Above-average Risk Research Articles

Abstract P2-12-06: Implementing a comprehensive genetic risk assessment and testing service at an outpatient breast imaging center

Abstract Breast cancer is the most common cancer in women, and there are a variety of available methods to determine which women have an above-average risk to develop breast cancer. However, it can be a challenge to identify patients who may benefit from genetic counseling and should be offered genetic testing. This study examines our data and experience in performing genetic risk assessment and offering on-site genetic counseling in an outpatient breast imaging center. A screening questionnaire asking about personal and family cancer history was created and given to every patient coming in for either screening or diagnostic mammogram. The questionnaires were reviewed by both the breast radiologist and nurse navigator, and those identified as appropriate were offered appointments with the genetic counselor. Genetic counseling appointments are available two days per month. Data was obtained over an eight month period from August 2012- March 2013. During this time, 8768 mammograms were performed and 406 individuals were identified as having a history suspicious for hereditary breast and ovarian cancer and offered an appointment with a genetic counselor. Out of these 406 individuals, 83 scheduled appointments with the genetic counselor, 108 declined appointments, and 215 are pending. Some of the genetic counseling appointments were made after March 31, 2013 and the outcomes are not included at this time. Thirty-six patients were ultimately seen for genetic counseling and risk assessment in this time frame, with 28 undergoing testing. Out of the 28 patients tested during this time period, one was positive and one had a variant of unknown significance. Out of the 36 patients seen for genetic counseling, 27 were identified as increased risk for breast cancer either by having a Gail risk assessment score ≥1.67% or Tyrer-Cuzick risk assessment score ≥19.5% and were eligible for chemoprevention or breast MRI, respectively. This clinic model demonstrates that on-site genetic counseling is feasible in an outpatient breast imaging setting. Prior to offering on-site genetic counseling, this center used the same questionnaire to identify patients and sent a recommendation for genetic counseling to the referring physician ordering the mammogram. This system relied on the physician to make a referral to an off-site genetic counselor. From the period of May 2012- August 2012, 139 patients were identified by the same questionnaire with 17 patients being referred to genetic counseling, and only 3 of these patients were ultimately seen by the genetic counselor. By providing on-site genetic counseling, the percentage of patients seen for genetic counseling increased from 2.15% (3/139) to 8.87% (36/406). In addition, more outcomes are known since 100% of patients identified to be at risk for Hereditary Breast and Ovarian cancer were offered genetic counseling, and if a patient declined, a reason was documented. The risk assessment algorithm outlined here identified more patients that either tested positive for a BRCA mutation or were at an increased 5-year or lifetime risk to develop breast cancer that may not have been detected otherwise. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P2-12-06.

Unequal Distribution of Educational Outcomes between Social Categories: ‘Children at Risk’ from a Sociological Perspective

This paper discusses the concept of ‘children at risk’ for poor educational outcomes from a sociological perspective. The broader concept of social inequality with its determinants and dimensions is introduced as a conceptual basis. The concept of ‘children at risk’ for adverse educational outcomes can be located within this framework: They are defined as children with an above-average risk of unfavourable educational outcomes because of their affiliation to a social category. The unequal distribution of educational outcomes between different social categories is a well-established research topic in sociology which is usually simply referred to as ‘educational inequality’. Its description and especially its explanation are the major tasks for sociologists in this field. The paper provides some selected examples for educational inequalities and introduces one exemplary theoretical explanation from a sociological perspective for this phenomenon. Furthermore, the concept of ‘children at risk’ is critically discussed in light of the usefulness as well as the complex of problems that may be associated with its application in sociology.

