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AHRQ Research Studies
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Research Studies is a compilation of published research articles funded by AHRQ or authored by AHRQ researchers.
Results
1 to 25 of 27 Research Studies DisplayedAlagoz O, Lowry KP, Kurian AW
Impact of the COVID-19 pandemic on breast cancer mortality in the US: estimates from collaborative simulation modeling.
This study’s objective was to project the impact of COVID-19 on future breast cancer mortality between 2020 and 2030. Three established Cancer Intervention and Surveillance Modeling Network breast cancer models were used to model reductions in mammography screening use, delays in symptomatic cancer diagnosis, and reduced use of chemotherapy for women with early-stage disease for the first 6 months of the pandemic with return to prepandemic patterns after that time. The models project by 2030 950 cumulative excess breast cancers deaths related to reduced screening, 1314 deaths associated with delayed diagnosis of symptomatic cases, and 151 deaths associated with reduced chemotherapy use in women with hormone positive, early-stage cancer.
AHRQ-funded; HS018366.
Citation: Alagoz O, Lowry KP, Kurian AW .
Impact of the COVID-19 pandemic on breast cancer mortality in the US: estimates from collaborative simulation modeling.
J Natl Cancer Inst 2021 Nov 2;113(11):1484-94. doi: 10.1093/jnci/djab097..
Keywords: COVID-19, Cancer: Breast Cancer, Cancer, Mortality, Women
Bowles EJA, O'Neill SC, Li T
Effect of a randomized trial of a web-based intervention on patient-provider communication about breast density.
This study evaluated a personalized web-based intervention between women and their providers designed to improve breast cancer risk communication. This randomized trial included women aged 40-69 years with 504 women in the control group and 492 women who used the intervention website. The website included information about breast density, personalized breast cancer risk, chemoprevention, and magnetic resonance imaging. Participants self-reported their communication about density with providers at 6 weeks and 12 months. Women in the intervention arm were 2.39 times more likely to report density communication at 6 weeks than the control arm. This effect persisted at 12 months. At 6 weeks the effect was only significant among women who reported versus those who did not report any previous density discussions. A quarter of women in each arm did not have a density conversation at any point during the study.
AHRQ-funded; HS022982.
Citation: Bowles EJA, O'Neill SC, Li T .
Effect of a randomized trial of a web-based intervention on patient-provider communication about breast density.
J Womens Health 2021 Nov;30(11):1529-37. doi: 10.1089/jwh.2021.0053.
AHRQ-funded; HS022982..
AHRQ-funded; HS022982..
Keywords: Communication, Women, Cancer: Breast Cancer, Cancer, Health Information Technology (HIT)
Kuijer A, Dominici LS, Rosenberg SM
Arm morbidity after local therapy for young breast cancer patients.
This study assessed patient-reported arm morbidity in the Young Women's Breast Cancer Study (YWS). Participants were over 1300 women with breast cancer diagnosed at age 40 or younger and who were enrolled in the YWS. Findings showed that high rates of self-reported arm morbidity in young breast cancer survivors were reported, particularly in patients receiving axillary lymph node dissection and post-mastectomy radiation therapy. Recommendations included attention to the risks and benefits of differing local therapy strategies for axillary lymph node dissection and post-mastectomy radiation therapy patients.
AHRQ-funded; HS023680.
Citation: Kuijer A, Dominici LS, Rosenberg SM .
Arm morbidity after local therapy for young breast cancer patients.
Ann Surg Oncol 2021 Oct;28(11):6071-82. doi: 10.1245/s10434-021-09947-3..
Keywords: Cancer: Breast Cancer, Cancer, Women, Surgery
Dominici L, Hu J, Zheng Y
Association of local therapy with quality-of-life outcomes in young women with breast cancer.
Researchers examined the association of surgery with longer-term satisfaction and quality of life (QOL) in young breast cancer survivors. Participants were women 40 years or older who enrolled in the Young Women's Breast Cancer Study. The results suggested that local therapy in young breast cancer survivors is persistently associated with poorer scores in multiple QOL domains, particularly among those treated with mastectomy and radiotherapy, irrespective of breast reconstruction. Socioeconomic stressors also appear to play a role.
AHRQ-funded; HS023680.
Citation: Dominici L, Hu J, Zheng Y .
