What Do We Need Standards For & What Can We Learn?

1. What Do We Need Standards For & What Can We Learn? A. Sonia Buist M.D. Oregon Health & Science University, Portland, Oregon, USA

2. Words….Words….Words • Standard of care • Quality of care • Guidelines • Disease management • Quality assurance • Quality improvement

4. First National Report Card on Quality of Health Care in America. “On average, patients receive 55% of recommended processes, including preventive care, acute care and care for chronic conditions.” RAND Elizabeth McGlynn, PhD

5. Aggressive vs Conservative Care, Medicare patients in US • Dartmouth Atlas of Health care study of seriously ill pts in ~3000 hospitals in US, 2001-2005 • In last 2 years of life, pts 65≥ yrs saw a Dr average of 109 times in LA, 88 x in Manhattan, 45x in Seattle • Pts in study were 65≥ yrs & treated for top 9 leading causes of death (including COPD) • Sizable variation in aggressiveness of treatment • “on average, aggressive hospitals do not have better outcomes & may be worse” www.consumerreportshealth.org June ‘08

6. Huge Variation in Cost of End-of-Life Treatment for Medicare Patients in US • Dartmouth Atlas of Health Care study of seriously ill pts in ~3000 hospitals in US, 2001-2005 • Total Medicare spending for last 2 years of life ranges from $93,842 (UCLA) to $53,432 (Mayo Clinic—all docs sallaried). JHU $85,729; MGH $78,729; Cleveland Clinic $55,333 • “Some chronically ill and dying Americans are receiving too much care—more than they & their families want or benefit from” JE Wennberg, Dartmouth Medical School • “Contrary to popular assumptions, it’s the volume of services, not the price per service, that account for most of the variation in Medicare spending” ibid Dartmouth Atlas of Health Care 2008

7. Why Do We Need Standards? • To reduce variation in management and outcomes • To reduce misdiagnosis • To reduce over-treatment • To reduce under-treatment • To provide optimal treatment

12. Why Standards? • In early 1890s Halsted developed radical mastectomy for breast cancer • Halsted procedure performed for >80 years without systematic evidence for success • Introduction of randomized controlled trials led to surprising finding that radical mastectomy no advantage over simpler operations (NEJM 1981) • Hierarchy of evidentiary rigor established

13. GOLD Workshop Report

14. Gap Between Evidence & Practice Grol & Grimshaw Lancet 2003; 363: 1225-30 • ~10,000 new RCTs are included in MEDLINE every year • Results from studies in US & Netherlands suggest that ~30-40% of patients do not receive care according to present scientific evidence • ~20-30% of care provided is not needed or is potentially harmful

15. The Science of Improvement Improved clinical evidence + Improved processof care = Improved quality of care

16. Why the Gap Between Evidence & Practice Grol & Grimshaw Lancet 2003; 363: 1225-30 • ~10,000 new RCTs are included in MEDLINE every year • Takes 15-20 years for implement of new knowledge • So our time frame has to be very LONG

17. Quality Movement Defects in the processes and outcomes of care documented including: • High rates of unscientific care • Inappropriate care • Geographic variations in practice • Latent disagreements among specialists • Often unrecognized medical injury to patients Berwick JAMA 2008: 299: 1182-4

18. Quality Movement • In 1999 & 2001, Institute of Medicine published 2 landmark reports on evidence of quality failure • Redesign of care systems called for to achieve improvements Kohn et al: To Err is Human: Building a Safe Health System. National Academies Press 1999 Hurtado et al: Crossing the Quality Chasm: a New Health Care System for the 21st Century. National Academies Press, 2001

19. Quality Chasm Crossing the Quality Chasm: A New Health System for the 21st Century. IOM 2001

20. Crossing the Quality Chasm: Six Aims for Improvement • Safe • Effective • Patient-centered • Timely • Efficient • Equitable Crossing the Quality Chasm: A New Health System for the 21st Century. IOM 2001

21. Crossing the Quality Chasm: Ten Rules for Redesign (1) • Care is based on continuous healing relationships • Care is customized according to patient needs & values • The patient is the source of control • Knowledge is shared & information flows freely • Decision making is evidence based • Safety is a system priority Crossing the Quality Chasm: A New Health System for the 21st Century. IOM 2001

22. Crossing the Quality Chasm: Ten Rules for Redesign (2) • Safety is a system priority • Transparency is necessary • Needs are anticipated • Waste is continuously decreased • Cooperation among clinicians is a priority Crossing the Quality Chasm: A New Health System for the 21st Century. IOM 2001

23. Crossing the Quality Chasm: Changing the Environment • Applying evidence to health care delivery • Using information technology • Aligning payment policies with quality improvement • Preparing the workforce Crossing the Quality Chasm: A New Health System for the 21st Century. IOM 2001

24. Challenges in Assessing Quality “Many of the things you can count, don’t count. Many of the things you can’t count, really count.” Einstein

27. Example of Use of Technology For each spontaneously reported medical error: • Chart review found 10 medical errors • Electronic “crawling” of medical records showed 100 medical errors Intermountain safety review in US

28. Who Needs to Be Included in Setting Standards of Care • Patient • Healthcare provider • Healthcare system • Society • Employer, school • Decision makers

29. Outcome-based privileging/credentialing Physician’s Dilemma Local guidelines and pathways CME Medical records Patients National guidelines Coding Risk management Informatics Formularies