A Machine-Learned Predictor of Colonic Polyps Based on Urinary Metabolomics

We report an automated diagnostic test that uses the NMR spectrum of a single spot urine sample to accurately distinguish patients who require a colonoscopy from those who do not. Moreover, our approach can be adjusted to tradeoff between sensitivity and specificity. We developed our system using a group of 988 patients (633 normal and 355 who required colonoscopy) who were all at average or above-average risk for developing colorectal cancer. We obtained a metabolic profile of each subject, based on the urine samples collected from these subjects, analyzed via 1H-NMR and quantified using targeted profiling. Each subject then underwent a colonoscopy, the gold standard to determine whether he/she actually had an adenomatous polyp, a precursor to colorectal cancer. The metabolic profiles, colonoscopy outcomes, and medical histories were then analysed using machine learning to create a classifier that could predict whether a future patient requires a colonoscopy. Our empirical studies show that this classifier has a sensitivity of 64% and a specificity of 65% and, unlike the current fecal tests, allows the administrators of the test to adjust the tradeoff between the two.

Breast cancer risk assessment across the risk continuum: genetic and nongenetic risk factors contributing to differential model performance

IntroductionClinicians use different breast cancer risk models for patients considered at average and above-average risk, based largely on their family histories and genetic factors. We used longitudinal cohort data from women whose breast cancer risks span the full spectrum to determine the genetic and nongenetic covariates that differentiate the performance of two commonly used models that include nongenetic factors - BCRAT, also called Gail model, generally used for patients with average risk and IBIS, also called Tyrer Cuzick model, generally used for patients with above-average risk.MethodsWe evaluated the performance of the BCRAT and IBIS models as currently applied in clinical settings for 10-year absolute risk of breast cancer, using prospective data from 1,857 women over a mean follow-up length of 8.1 years, of whom 83 developed cancer. This cohort spans the continuum of breast cancer risk, with some subjects at lower than average population risk. Therefore, the wide variation in individual risk makes it an interesting population to examine model performance across subgroups of women. For model calibration, we divided the cohort into quartiles of model-assigned risk and compared differences between assigned and observed risks using the Hosmer-Lemeshow (HL) chi-squared statistic. For model discrimination, we computed the area under the receiver operator curve (AUC) and the case risk percentiles (CRPs).ResultsThe 10-year risks assigned by BCRAT and IBIS differed (range of difference 0.001 to 79.5). The mean BCRAT- and IBIS-assigned risks of 3.18% and 5.49%, respectively, were lower than the cohort's 10-year cumulative probability of developing breast cancer (6.25%; 95% confidence interval (CI) = 5.0 to 7.8%). Agreement between assigned and observed risks was better for IBIS (HL X42 = 7.2, P value 0.13) than BCRAT (HL X42 = 22.0, P value <0.001). The IBIS model also showed better discrimination (AUC = 69.5%, CI = 63.8% to 75.2%) than did the BCRAT model (AUC = 63.2%, CI = 57.6% to 68.9%). In almost all covariate-specific subgroups, BCRAT mean risks were significantly lower than the observed risks, while IBIS risks showed generally good agreement with observed risks, even in the subgroups of women considered at average risk (for example, no family history of breast cancer, BRCA1/2 mutation negative).ConclusionsModels developed using extended family history and genetic data, such as the IBIS model, also perform well in women considered at average risk (for example, no family history of breast cancer, BRCA1/2 mutation negative). Extending such models to include additional nongenetic information may improve performance in women across the breast cancer risk continuum.

Abstract PR-02: Breast Cancer Risk Assessment: Genetic and Non-Genetic Risk Factors contributing to Differential Model Performance

