Abstract
This article describes the process of the Canadian Cardiovascular Society 2010 atrial fibrillation (AF) guidelines update. Guideline development was based on the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system of evaluation. GRADE separates the quality of evidence (very low, low, moderate, or high quality) from the strength of recommendations (strong or conditional, ie, weak). GRADE allows acknowledgement of values and preferences in the provision of clinical care as well as costs of interventions in determining the strength of recommendations. Disclosures of relationships with industry or other potential conflicts of interest were reported at the outset and annually. Each recommendation was approved by at least a two-thirds majority of the voting panel (those with a significant conflict recusing themselves from voting on those specific recommendations).
Résumé
Dans cet article, nous décrivons le processus de mise à jour des lignes directrices de 2010 en matière de fibrillation auriculaire (FA) de la Société Canadienne de Cardiologie. L'élaboration des lignes directrices repose sur le système d'évaluation Grading of Recommandations Assessment, Development and Evaluation (GRADE). Le système d'évaluation GRADE distingue la qualité de la preuve (très faible, faible, moyenne ou élevée) de la force des recommandations (forte ou conditionnelle, i.e. faible). Le système d'évaluation GRADE permet de reconnaître les valeurs et les préférences en ce qui a trait à la prestation des soins cliniques, ainsi que les coûts des interventions, pour déterminer la force des recommandations. Les relations du groupe d'experts avec l'industrie ou autres conflits d'intérêts potentiels ont été divulguées initialement et annuellement. Chaque recommandation a été approuvée par au moins les deux tiers du groupe d'experts (ceux qui étaient en conflit d'intérêt se sont abstenus de voter sur certaines recommandations).
Atrial fibrillation (AF) is the most common sustained arrhythmia treated in clinical practice and is associated with substantial morbidity. Indeed, the lifetime risk of developing AF in individuals older than 40 years is 1 in 4.
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The Canadian Cardiovascular Society (CCS) last published a set of recommendations on the diagnosis and management of AF in 2005.2
Since then, major advances in the management of AF have occurred, including the results of clinical trials providing guidance on pharmacologic therapies for management of AF,3
, 4
, 5
antithrombotic therapies for prevention of systemic thromboembolism,6
, 7
the continuing evolution of catheter ablation for treatment of AF,8
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, 10
and the development of a simple semiquantitative scale that closely approximates patient-reported subjective measures of quality of life in AF.11
In 2009, the CCS convened a primary panel of experts to undertake a comprehensive review of current knowledge and management strategies in the field of AF and to develop an up-to-date evidence-based set of recommendations, easily available to primary care physicians, emergency room physicians, internists, and cardiologists, on the diagnosis and management of patients with AF. The guidelines are broadly applicable across a spectrum of practice environments. It is expected that optimized management of AF may improve quality of life and reduce rates of stroke and hospitalization for AF-related causes across all levels of care in a large population of patients.Simultaneous with the evolution in treatments for AF, the CCS has been implementing a unique Canadian knowledge translation (KT) model for disseminating guidelines.
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Known as the CCS closed-loop model for KT, it has the aim of improving the uptake and integration of guidelines into clinical practice. The model involves assembling a multidisciplinary primary panel to draft guidelines and then using a multipronged, multimedia approach to dissemination. Dissemination strategies involve regional and national face-to-face, interactive, case-based workshops and a dedicated Web site featuring practical tools and tips for end users as well as synchronous and asynchronous e-learning programs. Feedback from KT program participants and guideline end users drives the selection and development of new content for subsequent annual guideline updates, which are then disseminated and evaluated as part of a regular annual cycle. This cyclical approach to guideline development, dissemination, and evaluation results in a powerful compendium of guidelines that address a specific topic and are highly relevant to and highly valued by care providers. The CCS experienced success with this model through applying it to heart failure beginning in 2005. As AF emerged as a major topic requiring updated, comprehensive, multidisciplinary guidelines, the CCS has embarked on this second closed-loop KT program.A primary working group was formed and met face-to-face in October 2009 to agree on the process of achieving consensus, to address issues related to real or perceived conflict of interest related to specific recommendations, to discuss the process of weighing the strength of a recommendation and the quality of evidence supporting the recommendation, to identify the full membership of the primary panel, to finalize topics for guideline development, and to develop writing groups for each topic. Conflicts were disclosed prior to forming the writing groups. The Appraisal of Guidelines for Research and Evaluation instrument was used to guide primary panel structure and guideline development.
