JAMA Facial Plastic Surgery: Evidence-Based Medicine and Level

JAMA Facial Plastic Surgery: Evidence-Based Medicine and Level

JAMA Facial Plastic Surgery: Evidence-Based Medicine and Level of Evidence Primer John S. Rhee, MD, MPH Wayne F. Larrabee, Jr, MD JAMA Facial Plastic Surgery jamanetwork.com JAMA Facial Plastic Surgery 1 What Is EvidenceBased Medicine? Evidence-Based Medicine and Level of Evidence Primer 2013 American Medical Association. All rights reserved. February 7, 2020

Slide 2 jamanetwork.com JAMA Facial Plastic Surgery What Is Evidence-Based Medicine? The conscientious, explicit and judicious use of the current best evidence in making decisions about the care of individual patients. Sackett et al1 Integration of 3 critical elements Best research evidence Clinical expertise Patient values Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isnt. BMJ. 1996;312(7023):71-72. 1 Evidence-Based Medicine and Level of Evidence Primer 2013 American Medical Association. All rights reserved.

February 7, 2020 Slide 3 jamanetwork.com JAMA Facial Plastic Surgery What Is Evidence-Based Medicine? Evidence-Based Medicine and Level of Evidence Primer 2013 American Medical Association. All rights reserved. February 7, 2020 Slide 4 jamanetwork.com JAMA Facial Plastic Surgery

What Evidence-Based Medicine Is Not EBM is not old hat Everyone is doing it already EBM is not impossible to practice EBM is not cookbook medicine EBM is not cost-cutting medicine EBM is not restricted to randomized controlled trials (RCTs) and meta-analyses Evidence-Based Medicine and Level of Evidence Primer 2013 American Medical Association. All rights reserved. February 7, 2020 Slide 5 jamanetwork.com JAMA Facial Plastic Surgery

Case Example Dr Nash has been in practice for 10 years. He sees a 60-year-old woman in his office who would be a good candidate for a face-lift. Patient asks about new medicine X that may decrease postsurgical bruising. He is unsure if he should recommend the use of this medication. Evidence-Based Medicine and Level of Evidence Primer 2013 American Medical Association. All rights reserved. February 7, 2020 Slide 6 jamanetwork.com JAMA Facial Plastic Surgery The MEDLINE Search MeSH, Google? rhytidectomy, new medicine X, aging face, ???

Limiting the search Randomized clinical trial (RCT)? Meta-analyses? Cochrane review? Level of evidence Best level is 4? Best level is 2? Evidence-Based Medicine and Level of Evidence Primer 2013 American Medical Association. All rights reserved. February 7, 2020 Slide 7 jamanetwork.com JAMA Facial Plastic Surgery Level of Evidence Table 1

Properly powered and conducted RCT, systematic review or meta-analysis of RCTs 2 Well-designed controlled trial without randomization; prospective comparative cohort trial 3 Case-control studies; retrospective cohort study 4 Case series with or without intervention; cross-sectional study 5 Opinion of respected authorities; case reports Adapted from Oxford Centre for Evidence Based Medicine. http://www.cebm.net/index.aspx?o=1001.

Evidence-Based Medicine and Level of Evidence Primer 2013 American Medical Association. All rights reserved. February 7, 2020 Slide 8 jamanetwork.com JAMA Facial Plastic Surgery Level of evidence plays a role in just 1 circle (current best evidence) in the EBM picture Evidence-Based Medicine and Level of Evidence Primer 2013 American Medical Association. All rights reserved. February 7, 2020 Slide 9 jamanetwork.com

JAMA Facial Plastic Surgery How to Critique an Original Study: Going Beyond Level of Evidence Are the results valid? Patient dropout rate Length of follow-up Patient cohort makeup What are the results? How large was the treatment effect? How precise was the estimate of the effect? How was the effect measured? Are the results applicable to my patients? Study patients similar to my patients? Outcome measures clinically relevant? Are my surgical skills and techniques similar to those of the study surgeons? Evidence-Based Medicine and Level of Evidence Primer

