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Tuesday, September 25, 2012

A VIEW FROM THE OFFICE
 
 
WHAT FORMS OF PREVENTION ARE OUR NATIONAL EXPERTS RECOMMENDING NOW?
 
 
PUBLICATION NOTICE

NOTICE:  Please be aware that the previous website associated with this publication (www.Kopes-eticHealth.com) has been removed. The new website for information about this and other publications is www.FPRevolution.netAlso note that long-time email address of cpkerr@nni.com is no longer valid. The new preferred email address appears above.
     
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THE CRAZINESS OF THE US PREVENTIVE SERVICES TASK FORCE

    While the USPSTF is the best source of a summary of the evidence relating to the most common important health interventions, they are far less competent at marshaling the evidence to make a sound recommendation. They sometimes miss the forest for the trees. I have recently discussed at length the major problem with their recently updated guideline of counseling for physical activity. Well, they have done it again--this time regarding counseling for improved nutritional behaviors in primary care. To make really clear the folly of their position on these two important issues I will contract these new guidelines with their recent guideline on counseling for behavioral changes to prevent skin cancer.

BEHAVIORAL COUNSELING TO PREVENT SKIN CANCER: The USPSTF is concerned because more than 2 million cases of skin cancer are diagnosed annually in the United States. Most of these (two-thirds) are basal cell skin cancer, which is not associated with significant mortality. Basal cell carcinoma accounts for less than 0.1% of patient deaths due to cancer. The USPSTF expresses specific concern about the rising incidence of melanoma without acknowledging that most of this is due to overdiagnosis [See Dr. Gil Welch, "Overdiagnosed", previously reviewed here this year: Chapter 5.] Increased screening and biopsy has led to an increase in diagnosed cases, but there has, as yet, been no accompanying reduction in mortality, which overall suggest much ado about nothing. The patient behaviors that are the focus of this guideline are the use of sunscreen and avoidance of indoor tanning.
    "Sunprotective counseling in primary care varies in frequency and content, despite data suggesting that these behaviors need to be improved." (This is based on the observation than not many people consistently engage in such behaviors, not on any evidence that such behaviors actually work.) Against this would be the observation that "most existing studies did not suggest a strong association between total or chronic sun exposure and squamous cell carcinoma or basal cell carcinoma." So how is counseling to avoid sun exposure expected to do any good? As to the existing evidence of the effectiveness of counseling to avoid sun exposure, the USPSTF notes: "Evidence in adults and parents of newborns suggests that behavioral interventions can minimally increase composite scores measuring sunprotective behaviors. It is unclear, however, whether the small differences in composite scores of self-reported sunprotective behaviors translate into clinically meaningful behavior change to prevent skin cancer or sunburns."  This last statement would seem to indicate that as yet no routine counseling for sunprotective behaviors is as yet ready for prime time.
    Nonetheless the USPSTF recommends counseling children, adolescents, and young adults aged 10 to 24 years who have fair skin about minimizing their exposure to ultraviolet radiation to reduce risk for skin cancer. They do not recommend such counseling for those older than 24 years (insufficient evidence).
    Thus in this recommendation statement the USPSTF seems willing to suggest that all physicians treating persons aged 0-24 years should modify their practices to include counseling in order to avoid a small risk with an intervention that has small evidence of a small effect. They find no evidence of harms from the recommended intervention, not even "the lost opportunity to provide other services that have a greater health effect."

