Diagnostic Invasiveness and Psychosocial Consequences of False-Positive Mammography

Bruno Heleno; Volkert Dirk Siersma; John Brodersen

doi:10.1370/afm.1762

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Author Reply to Dr. Arleo and to Dr Newell
Bruno Heleno

Published on: 18 May 2015
Falso positives as harms?
Mary S. Newell, MD

Published on: 14 May 2015
Misleading underlying premises
Elizabeth K. Arleo

Published on: 14 May 2015

Published on: (18 May 2015)
Page navigation anchor for Author Reply to Dr. Arleo and to Dr Newell
Author Reply to Dr. Arleo and to Dr Newell
Bruno Heleno, PhD-student
Other Contributors:
We thank Dr. Arleo and Dr. Newell for their interest in our work.
A) It is our impression that we are assigning different meanings to the word harm. We recognise that some dictionaries describe harm as "physical injury",(1) but by harm, we are thinking of the definition used in the CONSORT extension for harms(2): "The totality of possible adverse consequences of an intervention or therapy (...)". Recently, the h...
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We thank Dr. Arleo and Dr. Newell for their interest in our work.
A) It is our impression that we are assigning different meanings to the word harm. We recognise that some dictionaries describe harm as "physical injury",(1) but by harm, we are thinking of the definition used in the CONSORT extension for harms(2): "The totality of possible adverse consequences of an intervention or therapy (...)". Recently, the harms of screening were organised in four categories: physical, psychological, economic and opportunity costs.(3)
B) We agree that false-positives are seen in all tests. But we think there is a significant difference in diagnostic and screening tests because people undergoing screening they are often expecting reassurance that they are healthy,(4-6) positive tests come as a surprise and this generates anxiety and other negative psychosocial consequences. This is in contrast to people with symptoms, who are already alarmed that something might be wrong with them.
C) The adverse psychological consequences of false-positive mammography decreased with time, but persisted for the 36 months of follow-up. At the moment, we cannot tell whether the difference between women in the false-positive group and women with normal results was clinically relevant.
D) We agree that psychosocial harm should be taken in the broader context, and weighed against the potential benefits of screening. We are, however, concerned that the effect of screening in breast cancer mortality is less than the 40% found by model studies. A meta-analysis of the three randomised trials at low risk of bias describes a non-significant relative risk reduction of only 10% at 13 years of follow-up, and when all trials are included the relative risk reduction is of 19% (statistically significant).(7)
E) We also think that absolute figures are more informative to women than relative risk reduction, especially when multiple outcomes are being compared.(8,9) So to put psychosocial harm into its broader context, we can estimate that for every 1000 women screened biennially from age 50 to 70 years:
i. 68 would have breast cancer,(10)
ii. 4 would had their lives saved by screening, (10)
iii. 13 out of the 68 would be overdiagnosed.(10)
iv. Between 200 to 613 would have at least one false-positive mammography.(11,12)
We maintain our study conclusions: there is no evidence that use of more invasive diagnostics was associated with worse psychosocial consequences, and the invasiveness of subsequent diagnostic procedures does not help to identify women at higher risk for adverse psychosocial consequences of false-positive mammography. Finally, interventions to limit the psychosocial harm of mammography screening should focus on reducing the total number of false-positive tests.
References
1. Harm [Internet]. Oxford Dictionaries. [cited 2015 May 14]. Available from: http://www.oxforddictionaries.com/definition/english/harm
2. Ioannidis JPA, Evans SJW, Gotzsche PC, O'Neill RT, Altman DG, Schulz K, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med. 2004 Nov 16;141(10):781-8.
3. Harris RP, Sheridan SL, Lewis CL, Barclay C, Vu MB, Kistler CE, et al. The Harms of Screening: A Proposed Taxonomy and Application to Lung Cancer Screening. JAMA Internal Medicine. 2014 Feb 1;174(2):281.
4. Padgett DK, Yedidia MJ, Kerner J, Mandelblatt J. The emotional consequences of false positive mammography: African-American women's reactions in their own words. Women Health. 2001;33(3-4):1-14.
5. Solbjor M, Forsmo S, Skolbekken J-A, Sotnan AR. Experiences of Recall After Mammography Screening--A Qualitative Study. Health Care for Women International. 2011 Nov;32(11):1009-27.
6. Lindberg LG, Svendsen M, Domgaard M, Brodersen J. Better safe than sorry: a long-term perspective on experiences with a false-positive screening mammography in Denmark. Health Risk Soc. 2013 Oct 25;1-18.
7. Gotzsche PC, Jorgensen KJ. Screening for breast cancer with mammography. Cochrane Database Syst Rev. 2013;6:CD001877.
8. Akl EA, Oxman AD, Herrin J, Vist GE, Terrenato I, Sperati F, et al. Using alternative statistical formats for presenting risks and risk reductions. Cochrane Database Syst Rev. 2011;(3):CD006776.