Association of local therapy with quality-of-life outcomes in young women with breast cancer.
JAMA Surg 2021 Oct;156(10):e213758. 2021. doi: 10.1001/jamasurg.2021.3758..
Keywords: Cancer: Breast Cancer, Cancer, Quality of Life, Women, Surgery
Sella T, Poorvu PD, Ruddy KJ
Impact of fertility concerns on endocrine therapy decisions in young breast cancer survivors.
The diagnosis and treatment of breast cancer can have profound effects on a young woman's family planning and fertility, particularly among women with hormone receptor-positive breast cancer. In this paper the authors discuss the Young Women's Breast Cancer Study, a multicenter cohort of women aged 40 years or younger and newly diagnosed with breast cancer from 2006 to 2016. The investigators concluded that concern about fertility was a contributor to adjuvant ET decisions among a substantial proportion of young breast cancer survivors.
AHRQ-funded; HS023680.
Citation: Sella T, Poorvu PD, Ruddy KJ .
Impact of fertility concerns on endocrine therapy decisions in young breast cancer survivors.
Cancer 2021 Aug 15;127(16):2888-94. doi: 10.1002/cncr.33596..
Keywords: Cancer: Breast Cancer, Cancer, Women, Pregnancy, Decision Making
Baskin AS, Wang T, Bredbeck BC
Trends in contralateral prophylactic mastectomy utilization for small unilateral breast cancer.
This study describes trends in contralateral prophylactic mastectomy (CPM) utilization for small unilateral breast cancer instead of breast-conserving surgery (BCS) which is recommended. The authors used the National Cancer Database to identify women with unilateral, T1 breast cancer. Of the total cohort of 765,487, 69% underwent BCS and 31% chose mastectomy. Of 176,673 women aged 70 years or older, 75% underwent BCS and 25% chose mastectomy. CPM rates have increased in both cohorts since 2006. Patient factors such as younger age, white rate, private insurance, tumor factors, and facility factors were associated with increased CPM rates compared with unilateral mastectomy.
Citation: Baskin AS, Wang T, Bredbeck BC .
Trends in contralateral prophylactic mastectomy utilization for small unilateral breast cancer.
J Surg Res 2021 Jun;262:71-84. doi: 10.1016/j.jss.2020.12.057..
Keywords: Cancer: Breast Cancer, Cancer, Women, Surgery, Prevention, Healthcare Utilization
Glenn BA, Nonzee NJ, Hamilton AS
Cancer surveillance and preventive services in a diverse sample of breast and colorectal cancer survivors.
This study assessed engagement in surveillance for recurrence, cancer screening, and other recommended preventive health services among breast and colorectal cancer survivors with early-onset disease (age 50 years and younger) who were diagnosed in California. Findings showed that, although the majority of survivors received appropriate surveillance for recurrence, engagement in other preventive health services varied substantially. Implications included efforts to address gaps in the use of recommended cancer screening and preventive health services among cancer survivors.
AHRQ-funded; HS000046.
Citation: Glenn BA, Nonzee NJ, Hamilton AS .
Cancer surveillance and preventive services in a diverse sample of breast and colorectal cancer survivors.
J Cancer Surviv 2021 Apr;15(2):213-23. doi: 10.1007/s11764-020-00925-4..
Keywords: Cancer: Breast Cancer, Cancer: Colorectal Cancer, Cancer, Prevention, Screening
Rauscher GH, Murphy AM, Qiu Q
The "sweet spot" revisited: optimal recall rates for cancer detection with 2D and 3D digital screening mammography in the Metro Chicago Breast Cancer Registry.
The authors examined the trade-offs for higher recall rates in terms of biopsy recommendations and cancer detection in mammography in a single large health care organization. 2D analog, 2D digital, and 3D digital mammography screenings among women 40-79 years old with cancer follow-up were examined. They found that the results of their investigation were in contrast to those of a recent study suggesting appropriateness of higher recall rates. They concluded that optimal cancer detection appeared to be in the recall rate range of 7-9% for both 2D digital mammography and 3D tomosynthesis.
AHRQ-funded; HS018366.
Citation: Rauscher GH, Murphy AM, Qiu Q .
The "sweet spot" revisited: optimal recall rates for cancer detection with 2D and 3D digital screening mammography in the Metro Chicago Breast Cancer Registry.
