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1.  Use of BioSense for Rapid Assessment of the Safety of Medical Countermeasures 
Objective
To conduct an initial examination of the potential use of BioSense data to monitor and rapidly assess the safety of medical countermeasures (MCM) used for prevention or treatment of adverse health effects of biological, chemical, and radiation exposures during a public health emergency.
Introduction
BioSense is a national human health surveillance system for disease detection, monitoring, and situation awareness through near real-time access to existing electronic healthcare encounter information, including information from hospital emergency departments (EDs). MCM include antibiotics, antivirals, antidotes, antitoxins, vaccinations, nuclide-binding agents, and other medications. Although some MCM have been extensively evaluated and have FDA approval, many do not (1). Current FDA and CDC systems that monitor drug and vaccine safety have limited ability to monitor MCM safety, and in particular to conduct rapid assessments during an emergency (1).
Methods
To provide a preliminary assessment of the use of BioSense for this purpose, we reviewed selected publications evaluating the use of electronic health records (EHRs) to monitor safety of drugs and vaccinations (medications), focusing particularly on systematic reviews, reviewed BioSense data elements, and consulted with a number of subject matter experts.
Results
More than 40 studies have examined use of EHR data to monitor adverse effects (AEs) of medications using administrative, laboratory, and pharmacy records from inpatient- and out-patient settings, including EDs (2–4). To identify AEs, investigators have used diagnostic codes; administration of antidotes, laboratory measures of drug levels and of biologic response, text searches of unstructured clinical notes, and combinations of those data elements. BioSense ED data include chief complaint text, triage notes, text diagnosis, as well as diagnostic and medical procedure codes.
Investigations used a variety of study designs in various populations and settings; examined a wide range of medications, vaccinations, and AEs; and developed a diverse set of analytic algorithms to search EHR data to detect and signal AEs (2–4). Most research has been done on FDA-approved medications. Most studies used EHR data to identify individuals using specific medications and then searched for potential AEs identified from previous research. None of the studies investigated use of EHR data to monitor safety when records of an individual’s medication use could not be linked to that individual’s records of AEs. BioSense data could be used for AE detection, but linking AEs to MCM use would require follow-back investigation. Since there is limited research on AEs of some MCM, there would be limited information to guide identification of potential AEs.
Performance characteristics of the AE monitoring systems have been mixed with reported sensitivities ranging from 40–90%; specificities from 1% to 90%, and positive predictive values from < 1% to 64%, depending on the medication, AE and other characteristics of the study (2, 4). However, the small numbers of studies with common characteristics has limited the ability of reviewers to determine which types of systems have better performance for different medications and AEs.
Some experts suggest that data in BioSense, might contribute to safety surveillance of MCM. They also caution that poor predictive values and high rates of false positives reported in the literature raise concerns about burden to those conducting investigations in response to AE alerts, particularly in the context of a public health emergency.
Conclusions
These findings suggest that BioSense data could potentially contribute to rapid identification of safety issues for MCM and that some methods from published research could be applicable to the use of BioSense for this purpose. However, such use would require careful development and evaluation.
PMCID: PMC3692934
BioSense; countermeasures; safety; monitoring; medical
2.  Multilevel Research and the Challenges of Implementing Genomic Medicine 
Advances in genomics and related fields promise a new era of personalized medicine in the cancer care continuum. Nevertheless, there are fundamental challenges in integrating genomic medicine into cancer practice. We explore how multilevel research can contribute to implementation of genomic medicine. We first review the rapidly developing scientific discoveries in this field and the paucity of current applications that are ready for implementation in clinical and public health programs. We then define a multidisciplinary translational research agenda for successful integration of genomic medicine into policy and practice and consider challenges for successful implementation. We illustrate the agenda using the example of Lynch syndrome testing in newly diagnosed cases of colorectal cancer and cascade testing in relatives. We synthesize existing information in a framework for future multilevel research for integrating genomic medicine into the cancer care continuum.
