What we don't learn from clinical trials in epilepsy.
The randomized, double-blind trial design offers the most accurate data regarding the efficacy of antiepileptic treatments. However, translating the results of a trial into clinical care can be complex due to the intrinsic tension between the requirements for scientific methods that minimize systematic and random error, and the need for clinically relevant and generalizable data. The interpretation of the trial results is complicated further by the probable inaccuracy of self-reported seizure rates and spontaneously reported adverse effects in most trials. Patient preference may be a feasible outcome measure that allows patient-oriented validation of the results, and also inherently weighs the positive and negative effects of a treatment in a single endpoint.
Gilliam
Frank
F
Department of Neurology, Washington University, St. Louis, Missouri 63110, USA. gilliamf@neuro.wustl.edu
D000927:Anticonvulsants / Q000009:adverse effects / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004827:Epilepsy / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D015994:Incidence; D017063:Outcome Assessment, Health Care; D017060:Patient Satisfaction; D012640:Seizures / Q000453:epidemiology / Q000209:etiology; D013223:Statistics as Topic
D000927:Anticonvulsants