Ned Calonge, M.D., M.P.H. Chair, USPSTF

1. Recommendations from the U.S. Preventive Services Task Force: A Roadmap for Behavioral Medicine and Public Health (and some missing landmarks) Ned Calonge, M.D., M.P.H. Chair, USPSTF

2. Objectives Discuss: • Structure of the Task Force • Methods of the Task Force • Behavioral medicine recommendations • Missing landmarks

3. Behavior and prevention • “Another major contribution of the Guide is its emphasis on personal behavior and therefore behavioral counseling. Behavior and health are strongly linked. Improved control of behavioral risk factors, such as use of tobacco, alcohol, and other drugs, lack of exercise, and poor nutrition, could prevent half of premature deaths, one-third of all cases of acute disability, and half of all cases of chronic disability. It is extraordinarily important that physicians and other providers educate their patients about these matters.” Edward N Brandt, Jr, M.D., Ph.D in the Foreword, Guide to Clinical Preventive Services, USPSTF, 1989

4. Challenges for prevention • Most important messages about prevention may not be getting through • Not everything that might work does work • Many potential services, limited clinical time • Effective behavior change interventions need additional support outside of traditional health systems • Services should be supported by good evidence before they are widely recommended

5. The U.S. Preventive Services Task Force (USPSTF) • Independent panel of nationally recognized, non-federal researchers experienced in primary care, prevention, evidence-based medicine, and research methods • Member disciplines: family medicine, internal medicine/geriatrics, preventive medicine, pediatrics/adolescent medicine, Ob/Gyn, nursing, counseling/behavioral medicine, public health, and health policy

6. The U.S. Preventive Services Task Force (USPSTF) • Charged by Congress to: • review the scientific evidence for clinical preventive services and • develop evidence-based recommendations for the health care community

7. The U.S. Preventive Services Task Force (USPSTF) • Convened and supported by the Agency for Health Research and Quality (AHRQ) • Works with Evidence-based Practice Centers (EPCs) to conduct rigorous, impartial assessments of scientific evidence • USPSTF recommendations are considered by many to be the gold standard for clinical preventive services

8. AHRQ Support of USPSTF USPSTF Convenes Recommendations AHRQ Analytic framework development Evidence presented Contract to synthesize evidence EPC

9. Steps in explicit process • Define question and outcomes of interest within an analytic framework • Define and retrieve relevant evidence • Evaluate QUALITY of individual studies • Synthesize and judge STRENGTH of available evidence • Determine balance of benefits and harms • Link recommendation to judgment about net benefits

10. Analytic framework • There are very few screening studies that look at the primary question of screening efficacy in decreasing mortality • There are very few counseling studies that link the behavior change intervention with long-term health effects • Evidence-based reviews, focusing on RCTs, can put together a chain of evidence on which to base over-arching recommendations

11. Analytic framework for screening for a disease

12. Counseling topics—1st and 2nd Task Force methods • Counseling was recommended if there was evidence that changing the behavior would improve health outcomes, or even if the presence of the behavior was associated with increased risk compared with the absence of the behavior

13. Counseling topics—methodology changes of current Task Force • Based on analytic framework for screening • Uses two interrelated analytic frameworks: • Does changing individual health behavior improve health outcomes? • Can interventions in the clinical setting influence people to change their behavior? • Raises the bar for counseling interventions to that equivalent for other preventive services

14. Does changing individual health behavior improve health outcomes?

15. Can interventions in the clinical setting influence people to change their behavior?

16. Grades of Recommendation

17. Wording of recommendations A - Strongly recommend benefits substantially outweigh harms B - Recommend benefits outweigh harms C - USPSTF makes no recommendation benefits and harms closely balanced D - Recommend against routine use ineffective interventions or harms outweigh potential benefits

18. The I letter grade • Insufficient Evidence to Recommend for or against the intervention Common reasons: • Lack of evidence on clinical outcomes • Poor quality of existing studies • Good quality studies with conflicting results Possibility of clinically important benefits but more research needed to show the benefits

19. Reasons for Conflicting Recommendations • Evidence-based vs. consensus process • Clinical vs. intermediate outcomes • Consideration of possible harms • Effectiveness vs. efficacy • ideal setting vs. real world • Primary care vs. specialty perspective • Approach to uncertainty • “do no harm”