AJR Am J Roentgenol 2021 Apr;216(4):894-902. doi: 10.2214/ajr.19.22429.
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Keywords: Cancer: Breast Cancer, Cancer, Imaging, Screening, Diagnostic Safety and Quality, Women, Prevention
Wang T, Bredbeck BC, Sinco B
Variations in persistent use of low-value breast cancer surgery.
Through the Choosing Wisely campaign, surgical specialties identified 4 low-value breast cancer operations. Preliminary data suggest varying rates of deimplementation and have identified patient-level and clinician-level determinants of continued overuse. However, little information exists about facility-level variation or determinants of differential deimplementation. In this retrospective cohort study the investigators sought to identify variation and determinants of persistent use of low-value breast cancer surgical care.
AHRQ-funded; HS026030.
Citation: Wang T, Bredbeck BC, Sinco B .
Variations in persistent use of low-value breast cancer surgery.
JAMA Surg 2021 Apr;156(4):353-62. doi: 10.1001/jamasurg.2020.6942..
Keywords: Cancer: Breast Cancer, Cancer, Surgery, Women
Miglioretti DL, Bissell MCS, Kerlikowske K
Assessment of a risk-based approach for triaging mammography examinations during periods of reduced capacity.
Breast cancer screening, surveillance, and diagnostic imaging services were profoundly limited during the initial phase of the coronavirus disease 2019 (COVID-19) pandemic. The objective of this population-based cohort study was to develop a risk-based strategy for triaging mammograms during periods of decreased capacity. The investigators found that clinical indication and individual risk factors were associated with cancer detection and suggest these may be useful for prioritizing mammography in times and settings of decreased capacity.
AHRQ-funded; HS018366.
Citation: Miglioretti DL, Bissell MCS, Kerlikowske K .
Assessment of a risk-based approach for triaging mammography examinations during periods of reduced capacity.
JAMA Netw Open 2021 Mar;4(3):e211974. doi: 10.1001/jamanetworkopen.2021.1974..
Keywords: Screening, Cancer: Breast Cancer, Cancer, Women, Imaging, Access to Care, COVID-19
Lee CI, Zhu W, Onega T
Comparative access to and use of digital breast tomosynthesis screening by women's race/ethnicity and socioeconomic status.
This study looked at access to digital breast tomography (DBT) versus regular mammography and whether women of minority race/ethnicity and lower socioeconomic status experienced lower DBT access during the early adoption period and persistently lower DBT use over time. This cross-sectional study included 92 geographically diverse imaging facilities across 5 US states, with over 2.3 million screening examinations performed among women aged 40 to 89 years from January 1, 2011, to December 31, 2017. Data were analyzed from June 2019, to August 2020. Women who used DBT increased for all women from 3.3% in 2011 to 82.6% in 2017. In 2012, Black, Hispanic, Asian American, and women with less than a high school education had lower DBT access compared to White women attending the same facility and also college graduates. Lower DBT access continued over time regardless of the number of years after facility-level DBT adoption.
AHRQ-funded; HS018366.
Citation: Lee CI, Zhu W, Onega T .
Comparative access to and use of digital breast tomosynthesis screening by women's race/ethnicity and socioeconomic status.
JAMA Netw Open 2021 Feb;4(2):e2037546. doi: 10.1001/jamanetworkopen.2020.37546..
Keywords: Cancer: Breast Cancer, Cancer, Imaging, Access to Care, Women, Social Determinants of Health, Racial and Ethnic Minorities, Screening
Song H, Bergman A, Chen AT
Disruptions in preventive care: mammograms during the COVID-19 pandemic.
The objective of this study was to measure the extent to which the provision of mammograms was impacted by the COVID-19 pandemic and surrounding guidelines. The data source for the study were de-identified summary data derived from medical claims and eligibility files were provided by Independence Blue Cross for women receiving mammograms. The investigators concluded that the provision of mammograms has been significantly disrupted due to the COVID-19 pandemic.
AHRQ-funded; HS026116.
Citation: Song H, Bergman A, Chen AT .
Disruptions in preventive care: mammograms during the COVID-19 pandemic.
Health Serv Res 2021 Feb;56(1):95-101. doi: 10.1111/1475-6773.13596..
