Letters
The likelihood of this magnitude of imbalance is not known; from a clinical perspective it seems low, but it is possible that clusters of unmeasured confounders could create large imbalances. Even though the methods used in their study were sophisticated, observational studies are vulnerable to residual confounding. For example, a large body of observational data on the relationship between cardiovascular disease and postmenopausal hormone therapy overwhelmingly suggested benefit prior to the Women’s Health Initiative Clinical Trial, which proved that hormone therapy did not reduce the risk of heart disease and actually increased the risk of stroke.2,3 I agree with Roumie and colleagues that well-performed observational studies such as theirs provide invaluable information for both patients and their physicians, but I also urge caution in drawing causal inferences based on observational data, even with highly sophisticated analytic methods. Monika M. Safford, MD Author Affiliation: Department of Medicine, University of Alabama, Birmingham. Corresponding Author: Monika M. Safford, MD, Department of Medicine, University of Alabama, 1717 11th Ave S, Birmingham, AL 35294 ([email protected]). Conflict of Interest Disclosures: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. 1. Roumie CL, Greevy RA, Grijalva CG, et al. Association between intensification of metformin treatment with insulin vs sulfonylureas and cardiovascular events and all-cause mortality among patients with diabetes. JAMA. 2014;311(22): 2288-2296. 2. Rossouw JE, Anderson GL, Prentice RL, et al; Writing Group for the Women’s Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women’s Health Initiative randomized controlled trial. JAMA. 2002;288(3):321-333. 3. Shumaker SA, Legault C, Rapp SR, et al; WHIMS Investigators. Estrogen plus progestin and the incidence of dementia and mild cognitive impairment in postmenopausal women: the Women’s Health Initiative Memory Study: a randomized controlled trial. JAMA. 2003;289(20):2651-2662.
Breast Cancer Screening With Tomosynthesis and Digital Mammography To the Editor Dr Friedewald and colleagues1 demonstrated improved performance with both lower recall rates and improved invasive cancer detection by adding tomosynthesis to digital mammography. The report also documented the continued large variability of recall rates and cancer detection rates among sites.2 This variation may be even greater among individual radiologists. Recall rates in several facilities were higher than recommended in guidelines of the American College of Radiology (ACR),3,4 and recall rates with digital mammography alone also exceeded the guideline recall rate. With digital mammography alone, 7 of the 13 sites were above the ACR desirable goal of a 10% or less recall rate2 and 4 of 13 sites did not meet the more recent ACR goal for a recall rate of 12% or less.3 After adding tomosynthesis, which should decrease recall, 4 of 13 sites did not meet the standard of 10% or less, 2 of 13 did not meet the newer standard of 12% or less, 2 sites in-
creased recall rate over digital mammography alone, and 1 did not change. Consistent improvement in cancer detection was observed. This study does more than show improvement in performance with a new technology, bringing performance closer to recommended metrics. The value of audits, normative benchmark data5 such as the ACR National Mammography database program, and the critical role of optimal mammographic interpretation along with appropriate technology have been emphasized. David Seidenwurm, MD Robert Rosenberg, MD Author Affiliations: Sutter Medical Group, Sacramento, California (Seidenwurm); Radiology Associates of Albuquerque, Albuquerque, New Mexico (Rosenberg). Corresponding Author: David Seidenwurm, MD, Sutter Medical Group, 1500 Expo Pkwy, Sacramento, CA 95815 ([email protected]). Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Seidenwurm reported receiving personal fees for medical legal consulting as an expert witness and for serving as a reviewer for the American College of Radiology; receiving travel expenses from the American College of Radiology, National Quality Forum, AMP PCPI, and Radiological Associates of Sacramento; and having an ownership interest in Radiological Associates of Sacramento. No other disclosures were reported. 1. Friedewald SM, Rafferty EA, Rose SL, et al. Breast cancer screening using tomosynthesis in combination with digital mammography. JAMA. 2014;311(24): 2499-2507. 2. Rosenberg RD, Yankaskas BC, Abraham LA, et al. Performance benchmarks for screening mammography. Radiology. 2006;241(1):55-66. 3. American College of Radiology. ACR BI-RADS. Reston, VA: American College of Radiology; 2003. 4. Sickles E, Dorsi C. ACR BI-RADS: Follow-up and Outcome Monitoring. Reston, VA: American College of Radiology; 2013. 5. Schell MJ, Yankaskas BC, Ballard-Barbash R, et al. Evidence-based target recall rates for screening mammography. Radiology. 2007;243(3):681-689.
