Advertisement
Canadian Journal of Cardiology

Canadian Cardiovascular Society Atrial Fibrillation Guidelines 2010: Implementing GRADE and Achieving Consensus

  • Anne M. Gillis
    Correspondence
    Corresponding author: Dr Anne M. Gillis, Department of Cardiac Sciences, The University of Calgary, 3280 Hospital Dr NW, Calgary, Alberta, Canada T2N 4N1. Tel: 403-220-6841; fax: 403-270-0313
    Affiliations
    Department of Cardiac Sciences, University of Calgary and Libin Cardiovascular Institute of Alberta, Calgary, Alberta, Canada
    Search for articles by this author
  • Allan C. Skanes
    Affiliations
    Division of Cardiology, University Hospital, University of Western Ontario, London, Ontario, Canada
    Search for articles by this author
  • CCS Atrial Fibrillation Guidelines Committee
    Author Footnotes
    c For a complete listing of committee members, see page 30.
  • Author Footnotes
    c For a complete listing of committee members, see page 30.

      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.
      • Lloyd-Jones D.M.
      • Wang T.J.
      • Leip E.P.
      • et al.
      Lifetime risk for development of atrial fibrillation: the Framingham Heart Study.
      The Canadian Cardiovascular Society (CCS) last published a set of recommendations on the diagnosis and management of AF in 2005.
      • Kerr C.
      • Roy D.
      Canadian Cardiovascular Society Consensus Conference: Atrial fibrillation 2004 executive summary.
      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,
      • Roy D.
      • Talajic M.
      • Nattel S.
      • et al.
      Rhythm control versus rate control for atrial fibrillation and heart failure.
      • Van Gelder I.C.
      • Groenveld H.F.
      • Crijns H.J.
      • et al.
      Lenient versus strict rate control in patients with atrial fibrillation.
      • Hohnloser S.H.
      • Crijns H.J.
      • van Eickels M.
      • et al.
      Effect of dronedarone on cardiovascular events in atrial fibrillation.
      antithrombotic therapies for prevention of systemic thromboembolism,
      • Connolly S.J.
      • Ezekowitz M.D.
      • Yusuf S.
      • et al.
      Dabigatran versus warfarin in patients with atrial fibrillation.
      • Connolly S.J.
      • Pogue J.
      • Hart R.G.
      • et al.
      Effect of clopidogrel added to aspirin in patients with atrial fibrillation.
      the continuing evolution of catheter ablation for treatment of AF,
      • Nair G.M.
      • Nery P.B.
      • Diwakaramenon S.
      • et al.
      A systematic review of randomized trials comparing radiofrequency ablation with antiarrhythmic medications in patients with atrial fibrillation.
      • Cappato R.
      • Calkins H.
      • Chen S.A.
      • et al.
      Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation.
      • Wilber D.J.
      • Pappone C.
      • Neuzil P.
      • et al.
      Comparison of antiarrhythmic drug therapy and radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation: a randomized controlled trial.
      and the development of a simple semiquantitative scale that closely approximates patient-reported subjective measures of quality of life in AF.
      • Dorian P.
      • Guerra P.G.
      • Kerr C.R.
      • et al.
      Validation of a new simple scale to measure symptoms in atrial fibrillation: the Canadian Cardiovascular Society Severity in Atrial Fibrillation scale.
      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.
      • Graham M.M.
      • Pullen C.
      Renovating CCS guidelines and position statements: a new foundation.
      • Kerr C.R.
      CCS guidelines and position statements are important, but do they make the GRADE?.
      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.
      The AGREE Collaboration
      Development and validation of an international appraisal instrument for assessing the quality of clinical practice guidelines: the AGREE project.
      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,
      • Kerr C.R.
      CCS guidelines and position statements are important, but do they make the GRADE?.
      The AGREE Collaboration
      Development and validation of an international appraisal instrument for assessing the quality of clinical practice guidelines: the AGREE project.
      replacing the American College of Cardiology and American Heart Association scale for level of evidence that was used previously.
      • 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.
      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.
      • Sniderman A.D.
      • Furberg C.D.
      Why guideline-making requires reform.
      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.
      • Guyatt G.H.
      • Oxman A.D.
      • Vist G.
      • et al.
      GRADE: an emerging consensus on rating quality of evidence and strength of recommendations.
      • Guyatt G.H.
      • Oxman A.D.
      • Kunz R.
      • et al.
      GRADE Working Group
      Rating quality of evidence and strength of recommendations: what is “quality of evidence” and why is it important to clinicians?.
      • Schünemann H.J.
      • Oxman A.D.
      • Brozek J.
