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This cross-sectional study evaluates changes in the rate of germline BRCA testing among patients with ovarian cancer between 2008 and 2018 and analyzes factors associated with testing rates.

PURPOSE: To evaluate timing and outcomes of BRCA testing and definitive surgical treatment among patients with newly diagnosed breast cancer. METHODS: Patient-reported (n = 1,381) and deidentified health-plan (n = 2,369) data were analyzed from a consecutive national series of 3,750 women whose healthcare providers ordered BRCA testing between March 2014 and June 2015, within 1 year following breast cancer diagnosis. RESULTS: Among 1,209 respondents, 54.4% received the genetic test results presurgery, 23.2% tested presurgery but received the results postsurgery, and 22.3% tested postsurgery. Patients aware of mutation-positive results presurgery were more likely to choose bilateral mastectomy (BLM) (n = 32/37) compared with patients who learned of positive results postsurgery (n = 14/32), (odds ratio [OR] = 8.23, 95% CI = 2.55 to 26.59, P < .001). When compared with women tested postsurgery, only women unaware of negative results presurgery had higher BLM rates (adjusted OR = 1.70, 95% CI = 1.07 to 2.69, P = .02). Among women > 50 tested presurgery, those unaware of negative results presurgery were more likely to choose BLM (n = 28/81) compared with those aware of negative results (n = 32/168) (OR = 2.25, 95% CI = 1.23 to 4.08, negative results awareness × age interaction, and P = .007). CONCLUSION: Nearly half of participants did not receive BRCA results presurgery, which limited their ability to make fully informed surgical treatment decisions. This may represent suboptimal care for unaware mutation-positive patients compared with those who were aware presurgery. Women > 50 who test negative are significantly less likely to choose BLM, a costly surgery that does not confer survival advantage, if they are aware of negative results presurgery. These results have important implications for quality of care and costs in the US health system.

OBJECTIVE The American Diabetes Association recommends metformin as first-line therapy for type 2 diabetes. However, nonadherence to antihyperglycemic medication is common, and a clinician could confuse nonadherence with pharmacologic failure, potentially leading to premature prescribing of second-line therapies. We measured metformin use prior to second-line therapy initialization. RESEARCH DESIGN AND METHODS This retrospective cross-sectional study used unidentifiable member claims data from individuals covered from 2010 to 2015 by Aetna, a U.S. health benefits company. Beneficiaries with two physician claims or one hospitalization with a type 2 diabetes diagnosis were included. Recommended use of metformin was measured by the proportion of days covered over 60 days. Through sensitivity analysis, we varied estimates of the percentage of beneficiaries who used low-cost generic prescription medication programs. RESULTS A total of 52,544 individuals with type 2 diabetes were eligible. Of 22,956 patients given second-line treatment, only 1,875 (8.2%) had evidence of recommended use of metformin in the prior 60 days, and 6,441 (28.0%) had no prior claims evidence of having taken metformin. At the top range of sensitivity, only 49.5% patients could have had recommended use. Patients were more likely to be given an additional second-line antihyperglycemic medication or insulin if they were given their initial second-line medication without evidence of recommended use of metformin (P < 0.001). CONCLUSIONS Despite published guidelines, second-line therapy often is initiated without evidence of recommended use of first-line therapy. Apparent treatment failures, which may in fact be attributable to nonadherence to guidelines, are common. Point-of-care and population-level processes are needed to monitor and improve guideline adherence.

The growth in healthcare spending is an important topic in the United States, and preterm and low-birthweight infants have some of the highest healthcare expenditures of any patient population. We performed a retrospective cohort study of spending in this population using a large, national claims database of commercially insured individuals. A total of 763,566 infants with insurance coverage through Aetna, Inc. for the first 6 months of post-natal life were included, and received approximately $8.4 billion (2016 USD) in healthcare services. Infants with billing codes indicating preterm status (n = 50,511) incurred medical expenditures of $76,153 on average, while low-birthweight status (n = 418) had the highest per infant average expenditures of $603,778. Understanding the drivers of variation in costs within gestational age and birthweight bands is an important target for future studies.

