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Reflecting on Eight Editions of the American College of Chest Physicians Antithrombotic Guidelines

2008; Elsevier BV; Volume: 133; Issue: 6 Linguagem: Inglês

10.1378/chest.08-0782

1931-3543

Jack Hirsh, Gordon Guyatt, Sandra Zelman Lewis,

Clinical practice guidelines implementation

The American College of Chest Physicians (ACCP) guidelines addressing antithrombotic therapy, first published in 1986,1American College of Chest Physicians, National Heart, Lung, and Blood Institute ACCP-NHLBI National Conference on Antithrombotic Therapy.Chest. 1986; 89: 1S-106SPubMed Google Scholar have been updated about every 3 years. The eighth edition of the guidelines [now called “Antithrombotic and Thrombolytic Therapy: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition)]” is published as a special supplement of CHEST this month.2American College of Chest Physicians Antithrombotic and thrombolytic therapy: American College of Chest Physicians evidence-based clinical practice guidelines.Chest. 2008; 133 (8th edition): 67S-968SGoogle Scholar Over the past 2 decades, these guidelines have adapted to trends in evidence-based medicine and helped to raise the standards for guideline methodology.3American College of Chest Physicians 2nd ACCP Conference on Antithrombotic Therapy: June 21, 1988; proceedings.Chest. 1989; 95: 1S-169SPubMed Google Scholar, 4American College of Chest Physicians Third ACCP Consensus Conference on Antithrombotic Therapy.Chest. 1992; 102: 303S-549SPubMed Google Scholar, 5American College of Chest Physicians Fourth ACCP Consensus Conference on Antithrombotic Therapy.Chest. 1995; 108: 225S-522SPubMed Google Scholar, 6American College of Chest Physicians Fifth ACCP Consensus Conference on Antithrombotic Therapy.Chest. 1998; 114: 439S-769SPubMed Google Scholar, 7American College of Chest Physicians Sixth ACCP Consensus Conference on Antithrombotic Therapy.Chest. 2001; 119: 1S-370SPubMed Google Scholar, 8American College of Chest Physicians The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy: evidence-based guidelines.Chest. 2004; 126: 1S-703SPubMed Google Scholar The eighth edition has, judging by the numerous daily requests for the publication date, been one of the most anxiously anticipated products of the ACCP.This document provides an extensive update of evidence-based guidelines for the management of thromboembolic conditions affecting the venous and arterial systems (including the coronary, cerebral, and peripheral arteries), and the cardiac chambers, including native and prosthetic valves. The guidelines also address the management of thromboembolism in the pediatric population and during pregnancy, the management of patients who are treated with anticoagulants and require bridging therapy because of an intercurrent invasive procedure, and the management of heparin-induced thrombocytopenia. We also include chapters reviewing the pharmacology of the approved anticoagulants (heparin, low-molecular-weight heparins, fondaparinux, hirudin, bivalirudin, and argatroban), antiplatelet drugs (aspirin, clopidogrel, ticlopidine, dipyridamole, and the glycoprotein IIb/IIIa antagonists), and thrombolytic agents (streptokinase, tissue plasminogen activator, and the tissue plasminogen activator analogs tenecteplase and retoplase). These introductory chapters include recommendations for the dosing and monitoring of anticoagulants and antiplatelet agents.The grading system in the eighth edition of the guidelines has been modified slightly from the previous versions. The grading system in the eighth edition now reflects the system adopted for all ACCP guidelines, similar to the GRADE system, which is being widely adopted by many guideline development organizations. This system provides ratings of the quality of evidence (high quality [A], moderate quality [B], and low quality [C]) and of strength of recommendations based on the balance of risks or burdens to benefits (strong [1] and weak [2]).Since the initial publication of the guidelines >20 years ago, investigators have made enormous progress in generating high-quality data through well-designed, randomized trials that allow for strong recommendations. Table 1 shows this increase in high-quality evidence, which is reflected in the number of 1A recommendations (referred to as “A1” in earlier publications). Both the total number and the number of 1A recommendations have increased progressively with each publication of the guidelines. The proportion of 1A recommendations has varied between 17% and 25% of the total. The number and diversity of participants in the guideline development panels have also increased over time (Table 2).Table 1Trends in Number of Recommendations and Quality of Evidence Over Eight Editions of the Guidelines*The 1A recommendations were referred to as “A1” recommendations in earlier publications of the guidelines.Variables19861989199219951998200120042008Recommendations, total No.73129142201217260562741A1 or 1A recommendations, No.163131344950123182Proportion of 1A recommendations, %2224221723192225* The 1A recommendations were referred to as “A1” recommendations in earlier publications of the guidelines. Open table in a new tab Table 2Trends in Panel Composition Over Eight EditionsVariables19861989199219951998200120042008Panelists, No.32405270808591102 United