      • et al.
      Grading quality of evidence and strength of recommendations for diagnostic tests and strategies.
      • Guyatt G.H.
      • Oxman A.D.
      • Kunz R.
      • et al.
      Rating quality of evidence and strength of recommendations: incorporating considerations of resources use into grading recommendations.
      • Guyatt G.H.
      • Oxman A.D.
      • Kunz R.
      • et al.
      Rating quality of evidence and strength of recommendations: going from evidence to recommendations.
      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.
      • Guyatt G.H.
      • Oxman A.D.
      • Vist G.
      • et al.
      GRADE: an emerging consensus on rating quality of evidence and strength of recommendations.
      QualityComments
      HighFuture research unlikely to change confidence in estimate of effect; eg, multiple well-designed, well-conducted clinical trials
      ModerateFurther 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
      LowFurther 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 lowThe 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.
      • Guyatt G.H.
      • Oxman A.D.
      • Vist G.
      • et al.
      GRADE: an emerging consensus on rating quality of evidence and strength of recommendations.
      FactorComment
      Quality of evidenceThe 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 effectsThe 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 preferencesThe 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.
      CostThe 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:
      • 1
        Etiology and Initial Investigations
      • 2
        Management of Recent-Onset Atrial Fibrillation and Flutter in the Emergency Department
      • 3
        Rate and Rhythm Management
      • 4
        Catheter Ablation for Atrial Fibrillation/Atrial Flutter
      • 5
        Surgical Therapy
      • 6
        Prevention of Stroke and Systemic Thromboembolism in Atrial Fibrillation and Flutter
      • 7
        Prevention 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)CochairDept of Cardiac Sciences, University of Calgary, Libin Cardiovascular Institute of Alberta
      Allan Skanes, MD, FRCP(C)CochairDivision of Cardiology, University of Western Ontario
      Stuart Connolly, MD, FRCP(C)MemberDivision of Cardiology, Department of Medicine, McMaster University
      John Cairns, MD, FRCP(C),MemberFaculty of Medicine, University of British Columbia
      Jafna Cox, BA, MD, FRCP(C), FACCMemberDivision of Cardiology, Dalhousie University
      Paul Dorian, MD, MSc. FRCP(C)MemberDivision of Cardiology, University of Toronto
      Jeff Healey, MD, FRCP(C)MemberDivision of Cardiology, Medicine Department, McMaster University
      Laurent Macle, MD, FRCP(C)MemberElectrophysiology Service, Montreal Heart Institute, Université de Montréal
      Sean McMurty, MD, PhD, FRCP(C)MemberDivision of Cardiology, University of Alberta
      Brent Mitchell, MD, FRCP(C)MemberUniversity of Calgary, Libin Cardiovascular Institute of Alberta
      Stanley Nattel, MD, FRCP(C)MemberMontreal Heart Institute, Université de Montréal
      Pierre Page, MD, FRCPSMemberMontreal Heart Institute, Université de Montréal
      Ratika Parkash, MD, MSc, FRCP(C)MemberDivision of Cardiology, Dalhousie University
      P. Timothy Pollak, MD, PhD FRCP(C)MemberDepartment of Cardiac Sciences, and Physiology & Pharmacology, University of Calgary
      Michael Stephenson, MD, CCFP, FCFPMemberRepresentative of The College of Family Physicians of Canada, Ancaster, Ontario
      Ian Stiell, MD, MSc, FRCP(C)MemberDepartment of Emergency Medicine, Ottawa Hospital Research Institute, University of Ottawa
      Mario Talajic, MD, FRCP(C)MemberMontreal Heart Institute, Université de Montréal
      Teresa Tsang, MD, FRCP(C)MemberDivision of Cardiology, University of British Columbia
      Atul Verma, MD, FRCP(C)MemberHeart Rhythm Program, Southlake Regional Health Centre
      Jan Brozek, MD, PhDSpecial CollaboratorDepartments of Clinical Epidemiology & Biostatistics and Medicine. McMaster University
      Grant Stotts, MD, FRCP(C)Special CollaboratorUniversity of Ottawa, The Ottawa Hospital. Representative of the Canadian Stroke Network
      Secondary panel members
      Malcolm Arnold, MD, FRCP(C)MemberDivision of Cardiology, University of Western Ontario,
      David Bewick, MD, FRCP(C)MemberSt. John's, New Brunswick
      Vidal Essebag, MD, MSc, FRCP(C)MemberDepartment of Cardiology, McGill University Health Center
      Milan Gupta, MD, FRCP(C)MemberDivision of Cardiology, Brampton Civic Hospital
      Brett Heilbron, MBChB, FRCP(C)MemberSt. Paul's Hospital Heart Centre, University of British Columbia
      Charles Kerr, MD, FRCP(C),MemberSt. Paul's Hospital Heart Centre, University of British Columbia
      Bob Kiaii, MD, FRCS(C)MemberDivision of Cardiac Surgery, University of Western Ontario
      Jan Surkes, BA (hon) MD FRCP(C)MemberDepartment of Medicine, Langley Memorial Hospital, Langley, BC
      George Wyse, MD, PhD, FRCP(C)MemberDepartment of Cardiac Sciences, University of Calgary, Libin Cardiovascular Institute of Alberta