20. Abd. aortic aneurysm B Alcohol   B Aspirin for CVD  A  Blood pressure  A Breast cancer B Cervical cancer  A,D Chlamydial infection  A,B Colorectal cancer A Depression  B Diabetes   I,B Diet  B Lipids  A,B Obesity   B Osteoporosis  B Tobacco Use A Recent recommended services

21. Recent ratings for behavioral counseling—A&B recommendations • Tobacco use (A) • Alcohol use (B) • Breastfeeding (B) • Healthy diet in high risk adults (B)

22. Recent ratings for behavioral counseling—I recommendations • Prevent skin cancer • Prevent low back pain • Healthy diet in average risk adults • Physical activity • Vitamin supplementation to prevent CVD and cancer (I on the basis of insufficient evidence that vitamins reduce the risk, not based on counseling)

23. Recent ratings for screening related to behavior change • Screening for depression (B, I) • Screening for obesity in adults (B, I) • Screening for family violence (I) • Screening for suicide risk (I)

24. Recommendations not updated since 1996 • Prevent HIV infection • Prevent household and recreational injuries • Prevent motor vehicle injuries • Prevent youth violence • Prevent unintentional pregnancy

25. Example: Screening for Alcohol Misuse • The Task Force focused on screening for risky and harmful alcohol use • Risky drinkers are “At risk from exceeding daily, weekly or per occasion thresholds” • Harmful drinkers “Exhibit physical, social or psychological harm, but may not meet criteria for dependence” Fiellin et al. Screening for Alcohol Problems in Primary Care. Arch Intern Med, 2000

26. Analytic Framework Health Care System Influences Clinical Population Adolescents -Females -Males 7 1 INTERVENTION (with or without follow-up) 4 Adults -Females -Males ASSESSMENT 2 Reduction in All- Cause Mortality, Alcohol- Related Deaths, Accidents Injuries Harmful/ At-Risk Alcohol Users Measures of Lower Risk Alcohol Use Seniors (65+) -Females -Males 6 Women of Childbearing Age -Pregnant Adverse Effects 3 5 Adverse Effects Health Care Utilization, Sick Days, Costs)

27. KQ4: Do BCIs reduce risky/harmful alcohol use in adults? Average Consumption (11 fair-good quality RCTs and 1 fair quality CCT) • 5 studies tested Brief interventions (single contact< 15 minutes) • 4/5 showed no effect on mean alcohol (drinks/week) • 7 studies tested Brief Multi-contact interventions • 5/7 significantly reduced mean alcohol consumption • 1 study reports maintenance of reduced alcohol consumption after 4 years Overall evidence: GOOD

28. Net Reduction in Mean Drinks/Week(Control Group Change – Intervention Group Change)

29. KQ4: Do BCIs reduce risky/harmful alcohol use in adults? Proportion reporting binge use (6 RCTs) • In Brief and Brief Multicontact intervention groups, 3/6 studies showed decrease in binge drinking in treatment group • Large proportions of interventions and controls report binge use after intervention Overall evidence: FAIR-GOOD

30. KQ4: Do BCIs reduce risky/harmful alcohol use in adults? Proportion reporting safe/recommended use levels (10 fair-good RCTs) • In Brief and Brief Multicontact intervention studies, 7/10 studies, more intervention participants than controls achieved recommended or safe drinking levels. Overall evidence: GOOD

31. Clinical/net benefit summary in adults • No evidence on harms-assumed to be small/zero • Adults receiving brief multi-contact intervention reduce their drinking 3.5-5.0 drinks/week more than controls (10-25% net reduction in drinking) • Binge use is less commonly reduced and remains prevalent (25-50%) • 10-18% more intervention participants reported recommended or safe drinking

32. Alcohol Misuse – Screening and Behavioral Counseling • The U.S. Preventive Services Task Force (USPSTF) recommends screening and behavioral counseling interventions to reduce alcohol misuse by adults, including pregnant women, in primary care settings. B Recommendation

33. Alcohol Misuse – Screening and Behavioral Counseling • Rationale for B Recommendation The USPSTF found good evidence that screening in primary care settings can accurately identify patients whose levels or patterns of alcohol consumption do not meet criteria for alcohol dependence, but place them at risk for increased morbidity and mortality, and good evidence that brief behavioral counseling interventions with followup produce small to moderate reductions in alcohol consumption that are sustained over 6- to 12-month periods or longer.

