ACC/AHA TASK FORCE MEMBERS (2025)

The Development of Clinical Guidelines and Guidance Statements by the Clinical Guidelines Committee of the American College of Physicians: Update of Methods

Annals of Internal Medicine, 2019

Methodological quality and transparency of clinical practice guidelines for the pharmacological treatment of non-communicable diseases using the AGREE II instrument: a systematic review protocol

Systematic reviews, 2017

Non-communicable diseases (NCDs) are the leading cause of death worldwide. Clinical practice guidelines (CPGs) constitute an important tool for the promotion of evidence-based health, which may improve healthcare outcomes for individuals with NCDs. Studies have shown that many CPGs have poor or moderate quality. Therefore, the aim of the proposed study is to systematically identify and appraise CPGs for pharmacological treatment of the most prevalent NCDs in primary care. A comprehensive literature search will be conducted in the following databases: MEDLINE, Embase and Cochrane Library. Twelve databases specific to CPGs will also be searched. Three appraisers will assess the quality of the CPGs using the Appraisal of Guidelines Research and Evaluation (AGREE) Instrument, version II. The AGREE II results will be checked for discrepancies. Differences between scores equal than or greater to 2 will be considered discrepant and the appraisers will decide the final score by consensus. I...

Guideline to Guidelines. Implementation of scientific evidence into clinical guidelines

Research Square (Research Square), 2023

Background: The knowledge and help provided by the medical guidelines are essential to make informed clinical decisions. However, there are no systematic methods to assess the e cacy of guidelines, i.e., how much contribution they provide to informed decisions in various health conditions. Methods: A mathematical analysis was developed to assess the e cacy of guidelines. As an example, the "2020 ESC Guidelines on sports cardiology and exercise in patients with cardiovascular disease" (GL-SCE) was analysed/assessed. The analysis was conducted on the Classes of Recommendations (CLASS) and the Levels of Evidence (LEVEL). LEVEL areas under CLASS were calculated to form a Certainty Index (CI:-1 to+1). Results: The frequency of CLASS I ('to do') and CLASS III ('not to do') was relatively high in GL-SCE. Yet, the most frequent LEVEL was C, indicating a low quality of scienti c evidence. The GL-SCE showed a relatively high CI (+0.57), 78.4% Certainty and 21.6% Uncertainty. Conclusions: GL-SCE provides a substantial help to decision-making through the recommendations, but the supporting evidence in most CLASSes has low quality, which is well-re ected in the developed Certainty Index identifying issues that should be clari ed and investigated in future studies. We propose that the developed mathematical analysis should be used as a Guideline to Guidelines to assess their e cacy and support their implementation in clinical practice thus providing a 'quality control'. Contribution to the literature This study provides a mathematical analysis to objectively measure the help/contribution to medical decision-making provided by any medical Guidelines; this analysis allows a better understanding of the classes of recommendations and the levels of scienti c evidence. The higher level of scienti c evidence and/or clinical signi cance of lower evidence may be increased by conducting new experimental and clinical studies on uncertain issues revealed with this analysis on the Guidelines; thus, the e cacy of clinical decision-making can be increased. The outlined mathematical analysis provides a 'quality control', and as such, it can be used as a Guideline for assessing the e cacy of the Guidelines. Background Medical societies publish several guidelines to help medical professionals to make decisions in certain disease conditions. Recently by analysing four ESC GLs for CVDs, we revealed that the contribution provided by them to make a decision is uneven, based on the Certainty/Uncertainty ratio [1]. Indeed, the GLs' contribution to decision-making can vary based on the Levels of Evidence (LEVEL) and Classes of Recommendations (CLASS). It is obvious that in the recommendations of Class I (recommended/indicated) 'to do' and Class III (not recommended) 'not to do', the decision is clear

Misconceptions, Challenges, Uncertainty, and Progress in Guideline Recommendations

Seminars in Hematology, 2008

Although the quality of clinical practice guidelines has improved over the last decade, current guideline systems have limitations that reduce their validity and limit their acceptance. The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) working group, a worldwide collaboration of guideline developers, methodologists, and clinicians, has constructed a system for developing guidelines that addresses these shortcomings. The system includes a transparent and rigorous methodology for rating the quality of evidence, an explicit balancing of benefits and harms of healthcare interventions, an explicit acknowledgement of the values and preferences that underlie the recommendations, and whether the intervention represents a wise use of resources. These four elements determine whether a recommendation is strong or weak. A guideline panel offers strong recommendations when virtually all informed patients would choose the same management strategy. Weak recommendations imply that choices will differ across the range of patient values and preferences. The GRADE system has been tested in multiple practice settings and for a large spectrum of questions, refined and re-evaluated to ensure that it captures the complex issues involved in evidence assessment and grading recommendations while maintaining simplicity and practicality. Many guideline organizations and medical societies have endorsed the system and adopted it for their guideline processes. Semin Hematol 45:167-175

