Extending the Reach of Evidence-Based Medicine: A Proposed Categorization of Lower-Level Evidence.

Clinical practice involves making many treatment decisions for which only limited formal evidence exists. While the methodology of evidence-based medicine (EBM) has evolved tremendously, there is a need to better characterize lower-level evidence. This should enhance the ability to appropriately weigh the evidence against other considerations, and counter the temptation to think it is more robust than it actually is. A framework to categorize lower-level evidence is proposed, consisting of nonrandomized comparisons, extrapolation using indirect evidence, rationale, and clinical experience (ie, an accumulated general impression). Subtypes are recognized within these categories, based on the degree of confounding in nonrandomized comparisons, the uncertainty involved in extrapolation from indirect evidence, and the plausibility of a rationale. Categorizing the available evidence in this way can promote a better understanding of the strengths and limitations of using such evidence as the basis for treatment decisions in clinically relevant areas that are devoid of higher-level evidence.

Recommendations for kidney disease guideline updating: a report by the KDIGO Methods Committee.

Updating rather than de novo guideline development now accounts for the majority of guideline activities for many guideline development organizations, including Kidney Disease: Improving Global Outcomes (KDIGO), an international kidney disease guideline development entity that has produced guidelines on kidney diseases since 2008. Increasingly, guideline developers are moving away from updating at fixed intervals in favor of more flexible approaches that use periodic expert assessment of guideline currency (with or without an updated systematic review) to determine the need for updating. Determining the need for guideline updating in an efficient, transparent, and timely manner is challenging, and updating of systematic reviews and guidelines is labor intensive. Ideally, guidelines should be updated dynamically when new evidence indicates a need for a substantive change in the guideline based on a priori criteria. This dynamic updating (sometimes referred to as a living guideline model) can be facilitated with the use of integrated electronic platforms that allow updating of specific recommendations. This report summarizes consensus-based recommendations from a panel of guideline methodology professionals on how to keep KDIGO guidelines up to date.

Methodologies for the development of the management of cough: CHEST guideline and expert panel report.

BACKGROUND: This series of guidance documents on cough, which will be published over time, is a hybrid of two processes: (1) evidence-based guidelines and (2) trustworthy consensus statements based on a robust and transparent process. METHODS: The CHEST Guidelines Oversight Committee selected a nonconflicted Panel Chair and jointly assembled an international panel of experts in each clinical area with few, if any, conflicts of interest. PICO (population, intervention, comparator, outcome)-based key questions and parameters of eligibility were developed for each clinical topic to inform the comprehensive literature search. Existing guidelines, systematic reviews, and primary studies were assessed for relevance and quality. Data elements were extracted into evidence tables and synthesized to provide summary statistics. These, in turn, are presented to support the evidence-based graded recommendations. A highly structured consensus-based Delphi approach was used to provide expert advice on all guidance statements. Transparency of process was documented. RESULTS: Evidence-based guideline recommendations and consensus-based suggestions were carefully crafted to provide direction to health-care providers and investigators who treat and/or study patients with cough. Manuscripts and tables summarize the evidence in each clinical area supporting the recommendations and suggestions. CONCLUSIONS: The resulting guidance statements are based on a rigorous methodology and transparency of process. Unless otherwise stated, the recommendations and suggestions meet the guidelines for trustworthiness developed by the Institute of Medicine and can be applied with confidence by physicians, nurses, other health-care providers, investigators, and patients.

Overview of the management of cough: CHEST Guideline and Expert Panel Report.

This overview will demonstrate that cough is a common and potentially expensive health-care problem. Improvement in the quality of care of those with cough has been the focus of study for a variety of disciplines in medicine. The purpose of the Cough Guideline and Expert Panel is to synthesize current knowledge in a form that will aid clinical decision-making for the diagnosis and management of cough across disciplines and also identify gaps in knowledge and treatment options.

Methodologies for the development of CHEST guidelines and expert panel reports.

BACKGROUND: American College of Chest Physicians' (CHEST) new Living Guidelines Model will not only provide clinicians with guidance based on the most clinically relevant and current science but will also allow expert-informed guidance to fill in any gaps in the existing evidence. These guidance documents will be updated, as necessary, using one or more of three processes: (1) evidence-based guidelines, (2) trustworthy consensus statements, and (3) a hybrid of the other two. The new Living Guidelines Model will be more sustainable and will encourage maintenance of current and targeted recommendations and suggestions. METHODS: Over recent years, the Guidelines Oversight Committee (GOC), which consists of CHEST members with methodologic experience and other stakeholders, developed a rigorous process for evidence-based clinical practice guidelines. This guideline methodology will be used to the greatest extent permitted by the peer-reviewed literature. However, for some important problems clinicians seek guidance but insufficient research prevents establishing guidelines. For such cases, the GOC has created a carefully structured approach permitting a convened expert panel to develop such guidance. The foundation of this approach includes a systematic review of current literature and rigorously vetted, entrusted experts. RESULTS: Existing evidence, even if insufficient for a guideline, can be combined with a Delphi process for consensus achievement resulting in trustworthy consensus statements. This article provides a review of the CHEST methodologies for these guidance documents as well as the evidence-based guidelines. CONCLUSIONS: These reliable statements of guidance for health-care providers and patients are based on a rigorous methodology and transparency of process.

