After being banished from the public spotlight in 2010 and 2011 due to health reform politics, the evidence-generating operation known as the U.S. Preventive Services Task Force is finally making waves again. On Monday, the USPSTF got on board with a CDC guideline to screen all "baby boomers" born between 1945 and 1965. In their draft recommendation statement, the Task Force (which in 2004 found insufficient evidence for screening even patients with self-reported risk factors) assigned a level "C" rating to birth cohort screening for hepatitis C, which means they believe there is moderate certainty of at least a small net benefit. Although newspaper reports described this endorsement of the CDC's guideline as lukewarm, it is anything but that. For clinicians who have never given a thought to routinely screening my parents' generation for this virus, it is a sea change.
How beneficial a medical test or intervention would be for society is ultimately a subjective assessment. The CDC has argued that the prevalence of undiagnosed hepatitis C in baby boomers is higher than in the general population, and affected persons (who contracted the virus via intravenous drug use or tainted blood transfusions in the 1970s and 1980s) are more likely than younger people to be at risk for life-threatening problems such as cirrhosis and liver failure. Plus, treatments are more effective and less toxic than before. I'd still argue that the magnitude of benefit is less than either the CDC or Task Force say it is, but ultimately it's anyone's best guess.
The "moderate certainty" part bothers me more. Based on the USPSTF's extensive body of work and the evidence contained in two systematic reviews in the Annals of Internal Medicine, I don't see how they managed to get there. Generally, the first piece of evidence the Task Force looks for is a randomized clinical trial that compares a screened population to a non-screened population and follows them up long enough to see if fewer people in the screened population end up dying from the disease. It takes decades for hepatitis C to lead to premature death, though, so it's no surprise that the evidence review turned up no such trials.
Given the absence of "direct" evidence that screening for hepatitis C saves lives, the Task Force was forced to rely on an indirect chain of evidence, namely: screening tests detect hepatitis C, hepatitis C leads to bad outcomes for patients, treatment prevents these bad outcomes (or surrogate measures of these outcomes) without causing too much collateral damage in the process. This type of chain has been used in other recommendations; this is why, for example, the USPSPTF recommends screening older women for osteoporosis. For hepatitis C, this chain of evidence wasn't there in 2004. Now, the Task Force says it is.
The key point in the USPSTF's argument seems to be that two drugs that the FDA recently approved for hepatitis C infection, boceprevir and telaprevir, lead to a sustained virologic response (SVR) in substantially more patients (70 to 80 percent) than the previous treatment combo, pegylated interferon alfa plus ribavirin, which was not only poorly tolerated but led to SVR in fewer than half of patients. But how do we know that SVR from these new drugs is associated with fewer liver failures and deaths? Strictly speaking, we don't. The Task Force extrapolated from cohort studies that show that SVR was associated with lower mortality in patients who had been treated with interferon and ribavirin.
To summarize: there's no direct evidence that screening for hepatitis C saves lives. New treatments are more likely to lead to SVR, but there's no evidence that they save lives, either; the studies have not been done. We know that if patients stick out therapy with interferon and ribavirin and get a SVR, they seem to do better than patients who don't, but the Task Force knew that in 2004 and still declined to make a recommendation. To me, this chain of evidence doesn't hold up to scrutiny. In fact, it resembles screening for osteoporosis in men (which received an "I" rating from the USPSTF in 2011) more than screening in women. So for the second week in a row, I find myself saying that the Task Force missed the boat.
Wednesday, November 28, 2012
Sunday, November 25, 2012
Who should receive medications for influenza?
Flu season has begun in the U.S., and in addition to familiarizing themselves with the Advisory Committee on Immunization Practice's vaccination guidelines for the 2012-13 season (offer influenza vaccine to everyone 6 months of age or older), physicians should consider how they plan to diagnose patients with suspected influenza. Despite the availability of multiple antiviral medications for influenza, whom to treat remains a challenging question.
In a 2010 Cochrane for Clinicians commentary, Dr. William E. Cayley observed that the neuraminidase inhibitors oseltamivir and zanamivir provided limited benefits for prevention and treatment of otherwise healthy persons with influenza. However, this conclusion was based on incomplete data - that is, results from published trials only. Subsequently, the Cochrane review authors were able to access several unpublished "clinical study reports" from the manufacturers and modified the review to reflect these additional data. In an updated Cochrane for Clinicians, published in the October 1st issue of American Family Physician, Dr. Cayley finds that the evidence no longer supports using neuraminidase inhibitors to prevent influenza transmission:
The authors found that, based on clinical study reports, treatment with oseltamivir reduced the likelihood of an antibody response to influenza, the diagnostic marker that is typically used to determine the effectiveness of prophylaxis. In the absence of another way to measure the effectiveness of oseltamivir prophylaxis, it is uncertain whether the medication reduces the risk of influenza transmission.
Even for treatment of persons with influenza, the benefits of antivirals are modest: oseltamivir reduced the duration of symptoms by less than one day and had no effect on hospitalizations. Since these medications have side effects, physicians may reserve their use for persons at higher risk of complications, such as those with asthma or other chronic respiratory problems. As Dr. Cayley notes, existing guidelines are only as good as the evidence that supports them - and in the case of influenza treatments, not very good at all:
In a 2010 Cochrane for Clinicians commentary, Dr. William E. Cayley observed that the neuraminidase inhibitors oseltamivir and zanamivir provided limited benefits for prevention and treatment of otherwise healthy persons with influenza. However, this conclusion was based on incomplete data - that is, results from published trials only. Subsequently, the Cochrane review authors were able to access several unpublished "clinical study reports" from the manufacturers and modified the review to reflect these additional data. In an updated Cochrane for Clinicians, published in the October 1st issue of American Family Physician, Dr. Cayley finds that the evidence no longer supports using neuraminidase inhibitors to prevent influenza transmission:
The authors found that, based on clinical study reports, treatment with oseltamivir reduced the likelihood of an antibody response to influenza, the diagnostic marker that is typically used to determine the effectiveness of prophylaxis. In the absence of another way to measure the effectiveness of oseltamivir prophylaxis, it is uncertain whether the medication reduces the risk of influenza transmission.
Even for treatment of persons with influenza, the benefits of antivirals are modest: oseltamivir reduced the duration of symptoms by less than one day and had no effect on hospitalizations. Since these medications have side effects, physicians may reserve their use for persons at higher risk of complications, such as those with asthma or other chronic respiratory problems. As Dr. Cayley notes, existing guidelines are only as good as the evidence that supports them - and in the case of influenza treatments, not very good at all:
The contrast between the limited positive findings of this review and the strong support for treatment with neuraminidase inhibitors in public health guidelines (such as those from the CDC) highlights the importance of ongoing assessment of such recommendations and related educational materials, especially when evidence to support widespread implementation of an expensive intervention is lacking.
I have to admit that I prescribed antiviral medications for many "low risk" patients with influenza last year. After re-examining the weak evidence of benefit, I don't plan to do so again. But I doubt that studies like these actually change the way most clinicians practice, given that prescribing antivirals might be considered the lesser of two evils (the other being prescribing totally useless antibiotics) for patients with influenza who desire more than symptom-relieving medications.
