Assessing risk of bias in the meta-analysis of round 1 of the Health Care Innovation Awards.

BACKGROUND: Systematic reviews of observational studies can be affected by biases that lead to under- or over-estimates of true intervention effects. Several tools have been reported in the literature that attempt to characterize potential bias. Our objective in this study was to determine the extent to which study-specific bias may have influenced intervention impacts on total costs of care (TCOC) in round 1 of the Health Care Innovation Awards. METHODS: We reviewed 82 statistical evaluations of innovation impacts on Medicare TCOC. We developed five risk-of-bias measures and assessed their influence on TCOC impacts using meta-regression. RESULTS: The majority of evaluations used propensity score matching to create their comparison groups. One third of the non-randomized interventions were judged to have some risk of biased effects due largely to the way they recruited their treatment groups, and 35% had some degree of covariate imbalance remaining after propensity score adjustments. However, in the multivariable analysis of TCOC effects, none of the bias threats we examined (comparison group construction method, risk of bias, or degree of covariate imbalance) had a major impact on the magnitude of HCIA1 innovation effects. Evaluations using propensity score weighting produced larger but imprecise savings effects compared to propensity score matching. DISCUSSION: Our results suggest that it is unlikely that HCIA1 TCOC effect sizes were systematically affected by the types of bias we considered. Assessing the risk of bias based on specific study design features is likely to be more useful for identifying problematic characteristics than the subjective quality ratings used by existing risk tools.

Meta-Analysis of the Impact of Four Advanced Primary Care Redesign Initiatives on Medicare Expenditures.

We conducted a secondary analysis of the evaluations of 22 sites participating in four primary care redesign initiatives funded by the Centers for Medicare and Medicaid Services or the Center for Medicare and Medicaid Innovation. Our objectives were to determine the overall impact of the initiatives on Medicare expenditures and whether specific site-level program features influenced expenditure findings. Averaged over sites, the mean intervention effect was a statistically insignificant US$26 per beneficiary per year. Policy implications from meta-regression results suggest that funders should consider supporting technical assistance efforts and pay for performance incentives to increase savings. There was no evidence that paying for medical home transformation produced savings in total cost of care. We estimate that in future evaluations, data from 35 sites would be needed to detect feature effects of US$300 per beneficiary per year.

A Structural Model of Social Determinants of the Metabolic Syndrome.

Objectives: The metabolic syndrome (MetS) refers to a cluster of interrelated physiological characteristics that are associated with an increased risk of cardiovascular disease and diabetes. While the clinical usefulness of the MetS has been the subject of controversy for years, increasingly sophisticated methods are being used to measure the concept. Participants: Study of community health center patients who were not diabetic; study group was evenly divided between Black and White adults. Main Outcome Measures: Latent MetS score and MetS status based on the five-point scale developed by the National Cholesterol Education Panel (NCEP). Methods: Structural equation modeling of MetS incorporating the effects of race/ethnicity, racial discrimination, socioeconomic position (SEP), and selected mediating variables. Results: The largest influences on latent MetS scores were SEP (negative relationship) and male gender (higher scores for men). Two mediating variables, physical activity and stress-related eating, had smaller impacts. Self-reported racial discrimination was associated with cynical hostility but did not influence the MetS level among nondiabetics. Despite higher NCEP scores and MetS prevalence rates for Blacks compared with Whites, race did not have direct effect on MetS levels when adjusted for the other characteristics in our model. Conclusions: Neither race nor self-reported racial discrimination had direct effects on MetS level in our structural model. The large effects of socioeconomic position and male gender were not mediated by the other variables in the model.

Insurance Coverage, Employment Status, and Financial Well-Being of Young Women Diagnosed with Breast Cancer.