doi:10.1093/jncimonographs/lgs003
PMCID: PMC3482965  PMID: 22623603
3.  Genome-wide Copy Number Alterations in Subtypes of Invasive Breast Cancers in Young White and African American Women 
Genomic copy number alterations (CNA) are common in breast cancer. Identifying characteristic CNAs associated with specific breast cancer subtypes is a critical step in defining potential mechanisms of disease initiation and progression. We used genome-wide array comparative genomic hybridization (aCGH) to identify distinctive CNAs in breast cancer subtypes from 259 young (diagnosed with breast cancer at <55 years) African American (AA) and Caucasian American (CA) women originally enrolled in a larger population-based study. We compared the average frequency of CNAs across the whole genome for each breast tumor subtype and found that estrogen receptor (ER)-negative tumors had a higher average frequency of genome-wide gain (p<0.0001) and loss (p=0.02) compared to ER-positive tumors. Triple negative (TN) tumors had a higher average frequency of genome-wide gain (p<0.0001) and loss (p=0.003) than non-TN tumors. No significant difference in CNA frequency was observed between HER2-positive and negative tumors. We also identified previously unreported recurrent CNAs (frequency >40%) for TN breast tumors at 10q, 11p, 11q, 16q, 20p and 20q. In addition, we report CNAs that differ in frequency between TN breast tumors of AA and CA women. This is of particular relevance because TN breast cancer is associated with higher mortality and young AA women have higher rates of TN breast tumors compared to CA women. These data support the possibility that higher overall frequency of genomic alteration events as well as specific focal CNAs in TN breast tumors might contribute in part to the poor breast cancer prognosis for young AA women.
doi:10.1007/s10549-010-1297-x
PMCID: PMC3224104  PMID: 21264507
breast cancer; triple negative; genomic alteration; array comparative genomic hybridization; young women
4.  Family History of Colorectal Cancer: Clinicians' Preventive Recommendations and Patient Behavior 
Few population-based studies have addressed the role that family history of colorectal cancer (CRC) plays in clinician decision making or patient health choices. The objective of this study was to evaluate the effect of family history of CRC on clinician practice, patient CRC screening, and patient preventive behavior. We analyzed 2008 Oregon Behavioral Risk Factor Surveillance System data to examine associations between family history of CRC and 1) patient-reported clinician recommendations, 2) perceived risk of developing CRC, 3) adoption of preventive and screening behaviors, and 4) CRC risk factors among 1,795 respondents without CRC. A family history of CRC was positively associated with a higher likelihood of respondents reporting that their clinicians discussed colorectal cancer screening (OR, 4.2; 95% CI, 2.4-7.4) and of respondents having colorectal screening within the recommended time period (OR, 2.2; 95% CI, 1.3-3.9). A family history of CRC was also associated with respondents reporting lifestyle changes to prevent CRC (OR, 2.6; 95% CI, 1.7-4.0). A family history of CRC may prompt clinicians to recommend screening and preventive behavior changes and motivate patients to adopt such strategies.
PMCID: PMC3277407  PMID: 22172188
5.  A Case-Control Study of Body Mass Index and Breast Cancer Risk in White and African American Women 
Objective
Large body size has been associated with decreased risk of breast cancer in premenopausal, but with increased risk in postmenopausal women. Limited information is available about African American women and differences by estrogen- and progesterone-receptor (ERPR) status.
Methods
We analyzed data from the Women's Contraceptive and Reproductive Experiences (CARE) Study among 3,997 white and African American breast cancer case patients diagnosed in 1994-98 and 4,041 control participants aged 35 to 64. We calculated multivariate odds ratios (ORs) as measures of relative risk of breast cancer associated with self-reported body mass index (BMI) at age 18 and 5 years before diagnosis (recent BMI).