2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines

Hypertension (Dallas, Tex. : 1979), 2017

Since 1980, the American College of Cardiology (ACC) and American Heart Association (AHA) have translated scientific evidence into clinical practice guidelines (guidelines) with recommendations to improve cardiovascular health. In 2013, the National Heart, Lung, and Blood Institute (NHLBI) Advisory Council recommended that the NHLBI focus specifically on reviewing the highest-quality evidence and partner with other organizations to develop recommendations. P-1,P-2 Accordingly, the ACC and AHA collaborated with the NHLBI and stakeholder and professional organizations to complete and publish 4 guidelines (on assessment of cardiovascular risk, lifestyle modifications to reduce cardiovascular risk, management of blood cholesterol in adults, and management of overweight and obesity in adults) to make them available to the widest possible constituency. In 2014, the ACC and AHA, in partnership with several other professional societies, initiated a guideline on the prevention, detection, evaluation, and management of high blood pressure (BP) in adults. Under the management of the ACC/ AHA Task Force, a Prevention Subcommittee was appointed to help guide development of the suite of guidelines on prevention of cardiovascular disease (CVD). These guidelines, which are based on systematic methods to evaluate and classify evidence, provide a cornerstone for quality cardiovascular care. The ACC and AHA sponsor the development and publication of guidelines without commercial support, and members of each organization volunteer their time to the writing and review efforts. Guidelines are official policy of the ACC and AHA. Hypertension June 2018 of clinical practice. The Task Force may also invite organizations and professional societies with related interests and expertise to participate as partners, collaborators, or endorsers. Relationships With Industry and Other Entities The ACC and AHA have rigorous policies and methods to ensure that guidelines are developed without bias or improper influence. The complete relationships with industry and other entities (RWI) policy can be found online. Appendix 1 of the present document lists writing committee members' relevant RWI. For the purposes of full transparency, writing committee members' comprehensive disclosure information is available online. Comprehensive disclosure information for the Task Force is available online. Evidence Review and Evidence Review Committees In developing recommendations, the writing committee uses evidence-based methodologies that are based on all available data. P-6-P-9 Literature searches focus on randomized controlled trials (RCTs) but also include registries, nonrandomized comparative and descriptive studies, case series, cohort studies, systematic reviews, and expert opinion. Only key references are cited. An independent evidence review committee (ERC) is commissioned when there are 1 or more questions deemed of utmost clinical importance that merit formal systematic review. The systematic review will determine which patients are most likely to benefit from a drug, device, or treatment strategy and to what degree. Criteria for commissioning an ERC and formal systematic review include: a) the absence of a current authoritative systematic review, b) the feasibility of defining the benefit and risk in a time frame consistent with the writing of a guideline, c) the relevance to a substantial number of patients, and d) the likelihood that the findings can be translated into actionable recommendations. ERC members may include methodologists, epidemiologists, healthcare providers, and biostatisticians. The recommendations developed by the writing committee on the basis of the systematic review are marked with "SR." Guideline-Directed Management and Therapy The term guideline-directed management and therapy (GDMT) encompasses clinical evaluation, diagnostic testing, and pharmacological and procedural treatments. For these and all recommended drug treatment regimens, the reader should confirm the dosage by reviewing product insert material and evaluate the treatment regimen for contraindications and interactions. The recommendations are limited to drugs, devices, and treatments approved for clinical use in the United States. Class of Recommendation and Level of Evidence The Class of Recommendation (COR) indicates the strength of the recommendation, encompassing the estimated magnitude and certainty of benefit in proportion to risk. The Level of Evidence (LOE) rates the quality of scientific evidence that supports the intervention on the basis of the type, quantity, and consistency of data from clinical trials and other sources (Table 1

Discordant and inappropriate discordant recommendations in consensus and evidence based guidelines: empirical analysis