BACKGROUND: The economic cost of breast cancer is a major personal and public health problem in the United States. This study aims to evaluate the insurance, employment, and financial experiences of young female breast cancer survivors and to assess factors associated with financial decline. METHODS: We recruited 830 women under 40 years of age diagnosed with breast cancer between January 2013 and December 2014. The study population was identified through California, Florida, Georgia, and North Carolina population-based cancer registries. The cross-sectional survey was fielded in 2017 and included questions on demographics, insurance, employment, out-of-pocket costs, and financial well-being. We present descriptive statistics and multivariate analysis to assess factors associated with financial decline. RESULTS: Although 92.5% of the respondents were continuously insured over the past 12 months, 9.5% paid a "higher price than expected" for coverage. Common concerns among the 73.4% of respondents who were employed at diagnosis included increased paid (55.1%) or unpaid (47.3%) time off, suffering job performance (23.2%), and staying at (30.2%) or avoiding changing (23.5%) jobs for health insurance purposes. Overall, 47.0% experienced financial decline due to treatment-related costs. Patients with some college education, multiple comorbidities, late stage diagnoses, and self-funded insurance were most vulnerable. CONCLUSIONS: The breast cancer diagnosis created financial hardship for half the respondents and led to myriad challenges in maintaining employment. Employment decisions were heavily influenced by the need to maintain health insurance coverage. IMPACT: This study finds that a breast cancer diagnosis in young women can result in employment disruption and financial decline.

Impact Of Health Care Delivery System Innovations On Total Cost Of Care.

Using delivery system innovations to advance health care reform continues to be of widespread interest. However, it is difficult to generalize about the success of specific types of innovations, since they have been examined in only a few studies. To gain a broader perspective, we analyzed the results of forty-three ambulatory care programs funded by the first round of the Center for Medicare and Medicaid Innovation's Health Care Innovations Awards. The innovations' impacts on total cost of care were estimated by independent evaluators using multivariable difference-in-differences models. Through the first two years, most of the innovations did not show a significant effect on total cost of care. Using meta-regression, we assessed the effects on costs of five common components of these innovations. Innovations that used health information technology or community health workers achieved the greatest cost savings. Savings were also relatively large in programs that targeted clinically fragile patients-clinically complex populations at risk for disease progression. While the magnitude of these effects was often substantial, none achieved conventional levels of significance in our analyses. Meta-analyses of a larger number of delivery system innovations are needed to more clearly establish their potential for patient care cost savings.

Total cost of care lower among Medicare fee-for-service beneficiaries receiving care from patient-centered medical homes.

OBJECTIVE: To compare health care utilization and payments between NCQA-recognized patient-centered medical home (PCMH) practices and practices without such recognition. DATA SOURCES: Medicare Part A and B claims files from July 1, 2007 to June 30, 2010, 2009 Census, 2007 Health Resources and Services Administration and CMS Utilization file, Medicare's Enrollment Data Base, and the 2005 American Medical Association Physician Workforce file. STUDY DESIGN: This study used a longitudinal, nonexperimental design. Three annual observations (July 1, 2008-June 30, 2010) were available for each practice. We compared selected outcomes between practices with and those without NCQA PCMH recognition. DATA COLLECTION METHODS: Individual Medicare fee-for-service (FFS) beneficiaries and their claims and utilization data were assigned to PCMH or comparison practices based on where they received the plurality of evaluation and management services between July 1, 2007 and June 30, 2008. PRINCIPAL FINDINGS: Relative to the comparison group, total Medicare payments, acute care payments, and the number of emergency room visits declined after practices received NCQA PCMH recognition. The decline was larger for practices with sicker than average patients, primary care practices, and solo practices. CONCLUSIONS: This study provides additional evidence about the potential of the PCMH model for reducing health care utilization and the cost of care.

Racial discrimination & cardiovascular disease risk: my body my story study of 1005 US-born black and white community health center participants (US).

