RSS Feeds
Published letters
Displaying 1-10 letters out of 2287 published
-
"Screening for Breast Cancer: U.S. Preventive Services Task Force Recommendation Statement
Submit responseThe data search for published evidence from the RCTs used by the USPSTF ended in December 2008. In June 2009 Holmberg et al. (1) published a review of the data from the Swedish Two-County Trial, which showed that the methodology used in the previous overview (2) "resulted in a reduction of the estimate of the effect of screening." Data from this previous overview (2) were used for both the 2002 and 2009 USPSTF evaluations. Although this latest Swedish overview (1) did not present results specific to age categories, the material is available for such an analysis. It is unfortunate that none of the members of the USPSTF were aware of these recently revealed flaws in their database at the time when they were in the lengthy process of deciding that the benefits of mammography screening were less than previously calculated. A more concerted effort to communicate with individuals currently working with breast cancer screening could easily have brought this newer information to their attention.
The USPSTF evaluation (3) and supporting articles are plagued with ambiguity over the use of the terms "screen" and "screening" when used alone or in conjunction with the term "mammography." Whereas the evidence of benefit has been drawn exclusively from "intention to treat" publications, the numerical conclusions have been directly applied by the USPSTF to the case of the individual woman seeking advice from her physician. If the USPSTF evaluation is taken at face value, women will be told the estimated benefit of receiving an invitation to participate in a mammography screening program, a benefit considerably lower, by a factor of approximately 1.4, than the benefit of her actually getting mammograms (4).
The harms, on the contrary, are not calculated on an "intention to basis," so the USPSTF has introduced a considerable bias into their benefit/risk calculations.
The USPSTF purports to determine, in its own words, "potential harms" and limitations of the test(3)." The additional benefits of actually getting a mammogram have been measured in Sweden using the ongoing service screening programs (5), and results specific for women aged 40-49 have been submitted for publication. It does not appear to make good sense for the USPSTF to intentionally ignore such publications when attempting to answer their own question, since the analysis of benefit is jeopardized by exclusive reliance upon historic RCT data that were designed to answer a different question.
References
1. Holmberg L, Duffy SW, Yen AM, Tabar L, Vitak B, Nystrom L, Frisell J. Differences in endpoints between the Swedish W-E (two county) trial of mammographic screening and the Swedish overview: methodological consequences. J Med Screen. 2009;16(2):73-80.
2. Nystrom L, Andersson I, Bjurstam N, Frisell J, Nordenskojld B, Rutqvist LE. Long-term effects of mammography screening: updated overview of the Swedish randomised trials. Lancet. 2002 Mar 16;359(9310):909-19. Erratum in: Lancet 2002 Aug 31;360(9334):724.
3. U.S. Preventive Services Task Force. Screening for depression in adults: U.S. preventive services task force recommendation statement. Ann Intern Med. 2009 Dec 1;151(11):784-92.
4. Duffy SW, Tabar L, Chen HH, Holmqvist M, Yen MF, Abdsalah S, Epstein B, Frodis E, Ljungberg E, Hedborg-Melander C, Sundbom A, Tholin M, Wiege M, Akerlund A, Wu HM, Tung TS, Chiu YH, Chiu CP, Huang CC, Smith RA, Rosen M, Stenbeck M, Holmberg L. The impact of organized mammography service screening on breast carcinoma mortality in seven Swedish counties. Cancer. 2002 Aug 1;95(3):458-69.
5. Swedish Organised Service Screening Evaluation Group. Reduction in breast cancer mortality from organized service screening with mammography: 1. Further confirmation with extended data. Cancer Epidemiol Biomarkers Prev. 2006 Jan;15(1):45-51.
Conflict of Interest:
None declared
-
Rationing Health Care or Rational Health Care for Breast Cancer Screening?
