First Online: 28 November 2019
Compliance with ethical standards
: T. Lobban is the Founder and CEO of AF Assoc and Arrhythmia Alliance, a non-profit registered charity aiming to raise awareness of atrial fibrillation (AF), which receives funding from various sources, including donations, fundraising, grants, and trusts. Most of the authors are members of International Pharmacist for Anticoagulation Care Taskforce (FAC, VL, SA, MCC, DG, RV, JP, KML), an organization representing pharmacists with interests in anticoagulation, under the statutes of DRM-Foundation. DRM-Foundation has received funding in the past from Bayer Global and from Pfizer, Canada. S. Antoniou received personal fees and/or non-financial support from Bayer, Boehringer Ingelheim, Daiichi Sankyo and BMS/Pfizer related to AF anticoagulant management. B. Freedman reports grants to the institution, for investigator-initiated studies from Pfizer/BMS, and Bayer and Boehringer Ingelheim personal fees and/or non-financial support from Bayer, Boehringer Ingelheim, and BMS/Pfizer, related to screening for AF. None of these companies had any influence on the study design, conduct or review of results presented; neither did they provide any funding for the development of the study described.
: The Project was approved by Egas Moniz Ethical Review Board, Portugal (No. 319), Univerzita Karlova Eticka Komise, Czech Republic (No. 911), Barts Health NHS Trust Ethics Committee (No. 10357), the National Institute of Pharmacy and Nutrition in Hungary (No. 29517) and The Chinese University of Hong Kong Ethics Committee (CRE-2014.012). The remaining countries after consulting with their Local or National Committees, because the law mentions that as long as the activity is within the normal scope of pharmacy practice data may be used for observational studies, it was considered that the precedent decisions were valid. As an example, regulatory law for observation studies in France states that ethical approval by an Ethics Committee is not mandatory when looking at healthcare professional practices (Article R1121-1-II of the Public Health Code, Decree No. 2017-844, 9th May 2017; available at ExternalRef removed. In fact, the trend to use anonymous patient data as part of the provided care and support and acknowledge its use is being adopted in many countries by various research organisations following recommendations from patients themselves, quoting “This work uses data provided by patients and collected by the NHS as part of their care and support” available at ExternalRef removed collection was also notified to the competent bodies (e.g. Comissão Nacional de Proteção de Dados, Portugal). Patients agreeing to the EDAF gave their written consent. Only in Spain, France and Hungary were oral consent considered sufficient by the national legislation, as long as the pharmacist clearly provided all information orally, which was ensured.
: The informed consent included a section authorising publication of data in a compiled and anonymized format. The investigation conforms with the principles outlined in the Declaration of Helsinki [CitationRef removed].