PICOT QUESTION

ERI KA CAPALLA
UNI VERSI TY OF SAN DI EGO
MSNC 511: EVI DENCE-BASED PRACTI CE: ROLE OF THEORY AND
RESEARCH
 PICOT QUESTION

• In pediatric patients with intractable

epilepsy, how does treatment with a
ketogenic diet and anti-epileptic drugs
compared with treatment with anti-epileptic
drugs only affect seizure control?

• Outcome measurement: seizure control for pediatric

patients on KD
 KETOGENIC DIET

• In use since 1920s

• Diet of fat: carbohydrate and protein ratio of 3:1 or
4:1
• Side effects: GI symptoms, growth deceleration
• Modification of ketogenic diet
• Started in 1970s
• Medium Chain Triglycerides as alternative fat source
• More efficient absorption
• More ketones
 ONLINE SEARCH STRATEGY

• Search terms: Epilepsy, Seizures, Intractable,

Refractory, Ketogenic Diet, Anti-Epileptic Drugs
• Databases: CINAHL, PubMed/Medline, The
Cochrane Database
• Limits/Exclusion criteria: Age, Human
 EVIDENCE

• Type
• 4 RCTs
• 1 Non-experimental study
• Level/Quality
• RCT #1: IB-good quality
• RCT #2-4: IA-high quality
• Non-experimental study: IIIB-good quality
 ARTICLE CRITIQUE #1

• Neal, E.G., Chaffe, H., Schwartz, R.H., Lawson, M.S., Edwards,

N., Fitzsimmons, G., et al (2008). The ketogenic diet for the
treatment of childhood epilepsy: a randomised controlled trial.
Lancet-Neurology, 7, 500-506.

• Evidence type: RCT

• Evidence level and quality: IB
• Sample size and setting: 145 pediatric patients at a hospital center
and residential center, ketogenic diet vs control group
• Limitations: Children less than 2 yo not included, subjective errors d/t
caregiver recording
• Study findings
• Seizures in 54 children on diet fell to mean of 62% of baseline
• Responder rates similar to those seen in RCTs of newer AEDs vs placebo
 ARTICLE CRITIQUE #2

• Neal, E.G., Chaffe, H., Schwartz, R.H., Lawson, M.S., Edwards, N.,
Fitzsimmons, G., Whitney, A., et al (2009). A randomized trial of
classical and medium chain triglyceride ketogenic diets in the
treatment of childhood epilepsy. Epilepsia, 50, 1109-1117.

• Evidence type: RCT

• Evidence level and quality: IA
• Sample size and setting: 94 pediatric patients at a clinic, classical vs MCT
• Limitations: Some children had pre-existing behavioral feeding problems
that were not managed prior to start, questionnaire was subjective
• Study findings
• After 3 months of treatment, 26/45 children in classic diet and 27/49 children on MCT diet
could have AED dosage reduced
• Mean percentage of seizures after 3 months is 2.35% lower in classical diet group
 ARTICLE CRITIQUE #3

• Lambrechts, D., Kinderen, R., Vles, H., de Louw, A.,

Aldenkamp, A., Majoie, M. (2015). The MCT-ketogenic diet
as a treatment option in refractory epilepsy: a prospective
study with a 2 year follow up. Epilepsy and Behavior, 51, 261-
266.

• Evidence type: Non-experimental

• Evidence level and quality: IIIB
• Sample size and setting: 48 pediatric patients at tertiary referral
center
• Limitations: Non-randomized design, uncontrolled selection of
patients, limited sample size
• Study findings
• After 2 years, 75% of patients with seizure clusters were responders to treatment on the
ketogenic diet
 ARTICLE CRITIQUE #4

• Seo, J.H.; Lee, Y.M.; Lee, J.S.; Kang, H.C.; Kim, H.D. (2007).
Efficacy and tolerability of the ketogenic diet according to
lipid: nonlipid ratios-comparison of 3:1 with 4:1 diet. Epilepsia,
48, 801-805.

• Evidence type: RCT

• Evidence level and quality: IA
• Sample size and setting: 76 pediatric patients at a clinic, 3:1 vs 4:1
• Limitations: GI complications led to poor tolerability of diet
• Study findings
• 3 months after initiating KD, 55% on 4:1 diet and 30.5% on 3:1 diet were seizure free
• Anti-epileptic efficacy higher for 4:1 diet than 3:1 diet
 ARTICLE CRITIQUE #5

• Seo, J.H., Lee, Y.M., Lee, J.S., Kang, H.C., Kim, H.D. (2005).
Fasting versus gradual initiation of the ketogenic diet: a
prospective randomized clinical trial of efficacy. Epilepsia, 46,
1810-1819.

• Evidence type: RCT

• Evidence level and quality: IA
• Sample size and setting: 48 pediatric patients at a clinic, FAST vs
GRAD
• Limitations: Limited sample size
• Study findings
• After 3 months, 58% of subjects in FAST-KD group had greater than 50% reduction in
target seizures
• After 3 months, 67% of subjects in GRAD-KD group had greater than 50% reduction in
target seizures
 PICOT QUESTION ANSWERED:

• Treatment with AEDs and a ketogenic diet led to

positive outcomes and improved seizure control in
pediatric patients with intractable epilepsy
compared to treatment with AEDs only
 IMPLICATIONS

• Nursing Research:
• Further research in long term effects
• Further research on specific seizure types
• Nursing Education:
• Nurse training re: ketogenic diet
• Nursing Practice:
• Alternative treatment
• Gradual introduction
• 4:1 diet
• Ketogenic diet effective
 REFERENCES

• Neal, E.G., Chaffe, H., Schwartz, R.H., Lawson, M.S., Edwards, N., Fitzsimmons, G., et al
(2008). The ketogenic diet for the treatment of childhood epilepsy: a
randomised controlled trial. Lancet-Neurology, 7, 500-506.
• Neal, E.G., Chaffe, H., Schwartz, R.H., Lawson, M.S., Edwards, N., Fitzsimmons, G.,
Whitney, A., et al (2009). A randomized trial of classical and medium chain
triglyceride ketogenic diets in the treatment of childhood epilepsy. Epilepsia,
50, 1109-1117.
• Lambrechts, D., Kinderen, R., Vles, H., de Louw, A., Aldenkamp, A., Majoie, M. (2015). The
MCT-ketogenic diet as a treatment option in refractory epilepsy: a prospective
study with a 2 year follow up. Epilepsy and Behavior, 51, 261-266.
• Seo, J.H.; Lee, Y.M.; Lee, J.S.; Kang, H.C.; Kim, H.D. (2007). Efficacy and tolerability of the
ketogenic diet according to lipid: nonlipid ratios-comparison of 3:1 with 4:1 diet.
Epilepsia, 48, 801-805.
• Seo, J.H., Lee, Y.M., Lee, J.S., Kang, H.C., Kim, H.D. (2005). Fasting versus gradual initiation
of the ketogenic diet: a prospective randomized clinical trial of efficacy. Epilepsia,
46, 1810-1819.
QUESTIONS?