2013 American Medical Association. All rights reserved. February 7, 2020 Slide 10 jamanetwork.com JAMA Facial Plastic Surgery Incorporate All 3 Elements of EBM Evidence-Based Medicine and Level of Evidence Primer 2013 American Medical Association. All rights reserved. February 7, 2020 Slide 11 jamanetwork.com JAMA Facial Plastic Surgery Case Example (Reprise) Dr Nash integrates the 3 elements of evidence-based medicine to decide what to do for this patient Literature review and best evidence level

Best available evidence is 2, no RCTs Predominantly level 4 evidence supporting efficacy of this medication Clinical expertise Comfortable with own surgical procedure and past outcomes without new medication X Surgical cohort in study was predominantly male with different surgical technique, so results may not be applicable for his patient Patient values Patient is aware of surgeon experience with procedure and made aware of current level of evidence and accepts recommendations of surgeon not to use new

medication X Evidence-Based Medicine and Level of Evidence Primer 2013 American Medical Association. All rights reserved. February 7, 2020 Slide 12 jamanetwork.com JAMA Facial Plastic Surgery 2 Facing Levels of Evidence The JAMA Facial Plastic Surgery Initiative Evidence-Based Medicine and Level of Evidence Primer 2013 American Medical Association. All rights reserved. February 7, 2020 Slide 13 jamanetwork.com

JAMA Facial Plastic Surgery Levels of Evidence Designation Only applicable to clinical, therapeutic (disease treatment) studies Examples include any treatment or interventions in which outcomes are provided Nonratable articles include (but are not limited to) narrative reviews, editorials, videos, and studies that are basic science, nonhuman-based, diagnostic, and cadaver/anatomy and survey/questionnaire based Evidence-Based Medicine and Level of Evidence Primer 2013 American Medical Association. All rights reserved. February 7, 2020 Slide 14 jamanetwork.com JAMA Facial Plastic Surgery Building Blocks of Evidence-Based Practice Evidence-Based

Evidence-Based Medicine Medicine and andLevel Levelof ofEvidence Evidence Primer Primer 2013 American Medical Association. All rights reserved. Slide 15 15 February February7,7,2020 2020 Slide jamanetwork.com JAMA Facial Plastic Surgery Level of Evidence Table

1 Properly powered and conducted RCT, systematic review or meta-analysis of RCTs 2 Well-designed controlled trial without randomization; prospective comparative cohort trial 3 Case-control studies; retrospective cohort study 4 Case series with or without intervention; cross-sectional study 5 Opinion of respected authorities; case reports

Adapted from Oxford Centre for Evidence Based Medicine. http://www.cebm.net/index.aspx?o=1001. Evidence-Based Medicine and Level of Evidence Primer 2013 American Medical Association. All rights reserved. February 7, 2020 Slide 16 jamanetwork.com JAMA Facial Plastic Surgery Study Designs Study Designs Observational Descriptive Case Report Case Series Cross-Sectional

Experimental Analytic Case-Control Evidence-Based Medicine and Level of Evidence Primer 2013 American Medical Association. All rights reserved. Cohort Study vs Prospective Meta-analysis Clinical Trial Randomized Controlled Trial Nonrandomized Clinical Trial

February 7, 2020 Slide 17 jamanetwork.com JAMA Facial Plastic Surgery Descriptive Studies Observational, nonanalytic Describe patterns of distribution of disease Person, place, time Quick, easy, inexpensive Help in formulation of hypotheses Evidence-Based Medicine and Level of Evidence Primer 2013 American Medical Association. All rights reserved. February 7, 2020 Slide 18 jamanetwork.com JAMA Facial Plastic Surgery

Case Report Level of Evidence: 5 Observational, descriptive Detailed report of an unusual observed characteristic of a single patient Advantages Inexpensive May lead to formulation of hypothesis Disadvantages Based on experience of 1 patient Evidence-Based Medicine and Level of Evidence Primer 2013 American Medical Association. All rights reserved. February 7, 2020 Slide 19 jamanetwork.com JAMA Facial Plastic Surgery Case Series Level of Evidence: 4 Observational, descriptive

