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      A Delphi consensus on the management of oral anticoagulation in patients with non-valvular atrial fibrillation in Spain: ACOPREFERENCE study

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          Abstract

          Objective

          To evaluate the level of agreement between cardiologists regarding the management of oral anticoagulation (OAC) in patients with non-valvular atrial fibrillation (NVAF) in Spain.

          Materials and methods

          A two-round Delphi study was performed using an online survey. In round 1, panel members rated their level of agreement with the questionnaire items on a 9-point Likert scale. Item selection was based on acceptance by ≥66.6% of panellists and the agreement of the scientific committee. In round 2, the same panellists evaluated those items that did not meet consensus in round 1.

          Results

          A total of 238 experts participated in round 1; of these, 217 completed the round 2 survey. In round 1, 111 items from 4 dimensions (Thromboembolic and bleeding risk evaluation for treatment decision-making: 18 items; Choice of OAC: 39 items; OAC in specific cardiology situations: 12 items; Patient participation and education: 42 items) were evaluated. Consensus was reached for 92 items (83%). Over 80% of the experts agreed with the use of DOACs as the initial anticoagulant treatment when OAC is indicated. Panellists recommended the use of DOACs in patients at high risk of thromboembolic complications (CHA 2DS 2-VASc ≥3) (83%), haemorrhages (HAS-BLED ≥3) (89%) and poor quality of anticoagulation control (SAMe-TT 2R 2 >2) (76%), patients who fail to achieve an optimal therapeutic range after 3 months on VKA treatment (93%), and those who are to undergo cardioversion (80%). Panellists agreed that the efficacy and safety profile of each DOAC (98%), the availability of a specific reversal agent (72%) and patient’s preference (85%) should be considered when prescribing a DOAC. A total of 97 items were ultimately accepted after round 2.

          Conclusions

          This Delphi panel study provides expert-based recommendations that may offer guidance on clinical decision-making for the management of OAC in NVAF. The importance of patient education and involvement has been highlighted.

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          Most cited references24

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          Consulting the oracle: ten lessons from using the Delphi technique in nursing research.

          The aim of this paper was to provide insight into the Delphi technique by outlining our personal experiences during its use over a 10-year period in a variety of applications. As a means of achieving consensus on an issue, the Delphi research method has become widely used in healthcare research generally and nursing research in particular. The literature on this technique is expanding, mainly addressing what it is and how it should be used. However, there is still much confusion and uncertainty surrounding it, particularly about issues such as modifications, consensus, anonymity, definition of experts, how 'experts' are selected and how non-respondents are pursued. This issues that arise when planning and carrying out a Delphi study include the definition of consensus; the issue of anonymity vs. quasi-anonymity for participants; how to estimate the time needed to collect the data, analyse each 'round', feed back results to participants, and gain their responses to this feedback; how to define and select the 'experts' who will be asked to participate; how to enhance response rates; and how many 'rounds' to conduct. Many challenges and questions are raised when using the Delphi technique, but there is no doubt that it is an important method for achieving consensus on issues where none previously existed. Researchers need to adapt the method to suit their particular study.
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            Integrated care for chronic conditions: the contribution of the ICCC Framework.

            The aim of this research is to highlight the current relevance of the Innovative Care for Chronic Conditions (ICCC) Framework, as a model for change in health systems towards better care for chronic conditions, as well as to assess its impact on health policy development and healthcare redesign to date. The authors reviewed the literature to identify initiatives designed and implemented following the ICCC Framework. They also reviewed the evidence on the effectiveness, cost-effectiveness and feasibility of the ICCC and the earlier Chronic Care Model (CCM) that inspired it. The ICCC Framework has inspired a wide range of types of intervention and has been applied in a number of countries with diverse healthcare systems and socioeconomic contexts. The available evidence supports the effectiveness of this framework's components, although no study explicitly assessing its comprehensive implementation at a health system level has been found. As awareness of the need to reorient health systems towards better care for chronic patients grows, there is great potential for the ICCC Framework to serve as a road map for transformation, with its special emphasis on integration, and on the role of the community and of a positive political environment. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.
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              Performance of the HEMORR(2)HAGES, ATRIA, and HAS-BLED bleeding risk-prediction scores in patients with atrial fibrillation undergoing anticoagulation: the AMADEUS (evaluating the use of SR34006 compared to warfarin or acenocoumarol in patients with atrial fibrillation) study.