34. Alcohol Misuse – Screening and Behavioral Counseling • Rationale for B Recommendation cont. The USPSTF found some evidence that interventions lead to positive health outcomes 4 or more years post-intervention, but found limited evidence that screening and behavioral counseling reduce alcohol-related morbidity. The evidence on the effectiveness of counseling to reduce alcohol consumption during pregnancy is limited; however, studies in the general adult population show that behavioral counseling interventions are effective among women of childbearing age. The USPSTF concluded that the benefits of behavioral counseling interventions to reduce alcohol misuse by adults outweigh any potential harms.

35. Missing landmarks • Often counseling interventions studies don’t look at long term health outcomes, nor long term behavior change • There are few studies that provide evidence on the optimal approach to counseling in the primary care setting • There is very little data on potential harms of counseling

36. Healthy diet for average risk people • The USPSTF found fair evidence that brief, low- to medium-intensity behavioral dietary counseling in the primary care setting can produce small-to-medium changes in average daily intake of core components of an overall healthy diet (especially saturated fat and fruit and vegetables) in unselected patients. • The strength of this evidence, however, is limited by reliance on self-reported diet outcomes, limited use of measures corroborating reported changes in diet, limited followup data beyond 6 to 12 months, and enrollment of study participants who may not be fully representative of primary care patients.

37. Healthy diet (cont.) • In addition, there is limited evidence to assess possible harms. • As a result, the USPSTF concluded that there is insufficient evidence to determine the significance and magnitude of the benefit of routine counseling to promote a healthy diet in adults.

38. Physical Activity • The USPSTF reviewed only the literature on the effectiveness of primary care counseling to promote physical activity. • The USPSTF found insufficient evidence to determine whether counseling patients in primary care settings to promote physical activity leads to sustained increases in physical activity among adult patients.

39. Physical Activity (cont.) • Controlled trials of physical activity counseling in adult primary care patients were of variable quality and had mixed results. • Data on the feasibility and potential harms of routine physical activity counseling in primary care settings are limited. • As a result, the USPSTF could not determine the balance of potential benefits and harms of routine counseling to promote physical activity in adults.

40. Screening for family/intimate partner violence • The USPSTF found no direct evidence that screening for family and intimate partner violence leads to decreased disability or premature death. • The USPSTF found no existing studies that determine the accuracy of screening tools for identifying family and intimate partner violence among children, women, or older adults in the general population. • The USPSTF found fair to good evidence that interventions reduce harm to children when child abuse or neglect has been assessed.

41. Screening for family/intimate partner violence (cont.) • The USPSTF found limited evidence as to whether interventions reduce harm to women, and no studies that examined the effectiveness of interventions in older adults. • No studies have directly addressed the harms of screening and interventions for family and intimate partner violence. • As a result, the USPSTF could not determine the balance between the benefits and harms of screening for family and intimate partner violence among children, women, or older adults.

42. Other missing landmarks—public health • Most effective behavior change interventions require linkage to services outside the traditional health care system • For public health impact, services need to be available at the community level • Translation of behavioral change research into effective practice has additional challenges of: • Workforce capacity • Resources/funding • Integration with health care, other social systems

43. Filling in the gaps • It’s difficult to justify a positive recommendation when you can’t join all the links in the chain of evidence • Trials are essential to the evidence for behavioral interventions • Remember that an I recommendation is a call for research—it is not a conclusion that the intervention is not effective

44. Filling in the gaps • Can you accurately detect the behavior? • Does the intervention change the behavior? • What are the key components? • What is the feasibility of implementation? • Is the behavior change sustained? • Does the behavior change result in improvements in health outcomes, or at least in intermediate outcomes (and is there a good link between intermediate outcomes and health outcomes?

45. Thanks to… • Janelle Guirguis-Blake, MD (AHRQ) • Gurvaneet Randhawa, MD (AHRQ) • Russ Harris, MD (UNC) • Evelyn Whitlock, MD (Oregon EPC)

46. www.preventiveservices.ahrq.gov