Results
Risk tended to decrease with increasing BMI at age 18 in all women (ORBMI≥25 kg/m2 vs <20kg/m2=0.76, 95% CI:0.63–0.90, Ptrend=0.005) and with recent BMI in premenopausal women (ORBMI ≥35 kg/m2 vs <25kg/m2=0.81, 95% CI:0.61–1.06, Ptrend=0.05), unmodified by race. Among postmenopausal white but not African American women, there was an inverse relation between recent BMI and risk. High recent BMI was associated with increased risk of ERPR positive tumors among postmenopausal African American women (ORBMI ≥35 kg/m2 vs <25kg/m2=1.83, 95% CI:1.08–3.09, Ptrend=0.03).
Conclusion
Among women at age 35-64, BMI at age 18 is inversely associated with risk of breast cancer, but association with recent BMI varies by menopause status, race and hormone receptor status.
Impact
Our findings indicate that studies of BMI and breast cancer should consider breast cancer subtypes.
doi:10.1158/1055-9965.EPI-10-0025
PMCID: PMC2891096  PMID: 20501755
African American; Body Mass Index; Breast cancer; Premenopausal; Postmenopausal
6.  The Scientific Foundation for Personal Genomics: Recommendations from a National Institutes of Health–Centers for Disease Control and Prevention Multidisciplinary Workshop 
The increasing availability of personal genomic tests has led to discussions about the validity and utility of such tests and the balance of benefits and harms. A multidisciplinary workshop was convened by the National Institutes of Health and the Centers for Disease Control and Prevention to review the scientific foundation for using personal genomics in risk assessment and disease prevention and to develop recommendations for targeted research. The clinical validity and utility of personal genomics is a moving target with rapidly developing discoveries but little translation research to close the gap between discoveries and health impact. Workshop participants made recommendations in five domains: (1) developing and applying scientific standards for assessing personal genomic tests; (2) developing and applying a multidisciplinary research agenda, including observational studies and clinical trials to fill knowledge gaps in clinical validity and utility; (3) enhancing credible knowledge synthesis and information dissemination to clinicians and consumers; (4) linking scientific findings to evidence-based recommendations for use of personal genomics; and (5) assessing how the concept of personal utility can affect health benefits, costs, and risks by developing appropriate metrics for evaluation. To fulfill the promise of personal genomics, a rigorous multidisciplinary research agenda is needed.
doi:10.1097/GIM.0b013e3181b13a6c
PMCID: PMC2936269  PMID: 19617843
behavioral sciences; epidemiologic methods; evidence-based medicine; genetics; genetic testing; genomics; medicine; public health
7.  Meeting the mammography screening needs of underserved women: the performance of the National Breast and Cervical Cancer Early Detection Program in 2002–2003 (United States) 
Cancer Causes & Control   2006;17(9):1145-1154.
Objective
To examine the extent to which the National Breast and Cervical Cancer Early Detection Program (Program) has helped to meet the mammography screening needs of underserved women.
Methods
Low-income, uninsured women aged 40–64 are eligible for free mammography screening through the Program. We used data from the U.S. Census Bureau to estimate the number of women eligible for services. We obtained the number of women receiving Program-funded mammograms from the Program. We then calculated the percentage of eligible women who received mammograms through the Program.
Results
In 2002–2003, of all U.S. women aged 40–64, approximately 4 million (8.5%) had no health insurance and had a family income below 250% of the federal poverty level, meeting Program eligibility criteria. Of these women, 528,622 (13.2%) received a Program-funded mammogram. Rates varied substantially by race and ethnicity. The percentage of eligible women screened in each state ranged from about 2% to approximately 79%.
Conclusions
Although the Program provided screening services to over a half-million low-income, uninsured women for mammography, it served a small percentage of those eligible. Given that in 2003 more than 2.3 million uninsured, low-income, women aged 40–64 did not receive recommended mammograms from either the Program or other sources, there remains a substantial need for services for this historically underserved population.
doi:10.1007/s10552-006-0058-y
PMCID: PMC1764594  PMID: 17006720
Breast cancer; Mammography screening; Screening rates; Medically underserved

Results 1-7 (7)