BEHAVIORAL COUNSELING INTERVENTIONS TO PROMOTE A HEALTHFUL DIET AND PHYSICAL ACTIVITY FOR CARDIOVASCULAR DISEASE PREVENTION IN ADULTS:  On the subject of counseling interventions to promote a healthful diet and physical activity for cardiovascular prevention (an admittedly far more important health priority), the USPSTF is not so tolerant of an incomplete database even though 49.7% of US adults older than 20 years have at least one of the following CVD risk factors: uncontrolled hypertension, uncontrolled elevated LDL cholesterol levels, or current smoking. "Although the correlation among healthful diet, physical activity, and the incidence of CVD is strong, existing evidence indicates that the health benefit of initiating behavioral counseling in the primary care setting to promote a healthful diet and physical activity is small." Do they mean smaller than the benefit of recommending sunprotective behaviors? "All persons, regardless of risk status for CVD, can benefit from improved nutrition, healthy eating behaviors, and increased physical activity," but they are not going to recommend any interventions to promote such behaviors. It is certainly non-intuitive that the USPSTF believes that spending our time to try to reduce the limited risk of skin cancers is worthwhile, but routine counseling to prevent heart disease is not.
    The USPSTF acknowledges that "in adult patients without known hypertension, diabetes, hyperlipidemia, or CVD, there is adequate evidence that the benefits of medium- to high-intensity behavioral counseling interventions to improve diet and increase physical activity are small to moderate...The USPSTF concludes with moderate certainty that medium- or high-intensity behavioral counseling interventions in the primary care setting to promote a healthful diet and physical activity have a small net benefit in adult patients without CVD, hypertension, hyperlipidemia, or diabetes."  The intensity of the intervention was categorized by total patient contact time as low (1 to 30 minutes), medium (31 to 360 minutes), or high (> 360 minutes). For some reason they did not analyze their recommendation to counsel persons aged 0 to 24 by the required intensity of intervention required to have an effect.
    The USPSTF does recommend intensive behavioral dietary counseling for adult patients with hyperlipidemia and other known risk factors for cardiovascular and diet-related chronic disease. In order to address patient risk factor status, they implicitly recommend routine screening or assessment for cardiovascular risk using such risk calculators as the Framingham-based Adult Treatment Panel III calculator (available at http://hp2010.nhlbihin.net/atpiii/calculator.asp) along with routine lipid screening and screening for obesity. An important point that the USPSTF appears to miss completely is that these latter activities require time. For the first 15 years of my practice I was ardent in performing routine cardiac risk assessment. I found it time consuming even without an intervention. I finally made the decision, based purely on efficiency concerns, to skip the risk assessment component and to proceed directly to routine universal counseling for nutrition, exercise, and a healthy lifestyle for all patients, aged 4 to 100 years. This latter approach requires no more time than routine cardiac risk assessment yet includes the relevant intervention.
    The USPSTF declares that their lack of enthusiasm for nutrition, exercise, or lifestyle counseling is based not on the merits of the health benefits of physical activity, but on lack of clear evidence of the effectiveness of the counseling. This aspect of their recommendation reveals a major flaw in their analysis. They pay no attention to the now abundance evidence of the effectiveness of brief motivational interviewing. The evidence of the effectiveness as well as the details on the "how to" are well summarized in Rollnick. [http://search.barnesandnoble.com/Motivational-Interviewing-in-Health-Care-Stephen-Rollnick/e/9781593856120?r=1&cm_mmc=GooglePLA-_-Textbook-_-Q000000633-_-9781593856120&cm_mmca2=plaA handy 34 page guide to the technique is available free at http://www.psychmap.org/uploads/Motivational%20Interviewing%20brief%20guide.pdf. While a brief motivational interviewing is a relatively new technology [for which the majority of practicing physicians received no training at all] the evidence of effectiveness or just a 2-3 minute intervention on a repeated basis is compelling. It is currently that standard of care for changing behavior in health settings. The USPSTF needs to perform an evidence-review and recommendation of this technique and then reconsider their complete dismissal of low intensity interventions for diet and exercise counseling. Moreover, they need to explicitly consider that fact that regularly repeated brief motivational interviewing cumulatively constitutes a high-intensity counseling intervention.
    One final USPSTF point against routine counseling for diet and exercise derives from a potential harm of such counseling--"Harms may include the lost opportunity to provide other services that have greater health effect." This is a criterion that was not applied to their endorsement of counseling to promote sunprotective behavior between ages 0 and 24 years. Do they really believe that counseling for sunprotective behaviors has a greater effect than counseling for diet, exercise, or lifestyle? Once again I would like to remind readers of the benefits of a 5-element healthy lifestyle (based on 16 observational studies):

