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)• The classic 4:1 KD was provided by as a formula.
Modified Atkins DietModified Atkins diet consisted of a nearly balanced diet (60% fat, 30% protein, and 10% carbohydrates by weight) without restrictions.
Normal DietNormal accustomed diet with anti-epileptic polytherapy.

Arm Details

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

Sample Characteristics

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

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
CategoricalFrequency change
  • All Participants
  • 3 months
  • 6 months
CategoricalChalfont score change
  • All Participants
  • 3 months
  • 6 months
CategoricalAdverse EventVomiting
  • All Participants
  • Baseline
CategoricalAdverse EventWithdrawals due to diet intolerance
  • All Participants
  • Baseline
CategoricalAdverse EventConstipation
  • All Participants
  • Baseline
CategoricalAdverse EventDiarrhea
  • All Participants
  • Baseline
CategoricalAdverse EventDysphagia
  • All Participants
  • Baseline

Outcome Details

1. For RCTs: Generation of randomization sequence
Frequency change
Chalfont score change
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
2. For RCTs: Allocation concealment
Frequency change
Chalfont score change
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
3. For RCTs: Baseline imbalance
Frequency change
Chalfont score change
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
4. For RCTs: Patient blinded
Frequency change
Chalfont score change
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
5. For RCTs: Staff blinded
Frequency change
Chalfont score change
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
6. For RCTs: Differential ancillary treatments
Frequency change
Chalfont score change
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
7. For RCTs: Adherence
Frequency change
Chalfont score change
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
8. For RCTs: Analytic approach to address departures from intended intervention
Frequency change
Chalfont score change
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
9. For RCTs: Data on at least 80% of those enrolled
Frequency change
Chalfont score change
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
10. For RCTs: Differential dropout <=15%
Frequency change
Chalfont score change
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
11. For RCTs: Standard way to measure the outcome
Frequency change
Chalfont score change
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
12. For RCTs: Blinded outcome assessor
Frequency change
Chalfont score change
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
13. For RCTs: Bias in selection of reported results
Frequency change
Chalfont score change
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
14. For nonrandomized comparative studies: Confounding
Frequency change
Chalfont score change
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
15. For nonrandomized comparative studies: Selection into study
Frequency change
Chalfont score change
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
16. For nonrandomized comparative studies: Classification of interventions
Frequency change
Chalfont score change
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
17. For nonrandomized comparative studies: Differential ancillary treatments
Frequency change
Chalfont score change
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
18. For nonrandomized comparative studies: Adherence
Frequency change
Chalfont score change
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
19. For nonrandomized comparative studies: Data on at least 80% of those enrolled
Frequency change
Chalfont score change
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
20. For nonrandomized comparative studies: Differential dropout <=15%
Frequency change
Chalfont score change
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
21. For nonrandomized comparative studies: Standard way to measure the outcome
Frequency change
Chalfont score change
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
22. For nonrandomized comparative studies: Blinded outcome assessor
Frequency change
Chalfont score change
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
23. For nonrandomized comparative studies: Bias in selection of reported result
Frequency change
Chalfont score change
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?
Frequency change
Chalfont score change
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?
Frequency change
Chalfont score change
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
26. For single arm studies: Did the study maintain fidelity to the intervention protocol?
Frequency change
Chalfont score change
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)?
Frequency change
Chalfont score change
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?
Frequency change
Chalfont score change
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?
Frequency change
Chalfont score change
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?
Frequency change
Chalfont score change
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?
Frequency change
Chalfont score change
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?
Frequency change
Chalfont score change
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


Frequency change

All Participants
Descriptive StatisticsBetween Arm Comparisons
Ketogenic Diet (classic)Modified Atkins DietNormal Diet
3 months
Frequency change
Odds Ratio (OR)
Standard deviation
95% CI low (OR)
95% CI high (OR)
p value
6 months
Frequency change
Odds Ratio (OR)
Standard deviation
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Ketogenic Diet (classic)Modified Atkins DietNormal Diet

Chalfont score change

All Participants
Descriptive StatisticsBetween Arm Comparisons
Ketogenic Diet (classic)Modified Atkins DietNormal Diet
3 months
Frequency change
Odds Ratio (OR)
Standard deviation
95% CI low (OR)
95% CI high (OR)
p value
6 months
Frequency change
Odds Ratio (OR)
Standard deviation
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Ketogenic Diet (classic)Modified Atkins DietNormal Diet

Adverse Event (Vomiting)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Ketogenic Diet (classic)Modified Atkins DietNormal Diet
Baseline
Frequency change
Odds Ratio (OR)
Standard deviation
95% CI low (OR)
Total (N analyzed)
95% CI high (OR)
Events
p value
Percentage
Within Arm ComparisonsNet Comparisons
Ketogenic Diet (classic)Modified Atkins DietNormal Diet

Adverse Event (Withdrawals due to diet intolerance)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Ketogenic Diet (classic)Modified Atkins DietNormal Diet
Baseline
Frequency change
Odds Ratio (OR)
Standard deviation
95% CI low (OR)
Total (N analyzed)
95% CI high (OR)
Events
p value
Percentage
Within Arm ComparisonsNet Comparisons
Ketogenic Diet (classic)Modified Atkins DietNormal Diet

Adverse Event (Constipation)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Ketogenic Diet (classic)Modified Atkins DietNormal Diet
Baseline
Frequency change
Odds Ratio (OR)
Standard deviation
95% CI low (OR)
Total (N analyzed)
95% CI high (OR)
Events
p value
Percentage
Within Arm ComparisonsNet Comparisons
Ketogenic Diet (classic)Modified Atkins DietNormal Diet

Adverse Event (Diarrhea)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Ketogenic Diet (classic)Modified Atkins DietNormal Diet
Baseline
Frequency change
Odds Ratio (OR)
Standard deviation
95% CI low (OR)
Total (N analyzed)
95% CI high (OR)
Events
p value
Percentage
Within Arm ComparisonsNet Comparisons
Ketogenic Diet (classic)Modified Atkins DietNormal Diet

Adverse Event (Dysphagia)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Ketogenic Diet (classic)Modified Atkins DietNormal Diet
Baseline
Frequency change
Odds Ratio (OR)
Standard deviation
95% CI low (OR)
Total (N analyzed)
95% CI high (OR)
Events
p value
Percentage
Within Arm ComparisonsNet Comparisons
Ketogenic Diet (classic)Modified Atkins DietNormal Diet