This report describes the development of a measure of low-risk cesarean delivery by the Society for Maternal-Fetal Medicine (SMFM). Safely lowering the cesarean delivery rate is a priority for maternity care clinicians and health care delivery systems. Therefore, hospital quality assurance programs are increasingly tracking cesarean delivery rates among low-risk pregnancies. Two commonly used definitions of "low risk" are available, the Joint Commission (JC) and the Agency for Healthcare Research and Quality (AHRQ) measures, but these measures are not clinically comprehensive. We sought to refine the definition of the low-risk cesarean delivery rate to enhance the validity of the metric for quality measurement. We created this refined definition-called the SMFM definition-and compared it to the JC and AHRQ measures using claims-based data from the 2011 Nationwide Inpatient Sample of >863,000 births in 612 hospitals. Using these definitions, we calculated means and interquartile ranges (25th-75th percentile range) for hospital low-risk cesarean delivery rates, stratified by hospital size, teaching status, urban/rural location, and payer mix. Across all hospitals, the mean low-risk cesarean delivery rate was lowest for the SMFM definition (12.65%), but not substantially different from the JC and AHRQ measures (13.12% and 13.29%, respectively). We empirically examined the SMFM definition to ensure its validity and utility. This refined definition performs similarly to existing measures and has the added advantage of clinical perspective, enhanced face validity, and ease of use.

Research Objective Genomic tests predicting tumor recurrence risk may help inform treatment decisions and improve quality of care. Yet differences in information exchange and patient decision style about genomic tests may further exacerbate disparities in care, particularly if recommendations conflict with patients’ preferences or other prognostic information. This study looks at the information exchange between patients and physicians and patients’ preferences in decision-making in the context of receiving a genomic test for early-stage breast cancer. Study Design Retrospective study of women covered by a large national health insurer, who had received the most common, commercial genomic test for early-stage breast cancer prognosis. All eligible minority women (n=705) and a random sample of eligible white women (n=719) matched by age category, geography and diagnosis year, were invited to a mailed survey later linked to claims data. We used random-effects logistic regression models (cluster=state) to examine the association of patient self-reported race/ethnicity with 3 outcomes: 1) knowledge of being tested; 2) patient decision style (assessed with the Control Preference Scale and categorized as active (patient-based), shared, or passive (physician-based); 3) amount of information received on the test. Models were adjusted by patient age, education, income, family structure/support, year of testing, and plan type. Population Studied Privately insured women aged 64 years old or less, enrolled for at least 9 continuous months, with an insurance claim for the genomic test in 2009–2012. Principal Findings The 62% response rate yielded 896 respondents, including 108 Hispanics, 112 Black, 97 Asians, and 549 whites. 10% of the respondents were unaware that they had received the genomic test, with significant differences in this knowledge by race/ethnicity after controlling for age, education and income (OR= 3.8 for Hispanic and OR = 2.7 for Black women compared to White, both p < .010). Decision style was reported predominantly as active (47%) and shared (40%), and varied significantly with age, income, education and race. In particular, Blacks were more likely than Whites to report a passive rather than shared decision (OR = 1.6; p = .065). Black women were also more likely to rate the information received on the test’s clinical significance as insufficient (OR=2.1; p = .001). Conclusions While most women reported more active styles of decision-making, we found significant differences in information exchange that may lower the odds of a well-informed decision for minority patients. Variation in patient reports may reflect variation in understanding and retaining information about the genomic test, or in information delivery by physicians. Citation Format: Catherine Chanfreau-Coffinier, Ninez A Ponce, Patricia A Ganz, Michele Toscano, Joanne Armstrong, Jennifer S Haas. Patients' perspectives on using a genomic test for their breast cancer treatment decisions: Disparities in information exchange [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P1-11-01.

In 2015, the Society for Maternal-Fetal Medicine developed a low risk for cesarean delivery definition based on administrative claims-based diagnosis codes described by the International Classification of Diseases, Ninth Revision, Clinical Modification . The Society for Maternal-Fetal Medicine definition is a clinical enrichment of 2 available measures from the Joint Commission and the Agency for Healthcare Research and Quality measures. The Society for Maternal-Fetal Medicine measure excludes diagnosis codes that represent clinically relevant risk factors that are absolute or relative contraindications to vaginal birth while retaining diagnosis codes such as labor disorders that are discretionary risk factors for cesarean delivery. The introduction of the International Statistical Classification of Diseases, 10th Revision, Clinical Modification in October 2015 expanded the number of available diagnosis codes and enabled a greater depth and breadth of clinical description. These coding improvements further enhance the clinical validity of the Society for Maternal-Fetal Medicine definition and its potential utility in tracking progress toward the goal of safely lowering the US cesarean delivery rate. This report updates the Society for Maternal-Fetal Medicine definition of low risk for cesarean delivery using International Statistical Classification of Diseases, 10th Revision, Clinical Modification coding.

