Impact of alternative approaches to assess outlying and influential observations on health care costs

The distributions of medical costs are often skewed to the right because small numbers of patients use large amounts of health care resources. Using data from a study of colon cancer costs, we show, by example, the impact and magnitude of outliers and influential observations on health care costs and compared the effects of statistical costing methods for addressing the disproportionate influence of outliers and influential observations. We used data from a retrospective cohort study of 3,842 elderly veterans with colon cancer who were enrolled in and used health care from, both the Department of Veterans Affairs and Medicare in 1999–2004. After calculating the average colon cancer episode cost and distribution for the full cohort, we used box-plot methods, Winsorization, DFBETAs, and Cook's distance to identify and assess or adjust the outlying and/or influential observations. The number of observations identified as outlying and/or influential ranged from 13 when the predicted DFBETA measurement was greater than 0.15 and the observation was a qualified box-plot outlier to 384 cases using the Winsorization method at the 5th and 95th percentiles. Average costs of colon cancer episodes using these methods were similar. The method of choice from the results of this particular analysis can be conditionally based on whether the purpose is to control only for influential observations or to simultaneously control for outliers and influential observations. Understanding how estimates could change with each approach is important in assessing the impact of a particular method on the results

A System for Interactive Assessment and Management in Palliative Care

The availability of psychometrically sound and clinically relevant screening, diagnosis, and outcome evaluation tools is essential to high-quality palliative care assessment and management. Such data will enable us to improve patient evaluations, prognoses, and treatment selections, and to increase patient satisfaction and quality of life. To accomplish these goals, medical care needs more precise, efficient, and comprehensive tools for data acquisition, analysis, interpretation, and management. We describe a system for interactive assessment and management in palliative care (SIAM-PC), which is patient centered, model driven, database derived, evidence based, and technology assisted. The SIAM-PC is designed to reliably measure the multiple dimensions of patients’ needs for palliative care, and then to provide information to clinicians, patients, and the patients’ families to achieve optimal patient care, while improving our capacity for doing palliative care research. This system is innovative in its application of the state-of-the-science approaches, such as item response theory and computerized adaptive testing, to many of the significant clinical problems related to palliative care

Vitamin D Levels are Associated with Liver Disease Severity in Patients with Cirrhosis

Vitamin D deficiency is common in advanced liver disease but its clinical significance remains controversial. The aim of this study was to examine the correlation of 25-hydryoxyvitamin D levels with liver disease severity and calcium levels in adults with cirrhosis. This cross-sectional study included 180 adults with cirrhosis enrolled in a clinical cohort study at a single university hospital. The mean age was 58.8 (±9.2) years, and cirrhosis was attributed to alcohol use in 27.2%, hepatitis C in 35.0%, non-alcoholic steatohepatitis in 27.2%, and both alcohol and hepatitis C in 10.6%. The median model for end-stage liver disease-sodium (MELD-Na) score was 12.0 (interquartile range 9.0–16.0), and mean serum albumin levels were 3.4 (±0.7) gm/dl. Median serum 25-hydroxyvitamin D levels were 28.0 (interquartile range 20–38) ng/mL, with 16 patients (8.9%) having levels <12 ng/ml and 43 (23.9%) with 25(OH)D levels <20 ng/ml. No correlation was noted between levels of 25-hydroxyvitamin D and albumin-corrected calcium in the total group and in groups stratified by vitamin D supplementation. In contrast, both serum albumin (r = 0.32; P < 0.001) and MELD-Na scores were significantly correlated with 25-hydroxyvitamin D levels (r = –0.29; P < 0.001). Correlations between 25-hydroxyvitamin D levels and serum albumin (r = −0.39; P < 0.001) and MELD-Na scores did not change substantially after excluding 67 patients receiving vitamin D supplementation (r = −0.33; P = 0.009). In conclusion, total 25-hydroxyvitamin D levels correlate inversely with liver disease severity in adults with cirrhosis

Exploratory study evaluating the relationships between perinatal adversity, oxidative stress, and infant neurodevelopment across the first year of life.