              The objective of this study was to compare the predictive performance of bleeding risk-estimation tools in a cohort of patients with atrial fibrillation (AF) undergoing anticoagulation. Three bleeding risk-prediction schemes have been derived for and validated in patients with AF: HEMORR(2)HAGES (Hepatic or Renal Disease, Ethanol Abuse, Malignancy, Older Age, Reduced Platelet Count or Function, Re-Bleeding, Hypertension, Anemia, Genetic Factors, Excessive Fall Risk and Stroke), ATRIA (Anticoagulation and Risk Factors in Atrial Fibrillation), and HAS-BLED (Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio, Elderly, Drugs/Alcohol). Τhe relative predictive values of these bleeding scores have not previously been compared. We analyzed the dataset from the AMADEUS (Evaluating the Use of SR34006 Compared to Warfarin or Acenocoumarol in Patients With Atrial Fibrillation) trial, a multicenter, randomized, open-label noninferiority study that compared fixed-dose idraparinux with adjustable-dose oral vitamin K antagonist therapy in patients with AF. The principal safety outcome was any clinically relevant bleeding event, which was a composite of major bleeding plus clinically relevant nonmajor bleeding. The HAS-BLED score performed best in predicting any clinically relevant bleeding, reflected both in net reclassification improvement (10.3% and 13% improvement compared with HEMORR(2)HAGES and ATRIA, respectively) and receiver-operating characteristic (ROC) analyses (c-indexes: 0.60 vs. 0.55 and 0.50 for HAS-BLED vs. HEMORR(2)AGES and ATRIA, respectively). Using decision-curve analysis, the HAS-BLED score demonstrated superior performance compared with ATRIA and HEMORR(2)HAGES at any threshold probability for clinically relevant bleeding. HAS-BLED was the only score that demonstrated a significant predictive performance for intracranial hemorrhage (c-index: 0.75; p = 0.03). An ATRIA score >3 was not significantly associated with the risk for any clinically relevant bleeding on Cox regression or on ROC analysis (c-index: 0.50; p = 0.87). All 3 tested bleeding risk-prediction scores demonstrated only modest performance in predicting any clinically relevant bleeding, although the HAS-BLED score performed better than the HEMORR(2)HAGES and ATRIA scores, as reflected by ROC analysis, reclassification analysis, and decision-curve analysis. Only HAS-BLED demonstrated a significant predictive performance for intracranial hemorrhage. Given its simplicity, the HAS-BLED score may be an attractive method for the estimation of oral anticoagulant-related bleeding risk for use in clinical practice, supporting recommendations in international guidelines. Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
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                Author and article information

                Contributors
                Role: ConceptualizationRole: InvestigationRole: MethodologyRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: InvestigationRole: MethodologyRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: InvestigationRole: MethodologyRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: InvestigationRole: MethodologyRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: InvestigationRole: MethodologyRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: InvestigationRole: MethodologyRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: InvestigationRole: MethodologyRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                1 June 2020
                2020
                : 15
                : 6
                : e0231565
                Affiliations
                [1 ] Cardiology Department, Hospital Universitario La Paz, Madrid, Spain
                [2 ] Cardiology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
                [3 ] Cardiology Department, Hospital Clínico San Carlos, CIBERCV, Madrid, Spain
                [4 ] Cardiology Department, Hospital Universitario Lucus Augusti, Lugo, Spain
                [5 ] Cardiology Department, Hospital de Galdakao, Galdakao, Bizkaia, Spain
                [6 ] Cardiology Department, Hospital Marina Salud, Denia, Alicante, Spain
                [7 ] Cardiology Department, Hospital Universitario Virgen de la Victoria, CIBERCV, Málaga, Spain
                Policlinico Universitario Agostino Gemelli IRCCS, ITALY
                Author notes

                Competing Interests: CE has served on advisory boards for Boehringer, Pfizer/Bristol-Myers Squibb (BMS), Bayer and Daiichi Sankyo, and also received speaker fees from these companies. RBF has served on advisory boards for Boehringer, Novartis and Astra-Zeneca. CG-J has served on advisory boards for Boehringer, Astra-Zeneca, Novartis, and Bayer, and has also received research funding from Abbott, Boehringer, Astra-Zeneca, and Pfizer. AVM has served on advisory boards for MSD, Boehringher, Bayer, Daiichi, and Novartis; and has received honoraria for providing expert testimony from MSD, Boehringher, Bayer, Daiichi, Novartis, Amgen, Sanofi, Pzifer, Janssen, Astrazeneca, Servier, and Rovi. JJGD has received honoraria for advisory services from Bayer, Astrazeneca, MSD, Daiichi, BMS, Amgen and Sanofi. The other authors declare that they have no other competing interests. There are no patents, products in development or marketed products to declare. This does not alter our adherence to Plos One policies on sharing data and materials.

                Author information
                http://orcid.org/0000-0001-5584-4735
                Article
                PONE-D-19-21146
                10.1371/journal.pone.0231565
                7263623
                32479502
                bfdb02af-4fe0-415f-9ffc-4d79d44a3f64
                © 2020 Escobar et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 2 August 2019
                : 26 March 2020
                Page count
                Figures: 5, Tables: 2, Pages: 18
                Funding
                Funded by: funder-id http://dx.doi.org/10.13039/100008349, Boehringer Ingelheim;
                This study was funded by Boehringer Ingelheim. Boehringer Ingelheim participated in the study design and decision to publish, but this company had no role in data collection and analysis or in preparation of the manuscript. No additional external funding received for this study.
                Categories
                Research Article
                Medicine and Health Sciences
                Health Care
                Patients
                Medicine and Health Sciences
                Vascular Medicine
                Thromboembolism
                Medicine and Health Sciences
                Diagnostic Medicine
                Signs and Symptoms
                Hemorrhage
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                Pathology and Laboratory Medicine
                Signs and Symptoms
                Hemorrhage
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                Hemorrhage
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                Biology and Life Sciences
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                Medicine and Health Sciences
                Cardiology
                Arrhythmia
                Atrial Fibrillation
                Medicine and Health Sciences
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                All relevant data are within the manuscript and its Supporting Information files.

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