Follow-up of Patients With Stroke Based on Opt-out Choice: Potential Approach for Acute Care Quality Registries or Observational Studies

Ira Napierkowski; Irina Lorenz-Meyer; Annegret Hille; Martin Ebinger; Erik Freitag; Peter Harmel; Matthias Endres; Georg Hagemann; Hans-Christian Koennecke; Bruno-Marcel Mackert; Bob Siegerink; Heinrich J Audebert; Berlin–SPecific Acute Treatment in Ischemic or hAemorrhagic Stroke With Long Term Follow-up (B-SPATIAL) registry

doi:10.1212/WNL.0000000000200916

Follow-up of Patients With Stroke Based on Opt-out Choice: Potential Approach for Acute Care Quality Registries or Observational Studies

Neurology. 2022 Sep 27;99(13):e1335-e1344. doi: 10.1212/WNL.0000000000200916. Epub 2022 Aug 2.

Affiliations

¹ From the Center for Stroke Research Berlin (I.N., I.L.M, A.H., M.E., E.F., P.H., M.E., B.S., H.J.A.), Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Germany; Klinik für Neurologie (M.E.), Medical Park Berlin Humboldtmühle, Germany; Klinik und Hochschulambulanz für Neurologie (E.F., P.H., M.E.), Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Germany; German Centre for Cardiovascular Research (DZHK) (M.E.), Partner Site Berlin, Germany; German Center for Neurodegenerative Diseases (DZNE) (M.E.), Partner Site Berlin, Germany; NeuroCure Cluster of Excellence (M.E.), Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Germany; Helios Klinikum Berlin Buch (G.H.), Germany; Klinik für Neurologie Mit Stroke Unit (H.-C.K.); Vivantes Klinikum Im Friedrichshain, Berlin, Germany; Klinik für Neurologie Mit Stroke Unit (B.-M.M.), Vivantes Auguste-Viktoria-Klinikum, Berlin, Germany; and Department of Clinical Epidemiology (B.S.), Leiden University Medical Center, Leiden University, The Netherlands.
² From the Center for Stroke Research Berlin (I.N., I.L.M, A.H., M.E., E.F., P.H., M.E., B.S., H.J.A.), Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Germany; Klinik für Neurologie (M.E.), Medical Park Berlin Humboldtmühle, Germany; Klinik und Hochschulambulanz für Neurologie (E.F., P.H., M.E.), Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Germany; German Centre for Cardiovascular Research (DZHK) (M.E.), Partner Site Berlin, Germany; German Center for Neurodegenerative Diseases (DZNE) (M.E.), Partner Site Berlin, Germany; NeuroCure Cluster of Excellence (M.E.), Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Germany; Helios Klinikum Berlin Buch (G.H.), Germany; Klinik für Neurologie Mit Stroke Unit (H.-C.K.); Vivantes Klinikum Im Friedrichshain, Berlin, Germany; Klinik für Neurologie Mit Stroke Unit (B.-M.M.), Vivantes Auguste-Viktoria-Klinikum, Berlin, Germany; and Department of Clinical Epidemiology (B.S.), Leiden University Medical Center, Leiden University, The Netherlands. heinrich.audebert@charite.de.

PMID: 35918161
DOI: 10.1212/WNL.0000000000200916

Abstract

Background and objectives: Restricting follow-up assessment of both interventional and observational studies to patients who provide informed consent introduces relevant selection bias-particularly by underrepresenting patients with neurologic communication deficits and impaired capacity to consent. Many patients who are initially unable to give consent may be willing to do so after recovery. Informing patients on study purposes and procedures with offering them the option of nonparticipation but not requesting explicit consent is called "opt-out" approach. We investigated whether an opt-out strategy yields meaningful follow-up rates in an acute stroke registry with an embedded controlled study.

Methods: The citywide Berlin-SPecific Acute Treatment in Ischemic or hAemorrhagic Stroke With Long Term Follow-up (B-SPATIAL) registry was designed to provide reliable information on process indicators and outcomes of specific acute stroke treatments to inform health care providers about quality of care and best practice strategies including the effects of a mobile stroke unit implementation. Because this information was regarded of high public interest, Berlin data protection authorities permitted data sampling without prior informed consent, using instead follow-up assessment on an "opt-out" basis. Patients were included if they had neurologic symptoms at ambulance or hospital arrival within 6 hours of onset and had a final diagnosis of stroke or TIA. Information on data collection and outcome assessment was sent by letter to patients 1 month before follow-up.

Results: From February 1, 2017, to January 31, 2020, a total of 10,597 patients were assessed. Thirty-one (0.3%) patients declined any data use, whereas 578 (5.5%) opted out of follow-up assessment. Of those not opting out (n = 9,988), functional outcome (modified Rankin Scale) was collected in 8,330 patients (83.4%) and vital status in 9,741 patients (97.5%). We received no complaints regarding data collection procedures.

Discussion: Opt-out-based follow-up collection offers a way to achieve high follow-up rates along with respecting patients' preferences.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Data Collection
Follow-Up Studies
Humans
Quality of Health Care
Registries
Stroke* / diagnosis
Stroke* / therapy