Table 1 Consent options for the HeadPoST trial
Hierarchy of consent options proposed in this study | |
|---|---|
1. | Cluster guardian consent or appropriate approval (e.g., signed by general manager or chief executive of hospital or by head of neurology/stroke department) for the randomised head position to be the usual nursing care for patients with acute stroke, obtained before commencement of the study |
With any of the following: | |
2. | a. Recommended: Opt-out consent obtained from patients for the collection of data through in-person assessment and extraction of information from medical records during the hospital stay and follow-up, and release of personal information to allow centralised follow-up at 90 days after initial admission to the hospital for research purposes |
b. Alternative: Individual patient consent for collection of in-hospital data and for release of personalised information for research purposes to allow centralised follow-up at 90 days after the initial admission to the hospital | |