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Membership of the primary panel was expanded to include wide representation (from primary care, internal medicine, emergency medicine, and general cardiology, in addition to cardiac electrophysiology) and to increase the proportion of panel members having no conflict of interest or relationships with industry to 5 of 19 members (26%). Writing groups were developed with specific attention to content expertise and conflict of interest. It was decided that each recommendation must be approved by a two-thirds majority of the voting panel (those with a significant conflict recusing themselves from voting on those specific recommendations).The working groups undertook a review of the English language literature, using MEDLINE or Cochrane library searches and a critical appraisal of the evidence focusing predominantly on the results of randomized clinical trials and systematic reviews. In the absence of such data, recommendations were based on the results of large cohort studies or smaller clinical studies. The recommendations were finalized by informed consensus through one face-to-face meeting, conference calls, e-mail correspondence, and final review by all members of the primary panel. Specifically, the writing group presented each preliminary recommendation with its attendant supportive evidence in summary form. Following discussion, an anonymous vote was obtained in which a two-thirds majority was considered consensus. Failing consensus, further discussion was directed at areas of divergence of opinion until either consensus was reached or it was deemed by the chair(s) that consensus would not be reached and a recommendation could not be made. A two-thirds majority was achieved in all cases. The primary panelists were principally responsible for the document, but an independent secondary panel reviewed the recommendations and provided feedback. All members of the primary panel formally approved the final document prior to submission to the Guidelines Committee and CCS Executive for review and approval.
As outlined in a separate communication, this is the first CCS Guidelines Panel to use the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system of evaluation,
13
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replacing the American College of Cardiology and American Heart Association scale for level of evidence that was used previously.15
In the past, guidelines have been criticized as being inconsistent in how they rate quality of evidence and strength of recommendations, which may lead to confusion in interpretation of the recommendations and failure to adhere to the guidelines.- Fuster V.
- Rydén L.E.
- Cannom D.S.
- et al.
ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation: full text: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 guidelines for the management of patients with atrial fibrillation) developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society.
Circulation. 2006; 114: e257-e354
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GRADE (www.gradeworkinggroup.org) was created by a group of international guideline developers, including a large Canadian representation to address the shortcomings of other rating systems.17
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, 19
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, 21
The approach separates the quality of evidence (very low, low, moderate, or high quality; see Table 1), from the strength of recommendations (strong or conditional, ie, weak; see Table 2). GRADE allows acknowledgment of values and preferences in the provision of clinical care, as well as of the cost of therapies, in determining the strength of recommendations. GRADE has already been adopted by more than 45 international organizations, including the World Health Organization, the American College of Physicians, the Cochrane Collaboration, the American College of Chest Physicians, and many others.Table 1GRADE: Rating quality of evidence
Modified and reprinted with permission from Guyatt, et al.
17
| Quality | Comments |
|---|---|
| High | Future research unlikely to change confidence in estimate of effect; eg, multiple well-designed, well-conducted clinical trials |
| Moderate | Further research likely to have an important impact on confidence in estimate of effect and may change the estimate; eg, limited clinical trials, inconsistency of results or study limitations |
| Low | Further research very likely to have a significant impact on the estimate of effect and is likely to change the estimate; eg, small number of clinical studies or cohort observations |
| Very low | The estimate of effect is very uncertain; eg, case studies, consensus opinion |
GRADE, Grading of Recommendations Assessment, Development, and Evaluation.
Table 2Factors determining the strength of the recommendation
Modified and reprinted with permission from Guyatt, et al.
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| Factor | Comment |
|---|---|
| Quality of evidence | The higher the quality of evidence, the greater the probability that a strong recommendation is indicated; eg, strong recommendation that patients with AF at moderate to high risk of stroke be treated with oral anticoagulants. |
| Difference between desirable and undesirable effects | The greater the difference between desirable and undesirable effects, the greater the probability that a strong recommendation is indicated; eg, strong recommendation that patients with AF ≥ 48-h duration receive oral anticoagulation therapy for at least 3 wk prior to planned cardioversion and 4 wk following. |
| Values and preferences | The greater the variation or uncertainty in values and preferences, the higher the probability that a conditional recommendation is indicated; eg, aspirin may be a reasonable alternative to oral anticoagulant therapy in patients at low risk of stroke. |
| Cost | The higher the cost, the lower the likelihood that a strong recommendation is indicated; eg, conditional recommendation for catheter ablation as first-line therapy for AF. |
AF, atrial fibrillation.