Characteristics observed in group of patients Advantages Inexpensive Useful in formulation of hypothesis Disadvantages No control group Bias related to subject or characteristic selection Evidence-Based Medicine and Level of Evidence Primer 2013 American Medical Association. All rights reserved. February 7, 2020 Slide 20 jamanetwork.com JAMA Facial Plastic Surgery Cross-Sectional Studies Level of Evidence: 4 Observational, descriptive Data on individual patients at 1 point in time Exposure and disease measured simultaneously

Prevalence of disease and exposure can be calculated Useful for formulation of hypothesis about presence of association between exposure and disease Evidence-Based Medicine and Level of Evidence Primer 2013 American Medical Association. All rights reserved. February 7, 2020 Slide 21 jamanetwork.com JAMA Facial Plastic Surgery Cross-Sectional Studies Level of Evidence: 4 Advantages Inexpensive Best design for studying the status quo of disease or condition Disadvantages Provide only a snapshot in time The chicken or the egg dilemma

Difficult to choose control or comparison group Evidence-Based Medicine and Level of Evidence Primer 2013 American Medical Association. All rights reserved. February 7, 2020 Slide 22 jamanetwork.com JAMA Facial Plastic Surgery Study Designs Study Designs Observational Descriptive Case Report Case Series Cross-Sectional

Experimental Analytic Case-Control Evidence-Based Medicine and Level of Evidence Primer 2013 American Medical Association. All rights reserved. Cohort Study vs Prospective Meta-analysis Clinical Trial Randomized Controlled Trial Nonrandomized Clinical Trial

February 7, 2020 Slide 23 jamanetwork.com JAMA Facial Plastic Surgery Analytic Studies: Observational or Experimental Provide information about determinants of disease by testing hypotheses Observational analytic studies Investigator simply observes Experimental analytic studies Investigator allocates exposure Evidence-Based Medicine and Level of Evidence Primer 2013 American Medical Association. All rights reserved. February 7, 2020 Slide 24 jamanetwork.com JAMA Facial Plastic Surgery

Case-Control Studies Level of Evidence: 3 Observational, analytic Cases matched with controls Cases = those with disease/outcome of interest Control = comparative group without disease Past exposure is determined Proportions with the exposure within each group are compared Evidence-Based Medicine and Level of Evidence Primer 2013 American Medical Association. All rights reserved. February 7, 2020 Slide 25 jamanetwork.com JAMA Facial Plastic Surgery Case-Control Studies Level of Evidence: 3 Advantages

Quick and least expensive of analytic designs Efficient for rare diseases with long latent periods Disadvantages Control group selection difficult Disease incidence rates and relative risks cannot be calculated Temporal relationship between exposure and disease is sometimes difficult to establish Prone to selection and recall bias Evidence-Based Medicine and Level of Evidence Primer 2013 American Medical Association. All rights reserved. February 7, 2020 Slide 26 jamanetwork.com JAMA Facial Plastic Surgery Prospective Cohort Studies Level of Evidence: 2 Observational, analytic Participants are free of disease/outcome of interest at onset of study

Participants selected on exposure/risk factor under study Exposed group (treatment group) vs unexposed group Participants followed over period of time to assess occurrence of disease or outcome Formulation of incidence rates and relative risk Evidence-Based Medicine and Level of Evidence Primer 2013 American Medical Association. All rights reserved. February 7, 2020 Slide 27 jamanetwork.com JAMA Facial Plastic Surgery Prospective Cohort Studies Level of Evidence: 2 Advantages Establishment of temporal relationship between exposure (treatment) and disease Assessment of multiple effects of a single exposure (treatment) Calculation of incidence rates and relative risk

Selection bias can be controlled or minimized Disadvantages Very time-consuming and expensive Inefficient for rare diseases Dropout rate can affect validity of results An association but not necessarily causation between exposure (treatment) and disease can be made Evidence-Based Medicine and Level of Evidence Primer 2013 American Medical Association. All rights reserved. February 7, 2020 Slide 28 jamanetwork.com JAMA Facial Plastic Surgery Study Designs Study Designs Observational