**
The above post first appeared in the AFP Community Blog.
I have to admit that I prescribed antiviral medications for many "low risk" patients with influenza last year. After re-examining the weak evidence of benefit, I don't plan to do so again. But I doubt that studies like these actually change the way most clinicians practice, given that prescribing antivirals might be considered the lesser of two evils (the other being prescribing totally useless antibiotics) for patients with influenza who desire more than symptom-relieving medications.
**
The above post first appeared in the AFP Community Blog.
Monday, November 19, 2012
The case against universal HIV screening - Part 2 of 2
Although the U.S. Preventive Services Task Force is the most widely respected, unbiased organization producing evidence-based guidelines today, it isn't perfect. In 2002, the USPSTF recommended that women take aspirin to reduce their risk for heart attacks; later randomized trial evidence showed that aspirin only prevents heart attacks in men (it prevents strokes in women). More famously, the USPSTF once overestimated the benefits and underestimated the harms of mammography in women in their 40s, resulting an an apparent about-face in breast cancer screening recommendations in 2009 that made a great deal of political hay. This is the second of two posts explaining the reasons that I think the Task Force got it wrong when it recently endorsed screening all persons ages 15 to 65 years for HIV regardless of risk status. The first post is available here.
**
Potential Harms and Competing Priorities
Potential harms of HIV testing include false positive results, anxiety, labeling, and adverse medication effects. True positive HIV results can be stigmatizing and lead to discrimination, loss of employment, verbal abuse, and physical assault in 1 to 4 percent of patients (18). A new HIV diagnosis does not seem to be associated with increased partner violence or dissolution of partner relationships in observational studies (18). Adverse effects of highly active antiretroviral therapies are less common today than in previous years, with more treatment options and simplified dosing schedules (19).
Although the overall magnitude of harms related to testing is thought to be small, the USPSTF judged in its 2005 guideline that the modest benefits of routinely screening persons without risk factors for HIV did not necessarily outweigh them (6). Furthermore, HIV testing does not occur in a clinical vacuum, but competes for time in the typical medical visit with many other pressing preventive, chronic, and acute care issues (20, 21). In medical practices that are not part of integrated health systems, the decision to implement or not implement routine opt-out screening for HIV may come down to individual clinicians’ judgments about the uncertain yield of such testing in their population versus competing clinical priorities. Or, as one author has argued: “It would be appropriate for those who want to prioritize preventive services based on proven benefits to adopt the USPSTF recommendation and individualize decisions about HIV screening of low-risk patients. … For clinicians who place a high value on potentially reducing HIV incidence and are more willing to accept plausible but unproven benefits, it might be reasonable to adopt the CDC recommendations” (9).
Altering the Balance of Benefits and Harms
Since the publication of the USPSTF guideline in 2005 and the CDC guideline in 2006, there have been important advances in HIV care that likely increase the relative benefits of universal screening. The improved tolerability of current HAART regimens, combined with evidence from observational studies that earlier initiation of HAART (rather than delayed initiation below a certain CD4 cell count) reduces mortality, led the Department of Health and Human Services to recommend treatment of all patients with CD4 counts below 500 cells/mm3, and to consider treatment for patients with higher CD4 counts (22). If earlier treatment of asymptomatic persons with HIV improves health outcomes compared to delayed treatment, then the benefits of earlier HIV detection through screening will be magnified.
In addition, a recent randomized controlled trial confirmed the benefits of HAART in reducing the risk of HIV transmission to sexual partners (23). This multicenter trial enrolled 1750 HIV-discordant heterosexual and male homosexual couples in sub-Saharan Africa, Asia, Latin America and the United States. All HIV-infected patients had a CD4 count of 350 to 550 cells/mm3 at baseline. In this trial, antiretroviral treatment of HIV-infected partners substantially reduced the incidence of seroconversion in uninfected partners, yielding a rate ratio of 0.04 (95% confidence interval, 0.00-0.27) (23). Even if patients with HIV do not change their sexual behaviors after being diagnosed, this study highlights the value of early diagnosis and initiation of HAART to reduce viral transmission – another reason to believe that expanded screening could yield population-level benefits.
Conclusion
In summary, this comparison of the effectiveness of targeted (risk factor-based) and universal (routine opt-out) screening for HIV has highlighted multiple areas of evidence relevant to determining the optimal approach in the U.S. Provided that most persons who are offered HIV screening accept it, and that persons newly diagnosed with HIV subsequently modify high-risk behaviors to reduce viral transmission, the CDC’s recommendation for routine opt-out screening of adolescents and adults appears to be cost-effective. However, studies of opt-out screening performed in emergency department settings have thus far yielded disappointing results, identifying few new cases of HIV in persons without known risk factors, many of whom were diagnosed in symptomatic or late stages of disease. Harms of HIV screening are small, but may not necessarily outweigh benefits in low-risk populations. Finally, evidence that earlier initiation of HAART improves individual health outcomes and is highly effective at interrupting viral transmission has increased the relative benefits of HIV screening. Based on existing data, then, a routine opt-out screening approach such as that endorsed by the CDC is warranted in high-prevalence clinical settings; however, pending further studies, a risk factor-based approach such as the USPSTF’s is still reasonable in average or low-prevalence settings.
References 18-23
18. Chou R, Huffman LH, Fu R, Smits AK, Korthuis PT. Screening for HIV: a review of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med 2005;143:55-73.
19. Reust CE. Common adverse effects of antiretroviral therapy for HIV disease. Am Fam Physician 2011;83:1443-51.
20. Pollack KI, Krause KM, Yarnall KS, et al. Estimated time spent on preventive care services by primary care physicians. BMC Health Serv Res 2008;8:245.
21. Yarnall KS, Pollack KI, Ostbye T, et al. Primary care: is there time enough for prevention? Am J Public Health 2003;93:635-41.
22. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. U.S. Department of Health and Human Services. October 14, 2011; 1–167. Available at http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf.
23. Cohen MS, Chen YQ, McCauley M, et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med 2011;365:493-505.
**
Potential Harms and Competing Priorities
Potential harms of HIV testing include false positive results, anxiety, labeling, and adverse medication effects. True positive HIV results can be stigmatizing and lead to discrimination, loss of employment, verbal abuse, and physical assault in 1 to 4 percent of patients (18). A new HIV diagnosis does not seem to be associated with increased partner violence or dissolution of partner relationships in observational studies (18). Adverse effects of highly active antiretroviral therapies are less common today than in previous years, with more treatment options and simplified dosing schedules (19).
Although the overall magnitude of harms related to testing is thought to be small, the USPSTF judged in its 2005 guideline that the modest benefits of routinely screening persons without risk factors for HIV did not necessarily outweigh them (6). Furthermore, HIV testing does not occur in a clinical vacuum, but competes for time in the typical medical visit with many other pressing preventive, chronic, and acute care issues (20, 21). In medical practices that are not part of integrated health systems, the decision to implement or not implement routine opt-out screening for HIV may come down to individual clinicians’ judgments about the uncertain yield of such testing in their population versus competing clinical priorities. Or, as one author has argued: “It would be appropriate for those who want to prioritize preventive services based on proven benefits to adopt the USPSTF recommendation and individualize decisions about HIV screening of low-risk patients. … For clinicians who place a high value on potentially reducing HIV incidence and are more willing to accept plausible but unproven benefits, it might be reasonable to adopt the CDC recommendations” (9).