The updated guidelines are published in 7 articles:
- 1Etiology and Initial Investigations
- 2Management of Recent-Onset Atrial Fibrillation and Flutter in the Emergency Department
- 3Rate and Rhythm Management
- 4Catheter Ablation for Atrial Fibrillation/Atrial Flutter
- 5Surgical Therapy
- 6Prevention of Stroke and Systemic Thromboembolism in Atrial Fibrillation and Flutter
- 7Prevention and Treatment of Atrial Fibrillation Following Cardiac Surgery
A specific chapter on atrial tachyarrhythmias in the congenital heart disease population was not undertaken at this time but is planned for a future update.
Appendix 1. Primary and secondary panel members
Tabled
1
| Primary panel members | ||
|---|---|---|
| Anne M. Gillis, MD, FRCP(C) | Cochair | Dept of Cardiac Sciences, University of Calgary, Libin Cardiovascular Institute of Alberta |
| Allan Skanes, MD, FRCP(C) | Cochair | Division of Cardiology, University of Western Ontario |
| Stuart Connolly, MD, FRCP(C) | Member | Division of Cardiology, Department of Medicine, McMaster University |
| John Cairns, MD, FRCP(C), | Member | Faculty of Medicine, University of British Columbia |
| Jafna Cox, BA, MD, FRCP(C), FACC | Member | Division of Cardiology, Dalhousie University |
| Paul Dorian, MD, MSc. FRCP(C) | Member | Division of Cardiology, University of Toronto |
| Jeff Healey, MD, FRCP(C) | Member | Division of Cardiology, Medicine Department, McMaster University |
| Laurent Macle, MD, FRCP(C) | Member | Electrophysiology Service, Montreal Heart Institute, Université de Montréal |
| Sean McMurty, MD, PhD, FRCP(C) | Member | Division of Cardiology, University of Alberta |
| Brent Mitchell, MD, FRCP(C) | Member | University of Calgary, Libin Cardiovascular Institute of Alberta |
| Stanley Nattel, MD, FRCP(C) | Member | Montreal Heart Institute, Université de Montréal |
| Pierre Page, MD, FRCPS | Member | Montreal Heart Institute, Université de Montréal |
| Ratika Parkash, MD, MSc, FRCP(C) | Member | Division of Cardiology, Dalhousie University |
| P. Timothy Pollak, MD, PhD FRCP(C) | Member | Department of Cardiac Sciences, and Physiology & Pharmacology, University of Calgary |
| Michael Stephenson, MD, CCFP, FCFP | Member | Representative of The College of Family Physicians of Canada, Ancaster, Ontario |
| Ian Stiell, MD, MSc, FRCP(C) | Member | Department of Emergency Medicine, Ottawa Hospital Research Institute, University of Ottawa |
| Mario Talajic, MD, FRCP(C) | Member | Montreal Heart Institute, Université de Montréal |
| Teresa Tsang, MD, FRCP(C) | Member | Division of Cardiology, University of British Columbia |
| Atul Verma, MD, FRCP(C) | Member | Heart Rhythm Program, Southlake Regional Health Centre |
| Jan Brozek, MD, PhD | Special Collaborator | Departments of Clinical Epidemiology & Biostatistics and Medicine. McMaster University |
| Grant Stotts, MD, FRCP(C) | Special Collaborator | University of Ottawa, The Ottawa Hospital. Representative of the Canadian Stroke Network |
| Secondary panel members | ||
| Malcolm Arnold, MD, FRCP(C) | Member | Division of Cardiology, University of Western Ontario, |
| David Bewick, MD, FRCP(C) | Member | St. John's, New Brunswick |
| Vidal Essebag, MD, MSc, FRCP(C) | Member | Department of Cardiology, McGill University Health Center |
| Milan Gupta, MD, FRCP(C) | Member | Division of Cardiology, Brampton Civic Hospital |
| Brett Heilbron, MBChB, FRCP(C) | Member | St. Paul's Hospital Heart Centre, University of British Columbia |
| Charles Kerr, MD, FRCP(C), | Member | St. Paul's Hospital Heart Centre, University of British Columbia |
| Bob Kiaii, MD, FRCS(C) | Member | Division of Cardiac Surgery, University of Western Ontario |
| Jan Surkes, BA (hon) MD FRCP(C) | Member | Department of Medicine, Langley Memorial Hospital, Langley, BC |
| George Wyse, MD, PhD, FRCP(C) | Member | Department of Cardiac Sciences, University of Calgary, Libin Cardiovascular Institute of Alberta |
References
- Lifetime risk for development of atrial fibrillation: the Framingham Heart Study.Circulation. 2004; 110: 1042-1046
- Canadian Cardiovascular Society Consensus Conference: Atrial fibrillation 2004 executive summary.http://www.ccs.ca/download/consensus_conference/consensus_conference_archives/2004_Atrial_Fib_ES.pdf(Accessed November 11, 2010)
