Bergqvist 2005.
Study characteristics | ||
Methods | Prospective, randomised, single‐centre study comparing Fast KD and Grad KD over a 3‐month period. Baseline data of seizure activity was collected 28 days prior to diet initiation. | |
Participants |
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Interventions | Speed of introduction of KD: Fast KD (< 48 hour fast, followed by 4:1 KD with increase in portion size over 6 days) or Grad KD (gradual increase in KD ratio from 1:1 to 4:1 over 6 days) | |
Outcomes |
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Notes |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants stratified by age (1 to 2 years and 2 to 14 years); randomisation in permuted blocks of random size (2 to 4). |
Allocation concealment (selection bias) | Low risk | Randomisation through permuted blocks of random size of groups of 2 or 4 participants in order to prevent any ability to guess the next assignment. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding was not discussed in this paper, but considering the design of the study, blinding of participants and study personnel does not seem possible. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Blinding was not discussed in this paper, but considering the design of the study, blinding of outcome assessors does not seem possible. |
Incomplete outcome data (attrition bias) | Unclear risk | Similar attrition rate in both groups, numbers too small for statistical analysis. No ITT analysis completed. |
Selective reporting (reporting bias) | Unclear risk | Protocol unavailable. |
Other bias | Low risk | All participants admitted received same care; no other bias identified. |