Abstract TP292: Patient Reported Outcomes in Stroke Clinical Trials

Abstract

Stroke is the 5 th -leading cause of death in the US and the major cause of disability. Many patients who have suffered from strokes are left with permanent neurological deficits, new occupational and social difficulties, and reductions in quality of life that may be idiosyncratic or vary considerably from patient to patient. Solicitation of patient reported outcomes (PROs) in the treatment and recovery from strokes is therefore imperative. We examined a list compiled in 2013 for Stroke by Magin et al. of representative stroke-related, randomized clinical trials published in 10 high-impact journals between 2002 and 2012 to assess whether PROs were collected and which constructs were reported. We categorized PRO measures as stroke-specific (e.g. Stroke Impact Scale), health profile and utility scales (e.g. Beck Depression Scale), or general (e.g. pain visual analog scale). Two reviewers independently abstracted PRO measures from each article and disagreements were resolved by consensus. Fisher’s exact test was used for statistical analyses. Of the 99 articles that met study inclusion criteria, 20% concerned prevention, 22% acute treatment, and 58% rehabilitation. A plurality of trials were European (43%) followed by studies based in the US (25%), Asian countries (10%), and Australia (10%). Altogether, 37% of studies used a PRO of any kind. Stroke-specific PROs were collected in 17% of studies, health profile and utility scales were used in 17%, and general PROs were used in 23%. There were no significant differences in PRO use with regards to year of publication or study location. Health profile and utility scales (p=0.01) and unclassified PROs (p<0.001) were most-commonly reported in rehabilitation trials. Stroke-specific PROs were most commonly published in the journals Brain and Journal of Stroke and Cerebrovascular Diseases (p=0.001). Overall, our review and analysis detected a low prevalence and a large degree of heterogeneity of PRO measures reported in stroke-related clinical trials. Future stroke research must routinely incorporate PROs into the study design to help patients, caregivers, and providers make informed decisions about stroke prevention, treatment, and rehabilitation options that yield outcomes of greatest importance to them.