Publications by authors named "Michele Toscano"

20 Publications

  • Page 1 of 1

Evaluating Cardiovascular Health Disparities Using Estimated Race/Ethnicity: A Validation Study.

Med Care 2015 Dec;53(12):1050-7

*Department of Medicine, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Harvard Medical School, Boston, MA †Aetna, Hartford, CT ‡Aetna, Blue Bell, PA §CVS/Caremark, Woonsocket, RI.

Background: Methods of estimating race/ethnicity using administrative data are increasingly used to examine and target disparities; however, there has been no validation of these methods using clinically relevant outcomes.

Objective: To evaluate the validity of the indirect method of race/ethnicity identification based on place of residence and surname for assessing clinically relevant outcomes.

Data Sources: A total of 2387 participants in the Post-MI Free Rx Event and Economic Evaluation (MI FREEE) trial who had both self-reported and Bayesian Improved Surname Geocoding method (BISG)-estimated race/ethnicity information available.

Study Design: We used tests of interaction to compare differences in the effect of providing full drug coverage for post-MI medications on adherence and rates of major vascular events or revascularization for white and nonwhite patients based upon self-reported and indirect racial/ethnic assignment.

Results: The impact of full coverage on clinical events differed substantially when based upon self-identified race (HR=0.97 for whites, HR=0.65 for nonwhites; interaction P-value=0.05); however, it did not differ among race/ethnicity groups classified using indirect methods (HR=0.87 for white and nonwhites; interaction P-value=0.83). The impact on adherence was the same for self-reported and BISG-estimated race/ethnicity for 2 of the 3 medication classes studied.

Conclusions: Quantitatively and qualitatively different results were obtained when indirectly estimated race/ethnicity was used, suggesting that these techniques may not accurately describe aspects of race/ethnicity related to actual health behaviors.
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http://dx.doi.org/10.1097/MLR.0000000000000438DOI Listing
December 2015

Utilization and Outcomes of BRCA Genetic Testing and Counseling in a National Commercially Insured Population: The ABOUT Study.

JAMA Oncol 2015 Dec;1(9):1251-60

Morsani College of Medicine, University of South Florida, Tampa.

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.
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http://dx.doi.org/10.1001/jamaoncol.2015.3048DOI Listing
December 2015

Long-term cost-effectiveness of providing full coverage for preventive medications after myocardial infarction.

Circ Cardiovasc Qual Outcomes 2015 May 5;8(3):252-9. Epub 2015 May 5.

From the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (K.I., J.A., W.H.S., N.K.C.); Division of Geriatric Medicine, Department of Primary Care, University of New England College of Osteopathic Medicine, Biddeford, ME (K.I.); Office of Chief Medical Officer (M.T.) and Informatics (C.S.), Aetna, Hartford, CT; and CVS Health, Woonsocket, RI (W.H.S., T.B.).

Background: Adherence to drugs that are prescribed after myocardial infarction remains suboptimal. Although eliminating patient cost sharing for secondary prevention increases adherence and reduces rates of major cardiovascular events, the long-term clinical and economic implications of this approach have not been adequately evaluated.

Methods And Results: We developed a Markov model simulating a hypothetical cohort of commercially insured patients who were discharged from the hospital after myocardial infarction. Patients received β-blockers, renin-angiotensin system antagonists, and statins without cost sharing (full coverage) or at the current level of insurance coverage (usual coverage). Model inputs were extracted from the Post Myocardial Infarction Free Rx Event and Economic Evaluation trial and other published literature. The main outcome was an incremental cost-effectiveness ratio as measured by cost per quality-adjusted life year gained. Patients receiving usual coverage lived an average of 9.46 quality-adjusted life years after their event and incurred costs of $171,412. Patients receiving full coverage lived an average of 9.60 quality-adjusted life years and incurred costs of $167,401. Compared with usual coverage, full coverage would result in greater quality-adjusted survival (0.14 quality-adjusted life years) and less resource use ($4011) per patient. Our results were sensitive to alterations in the risk reduction for post-myocardial infarction events from full coverage.

