Outcomes Research and Evidence Based Medicine

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Outcomes Research and Evidence Based Medicine

Clinical Fundamentals
Author Credentials 

Michael G. Stewart, MD, MPH
Professor and Chairman, Department of Otolaryngology – Head & Neck Surgery
Vice Dean
Weill Cornell Medical College
New York-Presbyterian Hospital
New York, NY

Module Summary

The assessment of outcomes after treatment has evolved over the past few decades, with new tools and techniques available for outcomes measurement. Also, there is an appropriately increased focus on the assessment of quality of life and outcomes from the perspective of the patient, after medical care. In addition, interest in standardization of best practices has driven the creation of care guidelines. In order to incorporate the best evidence from the published literature into care decisions, the concept of “evidence-based medicine” has emerged, with a set of standard definitions and tools for identifying, evaluating, and using the best evidence in the practice of medicine. 

Module Learning Objectives 

I.  Clinical outcomes assessment

  1. Define “health services research” and where “outcomes research” fits into that schema
  2. Define quality of life
    1. Explain the differences between patient-based outcomes and standard clinical outcome measures
  3. Summarize the findings of research on geographic variations in healthcare utilization
  4. Describe how quality of life and functional status are assessed
  5. List some commonly used Global Quality of Life instruments
  6. Recognize examples of validated patient-based outcomes instruments available in Otolaryngology
    1. Voice
    2. Hearing
    3. Rhinosinusitis
    4. Head and Neck
    5. Pediatric Otolaryngology
  7. Cite results from examples of prospective patient-based outcomes studies in Otolaryngology
    1. Chronic rhinosinusitis
    2. Nasal septoplasty
  8. Explain the role of patient-based outcome measures in measurement of cost-effectiveness
  9. Recognize the importance of cost-effectiveness in assessing treatment effectiveness
  10. Describe how administrative databases can be used for clinical outcomes research

II.  Evidence-based medicine

  1. Define “Evidence-Based Medicine”
    1. Understand the three components necessary to practice evidence-based medicine
  2. Describe the five steps of practicing evidence-based medicine
  3. Give examples of focused clinical questions
  4. Explain the rationale for systematically searching the published literature
  5. Describe how to perform a thorough literature search
  6. Understand how to grade the evidence based on research methodology
    1. Randomized better than non-randomized
    2. Controlled better than uncontrolled
    3. Prospective better than retrospective
    4. Individual papers are assigned a LEVEL of evidence based on methodology
    5. The overall evidence is given a GRADE based on the levels of individual studies
  7. Recognize how to interpret the results from the best studies
    1. Understand the difference between clinical and statistical significance
    2. Understand measures of clinical significance, such as the “number needed to treat” and the confidence interval
  8. Review how to synthesize the results from multiple studies into a single recommendation
  9. Recognize how to practice evidence-based medicine by integrating the results from the best evidence with personal expertise and the patient’s preferences

Review

Review Questions 
  1. How are quality of life and functional status measured in Otolaryngology?
  2. What are some validated patient-based outcomes tools that can be used in Otolaryngology?
  3. What are the three fundamental principles that must be integrated to practice evidence-based medicine?
  4. How are studies graded into different levels in evidence-based medicine?
  5. What is the difference between statistical significance and clinical significance?
References 

Articles:

  1. Piccirillo JF, Stewart MG, Gliklich RE, Yueh B.  Outcomes research primer.  Otolaryngol Head Neck Surg 1997;117:380-7.
  2. Stewart MG, Neely JG, Hartman JM, Wallace MS, Forsen JW Jr.  Tutorials in clinical research: part V: outcomes research.  Laryngoscope. 2002 Feb;112(2):248-54.
  3. Stewart MG, Neely JG, Paniello RC, Fraley PL, Karni RJ, Nussenbaum B.  A practical guide to understanding outcomes research.  Otolaryngol Head Neck Surg 2007;137:700-6.
  4. Rosenfeld RM, Shiffman RN.  Clinical practice guidelines: a manual for developing evidence-based guidelines to facilitate performance measurement and quality improvement.  Otolaryngol Head Neck Surg 2006:135(4 Suppl): S1-28.
  5. Liu JC, Stewart MG.  Teaching evidence-based medicine in otolaryngology.  Otolaryngol Clin North Am 2007;40(6):1261-74.
  6. Shin JJ, Randolph GW, Rauch SD.  Evidence-based medicine in otolaryngology, part 1: the multiple faces of evidence-based medicine.  Otolaryngol Head Neck Surg. 2010 May;142(5):637-46.
  7. Carroll TL, Lee SE, Lindsay R, Locandro D, Randolph GW, Shin JJ.  Evidence-Based Medicine in Otolaryngology, Part 6: Patient-Reported Outcomes in Clinical Practice.  Otolaryngol Head Neck Surg. 2018 Jan;158(1):8-15.

Textbooks

  1. Straus SE, Glasziou P, Richardson WS, Haynes RB. Evidence-Based Medicine.  How to practice and teach EBM.  4th edition. London: Churchill Livingstone; 2010. 
  2. Shin JJ, Hartnick CJ, Randolph GW.  Evidence-based Otolaryngology.  New York: Springer publishers; 2008. 
Resources 

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  1. Annual Meeting Webcasts (AMW):