies: Were interventions/exposures assessed/defined using valid and reliable measures, implemented consistently across all study participants?
Seizure reduction/effective (90-99% reduction)
Seizure reduction/effective (50-90% reduction)
Seizure reduction/effective (<50% reduction)
Adverse Event
30. For single arm studies: Were outcomes assessed/defined using valid and reliable measures, implemented consistently across all study participants?
Seizure reduction/effective (90-99% reduction)
Seizure reduction/effective (50-90% reduction)
Seizure reduction/effective (<50% reduction)
Adverse Event
31. For single arm studies: Were confounding variables assessed using valid and reliable measures, implemented consistently across all study participants?
Seizure reduction/effective (90-99% reduction)
Seizure reduction/effective (50-90% reduction)
Seizure reduction/effective (<50% reduction)
Adverse Event
32. For single arm studies: Were the potential outcomes prespecified by the researchers? Are all prespecified outcomes reported?
Seizure reduction/effective (90-99% reduction)
Seizure reduction/effective (50-90% reduction)
Seizure reduction/effective (<50% reduction)
Adverse Event

Risk of Bias Assessment

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

Results

Categorical


Seizure reduction/effective (90-99% reduction)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Ketogenic Diet (classic)
3 months
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
6 months
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
12 months
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Ketogenic Diet (classic)

Seizure reduction/effective (50-90% reduction)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Ketogenic Diet (classic)
3 months
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
6 months
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
12 months
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Ketogenic Diet (classic)

Seizure reduction/effective (<50% reduction)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Ketogenic Diet (classic)
3 months
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
6 months
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
12 months
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Ketogenic Diet (classic)

Adverse Event (Reduction of Overweight/Obesity)

All participants
Descriptive StatisticsBetween Arm Comparisons
Ketogenic Diet (classic)
Before study
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
After study
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Ketogenic Diet (classic)