OBJECTIVES: To date, limited and inconsistent evidence exists regarding racial discrimination and risk of cardiovascular disease (CVD). METHODS: Cross-sectional observational study of 1005 US-born non-Hispanic black (n = 504) and white (n = 501) participants age 35-64 randomly selected from community health centers in Boston, MA (2008-2010; 82.4% response rate), using 3 racial discrimination measures: explicit self-report; implicit association test (IAT, a time reaction test for self and group as target vs. perpetrator of discrimination); and structural (Jim Crow status of state of birth, i.e. legal racial discrimination prior 1964). RESULTS: Black and white participants both had adverse cardiovascular and socioeconomic profiles, with black participants most highly exposed to racial discrimination. Positive crude associations among black participants occurred for Jim Crow birthplace and hypertension (odds ratio (OR) 1.92, 95% confidence interval (CI) 1.28, 2.89) and for explicit self-report and the Framingham 10 year CVD risk score (beta = 0.04; 95% CI 0.01, 0.07); among white participants, only negative crude associations existed (for IAT for self, for lower systolic blood pressure (SBP; beta = -4.86; 95% CI -9.08, -0.64) and lower Framingham CVD score (beta = -0.36, 95% CI -0.63, -0.08)). All of these associations were attenuated and all but the white IAT-Framingham risk score association were rendered null in analyses that controlled for lifetime socioeconomic position and additional covariates. Controlling for racial discrimination, socioeconomic position, and other covariates did not attenuate the crude black excess risk for SBP and hypertension and left unaffected the null excess risk for the Framingham CVD score. CONCLUSION: Despite worse exposures among the black participants, racial discrimination and socioeconomic position were not associated, in multivariable analyses, with risk of CVD. We interpret results in relation to constrained variability of exposures and outcomes and discuss implications for valid research on social determinants of health.

Solid lipid dispersions: potential delivery system for functional ingredients in foods.

Structured solid lipid (SL) systems have the advantages of long-term physical stability, low surfactant concentrations, and may exhibit controlled release of active ingredients. In this research work, the potential use of high-melting SLs for the production of the above structured SL carrier systems was investigated. Dispersions containing either SL or blend of solid lipid and oil (SL+O) were produced by a hot melt high-pressure homogenization method. Experiments involved the use of 3 different SLs for the disperse phase: stearic acid, candelilla wax and carnauba wax. Sunflower oil was incorporated in the disperse phase for the production of the dispersions containing lipid and oil. In order to evaluate the practical aspects of structured particles, analytical techniques were used including: static light scattering to measure particle sizes, transmission electron microscopy (TEM) for investigating particle morphology and differential scanning calorimetry (DSC) to investigate the crystallization behavior of lipids in bulk and in dispersions. Results showed different mean particle sizes depending on the type of lipid used in the disperse phase. Particle sizes for the 3 lipids were: stearic acid (SL: 195 ± 2.5 nm; SL+O: 138 ± 6.0 nm); candelilla wax (SL: 178 ± 1.7 nm; SL+O: 144 ± 0.6 nm); carnauba wax (SL: 303 ± 1.5 nm; SL+O: 295 ± 5.0 nm). TEM results gave an insight into the practical morphology, showing plate-like and needle-like structures. DSC investigations also revealed that SL dispersions melted and crystallized at lower temperatures than the bulk. This decrease can be explained by the small particle sizes of the dispersion, the high-specific surface area, and the presence of a surfactant.

Exposing racial discrimination: implicit & explicit measures--the My Body, My Story study of 1005 US-born black & white community health center members.

BACKGROUND: To date, research on racial discrimination and health typically has employed explicit self-report measures, despite their potentially being affected by what people are able and willing to say. We accordingly employed an Implicit Association Test (IAT) for racial discrimination, first developed and used in two recent published studies, and measured associations of the explicit and implicit discrimination measures with each other, socioeconomic and psychosocial variables, and smoking. METHODOLOGY/PRINCIPAL FINDINGS: Among the 504 black and 501 white US-born participants, age 35-64, randomly recruited in 2008-2010 from 4 community health centers in Boston, MA, black participants were over 1.5 times more likely (p<0.05) to be worse off economically (e.g., for poverty and low education) and have higher social desirability scores (43.8 vs. 28.2); their explicit discrimination exposure was also 2.5 to 3.7 times higher (p<0.05) depending on the measure used, with over 60% reporting exposure in 3 or more domains and within the last year. Higher IAT scores for target vs. perpetrator of discrimination occurred for the black versus white participants: for "black person vs. white person": 0.26 vs. 0.13; and for "me vs. them": 0.24 vs. 0.19. In both groups, only low non-significant correlations existed between the implicit and explicit discrimination measures; social desirability was significantly associated with the explicit but not implicit measures. Although neither the explicit nor implicit discrimination measures were associated with odds of being a current smoker, the excess risk for black participants (controlling for age and gender) rose in models that also controlled for the racial discrimination and psychosocial variables; additional control for socioeconomic position sharply reduced and rendered the association null. CONCLUSIONS: Implicit and explicit measures of racial discrimination are not equivalent and both warrant use in research on racial discrimination and health, along with data on socioeconomic position and social desirability.

