Standardizing ED-based migraine clinical research: a data-driven analysis of commonly-used trial outcome measures
Abstract
Introduction Although many high quality migraine clinical trials have been performed in the emergency department (ED) setting, almost as many different primary outcome measures have been used, making data aggregation and meta-analysis difficult. We assessed commonly used migraine trial outcomes in two ways. First, we examined the association of each commonly used outcome versus the following patient-centered variable: the research subject’s wish, when asked 24 hours after investigational medication administration, to receive the same medication the next time they presented to an ED with migraine (“would take again”). We chose this variable as the criterion standard because it provides a simple, dichotomous, clinically sensible outcome, which allows migraineurs to factor important intangibles of efficacy and adverse effects of treatment into an overall assessment of care. The second part of our analysis assessed how sensitive to true efficacy each outcome measure was by calculating sample size requirements based on results observed in previously conducted clinical trials. Methods Secondary analysis of data previously collected in four ED-based migraine randomized trials performed between 2003 and 2007. In each of these trials, subjects were asked 24 hours after administration of an investigational medication whether or not they would want to receive the same medication the next time they came to the ED with a migraine. Odds ratios (ORs) with 95%CI, adjusted for gender and…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 378 participants or records.
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