      References

        • Lloyd-Jones D.M.
        • Wang T.J.
        • Leip E.P.
        • et al.
        Lifetime risk for development of atrial fibrillation: the Framingham Heart Study.
        Circulation. 2004; 110: 1042-1046
        • Kerr C.
        • Roy D.
        Canadian Cardiovascular Society Consensus Conference: Atrial fibrillation 2004 executive summary.
        (Accessed November 11, 2010)
        • Roy D.
        • Talajic M.
        • Nattel S.
        • et al.
        Rhythm control versus rate control for atrial fibrillation and heart failure.
        N Engl J Med. 2008; 358: 2667-2677
        • Van Gelder I.C.
        • Groenveld H.F.
        • Crijns H.J.
        • et al.
        Lenient versus strict rate control in patients with atrial fibrillation.
        N Engl J Med. 2010; 362: 1363-1373
        • Hohnloser S.H.
        • Crijns H.J.
        • van Eickels M.
        • et al.
        Effect of dronedarone on cardiovascular events in atrial fibrillation.
        N Engl J Med. 2009; 360: 668-678
        • Connolly S.J.
        • Ezekowitz M.D.
        • Yusuf S.
        • et al.
        Dabigatran versus warfarin in patients with atrial fibrillation.
        N Engl J Med. 2009; 361: 1139-1151
        • Connolly S.J.
        • Pogue J.
        • Hart R.G.
        • et al.
        Effect of clopidogrel added to aspirin in patients with atrial fibrillation.
        N Engl J Med. 2009; 360: 2066-2078
        • Nair G.M.
        • Nery P.B.
        • Diwakaramenon S.
        • et al.
        A systematic review of randomized trials comparing radiofrequency ablation with antiarrhythmic medications in patients with atrial fibrillation.
        J Cardiovasc Electrophysiol. 2009; 20: 138-144
        • Cappato R.
        • Calkins H.
        • Chen S.A.
        • et al.
        Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation.
        Circ Arrhythm Electrophysiol. 2010; 3: 32-38
        • Wilber D.J.
        • Pappone C.
        • Neuzil P.
        • et al.
        Comparison of antiarrhythmic drug therapy and radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation: a randomized controlled trial.
        JAMA. 2010; 303: 333-340
        • Dorian P.
        • Guerra P.G.
        • Kerr C.R.
        • et al.
        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
        • Graham M.M.
        • Pullen C.
        Renovating CCS guidelines and position statements: a new foundation.
        Can J Cardiol. 2010; 26: 233-235
        • Kerr C.R.
        CCS guidelines and position statements are important, but do they make the GRADE?.
        Can J Cardiol. 2010; 26: 177-178
        • The AGREE Collaboration
        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
        • 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
        • Sniderman A.D.
        • Furberg C.D.
        Why guideline-making requires reform.
        JAMA. 2009; 301: 429-431
        • Guyatt G.H.
        • Oxman A.D.
        • Vist G.
        • et al.
        GRADE: an emerging consensus on rating quality of evidence and strength of recommendations.
        BMJ. 2008; 336: 924-926
        • Guyatt G.H.
        • Oxman A.D.
        • Kunz R.
        • et al.
        • GRADE Working Group
        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
        • Schünemann H.J.
        • Oxman A.D.
        • Brozek J.
        • et al.
        Grading quality of evidence and strength of recommendations for diagnostic tests and strategies.
        BMJ. 2008; 336: 1106-1110
        • Guyatt G.H.
        • Oxman A.D.
        • Kunz R.
        • et al.
        Rating quality of evidence and strength of recommendations: incorporating considerations of resources use into grading recommendations.
        BMJ. 2008; 336: 1170-1173
        • Guyatt G.H.
        • Oxman A.D.
        • Kunz R.
        • et al.
        Rating quality of evidence and strength of recommendations: going from evidence to recommendations.
        BMJ. 2008; 336: 1049-1051