Evidence-based Practice

Transcription

1 Evidence-based Practice Michael V. Burke, EdD Assistant Professor of Medicine Treatment Program Coordinator Mayo Clinic Nicotine Dependence Center March, 2013

2 Learning objectives At the end of this presentation you will be able to Identify and access research and resources 4 primary sources Define evidence-based practice Help patients to distinguish effective treatment Keep current with tobacco dependence treatment resources

3 Tobacco Treatment Specialists Practice evidence based medicine Provide a clear message identifying proven and effective tobacco dependence treatment Can knowledgeably discuss the evidence supporting treatment

4 People who are struggling with tobacco dependence are bombarded with bogus, misleading, and ineffective alternatives and sham treatments

5 Stop smoking with hypnosis No medicine, the only way

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8 Tobacco Industry 'Safe cigarette' claimed to cut cancer by 90%

9 Resources to learn about alternative products Quitting and Reducing Tobacco Use Inventory of Products FDA

10 Evidence Based Practice Current, best research evidence Clinical expertise Patient values Sackett D, 2002

11 Recommended sources 1. Surgeon General reports on Tobacco 2. Best Practices Comprehensive Tobacco Control (CDC) and Framework Convention on Tobacco Control (WHO) 3. Cochrane Reviews 4. USPHS Clinic Practice Guideline

12 Scientific Evidence Clinical experience Basic laboratory research Observational studies Randomized Control Trial (RCT) Meta-analysis and systematic reviews

13 Recommended sources 1. Surgeon General reports on Tobacco 2. Best Practices Comprehensive Tobacco Control (CDC) and Framework Convention on Tobacco Control (WHO) 3. Cochrane Reviews 4. USPHS Clinic Practice Guideline

14 First Surgeon General Report The question about cause and effect

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16 Association is not causation

17 Number of cigarettes per capita Age adjusted lung cancer death rates per 100, U.S. Per Capita Cigarette Consumption and Age Adjusted Lung Cancer Death Rate per 100, Year NCHS Vital Statistics; death rates are age-adjusted to 2000 US standard population

18 1964 Surgeon General Report Strength and association Consistency Specificity Temporality Biological gradient Biological plausibility Experimental evidence

19 Most Recent Surgeon General Reports The Health Consequences of Smoking 2004 The Health Consequences of Involuntary Exposure to Tobacco Smoke 2006 The Debate is Over How Tobacco Smoke Causes Disease: The Biology and Behavioral Basis for Smoking- Attributable Disease 2010

20 Recommended sources 1. Surgeon General reports on Tobacco 2. Best Practices Comprehensive Tobacco Control And Framework Convention on Tobacco Control (WHO) 3. Cochrane Reviews 4. USPHS Clinic Practice Guideline

21 What works for community interventions Best Practices Comprehensive Tobacco Control (CDC) MPOWER (WHO FCTC)

22 Best Practices for Comprehensive Tobacco Control Programs State and community interventions What should state plans include Health communication interventions Cessation interventions Surveillance and evaluation Administration and management

23 MPOWER Monitor tobacco use and prevention policies Protect people from tobacco smoke Offer help to quit tobacco use Warn about the dangers of tobacco Enforce bans on tobacco advertising, promotion and sponsorship Raise taxes on tobacco

24 Recommended sources 1. Surgeon General reports on Tobacco 2. Best Practices Comprehensive Tobacco Control (CDC) and Framework Convention on Tobacco Control (WHO) 3. Cochrane Reviews 4. USPHS Clinic Practice Guideline

25 Systematic Reviews and Meta-analysis Greenhalgh, T:BMJ 315: , 1997

26 Systematic reviews State objectives and search literature Assess study quality Assemble data and analyze May use meta-analysis Prepare a critical summary

27 Characteristics of a good study Randomization Blinding Placebo Size of study Complete follow-up Intention to treat analysis Biochemical validation

28 Three study comparison Please read parts of the three studies Alhatem and Black - Read first page Nohlert et. Al. Read Abstract, Methods, results, Figure 1 and Table 3 Jorenby et. Al. Read Abstract and pages 57, 58 Table 1 and Figure 3

29 Study Alhatem & Black Nohlert et al Jorenby et al Randomization Blinding Placebo Size Follow-up and ITT Biochemical validation

30 Cochrane reviews provide a comprehensive resource Complementary medicine Acupuncture, hypnosis, exercise, silver acetate Medications NRT, anti-depressants, nicotinic receptor agonists, cannabinoid receptors Behavioral interventions Self-help, individual counseling, group counseling, partner support, competitions, aversive smoking, relapse prevention Health care provider interventions Brief visit Telephone counseling Workplace interventions Community interventions

31 Cochrane Reviews available at.

32 Recommended sources 1. Surgeon General reports on Tobacco 2. Best Practices Comprehensive Tobacco Control (CDC) and Framework Convention on Tobacco Control (WHO) 3. Cochrane Reviews 4. USPHS Clinic Practice Guideline