Submit responseThe US Preventative Services Task Force's guidelines sensibly conclude that the decision about mammography should be an individual one, reflecting the patient's values regarding specific benefits and harms.(1) However, the Task Force did little to enable women to understand these risks and benefits and did not help women to make sound choices about screening. For women in their 40s, a 55% chance of a false alarm (2) to prevent one breast cancer death for every 1900 women screened was considered unacceptable. Curiously, they reached the opposite conclusion for women in their 50s, where "only" a 46% chance of a false alarm to prevent one breast cancer death for 1300 women screened is acceptable. The difference between 1 in 1300 and 1 in 1900 (0.053% vs. 0.077%) is so small that it is difficult to imagine a woman for whom it would matter, making this an odd policy distinction. This is a classic "close call" or "toss-up," and either choice should be acceptable.(3)
Other factors to consider are the psychological stress of treatment and the reassurance of having "done everything possible" by being screened. Women are entitled to know the chances that mammography will uncover a treatable cancer and the chances that screening will lead to useless, risky treatment. Reasonable women could make different choices, depending on how they feel about these risks and benefits. Rather than having numbers dictate their decision, women should decide how high a risk they want to take for how much potential benefit.
The public debate sadly veered to whether the Task Force served the interests of bureaucrats, eager to ration medical care, and insurance companies, eager to deny coverage. But history is repeating itself. A dozen years ago, an NIH consensus panel created similar guidelines and similarly suggested that women in their 40's 'decide for themselves' about screening.(4) Public reaction was similar: widespread concern that the recommendations were driven by health care costs, not science.(5) We should have learned that the motivation behind guidelines is easily misconstrued and that the public does not trust expert panels.
Patients cannot make informed medical decisions without adequate information that is clearly communicated. The difference between rationing health care and rational health care lies in who makes the decision. If policy makers or insurers limit the availability of tests, it feels like rationing. However, if informed patients choose to forego tests that are less effective, it becomes rational decision making.
References
1. Clinical Guidelines: Screening for Breast Cancer: U.S. Preventive Services Task Force Recommendation Statement. Ann Intern Med, November 17, 2009 151:716-26.
2. Christiansen CL, Wang F, Barton MB, Kreuter W, Elmore JG, Gelfand AE, Fletcher SW. Predicting the Cumulative Risk of False-Positive Mammograms. J Natl Cancer Inst 2000;92:1657-66.
3. Kassirer JP, Pauker SG. The "Toss Up". NEJM 1981;305:1467-69.
4. NIH Consensus statement. Breast Cancer Screening for Women Ages 40-49. NIH Consensus Statement. January 21-23, 1997;15:1-35.
5. Woloshin S, Schwartz L, Byram SJ, Sox HC, Fischhoff B, Welch GH. Women's understanding of the mammography screening debate. Arch Int Med 2000;160:1434-40.
Conflict of Interest:
None declared
-
Three Degrees of Separation
Submit responseDear Dr. Beckman, I have just finished reading your essay in the Annals. In my case, I am a nephrologist and not a "primary care" doctor per se. However, as you know, I have long term relationships with my patients extending years before and after their admissions. It seems now that the admission stands alone; that there is no past or future for the patient. I rarely get called by the ED or admitting hospitalist despite the fact that I can often facilitate care of the patient and expedite discharge on the basis of seeing the patient at dialysis 3 times a week. The essence of what has been lost, in my mind, is a sense of relationship and deeper meaning in what we do. The existing incentive assumes we are driven by monetary gain rather than our belief that we can mean something to patients even when we don't have a pill or test for them. I congratulate you on an excellent series of insights. I anticipate physicians will understand well what you are writing about. I worry that administrators, policy makers, and decision makers will not.
Conflict of Interest:
None declared
-
Risk Models for Breast Cancer Screening of Women in Their Forties
Submit responseThe U.S. Preventive Services Task Force recommended "against routine screening mammography in women aged 40 to 49 years," writing that the decision should be based on "patient context, including the patient's values regarding specific benefits and harms." These criteria do not explicitly include risk assessment. Indeed, the report (1) seems to dismiss risk assessment based on "demographic, physical or historical risk factors for breast cancer", stating that "none conveys clinically important absolute increased risk for cancer."