Altering the Balance of Benefits and Harms
Since the publication of the USPSTF guideline in 2005 and the CDC guideline in 2006, there have been important advances in HIV care that likely increase the relative benefits of universal screening. The improved tolerability of current HAART regimens, combined with evidence from observational studies that earlier initiation of HAART (rather than delayed initiation below a certain CD4 cell count) reduces mortality, led the Department of Health and Human Services to recommend treatment of all patients with CD4 counts below 500 cells/mm3, and to consider treatment for patients with higher CD4 counts (22). If earlier treatment of asymptomatic persons with HIV improves health outcomes compared to delayed treatment, then the benefits of earlier HIV detection through screening will be magnified.
In addition, a recent randomized controlled trial confirmed the benefits of HAART in reducing the risk of HIV transmission to sexual partners (23). This multicenter trial enrolled 1750 HIV-discordant heterosexual and male homosexual couples in sub-Saharan Africa, Asia, Latin America and the United States. All HIV-infected patients had a CD4 count of 350 to 550 cells/mm3 at baseline. In this trial, antiretroviral treatment of HIV-infected partners substantially reduced the incidence of seroconversion in uninfected partners, yielding a rate ratio of 0.04 (95% confidence interval, 0.00-0.27) (23). Even if patients with HIV do not change their sexual behaviors after being diagnosed, this study highlights the value of early diagnosis and initiation of HAART to reduce viral transmission – another reason to believe that expanded screening could yield population-level benefits.
Conclusion
In summary, this comparison of the effectiveness of targeted (risk factor-based) and universal (routine opt-out) screening for HIV has highlighted multiple areas of evidence relevant to determining the optimal approach in the U.S. Provided that most persons who are offered HIV screening accept it, and that persons newly diagnosed with HIV subsequently modify high-risk behaviors to reduce viral transmission, the CDC’s recommendation for routine opt-out screening of adolescents and adults appears to be cost-effective. However, studies of opt-out screening performed in emergency department settings have thus far yielded disappointing results, identifying few new cases of HIV in persons without known risk factors, many of whom were diagnosed in symptomatic or late stages of disease. Harms of HIV screening are small, but may not necessarily outweigh benefits in low-risk populations. Finally, evidence that earlier initiation of HAART improves individual health outcomes and is highly effective at interrupting viral transmission has increased the relative benefits of HIV screening. Based on existing data, then, a routine opt-out screening approach such as that endorsed by the CDC is warranted in high-prevalence clinical settings; however, pending further studies, a risk factor-based approach such as the USPSTF’s is still reasonable in average or low-prevalence settings.
References 18-23
18. Chou R, Huffman LH, Fu R, Smits AK, Korthuis PT. Screening for HIV: a review of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med 2005;143:55-73.
19. Reust CE. Common adverse effects of antiretroviral therapy for HIV disease. Am Fam Physician 2011;83:1443-51.
20. Pollack KI, Krause KM, Yarnall KS, et al. Estimated time spent on preventive care services by primary care physicians. BMC Health Serv Res 2008;8:245.
21. Yarnall KS, Pollack KI, Ostbye T, et al. Primary care: is there time enough for prevention? Am J Public Health 2003;93:635-41.
22. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. U.S. Department of Health and Human Services. October 14, 2011; 1–167. Available at http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf.
23. Cohen MS, Chen YQ, McCauley M, et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med 2011;365:493-505.
The case against universal HIV screening - Part 1 of 2
Today the U.S. Preventive Services Task Force released a draft statement that updates their previous (2005) recommendations on screening for HIV. Based on findings from a systematic review published in the Annals of Internal Medicine, the USPSTF now recommends routine HIV screening for all persons ages 15 to 65 years, regardless of risk status. Previously, the Task Force had only recommended screening in adolescents and adults at increased risk for HIV infection; this new statement, if finalized, makes the USPSTF's recommendations concordant with guidelines from the Centers for Disease Control and Prevention that have been in place since 2006.
I have had the privilege of caring for patients with HIV/AIDS since working in a Comprehensive Care Center during my family medicine residency. For the past eight years I have practiced in and around Washington, DC, which has the highest prevalence of HIV infection (3 percent) of any city in the United States. It is clear to me that all adults and sexually active adolescents in the DC area are at increased risk for HIV and should be offered routine HIV screening. Further, I believe that screening for HIV should be provided to any patient who requests it. Nonetheless, I disagree with the USPSTF's new recommendation for universal HIV screening in adolescents and adults. My next two posts, drawn from an unpublished paper that I presented in part at a Family Medicine Grand Rounds in November, 2011, explain why.
**
Although the introduction of highly active antiretroviral therapy has led to substantial declines in AIDS diagnoses and deaths from their peaks in the mid-1990s, an estimated 50,000 persons in the U.S. are infected with HIV each year, and more than 236,000 persons living with HIV are unaware of their diagnoses (1). Noting that many HIV infections occur in persons without identifiable risk factors, in 2006 the Centers for Disease Control and Prevention recommended routine opt-out testing of all persons between the ages of 13 and 64 in order to provide treatment at earlier stages of disease and curb behaviors associated with a high risk of HIV transmission (2). These recommendations, which have been endorsed by the American College of Physicians (3), the American Academy of Pediatrics (4), and the Office of National AIDS Policy (5), stand in contrast to those from the U.S. Preventive Services Task Force (USPTSF) (6) and the American Academy of Family Physicians (7), which support individualizing screening decisions in adolescents and adults not at increased risk of HIV infection.
I have had the privilege of caring for patients with HIV/AIDS since working in a Comprehensive Care Center during my family medicine residency. For the past eight years I have practiced in and around Washington, DC, which has the highest prevalence of HIV infection (3 percent) of any city in the United States. It is clear to me that all adults and sexually active adolescents in the DC area are at increased risk for HIV and should be offered routine HIV screening. Further, I believe that screening for HIV should be provided to any patient who requests it. Nonetheless, I disagree with the USPSTF's new recommendation for universal HIV screening in adolescents and adults. My next two posts, drawn from an unpublished paper that I presented in part at a Family Medicine Grand Rounds in November, 2011, explain why.
**
Although the introduction of highly active antiretroviral therapy has led to substantial declines in AIDS diagnoses and deaths from their peaks in the mid-1990s, an estimated 50,000 persons in the U.S. are infected with HIV each year, and more than 236,000 persons living with HIV are unaware of their diagnoses (1). Noting that many HIV infections occur in persons without identifiable risk factors, in 2006 the Centers for Disease Control and Prevention recommended routine opt-out testing of all persons between the ages of 13 and 64 in order to provide treatment at earlier stages of disease and curb behaviors associated with a high risk of HIV transmission (2). These recommendations, which have been endorsed by the American College of Physicians (3), the American Academy of Pediatrics (4), and the Office of National AIDS Policy (5), stand in contrast to those from the U.S. Preventive Services Task Force (USPTSF) (6) and the American Academy of Family Physicians (7), which support individualizing screening decisions in adolescents and adults not at increased risk of HIV infection.
