Synthesis, grading, and presentation of evidence in guidelines: article 7 in Integrating and coordinating efforts in COPD guideline development. An official ATS/ERS workshop report.

INTRODUCTION Professional societies, like many other organizations around the world, have recognized the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the seventh of a series of 14 articles that were prepared to advise guideline developers in respiratory and other diseases on approaches for guideline development. This article focuses on synthesizing, rating, and presenting evidence in guidelines. METHODS In this review we addressed the following questions. (1) What evidence should guideline panels use to inform their recommendations? (2) How should they rate the quality of the evidence they use? (3) How should they grade evidence regarding diagnostic tests? (4) What should they do when quality of evidence differs across outcomes? (5) How should they present the evidence in a guideline? We did not conduct systematic reviews ourselves. We relied on prior evaluations of electronic databases and systematic reviews suggesting that the Grades of Recommendation, Assessment, Development and Evaluation Working Group (GRADE) approach includes the desired features of a system for grading quality of evidence, including provision of models for presenting evidence for guideline panels, and for the consumers of practice guidelines. This article describes the GRADE approach to grading the quality of evidence and presenting evidence. Available evidence, the practice of leading guideline developers, and workshop discussions provide the basis for our conclusions. RESULTS AND DISCUSSION GRADE rates the quality of evidence for each outcome across studies rather than for each study. In the GRADE approach randomized trials start as high-quality evidence and observational studies as low-quality evidence, but both can be rated down or up. Five factors may lead to rating down the quality of evidence: study limitations or risk of bias, inconsistency of results, indirectness of evidence, imprecision, and publication bias. Three factors may lead to rating up the quality of evidence from observational studies: large magnitude of effect, dose-response gradient, and situations in which all plausible confounders would decrease an apparent treatment effect, or would create a spurious effect when results suggest no effect. GRADE suggests use of evidence profiles that provide a comprehensive way to display the key evidence relevant to a clinical question. Guideline developers who follow this structure will find the transparency of their recommendations markedly enhanced.

[1]  Michele Tarsilla Cochrane Handbook for Systematic Reviews of Interventions , 2010, Journal of MultiDisciplinary Evaluation.

[2]  V. Hasselblad,et al.  Biomarker-guided therapy in chronic heart failure: a meta-analysis of randomized controlled trials. , 2009, American heart journal.

[3]  H. Schünemann,et al.  A vision statement on guideline development for respiratory disease: the example of COPD , 2009, The Lancet.

[4]  Jennifer Spaeth,et al.  Task Force on Community Preventive Services , 2009 .

[5]  D. Muthu,et al.  Rapid Measurement of B-Type Natriuretic Peptide in the Emergency Diagnosis of Heart Failure , 2009 .

[6]  Gordon H. Guyatt,et al.  Presenting Results and ‘Summary of Findings’ Tables , 2008 .

[7]  J. Sch GRADE: grading quality of evidence and strength of recommendations for diagnostic tests and strategies , 2008, BMJ : British Medical Journal.

[8]  Jennifer S. Lin,et al.  Using Existing Systematic Reviews in Complex Systematic Reviews , 2008, Annals of Internal Medicine.

[9]  G. Guyatt,et al.  GRADE: an emerging consensus on rating quality of evidence and strength of recommendations , 2008, BMJ : British Medical Journal.

[10]  S. Salpeter,et al.  Meta-analysis: anticholinergics, but not β-agonists, reduce severe exacerbations and respiratory mortality in COPD , 2008, Journal of General Internal Medicine.

[11]  Jeremy M. Grimshaw,et al.  Increasing the demand for childhood vaccination in developing countries: a systematic review , 2009, BMC international health and human rights.

[12]  D. Brooks,et al.  Effect of oxygen on health quality of life in patients with chronic obstructive pulmonary disease with transient exertional hypoxemia. , 2007, American journal of respiratory and critical care medicine.

[13]  David Moher,et al.  Development of AMSTAR: a measurement tool to assess the methodological quality of systematic reviews , 2007, BMC medical research methodology.

[14]  Keiji Fukuda,et al.  WHO Rapid Advice Guidelines for pharmacological management of sporadic human infection with avian influenza A (H5N1) virus , 2006, The Lancet Infectious Diseases.

[15]  A. Oxman,et al.  Improving the use of research evidence in guideline development: 8. Synthesis and presentation of evidence , 2006, Health research policy and systems.

[16]  Andrew D Oxman,et al.  Improving the use of research evidence in guideline development , 2007 .