Although age is the most important risk factor over long age intervals, it is not as important as other risk factors over the age range 40 to 50 years. In 1998, Gail and Rimer (2) suggested that a woman in her forties should consider mammographic screening if her absolute risk was as great as that of a fifty year old women without other risk factors, because benefits are thought to outweigh risks for such a fifty year old woman, and, as argued in (2), the same should be true for a younger woman with comparable risk. The ratio of incidence rates of a fifty year old white woman with no risk factors to a forty year old white women with no risk factors is 2.46 (2). If the forty year old has risk factors that increase her risk at least 2.46 times above baseline, she has at least the absolute risk of the fifty year old. Many risk factors, such as two affected first-degree relatives, atypical hyperplasia, and at least 75% dense tissue on a mammogram have relative risks that exceed 2.46, as do many combinations of weaker risk factors (2, 3). For a 48 year old woman, risk factors need to increase baseline risk by only 6% to put her at the risk of a 50 year old with no risk factors (2).
Recent data (1) that screening reduces breast cancer mortality by 15% in women aged 39-49 and by 14% in women aged 50-59 only strengthen arguments (2) that a woman in the age range 40-49 years with the same absolute risk as a fifty year old woman has a similar ratio of benefits to adverse effects, such as false positive results requiring further evaluation. Thus, risk factors in addition to age should be considered when counseling a woman in her forties whether or not to have screening mammograms. Of course, "the patient's values regarding specific benefits and harms" should also be considered, as recommended by the Task Force (1).
References
1.U.S. Preventive Services Task Force. Screening for Breast Cancer: U.S. Preventive Services task Force Recommendation Statement. Ann Intern Med. 2009;151:716-726 [PMID: 19920273]
2.Gail M, Rimer B. Risk-based recommendations for mammographic screening for women in their forties. J Clin Oncol. 1998 Sep;16:3105-14. [PMID: 9738582]
3.Gail MH, Brinton LA, Byar DP, Corle DK, Green SB, Schairer C, Mulvihill JJ. Projecting individualized probabilities of developing breast cancer for white females who are being examined annually. J Natl Cancer Inst. 1989;81:1879-86. [PMID: 2593165]
Conflict of Interest:
None declared
-
response to dr. Finckh
Submit responseI think dr Finkh and I agree on most of the issues, but we differ in the wording of our conclusions. Scientifically it is wise to avoid firm conclusions in the face of shaky evidence. A model can never fully replace reality, and we probably need another 10 years of additional experience with biologics to be fully certain. Nevertheless, when we trust the model and it points unmistakably in one direction, we shouldn't be afraid to clearly communicate what it shows. This is especially important in the area of biologics in RA, where intense marketing pressure exists to push opinions in the other direction. In his reaction, dr Finkh uses a whole paragraph to describe the uncertainties inherent in modeling to conclude with the sentence I would have liked to have seen in the original article: "our findings support the use of aggressive DMARDs before biologics in very early RA from a cost-effectiveness perspective." It would have been even better if he would have said: "our findings CLEARLY support..." etc.
In his response to the glucocorticoid question, I feel dr Finkh is side-stepping my point that not modeling glucocorticoids is an unfortunate omission in the study. That glucocorticoids "in the doses originally used" (i.e., high doses) have many side effects is stating the obvious. He misrepresents our review on the published evidence of the safety of low- dose glucocorticoids (1) when he uses it to conclude that "the long term risk/benefit ratio of lower doses is debated." In fact, what we showed was that the popular conviction on the unacceptable harm of long-term low-dose glucocorticoid therapy in RA is based on poor quality or even nonexistent data; and that the, admittedly limited, good quality data that is available actually supports the contrary view that harms are limited and manageable. Together with strong evidence on benefit it follows that the role of this class of drugs in RA should no longer be ignored. Thus the study's value would have been greatly enhanced by including glucocorticoids explicitly in the model.