In Reply Drs Seidenwurm and Rosenberg correctly point out that the mean recall rate in our study with digital mammography alone (10.7%) was slightly higher than the ACR guidelines of 10% or less. This is not surprising given that prior analyses of performance benchmarks of mammographic interpretation in the United States have consistently acknowledged that recall rates in clinical practice commonly exceed these ACR guidelines.1,2 Recognition of this challenge led to the inclusion of a wider range of target recall rates (from 5% to 12%) in the latest outcome monitoring section of the ACR’s breast imaging reporting and data system (BI-RADS) guide.3 The range of recall rates seen in our study reinforces the representative nature of the practices included. It is well known that recall rates vary because of multiple issues, ranging from patient-level factors (eg, the presence or absence of prior studies, the interval since prior study, and breast density) to reader-level factors (eg, training and volume read), and to site-related factors (centers for comprehensive breast imaging vs centers for screening only).4 We did not investigate the basis for the diversity of performance across our sites and readers. However, as
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JAMA October 22/29, 2014 Volume 312, Number 16
Copyright 2014 American Medical Association. All rights reserved.
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Seidenwurm and Rosenberg suggest, continual monitoring with feedback is important so radiologists may assess their personal performance. This type of evaluation should be encouraged in all practices, regardless of the characteristics of the breast imaging site or the level of specialization of the interpreting radiologists. We chose not to exclude examinations read early after the implementation of tomosynthesis, which possibly falsely elevated the overall recall rate during this period. It is clear that there is a learning curve associated with interpreting mammography in general.5 For tomosynthesis, this curve may be steeper than with conventional mammography because the reader must learn to confidently ignore findings that would ordinarily be recalled on standard mammography but that do not persist on the tomosynthesis images. The 2 sites that failed to show a decrease in recall rate when tomosynthesis was added were sites that had either a short period of implementation or a small volume of cases per radiologist. These outcomes suggest the importance of training and experience in optimizing interpretation of this new technology. In addition, the link between the recall rate and the cancer detection rate has been well documented.6 Higher recall rates theoretically will lead to higher cancer detection rates. However, as we demonstrated in our study, when tomosynthesis was added, there was an increase in cancer detection in 12 of the 13 sites that was simultaneously coupled with a decrease in recall rate for 11 of the 13 sites. This could not be achieved strictly through improved adherence to recommended guidelines. More research investigating patient-level, physicianlevel, and site-level characteristics would be useful to further delineate how best to use this technology to maximize outcomes and personalize breast cancer screening. Sarah M. Friedewald, MD Elizabeth A. Rafferty, MD Emily F. Conant, MD Author Affiliations: Caldwell Breast Center, Advocate Lutheran General Hospital, Park Ridge, Illinois (Friedewald); Department of Radiology, Massachusetts General Hospital, Boston (Rafferty); Department of Radiology, University of Pennsylvania, Philadelphia (Conant). Corresponding Author: Sarah M. Friedewald, MD, Caldwell Breast Center, Center for Advanced Care, Advocate Lutheran General Hospital, 1700 Luther Ln, Park Ridge, IL 60068 ([email protected]). Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Drs Friedewald and Rafferty reported receiving a grant from Hologic Inc for the original study. Dr Conant reported receiving a grant from the National Cancer Institute. Drs Friedewald and Conant also reported serving on a scientific advisory board for Hologic. 1. Rosenberg RD, Yankaskas BC, Abraham LA, et al. Performance benchmarks for screening mammography. Radiology. 2006;241(1):55-66. 2. Carney PA, Sickles EA, Monsees BS, et al. Identifying minimally acceptable interpretive performance criteria for screening mammography. Radiology. 2010;255(2):354-361. 3. Dorsi CJ, Sickles EA, Mendelson EB, et al. Follow-up and outcome monitoring. In: ACR BI-RADS Atlas: Breast Imaging Reporting and Data System. Reston, VA: American College of Radiology; 2013:29. 4. Buist DS, Anderson ML, Haneuse SJ, et al. Influence of annual interpretive volume on screening mammography performance in the United States. Radiology. 2011;259(1):72-84. 1696
5. Miglioretti DL, Gard CC, Carney PA, et al. When radiologists perform best: the learning curve in screening mammogram interpretation. Radiology. 2009;253 (3):632-640. 6. Gur D, Sumkin JH, Hardesty LA, et al. Recall and detection rates in screening mammography. Cancer. 2004;100(8):1590-1594.