As the science of genomics matures, the number of genetic tests available for use in clinical care has increased greatly. By mid-2016, the National Institutes of Health’s Genetic Testing Registry included more than 48,000 tests related to more than 9,700 medical conditions [1]. The number of available tests is expected to increase in the years ahead as technology platforms and bioinformatics capabilities improve.

Aims: The Center for Comparative Effectiveness Research in Cancer Genomics completed a 2-year stakeholder-guided process for the prioritization of genomic tests for comparative effectiveness research studies. We sought to evaluate the effectiveness of engagement procedures in achieving project goals and to identify opportunities for future improvements. Materials & methods: The evaluation included an online questionnaire, one-on-one telephone interviews and facilitated discussion. Responses to the online questionnaire were tabulated for descriptive purposes, while transcripts from key informant interviews were analyzed using a directed content analysis approach. Results: A total of 11 out of 13 stakeholders completed both the online questionnaire and interview process, while nine participated in the facilitated discussion. Eighty-nine percent of questionnaire items received overall ratings of agree or strongly agree; 11% of responses were rated as neutral with the exception of a single rating of disagreement with an item regarding the clarity of how stakeholder input was incorporated into project decisions. Recommendations for future improvement included developing standard recruitment practices, role descriptions and processes for improved communication with clinical and comparative effectiveness research investigators. Conclusions: Evaluation of the stakeholder engagement process provided constructive feedback for future improvements and should be routinely conducted to ensure maximal effectiveness of stakeholder involvement.

One barrier to genetic testing is the lack of access to genetic counselors. We provided cancer genetic counseling via telephone, through a pilot project for employees of a national health insurer, Aetna, Inc. Knowledge transfer, behavioral intentions, and patient satisfaction were assessed by survey after genetic counseling. Aetna sent an individual email to its employees nationwide notifying them of the availability of a new telephone genetic counseling and testing program and providing a link to take a brief screening questionnaire to determine whether they may be at risk of hereditary cancer. Employees completing the questionnaire received immediate feedback regarding whether there appeared to be a risk of hereditary cancer. If so, they were invited to schedule a telephonic genetic counseling session. After the session, respondents completed an online survey. 397 individuals completed the questionnaire. 39 proceeded with telephone genetic counseling, and 22 completed the follow-up survey, including all 11 women with family history warranting genetic testing. One third reported prior discussion about inherited cancer risk with their primary care provider (PCP); 12% were referred to a geneticist; 20% had an accurate perception of their own cancer risk. After counseling, 94% reported understanding their risk for cancer and 87% were aware of available risk-reduction strategies. 87% of high-risk respondents intended to engage in risk-management interventions. 93% reported high satisfaction. 66% indicated they would not have pursued genetic counseling if it had not been available by phone. Results suggest telephone counseling is a viable option for increasing access to genetic experts. In this sample, telephone counseling increases knowledge of cancer risk, motivates intention to change health-related behaviors, and elicits a high satisfaction level. Consequently, Aetna now offers telephone cancer genetic counseling nationwide as a covered benefit.

Purpose: This study was undertaken to describe cancer risk assessment practices among primary care providers (PCPs). Methods: An electronic survey was sent to PCPs affiliated with a single insurance carrier. Demographic and practice characteristics associated with cancer genetic risk assessment and testing activities were described. Latent class analysis supported by likelihood ratio tests was used to define PCP profiles with respect to the level of engagement in genetic risk assessment and referral activity based on demographic and practice characteristics. Results: 860 physicians responded to the survey (39% family practice, 29% internal medicine, 22% obstetrics/gynecology (OB/GYN), 10% other). Most respondents (83%) reported that they routinely assess hereditary cancer risk; however, only 33% reported that they take a full, three-generation pedigree for risk assessment. OB/GYN specialty, female gender, and physician access to a genetic counselor were independent predictors of referral to cancer genetics specialists. Three profiles of PCPs, based upon referral practice and extent of involvement in genetics evaluation, were defined. Conclusion: Profiles of physician characteristics associated with varying levels of engagement with cancer genetic risk assessment and testing can be identified. These profiles may ultimately be useful in targeting decision support tools and services.