Conclusions: Providing full prescription drug coverage for evidence-based pharmacotherapy to commercially insured post-myocardial infarction patients has the potential to improve health outcomes and save money from the societal perspective over the long-term.

Clinical Trial Registration Information: https://www.clinicaltrials.gov. Unique identifier: NCT00566774.
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http://dx.doi.org/10.1161/CIRCOUTCOMES.114.001330DOI Listing
May 2015

Early diffusion of gene expression profiling in breast cancer patients associated with areas of high income inequality.

Health Aff (Millwood) 2015 Apr;34(4):609-15

Jennifer S. Haas is a professor of medicine at Harvard University and Brigham and Women's Hospital, in Boston, Massachusetts.

With the Affordable Care Act reducing coverage disparities, social factors could prominently determine where and for whom innovations first diffuse in health care markets. Gene expression profiling is a potentially cost-effective innovation that guides chemotherapy decisions in early-stage breast cancer, but adoption has been uneven across the United States. Using a sample of commercially insured women, we evaluated whether income inequality in metropolitan areas was associated with receipt of gene expression profiling during its initial diffusion in 2006-07. In areas with high income inequality, gene expression profiling receipt was higher than elsewhere, but it was associated with a 10.6-percentage-point gap between high- and low-income women. In areas with low rates of income inequality, gene expression profiling receipt was lower, with no significant differences by income. Even among insured women, income inequality may indirectly shape diffusion of gene expression profiling, with benefits accruing to the highest-income patients in the most unequal places. Policies reducing gene expression profiling disparities should address low-inequality areas and, in unequal places, practice settings serving low-income patients.
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http://dx.doi.org/10.1377/hlthaff.2014.1013DOI Listing
April 2015

American BRCA Outcomes and Utilization of Testing (ABOUT) study: a pragmatic research model that incorporates personalized medicine/patient-centered outcomes in a real world setting.

J Genet Couns 2015 Feb 12;24(1):18-28. Epub 2014 Sep 12.

Women's Health, Aetna, Hartford, CT, USA.

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.
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http://dx.doi.org/10.1007/s10897-014-9750-3DOI Listing
February 2015

Eliminating medication copayments reduces disparities in cardiovascular care.

Health Aff (Millwood) 2014 May;33(5):863-70

Substantial racial and ethnic disparities in cardiovascular care persist in the United States. For example, African Americans and Hispanics with cardiovascular disease are 10-40 percent less likely than whites to receive secondary prevention therapies, such as aspirin and beta-blockers. Lowering copayments for these therapies improves outcomes among all patients who have had a myocardial infarction, but the impact of lower copayments on health disparities is unknown. Using self-reported race and ethnicity for participants in the Post-Myocardial Infarction Free Rx Event and Economic Evaluation (MI FREEE) trial, we found that rates of medication adherence were significantly lower and rates of adverse clinical outcomes were significantly higher for nonwhite patients than for white patients. Providing full drug coverage increased medication adherence in both groups. Among nonwhite patients, it also reduced the rates of major vascular events or revascularization by 35 percent and reduced total health care spending by 70 percent. Providing full coverage had no effect on clinical outcomes and costs for white patients. We conclude that lowering copayments for medications after myocardial infarctions may reduce racial and ethnic disparities for cardiovascular disease.
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http://dx.doi.org/10.1377/hlthaff.2013.0654DOI Listing
May 2014

Untangling the relationship between medication adherence and post-myocardial infarction outcomes: medication adherence and clinical outcomes.

Am Heart J 2014 Jan 17;167(1):51-58.e5. Epub 2013 Oct 17.

Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.

Background: Patients who adhere to medications experience better outcomes than their nonadherent counterparts. However, these observations may be confounded by patient behaviors. The level of adherence necessary for patients to derive benefit and whether adherence to all agents is important for diseases that require multiple drugs remain unclear. This study quantifies the relationship between medication adherence and post-myocardial infarction (MI) adverse coronary events.