33 USPHS Clinical Practice Guideline

34 Clinical Practice Guideline: Treating Tobacco Use and Dependence Update History: 1996: Initial Guideline; reviewed 3,000 articles 2000: Revised Guideline another 3,000 articles 2008: Updated Guideline; another 2,700 articles Meta-analysis Select appropriate trials, combine to increase reliability and power

35 Clinical practice guidelines statistics Odds Ratio (O.R.) Confidence Interval (C.I.)

36 Calculating Odds Ratio Group Total n n Abstinent Active Placebo Group Ratio abstinent Odds abstinent Odds ratio Active 25 abstinent 75 not abstinent Placebo 10 abstinent 90 not abstinent.111

37 Odds ratio and confidence interval Medication Number of arms Estimated odds ratio (95% confidence) Estimated abstinence rate (95% confidence) Placebo Nicotine patch (6-14 weeks) ( ) 23.4 ( ) High dose patch (> 25 mg.) ( ) 26.5 ( ) Patch + ad-lib gum or spray ( ) 36.5 ( ) Varenicline (2 mg/day) ( ) 33.2 ( ) Fiore MC, Bailey WC, Cohen SJ. (U.S. Department of Health and Human Services. Public Health Service). Treating Tobacco Use and Dependence May.

38 USPHS Guidelines 10 Recommendations 1. Tobacco dependence is a chronic disease 1. requires repeated intervention 2. multiple attempts to quit. 2. Systems should identify and treat all tobacco users. 3. Tobacco dependence treatments are effective. Every patient willing should use counseling and medications. 4. Brief tobacco dependence treatment works.

39 USPHS Guidelines 10 Recommendations 5. Individual, group, and telephone counseling are all effective. 6. All patients should be encouraged to use medications unless contraindicated. 7. Counseling and medication are effective alone and more in combination.

40 USPHS Guidelines 10 Recommendations 8. Telephone quitline counseling is effective. 9. If a tobacco user currently is unwilling to make a quit attempt, use motivational treatments. 10.Tobacco dependence treatments are both clinically effective and highly cost-effective. 1. Insurers and purchasers should ensure that all insurance plans include counseling and medication as covered benefits.

41 Making the case for treating tobacco dependence

42 Rationale for coverage Smoking is the leading preventable cause of death in the US (1,2) Smokers who quit will, on average, live longer and have fewer years living with disability (3, 4) In 1999, each adult smoker cost employers $1,760 in lost productivity and $1,623 in excess medical expenditures (5) Tobacco treatment counseling is one of the top priorities among recommended preventive services (6,7)

43 Rationale for coverage There is a dose response relationship between treatment intensity, treatment effectiveness, and cost effectiveness (1) Cost sharing for preventive care reduces utilization (8,9,10,11) Cost sharing for prescription drugs and nicotine replacement medications can reduce utilization and negatively impact treatment outcomes (9, 12,13)

44 Provide coverage for evidence-based treatment As recommended by the Public Health Service Medication Over the counter Prescription In combination and as needed Counseling Group, individual, phone Eliminate or minimize co-pays or deductibles even small copayments reduce utilization 2013 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL 2011 RIGHTS MFMER RESERVED

45 2013 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL 2011 RIGHTS MFMER RESERVED

46 Comparably very cost effective Therapy Patient Cost per yrs of life saved Physician counseling and medication smoking cessation B-blocker Intensive glucose control Tobacco dependent $1,300-$3,900 Post MI High risk $ 3,600 Low risk $ 20,200 Diabetes Newly diagnosed type 2 $ 35,300 Lovastatin CABG Cholesterol > 300 mg/dl Men aged with no other risk factors Two-vessel CAD, severe angina $ 78,300 $ 42,500 Probstfield, 2003

47 Summary Evidence Based Practice should be utilized to deliver most effective methods of treatment. Four reliable sources for evidence based information. Responsibility of TTS to remain current with new information and be able to assess validity of studies and treatment program outcomes. The evidence supports that treating tobacco dependence is effective and highly costeffective

48 References See attached

49 The Debate is Over The Health Consequences of Involuntary Exposure to Tobacco Smoke

50 Tobacco Smoke Constituents Arsenic Benzene Benzo[a]pyrene Cadmium Chromium VI Cresol Formaldehyde Lead Nitrosamines Phenol Polonium 210 Polycyclic aromatic hydrocarbons Vinyl chloride

51 Group A Carcinogens Arsenic Asbestos Benzene Environmental tobacco smoke Radon Vinyl chloride

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53 Environmental Tobacco Smoke Background 1964 U.S. Surgeon General Report Smoking and Health 1986 U.S. Surgeon General Report The Health Consequences of Involuntary Smoking 1993 U.S. EPA Respiratory Health Effects of Passive Smoking: Lung Cancer and Other Disorders OSHA began rule making process which was blocked by the tobacco industry. There is no OSHA standard for secondhand smoke 2005 California EPA Health Effects of Exposure to Environmental Tobacco Smoke