The Patient Protection and Affordable Care Act of 2010 is the most sweeping health care legislation in a generation. The goal of the legislation is to increase access to both public and private insurance, and to improve the affordability and quality of care. Many provisions of the bill have a direct impact on the women's health care services. This paper provides an overview of the bill's provisions that have the largest impact on women's health care and provides data on the impact of the bill to date.

Importance BRCA genetic testing has substantial public health impact, yet little is known of the real-world experiences of the more than 100 000 Americans undergoing testing annually. Objective To identify factors associated with use of BRCA testing, assess whether delivery of genetic counseling and testing services adheres to professional guidelines, and measure the impact on patient-reported outcomes. Design, Setting, and Participants The American BRCA Outcomes and Utilization of Testing (ABOUT) Study analyzed data from a consecutive national series of 11 159 women whose clinicians ordered BRCA testing between December 2011 and December 2012. Aetna mailed recruitment information across the United States to commercial health plan members whose clinicians had ordered BRCA testing. A total of 3874 women (34.7%) completed questionnaires. Deidentified clinician-reported data from all respondents and a random sample of 2613 nonrespondents were also analyzed. Main Outcomes and Measures The proportion of eligible participants who met testing criteria and respondents’ report of receiving genetic counseling by a genetics clinician and its association with BRCA knowledge, understanding, and satisfaction were assessed. Results Among 3628 women respondents whose clinicians ordered comprehensive BRCA testing, most were white non-Hispanic (2502 [69.0%]), college educated (2953 [81.4%]), married (2751 [75.8%]), and had higher incomes (2011 [55.4%]). Approximately 16.4% (596) did not meet testing criteria. Mutations were identified in 161 (5.3%) of these women who received comprehensive testing. Only 1334 (36.8%) reported receiving genetic counseling from a genetics clinician prior to testing; the lowest rates (130 [12.3%]) were among patients of obstetrician/gynecologists. The most commonly reported reason for not receiving this clinical service was lack of clinician recommendation. Those who received it demonstrated greater knowledge about BRCA (mean score difference adjusted for demographics and clinician specialty, β = 0.99 [95% CI, 0.83-1.14]; P .001) and expressed greater understanding (β = 0.47 [95% CI, 0.41-0.54]; P .001) and satisfaction (β = 2.21 [95% CI, 1.60-2.81]; P .001). Conclusions and Relevance Despite improved patient knowledge, understanding, and satisfaction among patients who receive genetic counseling provided by a genetics clinician, as well as multiple guidelines emphasizing the importance of genetic counseling, most US women undergoing BRCA genetic testing do not receive this clinical service. Lack of physician recommendation is the most commonly reported reason. These findings demonstrate important gaps in clinical genetics services. Recently mandated coverage of genetic counseling services as a preventive service without patient cost sharing should contribute to improving clinical genetics services and associated outcomes in the future.

Background Accidental falls among people aged 65 years and older caused approximately 2,700,000 injuries, 27,000 deaths, and cost more than 34 billion dollars in the US annually in recent years. Here, we derive and validate a predictive model for falls based on a retrospective cohort of those 65 years and older. Methods Insurance claims from a 1-year observational period were used to predict a fall-related claim in the following 2 years. The predictive model takes into account a person's age, sex, prescriptions, and diagnoses. Through random assignment, half of the people had their claims used to derive the model, while the remaining people had their claims used to validate the model. Results Of 120,881 individuals with Aetna health insurance coverage, 12,431 (10.3%) members fell. During validation, people were risk stratified across 20 levels, where those in the highest risk stratum had 10.5 times the risk as those in the lowest stratum (33.1% vs 3.1%). Conclusions Using only insurance claims, individuals in this large cohort at high risk of falls could be readily identified up to 2 years in advance. Although external validation is needed, the findings support the use of the model to better target interventions.

The recent approval by the Food and Drug Administration of Makena, a new version of progesterone 17 alpha-hydroxyprogesterone caproate, will drive up the drug's cost about 100-fold, with minimal added clinical benefit.