Abstract Introduction: Clinicians use different breast cancer risk models for patients considered at average and above-average risk, based largely on their family histories and genetic factors. To explore the feasibility of a single model appropriate for all women, we used longitudinal cohort data from women whose breast cancer risks span the full spectrum to determine the covariates that differentiate the performance of two commonly used models, BCRAT, or also called GAIL model, (used for patients with average risk) and IBIS, or also called Tyrer Cuzick model, (for patients with above-average risk). Methods: We evaluated the performance of BCRAT and IBIS for ten-year absolute risk of breast cancer, using prospective data from 1,857 women over a mean follow-up length of 8.1 years, of whom 83 developed cancer. This cohort spans the continuum of breast cancer risk, with some subjects at lower than average population risk. Therefore, the wide-variation in individual risk makes it an interesting population to examine model performance across subgroups of women. For model calibration, we divided the cohort into quartiles of model-assigned risk and comparing differences between assigned and observed risks using the Hosmer-Lemeshow (HL) chi-squared statistic. For model discrimination, we computed the area under the receiver operator curve (AUC) and the case risk percentiles (CRPs). Results: The ten-year risks assigned by BCRAT and IBIS differed (range of difference 0.001 to 79.5). The mean BCRAT- and IBIS-assigned risks of 3.18% and 5.59%, respectively, were lower than the cohort's 10-year cumulative probability of developing breast cancer (6.25%; 95% confidence interval (CI) = 5.0-7.8%). Agreement between assigned and observed risks was better for IBIS (HL X42 =7.2, P-value 0.13) than BCRAT (HL X42 = 22.0, P-value &amp;lt; 0.001). The IBIS model also showed better discrimination (AUC = 69.5%, CI = 63.8% - 75.2%) than did the BCRAT model (AUC = 63.2%, CI = 57.6% - 68.9%). In almost all covariate-specific subgroups, BCRAT mean risks were significantly lower than the observed risks, while IBIS risks showed generally good agreement with observed risks, even in the subgroups of women considered at average risk (e.g., no family history of breast cancer, BRCA1/2 mutation negative). Conclusions: Models developed using extended family history and genetic data, such as the IBIS model, also perform well in women considered at average risk (e.g. no family history of breast cancer, BRCA1/2 mutation negative). Extending such models to include nongenetic information (e.g., breast biopsy history and race/ethnicity) may improve their performance among all women across the breast cancer risk continuum. This abstract is also presented as Poster A109. Citation Format: Anne S. Quante, Alice S. Whittemore, Mary Beth Terry. Breast cancer risk assessment: Genetic and nongenetic risk factors contributing to differential model performance. [abstract]. In: Proceedings of the Eleventh Annual AACR International Conference on Frontiers in Cancer Prevention Research; 2012 Oct 16-19; Anaheim, CA. Philadelphia (PA): AACR; Cancer Prev Res 2012;5(11 Suppl):Abstract nr PR-02.

Decreased Incidence of Pneumothorax in VLBW Infants After Increased Monitoring of Tidal Volumes

Pneumothorax is common in very low birth weight (VLBW) infants. In our NICU, we noted an above average incidence of pneumothorax compared with similar NICUs based on Vermont Oxford Network benchmarking. The quality improvement project was designed to decrease the incidence of pneumothorax in VLBW infants in a tertiary care NICU. The project was divided into 2 periods. During period 1, all VLBW infants were followed for 6 months for the presence of pneumothorax. A multidisciplinary team met regularly to review cases of pneumothorax and identify potential causes. High tidal volumes (VT) (>6 mL/kg) were noted around the time of occurrence of pneumothorax. Guidelines were developed for improved monitoring and rapid feedback of VT and peak inspiratory pressure between nursing staff and clinicians. During period 2, these guidelines were implemented and VLBW infants were again followed for 6 months. The incidence of pneumothorax was tracked. Run charts were used to monitor changes. The incidence of pneumothorax in VLBW infants decreased from 10.4% to 2.6% after the intervention (P = .04). By using process control, a reduction in pneumothorax was achieved in period 2. Increased vigilance and real-time monitoring of VT and peak inspiratory pressure decreased the incidence of pneumothorax in our population of VLBW infants. These interventions can be considered in other NICUs with an above-average risk adjusted incidence of pneumothorax in VLBW infants. Our data illustrate the benefits of comparative benchmarking and organized quality improvement in advancing patient care outcomes.

Tu1663 The Effect of the Third Eye® Retroscope® (TER) on Additional Adenoma Detection Rates (DR) During Colonoscopy in Above-Average Risk Patients for Colorectal Cancer in a Community Setting

The TER is a proprietary device used in addition to standard colonoscopy techniques to improve visualization of the colonic mucosal surface. This IRB-approved prospective trial, with one physician endoscopist in a community hospital and ambulatory endoscopy center, includes consecutive above-risk patients. The primary goal was to see if the adenoma DR were increased and comparable to other recently published studies. This is a non-industry sponsored study. A total of 85 patients were enrolled and 68 completed the protocol.

Where Is Social Work in the Social Entrepreneurship Movement?