30. >2000 guidelines www.guideline.gov

31. Types of Guideline Development Processes • Experts prepare without explicit decision rules • Experts prepare with formal consensus development process • Evidence-based approach-systematic & complete review of relevant literature: strength of recommendation linked to evidence • Explicit approach—the evidence used to document benefits, harms, & costs of treatment options are specified

32. ____________________     I

33. What Happened in the Smoke-Filled Rooms? • Group of “experts” got together • Reviewed the literature in un-standardized way • Wrote guidelines • Sent them for review to other “experts” • Disseminated the guidelines • Sat back satisfied • Usually had no long term plan (or budget) for regular updating

34. 1995-2008: 40++ Clinical Practice Guidelines for COPD including: • British Thoracic Society • UK National Institute for Clinical Excellence (NICE) • Canadian Thoracic Society • International Primary Care Group • Norwegian Institute of Pharmacotherapy • Polish Physiopneumonological Society • Societe de Pneumologie de Langue Francaise • Spanish Society of Pneumonology and Thoracic Surgery • Swiss Society of Pneumology • Thoracic Society of Australia and New Zealand • Global Initiative for Chronic Obstructive Lung Disease (GOLD) • ATS/ERS • American College of Physicians and American Society of Internal Medicine

35. GUIDELINE Development Process Literature review How? Which method? Guidelines developed External review. Who? Guidelines disseminated Mostly ignored Better pt outcomes Maybe?

36. What do Guidelines Change? “Most studies of the effect of practice guidelines have examined changes in physicians’ practices, not changes in patient outcomes” Peter Greco/John Eisenberg NEJM 1993;329:1271–73

37. How Guidelines are used by Physicians • Self-assessment of current practices • Aid to improving practices • Palm Pilot algorithms • Setting standards • Developing institutional guidelines • Raising awareness of a disease

38. Ways Guidelines are Used by Decision Makers • Setting standards • Allocation of resources • Developing institutional guidelines • Allocation of specialists/generalists • Raise awareness of a disease

39. Why is Adherence to Guidelines Poor? • Lack of perceived need • Aversion to “cookbook” medicine • Lack of awareness or familiarity with guidelines • Lack of confidence in developer • Suspicion that only purpose is cost control

40. Barriers to Implementing Guidelines • No sense of ownership (developed by a group of ‘experts’) • Disagree with recommendations (personal experience or weak scientific base) • Too complicated, not ‘user-friendly’ (eg, too much text, not enough tables/figures) • Too expensive or other practical barriers

41. Guidelines More Likely to be Followed When: • Easy to implement • Specific • Useful • Come from highly respected source • Strong science base for recommendations eg good RCTs

42. Feasibility of Using Guidelines in General Practice • Descriptive study of care in 14 practices (16 GPs) in The Netherlands, n=413 • GPs instructed in asthma/COPD guidelines and compliance assessed by patient report at 1 year • Compliance best for peak flow at every visit (98%), allergy test (78%), smoking advice (82%) • Lower compliance for spirometry (33%), checking MDI technique (38%) Jans et al Int J Qual in Health Care 1998;10:27

43. Quality of Obstructive Lung Disease Care for Adults in US • Telephone survey of adults in 12 communities representing US urban population: 20K + in starting sample • Medical record extraction for 2 yrs from 6,712 with ≥1 health care visit who agreed to do survey & at least 1 record was obtained • Quality indicators derived from RAND Quality Assessment Tools System • 2,394 care events among 260 asthma pts; 1,664 events among169 pts Mularski et al CHEST 2006; 130: 1844-50

44. Americans with Obstructive Lung Disease Received 55% of Appropriate Health Care 4058 EPISODES OF CARE Mularski RA et al. Chest 2006; 130(6):1844-1850.

45. Quality of Obstructive Lung Disease Care for Adults in US… Conclusion: “Americans with obstructive lung disease received only 55% of recommended care. The deficits and variability in the quality of care for obstructive lung disease present opportunities for quality improvement. Future endeavors should assess reasons for low adherence to recommend processes of care and access barriers in delivery of care” Mularski et al CHEST 2006; 130: 1844-50

46. Quality of Obstructive Lung Disease Care for Adults in US… Conclusion: …strategies to improve care may include: • Increasing the use of information technology • Increasing quality improvement and continuous assessment • Better chronic disease management • Improved care coordination • Establishing performance measures with active monitoring • Linking quality performance to reimbursement Mularski et al CHEST 2006; 130: 1844-50

47. Feasibility of Using Guidelines in General Practice Barriers to conforming to guidelines identified: • Time • Checking MDI technique, medication compliance is time consuming • GPs and patients unconvinced of need for long-term use of ICS in asthma • Spirometry not readily available Jans et al Int J Qual in Health Care 1998;10:27

48. Why is there a Move to Re-examine the Way Guidelines are Developed? • Development of high quality clinical practice guidelines is resource and time-intensive and requires dedication by guideline developers • Rigorous guideline development & updating methodology now exists

49. GRADE BMJ, 2004 Grades of Recommendation Assessment, Development and Evaluation

50. About GRADE • Began as informal working group in 2000 • Researchers/guideline developers with interest in guideline methodology from around the world • Aim: to develop a commonsystem for grading the quality of evidence and the strength of recommendations that is sensible and to explore the range of interventions and contexts for which it might be useful Grade Working Group. CMAJ 2003, BMJ 2004, BMC 2004, BMC 2005