Is excision biopsy of fibroadenomas based solely on size criteria warranted?

Fibroadenomas (FA) are the most common benign tumor in the female breast. Most are managed conservatively provided there is clinical, radiologic, and pathologic concordance. However, surgical excision is typically recommended for cellular fibroepithelial lesions or those lesions with clinical, radiologic, or pathologic features concerning for phyllodes tumor (PT). Some studies have suggested surgical excision in all FA >30 mm to reduce core needle biopsy (CNB) sampling errors. The aim of our study was to evaluate, in the absence of any other concerning clinicopathologic features, whether surgical excision of FA was warranted based on size criteria alone. Cork University Hospital is a large academic center in Southern Ireland. Its breast cancer center provides both a screening and symptomatic service and diagnoses approximately 600 cancers per year. The breast histopathological data base was reviewed for all CNBs from January 1, 2010, to June 30, 2015, with a diagnosis of FA that went on to have excision at our institution. We excluded all cellular fibroepithelial lesions and those cases with co-existent lobular neoplasia, ductal carcinoma in situ, invasive carcinoma, atypical ductal hyperplasia, or lesions which would require excision in their own right. Cases in which the radiologic targeted mass was discordant with a diagnosis of FA were also excluded. Patient demographics and preoperative radiologic size and the radiologic target were recorded in each case. All radiology was reviewed by a breast radiologist prior to inclusion in the study, and there was histologic radiologic concordance with a diagnosis of FA in all cases. A total of 12,109 consecutive radiologically guided CNB were performed January 2010-June 2015; 3438 with a diagnosis of FA were identified of which 290 cases went on to have surgical excision. Of those 290 cases; 98.28% (n = 285) were confirmed as FA on excision. The remaining 1.72% (n = 5) had atypical features-FA with LCIS (n = 1), benign PT (n = 3), and invasive ductal carcinoma (n = 1). Our study suggests that, excision based solely on size is not warranted in clinical and radiologically concordant cases with a diagnosis of FA on CNB.

What do women want? Valuing women's preferences and estimating demand for alternative models of maternity care using a discrete choice experiment.

In many countries, there has been a considerable shift towards providing a more woman-centred maternity service, which affords greater consumer choice. Maternity service provision in Ireland is set to follow this trend with policymakers committed to improving maternal choice at hospital level. However, women's preferences for maternity care are unknown, as is the expected demand for new services. In this paper, we used a discrete choice experiment (DCE) to (1) investigate women's strengths of preference for different features of maternity care; (2) predict market uptake for consultant- and midwifery-led care, and a hybrid model of care called the Domiciliary In and Out of Hospital Care scheme; and (3) calculate the welfare change arising from the provision of these services. Women attending antenatal care across two teaching hospitals in Ireland were invited to participate in the study. Women's preferred model of care resembled the hybrid model of care, with considerably more women expected to utilise this service than either consultant- or midwifery-led care. The benefit of providing all three services proved considerably greater than the benefit of providing two or fewer services. From a priority setting perspective, pursuing all three models of care would generate a considerable welfare gain, although the cost-effectiveness of such an approach needs to be considered.

A Cost-Benefit Analysis of Two Alternative Models of Maternity Care in Ireland.

BACKGROUND: The Irish government has committed to expand midwifery-led care alongside consultant-led care nationally, although very little is known about the potential net benefits of this reconfiguration. OBJECTIVES: To formally compare the costs and benefits of the major models of care in Ireland, with a view to informing priority setting using the contingent valuation technique and cost-benefit analysis. METHODS: A marginal payment scale willingness-to-pay question was adopted from an ex ante perspective. 450 pregnant women were invited to participate in the study. Cost estimates were collected primarily, describing the average cost of a package of care. Net benefit estimates were calculated over a 1-year cycle using a third-party payer perspective. RESULTS: To avoid midwifery-led care, women were willing to pay €821.13 (95% CI 761.66-1150.41); to avoid consultant-led care, women were willing to pay €795.06 (95% CI 695.51-921.15). The average cost of a package of consultant- and midwifery-led care was €1,762.12 (95% CI 1496.73-2027.51) and €1018.47 (95% CI 916.61-1120.33), respectively. Midwifery-led care ranked as the best use of resources, generating a net benefit of €1491.22 (95% CI 989.35-1991.93), compared with €123.23 (95% CI -376.58 to 621.42) for consultant-led care. CONCLUSIONS: While both models of care are cost-beneficial, the decision to provide both alternatives may be constrained by resource issues. If only one alternative can be implemented then midwifery-led care should be undertaken for low-risk women, leaving consultant-led care for high-risk women. However, pursuing one alternative contradicts a key objective of government policy, which seeks to improve maternal choice. Ideally, multiple alternatives should be pursued.