Although the business and public policy communities have ignited a national movement toward embracing social entrepreneurship as a laudable enterprise and a critical piece in addressing social problems, social work remains notably absent from the discussion and definition of this field. Though the values and practices of social entrepreneurship are closely aligned with social work, social work scholars and institutions have been less at the forefront of this movement than have representatives of other disciphnes. The Skoll Foundation, a leading agent for developing and promoting social entrepreneurship, listed three exemplary social entrepreneurs in their description of the concept (the document, Foundations of Entrepreneurship, has since the time of this writing been taken down; for general information, see http:// www.skollfoundation.org/). Among those listed is Jane Addams, founder of Hull House and one of the most influential figures in social work history. Yet social work has done little to align itself with the movement of social entrepreneurship. There remains an opportunity for the field of social work to avail itself of the resources and knowledge created by this movement and to infuse social work knowledge into the study of social entrepreneurship. Understanding the history and definition of social entrepreneurship helps to define potential roles and contributions for social work and provides an opportunity to explore their congruence and potential connections. DEFINITION OF SOCIAL ENTREPRENEURSHIP Consideration of the role of social work in the social entrepreneurship movement requires an understanding of the concept. Although there has been some debate about the definition of social entrepreneurship (Christie & Honig, 2006; Mair & Marti, 2006), common to all definitions is the goal of creating social value or mission rather than personal gain or financial wealth (Peredo & McLean, 2006). Bill Drayton, founder of Ashoka, a leading global organization that identifies and promotes social entrepreneurs, is generally credited with the term's origin. His famous statement embodies the concept: Social entrepreneurs are not content just to give a fish or teach how to fish. They will not rest until they have revolutionized the fishing industry (see http://usa.ashoka.org/social-entrepreneurs-are-not-content-just-givefish- or-teach-how-fish). Scholars have argued over whether social entrepreneurship has specific ingredients, including particular responses or specific characteristics of the entrepreneur. Dees (1998) defined social entrepreneurship as the combination of social mission with business discipline, innovation, and determination to respond to social needs. Martin and Osberg (2007) described social entrepreneurship as a response to an opportunity to create an out-of-the box solution to a novel problem. They described three components: (1) identification of a stable but unjust equilibrium; (2) creation of a transformational social response; and (3) the result being a new, stable equilibrium that alleviates suffering of the identified group. Their definition clarifies that social service provision, creation of local programs, and social activism that creates change through indirect action are not included. Some scholars have suggested that social entrepreneurs have certain characteristics like a willingness to accept above-average risk, being unusually resourceful (Peredo & McLean, 2006), or having a strong ability to seize presented opportunities (Thompson, 2002). In 2006, Light argued for a more inclusive definition. He defined social entrepreneurship as the effort of an individual, organization, network, or group of organizations to create large-scale, sustainable change by shifting an approach to solving social problems. He argued against the notion of a heroic, risk-taking individual, forwarding instead a concept that celebrates working together in novel ways to solve social problems. …

The incidence and severity of injuries at the 2011 South African Rugby Union (SARU) Youth Week tournaments

Background . Rugby Union, compared with other popular team sports, presents an above-average risk of injury to players that may increase with age and level of play. Elite schoolboy rugby players have been competing at the South African Rugby Union (SARU) Youth tournaments at the under-13 (CW13), under-16 (GK16) and under-18 (AW18 and CW18) tournaments annually since 1964. The injury epidemiology of these tournaments has yet to be established. Objectives . To determine the injury incidence densities (IIDs) and severity of SARU Youth Week tournament injuries, if the IID increases with age, and the types of injuries at the different age group levels, in 2011. Methods . All match-related injuries presenting to the Tournament Doctor during these tournaments were recorded and classified for severity and type, using the injury collection Consensus Statement for Rugby. Injury incidence per 1 000 match hours and 95% confidence intervals were calculated using overall player exposure time. Results . Match-related IIDs for ‘all’ (combined: 47.9 injuries/1000 match hours) and time-loss injuries (combined: 23.1 injuries/1000 match hours) were not significantly different by age group, despite a strong tendency to indicate differences. The absolute number of injuries per match increased with age. In general, there was a higher proportion of concussions at the GK16, AW18, and CW18 compared with the CW13 tournament(s). Conclusions . Time-loss IIDs at SARU Youth Weeks are similar to other elite junior rugby data. The absolute number and type/ classification of injuries per match may be more informative than IIDs alone for medical planning purposes.

