- Arthur T Evans, MD, MPH
Arthur T Evans, MD, MPH
- Professor of Medicine
- NewYork-Presbyterian Hospital
- Weill Cornell Medicine
- Gregory Mints, MD, FACP
Gregory Mints, MD, FACP
- Assistant Professor of Medicine
- Weill Cornell Medical College
Evidence-based medicine (EBM) is the care of patients using the best available research evidence to guide clinical decision making (figure 1) [1,2]. The value of EBM is heightened in light of the following considerations:
●The volume of evidence available to guide clinical decisions continues to grow at a rapid pace (figure 2).
●Improvements in research design, clinical measurements, and methods for analyzing data have led to a better understanding of how to produce valid clinical research.
●Despite advances in research methods, many published study results are false or draw misleading conclusions .
●Many clinicians, even those in good standing, do not practice medicine according to the best current research evidence.To continue reading this article, you must log in with your personal, hospital, or group practice subscription. For more information on subscription options, click below on the option that best describes you:
- Sackett DL, Straus SE, Richardson WS, et al. Evidence-based medicine: How to practice and teach EBM, 2nd ed, Churchill Livingstone, Edinburgh 2000.
- Sackett DL, Rosenberg WM, Gray JA, et al. Evidence based medicine: what it is and what it isn't. BMJ 1996; 312:71.
- Ioannidis JP. Why most published research findings are false. PLoS Med 2005; 2:e124.
- Richardson WS, Wilson MC, Nishikawa J, Hayward RS. The well-built clinical question: a key to evidence-based decisions. ACP J Club 1995; 123:A12.
- Assmann SF, Pocock SJ, Enos LE, Kasten LE. Subgroup analysis and other (mis)uses of baseline data in clinical trials. Lancet 2000; 355:1064.
- Sun X, Briel M, Busse JW, et al. Credibility of claims of subgroup effects in randomised controlled trials: systematic review. BMJ 2012; 344:e1553.
- Fernandez Y Garcia E, Nguyen H, Duan N, et al. Assessing Heterogeneity of Treatment Effects: Are Authors Misinterpreting Their Results? Health Serv Res 2010; 45:283.
- Head SJ, Kaul S, Tijssen JG, et al. Subgroup analyses in trial reports comparing percutaneous coronary intervention with coronary artery bypass surgery. JAMA 2013; 310:2097.
- Kasenda B, Schandelmaier S, Sun X, et al. Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications. BMJ 2014; 349:g4539.
- Zhang S, Liang F, Li W, Hu X. Subgroup Analyses in Reporting of Phase III Clinical Trials in Solid Tumors. J Clin Oncol 2015; 33:1697.
- Sun X, Ioannidis JP, Agoritsas T, et al. How to use a subgroup analysis: users' guide to the medical literature. JAMA 2014; 311:405.
- Fletcher J. Subgroup analyses: how to avoid being misled. BMJ 2007; 335:96.
- Aronson D. Subgroup analyses with special reference to the effect of antiplatelet agents in acute coronary syndromes. Thromb Haemost 2014; 112:16.
- Rothwell PM. Treating individuals 2. Subgroup analysis in randomised controlled trials: importance, indications, and interpretation. Lancet 2005; 365:176.
- Vickers AJ, de Craen AJ. Why use placebos in clinical trials? A narrative review of the methodological literature. J Clin Epidemiol 2000; 53:157.
- Serruys PW, Morice MC, Kappetein AP, et al. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med 2009; 360:961.
- Institute of Medicine (US) Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease; Editors Micheel CM and Ball JR. National Academies Press, Washington, DC. 2010. Available at: https://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0079490/ (Accessed on September 26, 2016).
- Downing NS, Aminawung JA, Shah ND, et al. Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012. JAMA 2014; 311:368.
- Yudkin JS, Lipska KJ, Montori VM. The idolatry of the surrogate. BMJ 2011; 343:d7995.
- Allahwala UK, Nadkarni A, Sebaratnam DF. Wikipedia use amongst medical students - new insights into the digital revolution. Med Teach 2013; 35:337.
- Azer SA, AlSwaidan NM, Alshwairikh LA, AlShammari JM. Accuracy and readability of cardiovascular entries on Wikipedia: are they reliable learning resources for medical students? BMJ Open 2015; 5:e008187.
- Kräenbring J, Monzon Penza T, Gutmann J, et al. Accuracy and completeness of drug information in Wikipedia: a comparison with standard textbooks of pharmacology. PLoS One 2014; 9:e106930.
- Kupferberg N, Protus BM. Accuracy and completeness of drug information in Wikipedia: an assessment. J Med Libr Assoc 2011; 99:310.
- Hasty RT, Garbalosa RC, Barbato VA, et al. Wikipedia vs peer-reviewed medical literature for information about the 10 most costly medical conditions. J Am Osteopath Assoc 2014; 114:368.
- Agoritsas T, Vandvik PO, Neumann I, et al. Finding Current Best Evidence. In: Users' Guides to the Medical Literature: A Manual for Evidence-Based Clinical Practice, 3rd Ed, Guyatt G, Rennie D, Meade MO, Cook DJ (Eds), McGraw-Hill Education, 2015. p.29.
- Burda BU, Norris SL, Holmer HK, et al. Quality varies across clinical practice guidelines for mammography screening in women aged 40-49 years as assessed by AGREE and AMSTAR instruments. J Clin Epidemiol 2011; 64:968.