Absent the USPSTF’s endorsement, routine HIV screening is not included in the list of preventive services that the 2010 Affordable Care Act requires health plans to cover without cost-sharing (8). Disagreements about the added value of a routine opt-out rather than risk factor-based screening approach may arise from differing interpretations of the former’s cost-effectiveness and potential benefits and harms (9). In this paper, I argue that while routine opt-out screening for HIV infection may be effective in many U.S. clinical settings, there is insufficient data to support universal implementation.
Cost Effectiveness
Any screening approach that tests more people is likely to diagnose more infections than a targeted approach. However, to be preferred to less intensive approaches, universal screening should also be cost-effective (diagnosing and treating additional infections at reasonable societal cost) and lead to improved health outcomes for infected patients and uninfected partners. To support its 2006 recommendations, the CDC relied on a mathematical model (10) that estimated that one-time universal HIV screening met a traditional cost-effectiveness threshold ($50,000 per quality-adjusted life-year) in settings with a HIV prevalence as low as 0.2 percent. The CDC suggests that routine opt-out screening can be discontinued when HIV prevalence is documented to be lower than 0.1 percent (2). In settings of higher HIV prevalence, universal screening every 3 or 5 years appears to be cost-effective (10). A key variable in this model is the impact of increasing diagnoses on changing risky behaviors and reducing HIV transmission rates, which has not been studied directly (11). A subsequent analysis projected that while expanded HIV screening alone will prevent few new infections, earlier initiation of antiretroviral therapy and modifications in risky sexual behavior together could reduce new infections by up to 65 percent (12).
In contrast, others have argued that the programmatic expense of fully implementing the 2006 CDC recommendations offers poor value relative to spending additional funds on pre- and post-test counseling within the existing risk factor-based screening infrastructure. According to a 2007 analysis, for the $864 million cost of offering routine opt-out testing to every American between the ages of 13 and 64, targeted counseling could potentially diagnose and prevent as 3 times as many HIV infections (13). This analysis was limited by its assumption that a substantial minority of patients offered HIV testing would decline it; the CDC, in contrast, observed that pregnant women rarely opt out of routine HIV testing, and asserted that uptake of testing in non-pregnant persons could be similarly high (2).
The vast majority of persons with HIV infection who are not diagnosed via screening will ultimately be diagnosed when they present to care with symptomatic AIDS. Therefore, a major benefit of routine opt-out testing is tied to identifying such persons earlier in the course of their infections, when antiretroviral medications and prophylaxis against opportunistic infections will prevent morbidity and mortality. The CDC guideline (2) and mathematical models that have postulated large benefits of expanded screening (10, 12) assume that a large number of persons will be diagnosed at early stages of disease.
Studies of Opt-Out Screening Effectiveness
Unfortunately, studies of routine opt-out HIV screening in emergency department settings have challenged this assumption. In a quasi-experimental time-samples study at a large emergency department in Denver, Colorado, researchers compared the effectiveness of opt-out rapid HIV testing with physician-directed diagnostic rapid HIV testing (14). More than 75 percent of eligible patients were either not offered or declined screening during the opt-out phase of the study; of the 6702 patients who received HIV testing, 10 (0.15%) tested positive. In contrast, 5 of 231(2.2%) patients who received HIV testing during the physician-directed phase tested positive for HIV. Moreover, 6 of 10 patients who tested positive during the opt-out phase had established risk factors for HIV infection (and would have been eligible for targeted screening) and 6 of 10 patients had CD4 counts lower than 350/µL. Similarly, in a study of opt-out rapid HIV testing in 29 emergency departments in metropolitan Paris, France, only 27% of 78,000 eligible patients were offered testing and only 16% (12,754) were actually tested (15). Of the 18 patients (0.14%) who tested positive, all but 1 belonged to a high-risk group, and 8 already had symptoms suggestive of opportunistic infections or AIDS.
One could argue that despite the large sample sizes of these two studies, the effectiveness of universal HIV screening can only be evaluated on a national level. The CDC recently reported the results of its Expanded HIV Testing Initiative, a program that provided more than $100 million from 2007-2010 to health departments in 24 U.S. states and the District of Columbia to increase screening rates and linkages to care among populations disproportionately affected by HIV, such as African Americans (16). To qualify for funding, health departments had to have reported at least 140 AIDS diagnoses among African Americans in 2005. Of more than 2.7 million HIV tests performed during the initiative, nearly 30,000 (1.1%) were positive, and the majority of patients with positive tests had not previously been aware of their HIV diagnosis (16). As encouraging as these results are, they are more supportive of the effectiveness of targeted testing (mostly performed in communities with well above-average HIV prevalence) than universal screening.
In 2009, the Veterans Administration implemented a new HIV testing policy in its health system that is consistent with the CDC’s 2006 recommendations for routine opt-out testing. Between 2009 and 2010, among VA patients with at least one outpatient visit, an electronic health record analysis indicated significant increases in the percentages of patients who had ever been tested for HIV (9.2 to 13.5 percent) and those who had been tested during that calendar year (2.9 to 5.8 percent) (17). Positive results were reported in 0.7 to 1.2 percent of tested patients; data was not available on how many of these patients were previously undiagnosed, would have been eligible for testing in a risk factor-based approach, or were diagnosed at preclinical stages of HIV infection (17).
- continued in my next post -
References 1-17
1. Centers for Disease Control and Prevention. HIV surveillance - United States, 1981-2008. MMWR Morb Mortal Wkly Rep 2011;60:689-93.
2. Centers for Disease Control and Prevention. Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR Recomm Rep 2006;55(RR-14):1-17.
3. Qaseem A, Snow V, Shekelle P, et al. Screening for HIV in health care settings: a guidance statement from the American College of Physicians and HIV Medicine Association. Ann Intern Med 2009;150:125-31.
4. American Academy of Pediatrics. Adolescents and HIV infection: the pediatrician’s role in promoting routine testing. Pediatrics 2011;128:1023-29.
5. Office of National AIDS Policy. National HIV/AIDS Strategy. Washington, DC: Office of National AIDS Policy; 2010. Available at: http://www.whitehouse.gov/administration/eop/onap/nhas
6. U.S. Preventive Services Task Force. Screening for HIV: recommendation statement. Ann Intern Med 2005;143:32-7.
7. Rodnick JE. The CDC and USPSTF recommendations for HIV testing. Am Fam Physician 2007;76:1456-59.
8. Bayer R, Oppenheimer GM. Routine HIV screening – what counts in evidence-based policy? N Engl J Med 2011;365:1265-8.
9. Chou R. Routine screening for chronic human immunodeficiency virus infection: why don’t the guidelines agree? Epidemiol Rev 2011;33:7–19.
10. Paltiel AD, Walensky RP, Schackman BR, et al. Expanded HIV screening in the United States: effect on clinical outcomes, HIV transmission, and costs. Ann Intern Med 2006;145:797-806.
11. Chou R, Huffman L. Screening for human immunodeficiency virus: focused update of a 2005 systematic evidence review for the U.S. Preventive Services Task Force. AHRQ Pub No. 07-0597-EF-1. Agency for Healthcare Research and Quality, April 2007. Available at: http://www.ncbi.nlm.nih.gov/books/NBK33475/
12. Long EF, Brandeau ML, Owens DK. The cost-effectiveness and population outcomes of expanded HIV screening and antiretroviral treatment in the United States. Ann Intern Med 2010;153;778-89.