Methods: This is a secondary analysis of the randomized MI FREEE trial. Patients who received full prescription coverage were classified as adherent (proportion of days covered ≥80%) or not based upon achieved adherence in the 6 months after randomization. First major vascular event or revascularization rates were compared using multivariable Cox models adjusting for comorbidity and health-seeking behavior.

Results: Compared with patients randomized to usual care, full coverage patients adherent to statin, β-blocker, or angiotensin-converting enzyme inhibitor/angiotensin receptor blocker were significantly less likely to experience the study's primary outcome (hazard ratio [HR] range 0.64-0.81). In contrast, nonadherent patients derived no benefit (HR range 0.98-1.04, P ≤ .01 for the difference in HRs between adherent and nonadherent patients). Partially adherent patients had no reduction in clinical outcomes for any of the drugs evaluated, although their achieved adherence was higher than that among controls.

Conclusion: Achieving high levels of adherence to each and all guideline-recommended post-MI secondary prevention medication is associated with improved event-free survival. Lower levels of adherence appear less protective.
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http://dx.doi.org/10.1016/j.ahj.2013.09.014DOI Listing
January 2014

Late MitraClip failure: removal technique for leaflet-sparing mitral valve repair.

J Card Surg 2012 Sep 4;27(5):543-5. Epub 2012 Jul 4.

Department of Cardiocirculatory Pathophysiology, Anesthesiology, and General Surgery, Sapienza University of Rome, Rome, Italy.

MitraClip system has been recently introduced in clinical practice for percutaneous mitral valve repair in selected patients. In the case of early or late detachment of the device dedicated tools, either with percutaneous or surgical approach, have been developed. We describe a novel technique to atraumatically remove the MitraClip.
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http://dx.doi.org/10.1111/j.1540-8191.2012.01483.xDOI Listing
September 2012

Full coverage for preventive medications after myocardial infarction.

N Engl J Med 2011 Dec 14;365(22):2088-97. Epub 2011 Nov 14.

Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA 02120, USA.

Background: Adherence to medications that are prescribed after myocardial infarction is poor. Eliminating out-of-pocket costs may increase adherence and improve outcomes.

Methods: We enrolled patients discharged after myocardial infarction and randomly assigned their insurance-plan sponsors to full prescription coverage (1494 plan sponsors with 2845 patients) or usual prescription coverage (1486 plan sponsors with 3010 patients) for all statins, beta-blockers, angiotensin-converting-enzyme inhibitors, or angiotensin-receptor blockers. The primary outcome was the first major vascular event or revascularization. Secondary outcomes were rates of medication adherence, total major vascular events or revascularization, the first major vascular event, and health expenditures.

Results: Rates of adherence ranged from 35.9 to 49.0% in the usual-coverage group and were 4 to 6 percentage points higher in the full-coverage group (P<0.001 for all comparisons). There was no significant between-group difference in the primary outcome (17.6 per 100 person-years in the full-coverage group vs. 18.8 in the usual-coverage group; hazard ratio, 0.93; 95% confidence interval [CI], 0.82 to 1.04; P=0.21). The rates of total major vascular events or revascularization were significantly reduced in the full-coverage group (21.5 vs. 23.3; hazard ratio, 0.89; 95% CI, 0.90 to 0.99; P=0.03), as was the rate of the first major vascular event (11.0 vs. 12.8; hazard ratio, 0.86; 95% CI, 0.74 to 0.99; P=0.03). The elimination of copayments did not increase total spending ($66,008 for the full-coverage group and $71,778 for the usual-coverage group; relative spending, 0.89; 95% CI, 0.50 to 1.56; P=0.68). Patient costs were reduced for drugs and other services (relative spending, 0.74; 95% CI, 0.68 to 0.80; P<0.001).