COMMENT: How on earth does the USPSTF reach the conclusion that these health benefits are not compelling or that appropriately performed brief motivational interviewing is not effective in leading to the related behavior changes? In part this is because they have broken down their analysis by individual components rather than by a simple global definition of a health lifestyle. This is important because such healthy behaviors have dramatic synergistic effects. The approach taken by the USPSTF suffers from a failure to prioritize recommendations based on the magnitude of health benefits and from the failure, where the evidence-base is still limited, to make recommendations based on relevant but lower quality studies such as the 16 observational studies that support the list of benefits above. To some extent Pascal's wager should apply to medicine. I would phrase it this way. If there is any possibility that the above benefits are real, then physicians should routinely recommend the 5 lifestyle behaviors to everyone just because the harms are nil.

SCREENING FOR AND MANAGEMENT OF OBESITY IN ADULTS: According to the USPSTF, while we should do no routine counseling for diet, exercise, or a healthy lifestyle, we should routinely screen adults for obesity. "The USPSTF recommends screening all adults for obesity. Clinicians should offer or refer patients with a body mass index (BMI) of 30 kg/m2 or higher to intensive, multicomponent behavioral interventions...The USPSTF concludes with moderate certainty that screening for obesity in adults has a moderate net benefit."  This recommendation is ultimately based primarily on the fact that "intensive, multicomponent behavioral interventions for obese adults can lead to an average weight loss of 4 to 7 kg...[and] also improve glucose tolerance and other physiologic risk factors for cardiovascular disease."

    The USPSTF does not explain why it believes it is more important to screen for obesity than to prevent it (i.e., with diet, exercise, and lifestyle interventions). We have no data on the efficacy of obesity prevention because it has never been tried. One of the reasons that it has never been tried is that expert organizations like the USPSTF don't recommend it. They say they don't recommend it because there is insufficient evidence, and this leaves us in a 'Catch 22' situation.
    Nor has it adequately answered the compelling critique of its last obesity recommendation in 2004. At that time an editor for Journal Watch commented: "Despite good evidence these recommendations will be difficult to implement. First BMI calculation requires measurement of height, which is not obtained routinely in adults. Second, and more important, medication and surgery are effective, but their use is limited to the severely obese, and surgery is not without risk. In addition, pharmacologic therapies should be given in the context of counseling; however high-intensity counseling (for which there is the best evidence) generally is available only by referral, is of limited availability, and requires substantial patient commitment."(4)
    Finally, we're missing the point that the obese know who they are. In a practice-based study in 1998 among 755 consecutive patients of a single practice, all obese patients (BMI > 30) were aware that they were overweight. Physician estimate of BMI (without actual measurement) turned out to be reasonably sensitive (70%), specific (99%), and predictive of measured BMI (93% PPV).(5) Why would physicians need to spend their time screening for a condition that is obvious and certainly known to patients? The futility of screening is highlighted by the fact that there are no proven treatments for obesity in the primary care setting. Either high-intensity counseling outside of the physician's office or a referral for a surgical-based approach are required.
COMMENT: The USPSTF has missed the boat. Somehow their principles or internal guidelines don't allow them to probe beyond the highest quality studies or to base their guidelines on heuristic principles. The fact that they endorse counseling for sunprotective behaviors and screening for obesity over what they know to be the sound principle of leading a healthy lifestyle is deeply disturbing. Everyone makes a mistake sometime. That is ordinary, and human, and very forgivable. But to make the same mistake year after year. That's not. That's extraordinary.