Research to date regarding identification and management of hereditary breast and ovarian cancer syndrome (HBOC) in the U.S. has been confined primarily to academic center-based studies with limited patient engagement. To begin to understand and address the current gaps and disparities in delivery of services for the appropriate identification and optimal risk management of individuals with HBOC, we designed and have initiated the American BRCA Outcomes and Utilization of Testing (ABOUT) Study. ABOUT relies on a collaborative patient advocacy, academic and industry partnership to recruit and engage U.S. individuals who are at increased risk for HBOC and investigate their experiences, decisions and outcomes. It utilizes an extensive research infrastructure, including an interactive web-based data system and electronic interfaces for secure online participation and automated data exchange. We describe the novel recruitment approach that was designed for collaboration with a national commercial health plan partner to identify all individuals for whom a healthcare provider orders a BRCA test and mail to each individual an invitation to participate and study packet. The study packet contains detailed information about the study, a baseline questionnaire and informed consent for participation in the study, for release of relevant medical and health plan records and for ongoing research engagement. This approach employs patient-reported, laboratory-reported and health plan-reported outcomes and facilitates longitudinal engagement. We believe that the type of innovative methodology and collaborative framework we have developed for ABOUT is an ideal foundation for a patient-powered research network. This approach can make substantial contributions to identifying current and best practices in HBOC, leading to improved strategies for clinical care and optimal health outcomes among individuals with high inherited risk for cancer.

Background Administrative claims and medical records are important data sources to examine healthcare utilization and outcomes. Little is known about identifying personalized medicine technologies in these sources. Objectives To describe agreement, sensitivity, and specificity of administrative claims compared with medical records for 2 pairs of targeted tests and treatments for breast cancer. Research Design Retrospective analysis of medical records linked to administrative claims from a large health plan. We examined whether agreement varied by factors that facilitate tracking in claims (coding and cost) and that enhance medical record completeness (records from multiple providers). Subjects Women (35 to 65 y of age) with incident breast cancer diagnosed in 2006 to 2007 (n=775). Measures Use of human epidermal growth factor receptor 2 (HER2) and gene expression profiling (GEP) testing, trastuzumab, and adjuvant chemotherapy in claims and medical records. Results Agreement between claims and records was substantial for GEP, trastuzumab, and chemotherapy, and lowest for HER2 tests. GEP, an expensive test with unique billing codes, had higher agreement (91.6% vs. 75.2%), sensitivity (94.9% vs. 76.7%), and specificity (90.1% vs. 29.2%) than HER2, a test without unique billing codes. Trastuzumab, a treatment with unique billing codes, had slightly higher agreement (95.1% vs. 90%) and sensitivity (98.1% vs. 87.9%) than adjuvant chemotherapy. Conclusions Higher agreement and specificity were associated with services that had unique billing codes and high cost. Administrative claims may be sufficient for examining services with unique billing codes. Medical records provide better data for identifying tests lacking specific codes and for research requiring detailed clinical information.

Given the likely proliferation of targeted testing and treatment strategies for cancer, a better understanding of the utilization patterns of human epidermal growth factor receptor 2 (HER2) testing and trastuzumab and newer gene expression profiling (GEP) for risk stratification and chemotherapy decision making are important.Cross-sectional.We performed a medical record review of women aged 35 to 65 years diagnosed between 2006 and 2007 with invasive localized breast cancer, identified using claims from a large national health plan (N = 775).Almost all women received HER2 testing (96.9%), and 24.9% of women with an accepted indication received GEP. Unexplained socioeconomic differences in GEP use were apparent after adjusting for age and clinical characteristics; specifically, GEP use increased with income. For example, those in the lowest income category ($40,000) were less likely than those with an income of $125,000 or more to receive GEP (odds ratio, 0.34; 95% confidence interval, 0.16 to 0.73). A majority of women (57.7%) with HER2-positive disease received trastuzumab; among these women, differences in age and clinical characteristics were not apparent, although surprisingly, those in the lowest income category were more likely than those in the high-income category to receive trastuzumab (P = .02). Among women who did not have a positive HER2 test, 3.9% still received trastuzumab. Receipt of adjuvant chemotherapy increased as GEP score indicated greater risk of recurrence.Identifying and eliminating unnecessary variation in the use of these expensive tests and treatments should be part of quality improvement and efficiency programs.