An investigation into the effect of alcohol consumption on health status and health care utilization in Ireland.

This paper presents a study of the effect of alcohol consumption on individual health status and health care utilization in Ireland using the 2007 Slán National Health and Lifestyle Survey, while accounting for the endogenous relationship between alcohol and health. Drinkers are categorized as those who never drank, non-drinkers, moderate drinkers, or heavy drinkers, based on national recommended weekly drinking levels in Ireland. The drinking-status equation is estimated using an ordered probit model. Predicted values for the inverse mills ratio are generated, which are then included in the health and health-care utilization equations. Differences in health status for each category of drinker are examined, and the relationship between both alcohol consumption and health with a host of other personal and socio-economic variables is also identified. Given that the measure of health status available is self-assessed, the effect of alcohol consumption on health-care utilization is also analyzed as an alternative measure of health. Findings show that in Ireland, moderate drinkers enjoy the best health status. More moderate drinkers report having very good or excellent health compared with heavy drinkers, non-drinkers, or those who never drank. While heavy drinkers do not report having as good a health status as moderate drinkers, they are better off in terms of health when compared with non-drinkers and those who are lifetime abstainers.

What women want: Exploring pregnant women's preferences for alternative models of maternity care.

Depending on obstetric risk, maternity care may be provided in one of two locations at hospital level: a consultant-led unit (CLU) or a midwifery-led unit (MLU). Care in a MLU is sparsely provided in Ireland, comprising as few as two units out of a total 21 maternity units. Given its potential for greater efficiencies of care and cost-savings for the state, there has been an increased interest to expand MLUs in Ireland. Yet, very little is known about women's preferences for midwifery-led care, and whether they would utilise this service when presented with the choice of delivering in a CLU or MLU. This study seeks to involve women in the future planning of maternity care by investigating their preferences for care and subsequent motivations when choosing place of birth. Qualitative research is undertaken to explore maternal preferences for these different models of care. Women only revealed a preference for the MLU when co-located with a CLU due to its close proximity to medical services. However, the results suggest women do not have a clear preference for either model of care, but rather a hybrid model of care which encompasses features of both consultant- and midwifery-led care.

The effect of alcohol consumption on household income in Ireland.

This paper presents a study of the effects of alcohol consumption on household income in Ireland using the Slán National Health and Lifestyle Survey 2007 dataset, accounting for endogeneity and selection bias. Drinkers are categorised into one of four categories based on the recommended weekly drinking levels by the Irish Health Promotion Unit; those who never drank, non-drinkers, moderate and heavy drinkers. A multinomial logit OLS Two Step Estimate is used to explain individual's choice of drinking status and to correct for selection bias which would result in the selection into a particular category of drinking being endogenous. Endogeneity which may arise through the simultaneity of drinking status and income either due to the reverse causation between the two variables, income affecting alcohol consumption or alcohol consumption affecting income, or due to unobserved heterogeneity, is addressed. This paper finds that the household income of drinkers is higher than that of non-drinkers and of those who never drank. There is very little difference between the household income of moderate and heavy drinkers, with heavy drinkers earning slightly more. Weekly household income for those who never drank is €454.20, non-drinkers is €506.26, compared with €683.36 per week for moderate drinkers and €694.18 for heavy drinkers.

Effectiveness of telaprevir and boceprevir triple therapy for patients with hepatitis C virus infection in a large integrated care setting.

