Clinical trials for treatments to prevent recurring strokes typically only include participants who have little to no disability from a prior stroke. A new Yale study finds that leaving patients with such disability out of trials may limit what can be concluded from their results. Patients with -induced disability—which might include being unable to walk or needing help with day-to-day activities—account for more than half of the stroke survivor population.
Including them in trials would yield study cohorts that better reflect—and treatments that better support—the real-world population, researchers say. The findings were in . For the study, researchers used data from two that did include with moderate or severe disability: one that took place between 2003 and 2008 and included over 20,000 patients, and another that enrolled over 3,800 patients between 2005 and 2015.
Stroke-induced disability is measured by the modified Rankin Scale (mRS) on a scale of increasing severity from zero to five. The study categorized patients as having no symptoms (mRS score of zero), mild disability (mRS score of one or two), or moderate to severe disability (mRS score of three or greater). For the new study, the researchers looked at the severity of patients' post-stroke disability and whether they later experienced another stroke or major cardiovascular event.
"We found that rates of both recurrent stroke and major cardiovascular events were significantly higher in the participants with.