Conclusions: The elimination of copayments for drugs prescribed after myocardial infarction did not significantly reduce rates of the trial's primary outcome. Enhanced prescription coverage improved medication adherence and rates of first major vascular events and decreased patient spending without increasing overall health costs. (Funded by Aetna and the Commonwealth Fund; MI FREEE ClinicalTrials.gov number, NCT00566774.).
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http://dx.doi.org/10.1056/NEJMsa1107913DOI Listing
December 2011

Genomic testing and therapies for breast cancer in clinical practice.

J Oncol Pract 2011 May;7(3 Suppl):e1s-7s

Brigham and Women's Hospital; Dana-Farber Cancer Institute, Boston, MA; University of California, San Francisco, San Francisco, CA; Memorial Sloan-Kettering Cancer Center, New York, NY; and Aetna, Hartford, CT.

Purpose: 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.

Study Design: Cross-sectional.

Methods: We performed a medical record review of women age 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).

Results: 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% CI, 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.

Conclusion: Identifying and eliminating unnecessary variation in the use of these expensive tests and treatments should be part of quality improvement and efficiency programs.
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http://dx.doi.org/10.1200/JOP.2011.000299DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3092459PMC
May 2011

Genomic testing and therapies for breast cancer in clinical practice.

Am J Manag Care 2011 May 1;17(5 Spec No):e174-81. Epub 2011 May 1.

Division of General Medicine and Primary Care, Boston, MA 02120, USA.

Objective: 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.

Study Design: Cross-sectional.

Methods: 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).

Results: 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.

Conclusion: Identifying and eliminating unnecessary variation in the use of these expensive tests and treatments should be part of quality improvement and efficiency programs.
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May 2011

Short-term results of a randomized trial examining timing of carotid endarterectomy in patients with severe asymptomatic unilateral carotid stenosis undergoing coronary artery bypass grafting.

J Vasc Surg 2011 Oct 23;54(4):993-9; discussion 998-9. Epub 2011 Jun 23.

"Francesco Durante" Department of Surgery, University of Rome "La Sapienza," Rome, Italy.

Objective: This study evaluated the timing of carotid endarterectomy (CEA) in the prevention of stroke in patients with asymptomatic carotid stenosis >70% receiving a coronary artery bypass graft (CABG).

Methods: From January 2004 to December 2009, 185 patients with unilateral asymptomatic carotid artery stenosis >70%, candidates for CABG, were randomized into two groups. In group A, 94 patients received a CABG with previous or simultaneous CEA. In group B, 91 patients underwent CABG, followed by CEA. All patients underwent preoperative helical computed tomography scans, excluding significant atheroma of the ascending aorta or aortic arch. Baseline characteristics of the patients, type of coronary artery lesion, and preoperative myocardial function were comparable in the two groups. In group A, all patients underwent CEA under general anesthesia with the systematic use of a carotid shunt, and 79 patients had a combined procedure and 15 underwent CEA a few days before CABG. In group B, all patients underwent CEA, 1 to 3 months after CABG, also under general anesthesia and with systematic carotid shunting.

Results: Two patients (one in each group) died of cardiac failure in the postoperative period. Operative mortality was 1.0% in group A and 1.1% in group B (P = .98). No strokes occurred in group A vs seven ipsilateral ischemic strokes in group B, including three immediate postoperative strokes and four late strokes, at 39, 50, 58, and 66 days, after CABG. These late strokes occurred in patients for whom CEA was further delayed due to an incomplete sternal wound healing or because of completion of a cardiac rehabilitation program. The 90-day stroke and death rate was 1.0% (one of 94) in group A and 8.8% (eight of 91) in group B (odds ratio [OR], 0.11; 95% confidence interval [CI], 0.01-0.91; P = .02). Logistic regression analysis showed that only delayed CEA (OR, 14.2; 95% CI, 1.32-152.0; P = .03) and duration of cardiopulmonary bypass (OR, 1.06; 95% CI, 1.02-1.11; P = .004) reliably predicted stroke or death at 90 days.