Early childhood adversity increases risk for negative lifelong impacts on health and wellbeing. Identifying the risk factors and the associated biological adaptations early in life is critical to develop scalable early screening tools and interventions. Currently, there are limited, reliable early childhood adversity measures that can be deployed prospectively, at scale, to assess risk in pediatric settings. The goal of this two-site longitudinal study was to determine if the gold standard measure of oxidative stress, F2-Isoprostanes, is potentially a reliable measure of a physiological response to adversity of the infant and mother. The study evaluated the independent relationships between F2-Isoprostanes, perinatal adversity and infant neurocognitive development. The study included mother-infant dyads born >36 weeks' gestation. Maternal demographic information and mental health assessments were utilized to generate a perinatal cumulative risk score. Infants' development was assessed at 6 and 12 months and both mothers and infants were assayed for F2-isoprostane levels in blood and urine, respectively. Statistical analysis revealed that cumulative risk scores correlated with higher maternal (p = 0.01) and infant (p = 0.05) F2-isoprostane levels at 6 months. Infant F2-isoprostane measures at 2 months were negatively associated with Mullen Scales of Early Learning Composite scores at 12 months (p = 0.04). Lastly, higher cumulative risk scores predicted higher average maternal F2-isoprostane levels across the 1-year study time period (p = 0.04). The relationship between perinatal cumulative risk scores and higher maternal and infant F2-isoprostanes at 6 months may reflect an oxidative stress status that informs a sensitive period in which a biomarker can be utilized prospectively to reveal the physiological impact of early adversity

Statin and Aspirin Use Among Hispanic and Latino Adults at High Cardiovascular Risk: Findings From the Hispanic Community Health Study/Study of Latinos

BACKGROUND: Despite variations in the prevalence of cardiovascular disease and related risk factors among US Hispanic/Latino adults of diverse backgrounds, there is little information on whether disparities exist in the use of medications for the primary and secondary prevention of cardiovascular disease. We examined the prevalence of statin and aspirin use among diverse US Hispanic/Latino adults at high cardiovascular risk. METHODS AND RESULTS: A multicenter population-based study, the Hispanic Community Health Study/Study Of Latinos, included a total of 16 415 participants of Mexican, Puerto Rican, Cuban, Dominican, South American, and Central American backgrounds who were aged 18 to 74 years and enrolled between March 2008 and June 2011. Our analyses were limited to 4139 participants considered to be at high cardiovascular risk. Age-adjusted prevalence of statin and aspirin use was 25% and 44%, respectively, overall but varied by Hispanic/Latino background among those at high cardiovascular risk; statin use was significantly higher (P<0.001) among adults of Puerto Rican (33%) and Dominican (28%) backgrounds compared with adults of other backgrounds (Mexican, 24%; Cuban, 22%; Central American, 20%; South American, 22%). There was no difference in aspirin use. After adjusting for health insurance coverage, the difference in prevalence of statin use was substantially reduced among participants with a Puerto Rican background, from an odds ratio of 1.73 (95% CI 1.30-2.31) to 1.30 (95% CI 0.97-1.75), and with a Dominican background, from an odds ratio of 1.45 (95% CI 1.04-2.02) to 1.07 (95% CI 0.75-1.52), in comparison to their counterparts. CONCLUSIONS: Among Hispanic/Latino adults of diverse backgrounds, statin use was more prevalent among adults with Puerto Rican and Dominican backgrounds at high cardiovascular risk. These differences in statin use were explained, in part, by differences in insurance coverage. These findings have important implications for the prevention of disparities in cardiovascular outcomes within the growing US Hispanic/Latino population

A cardiovascular educational intervention for primary care professionals in Spain: positive impact in a quasi-experimental study

Background Routine general practice data collection can help identify patients at risk of cardiovascular disease. Aim To determine whether a training programme for primary care professionals improves the recording of cardiovascular disease risk factors in electronic health records. Design and setting A quasi-experimental study without random assignment of professionals. This was an educational intervention study, consisting of an online-classroom 1-year training programme, and carried out in the Valencian community in Spain. Method The prevalence rates of recording of cardiovascular factors (recorded every 6 months over a 4-year period) were compared between intervention and control group. Clinical relevance was calculated by absolute risk reduction (ARR), relative risk reduction (RRR), and number of patients needed-to-attend (NNA), to avoid under-recording, with their 95% confidence intervals (CIs). Linear regression models were used for each of the variables. Results Of the 941 professionals initially registered, 78.1% completed the programme. The ARR ranged from 1.87% (95% CI = 1.79 to 1.94) in the diagnosis of diabetes to 15.27% (95% CI = 15.14 to 15.40) in the recording of basal blood glucose. The NNA ranged from 7 in blood pressure, cholesterol, and blood glucose recording to 54 in the diagnosis of diabetes. The RRR ranged from 26.7% in the diagnosis of diabetes to 177.1% in the recording of the Systematic Coronary Risk Evaluation (SCORE). The rates of change were greater in the intervention group and the differences were significant for recording of cholesterol (P<0.001), basal blood glucose (P<0.001), smoking (P<0.001), alcohol (P<0.001), microalbuminuria (P = 0.001), abdominal circumference (P<0.001), and SCORE (P<0.001). Conclusion The education programme had a beneficial effect at the end of the follow-up that was significant and clinically relevant.We are grateful to Conselleria de Sanidad for allowing access to the ABUCASIS system and Antonio Fernandez who provided technical support during the study period