Methodology for development of guidelines for lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines.

BACKGROUND: The objective was to develop high-quality and comprehensive evidence-based guidelines on the diagnosis and management of lung cancer. METHODS: A carefully crafted panel of lung cancer experts, methodologists, and other specialists was assembled and reviewed for relevant conflicts of interest. The American College of Chest Physicians guideline methodology was used. Population, intervention, comparator, outcome (PICO)-based key questions and defined criteria for eligible studies were developed to inform the search strategies, subsequent evidence summaries, and recommendations. Research studies, systematic reviews, and meta-analyses, where they existed, were assessed for quality and summarized to inform the recommendations. RESULTS: Each recommendation was developed with supporting evidence and the consensus of the writing committees. Controversial recommendations were identified for further consultation by the entire panel, with anonymous voting to achieve consensus. CONCLUSIONS: The final recommendations can be trusted by health-care providers, patients, and other stakeholders since they are based on the current evidence in these areas and were developed with trustworthy processes for guideline development.

Introduction to the ninth edition: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines.

The Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines differs substantially from the prior versions both in process and in content. In this introduction, we describe some of the differences and the rationale for the changes.

Methodology for the development of antithrombotic therapy and prevention of thrombosis guidelines: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines.

BACKGROUND: To develop the Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: ACCP Evidence-Based Clinical Practice Guidelines (AT9), the American College of Chest Physicians (ACCP) assembled a panel of clinical experts, information scientists, decision scientists, and systematic review and guideline methodologists. METHODS: Clinical areas were designated as articles, and a methodologist without important intellectual or financial conflicts of interest led a panel for each article. Only panel members without significant conflicts of interest participated in making recommendations. Panelists specified the population, intervention and alternative, and outcomes for each clinical question and defined criteria for eligible studies. Panelists and an independent evidence-based practice center executed systematic searches for relevant studies and evaluated the evidence, and where resources and evidence permitted, they created standardized tables that present the quality of the evidence and key results in a transparent fashion. RESULTS: One or more recommendations relate to each specific clinical question, and each recommendation is clearly linked to the underlying body of evidence. Judgments regarding the quality of evidence and strength of recommendations were based on approaches developed by the Grades of Recommendations, Assessment, Development, and Evaluation Working Group. Panel members constructed scenarios describing relevant health states and rated the disutility associated with these states based on an additional systematic review of evidence regarding patient values and preferences for antithrombotic therapy. These ratings guided value and preference decisions underlying the recommendations. Each topic panel identified questions in which resource allocation issues were particularly important and, for these issues, experts in economic analysis provided additional searches and guidance. CONCLUSIONS: AT9 methodology reflects the current science of evidence-based clinical practice guideline development, with reliance on high-quality systematic reviews, a standardized process for quality assessment of individual studies and the body of evidence, an explicit process for translating the evidence into recommendations, disclosure of financial as well as intellectual conflicts of interest followed by management of disclosed conflicts, and extensive peer review.

The vexing problem of guidelines and conflict of interest: a potential solution.

Issues of financial and intellectual conflict of interest in clinical practice guidelines have raised increasing concern. Professional organizations have responded by more rigorous regulation of conflict of interest. Nevertheless, tension remains between the competing goals of optimizing guideline quality by using the experience and insight of experts and ensuring that financial and intellectual conflicts of interest do not influence recommendations. The executive committee of the American College of Chest Physicians' Antithrombotic Guidelines has developed a strategy comprising 3 innovative aspects to address this tension: First, place equal emphasis on intellectual and financial conflicts and provide explicit criteria for both; second, a methodologist without important conflicts of interest should have primary responsibility for each chapter; and third, experts with important financial or intellectual conflicts of interest can collect and interpret evidence, but only panel members without important conflicts can be involved in developing the recommendation for a specific question. These strategies may help to achieve the benefits of expert input without conflicts of interest influencing recommendations.

Methodology for lung cancer evidence review and guideline development: ACCP evidence-based clinical practice guidelines (2nd Edition).