13. Holtgrave DR. Costs and consequences of the US Centers for Disease Control and Prevention’s recommendations for opt-out HIV testing. PLoS Med 2007;4:e194.
14. Haukoos JS, Hopkins E, Conroy AA. Routine opt-out rapid HIV screening and detection of HIV infection in Emergency Department patients. JAMA 2010;304:284-92.
15. Wilson d’Almeida K, Kierzek G, Truchis P, et al. Modest public health impact of nontargeted human immunodeficiency virus screening in 29 emergency departments. Arch Intern Med 2011 Oct 24 [Epub ahead of print] doi:10.1001/archinternmed.2011.535
16. Centers for Disease Control and Prevention. Results of the expanded HIV testing initiative – 25 jurisdictions, United States, 2007-2010. MMWR Morb Mortal Wkly Rep 2011;60:805-10.
17. Halloran J, Czarnogorski M, Dursa EK, et al. HIV testing in the Department of Veterans Affairs, 2009-2010. Arch Intern Med 2011 Oct 24 [Epub ahead of print] doi:10.1001/archinternmed.2011.510
Cost Effectiveness
Any screening approach that tests more people is likely to diagnose more infections than a targeted approach. However, to be preferred to less intensive approaches, universal screening should also be cost-effective (diagnosing and treating additional infections at reasonable societal cost) and lead to improved health outcomes for infected patients and uninfected partners. To support its 2006 recommendations, the CDC relied on a mathematical model (10) that estimated that one-time universal HIV screening met a traditional cost-effectiveness threshold ($50,000 per quality-adjusted life-year) in settings with a HIV prevalence as low as 0.2 percent. The CDC suggests that routine opt-out screening can be discontinued when HIV prevalence is documented to be lower than 0.1 percent (2). In settings of higher HIV prevalence, universal screening every 3 or 5 years appears to be cost-effective (10). A key variable in this model is the impact of increasing diagnoses on changing risky behaviors and reducing HIV transmission rates, which has not been studied directly (11). A subsequent analysis projected that while expanded HIV screening alone will prevent few new infections, earlier initiation of antiretroviral therapy and modifications in risky sexual behavior together could reduce new infections by up to 65 percent (12).
In contrast, others have argued that the programmatic expense of fully implementing the 2006 CDC recommendations offers poor value relative to spending additional funds on pre- and post-test counseling within the existing risk factor-based screening infrastructure. According to a 2007 analysis, for the $864 million cost of offering routine opt-out testing to every American between the ages of 13 and 64, targeted counseling could potentially diagnose and prevent as 3 times as many HIV infections (13). This analysis was limited by its assumption that a substantial minority of patients offered HIV testing would decline it; the CDC, in contrast, observed that pregnant women rarely opt out of routine HIV testing, and asserted that uptake of testing in non-pregnant persons could be similarly high (2).
The vast majority of persons with HIV infection who are not diagnosed via screening will ultimately be diagnosed when they present to care with symptomatic AIDS. Therefore, a major benefit of routine opt-out testing is tied to identifying such persons earlier in the course of their infections, when antiretroviral medications and prophylaxis against opportunistic infections will prevent morbidity and mortality. The CDC guideline (2) and mathematical models that have postulated large benefits of expanded screening (10, 12) assume that a large number of persons will be diagnosed at early stages of disease.
Studies of Opt-Out Screening Effectiveness
Unfortunately, studies of routine opt-out HIV screening in emergency department settings have challenged this assumption. In a quasi-experimental time-samples study at a large emergency department in Denver, Colorado, researchers compared the effectiveness of opt-out rapid HIV testing with physician-directed diagnostic rapid HIV testing (14). More than 75 percent of eligible patients were either not offered or declined screening during the opt-out phase of the study; of the 6702 patients who received HIV testing, 10 (0.15%) tested positive. In contrast, 5 of 231(2.2%) patients who received HIV testing during the physician-directed phase tested positive for HIV. Moreover, 6 of 10 patients who tested positive during the opt-out phase had established risk factors for HIV infection (and would have been eligible for targeted screening) and 6 of 10 patients had CD4 counts lower than 350/µL. Similarly, in a study of opt-out rapid HIV testing in 29 emergency departments in metropolitan Paris, France, only 27% of 78,000 eligible patients were offered testing and only 16% (12,754) were actually tested (15). Of the 18 patients (0.14%) who tested positive, all but 1 belonged to a high-risk group, and 8 already had symptoms suggestive of opportunistic infections or AIDS.
One could argue that despite the large sample sizes of these two studies, the effectiveness of universal HIV screening can only be evaluated on a national level. The CDC recently reported the results of its Expanded HIV Testing Initiative, a program that provided more than $100 million from 2007-2010 to health departments in 24 U.S. states and the District of Columbia to increase screening rates and linkages to care among populations disproportionately affected by HIV, such as African Americans (16). To qualify for funding, health departments had to have reported at least 140 AIDS diagnoses among African Americans in 2005. Of more than 2.7 million HIV tests performed during the initiative, nearly 30,000 (1.1%) were positive, and the majority of patients with positive tests had not previously been aware of their HIV diagnosis (16). As encouraging as these results are, they are more supportive of the effectiveness of targeted testing (mostly performed in communities with well above-average HIV prevalence) than universal screening.
In 2009, the Veterans Administration implemented a new HIV testing policy in its health system that is consistent with the CDC’s 2006 recommendations for routine opt-out testing. Between 2009 and 2010, among VA patients with at least one outpatient visit, an electronic health record analysis indicated significant increases in the percentages of patients who had ever been tested for HIV (9.2 to 13.5 percent) and those who had been tested during that calendar year (2.9 to 5.8 percent) (17). Positive results were reported in 0.7 to 1.2 percent of tested patients; data was not available on how many of these patients were previously undiagnosed, would have been eligible for testing in a risk factor-based approach, or were diagnosed at preclinical stages of HIV infection (17).
- continued in my next post -
References 1-17
1. Centers for Disease Control and Prevention. HIV surveillance - United States, 1981-2008. MMWR Morb Mortal Wkly Rep 2011;60:689-93.
2. Centers for Disease Control and Prevention. Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR Recomm Rep 2006;55(RR-14):1-17.
3. Qaseem A, Snow V, Shekelle P, et al. Screening for HIV in health care settings: a guidance statement from the American College of Physicians and HIV Medicine Association. Ann Intern Med 2009;150:125-31.
4. American Academy of Pediatrics. Adolescents and HIV infection: the pediatrician’s role in promoting routine testing. Pediatrics 2011;128:1023-29.
5. Office of National AIDS Policy. National HIV/AIDS Strategy. Washington, DC: Office of National AIDS Policy; 2010. Available at: http://www.whitehouse.gov/administration/eop/onap/nhas
6. U.S. Preventive Services Task Force. Screening for HIV: recommendation statement. Ann Intern Med 2005;143:32-7.
7. Rodnick JE. The CDC and USPSTF recommendations for HIV testing. Am Fam Physician 2007;76:1456-59.
8. Bayer R, Oppenheimer GM. Routine HIV screening – what counts in evidence-based policy? N Engl J Med 2011;365:1265-8.
9. Chou R. Routine screening for chronic human immunodeficiency virus infection: why don’t the guidelines agree? Epidemiol Rev 2011;33:7–19.