Effect of antibloom fat migration from a nut oil filling on the polymorphic transformation of cocoa butter.

In confectionery products, loss in texture contrast between chocolate and filling and the appearance of fat bloom on the surface of the chocolate can be caused by fat migration. Bloom is often linked to the transformation of the cocoa butter betaV polymorph into betaVI. A previous study showed that small additions (1%) of nut oil can have a significant impact on the rate of transformation and that migration of nut oil from a filling would increase polymorphic transformation of cocoa butter. In the present study, antibloom fat was added to the filling in a model system. The antibloom fat migrated with the nut oil and inhibited the transformation of cocoa butter from the betaV polymorph into betaVI. Despite experiencing migration of greater amounts of nut oil, cocoa butter closest to the filling transformed more slowly than that farther away (i.e., the reverse of the situation in the absence of antibloom fat).

Crystallization behavior and texture of trans-containing and trans-free palm oil based confectionery fats.

The objective of this study was to gain insight into the role of trans fatty acids in determining the crystallization behavior and texture of palm-based confectionery fats. Therefore, the isothermal crystallization behavior of two series, each of three fats, one trans-containing and one trans-free, was examined by pNMR, DSC, and rheology. Furthermore, the hardness of these samples was examined at three different storage times at 10 degrees C. All of the trans free samples showed a two-step crystallization at 10 degrees C which is hypothesized to be an alpha-mediated beta' crystallization for two of the samples and a fractionated crystallization in the beta' polymorph for the third, while the trans-containing fats crystallized in a single step, probably a direct beta' crystallization. The trans-containing fat series clearly crystallized faster than the trans-free fat series and also yielded higher hardness values at all storage times investigated. The presence of trans fatty acids seems to reduce the effect of compositional variations on the crystallization process. For the trans free fats, chemical composition was much more critical in determining the crystallization rate, the SFC, and the final hardness value.

Slow recrystallization of tripalmitoylglycerol from MCT oil observed by 2H NMR.

The crystallization and recrystallization of fats have a significant impact on the properties and quality of many food products. While crystallization has been the subject of a number of studies using pure triacylglycerols (TAG), recrystallization in similarly pure systems is rarely studied. In this work, perdeuterated tripalmitoylglycerol ( (2)H-PPP) was dissolved in medium chain triacylglycerol oil (MCT) to yield a saturated solution. The solution was heated to cause partial melting of the solid and dissolution of the molten fraction of (2)H-PPP in MCT and was then cooled to the original temperature to induce recrystallization from the supersaturated solution. (2)H NMR was used to monitor the disappearance of (2)H-PPP from the solution and showed that recrystallization occurred in two steps. The first step was rapid, taking place over a few minutes, and accounted for more than two-thirds of the total recrystallization. The second step was much slower, taking place over a remarkably long timescale of hours to days. It is proposed that dissolution occurs from all parts of the crystals, leaving an etched and pitted surface. The first step of crystallization is the infilling of these pits, while the second step is the continued growth on the smoothed crystal faces.

Relationship between crystallization behavior, microstructure, and macroscopic properties in trans-containing and trans-free filling fats and fillings.