SCREENING FOR ALCOHOL MISUSE: THE NEW USPSTF RECOMMENDATION:  The Task Force has been very busy. In this updated recommendation they confirm their previous 2004 recommendation: "The USPSTF recommends that clinicians screen adults, including young adults and pregnant women, for alcohol misuse and provide persons engaged in risky or hazardous drinking with brief behavioral counseling interventions to reduce alcohol misuse." In the related systematic review in Annals of Internal Medicine the Task Force summarizes the evidence for this recommendation as follows:
        "The 23 included trials generally excluded persons with alcohol dependence. The best evidence was for brief (10- to 15-minute) multicontact interventions. ['Very brief single contact (e.g., < 5 minutes) has limited impact.'] Among adults receiving behavioral interventions, consumption decreased by 3.6 drinks per week from baseline; 12% fewer adults reported heavy drinking episodes; and 11% more adults reported drinking less than the recommended limits. Evidence was insufficient to draw conclusions about accidents, injuries, or alcohol-related liver problems. Trials enrolling young adults or college students showed reduced consumptions and fewer heavy drinking episodes."
COMMENT: While we can all agree that moderate alcohol use is important to a healthy lifestyle, it is difficult to see why it is rated as more important than nutrition [actually an alcohol intervention ought to be considered a component of a global nutritional intervention] or exercise counseling. The reason for the difference in recommendations appears to be that the USPSTF considers alcohol counseling to be worth a more intense intervention (brief multicontact [each contact is 6-15 minutes) whereas it concludes that nutrition and exercise counseling only merit brief intervention counseling, which is ineffective according to their data, just as it is ineffective for alcohol counseling. Why the USPSTF is now willing to endorse 'brief multicontact interventions of 6-15 minutes for nutrition and exercise counseling is a mystery. Furthermore, the results cited in their evidence summary for the alcohol intervention involves only intermediate outcomes (i.e., the amount of alcohol consumed); the evidence is not adequate to demonstrate improved outcomes that matter--reduced accidents, lost time from work, less cirrhosis, etc. Certainly the poster above for lifestyle counseling shows far more significant improvements in outcomes that matter (incidence of major chronic diseases, cancer, and overall mortality).
        The USPSTF appears to have some kind of bias against nutrition and exercise counseling that is not explained by the evidence. Go figure.

