Managing the Increasing Burden of Atrial Fibrillation through Integrated Care in Primary Care: A Cost-Effectiveness Analysis.

"Competing Interests The authors have no competing interests to declare."

"The ALL-IN trial is funded with an unrestricted grant from the Stichting Achmea Gezondheidszorg (SAG number Z646), the Hein Hogerzeil Stichting and Roche Diagnostics Nederland B.V. There are no restrictions to the execution of the study or the publication process by any of the subsiding parties of this study."

"The study design of the ALL-IN trial was described in detail previously []. In addition, a detailed comparison of the intervention with usual care is provided in the Additional file, Table A1. In short, we performed a cluster-randomised, pragmatic, non-inferiority trial in primary care practices in the Netherlands, starting in 2016 with a follow-up period of 2 years. After randomisation of primary care practices, patients with documented AF aged 65 years or older were included. The main exclusion criteria were valvular AF or the presence of an internal cardioverter defibrillator or cardiac resynchronisation therapy device []. In practices randomised to the index intervention, patients who provided informed consent for participating in the intervention received integrated care and also a questionnaire on quality of life and resource use at baseline, after 12 months and after 24 months of follow-up. A modified informed consent procedure was carried out, in which a waiver for informed consent to collect data on baseline characteristics and clinical outcomes from the primary care electronic medical records (EMRs) was provided by the Medical Ethics Committee of the Isala Clinics Zwolle []. Such a waiver of informed consent for anonymised data collection was necessary to ensure the scientific validity of the cluster randomised trial, for three reasons: (i) to assess otherwise undetectable possible selection bias caused by providing individual informed consent for participation after cluster randomization, (ii) to enhance the generalizability of the results, especially to frail elderly AF patients, and (iii) informing the eligible patients in the usual care practices about the aims of the study would imply patient education about AF and its risks, thus inducing a risk of contamination. Patients in control practices were asked for informed consent to fill out the questionnaires on quality of life and resource use. The ALL-IN trial is registered at the Netherlands Trial Register (NL5407)."