Addressing the Trauma of Hospitalization To the Editor Drs Detsky and Krumholz1 highlighted an important problem facing hospitalized patients and their family members and suggested interventions to reduce the potential for traumatization by the experience of being hospitalized for a medical illness or surgical procedure. However, hospitalization is not inherently traumatizing for all patients, and interventions targeting posthospitalization syndrome should also consider premorbid patient characteristics. Nearly one-third of patients surviving intensive care unit hospitalizations may have clinically important posttraumatic stress disorder, depressive symptoms, or both during the year after their hospitalization,2 and a key risk factor for these outcomes in the aftermath of medicalsurgical hospitalization not considered by Detsky and Krumholz is a premorbid history of psychiatric illness. Patients with a prior history of depressive or anxiety disorders are more likely to develop symptoms of psychological distress prior to hospital discharge, which could interfere with in-hospital rehabilitation efforts as well as persist as posttraumatic stress disorder or major depression.2,3 A prehospitalization history of psychiatric illness may convey a greater risk for posthospitalization psychological morbidity than any specific clinical aspect of the hospitalization itself.3 Furthermore, prehospitalization psychiatric illness could also convey risk for other aspects of the posthospitalization syndrome, such as persistent cognitive dysfunction.4 As Detsky and Krumholz emphasized,1 health care payers are interested in reducing the number of potentially preventable hospitalizations and rehospitalizations in an effort to bend the health care cost curve. Psychiatric illness may be an important risk factor for potentially preventable hospitalizations such as those for ambulatory care–sensitive conditions.5 Thus, a history of psychiatric illness could be a marker identifying a subgroup of patients at risk for a vicious cycle of hospitalization, subsequent psychological morbidity and functional decline, and rehospitalization. Therefore, in addition to encouraging mobility, decreasing disruptions, reducing unnecessary tests and medication changes, and promoting personalization, consideration should also be given to a hospitalized patient’s mental health. Acute distress or delirium should be addressed prior to hospital discharge, and psychiatric illness should be accounted for in discharge planning. These considerations support the need for greater integration of evidence-based mental health care throughout medical care settings, including on the medical-surgical wards and in the intensive care units of hospitals. Dimitry S. Davydow, MD, MPH Wayne J. Katon, MD
JAMA October 22/29, 2014 Volume 312, Number 16
Copyright 2014 American Medical Association. All rights reserved.
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The likelihood of this magnitude of imbalance is not known; from a clinical perspective it seems low, but it is possible that clusters of unmeasured confounders could create large imbalances. Even though the methods used in their study were sophisticated, observational studies are vulnerable to residual confounding. For example, a large body of observational data on the relationship between cardiovascular disease and postmenopausal hormone therapy overwhelmingly suggested benefit prior to the Women’s Health Initiative Clinical Trial, which proved that hormone therapy did not reduce the risk of heart disease and actually increased the risk of stroke.2,3 I agree with Roumie and colleagues that well-performed observational studies such as theirs provide invaluable information for both patients and their physicians, but I also urge caution in drawing causal inferences based on observational data, even with highly sophisticated analytic methods. Monika M. Safford, MD Author Affiliation: Department of Medicine, University of Alabama, Birmingham. Corresponding Author: Monika M. Safford, MD, Department of Medicine, University of Alabama, 1717 11th Ave S, Birmingham, AL 35294 ([email protected]). Conflict of Interest Disclosures: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. 1. Roumie CL, Greevy RA, Grijalva CG, et al. Association between intensification of metformin treatment with insulin vs sulfonylureas and cardiovascular events and all-cause mortality among patients with diabetes. JAMA. 2014;311(22): 2288-2296. 2. Rossouw JE, Anderson GL, Prentice RL, et al; Writing Group for the Women’s Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women’s Health Initiative randomized controlled trial. JAMA. 2002;288(3):321-333. 3. Shumaker SA, Legault C, Rapp SR, et al; WHIMS Investigators. Estrogen plus progestin and the incidence of dementia and mild cognitive impairment in postmenopausal women: the Women’s Health Initiative Memory Study: a randomized controlled trial. JAMA. 2003;289(20):2651-2662.