In contrast to dr. Finkh's belief, data shows practitioners in the field have already got the message: current glucocorticoid use in RA in North America is dynamic, but these drugs are not being used only to "put out fires" but applied for extended periods in many patients(2).
REFERENCES
1. Da Silva JA, Jacobs JW, Kirwan JR, et al. Safety of low dose glucocorticoids treatment in rheumatoid arthritis: published evidence and prospective trial data. Ann Rheum Dis 2006;65:285-93.
2. Caplan C, Wolfe F, Russell AS, et al. Corticosteroid use in rheumatoid arthritis: prevalence, predictors, correlates, and outcomes. J Rheumatol 2007;34:696-705.
Conflict of Interest:
None declared
-
An age specific clear guideline for management of subclinical hypothyroidism
Submit responseIn the clinical review on Hypothyroidism (published on December 01, 2009) the authors stated that patients who have serum TSH levels higher than 10 mU/L should be considered for thyroid replacement treatment and patients with serum TSH levels of 5 to 10 mU/L should also be considered for treatment if they have symptoms of thyroid hormone deficiency. This statement is not acceptable for all age groups particularly the elderly population. Evidence suggests that the mean serum TSH ranges from 1.2 to 1.5 mIU/L and the upper limit for the 97.5th percentile is 2.5 mIU/L(1). The reanalysis of NHANES III data shows, in a population without reported or known thyroid disease or antithyroid antibodies, not taking thyroid medication, and with no other risk factors for thyroid dysfunction (reference population), the 97.5th percentile of the TSH upper limit is approximately 5.9 mIU/L in people who are aged 70 to 79 years and 7.5 mIU/L in those 80 years and older, indicating higher concentrations of TSH with increasing age(2). Prior research also indicates that the prevalence of subclinical hypothyroidism increases with age, affecting approximately 6% of persons aged 70 to 79 years and 10% of those 80 years or older(3). Moreover, one study reports that subclinical hypothyroidism occurs in about 15 percent of women over the age of 60 years(4). Although subclinical hypothyroidism does not significantly affect functional mobility in elderly(5), its risk of progression to overt hypothyroid disease, elevated lipid levels, increased risk of cognitive impairment, and cardiovascular conditions, including myocardial infarction is well recognized. Therefore, it would be important to have an age specific clear guideline for management of subclinical hypothyroidism.
References
1. Wartofsky L, Dickey RA. The evidence for a narrower thyrotropin reference range is compelling. J Clin Endocrinol Metab. 2005;90(9):5483- 5488.
2. Hollowell, JG, Staehling, NW, Flanders, WD, et al. Serum TSH, T4 and thyroid antibodies in the United States population (1988 to 1994): National Health and Examination Survey (NHANES III). J Clin Endocrinol Metab 2002; 87:489-499.
3. Surks MI, Hollowell JG. Age-specific distribution of serum thyrotropin and antithyroid antibodies in the US population: implications for the prevalence of subclinical hypothyroidism. J Clin Endocrinol Metab. 2007;92(12):4575-4582.
4. Sawin, CT, Chopra, D, Azizi, F, et al. The aging thyroid. Increased prevalence of elevated serum thyrotropin levels in the elderly. JAMA 1979; 242:247.
5. Simonsick EM et al. Subclinical Hypothyroidism and Functional Mobility in Older Adults. Arch Intern Med. 2009;169(21):2011-2017.
Conflict of Interest:
None declared
-
Screening for Breast Cancer: An Update for the US Preventive Services Task Force
Submit responseThe recent changes to the U.S. Preventive Services Task Force (USPSTF) breast cancer screening recommendations are welcome and reflect the best available current evidence (1). The updated systematic review by Heidi Nelson and colleagues, which is the basis for the changes, concurs substantially with the relevant Cochrane review on mammography and indeed also the Cochrane review of breast self-examination or clinical examination(2,3,4).
