Pharmacist-led intervention for older people with atrial fibrillation in long-term care (PIVOTALL study): a randomised pilot and feasibility study.

"Declarations Ethics approval and informed consent to participateThe study received sponsorship from the University of Liverpool (ref: UoL001537) on 05/05/2020. Ethical approval was obtained from Health and Care Research Wales (08/06/2020) and the Health Research Authority (15/06/2020) after favourable review by Wales Research Ethics Committee 4 (ref: 20/WA/0164). Informed consent was obtained following International Conference on Harmonisation Good Clinical Practice and Health Research Authority guidance. Adults with capacity were provided with a participant information sheet (PIS) and given as much time as they need to read over the information before obtaining written consent. Information provided within the PIS to covered the scenario of loss of capacity during the research. For adults without capacity, the LPA of Health and Welfare was provided with a consultee information sheet (CIS) and given as much time as they need to read over the information before obtaining a Consultee Declaration form. Information provided within the CIS to cover the scenario of regaining capacity during the research. Information sheets and consent/declaration forms sent via post if necessary due to COVID-19. Consent for publicationObtained on enrolment into research study. Information provided within the PIS and CIS explained that study results would be published in a scientific journal, but participants would not be identifiable from the published results. Competing interestsPEP owns four shares in AstraZeneca PLC and has received honoraria and/or travel reimbursement for events sponsored by AKCEA, Amgen, AMRYT, Link Medical, Napp, Sanofi. GYHL has been a consultant and speaker for BMS/Pfizer, Boehringer Ingelheim, Anthos and Daiichi-Sankyo, no fees are received personally. GYHL is co-principal investigator of the AFFIRMO project on multimorbidity in AF, which has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 899871. DAL has received investigator-initiated educational grants from Bristol-Myers Squibb (BMS), has been a speaker for Bayer, Boehringer Ingelheim, and BMS/Pfizer and has consulted for BMS, and Boehringer Ingelheim; LAR and AA have no competing interests to report. Competing interests PEP owns four shares in AstraZeneca PLC and has received honoraria and/or travel reimbursement for events sponsored by AKCEA, Amgen, AMRYT, Link Medical, Napp, Sanofi. GYHL has been a consultant and speaker for BMS/Pfizer, Boehringer Ingelheim, Anthos and Daiichi-Sankyo, no fees are received personally. GYHL is co-principal investigator of the AFFIRMO project on multimorbidity in AF, which has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 899871. DAL has received investigator-initiated educational grants from Bristol-Myers Squibb (BMS), has been a speaker for Bayer, Boehringer Ingelheim, and BMS/Pfizer and has consulted for BMS, and Boehringer Ingelheim; LAR and AA have no competing interests to report."

"Funding University of Liverpool funded PhD studentship."

"The pharmacist-led intervention for AF in long-term care (PIVOTALL) study was a single-blinded, individually randomised pilot and feasibility study, consistent with a consensus-agreed conceptual framework proposed for defining pilot and feasibility studies []. It was conducted in accordance with the Consolidated Standards of Reporting Trials (CONSORT) statement extension for pilot and feasibility studies []. Ethical approval was obtained from Health and Care Research Wales (08/06/2020) and the Health Research Authority (15/06/2020) after favourable review by Wales Research Ethics Committee 4 (ref: 20/WA/0164). The study was prospectively registered on 02/10/2020 with the International Standard Randomised Controlled Trial Number Registry (ISRCTN14747952) []. A formal sample size calculation was not performed to determine the target sample size, but the study aimed to recruit a minimum of 50 residents in keeping with previously reported sample sizes per group for pilot studies (median of 30; range 8 to 114 participants) and feasibility studies (median of 36; range 10 to 300 participants) registered on the UK Clinical Research Network []."