Breast Cancer Screening With Tomosynthesis and Digital Mammography To the Editor Dr Friedewald and colleagues1 demonstrated improved performance with both lower recall rates and improved invasive cancer detection by adding tomosynthesis to digital mammography. The report also documented the continued large variability of recall rates and cancer detection rates among sites.2 This variation may be even greater among individual radiologists. Recall rates in several facilities were higher than recommended in guidelines of the American College of Radiology (ACR),3,4 and recall rates with digital mammography alone also exceeded the guideline recall rate. With digital mammography alone, 7 of the 13 sites were above the ACR desirable goal of a 10% or less recall rate2 and 4 of 13 sites did not meet the more recent ACR goal for a recall rate of 12% or less.3 After adding tomosynthesis, which should decrease recall, 4 of 13 sites did not meet the standard of 10% or less, 2 of 13 did not meet the newer standard of 12% or less, 2 sites in-
creased recall rate over digital mammography alone, and 1 did not change. Consistent improvement in cancer detection was observed. This study does more than show improvement in performance with a new technology, bringing performance closer to recommended metrics. The value of audits, normative benchmark data5 such as the ACR National Mammography database program, and the critical role of optimal mammographic interpretation along with appropriate technology have been emphasized. David Seidenwurm, MD Robert Rosenberg, MD Author Affiliations: Sutter Medical Group, Sacramento, California (Seidenwurm); Radiology Associates of Albuquerque, Albuquerque, New Mexico (Rosenberg). Corresponding Author: David Seidenwurm, MD, Sutter Medical Group, 1500 Expo Pkwy, Sacramento, CA 95815 ([email protected]). Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Seidenwurm reported receiving personal fees for medical legal consulting as an expert witness and for serving as a reviewer for the American College of Radiology; receiving travel expenses from the American College of Radiology, National Quality Forum, AMP PCPI, and Radiological Associates of Sacramento; and having an ownership interest in Radiological Associates of Sacramento. No other disclosures were reported. 1. Friedewald SM, Rafferty EA, Rose SL, et al. Breast cancer screening using tomosynthesis in combination with digital mammography. JAMA. 2014;311(24): 2499-2507. 2. Rosenberg RD, Yankaskas BC, Abraham LA, et al. Performance benchmarks for screening mammography. Radiology. 2006;241(1):55-66. 3. American College of Radiology. ACR BI-RADS. Reston, VA: American College of Radiology; 2003. 4. Sickles E, Dorsi C. ACR BI-RADS: Follow-up and Outcome Monitoring. Reston, VA: American College of Radiology; 2013. 5. Schell MJ, Yankaskas BC, Ballard-Barbash R, et al. Evidence-based target recall rates for screening mammography. Radiology. 2007;243(3):681-689.
In Reply Drs Seidenwurm and Rosenberg correctly point out that the mean recall rate in our study with digital mammography alone (10.7%) was slightly higher than the ACR guidelines of 10% or less. This is not surprising given that prior analyses of performance benchmarks of mammographic interpretation in the United States have consistently acknowledged that recall rates in clinical practice commonly exceed these ACR guidelines.1,2 Recognition of this challenge led to the inclusion of a wider range of target recall rates (from 5% to 12%) in the latest outcome monitoring section of the ACR’s breast imaging reporting and data system (BI-RADS) guide.3 The range of recall rates seen in our study reinforces the representative nature of the practices included. It is well known that recall rates vary because of multiple issues, ranging from patient-level factors (eg, the presence or absence of prior studies, the interval since prior study, and breast density) to reader-level factors (eg, training and volume read), and to site-related factors (centers for comprehensive breast imaging vs centers for screening only).4 We did not investigate the basis for the diversity of performance across our sites and readers. However, as
jama.com
JAMA October 22/29, 2014 Volume 312, Number 16
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a J H Quillen College User on 05/31/2015
1695
Letters
Seidenwurm and Rosenberg suggest, continual monitoring with feedback is important so radiologists may assess their personal performance. This type of evaluation should be encouraged in all practices, regardless of the characteristics of the breast imaging site or the level of specialization of the interpreting radiologists. We chose not to exclude examinations read early after the implementation of tomosynthesis, which possibly falsely elevated the overall recall rate during this period. It is clear that there is a learning curve associated with interpreting mammography in general.5 For tomosynthesis, this curve may be steeper than with conventional mammography because the reader must learn to confidently ignore findings that would ordinarily be recalled on standard mammography but that do not persist on the tomosynthesis images. The 2 sites that failed to show a decrease in recall rate when tomosynthesis was added were sites that had either a short period of implementation or a small volume of cases per radiologist. These outcomes suggest the importance of training and experience in optimizing interpretation of this