Those raising concerns about the Nelson review should be reassured that the summary breast cancer mortality reduction of 15% from screening mammography is a comparable figure to that presented in the Cochrane review, which was performed independently, and leads to similar estimates of the numbers needed to invite for examination to prevent or delay one death from breast cancer.
Perhaps the most important addition to the revised USPSTF recommendations is the examination of harms from screening, in particular false positive results and over-diagnosis. Again, the figures for false positive results are similar across the two reviews, and suggest that almost half of the women screened 10 times in the US may expect at least one falsely positive result as a consequence of mammography. Both the USPSTF and Cochrane reviews found over-diagnosis related to mammography to be a concern, although the estimation of its frequency varies between the two assessments.
Evidence-based decision making requires high quality reliable reviews. The similar findings of the Nelson and Cochrane reviews should be reassuring to women working with their doctors to make an evidence- informed decision about screening mammography.
References
1. US Preventive Services Task Force. Screening for breast cancer: US Preventive Services Task Force Recommendation Statement. Ann Intern Med 2009; 151:716-726.
2. Nelson HD, Tyne K, Naik A, Bougatsos C, Chan BK, Humphrey L. Screening for Breast Cancer: An Update for the U.S. Preventive Services Task Force. Ann Intern Med 2009; 151: 727-37.
3. Gotzsche PC, Nielsen M. Screening for breast cancer with mammography. Cochrane Database of Systematic Reviews 2009, Issue 4. Art. No.: CD001877. DOI: 10.1002/14651858.CD001877.pub3.
4. Kosters JP, Gotzsche PC. Regular self-examination or clinical examination for early detection of breast cancer. Cochrane Database of Systematic Reviews 2003, Issue 2. Art. No.: CD003373. DOI: 10.1002/14651858.CD003373.
Conflict of Interest:
All authors are members of the Cochrane Collaboration, which has published related reviews.
-
Keep Lemierre's syndrome in the back of your mind.
Submit responseBased on a recent serious case of a sore throat we have seen in our facility (1), I concur with the importance of the spreading the awareness among health care providers and the ER physicians about Lemierre's syndrome and expanding the pharyngitis paradigm for young patients. Being one of the critical care team residents that time, I had the chance to take care of that young patient who presented with a simple complaint of sore throat then was complicated with serious life threatening issues. I keep that diagnosis in the back of my mind every time I see young patient with atypical presentation of sore throat. From my perspective, I believe that anecdotal evidence also has a significant role in practice change because the source of practice change was not only based on medical literature but also related to that anecdotal event.
References:
(1) A sore throat--potentially life-threatening? Li HY, Grubb M, Panda M, Jones R. J Gen Intern Med. 2009 Jul;24(7):872-5. Epub 2009 May 10.
Conflict of Interest:
None declared
-
Would Insuring the Near-Elderly Reduce Medicare Spending Beginning at Age 65?
Submit responseMcWilliams and colleagues (1) find that Medicare spending is higher for the previously uninsured and use this finding to suggest that nearly half of the cost of expanding health insurance coverage to uninsured near- elderly adults might be offset by reduced spending once the age of 65 has been reached. We do not believe this research supports the notion of cost savings from insuring the uninsured, because a large fraction of higher Medicare expenditures observed for the previously uninsured cannot be avoided by insuring people earlier. As pointed out by Bhattacharya (2), this may be particularly true if poor health caused them to be uninsured rather than poor health resulting from lack of insurance.