[17]  I. Olkin,et al.  The case of the misleading funnel plot , 2006, BMJ : British Medical Journal.

[18]  Michael K Gould,et al.  An official ATS statement: grading the quality of evidence and strength of recommendations in ATS guidelines and recommendations. , 2006, American journal of respiratory and critical care medicine.

[19]  G. Guyatt,et al.  Grading strength of recommendations and quality of evidence in clinical guidelines: report from an american college of chest physicians task force. , 2006, Chest.

[20]  Y. Lacasse,et al.  Randomised trial of ambulatory oxygen in oxygen-dependent COPD , 2005, European Respiratory Journal.

[21]  J. Bradley,et al.  Short term ambulatory oxygen for chronic obstructive pulmonary disease. , 2005, The Cochrane database of systematic reviews.

[22]  J. Steurer,et al.  Oral purified bacterial extracts in chronic bronchitis and COPD: systematic review. , 2004, Chest.

[23]  G. Guyatt,et al.  Grading quality of evidence and strength of recommendations , 2004, BMJ : British Medical Journal.

[24]  C. Hall Essential biochemistry and physiology of (NT‐pro)BNP , 2004, European journal of heart failure.

[25]  Emil H Schemitsch,et al.  Association between industry funding and statistically significant pro-industry findings in medical and surgical randomized trials. , 2004, CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne.

[26]  M. Pfisterer,et al.  Use of B-type natriuretic peptide in the evaluation and management of acute dyspnea. , 2004, The New England journal of medicine.

[27]  M. Ebell,et al.  Strength of recommendation taxonomy (SORT): a patient-centered approach to grading evidence in the medical literature. , 2004, The Journal of the American Board of Family Practice.

[28]  Aniruddha M. Deshpande,et al.  Standardized Reporting of Clinical Practice Guidelines: A Proposal from the Conference on Guideline Standardization , 2003, Annals of Internal Medicine.

[29]  E. Antman,et al.  American College of Cardiology/American Heart Association clinical practice guidelines: Part I: where do they come from? , 2003, Circulation.

[30]  M. Mäkelä,et al.  Towards evidence-based clinical practice: an international survey of 18 clinical guideline programs. , 2003, International journal for quality in health care : journal of the International Society for Quality in Health Care.

[31]  P. Young,et al.  Ambulatory oxygen improves quality of life of COPD patients: a randomised controlled study , 2002, European Respiratory Journal.

[32]  J. Hollander,et al.  B-Type Natriuretic Peptide and Clinical Judgment in Emergency Diagnosis of Heart Failure: Analysis From Breathing Not Properly (BNP) Multinational Study , 2002, Circulation.

[33]  N McKoy,et al.  Systems to rate the strength of scientific evidence. , 2002, Evidence report/technology assessment.

[34]  B. Dobkin,et al.  Philadelphia Panel evidence-based clinical practice guidelines on selected rehabilitation interventions: overview and methodology. , 2001, Physical therapy.

[35]  R. Harbour,et al.  A new system for grading recommendations in evidence based guidelines , 2001, BMJ : British Medical Journal.

[36]  C. Mulrow,et al.  Current methods of the US Preventive Services Task Force: a review of the process. , 2001, American journal of preventive medicine.

[37]  Patricia Dolan Mullen,et al.  Developing an Evidence-Based Guide to Community Preventive Services—Methods , 2000 .

[38]  A R Hinman,et al.  Developing the Guide to Community Preventive Services--overview and rationale. The Task Force on Community Preventive Services. , 2000, American journal of preventive medicine.

[39]  P D Mullen,et al.  Developing an evidence-based Guide to Community Preventive Services--methods. The Task Force on Community Preventive Services. , 2000, American journal of preventive medicine.

[40]  J. Chmiel,et al.  Sexual Adventurism, High‐Risk Behavior, and Human Immunodeficiency Virus‐1 Seroconversion Among the Chicago MACS‐CCS Cohort, 1984 to 1992: A Case‐Control Study , 1996, Sexually transmitted diseases.

[41]  I. Marschner,et al.  Exertional oxygen of limited benefit in patients with chronic obstructive pulmonary disease and mild hypoxemia. , 1995, American journal of respiratory and critical care medicine.

[42]  J. Chmiel,et al.  Seroconversion, sexual activity, and condom use among 2915 HIV seronegative men followed for up to 2 years. , 1989, Journal of acquired immune deficiency syndromes.

[43]  E. Liker,et al.  Portable oxygen in chronic obstructive lung disease with hypoxemia and cor pulmonale. A controlled double-blind crossover study. , 1975, Chest.