new technology. In addition, the link between the recall rate and the cancer detection rate has been well documented.6 Higher recall rates theoretically will lead to higher cancer detection rates. However, as we demonstrated in our study, when tomosynthesis was added, there was an increase in cancer detection in 12 of the 13 sites that was simultaneously coupled with a decrease in recall rate for 11 of the 13 sites. This could not be achieved strictly through improved adherence to recommended guidelines. More research investigating patient-level, physicianlevel, and site-level characteristics would be useful to further delineate how best to use this technology to maximize outcomes and personalize breast cancer screening. Sarah M. Friedewald, MD Elizabeth A. Rafferty, MD Emily F. Conant, MD Author Affiliations: Caldwell Breast Center, Advocate Lutheran General Hospital, Park Ridge, Illinois (Friedewald); Department of Radiology, Massachusetts General Hospital, Boston (Rafferty); Department of Radiology, University of Pennsylvania, Philadelphia (Conant). Corresponding Author: Sarah M. Friedewald, MD, Caldwell Breast Center, Center for Advanced Care, Advocate Lutheran General Hospital, 1700 Luther Ln, Park Ridge, IL 60068 ([email protected]). Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Drs Friedewald and Rafferty reported receiving a grant from Hologic Inc for the original study. Dr Conant reported receiving a grant from the National Cancer Institute. Drs Friedewald and Conant also reported serving on a scientific advisory board for Hologic. 1. Rosenberg RD, Yankaskas BC, Abraham LA, et al. Performance benchmarks for screening mammography. Radiology. 2006;241(1):55-66. 2. Carney PA, Sickles EA, Monsees BS, et al. Identifying minimally acceptable interpretive performance criteria for screening mammography. Radiology. 2010;255(2):354-361. 3. Dorsi CJ, Sickles EA, Mendelson EB, et al. Follow-up and outcome monitoring. In: ACR BI-RADS Atlas: Breast Imaging Reporting and Data System. Reston, VA: American College of Radiology; 2013:29. 4. Buist DS, Anderson ML, Haneuse SJ, et al. Influence of annual interpretive volume on screening mammography performance in the United States. Radiology. 2011;259(1):72-84. 1696
5. Miglioretti DL, Gard CC, Carney PA, et al. When radiologists perform best: the learning curve in screening mammogram interpretation. Radiology. 2009;253 (3):632-640. 6. Gur D, Sumkin JH, Hardesty LA, et al. Recall and detection rates in screening mammography. Cancer. 2004;100(8):1590-1594.
Addressing the Trauma of Hospitalization To the Editor Drs Detsky and Krumholz1 highlighted an important problem facing hospitalized patients and their family members and suggested interventions to reduce the potential for traumatization by the experience of being hospitalized for a medical illness or surgical procedure. However, hospitalization is not inherently traumatizing for all patients, and interventions targeting posthospitalization syndrome should also consider premorbid patient characteristics. Nearly one-third of patients surviving intensive care unit hospitalizations may have clinically important posttraumatic stress disorder, depressive symptoms, or both during the year after their hospitalization,2 and a key risk factor for these outcomes in the aftermath of medicalsurgical hospitalization not considered by Detsky and Krumholz is a premorbid history of psychiatric illness. Patients with a prior history of depressive or anxiety disorders are more likely to develop symptoms of psychological distress prior to hospital discharge, which could interfere with in-hospital rehabilitation efforts as well as persist as posttraumatic stress disorder or major depression.2,3 A prehospitalization history of psychiatric illness may convey a greater risk for posthospitalization psychological morbidity than any specific clinical aspect of the hospitalization itself.3 Furthermore, prehospitalization psychiatric illness could also convey risk for other aspects of the posthospitalization syndrome, such as persistent cognitive dysfunction.4 As Detsky and Krumholz emphasized,1 health care payers are interested in reducing the number of potentially preventable hospitalizations and rehospitalizations in an effort to bend the health care cost curve. Psychiatric illness may be an important risk factor for potentially preventable hospitalizations such as those for ambulatory care–sensitive conditions.5 Thus, a history of psychiatric illness could be a marker identifying a subgroup of patients at risk for a vicious cycle of hospitalization, subsequent psychological morbidity and functional decline, and rehospitalization. Therefore, in addition to encouraging mobility, decreasing disruptions, reducing unnecessary tests and medication changes, and promoting personalization, consideration should also be given to a hospitalized patient’s mental health. Acute distress or delirium should be addressed prior to hospital discharge, and psychiatric illness should be accounted for in discharge planning. These considerations support the need for greater integration of evidence-based mental health care throughout medical care settings, including on the medical-surgical wards and in the intensive care units of hospitals. Dimitry S. Davydow, MD, MPH Wayne J. Katon, MD
JAMA October 22/29, 2014 Volume 312, Number 16
Copyright 2014 American Medical Association. All rights reserved.
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