- Clinical Practice Guidelines We Can Trust. In: Graham R, Mancher M, Wolman DM, Greenfield S, Steinberg E, eds. Washington, D.C.: The National Academies Press. Committee on Standards for Developing Trustworthy Clinical Practice Guidelines; Board on Health Care Services; Institute of Medicine of the National Academy of Sciences.; 2011. Available at: https://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0079468/ (Accessed on September 28, 2016).
- Brouwers MC, Kho ME, Browman GP, et al. Development of the AGREE II, part 1: performance, usefulness and areas for improvement. CMAJ 2010; 182:1045.
- Brouwers MC, Kho ME, Browman GP, et al. Development of the AGREE II, part 2: assessment of validity of items and tools to support application. CMAJ 2010; 182:E472.
- Neumann I, Santesso N, Akl EA, et al. A guide for health professionals to interpret and use recommendations in guidelines developed with the GRADE approach. J Clin Epidemiol 2016; 72:45.
- Guyatt G, Oxman AD, Akl EA, et al. GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables. J Clin Epidemiol 2011; 64:383.
- Andrews JC, Schünemann HJ, Oxman AD, et al. GRADE guidelines: 15. Going from evidence to recommendation-determinants of a recommendation's direction and strength. J Clin Epidemiol 2013; 66:726.
- Thornton J, Alderson P, Tan T, et al. Introducing GRADE across the NICE clinical guideline program. J Clin Epidemiol 2013; 66:124.
- GRADE working group. Organizations that have endorsed or that are using GRADE. Available at: http://www.gradeworkinggroup.org (Accessed on September 28, 2016).
- Users' Guides to the Medical Literature: A manual for evidence-based clinical practice, 3rd Ed, Guyatt G, Drummond R, Meade MO, Cook DJ (Eds), McGraw-Hill Education, 2015.
- Moher D, Liberati A, Tetzlaff J, et al. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann Intern Med 2009; 151:264.
- Moher D, Shamseer L, Clarke M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Syst Rev 2015; 4:1.
- Schulz KF, Altman DG, Moher D, CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med 2010; 152:726.
- Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013; 158:200.
- Vandenbroucke JP, von Elm E, Altman DG, et al. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration. Ann Intern Med 2007; 147:W163.
- Bossuyt PM, Reitsma JB, Bruns DE, et al. Towards complete and accurate reporting of studies of diagnostic accuracy: The STARD Initiative. Ann Intern Med 2003; 138:40.
- Collins GS, Reitsma JB, Altman DG, Moons KG. Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis (TRIPOD): the TRIPOD statement. Ann Intern Med 2015; 162:55.
- Moons KG, Altman DG, Reitsma JB, et al. Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis (TRIPOD): explanation and elaboration. Ann Intern Med 2015; 162:W1.
- Kent DM, Hayward RA. Limitations of applying summary results of clinical trials to individual patients: the need for risk stratification. JAMA 2007; 298:1209.
- Vickers AJ, Kent DM. The Lake Wobegon Effect: Why Most Patients Are at Below-Average Risk. Ann Intern Med 2015; 162:866.
- Dwan K, Altman DG, Clarke M, et al. Evidence for the selective reporting of analyses and discrepancies in clinical trials: a systematic review of cohort studies of clinical trials. PLoS Med 2014; 11:e1001666.
- Schulz KF, Grimes DA. Multiplicity in randomised trials II: subgroup and interim analyses. Lancet 2005; 365:1657.
- Randomised trial of intravenous streptokinase, oral aspirin, both, or neither among 17,187 cases of suspected acute myocardial infarction: ISIS-2. ISIS-2 (Second International Study of Infarct Survival) Collaborative Group. Lancet 1988; 2:349.
- Wittes J. On looking at subgroups. Circulation 2009; 119:912.
- Brookes ST, Whitley E, Peters TJ, et al. Subgroup analyses in randomised controlled trials: quantifying the risks of false-positives and false-negatives. Health Technol Assess 2001; 5:1.
- Reinhart A. Statistics Done Wrong: The Woefully Complete Guide., No Starch Press, San Francisco, CA 2015.
- Lauer MS. From hot hands to declining effects: the risks of small numbers. J Am Coll Cardiol 2012; 60:72.
- Wallach JD, Sullivan PG, Trepanowski JF, et al. Evaluation of Evidence of Statistical Support and Corroboration of Subgroup Claims in Randomized Clinical Trials. JAMA Intern Med 2017; 177:554.
- Kent DM, Nelson J, Dahabreh IJ, et al. Risk and treatment effect heterogeneity: re-analysis of individual participant data from 32 large clinical trials. Int J Epidemiol 2016; 45:2075.
- Haynes B, Haines A. Barriers and bridges to evidence based clinical practice. BMJ 1998; 317:273.
- Davis DA, Thomson MA, Oxman AD, Haynes RB. Changing physician performance. A systematic review of the effect of continuing medical education strategies. JAMA 1995; 274:700.
- FORMULATING A CLINICAL QUESTION
- Patient population
- FINDING THE EVIDENCE
- EBM resources
- Categories of evidence
- ASSESSING THE VALIDITY OF THE EVIDENCE
- Internal validity
- External validity
- - Indirect evidence
- - Subgroup analyses
- APPLYING THE EVIDENCE IN PRACTICE
- SUMMARY AND RECOMMENDATIONS