Conclusions: This study suggests that previous or simultaneous CEA in patients with unilateral severe asymptomatic carotid stenosis undergoing CABG could prevent stroke better than delayed CEA, without increasing the overall surgical risk.
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http://dx.doi.org/10.1016/j.jvs.2011.03.284DOI Listing
October 2011

Minimally invasive aortic valve replacement in a transplanted heart.

Ann Thorac Surg 2010 Nov;90(5):1688-90

Department of Cardiothoracic Surgery, Foundation IRCCS Policlinico S.Matteo, Pavia University School of Medicine, Pavia, Italy.

Heart transplantation is subject to a number of chronic complications that may limit graft survival and be detrimental to the patient's quality of life. Aortic valve stenosis is a rare complication found after cardiac transplantation, which we believe has never been described on a tricuspid normal aortic valve. In the present study, we report a case of successful aortic valve replacement performed 16 years after cardiac transplantation on an extensively calcified tricuspid valve. Surgery was performed by using a minimally invasive approach with a reverse T upper mini-sternotomy, and the aortic valve was replaced by a biological prosthesis. The postoperative course was uneventful and the patient was discharged 7 days after the operation.
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http://dx.doi.org/10.1016/j.athoracsur.2010.08.013DOI Listing
November 2010

Real world experience with cancer genetic counseling via telephone.

Fam Cancer 2010 Dec;9(4):681-9

University of South Florida College of Medicine, Tampa, FL, USA.

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.
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http://dx.doi.org/10.1007/s10689-010-9369-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3303219PMC
December 2010

Long-term mortality prediction after operations for type A ascending aortic dissection.

J Cardiothorac Surg 2010 May 25;5:42. Epub 2010 May 25.

Department of the Heart and Great Vessels Attilio Reale, University of Rome La Sapienza, Rome, Italy.

Background: There are few long-term mortality prediction studies after acute aortic dissection (AAD) Type A and none were performed using new models such as neural networks (NN) or support vector machines (SVM) which may show a higher discriminatory potency than standard multivariable models.

Methods: We used 32 risk factors identified by Literature search and previously assessed in short-term outcome investigations. Models were trained (50%) and validated (50%) on 2 random samples from a consecutive 235-patient cohort. NN were run only on patients with complete data for all included variables (N = 211); SVM on the overall group. Discrimination was assessed by receiver operating characteristic area under the curve (AUC) and Gini's coefficients along with classification performance.

Results: There were 84 deaths (36%) occurring at 564 +/- 48 days (95%CI from 470 to 658 days). Patients with complete variables had a slightly lower death rate (60 of 211, 28%). NN classified 44 of 60 (73%) dead patients and 147 of 151 (97%) long-term survivors using 5 covariates: immediate post-operative chronic renal failure, circulatory arrest time, the type of surgery on ascending aorta plus hemi-arch, extracorporeal circulation time and the presence of Marfan habitus. Global accuracies of training and validation NN were excellent with AUC respectively 0.871 and 0.870 but classification errors were high among patients who died. Training SVM, using a larger number of covariates, showed no false negative or false positive cases among 118 randomly selected patients (error = 0%, AUC 1.0) whereas validation SVM, among 117 patients, provided 5 false negative and 11 false positive cases (error = 22%, AUC 0.821, p < 0.01 versus NN results). An html file was produced to adopt and manipulate the selected parameters for practical predictive purposes.

Conclusions: Both NN and SVM accurately selected a few operative and immediate post-operative factors and the Marfan habitus as long-term mortality predictors in AAD Type A. Although these factors were not new per se, their combination may be used in practice to index death risk post-operatively with good accuracy.
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http://dx.doi.org/10.1186/1749-8090-5-42DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2902218PMC
May 2010

Cancer genetic risk assessment and referral patterns in primary care.

Genet Test Mol Biomarkers 2009 Dec;13(6):735-41

Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.

