John P. Holland, MD, MPH Past-President, ACOEM Chair, Guidelines Steering Committee

1. ACOEM Practice GuidelinesPerspectives on their use in guiding clinical care and utilization management John P. Holland, MD, MPHPast-President, ACOEMChair, Guidelines Steering Committee California Division of Workers’ Compensation12th Annual Educational Conference February 23 - 24, 2005 – Los AngelesFebruary 28 – March 1, 2005 – Oakland

2. Presentation Overview Overview and Current Issues • ACOEM perspective and why EBM matters • Use of evidence in developing APGs New Initiatives • APG Insights – newsletter • Utilization Management Tool (UMT) • Plans for the next generation of clinical practice guidelines

3. The ACOEM Perspective - and why evidence-based medicine is important

4. The ACOEM Perspective Our core mission - • Promote the health and productivity of workers, workplaces and the environment Our core values - • Use science to guide practice, programs and policy • Promote fairness for individuals, employers and society • Use processes that are inclusive, transparent and rationally consistent

5. What is evidence-based medicine (EBM)? “Evidence-based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients.” - David Sackett John P. Holland, MD, MPH

6. Evidence-based medicine Evidence-based Medicine Gathering medical information Evaluating quality of medical information Making medical decisions using best evidence John P. Holland, MD, MPH

7. Elements of EBM - identify relevant best evidence • Define clinical question to be answered (for a specific clinical situation) • Find best scientific evidence relevant to the specific clinical question (using systematic methods) • Rely on best evidence to guide clinical decision-making

8. Elements of EBM - identify relevant best evidence Original evidence • clinical epidemiology (e.g. clinical) trials • descriptive epidemiology • outcomes research / economic studies Literature synthesis / analysis • systematic literature reviews / meta-analyses • clinical practice guidelines • cost-effectiveness studies John P. Holland, MD, MPH

9. Elements of EBM - focus on clinical outcomes Clinical outcomes (things that matter to patients and families) • survival • impairment / disability / disfigurement • symptom severity • quality of life (QOL) • cost / convenience John P. Holland, MD, MPH

10. Elements of EBM - use standard measures of effect • Evaluate therapies using standard measures:How does it affect rate, degree or timing of: • Physical impairment, disfigurement or death • Return to normal functioning • Symptom resolution • Potential harms (from therapy) • Total costs (for patient, employer and society) • Allows comparisons of benefits and harms of different clinical methods John P. Holland, MD, MPH

11. Elements of EBM - assess likely benefits / harms • Evaluate clinical methods on benefits / harms • Beneficial • Likely to be beneficial • Trade off between benefits and harms • Unknown effectiveness • Unlikely to be beneficial • Likely to be ineffective or harmful • Promotes informed decision-making by clinicians and patients John P. Holland, MD, MPH

12. Elements of EBM - base decisions on best evidence • Find best scientific evidence that is applicable to the specific clinical situation • individual patient’s clinical situation • program or policy decision • Use evidence to guide decision-making • does the likelihood of benefit outweigh likelihood of harm enough to justify the cost? • same question applies to individual and society

13. EBM is important because - provides a science-based method for • Improving physician practice • increase effectiveness / decrease harms (better clinical outcomes / cost-effectiveness) • Increasing consumer knowledge • understand potential benefits / harms • Building quality into healthcare systems • using practice guidelines, quality indicators • Guiding government / employer policies • guide programs / policies on healthcare John P. Holland, MD, MPH

14. Use of Evidence in Developing the ACOEM Clinical Practice Guidelines (APGs)

15. What are clinical practice guidelines? Clinical practice guidelines are recommendations for clinicians and consumers about optimal and appropriate care for specific clinical situations

16. Formal or informal guidelines are the basis for all clinical practice • Basis for most clinical decisions • Foundation of clinical teaching • Mental short-cuts and memory aids for common or complex problems • Primary method to evaluate care patterns and monitor standards of care

17. Types of guidelines - major focus • clinical assessment / treatment • management of cardiac arrest (ACLS) • risk assessment / prevention • drugs to use in pregnancy (ACOG) • administrative • insurance pre-approval for surgery

18. When are guidelines needed ? • Institute of Medicine (IOM) criteria – clinical practice guidelines are useful when: • the problem is common or expensive • there is great variation in practice patterns • there is enough scientific evidence to determine appropriate and optimal care (IOM , 1992)

19. Types of guideline development approaches • Single author - expert opinion • Single author - systematic literature review • Consensus panel using expert opinion only • Consensus panel using evidenced-based approach (AHCPR methodology)

20. Steps in developing guideline recommendations • define clinical questions of interest • develop summary of evidence on: • clinical efficacy (potential benefits) • potential harms / projected costs • weigh likelihood of benefit versus likelihood of harms, and consider costs • develop finding / recommendation statements • document all aspects of the process

21. Evidence-based guidelines - need to explicitly document • methodology and assumptions • evidence reviewed • summary of findings • decision-making rules for recommendations • rationale for each conclusion and recommendation statement

