PICO and Critical Appraisal - Ketogenic Diet For Epilepsy in Children - Part 1. Validity

STUDENT PROJECT
THERAPY ASPECT
SGD KUB 3
Introduction
The incidence of epilepsy is greatest in the first 2 years of life.
Early control of seizures can be associated with better
developmental outcome but many of the epilepsies presenting
in infancy are poorly responsive to antiepileptic medication.
The ketogenic diet (KD) is a high fat, low-carbohydrate diet

designed to mimic the effects starvation on the body. Dietary fat
is converted into ketones in the body and used as an energy
source by the brain. The KD has been shown to be and used as
an energy source by the brain. The KD has been shown to be
successful in controlling seizures in many observational studies.
However the pediatric neurologist want to find the best evidence
of KD in children.
PICO
Population/Patient Infancy or Infant or Infants or Young Children
or First 2 Years or Children or Pediatric or
Paediatric or Pediatry or Paediatry
and
Epilepsy or Seizure or Seizures or Convulsion
or Convulsions
Intervention Ketogenic Diet or KD or Ketogenic
Control/Comparison Not Ketogenic Diet
Outcome Control Seizure or Control Seizures or Control
Epilepsy or Control or Remission
Clinical Research Question
In children under two years old with epilepsy, is
ketogenic diet effective in controlling seizures?
Best Evidence (Journal)
Objective To evaluate the efficacy and tolerability of the ketogenic
diet (KD) during the first 4 months of a randomized
controlled trial (RCT) in refractory epilepsy patients aged
1–18 years.
Methods Children and adolescents with refractory epilepsy, not

eligible for epilepsy surgery, were included.
Following 1 month at baseline, patients were randomized

to either the KD or to care as usual (CAU).
Primary outcome is the proportion of patients with at least

50% reduction in seizure frequency at 4 months.
Secondary outcomes are mean percentage of baseline

seizures, seizure severity, and side effects.
Critical Appraisal
01 Validity
02 Importance
03 Calculation
04 Applicability
Validity
Are the results of this single preventive or
therapeutic trial valid?
Was the assignment of patients to
treatments randomized?
◉ Yes, patients were randomized to either the KD or to

CAU after a 1-month baseline period.
◉ A total of 58 patients were included in the study. Each group
has almost equal amounts of patients. The difference only
the intervention.
Was the randomization list concealed?
◉ Yes,
◉ A software package (ALEA) was used to support the
randomization, which was based on the minimization
method. Computer software is an adequate allocation
concealment.
Was follow-up of patients sufficiently long
and complete?
◉ Yes, there are no loss follow up of patients greater than

20%. 84.21% patients complete the clinical trial
◉ Based on a minimum detectable difference in success rate
of 35% between the KD group and CAU, and assuming that
alpha = 5% and power = 80%, it is needed 22 children for
each group. (Final patients: CAU 22; KD 26)
Were all patients analyzed in the groups to
which they were randomized?
◉ Yes, An intention-to-treat (ITT) analysis was performed.

Were patients, clinicians, and study
personnel kept “blind” to treatment?
No, the project proposed an open-label, Ketogenic Diet has

never been tested in a blinded manner. Morever it was
stated that the KD was introduced according to the Dutch
guideline during a 5-day hospitalization at the epilepsy
center and the form applied most frequently was the MCT
diet after asking what patient’s preference.
Were the groups treated equally, apart
from the experimental treatment?
Yes, before starting the experiment, all of the groups

were taking AED regime as their treatment. When the
experiment finished, consuming AED regime was still
continuing and change of the AED regime was only
allowed if medically necessary.
Were the groups similar at the start of the
trial apart from the experimental therapy?
◉ Yes, it was stated that children and adolescents, aged

between 1 and 18 years, with refractory epilepsy not
eligible for epilepsy surgery, were included. Patients were
excluded if there were medical contra-indications or the
expectation that compliance with the diet was not
possible because of severe behavioral or motivational
problems.
◉ Before starting the baseline, 1 was excluded due to
undetected dyslipidemia

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STUDENT PROJECT

The ketogenic diet (KD) is a high fat, low-carbohydrate diet

Methods Children and adolescents with refractory epilepsy, not

Following 1 month at baseline, patients were randomized

Primary outcome is the proportion of patients with at least

Secondary outcomes are mean percentage of baseline

◉ Yes, patients were randomized to either the KD or to

◉ Yes, there are no loss follow up of patients greater than

◉ Yes, An intention-to-treat (ITT) analysis was performed.

No, the project proposed an open-label, Ketogenic Diet has

Yes, before starting the experiment, all of the groups

◉ Yes, it was stated that children and adolescents, aged

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