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.
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http://dx.doi.org/10.1089/gtmb.2009.0037DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2935840PMC
December 2009

Impact of high titre of antiphospholipid antibodies on postoperative outcome following pulmonary endarterectomy.

Interact Cardiovasc Thorac Surg 2010 Mar 24;10(3):418-22. Epub 2009 Nov 24.

Division of Cardiac Surgery, IRCCS Foundation S. Matteo, Pavia, Italy.

Objectives: Antiphospholipid (a-PL) antibodies, especially IgG isotype, have been associated with a variety of neurological manifestations related to thrombotic mechanism and reactivity against nervous tissues. Furthermore, high titre of a-PL antibodies has been also correlated to chronic thromboembolic pulmonary hypertension (CTEPH) and, therefore, is frequently reported in patients undergoing pulmonary endarterectomy (PEA). The impact of a-PL antibodies in postoperative outcome following PEA, however, has not been clearly evaluated yet. In this paper, we investigated the impact of a high a-PL IgG titre (HAPT) on postoperative outcome following PEA.

Methods: From April 1994 to October 2008, out of 204 patients undergoing PEA at our centre, 184 were prospectively screened for a-PL antibodies. According to the preoperative IgG titre, patients were divided into two groups: Group A (high a-PL antibodies titre - HAPT) with a-PL IgG titre >10 U/ml and Group B (low a-PL antibodies titre - LAPT) with a-PL IgG titre
Results: Twenty-eight patients (15%) were included in Group A, whereas 156 (85%) patients were included in Group B. HAPT influenced preoperative parameters as patients of Group A were younger compared to those of Group B (42+/-16 and 52+/-16 for Group A and B, respectively, P=0.001) and presented more frequently a previous history of deep venous thrombosis (DVT) (96% and 62% for Group A and B, respectively, P=0.001). The two groups were homogeneous for all other operative parameters. As far as postoperative outcome, in terms of mortality and major complications, there were no differences between the two groups. Incidence of transient neurological complications, however, was significantly different (32% and 10% for Group A and B, respectively, P=0.023).

Conclusions: The presence of high titre of IgG isotype a-PL antibodies significantly influences preoperative characteristics of patients undergoing PEA. Furthermore, despite that no significant differences were shown in major end points, the presence of high titre of a-PL did interfere with postoperative course as caused by an increased rate of minor and transient neurological impairment (TNI). An accurate monitoring especially during hypothermic circulatory arrest (CA) period seems, therefore, mandatory in this subgroup of patients undergoing PEA.
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http://dx.doi.org/10.1510/icvts.2009.221630DOI Listing
March 2010

Artificial neural networks versus multiple logistic regression to predict 30-day mortality after operations for type a ascending aortic dissection.

Open Cardiovasc Med J 2009 Jul 7;3:81-95. Epub 2009 Jul 7.

Department of the Heart and Great Vessels "Attilio Reale", UOC of Cardiac Surgery.

Background: There are few comparative reports on the overall accuracy of neural networks (NN), assessed only versus multiple logistic regression (LR), to predict events in cardiovascular surgery studies and none has been performed among acute aortic dissection (AAD) Type A patients.

Objectives: We aimed at investigating the predictive potential of 30-day mortality by a large series of risk factors in AAD Type A patients comparing the overall performance of NN versus LR.

Methods: We investigated 121 plus 87 AAD Type A patients consecutively operated during 7 years in two Centres. Forced and stepwise NN and LR solutions were obtained and compared, using receiver operating characteristic area under the curve (AUC) and their 95% confidence intervals (CI) and Gini's coefficients. Both NN and LR models were re-applied to data from the second Centre to adhere to a methodological imperative with NN.

