Outcome evaluation by patient reported outcome measures in stroke clinical practice (EPOS) protocol for a prospective observation and implementation study

• DOI: 10.1186/s42466-019-0034-0
• Publication Date: 2019-11-01T09:43:24Z
• Authors: D. Leander Rimmele; Lisa Lebherz; Marc Frese; Hannes Appelbohm; Hans-Jürgen Bartz; Levente Kriston; Christian Gerloff; Martin Härter; Götz Thomalla
• Keywords: Stroke; Patient-reported outcome

Abstract Introduction The impact of stroke-related impairment on activities daily living may vary between patients, and can only be estimated by applying patient-reported outcome measures. International Consortium for Health Outcome Measurement has developed a standard set instruments that combine clinical longitudinal measures stroke. present study was designed (1) to implement evaluate the feasibility use it as consistent measure in routine at stroke center German university hospital, (2) characterize everyday life caused stroke, (3) identify predictive factors associated with patient-relevant outcomes. Methods We plan enroll 1040 consecutive patients diagnosis acute ischemic transient attack, or intracerebral hemorrhage prospective observational study. Demographics, cardiovascular risk factors, situation are assessed inpatient surveillance. At 90 days 12 months after inclusion, follow-up assessments take place including Patient-reported Outcomes Information System 10-Question Short Form (PROMIS-10), Patient- Questionnaire-4, simplified modified Ranking Scale questionnaire. acceptance will process evaluation through qualitative semi-structured interviews staff quantitative analyses data quality evaluating practicability, acceptance, adoption, fidelity protocol. primary objective 2 3 is health-related measured PROMIS-10. Additional outcomes depressive anxiety symptoms patient participation their social roles. course using (generalized) mixed regressions. Exploratory descriptive inference statistical used find patterns characteristics domains. Perspective results describe further establish standardized PROMs life. Trial registration trial registered ClinicalTrials.gov ( NCT03795948 ). Approval local ethics committee (Ethik-Kommission der Ärztekammer Hamburg) been obtained.