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Design Details
Arms
Arm Details
Sample Characteristics
Outcomes
Outcome Details
Risk of Bias Assessment
Results
Print Data

Extraction form for project: Management of Infantile Epilepsies

Design Details

1. Study Design


	RCT Nonrandomized comparative study Pre/post observational study

2. Country


	USA

3. Total sample size


	155

4. Intervention Type


	Pharmacological Dietary Surgery

5. Funding source


	Pediatric Epilepsy Research Foundation

Arms

Arm Name	Arm Description
Levetiracetam	First ASM prescribed by a neurologist, as monotherapy. No details of titration schedules. Median target dose 25 mg/kg/d
Phenobarbital	First ASM prescribed by a neurologist, as monotherapy. No details of titration schedules. Median target dose 5 mg/kg/d

Arm Details

1. Sample size for arm

Levetiracetam


	117

Phenobarbital


	38

2. Inclusion Criteria

Levetiracetam

Phenobarbital

3. Exclusion Criteria

Levetiracetam

Phenobarbital

4. Treatment details

Levetiracetam


	First ASM prescribed by a neurologist, as monotherapy. No details of titration schedules. Median target dose 25 mg/kg/d

Phenobarbital


	First ASM prescribed by a neurologist, as monotherapy. No details of titration schedules. Median target dose 5 mg/kg/d

Sample Characteristics

1. Gender, number of male

Levetiracetam


	56

Phenobarbital


	18

Total


	74

2. Gender, percentage of male

Levetiracetam


	48

Phenobarbital


	47

Total


	47.5

3. Age at intervention (mean)

Levetiracetam


	NR

Phenobarbital


	NR

Total


	NR

4. Age at intervention (SD)

Levetiracetam


	NR

Phenobarbital


	NR

Total


	NR

5. Age at intervention (range)

Levetiracetam


	NR

Phenobarbital


	NR

Total


	NR

6. Age at intervention (median)

Levetiracetam


	NR

Phenobarbital


	NR

Total


	NR

7. Seizure types and/or etiology

Levetiracetam


	All had nonsyndromic epilepsy. 60% unknown etiology, 17% developmental structural abnormality, 9% acquired etiology, 7% genetic etiology, 3% neurocutaneous etiology, 4% other.

Phenobarbital


	All had nonsyndromic epilepsy. 42% unknown etiology, 32% developmental structural abnormality, 13% acquired etiology, 8% genetic etiology, 3% neurocutaneous etiology, 3% other.

Total


	For levetiracetam, all had nonsyndromic epilepsy. 60% unknown etiology, 17% developmental structural abnormality, 9% acquired etiology, 7% genetic etiology, 3% neurocutaneous etiology, 4% other. For phenobarbital, all had nonsyndromic epilepsy. 42% unknown etiology, 32% developmental structural abnormality, 13% acquired etiology, 8% genetic etiology, 3% neurocutaneous etiology, 3% other.

8. Prior treatment

Levetiracetam


	No concomitant treatments were administered

Phenobarbital


	No concomitant treatments were administered

Total


	No concomitant treatments were administered

9. Comments

Levetiracetam

Phenobarbital

Total


	17 sites in the USA

Outcomes

Type	Domain	Specific measurement (i.e., tool/definition/specific outcome)	Populations	Timepoints
Categorical	Seizure Freedom	Freedom from monotherapy failure (no seizures during months 4-6 months after treatment initiation, AND no second ASM other than pyridoxine was prescribed during the full six months)	Patients	6 months

Outcome Details

1. For RCTs: Generation of randomization sequence

Seizure Freedom

2. For RCTs: Allocation concealment

Seizure Freedom

3. For RCTs: Baseline imbalance

Seizure Freedom

4. For RCTs: Patient blinded

Seizure Freedom

5. For RCTs: Staff blinded

Seizure Freedom

6. For RCTs: Differential ancillary treatments

Seizure Freedom

7. For RCTs: Adherence

Seizure Freedom

8. For RCTs: Analytic approach to address departures from intended intervention

Seizure Freedom

9. For RCTs: Data on at least 80% of those enrolled

Seizure Freedom

10. For RCTs: Differential dropout <=15%

Seizure Freedom

11. For RCTs: Standard way to measure the outcome

Seizure Freedom

12. For RCTs: Blinded outcome assessor

Seizure Freedom

13. For RCTs: Bias in selection of reported results

Seizure Freedom

14. For nonrandomized comparative studies: Confounding

Seizure Freedom

15. For nonrandomized comparative studies: Selection into study

Seizure Freedom

16. For nonrandomized comparative studies: Classification of interventions

Seizure Freedom

17. For nonrandomized comparative studies: Differential ancillary treatments

Seizure Freedom

18. For nonrandomized comparative studies: Adherence

Seizure Freedom

19. For nonrandomized comparative studies: Data on at least 80% of those enrolled

Seizure Freedom

20. For nonrandomized comparative studies: Differential dropout <=15%

Seizure Freedom

21. For nonrandomized comparative studies: Standard way to measure the outcome

Seizure Freedom

22. For nonrandomized comparative studies: Blinded outcome assessor

Seizure Freedom

23. For nonrandomized comparative studies: Bias in selection of reported result

Seizure Freedom

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

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

26. For single arm studies: Did the study maintain fidelity to the intervention protocol?

Seizure Freedom

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

28. For single arm studies: Were the outcome assessors blinded to the intervention or exposure status of participants?

Seizure Freedom

29. For single arm studies: Were interventions/exposures assessed/defined using valid and reliable measures, implemented consistently across all study participants?

Seizure Freedom

30. For single arm studies: Were outcomes assessed/defined using valid and reliable measures, implemented consistently across all study participants?

Seizure Freedom

31. For single arm studies: Were confounding variables assessed using valid and reliable measures, implemented consistently across all study participants?

Seizure Freedom

32. For single arm studies: Were the potential outcomes prespecified by the researchers? Are all prespecified outcomes reported?

Seizure Freedom

Risk of Bias Assessment

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

Results

Categorical

Seizure Freedom (Freedom from monotherapy failure (no seizures during months 4-6 months after treatment initiation, AND no second ASM other than pyridoxine was prescribed during the full six months))

Patients
		Descriptive Statistics			Between Arm Comparisons
		Levetiracetam	Phenobarbital
6 months
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
				p value
		Within Arm Comparisons			Net Comparisons
		Levetiracetam	Phenobarbital