Predicting Thyroid Dysfunction When Baseline TSH Is “Normal”

Thyroid-stimulating hormone (TSH) levels near the upper and lower limits of the designated normal range may predict above-average risk for hypothyroidism and hyperthyroidism, respectively. In a population-based Norwegian study, researchers identified 15,000 euthyroid adults (age range of most, 40–70) who had serum TSH levels between 0.2 …

Electronic Patient Messages to Promote Colorectal Cancer Screening

Colorectal cancer is a leading cause of cancer mortality, yet effective screening tests are often underused. Electronic patient messages and personalized risk assessments delivered via an electronic personal health record could increase screening rates. We conducted a randomized controlled trial in 14 ambulatory health centers involving 1103 patients ranging in age from 50 to 75 years with an active electronic personal health record who were overdue for colorectal cancer screening. Patients were randomly assigned to receive a single electronic message highlighting overdue screening status with a link to a Web-based tool to assess their personal risk of colorectal cancer. The outcomes included colorectal cancer screening rates at 1 and 4 months. Screening rates were higher at 1 month for patients who received electronic messages than for those who did not (8.3% vs 0.2%, P < .001), but this difference was no longer significant at 4 months (15.8% vs 13.1%, P = .18). Of 552 patients randomized to receive the intervention, 296 (54%) viewed the message, and 47 (9%) used the Web-based risk assessment tool. Among 296 intervention patients who viewed the electronic message, risk tool users were more likely than nonusers to request screening examinations (17% vs 4%, P = .04) and to be screened (30% vs 15%, P = .06). One-fifth of patients (19%) using the risk assessment tool were estimated to have an above-average risk for colorectal cancer. Electronic messages to patients produce an initial increase in colorectal cancer screening rates, but this effect is not sustained over time. clinicaltrials.gov Identifier: NCT01032746.

Early thoracic aorta enlargement in asymptomatic individuals at risk for cardiovascular disease: determinant factors and clinical implication

We analyzed, in above-average risk asymptomatic individuals, the factors determining early thoracic aorta enlargement. Ascending aortic diameter (AAD) was measured with noncontrast multidetector computed tomography in 345 participants (mean age 56 years; 78% men) without cardiovascular disease. We analyzed the associations of AAD with risk factors and Framingham risk score (FRS), multidetector computed tomography-assessed coronary artery calcium (CAC), and ultrasound interrogation of plaque presence at five sites (right and left carotid arteries, right and left femoral arteries, and abdominal aorta), the number of diseased sites with presence of plaque being counted from 0 to 5. AAD was positively associated with age (P < 0.001), male sex (P < 0.01), body surface area (BSA; P < 0.001), hypertension (P < 0.001), systolic and diastolic blood pressures in individuals without antihypertensive medication (P < 0.05, P < 0.01), and FRS (P < 0.001). AAD was positively associated with CAC score after adjusting for age, sex, and BSA (P < 0001) or for FRS and BSA (P < 0.001). AAD was higher in the presence of three, four, or five than in the presence of no, one, or two diseased sites with plaque, after adjusting for age, sex, and BSA (P < 0.05) or for FRS and BSA (P < 0.001). When participants were divided into subsets by AAD tertiles and by number of sites with plaque, FRS and CAC score were greatest in individuals with AAD top tertile and 3-5 sites with plaque and lowest in those with AAD bottom tertile and 0-2 sites with plaque (P < 0.001). These findings suggest that thoracic ascending aorta dilatation is related to hypertension and represents a part of a generalized atherosclerotic process of the entire vasculature.