Keywords: COVID-19, Screening, Cancer: Breast Cancer, Cancer, Women, Prevention
Baskin AS, Wang T, Mott NM
Gaps in online breast cancer treatment information for older women.
This study’s goal was to assess the availability of web-based educational materials targeting older women facing early-stage breast cancer treatment. Routine use of sentinel lymph node biopsy (SLNB) and adjuvant radiotherapy offers no overall survival benefit and may not be perceived as desirable by older women. National guidelines allow omission of these treatments for older women. The authors systematically reviewed the top 25 hospital websites ranked as “Best Hospitals for Cancer” by U.S. News & World Report, as well as the websites of four prominent national cancer organizations. Only one national organization and no hospital websites included the recommendation to avoid routine SLNB. Only 2 hospitals and 2 national organizations included information for patients older than 70 years suggesting possible omission of adjuvant radiotherapy.
AHRQ-funded; HS026030.
Citation: Baskin AS, Wang T, Mott NM .
Gaps in online breast cancer treatment information for older women.
Ann Surg Oncol 2021 Feb;28(2):950-57. doi: 10.1245/s10434-020-08961-1..
Keywords: Elderly, Education: Patient and Caregiver, Health Information Technology (HIT), Cancer: Breast Cancer, Cancer, Women
Mott N, Wang T, Miller J
Medical maximizing-minimizing preferences in relation to low-value services for older women with hormone receptor-positive breast cancer: a qualitative study.
In this qualitative study, researchers conducted 30 semi-structured interviews with women age 70 or older without a previous diagnosis of breast cancer in order to elicit perspectives on breast cancer treatment in relation to their medical maximizing-minimizing preferences, as determined by the single-item maximizer-minimizer elicitation question (MM1). They found that medical maximizing-minimizing preferences in older women corresponded with preferences for breast cancer treatment options that guidelines identify as potentially unnecessary.
AHRQ-funded; HS026030.
Citation: Mott N, Wang T, Miller J .
Medical maximizing-minimizing preferences in relation to low-value services for older women with hormone receptor-positive breast cancer: a qualitative study.
Ann Surg Oncol 2021 Feb;28(2):941-49. doi: 10.1245/s10434-020-08924-6..
Keywords: Elderly, Women, Cancer: Breast Cancer, Cancer
Wang T, Baskin A, Miller J
Trends in breast cancer treatment de-implementation in older patients with hormone receptor-positive breast cancer: a mixed methods study.
Guidelines allow for the omission of sentinel lymph node biopsy (SLNB) and post-lumpectomy radiotherapy in women >/= 70 years of age with hormone receptor-positive (HR +) breast cancer. Despite this, national data suggest these procedures have not been widely de-implemented. The objectives of this study were to evaluate trends in SLNB and post-lumpectomy radiotherapy utilization in patients who were eligible for omission and evaluate patient preferences as a target for de-implementation of low-value care.
AHRQ-funded; HS026030.
Citation: Wang T, Baskin A, Miller J .
Trends in breast cancer treatment de-implementation in older patients with hormone receptor-positive breast cancer: a mixed methods study.
Ann Surg Oncol 2021 Feb;28(2):902-13. doi: 10.1245/s10434-020-08823-w..
Keywords: Elderly, Cancer: Breast Cancer, Cancer, Healthcare Utilization, Practice Patterns, Women
Eyrich NW, Sloss KR, Howard RA
Opioid prescribing exceeds consumption following common surgical oncology procedures.
Researchers aimed to compare opioid prescribing to opioid consumption for common surgical oncology procedures. They found that the median quantity of opioid prescribed was significantly larger than consumed following breast biopsy, lumpectomy, and mastectomy or wide local excision. The majority of patients reported receiving education on taking opioids, but only 27% received instructions on proper disposal; 82% of prescriptions filled resulted in unused opioids, and only 11% of these patients safely disposed of them. They concluded that their study demonstrated that opioid prescribing exceeds consumption following common surgical oncology procedures, thus indicating the potential for reductions in prescribing.
AHRQ-funded; HS023313.
Citation: Eyrich NW, Sloss KR, Howard RA .
Opioid prescribing exceeds consumption following common surgical oncology procedures.
J Surg Oncol 2021 Jan;123(1):352-56. doi: 10.1002/jso.26272..