10. Paltiel AD, Walensky RP, Schackman BR, et al. Expanded HIV screening in the United States: effect on clinical outcomes, HIV transmission, and costs. Ann Intern Med 2006;145:797-806.
11. Chou R, Huffman L. Screening for human immunodeficiency virus: focused update of a 2005 systematic evidence review for the U.S. Preventive Services Task Force. AHRQ Pub No. 07-0597-EF-1. Agency for Healthcare Research and Quality, April 2007. Available at: http://www.ncbi.nlm.nih.gov/books/NBK33475/
12. Long EF, Brandeau ML, Owens DK. The cost-effectiveness and population outcomes of expanded HIV screening and antiretroviral treatment in the United States. Ann Intern Med 2010;153;778-89.
13. Holtgrave DR. Costs and consequences of the US Centers for Disease Control and Prevention’s recommendations for opt-out HIV testing. PLoS Med 2007;4:e194.
14. Haukoos JS, Hopkins E, Conroy AA. Routine opt-out rapid HIV screening and detection of HIV infection in Emergency Department patients. JAMA 2010;304:284-92.
15. Wilson d’Almeida K, Kierzek G, Truchis P, et al. Modest public health impact of nontargeted human immunodeficiency virus screening in 29 emergency departments. Arch Intern Med 2011 Oct 24 [Epub ahead of print] doi:10.1001/archinternmed.2011.535
16. Centers for Disease Control and Prevention. Results of the expanded HIV testing initiative – 25 jurisdictions, United States, 2007-2010. MMWR Morb Mortal Wkly Rep 2011;60:805-10.
17. Halloran J, Czarnogorski M, Dursa EK, et al. HIV testing in the Department of Veterans Affairs, 2009-2010. Arch Intern Med 2011 Oct 24 [Epub ahead of print] doi:10.1001/archinternmed.2011.510
Wednesday, November 14, 2012
Strategies for preventing physician burnout
Although they probably came as little surprise to physicians who practice primary care, the results of a national survey of physician burnout in the Archives of Internal Medicine earlier this year made headlines in The New York Times and The Atlantic. This study found that 1) physicians are more likely to experience symptoms of burnout than similarly educated workers in the U.S. general population; and 2) physicians on the front lines of care access - family physicians, general internists, and emergency medicine physicians - had the highest rates of burnout.
A Curbside Consultation in the November 1st issue of American Family Physician discussed the distinct but closely related problem of demoralization in a family physician who serves as the part-time medical director for a financially troubled clinic for children with developmental disorders. This physician was forced to accept layoffs of several key staff members without a corresponding decrease in workload:
She recognized the great need of these children and families, and had talked with other staff and administration about additional programs she wanted to develop. She now would have to say good-bye to coworkers and abandon her hopes for a larger and more robust program. She realized that the remaining staff, herself included, would have to work harder, and that she would have less time to spend with patients, the part of the work she found most fulfilling. Patients who needed the most help would, in fact, get less help. ... Over the next week, she became dejected and sad.
A Curbside Consultation in the November 1st issue of American Family Physician discussed the distinct but closely related problem of demoralization in a family physician who serves as the part-time medical director for a financially troubled clinic for children with developmental disorders. This physician was forced to accept layoffs of several key staff members without a corresponding decrease in workload:
She recognized the great need of these children and families, and had talked with other staff and administration about additional programs she wanted to develop. She now would have to say good-bye to coworkers and abandon her hopes for a larger and more robust program. She realized that the remaining staff, herself included, would have to work harder, and that she would have less time to spend with patients, the part of the work she found most fulfilling. Patients who needed the most help would, in fact, get less help. ... Over the next week, she became dejected and sad.
In the accompanying commentary, Dr. Stewart Gabel connected the often temporary state of demoralization to the more serious and persistent state of burnout:
Demoralization is a state of hopelessness and helplessness that is akin to, but separable from, depression. It is associated with a sense of subjective incompetence, the belief that a person is unable to express his or her values and achieve his or her goals. Demoralization has an existential dimension that is associated with the affected person's experienced losses. ... Moving past demoralization involves remoralization, or the renewal of one's personal values and the activities that stem from these values. ... However, if not addressed, persistent feelings of demoralization are likely to result in or contribute to burnout.
Demoralization is a state of hopelessness and helplessness that is akin to, but separable from, depression. It is associated with a sense of subjective incompetence, the belief that a person is unable to express his or her values and achieve his or her goals. Demoralization has an existential dimension that is associated with the affected person's experienced losses. ... Moving past demoralization involves remoralization, or the renewal of one's personal values and the activities that stem from these values. ... However, if not addressed, persistent feelings of demoralization are likely to result in or contribute to burnout.
How can physicians prevent the demands of practicing present-day medicine from leading them down the road to burnout? An article in Family Practice Management suggested eight ideas, including joining a physician support group; strengthening interpersonal communication skills; and making it a priority to address the spiritual needs of patients and themselves.
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The above post first appeared on the AFP Community Blog.
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The above post first appeared on the AFP Community Blog.
Sunday, November 11, 2012
Lockboxes, Medicare reform, and the myth of "free stuff"
Recently, I had an interesting conversation with my dad about the current policy debates involving the Medicare program. Since he, along with my mother, is one of the two most important Medicare beneficiaries in my life, hearing his perspective was immensely valuable. Essentially, my dad said that what really upsets him when politicians describe Medicare is the use of the term "entitlement," which implies that people like my parents who paid Medicare taxes for several decades doesn't deserve to reap the full benefits of that investment.
I pointed out that the reason Medicare is running out of money is that the dollar value of health benefits that seniors use today far exceeds the amount they paid in to the system thirty, twenty, or even ten years ago, since Medicare only began to pay for prescription drugs in 2006 and annual increases in the cost of health care have exceeded inflation since, well, forever. He countered that it was totally appropriate for retirees to get back more than they put in, since all good investors expect their money to grow over time. He's right. The problem with this argument isn't his fault: the federal government doesn't put revenue from Medicare payroll taxes into the stock market, a savings account, or even the "lockbox" that Al Gore made famous during the 2000 presidential campaign. It spends those dollars, immediately, often on programs that have nothing to do with health care for seniors.
As a nation, we can and should debate the best ways to keep Medicare solvent for my generation and my children's generation. The President and Congress could, for example, turn the program into one with fixed costs but not necessarily fixed benefits. They could agree to large increases in the payroll tax that funds the program, rather than continuing the temporary payroll tax holiday put in to place to cushion families from the worst of the recession. They could cut Medicare payments to doctors by 30 percent, cross their fingers, and hope that at least a few of us would continue to see Medicare patients anyway. They could do some or all of these things at the same time.