States2529354854525146 Canada57141518222120 Europe2437891821 Other000002 (Mexico and Australia)1 (Australia)1 (Australia)Resource allocation consultants, No.2Patient values and preferences consultants, No.3 Open table in a new tab We have also improved the scientific rigor of the review process in a number of ways. Each recommendation corresponds to a clearly defined and clearly documented structured research question, and a team of methodologists has conducted a systematic search for relevant evidence. We have standardized the criteria for rating the quality of individual randomized trials and observational studies, and the criteria for rating overall quality of evidence and recommendations are increasingly refined and rigorous. Resource allocation has been considered for selected recommendations in several chapters.Over the iterations of the ACCP thrombosis guidelines, the panelists have become increasingly, and now vividly, aware that values and preferences underlie all recommendations. Whose values and preferences should guide tradeoffs such as those between avoiding thrombotic events and precipitating bleeding? Most would agree that patient and community values should drive the recommendations. That awareness presents a challenge: evidence regarding patient and community values and preferences is very limited, and generally of low quality. Nevertheless, the conceptual framework that guided the panelists stresses the need to do the best job possible of ensuring that recommendations are consistent with patient and community values. Where panelists perceived values and preferences might vary and were crucial, they explicitly articulated the values underlying particular recommendations.The ACCP guidelines are important not only for clinicians, but are used by litigating attorneys and by the pharmaceutical industry to promote their antithrombotic drugs. For these reasons, and for reasons of scientific integrity, every effort has been made to remove bias from the recommendations. The panelists who write the chapters and make the recommendations are from diverse institutions. Each chapter is reviewed by at least two editors, and modifications are made through an iterative process. The recommendations are made available and presented to all participants at an open 2-day meeting at which controversial issues are debated extensively. Finally, we have introduced an innovation to further increase the rigor of the guidelines by adding an external review process. Under the oversight of the ACCP Health and Science Policy Committee, the review process has been extended by including nearly 30 individuals from the ACCP Cardiovascular NetWork, the Health and Science Policy Committee, and the Board of Regents, as well as external peer reviewers at the invitation of the journal.The ACCP has a policy of constant renewal, replacing panelists and panel chairmen with new members at each iteration. The year 2008 guidelines also herald a change in the Chairmanship of the editors, with the oldest active editor (Jack Hirsh, MD, FCCP) retiring and being replaced for the next iteration by Gordon Guyatt, MD, FCCP. The last 22 years has seen marked improvements in the management of thromboembolic disease, and we can look forward to a bright future with further improvements and innovation. The American College of Chest Physicians (ACCP) guidelines addressing antithrombotic therapy, first published in 1986,1American College of Chest Physicians, National Heart, Lung, and Blood Institute ACCP-NHLBI National Conference on Antithrombotic Therapy.Chest. 1986; 89: 1S-106SPubMed Google Scholar have been updated about every 3 years. The eighth edition of the guidelines [now called “Antithrombotic and Thrombolytic Therapy: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition)]” is published as a special supplement of CHEST this month.2American College of Chest Physicians Antithrombotic and thrombolytic therapy: American College of Chest Physicians evidence-based clinical practice guidelines.Chest. 2008; 133 (8th edition): 67S-968SGoogle Scholar Over the past 2 decades, these guidelines have adapted to trends in evidence-based medicine and helped to raise the standards for guideline methodology.3American College of Chest Physicians 2nd ACCP Conference on Antithrombotic Therapy: June 21, 1988; proceedings.Chest. 1989; 95: 1S-169SPubMed Google Scholar, 4American College of Chest Physicians Third ACCP Consensus Conference on Antithrombotic Therapy.Chest. 1992; 102: 303S-549SPubMed Google Scholar, 5American College of Chest Physicians Fourth ACCP Consensus Conference on Antithrombotic Therapy.Chest. 1995; 108: 225S-522SPubMed Google Scholar, 6American College of Chest Physicians Fifth ACCP Consensus Conference on Antithrombotic Therapy.Chest. 1998; 114: 439S-769SPubMed Google Scholar, 7American College of Chest Physicians Sixth ACCP Consensus Conference on Antithrombotic Therapy.Chest. 2001; 119: 1S-370SPubMed Google Scholar, 8American College of Chest Physicians The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy: evidence-based guidelines.Chest. 