Moderate-vigorous physical activity and health-related quality of life among Hispanic/Latino adults in the Hispanic Community Health Study/Study of Latinos (HCHS/SOL).

BackgroundPhysical activity is a modifiable healthy behavior that has been shown to positively influence health-related quality of life. However, research examining the link between physical activity and health-related quality of life among Hispanic/Latino adults is limited and inconsistent. The purpose of this study is to assess whether accelerometer-measured moderate-vigorous physical activity (MVPA) is associated with self-reported (a) mental health-related quality of life, and (b) physical health-related quality of life among diverse Hispanic/Latino adults in the US.MethodsCross-sectional data from 12,379 adults ages 18-74 years in 2008-2011, who participated in HCHS/SOL and had complete data were analyzed using complex survey design methods. Accelerometer data were categorized into no MVPA, low, moderate, and high MVPA. Health-related quality of life was assessed with the Short-Form 12 and we used the mental and physical component subscales where higher scores indicate better health-related quality of life. Multivariate linear regression models were used to derive adjusted means with 95% confidence intervals and linear trends.ResultsWe observed no significant linear trend between accelerometer-measured MVPA and mental health-related quality of life (ptrend = 0.73). There was a significant positive association between MVPA and physical health-related quality of life (ptrend &lt; 0.001) where higher MVPA corresponded with higher scores in physical health-related quality of life. The adjusted means were 46.67 (44.85-48.48) for no MVPA, 49.33 (49.03-49.63) for low MVPA, 50.61 (50.09-51.13) for moderate MVPA, and 51.36 (50.86-51.86) for high MVPA.ConclusionsAmong diverse Hispanic/Latino adults in the US, accelerometer-measured MVPA was associated with physical health-related quality of life, but not mental health-related quality of life. Future interventions should evaluate if increases in MVPA lead to improvements in health-related quality of life

Distribution of metals exposure and associations with cardiometabolic risk factors in the “Modeling the Epidemiologic Transition Study”

Background: Metals are known endocrine disruptors and have been linked to cardiometabolic diseases via multiple potential mechanisms, yet few human studies have both the exposure variability and biologically-relevant phenotype data available. We sought to examine the distribution of metals exposure and potential associations with cardiometabolic risk factors in the “Modeling the Epidemiologic Transition Study” (METS), a prospective cohort study designed to assess energy balance and change in body weight, diabetes and cardiovascular disease risk in five countries at different stages of social and economic development. Methods: Young adults (25–45 years) of African descent were enrolled (N = 500 from each site) in: Ghana, South Africa, Seychelles, Jamaica and the U.S.A. We randomly selected 150 blood samples (N = 30 from each site) to determine concentrations of selected metals (arsenic, cadmium, lead, mercury) in a subset of participants at baseline and to examine associations with cardiometabolic risk factors. Results: Median (interquartile range) metal concentrations (μg/L) were: arsenic 8.5 (7.7); cadmium 0.01 (0.8); lead 16.6 (16.1); and mercury 1.5 (5.0). There were significant differences in metals concentrations by: site location, paid employment status, education, marital status, smoking, alcohol use, and fish intake. After adjusting for these covariates plus age and sex, arsenic (OR 4.1, 95% C.I. 1.2, 14.6) and lead (OR 4.0, 95% C.I. 1.6, 9.6) above the median values were significantly associated with elevated fasting glucose. These associations increased when models were further adjusted for percent body fat: arsenic (OR 5.6, 95% C.I. 1.5, 21.2) and lead (OR 5.0, 95% C.I. 2.0, 12.7). Cadmium and mercury were also related with increased odds of elevated fasting glucose, but the associations were not statistically significant. Arsenic was significantly associated with increased odds of low HDL cholesterol both with (OR 8.0, 95% C.I. 1.8, 35.0) and without (OR 5.9, 95% C.I. 1.5, 23.1) adjustment for percent body fat. Conclusions: While not consistent for all cardiometabolic disease markers, these results are suggestive of potentially important associations between metals exposure and cardiometabolic risk. Future studies will examine these associations in the larger cohort over time