Business Owners, Financial Risk, and Wealth

Using 1989 to 2007 Survey of Consumer Finances data, this paper addresses three questions: 1) Are business owners generally more or less financially conservative than their non-business-owning counterparts?; 2) Do business owners accumulate more wealth?; and, 3) Do business owners hold a smaller share of their financial assets in risky stock holdings? Results indicate that business owners are financially conservative based on borrowing and savings questions but are more likely to be willing to assume above-average risk for financial gain. Consistent with earlier evidence that entrepreneurs save more, business owners accumulate more wealth over time. Business owners and non-business owners invest similar shares of their financial portfolios in safe assets. Taken together, the results suggest that policies aimed at increasing business ownership should focus on helping households identify high-value business opportunities through transparent tax, legal, and regulatory systems. Efforts to reduce risk should focus on the business venture, such as full loss offsets, rather than focusing on reductions in other financial risks.

Prior Consequences and Subsequent Risk Taking: New Field Evidence from the Taiwan Futures Exchange

We use a data set from market participants in the Taiwan Stock Exchange Capitalization Weighted Stock Index options markets to demonstrate a strong positive relationship between prior trading outcomes and subsequent risk taking. In particular, investors in this market take above-average risks in afternoon trading after morning gains. The phenomenon is prevalent in all three types of market makers' accounts and across different types of market participants. Our findings are consistent with the argument that prior outcomes affect subsequent risk taking through a relationship that is sensitive to the model parameters (i.e., expected return, trading period, and curvature of the value function), because prospect theory can predict both increased and decreased levels of subsequent risk taking. We provide possible explanations behind the phenomenon and discuss reasons for the variety of findings in the existing literature.

Comparing Lead Poisoning Risk Assessment Methods: Census Block Group Characteristics vs. Zip Codes as Predictors

We determined which children should be tested for elevated blood lead levels (BLLs) in the face of financial and practical barriers to universal screening efforts and within 2009 Centers for Disease Control and Prevention recommendations allowing health departments to develop BLL screening strategies. We used the Michigan database of BLL tests from 1998 through 2005, which contains address, Medicaid eligibility, and race data. Linking addresses to U.S. Census 2000 data by block group provided neighborhood sociodemographic and housing characteristics. To derive an equation predicting BLL, we treated BLL as a continuous variable and used Hierarchical Linear Modeling to estimate the prediction equation. Census block groups explained more variance in BLL than tracts and much more than dichotomized zip code risk (which is current pediatric practice). Housing built before 1940, socioeconomic status and racial/ethnic characteristics of the block group, child characteristics, and empirical Bayesian residuals explained more than 41% of the variance in BLL during 1998-2001. By contrast, zip code risk and Medicaid status only explained 15% of the BLL variance. An equation using 1998-2001 BLL data predicted well for BLL tests performed in 2002-2005. While those who received BLL tests had above-average risk, this method produced minimal bias in using the prediction equation for all children. Our equation offers better specificity and sensitivity than using dichotomized zip codes and Medicaid status, thereby identifying more high-risk children while also offering substantial cost savings. Our prediction equation can be used with a simple Internet-based program that allows health-care providers to enter minimal information and determine whether a BLL test is recommended.