The objective of this study is to investigate the architecture to feature physical functionality of filling fats. This means an investigation of the different structure levels (crystallization, microstructure, macrostructure, etc.) that lead to good technological functionality. The isothermal crystallization behavior of two filling fats (one trans-containing and one trans-free) was examined by differential scanning calorimetry and microscopy. Furthermore, the hardness of the samples was examined after cooling in a water bath at two different temperatures and at three different storage times. The trans-containing filling fat crystallized faster and in smaller crystals as compared to the trans-free filling fat. The crystallization behavior of the trans-free filling fat was more complex, with the formation of different polymorphic forms. The hardness of the fillings was not only governed by the amount of solid fat present in the network but also by the structure of this network. The filling matrix components seem to have a pronounced influence on the microstructure and thus on the macroscopic properties.

Relationship between crystallization behavior, microstructure, and macroscopic properties in trans containing and trans free coating fats and coatings.

The objective of this study is to gain further understanding into the relationship between crystallization behavior, microstructure, and macroscopic properties in coating fats. The isothermal crystallization behavior of two coating fats (one trans containing and one trans free) was examined, both as pure fats and in coatings, by DSC and microscopy. Furthermore, the hardness of the samples was examined after cooling in a water bath at two different temperatures and at three different storage times. Both fats seemed to show an alpha-mediated beta' crystallization at lower temperatures and a direct beta' crystallization at higher temperatures. The trans free coating fat clearly crystallized faster and in smaller crystals. The hardness was governed not only by the amount of solid fat present in the network but also by the structure of this network. The coating matrix components seem to have a pronounced influence on the microstructure and thus on the macroscopic properties.

The impact of publicly funded managed care on adolescent substance abuse treatment outcomes.

This study compares the 12-month changes in substance use following admission to substance abuse treatment in Massachusetts between adolescents enrolled in Medicaid managed care and other publicly funded adolescents. Two hundred and fifty-five adolescents were interviewed as they entered substance abuse treatment and at 6 and 12 month follow-ups. Medicaid enrollment data were used to determine the managed care enrollment status. One hundred forty two (56%) adolescents were in the managed care group and 113 (44%) comprise the comparison group. Substance use outcomes include a count of negative consequences of substance use, days of alcohol use, days of cannabis use, and days of any substance use in the previous 30 days. Repeated measures analysis of covariance (ANCOVA) was used to assess change with time of measurement and managed care status as main effects and the interaction of time and managed care included to measure differences between the groups over time. Although several changes across time were detected for all four outcomes, we found no evidence of an impact of managed care for any of the outcomes. The results of our study do not support the fears that behavioral managed care, by imposing limits on services provided, would substantially reduce the effectiveness of substance abuse treatment for adolescents. At the same time, the results do not support those who believe that the continuity of care and improved resource utilization claimed for managed care would improve outcomes.

Factors associated with participation in breast cancer treatment clinical trials.

PURPOSE: It is well established that recruitment to clinical trials (CTs) is difficult and time consuming. This article reports on factors related to CT participation among women who were invited to participate in a CT for breast cancer. PATIENTS AND METHODS: Breast cancer patients who were eligible for a CT were identified by 16 different cancer centers. After their invitation to participate in a trial, patients who were undecided about participation in a CT were recruited into the present study at that time. After a patient made a decision about trial participation, a telephone interview was conducted to assess knowledge of CTs, perceived benefits and drawbacks of CTs, and personal factors affecting the women's decision regarding participation. RESULTS: A total of 208 patients participated in the study. Fifty-eight percent of the patients decided to participate in a trial. Logistic regression analyses showed that the factors best explaining participation were trial phase, perceived drawbacks, time and travel considerations, therapeutic benefit of trial, and physician recommendation. Participation rates were similar for both phase I and phase III trials. However, a higher percentage of women recruited to phase II trials accepted. CONCLUSION: This study suggests that reducing drawbacks of CT participation, particularly travel time, and improving physician communication of trials are needed to increase trial participation.

Assessing quality of life in adult cancer survivors (QLACS).

