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 neurological 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 non-participation 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 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 in order 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, employing instead follow-up assessment on “opt-out” basis. Patients were included if they had neurological symptoms at ambulance or hospital arrival within 6h of onset and had a final diagnosis of stroke or TIA. Information on data collection and outcome assessment was sent by letter to patients one month before follow-up.
Results: From 1st Feb 2017 to 31st Jan 2020, a total of 10,597 patients were assessed. Thirty-one (0.3%) patients declined any data use, while 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.
- Received October 4, 2021.
- Accepted in final form May 17, 2022.
- © 2022 American Academy of Neurology
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