- Rhythm control versus rate control for atrial fibrillation and heart failure.N Engl J Med. 2008; 358: 2667-2677
- Lenient versus strict rate control in patients with atrial fibrillation.N Engl J Med. 2010; 362: 1363-1373
- Effect of dronedarone on cardiovascular events in atrial fibrillation.N Engl J Med. 2009; 360: 668-678
- Dabigatran versus warfarin in patients with atrial fibrillation.N Engl J Med. 2009; 361: 1139-1151
- Effect of clopidogrel added to aspirin in patients with atrial fibrillation.N Engl J Med. 2009; 360: 2066-2078
- A systematic review of randomized trials comparing radiofrequency ablation with antiarrhythmic medications in patients with atrial fibrillation.J Cardiovasc Electrophysiol. 2009; 20: 138-144
- Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation.Circ Arrhythm Electrophysiol. 2010; 3: 32-38
- Comparison of antiarrhythmic drug therapy and radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation: a randomized controlled trial.JAMA. 2010; 303: 333-340
- Validation of a new simple scale to measure symptoms in atrial fibrillation: the Canadian Cardiovascular Society Severity in Atrial Fibrillation scale.Circ Arrhythm Electrophysiol. 2009; 2: 218-224
- Renovating CCS guidelines and position statements: a new foundation.Can J Cardiol. 2010; 26: 233-235
- CCS guidelines and position statements are important, but do they make the GRADE?.Can J Cardiol. 2010; 26: 177-178
- Development and validation of an international appraisal instrument for assessing the quality of clinical practice guidelines: the AGREE project.Qual Saf Health Care. 2003; 12: 18-23
- ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation: full text: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 guidelines for the management of patients with atrial fibrillation) developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society.Circulation. 2006; 114: e257-e354
- Why guideline-making requires reform.JAMA. 2009; 301: 429-431
- GRADE: an emerging consensus on rating quality of evidence and strength of recommendations.BMJ. 2008; 336: 924-926
- Rating quality of evidence and strength of recommendations: what is “quality of evidence” and why is it important to clinicians?.BMJ. 2008; 336: 995-998
- Grading quality of evidence and strength of recommendations for diagnostic tests and strategies.BMJ. 2008; 336: 1106-1110
- Rating quality of evidence and strength of recommendations: incorporating considerations of resources use into grading recommendations.BMJ. 2008; 336: 1170-1173
- Rating quality of evidence and strength of recommendations: going from evidence to recommendations.BMJ. 2008; 336: 1049-1051
Article Info
Publication History
Accepted:
November 11,
2010
Received:
November 4,
2010
Footnotes
The disclosure information of the authors and reviewers are available from the CCS on the following Web sites: www.ccs.ca and www.ccsguidelineprograms.ca.
This statement was developed following a thorough consideration of medical literature and the best available evidence and clinical experience. It represents the consensus of a Canadian panel comprised of multidisciplinary experts on this topic with a mandate to formulate disease-specific recommendations. These recommendations are aimed to provide a reasonable and practical approach to care for specialists and allied health professionals obliged with the duty of bestowing optimal care to patients and families, and can be subject to change as scientific knowledge and technology advance and as practice patterns evolve. The statement is not intended to be a substitute for physicians using their individual judgment in managing clinical care in consultation with the patient, with appropriate regard to all the individual circumstances of the patient, diagnostic and treatment options available and available resources. Adherence to these recommendations will not necessarily produce successful outcomes in every case.
A complete list of the Primary and Secondary Panel Members are listed in the Appendix on page 30.
Identification
Copyright
© 2011 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.