Direct-to-Consumer Genetic Tests and the Right to Know

My daughter recently convinced me to have my first genetic test, after she tested positive for factor V Leiden thrombophilia, a risk factor for blood clotting disorder. My doctor agreed to write an order for the gene test, but she didn't think it would matter much if I tested positive. After all, she said, you've lived with it this long. Waiting for the result, I remember wishing hard that my daughter's mutated gene came from my ex-husband's side of the family, rather than mine. I felt an odd sense of shame at the idea of passing on a bad gene. I was reminded of the old movie about a young murderer called The Bad Seed. Bad genes seemed a stain on my family pride. Dealing with genetic knowledge is new for many of us, although families with devastating hereditary diseases such as cystic fibrosis and Tay-Sachs have dealt with it for decades. In recent years there's been an avalanche of studies identifying the genes shared by people who have various disorders. Often, the genetic tests become available to the public long before this knowledge has been confirmed or proven useful for predictive purposes. For several years it's been possible to order specific tests or analysis of your whole genome by sending a cheek tissue scraping or saliva sample to a lab. For a fee, some companies will also update the analysis of your genome as new knowledge is uncovered. The price of genetic testing has been falling, but recent efforts to bring it to a wider market have met with resistance. Pathway Genomics Corporation and Walgreens announced in May that they would offer genetic testing collection kits at the drug chain. The Food and Drug Administration took notice. In a May 10th letter, the agency notified Pathway Genomics that its product, intended to report customary and personal genetic health disposition results for more than 70 health conditions . . . Appears to meet the definition of a device as regulated under the Federal Food and Drug and Cosmetic Act, thus requiring FDA approval. The company has delayed plans to market the product. A similar letter was sent to five other direct-to-consumer testing companies in June. Most telling, on July 22, the Government Accountability Office released a study in which it sent identical DNA samples to four genetic testing firms to test for fifteen common diseases and conditions. Contradictory results abounded. For example, various companies told a forty-eight-year-old male that he had average, below-average, or above-average risk for prostate cancer. These contradictions can be explained, in part, by the fact that companies analyzed different genetic markers, and that scientists disagree about what these mean in real-life situations. However, in this study the risk predictions often conflicted with the donors' actual illnesses and family medical histories. One company said a donor had below-average risk of atrial fibrillation, when in fact he had had a pacemaker implanted thirteen years earlier to treat the disease. And, in a separate GAO study of marketing practices, two of fifteen genetic testing companies used information from consumers' profiles to recommend that they buy expensive nutritional supplements. Right to Know (or Not) Not surprisingly, a poll that came out after the Walgreens incident found that 74 percent of consumers but only 29 percent of doctors thought it was appropriate for pharmacies to sell home genetic testing kits. This can be viewed as doctors claiming the turf for themselves, or as their attempt to protect themselves from patients bearing genome printouts and demanding help to interpret and use the results--help that doctors are not prepared to deliver. It may also be a genuine expression of concern that this information, provided out of context, is too complex for individuals to deal with. Interestingly, this paternalism has not been applied to paternity testing. For an over-the-counter kit costing about a hundred and fifty dollars and a few cheek swabs, a man can find out if a child is genetically his. …

Does Presenting Colorectal Cancer Risk Information Increase Colorectal Cancer Screening Rates in Primary Care Patients?

Purpose: Although colorectal cancer (CRC) screening is recommended in the U.S. for all adults age 50 and over, actual screening rates fall short of this target. This study evaluated the effectiveness of presenting an individualized bar graph of CRC risk versus a standard screening handout of increasing screening rates in a primary care setting. Methods: Outpatient records were reviewed to identify potential subjects: no prior documented screening and age >50. Potential subjects were scheduled for a routine visit in a university-based primary care clinic and were determined to be at above-average risk for CRC based on 1 or more of the following 4 risk factors: body mass index (BMI) > 27, having inflammatory bowel disease for more than 10 years, lack of folic acid supplementation, and 1 or more first degree relative with CRC. 1147 subjects were approached to determine eligibility. 210 (38%) out of 557 eligible subjects were randomized to receive from clinic staff either individualized CRC risk information presented as a bar graph and calculated from the Harvard Cancer Risk Index or a standard CRC screening handout from the CDC. All subjects were offered fecal occult blood tests (FOBT) cards and an appointment for a flexible sigmoidoscopy (FS). Chart audits were completed 6 months after index visit. Outcome measures included the number of subjects completing any CRC screening test (FOBT, FS, and/or colonoscopy). Results: The intervention group had a mean age of 55.7±4.8 and BMI of 32.0 ± 8.1 and the control group had a mean age of 55.6±4.6 and BMI of 31.3 ± 6.9. There were 67% females in each group, and there were 57% white subjects and 46% black subjects in the intervention group and 49% white subjects and 50% black subjects in the control group (p=.400). 75% of intervention subjects and 76% of control subjects were willing to take FOBT cards home (p=0.961), but only 7% of intervention subjects and 11% of control subjects completed FOBT cards (p=0.381). No subjects completed FS. 22% of intervention subjects and 23% of control subjects completed colonoscopy (p=0.951). A total of 28% of intervention subjects and 30% of control subjects completed 1 or more CRC screening test (p=0.661). Conclusion: Presentation of individualized CRC risk information by clinic staff does not result in higher CRC screening rates in primary care patients than the simple provision of general CRC screening information. Future research is needed to determine if physician presentation of CRC risk information would result in increasing screening rates.