22. Types of guideline statements Based on AHCPR guidelines, the types of guideline statements are: • Recommendation for use • Option for use • Recommendation against use

23. Strength of evidence ratings for guideline recommendations • A = Strong research based evidence • multiple relevant, high quality studies • B = Moderate research based evidence • one relevant, high quality study • C = Limited research based evidence • one adequate study, somewhat relevant • D = Panel opinion • based on information not meeting criteria for A-C

24. Criteria for determining is a study contains “High quality” evidence • Clinical epidemiology is the study of the effectiveness of clinical assessment and treatment methods • There is general consensus among experts on what constitutes a high quality study – but specific criteria vary on subtle details • APGs relied on criteria for determining high quality studies used by the AHCPR low back guideline and Cochrane ReviewsACOEM Practice Guidelines, 2nd Ed., page 501)

25. ACOEM New Directions - APG Insights

26. APG Insights - newsletter • Newsletter devoted to discussing issues relevant to use of the ACOEM Practice Guidelines (APGs) • Separate editorial board • Anticipate about 6 issues per year • First issue was in fall of 2004, next issue in March 2005 • For information go to acoem.org

27. APG Insights - purpose APG Insights will • Provide suggestions and examples on how APGs can be used in clinical care / utilization management • Provide summaries of scientific evidence (systematic reviews) on clinical topics relevant to the APGs APG Insights will not • Explain or justify how APG were developed (APGs must speak for themselves) • Be a revision or update of the guideline (no presumption of correctness in California)

28. APG Insights – Fall 2004- APG guidance on chronic conditions • States “Unequivocally” that APGs do apply to conditions after 90 days (chronic conditions) • APGs - “Mostly focus on the first 90 days following workplace injury because approximately 90% of injuries are resolved during this time period.” • Chapters 1-7 of APGs give general approach for assessment and treatment of injured workers - “These basic components remain constant throughout the life of the claim” • Chapter 6 deals extensively with chronic pain (generally defined as pain lasting over 3-6 months)

29. ACOEM New Directions - Utilization Management Tool (UMT)

30. Utilization Management Tool Purpose of UMT is to provide • Accurate interpretation of APG recommendations claims staff can rely upon in making decisions • Consistent interpretations to reconcile perceived inconsistencies within APG • Easy to use tool to foster efficient and consistentutilization management based on APG • Create written summaryof relevant APG guidance relied upon in making claim decision (based on UMT)

31. ACOEM New Directions - Next Generation of Clinical Practice Guidelines

32. Next Generation of Clinical Practice Guidelines • ACOEM is committed to moving to the “next level” in working to develop a new generation of clinical practice guidelines • We continue to learn about how guidelines are best used in WC settings • We are committed to increasing scientific rigor, documentation and usefulness in future guideline development efforts • In our work on developing a new generation of practice guidelines – we are committed to following our core mission and core values in these efforts

33. The ACOEM Perspective Our core mission - • Promote the health and productivity of workers, workplaces and the environment Our core values - • Use science to guide practice, programs and policy • Promote fairness for individuals, employers and society • Use processes that are inclusive, transparent and rationally consistent

34. ReferencesEvidence-based medicine and practice guidelines

35. References – Evidence-based medicine and practice guidelines Book chapters and journal articles • American College of Occupational and Environmental Medicine (2004). ACOEM Clinical Practice Guidelines, 2nd Edition. Glass L (Ed.). (Beverly Farms, MA; OEM Press). • Bigos SJ, et. al. (1994) U.S. Agency for Health Care Policy and Research (AHCPR) Clinical Practice Guideline #14: Acute low back problems in adults.Pub. 95-0642 (U.S. Department of Health and Human Services, Public Health Service, Rockville, MD). • Holland JP. (1995) Developing evidence-based clinical practice guidelines.Current Opinion in Orthopedics. 6: 63-69.

36. References – Evidence-based medicine and practice guidelines Book chapters and journal articles (continued) • Holland JP, Holland CL, Webster JS, Bigos SJ. (2003) How to critically evaluate the literature on low back problems: The foundation for an evidence-based approach to care.Seminars in Spine Surgery. 15: 54-67. • Institute of Medicine, Committee on Clinical Practice Guidelines. (1992) Guidelines for Clinical Practice: From Development to Use. Field M, Lohr K (Eds). (Washington, DC; National Academy Press). • Sackett D, Haynes R, Guyatt G, et al. (1991). Clinical Epidemiology: A Basic Science for Clinical Medicine, 2nd Edition. (Boston, MA; Little, Brown).

37. References – Evidence-based medicine and practice guidelines Book chapters and journal articles (continued) • Sackett D, Straus S, Richardson W, et al. (2000). Evidence-based Medicine: How to Practice and Teach EBM. (New York, NY; Churchill Livingstone). Websites • www.acoem.org - ACOEM’s website. For information on APG Insights, a newsletter on issues relevant to the ACOEM Clinical Practice Guidelines. • www.cochrane.org - The Cochrane Collaboration website; a source for systematic reviews on medical intervention