- Arthur T Evans, MD, MPH
Arthur T Evans, MD, MPH
- Professor of Medicine
- Weill Cornell Medical College
- 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.
- 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