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

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

Journal

Neurology
ISSN: 1526-632X
Titre abrégé: Neurology
Pays: United States
ID NLM: 0401060

Informations de publication

Date de publication:
27 09 2022
Historique:
received: 04 10 2021
accepted: 17 05 2022
pubmed: 3 8 2022
medline: 28 9 2022
entrez: 2 8 2022
Statut: ppublish

Résumé

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

Sections du résumé

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.

Identifiants

DOI: 10.1212/WNL.0000000000200916 PMID: 35918161
pubmed: 35918161
pii: WNL.0000000000200916
doi: 10.1212/WNL.0000000000200916
doi:

Types de publication

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

Langues

eng

Sous-ensembles de citation

IM

Pagination

e1335-e1344

Informations de copyright

© 2022 American Academy of Neurology.

Auteurs

Ira Napierkowski (I)

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.
ORCID: 0000-0003-0072-524X

Irina Lorenz-Meyer (I)

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.

Annegret Hille (A)

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.

Martin Ebinger (M)

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.

Erik Freitag (E)

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.

Peter Harmel (P)

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.

Matthias Endres (M)

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.

Georg Hagemann (G)

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.

Hans-Christian Koennecke (HC)

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.

Bruno-Marcel Mackert (BM)

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.

Bob Siegerink (B)

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.
ORCID: 0000-0002-8454-9142

Heinrich J Audebert (HJ)

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.

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Classifications MeSH

questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Collecte de données › Follow-up of Patients With Stroke Based on...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études épidémiologiques › Études de cohortes › Études de suivi › Follow-up of Patients With Stroke Based on...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Follow-up of Patients With Stroke Based on...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › Follow-up of Patients With Stroke Based on...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Collecte de données › Enregistrements › Follow-up of Patients With Stroke Based on...
questionsmedicales.fr › Maladies cardiovasculaires › Maladies vasculaires › Angiopathies intracrâniennes › Accident vasculaire cérébral › Follow-up of Patients With Stroke Based on...