This article describes development of a quality of life measure designed to assess issues relevant to long-term cancer survivors. In-depth semi-structured interviews were conducted with 58 long-term cancer survivors to identify domains most relevant to long-term survivors (> or = 5 years post-diagnosis). Self-report items were developed from these interviews and administered to a second sample of 242 long-term survivors. Domains and items were selected from the item pool by a combination of factor analysis and criterion-based item selection. Five cancer-specific domains were identified (appearance concerns, financial problems, distress over recurrence, family-related distress, and benefits of cancer) along with seven generic QOL domains (negative feelings, positive feelings, cognitive problems, sexual problems, physical pain, fatigue, and social avoidance). Cronbach's alpha was 0.72 or greater for each domain. Correlations between domain scores and criterion measures were 0.72 or higher in all but one generic domain (social avoidance), but somewhat lower on cancer-specific domains. The new multidimensional measure has good internal consistency and validity and is appropriate for comparisons between cancer and non-cancer populations, as well as long-term follow-up of cancer patients.

Evaluating the performance of medicare fee-for-service providers using the health outcomes survey: a comparison of two methods.

BACKGROUND: Health status measures are now being used for evaluating the performance of health care organizations. Trends in SF-36 component scores have previously been examined for Medicare-managed care plans but not for providers serving Medicare fee-for-service (FFS) beneficiaries. We compared 2 methods for evaluating the performance of Medicare FFS providers, the Research Triangle Institute (RTI) and Health Assessment Laboratory (HAL) methods. METHODS: Data were collected from 6547 Medicare FFS beneficiaries in 10 cohorts. SF-36 Physical Health (PCS) and Mental Health (MCS) component scores were computed at baseline and after a 2-year follow-up. The RTI approach predicts follow-up scores based on a standard care regression model. The HAL approach determines the percentage of beneficiaries whose status is the "same or better" at follow-up. Both approaches then compare observed to expected scores for each cohort. RESULTS: The HAL method did not detect any statistically significant differences for the PCS; the RTI method detected a small PCS difference for one cohort. The HAL method identified 4 cohorts that had significantly higher MCS scores; the RTI approach identified one cohort with significantly lower scores. CONCLUSIONS: The 2 approaches provided consistent assessments of provider performance for the PCS but not for the MCS. The differences in the MCS results may have been affected by differing treatment of deaths during follow-up. The HAL approach disregards deaths for the MCS, whereas the RTI method imputes values for death. Implications of using self-reported health status for monitoring provider performance are discussed.

Kinetic analysis of nonisothermal differential scanning calorimetry of 1,3-dipalmitoyl-2-oleoylglycerol.

The crystallization of fats has been extensively studied because of its importance in the processing of food and food ingredients. Differential scanning calorimetry (DSC) is widely used in such studies. The aim of this study was to examine the determination of kinetic parameters from nonisothermal DSC crystallization of a model fat, 1,3-dipalmitoyl-2-oleoylglycerol. We applied peak and isoconversional methods to determine activation energies and compared these techniques with a nonparametric method, which separates the temperature dependence and degree of crystallization dependence of the crystallization rate. The Johnson-Mehl-Avrami-Erofeyev-Kolmogorov (JMAEK) model provided the best fit to the data, while the temperature dependence of the rate constant was best explained by a Vogel-Fulcher relationship, where the reference temperature was the melting point of the crystallizing species.

Adoption of naltrexone to treat alcohol dependence.

Three surveys (1997, 1999, and 2001) of outpatient substance abuse treatment centers in Connecticut, Massachusetts, Rhode Island, Maine, Vermont, and New Hampshire examined organizational characteristics that influenced the adoption of naltrexone. Structural equation modeling with manifest variables assessed predictors related to the use of naltrexone. Use of naltrexone increased over time from 14% in 1997 to 25% in 2001. In 1997, programs funded by managed care were more likely, and clinics that provided only substance abuse services were less likely to use psychiatric medication and naltrexone. In subsequent years, counselor education level and organization size also influenced use of naltrexone.