McWilliams and colleagues are unable to adequately control for this reverse causation. This problem is exacerbated by including in their sample individuals from the Health and Retirement Study who acquired public insurance after 1992 but before turning age 65. (Of these, individuals who are ever uninsured before turning 65 are included in the "uninsured" sample.) Adults who transition to public insurance before age 65 are likely to have had a health event that led them to become eligible for public insurance. This health event may have also caused them to be uninsured prior to obtaining public coverage. For example, individuals who quality for Medicare prior to age 65 due to participation in Social Security Disability Insurance (SSDI) qualify only after a 24-month waiting period following SSDI entitlement. Since they must be too disabled to work in order to qualify for SSDI, a substantial fraction are uninsured during the waiting period. (3) According to our estimates using McWilliams' sample definitions, 25% of the "uninsured" but only 11% of the "insured" transitioned to public insurance before turning 65. Because the disabled are more likely to use health care services and because their health characteristics are not adequately captured in the control variables, the McWilliams estimate includes spending that could not be avoided by insuring the uninsured. Our calculations suggest that the McWilliams estimate of the difference in Medicare spending between the uninsured and insured would drop by 50% if those ever public insured before age 65 are dropped from the sample.
Unrealistic expectations about the cost of health reform could lead to early dissatisfaction with reform efforts and result in their curtailment. The costs of insuring the near-elderly uninsured are unlikely to be offset by significant reductions in Medicare spending after age 65.
References
1. McWilliams JM, Meara E, Zaslavsky AM, Ayanian JZ. Medicare spending for previously uninsured adults. Ann Intern Med. 2009;151.
2. Bhattacharya J. Insuring the Near-Elderly: How Much Would Medicare Save? Ann Intern Med. 2009;151.
3. Riley GF. Health Insurance and Access to Care among Social Security Disability Insurance Beneficiaries during the Medicare Waiting Period. Inquiry. 2006. 43; 222-230.
Note: The views expressed in this letter reflect those of the authors and do not necessarily represent the views of the Centers for Disease Control and Prevention.
Conflict of Interest:
None declared
-
False-positive mammography results cause breast cancer-related distress
Submit responseTwo recent U.S. Preventive Services Task Force (USPSTF) statements on screening for breast cancer identify harms of false-positive mammography screening test results, including psychological distress (1,2). Unfortunately, the reports drift away from published evidence about psychological distress from false-positive mammograms. The summary report dismisses the problem: "Anxiety, distress, and other psychosocial effects can exist with abnormal mammography results but fortunately are usually transient (1)." We believe this statement mischaracterizes the empirical literature, and indeed what the USPSTF reports to an extent in its own detailed concurrent report (2), which more correctly states that "False-positive mammography results had no consistent effect on most women's general anxiety and depression but increased breast cancer specific distress, anxiety, apprehension, and perceived breast cancer risk for some (2)." This statement is consistent with our own recent research where we found that false-positive mammography results cause small but reliable elevations in breast cancer-specific distress (3).
The USPSTF summary also comes to a different conclusion about transience of the effects of false-positive mammograms (1,2) than two previous systematic reviews (4,5). Brett et al. state that "women who have further investigations following their routine mammogram experience significant anxiety in the short-term, and possibly in the long-term (4)." Brett et al. did not emphasize the transience of false-positive's effects as a general finding. Similarly, our own systematic review concluded that the effects of false-positive mammography results endure over the long-term, well after cancer has been ruled out (5). We believe the correct conclusion is that false-positive mammography results cause small but reliable distress that endures for months and years.
References
1. US Preventive Services Task Force. Screening for breast cancer: U.S. Preventive Services Task Force Recommendation Statement. Ann Intern Med. 2009; 151(10):716-26.
2. Nelson HD, Tyne K, Naik A, Bougatsos C, Chan BK, Humphrey L; U.S. Preventive Services Task Force. Screening for breast cancer: An update for the U.S. Preventive Services Task Force. Ann Intern Med. 2009; 151(10):727-37.
3. Salz T, Richman A, Brewer NT. The long-term consequences of false- positive mammograms on outcomes specific to breast cancer. Pyscho- oncology. Forthcoming.
4. Brett J, Bankhead C, Henderson B, Watson E, Austoker J. The psychological impact of mammographic screening. A systematic review. Psycho-Oncology. 2005; Nov 14(11):917-938.
5. Brewer NT, Salz T, Lillie SE. Systematic review: The long-term effects of false-positive mammograms. Annals of Internal Medicine. 2007; 146(7):502-510.
Conflict of Interest:
None declared