54 California EPA Report on ETS 2005 Excess Morbidity and Mortality in USA Pregnancy Low birth weight infants Pre Term Delivery Children 24,500 71,900 Asthma Episodes 202,300 Lower Respiratory Illness 150, ,000 Otitis Media Office Visits 790,000 SIDS 430 Adults Cardiac Deaths 46,000 (22,700-69,600) Lung Cancer Deaths 3,400

55 Standardized mortality rate for lung cancer/100,000 Lung Cancer Mortality and Smoking Nonsmoker wives of non-smoker husbands 8.70 Non-smoker wives of husbands with smoking habits Women with smoking habits Cigarette smokers Total 108, ,895 69,645 17,366 Population at enrollment Hirayama T. BMJ 282:183, 1981 CP

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57 Dr. Adlkofer who is the Scientific Director of the German Verbandt, has committed himself to the position that Lee and Hirayama are correct They believe Hirayama is a good scientist and that his nonsmoking wives publication was correct. He replied with a strong statement that Hirayama was correct, that the TI knew it and that the TI published its statement about Hirayama knowing that the work was correct.

58 ETS and Coronary Heart Disease 4729 men age followed for 20 years Baseline tobacco use status and serum cotinine Nonsmokers classified as light ETS exposure ( 0.7 ng/ml) or heavy ETS exposure ( ng/ml) Risk of CHD among heavy ETS exposure similar to light smokers (1-9 cpd) Whincup PH, et al. BMJ, doi: /bmj (published 30 June 2004)

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60 probably the single most important challenge we currently face. This will have a very direct and major impact on consumption -- an impact which will be as bad as, or worse than, excise tax increases.

61 We have been referring to our initial approach as sand in the gears. Our objective was to slow down the ETS risk assessment until we could get broader policy declarations out of the Administration. To be honest, we made every effort to prevent the Risk Assessment.

62 Science for Hire Global ETS consultant program intended to influence public opinion on secondhand smoke Program run by U.S. lawyers because they have expertise in both scientific and public affairs arenas. Consultants wrote articles and books for scientific and lay press, presented at conferences, lobbied political figures, testified before legislative bodies Hurt RD, et al. Nicotine Tob Res 5: , 2003

63 We do know that choice and accommodation with regard to smoking are two powerful and positive positions. And, our spokesmen cannot utter those two words enough.

64 The Debate is Over The Health Consequences of Involuntary Exposure to Tobacco Smoke Surgeon General Richard H. Carmona June 27, 2006

65 U.S. Surgeon General Report Key Findings Tobacco smoke is detectable in non-smokers Secondhand smoke causes disease and premature death in children and adults Increased risk SIDS Acute respiratory infections and ear infections Asthma

66 U.S. Surgeon General Report Key Findings (cont.) ETS causes heart disease and lung cancer in nonsmokers and has immediate adverse effects on C.V. system No risk-free level of exposure Eliminating smoking indoors protects non-smokers ventilation and/or separation do not.

67 2006 U.S. Surgeon General Report Cigarette Company Response Philip Morris- We are studying the report. R.J. Reynolds-..does not change our views about secondhand smoke. There are still legitimate scientific questions concerning the reported risks of secondhand smoke. People who don t want to work around it don t have to work at that establishment

68 Smoke-Free Ordinances and Heart Attacks Helena, MT: Decrease in monthly admissions for AMI 40% for six month period after ban. Returned to previous rate after ban resinded Sargent, RP. BMJ 328:977, Pueblo & El Paso, CO: Admissions for AMI Bartecchi, C. Circulation 114:1490, Piedmont Region, Italy: Admissions for AMI down significantly Barone-Adesi, F. Eur Heart J 27:2468, 2006.

69 AMI admissions Helena and outside Helena

70 AMI Counts Per 100,000 Person Years Bartecchi, C. Circualtion. 114:1490, 2006.

71 moke-free Laws and Reduced AMI ow Could This Be True? SHS Causes Increased platelet adhesiveness Reduced arterial dilatation SHS Reduced coronary velocity reserve All people should avoid SHS exposure but people with known CV disease should have NO exposure to SHS Juster HR, et al, Am J Public Health 97:2035, 2007

72 Olmsted County, MN Smoke free ordinances implemented on 2 different dates January 1, 2002: smoke-free restaurant law (Ordinance 1) October 1, 2007: all workplaces became smoke-free (Ordinance 2)

73 Secular Trends and Incidence of MI and SCD in Olmsted Co MN

74 Conclusions The implementation of smoke-free ordinances was associated with 33% decrease (p< 0.01) in MI and 17% decrease (p= 0.13) in SCD The magnitude is not explained by other health changes (e.g. BMI or Diabetes)

75 Smoke-Free New York City 2004 Employment in NYC bars and restaurants highest in over a decade Business tax receipts in bars and restaurants by 8.7% Bar licenses by 234 Bar restaurant air quality significantly improved ( air cotinine by 85%) 97% compliance smoking prevalence 21.6% in 2002 to 19.3% in 2003

76 Also, the economic arguments often used by the industry to scare off smoking ban activity were no longer working, if indeed they ever did. These arguments simply had no credibility with the public, which isn t surprising when you consider that our dire predictions in the past rarely came true.