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Open Access 01-12-2019 | Stroke | Clinical trial protocol

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

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

Published in: Neurological Research and Practice | Issue 1/2019

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.

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Title: Outcome evaluation by patient reported outcome measures in stroke clinical practice (EPOS) protocol for a prospective observation and implementation study
Authors: D. Leander Rimmele
Lisa Lebherz
Marc Frese
Hannes Appelbohm
Hans-Jürgen Bartz
Levente Kriston
Christian Gerloff
Martin Härter
Götz Thomalla
Publication date: 01-12-2019
Publisher: BioMed Central
Keywords: Stroke
Care
Stroke Unit
Published in: Neurological Research and Practice / Issue 1/2019
Electronic ISSN: 2524-3489
DOI: https://doi.org/10.1186/s42466-019-0034-0

At a glance: The STEP trials

Springer Medicine

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

Abstract

Introduction

Methods

Perspective

Trial registration

At a glance: The STEP trials

Springer Medicine

Abstract

Introduction

Methods

Perspective

Trial registration

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