BACKGROUND: To assemble a geographically diverse panel of experts in the diagnosis and treatment of lung cancer, representative of multiple clinical specialties, with the intention of developing clinically relevant practice guidelines for chest medicine and primary care physicians, including recommendations covering the full spectrum of care of the patient with non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). METHODS: The Duke University Center for Clinical Health Policy Research was selected to review and summarize the current evidence in the treatment of NSCLC. The BlueCross BlueShield Association Technology Evaluation Center was chosen and funded by the Agency for Healthcare Research and Quality to review and synthesize the current evidence on treatment of SCLC. Other chapters received existing guidelines, systematic reviews, and metaanalyses that were published since the first edition of these guidelines, as collected by the Duke University Evidence-based Practice Center. The writing committees for these chapters conducted searches for the primary articles and additional evidence in their topic area. The expert panel established clinical recommendations founded on the synthesis of this evidence. CONCLUSIONS: This section describes the approach used to develop the guidelines, including identifying, evaluating, and synthesizing the evidence, assessing the strength of evidence and grading the individual recommendations, and suggestions for implementation of the guidelines.

ACCP evidence-based guideline development: a successful and transparent approach addressing conflict of interest, funding, and patient-centered recommendations.

Evidence-based clinical practice guidelines (EBGs) can provide an invaluable distillation of knowledge regarding best practices based on the available evidence. EBGs, providing accurate and useful guidance to best clinical practices, require a rigorous development process. The American College of Chest Physicians (ACCP) has developed a process that embodies transparency, thoroughness, and timeliness, and effective conflict-of-interest management, and it continues to evolve. This process employs a quantitative and rigorous grading of the strength of recommendations and of the quality of evidence that incorporates sensitivity to health-care resource utilization and patient values and preferences. A review of this process is provided to inform the ACCP membership and those wishing to embark on EBG development.

Grading strength of recommendations and quality of evidence in clinical guidelines: report from an american college of chest physicians task force.

While grading the strength of recommendations and the quality of underlying evidence enhances the usefulness of clinical guidelines, the profusion of guideline grading systems undermines the value of the grading exercise. An American College of Chest Physicians (ACCP) task force formulated the criteria for a grading system to be utilized in all ACCP guidelines that included simplicity and transparency, explicitness of methodology, and consistency with current methodological approaches to the grading process. The working group examined currently available systems, and ultimately modified an approach formulated by the international GRADE group. The grading scheme classifies recommendations as strong (grade 1) or weak (grade 2), according to the balance among benefits, risks, burdens, and possibly cost, and the degree of confidence in estimates of benefits, risks, and burdens. The system classifies quality of evidence as high (grade A), moderate (grade B), or low (grade C) according to factors that include the study design, the consistency of the results, and the directness of the evidence. For all future ACCP guidelines, The College has adopted a simple, transparent approach to grading recommendations that is consistent with current developments in the field. The trend toward uniformity of approaches to grading will enhance the usefulness of practice guidelines for clinicians.

Addressing resource allocation issues in recommendations from clinical practice guideline panels: suggestions from an American College of Chest Physicians task force.

Most panels that develop clinical practice guidelines are poorly equipped to address resource allocation or cost issues associated with management options. This risks neglect, arbitrariness, lack of transparency, and methodological flaws in consideration of resource allocation. We provide recommendations for guideline panels to promote greater transparency and rigor. We suggest focusing on resource allocation issues for only a limited number of recommendations and provide criteria for selecting those in which economic considerations are likely to influence the direction or strength of the recommendation. Panels should involve a health economist to assist with the systematic review and critical interpretation of relevant economic analyses. They should carefully define the intended audience and may consider issuing alternative recommendations when available resources vary widely across target clinical settings. Targeting a limited number of recommendations for the consideration of resource allocation issues, and ensuring methodologically high-quality review, will best serve guideline panels, and the health-care providers and patients they hope to assist.

Methodology and grading of the evidence for the diagnosis and management of cough: ACCP evidence-based clinical practice guidelines.

OBJECTIVES: To assemble a multidisciplinary, geographically diverse panel of experts in the diagnosis and treatment of cough with the intention of developing clinically relevant practice guidelines for pulmonary and primary care physicians, including recommendations covering many etiologies of cough, adult and pediatric evaluation and treatment, and empiric yet integrative algorithms for the management of the patient with cough. METHODS: The Duke University Center for Clinical Health Policy Research was selected to review and summarize the current evidence in this area. The expert panel established clinical recommendations and algorithms founded on the synthesis of this evidence. CONCLUSIONS: This section describes the approach used to develop the guidelines, including identifying, evaluating, and synthesizing the evidence, assessing the strength of evidence pertinent to individual guidelines, and grading the guideline recommendations.

Methodology and grading for pulmonary hypertension evidence review and guideline development.

The American College of Chest Physicians assembled a multidisciplinary, geographically diverse panel of experts in the treatment of pulmonary hypertension to develop clinically relevant practice guidelines for the diagnosis and treatment of pulmonary hypertension in its many variations. That group of experts produced recommendations covering five topic areas, each related to a distinct set of patient-management decisions. This article describes the approach used to develop the guidelines, including identifying, evaluating, and synthesizing the evidence, assessing the strength of evidence pertinent to individual guidelines, and grading guideline recommendations.