OTHER FACTORS YOU MIGHT WANT TO CONSIDER:
    1. Sunscreen is expensive: These investigators performed a cost analysis study of sunscreen needs in two scenarios: a family of four on a 1-week beach vacation (4 hours/day in the sun), females in bikinis, males in swim trunks, reapplying sunscreen twice for adults and 3 times for children, and no other sun-protective measures taken), and a transplant patients using sunscreen year round. They also evaluated costs of 607 sunscreens from 17 Internet drugstores in 7 countries. Median sunscreen price was $1.70 per 10 g. Assuming that standard sunscreen application recommendations (2 mg/cm2) were followed, the median cost to the family varied from 4178.20 per week (if children were 2-year olds) to $238.40 per week (if children were 10-year-olds). The cost decreased by 33% if the family wore UV-protective T-shirts and by 41% if large-volume bottles were used--both strategies combined reduced the costs by 58%. The median cost to a transplant patients vai3ed from $245 to 292 per year.(6)
    2. Lifestyle changes could prevent 50% of common cancers: A research presenting at the Union for International Cancer Control (UICC) World Cancer Congress 2012 states: "More than 50% of cancer could be prevented if people simply implemented what is already known about cancer prevention." Most of this derives from lifestyle interventions. While the 'biggest buy' from lifestyle intervention is smoking cessation. It is also estimated that being overweight or obese causes approximately 20% of cancer. If people could maintain a healthy body mass index, the incidence of cancer could be reduced by approximately 50% in 2 to 20 years. (A healthy BMI for cancer prevention is from 21 to 23 kg/m2. Poor diet and lack of exercise are each associated with about 5% of all cancers. Improvement in diet could reduce cancer incidence by 50% and increases in physical activity could reduce cancer incidence by as much as 85% in 5 to 20 years.(7) COMMENT: Nonetheless the USPSTF remains far more interested in expensive and inconvenient screening strategies like mammography, occult blood stool testing, and colonoscopy to reduce breast cancer and colon cancer, respectively, by a mere 15%. The evidence is good, the impact and cost:benefit ratios, however, are disappointing.
    3. An alternative approach to obesity--prevention: The Institute of Medicine (supported by he Robert Wood Johnson Foundation) has issued a report on the prevention of obesity.(8) "Obesity has become so pervasive and severe that it 'constitutes a startling setback to major improvements achieved in other areas of health during the past century.'...What the country needs now is a set of obesity prevention action that, both individually and together, can accelerate meaningful change on a societal level." The Committee's recommendations include aggressive promotion of physical activity [Take note, USPSTF!], creation of environments conducive to healthy eating, and expanding the role of health care providers, employers, and schools in obesity prevention. The report identified 5 critical areas, or 'environments,' from which to attack the problem: physical activity, food and beverage, message (or marketing), health care and work, and schools. The 5 major goals for these environments are:
  1. To make physical activity an integral and routine part of daily life.
  2. To create food and beverage 'environments' that ensure that healthy options are routine and easy choices.
  3. To transform messages about physical activity and nutrition.
  4. To expand the role of health care providers, insurers, and employers in obesity prevention.
  5. To make schools a national focal point for the prevention of obesity.
Specifically, with respect to health care providers, they recommend:
  • Health care providers' standards of practice should include routine body mass index screening, counseling, and behavioral interventions for children, adolescents, and adults to improve physical activity behaviors and dietary choices.
  • Medical, nursing, and physician assistants schools, and other relevant health care professional training programs and continuing education should include instruction in prevention, screening, diagnosis, and treatment of overweight and obesity in children, adolescents, and adults.
  • Health care providers should serve as role models for their patients.
 
 
 
   350
parts per million of atmospheric carbon compatible with a familiar, sustainable planet Earth



REFERENCES:
 
1.  Lin JS, Eder M, Weinmann S. Behavioral counseling to prevent skin cancer: A systematic review for the US Preventive Services Task Force. Ann Intern Med 2011; 154: 190-201. Guideline: http://www.uspreventiveservicestaskforce.org/uspstf11/skincancouns/skincancounsrs.htm

2.  Moyer VA. Behavioral counseling interventions to promote a healthful diet and physical activity for cardiovascular disease prevention in adults: US Preventive Services Task Force Recommendation Statement. Ann Intern Med 2012; 157: 367-72.

3. Moyer VA. Screening for and management of obesity in adults: US Preventive Services Task Force Recommendation Statement. Ann Intern Med 2012; 157: 373-8.

4. Journal Watch 2004; 24 No 2: 18; cited in Action Advisor for Primary Care 2004; Vol 6 No 1: 3.

5. Little P. GP documentation of obesity: What does it achieve? Br J Gen Pract 1998; 48: 890-4; abstracted in The Family Practice Newsletter 1998; Vol 13 No 6: 24.

6. Mahe E et al. Are sunscreens luxury products? J Am Acad Dermatol 2011 Jul 11; [e-pub ahead of print]; http://dx.doi.org/10.1016/j.jaad.2010.06.043; abstracted in Journal Watch 2011.

7. Harrison P. Lifestyle changes could prevent 50% of common cancers. September 5, 2012 (Montreal, Quebec). Union of International Cancer Control (UICC) World Cancer Congress 2012. Presented August 29, 2012; reported in Medscape Medical News 2012: http://www.medscape.com/viewarticle/770357

8. Institute of Medicine. Accelerating progress in obesity prevention: Solving the weight of the nation. http://www.medscape.org/viewarticle/763753

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