Vitamin D Supplementation for the Treatment of Depressive Symptoms in Women with Type 2 Diabetes: A Randomized Clinical Trial

Aim. To determine the efficacy and safety of vitamin D3 supplementation in reducing depressive symptoms in women with type 2 diabetes (T2D), depression, and low vitamin D. Methods. In this double-blind randomized active comparator-controlled trial, women with significant depressive symptoms as assessed by the Center for Epidemiologic Studies Depression (CES-D) scale received weekly oral vitamin D3 supplementation (50,000 IU) or an active comparator (5,000 IU) for 6 months. Assessments of vitamin D, 25-hydroxyvitamin D [25 (OH) D], and depression were measured at baseline, 3 months, and 6 months. Results. A total of 129 women were randomized, from which 119 completed the study (57 in lower dose and 62 in higher dose). Participants had an average 25 (OH) D and HbA1c of 20.8 ng/mL and 7.8%, respectively, at baseline. They were diverse (48% Black) and had a mean age of 50 and T2D for about 8 years. Upon completion of vitamin D3 supplementation, serum 25 (OH) D levels increased with 50,000 IU (+34 ng/mL) and 5,000 IU (+10 ng/mL). There was no difference in CES-D scores by treatment dose. Overall, depressive symptoms significantly improved over time with an average CES-D decline of 12.98 points (95% CI: −15.04 to −10.93; ). Among women with moderate baseline depressive symptoms, those receiving the lower dose had nominally lower depression scores at follow-up than those in the higher dose cohort. Among women with severe baseline depressive symptoms, the improvement in follow-up depression scores was the same regardless of dose. Conclusions. There was no difference in the dosing effect of vitamin D3 supplementation for the treatment of depressive symptoms in women with T2D who present with significant symptoms and low vitamin D. Regardless of the dose, participants’ mood improved over time. Further study of vitamin D to target depressive symptoms in comorbid populations is needed

Potential Deaths Averted and Serious Adverse Events Incurred From Adoption of the SPRINT (Systolic Blood Pressure Intervention Trial) Intensive Blood Pressure Regimen in the United States: Projections From NHANES (National Health and Nutrition Examination Survey)

BACKGROUND: SPRINT (Systolic Blood Pressure Intervention Trial) demonstrated a 27% reduction in all-cause mortality with a systolic blood pressure (SBP) goal ofmellitus, stroke, or heart failure. To quantify the potential benefits and risks of SPRINT intensive goal implementation, we estimated the deaths prevented and excess serious adverse events incurred if the SPRINT intensive SBP treatment goal were implemented in all eligible US adults. METHODS: SPRINT eligibility criteria were applied to the 1999 to 2006 National Health and Nutrition Examination Survey and linked with the National Death Index through December 2011. SPRINT eligibility included age ≥50 years, SBP of 130 to 180 mm Hg (depending on the number of antihypertensive medications being taken), and high cardiovascular disease risk. Exclusion criteria were diabetes mellitus, history of stroke, \u3e1 g proteinuria, heart failure, estimated glomerular filtration ratemL·min RESULTS: The mean age was 68.6 years, and 83.2% and 7.4% were non-Hispanic white and non-Hispanic black, respectively. The annual mortality rate was 2.20% (95% confidence interval [CI], 1.91-2.48), and intensive SBP treatment was projected to prevent ≈107 500 deaths per year (95% CI, 93 300-121 200) and give rise to 56 100 (95% CI, 50 800-61 400) episodes of hypotension, 34 400 (95% CI, 31 200-37 600) episodes of syncope, 43 400 (95% CI, 39 400-47 500) serious electrolyte disorders, and 88 700 (95% CI, 80 400-97 000) cases of acute kidney injury per year. The analysis-of-extremes approach indicated that the range of estimated lower- and upper-bound number of deaths prevented per year with intensive SBP control was 34 600 to 179 600. Intensive SBP control was projected to prevent 46 100 (95% CI, 41 800-50 400) cases of heart failure annually. CONCLUSIONS: If fully implemented in eligible US adults, intensive SBP treatment could prevent ≈107 500 deaths per year. A consequence of this treatment strategy, however, could be an increase in serious adverse events