Descriptive Case Report Case Series Cross-Sectional Experimental Analytic Case-Control Evidence-Based Medicine and Level of Evidence Primer 2013 American Medical Association. All rights reserved. Cohort Study vs Prospective Meta-analysis Clinical Trial

Randomized Controlled Trial Nonrandomized Clinical Trial February 7, 2020 Slide 29 jamanetwork.com JAMA Facial Plastic Surgery Therapeutic Experimental Studies Randomized or nonrandomized Analytic studies Commonly called clinical trials Exposure/intervention is controlled or allocated by investigator Experimental group vs control group

Participants screened for eligibility Evidence-Based Medicine and Level of Evidence Primer 2013 American Medical Association. All rights reserved. February 7, 2020 Slide 30 jamanetwork.com JAMA Facial Plastic Surgery Nonrandomized Clinical Trials Level of Evidence: 2 Comparison group is historical Historical controls Can lead to bias in analysis Weaker study design due to bias in patient assignment Evidence-Based Medicine and Level of Evidence Primer 2013 American Medical Association. All rights reserved. February 7, 2020 Slide 31

jamanetwork.com JAMA Facial Plastic Surgery Randomized Clinical Trials Level of Evidence: 1 Gold standard in study designs Randomized assignment to either experimental or control group Removes potential selection bias Potential for bias is prevented by blinding the participant to the intervention Double-blinded = when both investigator and participant are blinded to the intervention Evidence-Based Medicine and Level of Evidence Primer 2013 American Medical Association. All rights reserved. February 7, 2020 Slide 32 jamanetwork.com JAMA Facial Plastic Surgery

Randomized Clinical Trials Level of Evidence: 1 Advantages Provide strongest evidence for determining causation Least number of problems or biases Best design to assess efficacy of a treatment or procedure Disadvantages Very expensive and time-consuming Inefficient if effect of treatment is small Criteria for measuring outcome may be controversial Ethical issues Evidence-Based Medicine and Level of Evidence Primer 2013 American Medical Association. All rights reserved. February 7, 2020 Slide 33 jamanetwork.com

JAMA Facial Plastic Surgery Meta-analysis Studies Level of Evidence: 1 Results from published studies combined to provide overall conclusion Ideally comprised of RCTs only Smaller samplesized studies that do not achieve statistical significance are combined Studies need to be similar with respect to disease and exposure/intervention Evidence-Based Medicine and Level of Evidence Primer 2013 American Medical Association. All rights reserved. February 7, 2020 Slide 34 jamanetwork.com JAMA Facial Plastic Surgery Meta-analysis Studies Level of Evidence: 1 Advantages

Provide a reliable estimate of most likely effect of an exposure/intervention Useful for planning future trial with adequate power Disadvantages Carry risk of several biases Meta-analysis of observational studies especially suspect Too much bias and too many confounding variables Evidence-Based Medicine and Level of Evidence Primer 2013 American Medical Association. All rights reserved. February 7, 2020 Slide 35 jamanetwork.com JAMA Facial Plastic Surgery Systematic Reviews Level of Evidence: Variable A thorough and systematic review of the literature targeted by a specific

research question Methods and results should be reproducible and transparent to all May assign levels of evidence to existing studies Identify knowledge gaps and point to needed areas of investigation Dependent on level of evidence of primary literature Evidence-Based Medicine and Level of Evidence Primer 2013 American Medical Association. All rights reserved. February 7, 2020 Slide 36 jamanetwork.com JAMA Facial Plastic Surgery Meta-analysis Systematic Review Systematic Review Meta-analysis Evidence-Based Medicine and Level of Evidence Primer 2013 American Medical Association. All rights reserved.

February 7, 2020 Slide 37 jamanetwork.com JAMA Facial Plastic Surgery: Evidence-Based Medicine and Level of Evidence Primer John S. Rhee, MD, MPH Wayne F. Larrabee, Jr, MD JAMA Facial Plastic Surgery jamanetwork.com

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