96 CHAPTER 6 Patient and public involvement A patient representative is part of the study board of the FRAIL-AF trial (WFB). He was not explicitly involved in the initial conception of the study, which was investigator initiated, but played an important role in the writing and further conceptualisation of the study protocol, particularly related to how to inform patients on consent and study procedures, including an assessment of the burden of the intervention. He also plays an important part in monitoring the progress of patients in the study and is actively involved in all study board progress meetings. Results will be disseminated to all study participants and their care givers after study completion. ETHICS AND DISSEMINATION The FRAIL-AF study will be conducted according to the principles of the Declaration of Helsinki and in accordance with Dutch law (the Medical Research Involving Human Subjects Act (WMO)).29,30 The protocol was approved by the Medical Research Ethics Committee of the UMC Utrecht, the Netherlands (reviewing committee), and by the Central Committee on Research Involving Human Subjects, the Netherlands (competent authority). All patients are asked written informed consent before being randomised or followed observationally. Patients’ personal data will be saved separate from baseline and follow-up data, and their privacy will be guaranteed throughout the entire study. The progress of the study, the occurrence of (serious) adverse events and finally the overall safety of the frail elderly participating in this trial will be assessed on a frequent basis by an independent data safety monitoring board. In addition, quality assurance will be guaranteed by monitoring. Results are expected in 2022 and will be disseminated through peer-reviewed publications and presentations at national and international conferences. DISCUSSION The FRAIL-AF open-label pragmatic randomised trial will be the first study to evaluate whether switching from INR guided VKA management to a NOAC based treatment strategy is a safe alternative for continuing INR guided VKA management in frail elderly patients with AF. A recent randomised pilot study confirmed the safety and effectiveness of switching VKA treatment to a NOAC (n=121) compared with continuing a VKA (n=120), although in a different study population namely those with a time in therapeutic INR range of 70% or higher and a mean age of 73.0 years in those switching from VKA treatment to a NOAC.31 Hence, frail elderly patients with AF are underrepresented in the existing trial evidence on the safety and efficacy of NOAC treatment for stroke prevention, compared with
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