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 DietKD was initiated at a ratio of 1:1 (fat grams: carbohydrate + protein grams) without a fast as an inpatient in the hospital. The keto ratio was increased daily, reaching up to 3:1 on day 3. On day 4, patients were discharged home at the ratio of 3:1 with full calories. Fluids were not restricted.

Arm Details

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

Sample Characteristics

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

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
CategoricalSeizure freedom
  • All Participants
  • 3 months
  • 6 months
  • 12 months
  • 6 months after KD
CategoricalAdverse EventWithdrawal due to AE
  • All Participants
  • Baseline
CategoricalAdverse EventConstipation
  • All Participants
  • Baseline
CategoricalAdverse EventDecreased HC03 level
  • All Participants
  • Baseline
CategoricalAdverse EventVomiting or reflux
  • All Participants
  • Baseline
CategoricalAdverse EventLow free carnitine level
  • All Participants
  • Baseline
CategoricalAdverse EventFeeding difficulty
  • All Participants
  • Baseline
CategoricalAdverse EventKidney stone
  • All Participants
  • Baseline
CategoricalAdverse EventTransient hypoglycemia
  • All Participants
  • Baseline
CategoricalAdverse EventOther
  • All Participants
  • Baseline

Outcome Details

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

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
Ketogenic Diet
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
6 months after KD
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Ketogenic Diet

Adverse Event (Withdrawal due to AE)

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

Adverse Event (Constipation)

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

Adverse Event (Decreased HC03 level)

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

Adverse Event (Vomiting or reflux)

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

Adverse Event (Low free carnitine level )

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

Adverse Event (Feeding difficulty)

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

Adverse Event (Kidney stone)

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

Adverse Event (Transient hypoglycemia)

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

Adverse Event (Other)

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