9. Hoffrage U, Gigerenzer G. Using natural frequencies to improve diagnostic inferences. Acad Med. 1998 May;73(5):538-40.
10. The Independent UK Panel on Breast Cancer Screening. The benefits and harms of breast cancer screening: an independent review. The Lancet. 2012 Nov;380(9855):1778-86.
11. Roman M, Hubbard R, Sebuodegard S, Miglioretti D, Castells X, Hofvind S. The cumulative risk of false-positive results in the Norwegian Breast Cancer Screening Program: updated results. Cancer. 2013 Nov 15;119(22):3952-8.
12. Hubbard RA, Kerlikowske K, Flowers CI, Yankaskas BC, Zhu W, Miglioretti DL. Cumulative probability of false-positive recall or biopsy recommendation after 10 years of screening mammography: a cohort study. Ann Intern Med. 2011 Oct 18;155(8):481-92.
Competing interests: None declared
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Competing Interests: None declared.
Published on: (14 May 2015)
Page navigation anchor for Falso positives as harms?
Falso positives as harms?
Mary S. Newell, MD, Associate Professor of Radiology and Imaging Sciences
I read with interest the results of Dr. Heleno's and associates study ("Diagnostic Invasiveness and Psychosocial Consequences of False-Positive Mammography") but suggest that its findings are best considered in a larger context:
-False positive results are by no means specific to screening mammography. They are an inherent part of all testing. They should not be ascribed as a "harm" in this situation any more t...
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I read with interest the results of Dr. Heleno's and associates study ("Diagnostic Invasiveness and Psychosocial Consequences of False-Positive Mammography") but suggest that its findings are best considered in a larger context:
-False positive results are by no means specific to screening mammography. They are an inherent part of all testing. They should not be ascribed as a "harm" in this situation any more than to the myriad of tests we order every day without consideration of the anxiety that may ensue.
-While the authors showed that psychosocial consequences were initially elevated with false positive screening results, they subsequently largely subsided.
-Most importantly, while 272 (out of 30,00 screened) women experienced some initial psychosocial consequences as a result of false positive testing, 174 had their breast cancer diagnosed before it became clinically evident, thereby improving their chance for cure and potentially lessening the intensity of treatment.
Examination of the risks of a test must be balanced by consideration of its benefits: in this situation, I would consider it a "no-contest" call.
Competing interests: None declared
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Competing Interests: None declared.
Published on: (14 May 2015)
Page navigation anchor for Misleading underlying premises
Misleading underlying premises
Elizabeth K. Arleo, Assistant Professor of Radiology, Assistant Attending Radiologist
The stated hypothesis of the study by Heleno et al was that women with false-positive mammography managed with biopsy have worse psychosocial consequences than those managed with just additional imaging. A "false positive" is defined as test result which erroneously indicates a particular condition. Although the authors concluded that the study provided no evidence to support this hypothesis, there are several misleading...
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The stated hypothesis of the study by Heleno et al was that women with false-positive mammography managed with biopsy have worse psychosocial consequences than those managed with just additional imaging. A "false positive" is defined as test result which erroneously indicates a particular condition. Although the authors concluded that the study provided no evidence to support this hypothesis, there are several misleading underlying premises. In their opening sentence, the authors state that "the psychological consequences of false-positive findings are among the important harms of mammography screening." However, by definition, false-positive results are not unique to screening mammography -- they are a risk inherent to all medical tests, not just to breast imaging. Furthermore, harm is defined as physical damage - therefore, a "false positive" is a risk of mammography screening (and all other medical tests), not a harm. Finally, what should ultimately be emphasized is that whatever the arguable risks, they are far outweighed by benefits of screening mammography, namely: a nearly 40% reduction in deaths from breast cancer in women ages 40-84 who have annual screening mammography, and decreased morbidity (e.g., fewer mastectomies, less frequent and less toxic chemotherapy) as well (Hendrick RE, Helvie MA, Hardesty LA, Implications of CISNET modeling on number needed to screen and mortality reduction with digital mammography in women 40-49 years old. 2014;203(6):1379-81.).
Competing interests: None declared
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Competing Interests: None declared.