Importance BRCA genetic testing has substantial public health impact, yet little is known of the real-world experiences of the more than 100 000 Americans undergoing testing annually. Objective To identify factors associated with use of BRCA testing, assess whether delivery of genetic counseling and testing services adheres to professional guidelines, and measure the impact on patient-reported outcomes. Design, Setting, and Participants The American BRCA Outcomes and Utilization of Testing (ABOUT) Study analyzed data from a consecutive national series of 11 159 women whose clinicians ordered BRCA testing between December 2011 and December 2012. Aetna mailed recruitment information across the United States to commercial health plan members whose clinicians had ordered BRCA testing. A total of 3874 women (34.7%) completed questionnaires. Deidentified clinician-reported data from all respondents and a random sample of 2613 nonrespondents were also analyzed. Main Outcomes and Measures The proportion of eligible participants who met testing criteria and respondents’ report of receiving genetic counseling by a genetics clinician and its association with BRCA knowledge, understanding, and satisfaction were assessed. Results Among 3628 women respondents whose clinicians ordered comprehensive BRCA testing, most were white non-Hispanic (2502 [69.0%]), college educated (2953 [81.4%]), married (2751 [75.8%]), and had higher incomes (2011 [55.4%]). Approximately 16.4% (596) did not meet testing criteria. Mutations were identified in 161 (5.3%) of these women who received comprehensive testing. Only 1334 (36.8%) reported receiving genetic counseling from a genetics clinician prior to testing; the lowest rates (130 [12.3%]) were among patients of obstetrician/gynecologists. The most commonly reported reason for not receiving this clinical service was lack of clinician recommendation. Those who received it demonstrated greater knowledge about BRCA (mean score difference adjusted for demographics and clinician specialty, β = 0.99 [95% CI, 0.83-1.14]; P .001) and expressed greater understanding (β = 0.47 [95% CI, 0.41-0.54]; P .001) and satisfaction (β = 2.21 [95% CI, 1.60-2.81]; P .001). Conclusions and Relevance Despite improved patient knowledge, understanding, and satisfaction among patients who receive genetic counseling provided by a genetics clinician, as well as multiple guidelines emphasizing the importance of genetic counseling, most US women undergoing BRCA genetic testing do not receive this clinical service. Lack of physician recommendation is the most commonly reported reason. These findings demonstrate important gaps in clinical genetics services. Recently mandated coverage of genetic counseling services as a preventive service without patient cost sharing should contribute to improving clinical genetics services and associated outcomes in the future.

More than 100 therapeutics, mostly for oncology, have biomarker tests recommended in their US Food and Drug Administration (FDA) labels.1 Moreover, a strategy to codevelop and cosubmit to the FDA a diagnostic test (companion diagnostic [CoDx]) that specifically targets a drug to patients predicted to respond has had success recently with vemurafenib, targeting the BRAF V600 mutation in metastatic melanoma, and with crizotinib, targeting the EML4-ALK mutation in non–small cell lung cancer.2 Companion diagnostic tests define the subset of patients who are most likely to benefit from a therapy or who should not receive the therapy because of ineffectiveness or predicted adverse effects.3 Genome-based, targeted therapeutics and codeveloped CoDx tests are the foundation of personalized medicine and have potential for contributing to high-value health care.

Preterm birth: a public health emergency The health and economic toll of preterm birth on the United States healthcare system is large, and rising. In 2004, 12.5% of all births in the United States, more than half a million infants, were born preterm ( 37 weeks’ gestation), the majority (85%) of whom were born moderately preterm (32-36 weeks’ gestation). Among African American women, almost 1 in every 5 births is preterm. The national preterm birth rate climbed 30% between 1980 and 2004, with most of the recent rate increase occurring in the gestational age group of 32-36 weeks. The health consequences of prematurity are considerable. In the United States, preterm birth is the leading cause of neonatal deaths and the leading cause of pediatric neurodevelopmental disability, including cerebral palsy and mental retardation. It is also an important cause of chronic lung disease, visual impairment, and other chronic illness in children. Prematurityassociated medical complications experienced in the neonatal period portend future health, educational, and occupational impairment that extend into late childhood and beyond. Although mortality and serious morbidity are concentrated in the group of infants born very preterm or less than 32 weeks’ gestation, infants born between 32 and 36 weeks are at greater risk for adverse health and developmental problems compared with term infants.