Do Meniscal Tears Predispose Patients to Knee Osteoarthritis

A patient who undergoes surgical removal of a torn meniscus is at above-average risk for subsequent knee osteoarthritis (OA). Whether meniscal damage

Predicting major adverse events after cardiac surgery in children

To develop a reliable predictor of major adverse events after pediatric cardiac surgery, with the aim of reducing mortality of cardiac extracorporeal life support through earlier, more accurate patient selection. Prospective observational study. Tertiary level pediatric intensive care unit. Fifty-two children undergoing open heart surgery considered above-average risk based on preoperative assessment. None; strictly observational study. A wide range of measurements was made at 3, 6, 9, 12, and 24 hrs after surgery, including: oxygen consumption, central venous pressure and oxygen saturation (Scvo2), cardiac output (Fick), heart rate, arterial pressure, arterial lactate, urine output, core-toe temperature gradient, and derived hemodynamic variables. Six children had major adverse events; three needed extracorporeal life support, two died. There were no correlations between routine postoperative measurements (blood pressure, pulse, temperature gradient, central venous pressure) and any measure of cardiac function, and neither group of variables predicted adverse outcomes. Lactate (>8 mmol/L) and Scvo2 (<40%) had high sensitivity (both 73.7%) and specificity (96.3% and 95.4%, respectively), for predicting major adverse event but positive predictive values for both were low (63.6% and 58.3%, respectively). The ratio of the two had better predictive power than the individual values. When the ratio (Scvo2, %)/(lactate, mmol/L) fell below 5, the positive predictive value for major adverse event was 93.8% (sensitivity 78.9%, specificity 90.5%). The effect was present at all postoperative time points. Lactate and Scvo2 are the only postoperative measurements with predictive power for major adverse events. Forming a ratio of the two (Scvo2/lactate), seems to improve predictive power, presumably by combining their individual predictive strengths. Both measures have excellent specificities but lower sensitivities. Predictive power of single measures is only fair but can be improved, in high risk patients, by monitoring repeated measures over time.

Comparison of an Established Simple Office-Based Immunological FOBT With Fecal Tumor Pyruvate Kinase Type M2 (M2-PK) for Colorectal Cancer Screening: Prospective Multicenter Study

The immunological fecal occult blood test (IFOBT) has established itself as a more precise marker for colorectal cancer (CRC) screening than traditional guaiac-based FOBT. The simpler, cheaper, and more convenient newer office-based IFOBTs have been validated for diagnosing CRC. Dimeric isoenzyme of pyruvate kinase, M2-PK, expressed by tumor cells, has as well been proposed as a screening tool for CRC. This is the first study comparing fecal M2-PK as a screening biomarker for CRC against previously evaluated office-based IFOBT and colonoscopy. Six hundred forty consecutive subjects (symptomatic, as well as for CRC screening) referred for colonoscopy for various indications across five centers in Germany provided the stool samples for performing M2-PK and an immunochemical FOB strip test. The IFOBT used was a rapid immunochromatographic assay for detection of fecal hemoglobin. For M2-PK, a commercially available sandwich enzyme-linked immunosorbent assay (ELISA) was used. The M2-PK test needs 6 h, while the office-based test can be read in just 10 min and is five times cheaper. Office-based IFOBT had sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and positive and negative likelihood ratios (LR) of 64.5, 96.3, 72.0, 94.9, 17.5, and 0.4 for diagnosing colorectal neoplasia (CRN), while the above performance characteristics for M2-PK at a cutoff value of 4 U/mL were 72.4, 73.8, 29.0, 94.8, 2.8, and 0.8 respectively. This office-based IFOBT was found to have significantly higher specificity, PPV, and positive LR as compared with M2-PK. IFOBT proved to be a convenient, noncumbersome, quick, and cheap tool in patients with above-average risk for detection of CRN.