Keywords: Opioids, Medication, Surgery, Cancer: Breast Cancer, Cancer, Practice Patterns, Pain
Vyas A, Madhavan S, Sambamoorthi U
Association between persistence with mammography screening and stage at diagnosis among elderly women diagnosed with breast cancer.
The objective of this study is to determine the association between persistence with mammography screening and stage at breast cancer (BC) diagnosis among elderly women. It found that, as compared to women who were not persistent with mammography screening, women who were persistent with mammography screening were significantly more likely to be diagnosed at earlier stages of BC.
AHRQ-funded; HS018622.
Citation: Vyas A, Madhavan S, Sambamoorthi U .
Association between persistence with mammography screening and stage at diagnosis among elderly women diagnosed with breast cancer.
Breast Cancer Res Treat 2014 Dec;148(3):645-54. doi: 10.1007/s10549-014-3204-3..
Keywords: Cancer, Cancer: Breast Cancer, Diagnostic Safety and Quality, Elderly, Prevention, Screening, Women
Wheeler SB, Kohler RE, Reeder-Hayes KE
Endocrine therapy initiation among Medicaid-insured breast cancer survivors with hormone receptor-positive tumors.
The researchers sought to characterize endocrine therapy (ET) use in a low-income Medicaid-insured population in North Carolina. They found that, of 222 women meeting the inclusion criteria, only 50 percent filled a prescription for ET. Results suggest substantial underutilization of ET in this population.
AHRQ-funded; HS019468.
Citation: Wheeler SB, Kohler RE, Reeder-Hayes KE .
Endocrine therapy initiation among Medicaid-insured breast cancer survivors with hormone receptor-positive tumors.
J Cancer Surviv 2014 Dec;8(4):603-10. doi: 10.1007/s11764-014-0365-3..
Keywords: Cancer: Breast Cancer, Healthcare Utilization, Medicaid, Medication, Patient-Centered Outcomes Research
Wen KY, Hu A, Ma GX
Information and communication needs of Chinese American breast cancer patients: perspectives on survivorship care planning.
The researchers conducted a qualitative study to examine the information and communication needs as well as survivorship care preferences of Chinese American breast cancer survivors. The main themes identified through analysis of interview transcripts were: the need for evidence-based and culturally and linguistically appropriate health information; the role of language or communication barriers and culture in accessing care and communicating with providers; and preferences for care plan elements and format.
AHRQ-funded; HS019001.
Citation: Wen KY, Hu A, Ma GX .
Information and communication needs of Chinese American breast cancer patients: perspectives on survivorship care planning.
J Community Support Oncol 2014 Dec;12(12):439-45. doi: 10.12788/jcso.0095..
Keywords: Cancer: Breast Cancer, Cultural Competence, Clinician-Patient Communication, Racial and Ethnic Minorities
Thompson CA, Gomez SL, Chan A
Patient and provider characteristics associated with colorectal, breast, and cervical cancer screening among Asian Americans.
The researchers performed multivariable modeling to evaluate potential predictors (at the provider- and patient-level) of screening completion among Asian patients. They concluded that language- and gender-concordant primary care providers and culturally tailored online health resources may help improve preventive cancer screening in Asian patient populations.
AHRQ-funded; HS019815.
Citation: Thompson CA, Gomez SL, Chan A .
Patient and provider characteristics associated with colorectal, breast, and cervical cancer screening among Asian Americans.
Cancer Epidemiol Biomarkers Prev 2014 Nov;23(11):2208-17. doi: 10.1158/1055-9965.epi-14-0487..
Keywords: Cancer: Breast Cancer, Cancer: Cervical Cancer, Cancer: Colorectal Cancer, Healthcare Utilization, Screening
Vilhauer RP
Computer-mediated and face-to-face communication in metastatic cancer support groups.
This study compared the experiences of women with metastatic breast cancer (MBC) in computer-mediated and face-to-face support groups. Themes examined included convenience, level of support, intimacy, ease of expression, range of information, and dealing with debilitation and dying. Computer-mediated support groups (CMSGs) may provide a sense of control and a greater level of support. Intimacy may take longer to develop in a CMSG, but women may have more opportunities to get to know each other.
AHRQ-funded; HS010565.
Citation: Vilhauer RP .
Computer-mediated and face-to-face communication in metastatic cancer support groups.
Palliat Support Care 2014 Aug;12(4):287-97. doi: 10.1017/s1478951513000126..
