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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.
Glossary
- B_PROUD=
- Berlin_PRehospital Or Usual Delivery of acute stroke care;
- B-SPATiAL=
- Berlin–SPecific Acute Treatment in Ischemic or hAemorrhagic Stroke With Long Term Follow-up;
- EMS=
- emergency medical services;
- EVT=
- endovascular treatment;
- ICD-10=
- International Classification of Diseases, Tenth Revision;
- MSU=
- mobile stroke unit;
- PHANTOM-S=
- Prehospital Acute Neurological Treatment and Optimization of Medical care in Stroke
Footnotes
Go to Neurology.org/N for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
The Berlin–SPecific Acute Treatment in Ischemic or hAemorrhagic Stroke With Long Term Follow-up (B-SPATIAL) registry coinvestigators are listed in the appendix at the end of the article.
↵* These authors contributed equally to this work as co-first authors.
Submitted and externally peer reviewed. The handling editors were José Merino, MD, MPhil, FAAN, and Brad Worrall, MD, MSc, FAAN.
Editorial, page 545
- Received October 4, 2021.
- Accepted in final form May 17, 2022.
- © 2022 American Academy of Neurology
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