What we as citizens cannot do is allow them to continue to point fingers at each other and, for purely political reasons, avoid the question of what to do. Which brings me to one of my pet peeves about health reform in general, and the Affordable Care Act in particular: the selling of reforms as good because they provide people who already have health insurance with more "free stuff." Thanks to the ACA / Congressional Democrats / President Obama, a typical political ad will say, women can now get free mammograms, Pap smears, cholesterol tests, and birth control pills! Isn't that great? This kind of ad is misleading because none of the preventive health services defined by the bill have suddenly become free. In fact, some cost hundreds or even thousands of dollars. Instead, the costs of these (often but not always worthwhile) services have just been shifted - into higher insurance premiums, on to an employer, or to the federal government (and therefore the individual taxpayer or an international investor that holds some portion of the U.S.'s $16 trillion national debt).
The above discussion notwithstanding, my fellow blogger Josh Freeman recently made the very good point that health should generally not be considered a commodity, but a social good. I supported most provisions of the Affordable Care Act because its implementation will eventually allow millions more Americans to more reliably access health care, especially primary care, when they need it. As a family physician, I do not believe that any group of people "deserves" health care any more than others. My dad and mom deserve their health care. But so do I, so do my wife and kids, and so do you and your loved ones. And our country will never have an honest debate about health reform as a social good and a shared sacrifice if we let politicians of both parties, only concerned about the next election, portray it as a false choice between rationing and free stuff.
I pointed out that the reason Medicare is running out of money is that the dollar value of health benefits that seniors use today far exceeds the amount they paid in to the system thirty, twenty, or even ten years ago, since Medicare only began to pay for prescription drugs in 2006 and annual increases in the cost of health care have exceeded inflation since, well, forever. He countered that it was totally appropriate for retirees to get back more than they put in, since all good investors expect their money to grow over time. He's right. The problem with this argument isn't his fault: the federal government doesn't put revenue from Medicare payroll taxes into the stock market, a savings account, or even the "lockbox" that Al Gore made famous during the 2000 presidential campaign. It spends those dollars, immediately, often on programs that have nothing to do with health care for seniors.
As a nation, we can and should debate the best ways to keep Medicare solvent for my generation and my children's generation. The President and Congress could, for example, turn the program into one with fixed costs but not necessarily fixed benefits. They could agree to large increases in the payroll tax that funds the program, rather than continuing the temporary payroll tax holiday put in to place to cushion families from the worst of the recession. They could cut Medicare payments to doctors by 30 percent, cross their fingers, and hope that at least a few of us would continue to see Medicare patients anyway. They could do some or all of these things at the same time.
What we as citizens cannot do is allow them to continue to point fingers at each other and, for purely political reasons, avoid the question of what to do. Which brings me to one of my pet peeves about health reform in general, and the Affordable Care Act in particular: the selling of reforms as good because they provide people who already have health insurance with more "free stuff." Thanks to the ACA / Congressional Democrats / President Obama, a typical political ad will say, women can now get free mammograms, Pap smears, cholesterol tests, and birth control pills! Isn't that great? This kind of ad is misleading because none of the preventive health services defined by the bill have suddenly become free. In fact, some cost hundreds or even thousands of dollars. Instead, the costs of these (often but not always worthwhile) services have just been shifted - into higher insurance premiums, on to an employer, or to the federal government (and therefore the individual taxpayer or an international investor that holds some portion of the U.S.'s $16 trillion national debt).
The above discussion notwithstanding, my fellow blogger Josh Freeman recently made the very good point that health should generally not be considered a commodity, but a social good. I supported most provisions of the Affordable Care Act because its implementation will eventually allow millions more Americans to more reliably access health care, especially primary care, when they need it. As a family physician, I do not believe that any group of people "deserves" health care any more than others. My dad and mom deserve their health care. But so do I, so do my wife and kids, and so do you and your loved ones. And our country will never have an honest debate about health reform as a social good and a shared sacrifice if we let politicians of both parties, only concerned about the next election, portray it as a false choice between rationing and free stuff.
Wednesday, November 7, 2012
Redefining Alzheimer's dementia: for better or for worse?
Last year, the National Institute on Aging and the Alzheimer's Association published new criteria for the diagnosis of Alzheimer's disease that include biomarker measurements in addition to traditional clinical criteria. The rationale for the new guideline was that more sensitive criteria were needed in order to test interventions to prevent Alzheimer's disease; by the time symptoms are obvious, proponents argue, it is likely too late to alter the patient's prognosis. However, the downside to creating a new category of "pre-symptomatic Alzheimer's" is that many otherwise healthy adults could now receive an Alzheimer's diagnosis when there is no effective treatment - a label that leads to no health benefit and possible psychological harm. Therefore, experts recommend that this category only be used for patients who are enrolled in clinical trials of Alzheimer's prevention.
In an editorial in American Family Physician, Drs. Carla Perissinotto and Victor Valcour reviewed the numerous gaps in the evidence for preventing dementia that complicate public health strategies for reducing the rising incidence and morbidity from this chronic disease. They argued that current knowledge supports a tertiary prevention strategy:
It is reasonable to look to prior public health campaigns as models for our educational and prevention efforts for dementia. Educational efforts should first focus on ensuring that the public understands that a diagnosis of dementia represents a spectrum of cognitive impairment, and that Alzheimer disease is only one of several subtypes. Until strategies targeting primary and secondary prevention emerge, our greatest impact may be in tertiary prevention—in the prevention of dementia morbidity. Such work may require early recognition, in which strategies targeting home and financial safety have a clear impact on those at highest risk.
Family physicians have always played an important role in caring for patients with dementia and their caregivers. In addition to prevention, Alzheimer's patients must make difficult decisions about the initiation and discontinuation of drug therapies, which have modest, time-limited benefits that are frequently exaggerated in deceptive advertisements.
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A modified version of the above post first appeared on the AFP Community Blog.
In an editorial in American Family Physician, Drs. Carla Perissinotto and Victor Valcour reviewed the numerous gaps in the evidence for preventing dementia that complicate public health strategies for reducing the rising incidence and morbidity from this chronic disease. They argued that current knowledge supports a tertiary prevention strategy:
It is reasonable to look to prior public health campaigns as models for our educational and prevention efforts for dementia. Educational efforts should first focus on ensuring that the public understands that a diagnosis of dementia represents a spectrum of cognitive impairment, and that Alzheimer disease is only one of several subtypes. Until strategies targeting primary and secondary prevention emerge, our greatest impact may be in tertiary prevention—in the prevention of dementia morbidity. Such work may require early recognition, in which strategies targeting home and financial safety have a clear impact on those at highest risk.
Family physicians have always played an important role in caring for patients with dementia and their caregivers. In addition to prevention, Alzheimer's patients must make difficult decisions about the initiation and discontinuation of drug therapies, which have modest, time-limited benefits that are frequently exaggerated in deceptive advertisements.
**
A modified version of the above post first appeared on the AFP Community Blog.
Tuesday, November 6, 2012
Why you should vote in today's elections
- President Abraham Lincoln at Gettysburg, Pennsylvania, November 19, 1863
Four score and seven years ago our fathers brought forth on this continent a new nation, conceived in liberty, and dedicated to the proposition that all men are created equal.