Keywords: Cancer: Breast Cancer, Communication, Health Information Technology (HIT)
Davidoff AJ, Gardner LD, Zuckerman IH
AHRQ Author: Davidoff AJ
Validation of disability status, a claims-based measure of functional status for cancer treatment and outcomes studies.
The researchers implemented and validated a disability status (DS) measure in 4 cohorts of cancer patients. They found that the DS measure is a significant independent predictor of cancer-directed treatment, but unobserved factors continue to play a role in determining treatments.
AHRQ-authored.
Citation: Davidoff AJ, Gardner LD, Zuckerman IH .
Validation of disability status, a claims-based measure of functional status for cancer treatment and outcomes studies.
Med Care 2014 Jun;52(6):500-10. doi: 10.1097/mlr.0000000000000122.
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Keywords: Cancer, Cancer: Breast Cancer, Disabilities, Health Status, Cancer: Lung Cancer
Yaghjyan L, Wolin K, Chang SH
Racial disparities in healthy behaviors and cancer screening among breast cancer survivors and women without cancer: National Health Interview Survey 2005.
This study aimed to compare healthy behaviors and cancer screening practices among breast cancer survivors and respondents without cancer separately in Caucasian, African American, and Hispanic women. It found that most differences were suggestive and do not differ by race.
AHRQ-funded; HS022330.
Citation: Yaghjyan L, Wolin K, Chang SH .
Racial disparities in healthy behaviors and cancer screening among breast cancer survivors and women without cancer: National Health Interview Survey 2005.
Cancer Causes Control. 2014 May;25(5):605-14. doi: 10.1007/s10552-014-0365-7..
Keywords: Cancer: Breast Cancer, Cancer, Racial and Ethnic Minorities, Women, Disparities, Screening
Nelson HD, Pappas M, Zakher B
Risk assessment, genetic counseling, and genetic testing for BRCA-related cancer in women: a systematic review to update the U.S. Preventive Services Task Force recommendation.
This systematic review was done in support of the U.S. Preventive Services Task Force (USPSTF) updated recommendation on the benefit and harms of risk assessment, genetic testing, and genetic counseling for BRCA-related cancer in women. A systematic review was done on literature from 2004 to July 30, 2013 from MEDLINE, PsycINFO, the Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Health Technology Assessment, Scopus, and reference lists. Data on the participants, study design, analysis, follow-up, and results was extracted and a second investigator confirmed key data. The studies were rated on study quality and applicability. The analysis found women with high-risk for breast cancer had decreased risk of breast cancer by 85% to 100% by having a mastectomy, and risk of mortality by 81% to 100% compared to women without surgery. There was also a lower risk of breast and ovarian cancer after having salpingo-oopherectomy surgery.
AHRQ-funded; 290200710057
Citation: Nelson HD, Pappas M, Zakher B .
Risk assessment, genetic counseling, and genetic testing for BRCA-related cancer in women: a systematic review to update the U.S. Preventive Services Task Force recommendation.
Ann Intern Med 2014 Feb 18;160(4):255-66. doi: 10.7326/m13-1684..
Keywords: U.S. Preventive Services Task Force (USPSTF), Cancer: Breast Cancer, Cancer: Ovarian Cancer, Cancer, Genetics, Screening, Prevention, Guidelines, Evidence-Based Practice, Women, Risk, Family Health and History
Ezaz G, Long JB, Gross CP
Risk prediction model for heart failure and cardiomyopathy after adjuvant trastuzumab therapy for breast cancer.
The investigators sought to develop a clinical risk score that identifies older women with breast cancer who are at higher risk of heart failure or cardiomyopathy after trastuzumab. That found that a 7-factor risk score was able to stratify 3-year risk of heart failure/cardiomyopathy after trastuzumab between the lowest and highest risk groups by more than 2-fold in a Medicare population.
AHRQ-funded; HS018781.
Citation: Ezaz G, Long JB, Gross CP .
Risk prediction model for heart failure and cardiomyopathy after adjuvant trastuzumab therapy for breast cancer.
J Am Heart Assoc 2014 Feb;3(1):e000472. doi: 10.1161/jaha.113.000472.
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Keywords: Cancer: Breast Cancer, Heart Disease and Health, Medication, Patient Safety, Risk