2004; 126: 1S-703SPubMed Google Scholar The eighth edition has, judging by the numerous daily requests for the publication date, been one of the most anxiously anticipated products of the ACCP. This document provides an extensive update of evidence-based guidelines for the management of thromboembolic conditions affecting the venous and arterial systems (including the coronary, cerebral, and peripheral arteries), and the cardiac chambers, including native and prosthetic valves. The guidelines also address the management of thromboembolism in the pediatric population and during pregnancy, the management of patients who are treated with anticoagulants and require bridging therapy because of an intercurrent invasive procedure, and the management of heparin-induced thrombocytopenia. We also include chapters reviewing the pharmacology of the approved anticoagulants (heparin, low-molecular-weight heparins, fondaparinux, hirudin, bivalirudin, and argatroban), antiplatelet drugs (aspirin, clopidogrel, ticlopidine, dipyridamole, and the glycoprotein IIb/IIIa antagonists), and thrombolytic agents (streptokinase, tissue plasminogen activator, and the tissue plasminogen activator analogs tenecteplase and retoplase). These introductory chapters include recommendations for the dosing and monitoring of anticoagulants and antiplatelet agents. The grading system in the eighth edition of the guidelines has been modified slightly from the previous versions. The grading system in the eighth edition now reflects the system adopted for all ACCP guidelines, similar to the GRADE system, which is being widely adopted by many guideline development organizations. This system provides ratings of the quality of evidence (high quality [A], moderate quality [B], and low quality [C]) and of strength of recommendations based on the balance of risks or burdens to benefits (strong [1] and weak [2]). Since the initial publication of the guidelines >20 years ago, investigators have made enormous progress in generating high-quality data through well-designed, randomized trials that allow for strong recommendations. Table 1 shows this increase in high-quality evidence, which is reflected in the number of 1A recommendations (referred to as “A1” in earlier publications). Both the total number and the number of 1A recommendations have increased progressively with each publication of the guidelines. The proportion of 1A recommendations has varied between 17% and 25% of the total. The number and diversity of participants in the guideline development panels have also increased over time (Table 2). We have also improved the scientific rigor of the review process in a number of ways. Each recommendation corresponds to a clearly defined and clearly documented structured research question, and a team of methodologists has conducted a systematic search for relevant evidence. We have standardized the criteria for rating the quality of individual randomized trials and observational studies, and the criteria for rating overall quality of evidence and recommendations are increasingly refined and rigorous. Resource allocation has been considered for selected recommendations in several chapters. Over the iterations of the ACCP thrombosis guidelines, the panelists have become increasingly, and now vividly, aware that values and preferences underlie all recommendations. Whose values and preferences should guide tradeoffs such as those between avoiding thrombotic events and precipitating bleeding? Most would agree that patient and community values should drive the recommendations. That awareness presents a challenge: evidence regarding patient and community values and preferences is very limited, and generally of low quality. Nevertheless, the conceptual framework that guided the panelists stresses the need to do the best job possible of ensuring that recommendations are consistent with patient and community values. Where panelists perceived values and preferences might vary and were crucial, they explicitly articulated the values underlying particular recommendations. The ACCP guidelines are important not only for clinicians, but are used by litigating attorneys and by the pharmaceutical industry to promote their antithrombotic drugs. For these reasons, and for reasons of scientific integrity, every effort has been made to remove bias from the recommendations. The panelists who write the chapters and make the recommendations are from diverse institutions. Each chapter is reviewed by at least two editors, and modifications are made through an iterative process. The recommendations are made available and presented to all participants at an open 2-day meeting at which controversial issues are debated extensively. Finally, we have introduced an innovation to further increase the rigor of the guidelines by adding an external review process. Under the oversight of the ACCP Health and Science Policy Committee, the review process has been extended by including nearly 30 individuals from the ACCP Cardiovascular NetWork, the Health and Science Policy Committee, and the Board of Regents, as well as external peer reviewers at the invitation of the journal. The ACCP has a policy of constant renewal, replacing panelists and panel chairmen with new members at each iteration. The year 2008 guidelines also herald a change in the Chairmanship of the editors, with the oldest active editor (Jack Hirsh, MD, FCCP) retiring and being replaced for the next iteration by Gordon Guyatt, MD, FCCP. The last 22 years has seen marked improvements in the management of thromboembolic disease, and we can look forward to a bright future with further improvements and innovation.