BMJ, 2021

OBJECTIVE To investigate whether alignment of strength of recommendations with quality of evidence differs in consensus based versus evidence based guidelines. DESIGN Empirical analysis. DATA SOURCE Guidelines developed by the American College of Cardiology and the American Heart Association (ACC/ AHA) and the American Society of Clinical Oncology (ASCO) up to 27 March 2021. STUDY SELECTION Recommendations were clearly categorised as consensus or evidence based, were separated from the remainder of the text, and included both the quality of evidence and the strength of the recommendations. DATA EXTRACTION Paired authors independently extracted the recommendation characteristics, including type of recommendation (consensus or evidence based), grading system used for developing recommendations, strength of the recommendation, and quality of evidence. The study team also calculated the number of discordant recommendations (strong recommendations with low quality evidence) and inappropriate discordant recommendations (those that did not meet grading of recommendations assessment, development, and evaluation criteria of appropriateness). RESULTS The study included 12 ACC/AHA guidelines that generated 1434 recommendations and 69 ASCO guidelines that generated 1094 recommendations. Of the 504 ACC/AHA recommendations based on low quality evidence, 200 (40%) proved to be consensus based versus 304 (60%) evidence based; of the 404 ASCO recommendations based on low quality evidence, 292 (72%) were consensus based versus 112 (28%) that were evidence based. In both ACC/ AHA and ASCO guidelines, the consensus approach yielded more discordant recommendations (ACC/AHA: odds ratio 2.1, 95% confidence interval 1.5 to 3.1; ASCO: 2.9, 1.1 to 7.8) and inappropriate discordant recommendations (ACC/AHA: 2.6, 1.7 to 3.7; ASCO: 5.1, 1.6 to 16.0) than the evidence based approach. CONCLUSION Consensus based guidelines produce more recommendations violating the evidence based medicine principles than evidence based guidelines. Ensuring appropriate alignment of quality of evidence with the strength of recommendations is key to the development of "trustworthy" guidelines.

Users' guides to the Medical Literature. VIII. How to use clinical practice guidelines. B. what are the recommendations and will they help you in caring for your patients? The Evidence-Based Medicine Working Group

Jama-journal of The American Medical Association, 1995

Clinical practice guidelines: the need for greater transparency in formulating recommendations

The Medical Journal of Australia, 2011

2 The Grading of Recommendations Assessment, Development and Evaluation (GRADE) system 23 GRADE proposes that the quality of evidence associated with each outcome of importance to patients be evaluated separately. The GRADE system classifies quality of evidence into 4 levels: high, moderate, low or very low. Evidence from randomised controlled trials (RCTs) begins as high quality, but may be rated down if trials demonstrate one of five categories of limitations. Observational studies begin as low-quality evidence, but may be rated up if associated with one of three categories of special strengths. Reasons for rating down quality of evidence Risk of bias: Quality will be lower if most of the evidence from available RCTs is compromised by limitations such as: lack of allocation concealment; lack of blinding (particularly if outcome assessment is highly susceptible to bias); large losses to follow-up; failure to analyse patients in the groups to which they were randomised; premature termination for benefit; or failure to report outcomes (often those for which no effect was observed). Inconsistent results: Widely differing estimates of treatment effect across studies suggest true differences in underlying treatment effect, and if investigators fail to identify a plausible explanation, quality of evidence decreases. Variability may arise from differences in populations, interventions, or outcomes. Indirectness of evidence: In comparing effects of two active treatments, randomised head-to-head trials constitute high-quality evidence. Indirect comparisons of the magnitude of effects seen in separate placebo-controlled trials of each treatment constitute lower quality evidence. Another type of indirectness arises if there are important differences between the populations (eg, elderly v non-elderly), interventions (eg, low v high dose) and outcomes (patient-important v surrogate) measured in trials and those under consideration in the guideline. Imprecision: When studies include relatively few patients and few events and thus have wide confidence intervals, quality of evidence decreases. Publication bias: Failure to report studies that typically show no effect reduces evidence quality. Such publication bias is more likely when only a small number of trials, all funded by industry, are available. Reasons for rating up quality of evidence Large and consistent effect sizes: If several large and methodologically strong observational studies report a very large effect size and confounding is unlikely to explain all or most of the apparent benefit, quality of evidence can be rated up (eg, hip replacement in severe osteoarthritis or dialysis for end-stage renal failure). Presence of a dose-response gradient: Where intensity of intervention (eg, dose, duration, or parenteral v oral method of administration) shows a correlation with effect size, the quality of evidence may increase. Accounting for all plausible confounding: Where investigators have accounted for all plausible biases which might decrease the magnitude of an apparent effect or create a spurious effect when results show no effect, the quality of evidence increases.

Evidence-Based Guidelines--An Introduction

Hematology, 2008

Recommendations in the form of clinical practice guidelines are increasingly common. Clinical guidelines are systematically developed statements designed to help administrators, practitioners and patients make decisions about appropriate health care for specific circumstances. In North America, guidelines developed by professional societies, government panels and cooperative groups are frequently used to measure quality, to allocate resources and to determine how health care dollars are spent. For clinicians, guidelines provide a summary of the relevant medical literature and offer assistance in deciding which diagnostic tests to order, which treatments to use for specific conditions, when to discharge patients from the hospital, and many other aspects of clinical practice.

GRADE: an emerging consensus on rating quality of evidence and strength of recommendations

BMJ, 2008