BACKGROUND: In 2011, the FDA approved telaprevir (TVR) and boceprevir (BOC) for use with pegylated interferon and ribavirin to treat hepatitis C virus (HCV) genotype 1. We aimed to evaluate the real-world application, tolerability, and effectiveness of TVR- and BOC-based HCV treatment in a large integrated care setting. METHODS: We utilized Northern California Kaiser Permanente Medical Care Program (KPNC) electronic databases and medical records to study the experience of all KPNC patients who initiated TVR or BOC from June 2011 to March 2012. RESULTS: Compared with the pool of 5,194 treatment-eligible patients, the 352 treatment initiators were more likely to be cirrhotic (24 vs. 10%, p < 0.001) and treatment-experienced (44 vs. 22%, p < 0.001). Among the treatment initiators, 211 received TVR and 141 BOC. Overall, 31% discontinued treatment prematurely; 16% of patients stopped treatment early because of side effects. One patient with cirrhosis died of sepsis during treatment. Premature discontinuation was highest among TVR-treated cirrhotic patients (58%). Sustained virologic response (SVR) was achieved in 55% overall and was similar comparing the TVR (56%)- and BOC (53%)-treated groups. The only independent predictors of treatment failure were cirrhosis at baseline [odds ratio (OR) for SVR 0.44, p = 0.004] and prior partial or null response (OR for SVR 0.57, p = 0.02). CONCLUSIONS: In the initial application of TVR and BOC, patients with cirrhosis and prior treatment failure were prioritized for treatment. In this real-world experience, most patients successfully completed a full treatment course. However, side effect-related premature discontinuations were common, and SVR rates were lower than reported in clinical trials.

Physical, social, and psychological consequences of treatment for hepatitis C : a community-based evaluation of patient-reported outcomes.

BACKGROUND: Hepatitis C virus (HCV) antiviral therapy entails a long treatment course, as well as significant side effects that can lead to medication non-adherence and premature termination of treatment. Few large studies have comprehensively examined patient perspectives on the treatment experience, particularly the social and personal effects. OBJECTIVE: We sought to understand how a diverse group of patients' lives were affected during HCV treatment, and to obtain suggestions about how to better support patients during treatment. METHODS: On average, 13 months after therapy we interviewed by telephone a consecutive sample of 200 patients treated for hepatitis C with ribavirin and pegylated interferon in a comprehensive, integrated health plan in the years 2008-2010. Mixed (quantitative and qualitative) survey methods were used. RESULTS: The response rate was 68.9 %. Mean age at treatment was 51 years; 63.0 % were men; and Black, Hispanic, Asian, and White non-Hispanic racial/ethnic groups were similarly represented. Patients whose treatment was managed by nurses or clinical pharmacists (vs. physicians) were more likely to report their providers as being part of their support system (83.5 % vs. 58.9 %; p < 0.001). Most patients reported flu-like symptoms (93.5 %) and psychiatric problems (84.5 %), and 42.5 % reported side effects lasted up to 6 months after treatment. Black patients reported discontinuing treatment prematurely due to side effects more often than non-Blacks (29.4 % vs. 12.1 %; p < 0.001). Physical side effects (69.5 % of patients), psychiatric issues (43.5 %), and employment (27.4 %) were ranked among the three most difficult challenges. Patients desired help in anticipating and arranging work modifications during treatment. Most patients rated peer support, nutritional guidance, and weekly provider contact by telephone as potentially helpful resources for future patients undergoing HCV treatment. CONCLUSIONS: Patient perspectives can help formulate and refine HCV treatment support programs. Effective support programs for diverse populations are crucial as the complexities and costs of HCV treatment increase. The call for greater support from peers, providers, and employers demands new systems such as patient-centered care teams.

Distribution of hepatitis C virus genotypes in a diverse US integrated health care population.

