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

Abstract

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

Prognostication after intracerebral hemorrhage: a review

“…Further frequently used PROM scales include the EQ-5D, the Sickness Impact Profile, the Telephone Interview for Cognitive Status (TICS) and the SF-36. The prospective Patient Reported Outcomes in Stroke Care (EPOS, NCT03795948) study as well as the coordinated treatment of stroke patients with patient-orientated outcome measurement (StroCare, NCT04159324) study will hopefully further characterize the role PROMs in stroke-related outcomes research [ 77 , 78 ]…”

MORe PREcISE: A Multicenter Prospective Cohort of Patient Reported Outcome Measures in Stroke

“…The PROMIS 10 has been shown as a feasible instrument in stroke survivors [19][20][21][22][23][24] and exhibited the components of patient reported morbidity. Particularly when considering the high post-stroke prevalence of PROM morbidity immediately after stroke.…”

Profiles of patients’ self-reported health after acute stroke

“…Data were collected according the ICHOM guidelines and the study protocol [ 11 , 28 ]. Diagnosis, patient history, demographics, cardio-vascular risk factors, and therapy were collected from interviews and electronic records prior to discharge.…”