Now we are engaged in a great civil war, testing whether that nation, or any nation, so conceived and so dedicated, can long endure. We are met on a great battle-field of that war. We have come to dedicate a portion of that field, as a final resting place for those who here gave their lives that that nation might live. It is altogether fitting and proper that we should do this.
Four score and seven years ago our fathers brought forth on this continent a new nation, conceived in liberty, and dedicated to the proposition that all men are created equal.
Now we are engaged in a great civil war, testing whether that nation, or any nation, so conceived and so dedicated, can long endure. We are met on a great battle-field of that war. We have come to dedicate a portion of that field, as a final resting place for those who here gave their lives that that nation might live. It is altogether fitting and proper that we should do this.
But, in a larger sense, we can not dedicate, we can not consecrate, we can not hallow this ground. The brave men, living and dead, who struggled here, have consecrated it, far above our poor power to add or detract.
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| African-American Civil War Memorial |
The world will little note, nor long remember what we say here, but it can never forget what they did here. It is for us the living, rather, to be dedicated here to the unfinished work which they who fought here have thus far so nobly advanced.
It is rather for us to be here dedicated to the great task remaining before us—that from these honored dead we take increased devotion to that cause for which they gave the last full measure of devotion—that we here highly resolve that these dead shall not have died in vain—that this nation, under God, shall have a new birth of freedom—and that government of the people, by the people, for the people, shall not perish from the earth.
Sunday, November 4, 2012
To protect patients, practice guidelines must meet higher standards
Recent news stories have suggested that many of the ills of our health system could be prevented if more physicians followed guidelines on appropriate indications for tests and treatments. For example, a Wonkblog post by The Washington Post's Sarah Kliff noted that 43 percent of cardiac surgeries performed in Michigan were unnecessary, according to practice guidelines. Kliff attributed the disconnect between guidelines and physicians' behavior to two factors: 1) surgeons who perform more surgery earn more income for themselves and their institutions; and 2) the "oculostenotic reflex," which Kliff defined as "the 'irresistible temptation' on the part of interventional cardiologists to expand narrowed coronary arteries, despite ... guidelines suggesting the use of a different intervention, such as medication (which comes with fewer risks and at a lower cost)." Extended across other medical specialties that tend to provide too many aggressive (and profitable) interventions, another way to say this is that if you've got a hammer, everything looks like a nail.
But how can clinicians be sure that a practice guideline is any good? In an article published in American Family Physician a few years ago, family medicine professor David Slawson and I proposed several attributes that health professionals should use to identify good clinical practice guidelines. Here's our list, which became the basis for a lecture I gave in the spring and fall of this year at the Temple University Family Practice Review Course:
1. Comprehensive, systematic evidence search with end date noted
2. Evidence linked directly to recommendations via strength of recommendation grading system
3. Recommendations based on patient-oriented rather than disease-oriented outcomes
4. Transparent guideline development process
5. Potential conflicts of interest identified and addressed
6. Prospectively validated (i.e., guideline use has been shown to improve patient-oriented outcomes)
7. Recommendations offer flexibility in various clinical situations
In 2011, an Institute of Medicine panel published an important report titled Clinical Practice Guidelines We Can Trust. Despite not having consulted Dr. Slawson or me, they produced a longer list of standards for developing trustworthy clinical practice guidelines that was nonetheless very similar to ours. Later that year, the American Cancer Society announced that it would revise its methods for creating cancer screening guidelines to be consistent with the IOM's standards.
That's a positive step, especially for a group that has produced some poor-quality guidelines in the past, but are others doing the same? Unfortunately, no. A recent study in the Archives of Internal Medicine surveyed a random sample of 130 guidelines in AHRQ's National Guideline Clearinghouse for adherence to the IOM's standards. The findings were disappointing, to say the least: "Fewer than half of the guidelines surveyed met more than 50% of the IOM standards. Barely a third of the guidelines produced by subspecialty societies satisfied more than 50% of the IOM standards surveyed." In the straightforward words of an editorial that accompanied the study, "guidelines are still not following guidelines."
In a fee-for-service payment system, doctors already have few incentives to follow practice guidelines, resulting not only in unnecessary heart surgery, but other abuses of patients such as excessive rates of screening colonoscopy. And as the Archives study showed, even conscientious physicians who provide guideline-concordant care may in fact be relying on documents that are worth little more than the paper they are printed on, especially if they were written by specialists whose incomes depend on doing more consultations and procedures.
The bottom line is that all of us - patients, advocates, policymakers, and health professionals alike - must demand that guideline-producing organizations meet higher standards. Groups that continue to convene guideline panels with financial and other conflicts of interest; continue to value the opinions of specialists more than those of generalists; and continue to make strong recommendations based on disease-oriented evidence or, worse yet, no evidence at all; should be called out for what they are: a clear and present danger to the health and well-being of every person who seeks health care.
But how can clinicians be sure that a practice guideline is any good? In an article published in American Family Physician a few years ago, family medicine professor David Slawson and I proposed several attributes that health professionals should use to identify good clinical practice guidelines. Here's our list, which became the basis for a lecture I gave in the spring and fall of this year at the Temple University Family Practice Review Course:
1. Comprehensive, systematic evidence search with end date noted
2. Evidence linked directly to recommendations via strength of recommendation grading system
3. Recommendations based on patient-oriented rather than disease-oriented outcomes
4. Transparent guideline development process
5. Potential conflicts of interest identified and addressed
6. Prospectively validated (i.e., guideline use has been shown to improve patient-oriented outcomes)
7. Recommendations offer flexibility in various clinical situations
In 2011, an Institute of Medicine panel published an important report titled Clinical Practice Guidelines We Can Trust. Despite not having consulted Dr. Slawson or me, they produced a longer list of standards for developing trustworthy clinical practice guidelines that was nonetheless very similar to ours. Later that year, the American Cancer Society announced that it would revise its methods for creating cancer screening guidelines to be consistent with the IOM's standards.
That's a positive step, especially for a group that has produced some poor-quality guidelines in the past, but are others doing the same? Unfortunately, no. A recent study in the Archives of Internal Medicine surveyed a random sample of 130 guidelines in AHRQ's National Guideline Clearinghouse for adherence to the IOM's standards. The findings were disappointing, to say the least: "Fewer than half of the guidelines surveyed met more than 50% of the IOM standards. Barely a third of the guidelines produced by subspecialty societies satisfied more than 50% of the IOM standards surveyed." In the straightforward words of an editorial that accompanied the study, "guidelines are still not following guidelines."
In a fee-for-service payment system, doctors already have few incentives to follow practice guidelines, resulting not only in unnecessary heart surgery, but other abuses of patients such as excessive rates of screening colonoscopy. And as the Archives study showed, even conscientious physicians who provide guideline-concordant care may in fact be relying on documents that are worth little more than the paper they are printed on, especially if they were written by specialists whose incomes depend on doing more consultations and procedures.
The bottom line is that all of us - patients, advocates, policymakers, and health professionals alike - must demand that guideline-producing organizations meet higher standards. Groups that continue to convene guideline panels with financial and other conflicts of interest; continue to value the opinions of specialists more than those of generalists; and continue to make strong recommendations based on disease-oriented evidence or, worse yet, no evidence at all; should be called out for what they are: a clear and present danger to the health and well-being of every person who seeks health care.