Hepatitis C virus (HCV) genotypes influence response to therapy, and recently approved direct-acting antivirals are genotype-specific. Genotype distribution information can help to guide antiviral development and elucidate infection patterns. HCV genotype distributions were studied in a diverse cross-section of patients in the Northern California Kaiser Permanente health plan. Associations between genotype and race/ethnicity, age, and sex were assessed with multivariate logistic regression models. The 10,256 patients studied were median age 56 years, 62% male, 55% White non-Hispanic. Overall, 70% were genotype 1, 16% genotype 2, 12% genotype 3, 1% genotype 4, <1% genotype 5, and 1% genotype 6. Blacks (OR 4.5 [3.8-5.5]) and Asians (OR 1.2 [1.0-1.4]) were more likely to have genotype 1 than 2/3 versus non-Hispanic Whites. Women less likely had genotype 1 versus 2/3 than did men (OR 0.86 [0.78-0.94]). Versus non-Hispanic Whites, Asians (OR 0.38 [0.31-0.46]) and Blacks (OR 0.73 [0.63-0.84]) were less likely genotype1a than 1b; Hispanics (OR 1.3 [1.1-1.5]) and Native Americans (OR 1.9 [1.2-2.8]) more likely had genotype 1a than 1b. Patients age ≥65 years less likely had genotype 1a than 1b versus those age 45-64 (OR 0.34 [0.29-0.41]). The predominance of genotype 1 among all groups studied reinforces the need for new therapies targeting this genotype. Racial/ethnic variations in HCV genotype and subtype distribution must be considered in formulating new agents and novel strategies to successfully treat the diversity of hepatitis C patients.

The polycystic ovary post-rotterdam: a common, age-dependent finding in ovulatory women without metabolic significance.

INTRODUCTION: The age-specific prevalence of polycystic ovaries (PCO), as defined by the Rotterdam criteria, among normal ovulatory women, has not yet been reported. It is also uncertain whether these women differ from their peers in the hormonal or metabolic profile. METHODS: A total of 262 ovulatory Caucasian women aged 25-45 yr, enrolled in a community-based ovarian aging study (OVA), underwent transvaginal ultrasound assessment of ovarian volume and antral follicle count (AFC) in the early follicular phase and were categorized as to whether they met the Rotterdam definition of PCO by AFC (≥12 in one ovary) and/or by volume (>10 cm(3) for one ovary). The effect of age on prevalence of PCO was assessed. Serum hormones and metabolic measures were compared between women meeting each element of the Rotterdam criterion and those without PCO using age-adjusted linear regressions. RESULTS: The prevalence of PCO by AFC was 32% and decreased with age. Those with PCO by AFC had lower FSH; higher anti-Müllerian hormone, estrone, dehydroepiandrostenedione sulfate, and free androgen index; and slightly higher total testosterone than those without PCO. However, slightly higher body mass index and waist circumference were the only metabolic differences. Women with PCO by volume had higher anti-Müllerian hormone and free androgen index but did not differ in any other hormonal or metabolic parameter. DISCUSSION: PCO is a common, age-dependent finding among ovulatory women. These women lack the metabolic abnormalities seen in PCO syndrome. Isolated PCO in an ovulatory woman is not an indication for metabolic evaluation.

The epidemiology and clinical characteristics of patients with newly diagnosed alcohol-related liver disease: results from population-based surveillance.

GOALS: We describe the epidemiology of outpatients newly diagnosed with chronic alcoholic liver disease and describe predictors of cirrhosis and referral for specialty care. BACKGROUND: Alcohol is a major cause of liver disease in the United States. Most previous work has described hospitalized patients. STUDY: Participants were identified through prospective population-based surveillance in gastroenterology practices Multnomah County, Oregon and New Haven County, Connecticut; and primary care and gastroenterology practices from Kaiser Permanente Northern California in Alameda County during 1999 to 2001. Patients were interviewed, a blood specimen obtained, and their medical record reviewed. RESULTS: We identified 82 patients from gastroenterology practices with newly diagnosed alcoholic liver disease. Their median age was 50.0 years. 72.0% were male and 79.3% were White. The median age at initiation of alcohol use was 17.0 years. 43.9% of patients had evidence of cirrhosis at the time of diagnosis. Only 40.2% reported alcohol as the cause of their liver disease. Patients with cirrhosis were more likely to be older, have a higher median number of years of heavy alcohol consumption, and to have been hospitalized for a liver-related complication than noncirrhotic patients. An additional 83 primary care patients were more likely to be older, to be drinking alcohol at study interview, and to not have cirrhosis than patients referred for gastroenterology care. CONCLUSIONS: Patients with alcoholic liver disease may present at a late stage and may not identify alcohol as a cause for their liver disease. Improved patient screening and education may limit morbidity and mortality.

