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

D Leander Rimmele, Lisa Lebherz, Marc Frese, Hannes Appelbohm, Hans-Jürgen Bartz, Levente Kriston, Christian Gerloff, Martin Härter, Götz Thomalla, D Leander Rimmele, Lisa Lebherz, Marc Frese, Hannes Appelbohm, Hans-Jürgen Bartz, Levente Kriston, Christian Gerloff, Martin Härter, Götz Thomalla

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 patient-reported 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.

Keywords: Feasibility; Health-related quality of life; ICHOM; Inpatient treatment; Long term assessment; Patient-relevant care; Patient-reported outcome measures; Process evaluation; Stroke care.

Conflict of interest statement

Competing interestsLR, LL, MF, HA, HJB, LK, and MH have no conflict of interest. CG reports personal fees from Amgen, Bayer Vital, Bristol-Myers Squibb, Boehringer Ingelheim, Sanofi Aventis, Abbott, and Prediction Biosciences outside the submitted work. GT reports receiving consulting fees from Acandis, grant support, and lecture fees from Bayer, lecture fees from Boehringer Ingelheim, Bristol-Myers Squibb/Pfizer, and Daiichi Sankyo, and consulting fees and lecture fees from Stryker outside the submitted work.

© The Author(s) 2019.

Figures

Fig. 1
Fig. 1
Estimated number of included patients after recruitment. Abbreviations: AIS acute ischemic stroke, TIA transient ischemic attack, ICH intracerebral hemorrhage
Fig. 2
Fig. 2
Timepoints and content of determined data

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