Results: Forced LR solutions provided AUC 87.9±4.1% (CI: 80.7 to 93.2%) and 85.7±5.2% (CI: 78.5 to 91.1%) in the first and second Centre, respectively. Stepwise NN solution of the first Centre had AUC 90.5±3.7% (CI: 83.8 to 95.1%). The Gini's coefficients for LR and NN stepwise solutions of the first Centre were 0.712 and 0.816, respectively. When the LR and NN stepwise solutions were re-applied to the second Centre data, Gini's coefficients were, respectively, 0.761 and 0.850. Few predictors were selected in common by LR and NN models: the presence of pre-operative shock, intubation and neurological symptoms, immediate post-operative presence of dialysis in continuous and the quantity of post-operative bleeding in the first 24 h. The length of extracorporeal circulation, post-operative chronic renal failure and the year of surgery were specifically detected by NN.

Conclusions: Different from the International Registry of AAD, operative and immediate post-operative factors were seen as potential predictors of short-term mortality. We report a higher overall predictive accuracy with NN than with LR. However, the list of potential risk factors to predict 30-day mortality after AAD Type A by NN model is not enlarged significantly.
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http://dx.doi.org/10.2174/1874192400903010081DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2720513PMC
July 2009

Rationale and design of the Post-MI FREEE trial: a randomized evaluation of first-dollar drug coverage for post-myocardial infarction secondary preventive therapies.

Am Heart J 2008 Jul 6;156(1):31-6. Epub 2008 Jun 6.

Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston, MA 02120, USA.

Background: Medication nonadherence is a major public health problem, especially for patients with coronary artery disease. The cost of prescription drugs is a central reason for nonadherence, even for patients with drug insurance. Removing patient out-of-pocket drug costs may increase adherence, improve clinical outcomes, and even reduce overall health costs for high-risk patients. The existing data are inadequate to assess whether this strategy is effective.

Trial Design: The Post-Myocardial Infarction Free Rx and Economic Evaluation (Post-MI FREEE) trial aims to evaluate the effect of providing full prescription drug coverage (ie, no copays, coinsurance, or deductibles) for statins, beta-blockers, angiotensin-converting enzyme inhibitors, and angiotensin II receptor blockers to patients after being recently discharged from the hospital. Potentially eligible patients will be those individuals who receive their health and pharmacy benefits through Aetna, Inc. Patients enrolled in a Health Savings Account plan, who are > or =65 years of age, whose plan sponsor (ie, the employer, union, government, or association that sponsors the particular benefits package) has opted out of participating in the study, and who do not receive both medical services and pharmacy coverage through Aetna will be excluded. The plan sponsor of each eligible patient will be block randomized to either full drug coverage or current levels of pharmacy benefit, and all subsequently eligible patients of that same plan sponsor will be assigned to the same benefits group. The primary outcome of the trial is a composite clinical outcome of readmission for acute MI, unstable angina, stroke, congestive heart failure, revascularization, or inhospital cardiovascular death. Secondary outcomes include medication adherence and health care costs. All patients will be followed up for a minimum of 1 year.

Conclusion: The Post-MI FREEE trial will be the first randomized study to evaluate the impact of reducing cost-sharing for essential cardiac medications in high-risk patients on clinical and economic outcomes.
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http://dx.doi.org/10.1016/j.ahj.2008.03.021DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2697130PMC
July 2008

Black cardiac paraganglioma in a multiple paraganglioma syndrome.

Eur J Cardiothorac Surg 2007 Dec 27;32(6):940-2. Epub 2007 Sep 27.

Department of Heart and Great Vessels Attilio Reale, University La Sapienza, Rome, Italy.

We describe a unique case of a patient with a 'pigmented' cardiac paraganglioma in a multiple paraganglioma syndrome. She was symptomatic for arrhythmias, hypertensive crises and dyspnoea due to a cardiac tumour, which was richly vascularised from the right coronary artery and was partially obstructing the right atrioventricular inflow. She was operated on, but the mass was not completely resectable due to its relationship with cardiac structures. The histological findings were paraganglioma with abundant, dark granular pigment. To our knowledge, pigment presence has never been cited in surgical cases of cardiac paragangliomas.
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http://dx.doi.org/10.1016/j.ejcts.2007.08.026DOI Listing
December 2007