Complementary and alternative medicine use in chronic liver disease patients.

GOALS: To examine a wide range of sociodemographic and clinical characteristics as potential predictors of complementary and alternative medicine (CAM) use among chronic liver disease (CLD) patients, with a focus on CAM therapies with the greatest potential for hepatotoxicity and interactions with conventional treatments. BACKGROUND: There is some evidence that patients with CLD commonly use CAM to address general and CLD-specific health concerns. STUDY: Patients enrolled in a population-based surveillance study of persons newly diagnosed with CLD between 1999 and 2001 were asked about current use of CAM specifically for CLD. Sociodemographic and clinical information was obtained from interviews and medical records. Predictors of CAM use were examined using univariate and multivariate logistic regression analysis. RESULTS: Of the 1040 participants, 284 (27.3%) reported current use of at least 1 of 3 CAM therapies of interest. Vitamins or other dietary supplements were the most commonly used therapy, reported by 188 (18.1%) patients. This was followed by herbal medicine (175 patients, 16.8%) and homeopathy (16 patients, 1.5%). Several characteristics were found to be independent correlates of CAM use: higher education and family income, certain CLD etiologies (alcohol, hepatitis C, hepatitis C and alcohol, and hepatitis B), and prior hospitalization for CLD. CONCLUSIONS: Use of CAM therapies that have the potential to interact with conventional treatments for CLD was quite common among this population-based sample of patients with CLD. There is a need for patient and practitioner education and communication regarding CAM use in the context of CLD.

Respiratory illnesses at the 2009 U.S. Army ROTC Advanced Camp.

Every summer the U.S. Army Reserve Officer Training Corps (ROTC) conducts the Leader Development Assessment Course (LDAC) for several thousand upcoming senior-year cadets. This study describes respiratory illnesses at 2009 ROTC LDAC after the emergence of the novel H1N1 influenza pandemic. This retrospective cohort study examines 5554 cadets and 1,616 cadres from 2009, and 5180 LDAC 2008 cadets. Respiratory clinic visits for 2009 cadets were higher than 2009 cadres and 2008 cadets, at 8.7, 2.0, and 4.2 visits per 1000 person-days available, respectively (p < 0.001). Further, respiratory illness hospitalizations and isolations were higher for 2009 cadets than cadres (p = 0.020). Although substantial efforts were made to prevent respiratory infections, there was considerable impact from respiratory illnesses, in the context of the novel H1N1 influenza pandemic, among 2009 ROTC LDAC participants. Our experience offers important lessons for future LDAC planning and for similar close quarters living circumstances.

The epidemiology of newly diagnosed chronic liver disease in gastroenterology practices in the United States: results from population-based surveillance.

OBJECTIVES: Chronic liver disease (CLD) is an important cause of morbidity and mortality, but the epidemiology is not well described. We conducted prospective population-based surveillance to estimate newly diagnosed CLD incidence, characterize etiology distribution, and determine disease stage. METHODS: We identified cases of CLD newly diagnosed during 1999-2001 among adult county residents seen in any gastroenterology practice in New Haven County, Connecticut; Multnomah County, Oregon; and Northern California Kaiser Permanente Medical Care Program (KPMCP, Oakland, California [total population 1.48 million]). We defined CLD as abnormal liver tests of at least 6 months' duration or pathologic, clinical, or radiologic evidence of CLD. Consenting patients were interviewed, a blood specimen obtained, and the medical record reviewed. RESULTS: We identified 2,353 patients with newly diagnosed CLD (63.9 cases/100,000 population), including 1,225 hepatitis C patients (33.2 cases/100,000). Men aged 45-54 yr had the highest hepatitis C incidence rate (111.3/100,000). Among 1,040 enrolled patients, the median age was 48 yr (range 19-86 yr). Hepatitis C, either alone (442 [42%]) or in combination with alcohol-related liver disease (ALD) (228 [22%]), accounted for two-thirds of the cases. Other etiologies included nonalcoholic fatty liver disease (NAFLD, 95 [9%]), ALD (82 [8%]), and hepatitis B (36 [3%]). Other identified etiologies each accounted for <3% of the cases. A total of 184 patients (18%) presented with cirrhosis, including 44% of patients with ALD. CONCLUSIONS: Extrapolating from this population-based surveillance network to the adult U.S. population, approximately 150,000 patients with CLD were diagnosed in gastroenterology practices each year during 1999-2001. Most patients had hepatitis C; heavy alcohol consumption among these patients was common. Almost 20% of patients, an estimated 30,000 per year, had cirrhosis at presentation. These results provide population-level baseline data to evaluate trends in identification of patients with CLD in gastroenterology practices.