1608 Background: An estimated 100,000 individuals currently undergo genetic testing for hereditary susceptibility to breast and ovarian cancer annually in the U.S., yet little is known about their characteristics, testing experience or outcomes. Research in this high-risk group has been limited to patients recruited at academic medical centers where case ascertainment, health services delivery, decision-making and, quite likely, outcomes are different from those in the community setting where the majority of individuals currently receive healthcare services. Methods: Eligible subjects include 10,000 consecutive individuals requesting BRCA testing through the nation’s third-largest health insurer, Aetna, beginning in December, 2011. De-identified data are analyzed from each test request form submitted by the ordering provider. Each eligible subject is mailed a study packet inviting them to complete a questionnaire (by mail, online or telephone) designed to investigate informational and healthcare services, test results, knowledge, risk perception and medical intentions. Results: Of 442 subjects contacted during the first two weeks of accrual, 143 (32%) have completed the questionnaire to date. Similar to Aetna member demographics, 7% are African-American and 7% report Hispanic ethnicity. Based on Chi-Square tests, there were no differences between respondents and non-respondents with regard to age (51% under age 50), race, ethnicity or personal history of cancer (58%). Among respondents, deleterious mutations were identified in 8%. Testing for a known familial mutation was performed in 8%. Among women with breast cancer, 13% were undergoing testing prior to initial surgical treatment. Updated results from 3000 eligible subjects will be presented. Conclusions: This innovative, academic-industry collaboration enables an unprecedented investigation of significant issues surrounding individuals at increased risk for hereditary breast and ovarian cancer and undergoing genetic testing in the U.S. The results will guide the development and dissemination of more targeted decision-support tools and strategies to improve medical outcomes for such individuals.

e17518 Background: HER2 testing and the use of trastuzumab is considered a prototype for the translation of a genomic therapy, yet almost nothing is known about use in practice. Uncertainties about the performance of the two types of HER2 tests, immunohistochemistry (IHC) and fluorescence-in-situ-hybridization (FISH) have led to debate about how best to identify women who are most likely to benefit from this costly treatment. Similarly, little is known about the use of gene expression profiling (GEP - e.g., OncotypeDx), which offers the possibility of better recurrence estimation to tailor the use of adjuvant chemotherapy. Methods: Cross-sectional record review of women, 36–64 years, with a new diagnosis of breast cancer in 2006–2007, identified using claims from a large, national health plan (n = 392 to date). Results: Almost all women had a HER2 test (97.7%): 56.2% had IHC alone, 17.4% had FISH alone, and 24.0% had both (2.4% had documentation of a test but not test type). Data for women with both IHC and FISH is shown below. Using the maximum of all available results, 24.9% were HER2-positive, 11.1% intermediate, and 63.9% HER2-negative. Only 55.2% of HER2-positive women received trastuzumab, compared to 16.7% of women with an intermediate score, and no HER2-negative women. The majority of women (85.7%) did not have GEP. Among women with GEP, 58.9% indicated low recurrence risk, 21.4% medium risk, and 5.4% high risk. Adjuvant chemotherapy was received by 27.3%, 91.7%, and 100% respectively (p < 0.001). Conclusions: HER2 tests, primarily IHC, are widely used. There are discrepancies in classification of HER2 status based on IHC vs. FISH. We did not find evidence of overuse of trastuzumab by women who were HER2-negative. Further work should clarify whether the lack of trastuzumab for HER2-positive women is clinically appropriate. We found modest adoption of GEP, and GEP score was associated with the use of adjuvant chemotherapy. [Table: see text] No significant financial relationships to disclose.

Objective: To determine the prevalence and incidence of domestic violence in an ambulatory gynecology population and to describe risk factors associated with abuse. Methods: All patients presenting for initial ambulatory gynecology care at an urban private practice over 1 year were asked by a physician about the occurrence of domestic violence using a modified abuse assessment screen (AAS). The prevalence and incidence of physical, emotional, and sexual abuse were calculated. The patient’s records were abstracted for demographic and medical variables. Associations between these variables and the prevalence of abuse were analyzed. Results: Four hundred forty-three women were interviewed. No woman refused to answer the AAS. Among 424 women with completed AASs, 72 (16.2%) reported some form of domestic violence in the past. Among ever-abused women, 46 out of 72 (63.8%) reported physical abuse, 12 (16.6%) reported emotional abuse, and 4 (5.6%) reported sexual abuse. The incidence of physical abuse was 1.6%. In univariate analysis, risk factors associated with lifetime abuse included age greater than 40 (P = 0.006), non-single status (P = 0.003), black race (P = 0.006), history of depression (P = 0.0001), and sexual inactivity (P = 0.007). A history of depression (P = 0.001) and black race (P = 0.01) were the only factors associated with a past history of domestic abuse in regression analysis. Conclusions: The prevalence of domestic abuse ascertained by the AAS in an ambulatory gynecology setting is high. Demographic and health factors do not accurately predict a history of domestic abuse. Screening of all patients for domestic violence should be a routine part of ambulatory gynecologic care.