Hepatic effects of lovastatin exposure in patients with liver disease: a retrospective cohort study.

BACKGROUND: Little is known about the potential adverse hepatic effects of HMG-CoA reductase inhibitors ('statins') in patients with existing liver disease; therefore, we examined the risk of liver toxicity with lovastatin exposure in these patients. METHODS: A retrospective cohort study was performed using data from a large integrated health plan in Northern California, USA. Patients with laboratory or clinical evidence of liver disease were identified and their exposure to lovastatin was determined. The primary outcome was a pattern of liver-test abnormalities associated with a poor prognosis among patients with drug-induced liver disease, based on Hy's Rule. Secondary outcomes included liver injury (defined as moderate or severe, depending on the degree of ALT level elevations) or the development of either clinical cirrhosis or liver failure. Incidence rate ratios (IRRs) were calculated and multivariate analyses conducted using extended Cox models. RESULTS: A total of 93 106 patients met the entry criteria. Lovastatin exposure was associated with a lower incidence of all endpoints, including the primary outcome (IRR = 0.28, 95% CI 0.12, 0.55), moderate liver injury (IRR = 0.56, 95% CI 0.47, 0.65), severe liver injury (IRR = 0.50, 95% CI 0.29, 0.81) and the occurrence of either cirrhosis or liver failure (IRR = 0.29, 95% CI 0.21, 0.38); adjustment for age and sex resulted in some attenuation of this reduction in incidence. The observed effects were generally consistent across a range of baseline liver-disease diagnoses and greater cumulative lovastatin exposure was associated with fewer outcome events for some endpoints. CONCLUSIONS: In this retrospective analysis, exposure to lovastatin was not associated with an increased risk of adverse hepatic outcomes. These results do not support concern regarding lovastatin-related hepatotoxicity in patients with existing liver disease.

Limitations of conventionally derived chronic liver disease mortality rates: Results of a comprehensive assessment.

UNLABELLED: Standard death certificate-based methods for ascertaining deaths due to chronic liver disease (CLD), such as the U.S. vital statistics approach, rely on a limited set of diagnostic codes to define CLD. These codes do not include viral hepatitis or consider hepatocellular carcinoma (HCC) deaths, and thus, underestimate the true burden of CLD mortality. Deaths associated with CLD may be further misunderstood because of the inherent limitations of death record information. Using a comprehensive list of CLD-related codes to search death records, we investigated the CLD mortality rate and associated etiologies (derived from medical records) in a large managed care health plan. From the 16,970 deaths among health plan members in 2000, we confirmed 355 (2.1%) as CLD related, including 75 with HCC. The age-adjusted CLD mortality rate using the comprehensive codes was 11.9 per 100,000 compared with 6.3 per 100,000 using only conventional codes. Based on medical records, the underlying CLD was attributed to alcoholic liver disease (ALD) in 44% of deaths, HCV infection with ALD in 16%, HCV without ALD in 18%, and chronic HBV infection in 7%. Only 64% of HCV-associated, 48% of HBV-associated, and 64% of ALD-associated deaths ascertained by medical record had that specific etiology mentioned on the death certificate. CONCLUSION: CLD mortality burden was almost doubled by using a comprehensive list of mortality codes and considering HCC deaths as CLD related. Furthermore, the contributions of viral hepatitis and ALD to CLD mortality may be underestimated if based solely on death records.