Cost-effectiveness of mifepristone and misoprostol versus misoprostol alone for the management of missed miscarriage: an economic evaluation based on the MifeMiso trial.

OBJECTIVE: To assess the cost-effectiveness of mifepristone and misoprostol (MifeMiso) compared with misoprostol only for the medical management of a missed miscarriage. DESIGN: Within-trial economic evaluation and model-based analysis to set the findings in the context of the wider economic evidence for a range of comparators. Incremental costs and outcomes were calculated using nonparametric bootstrapping and reported using cost-effectiveness acceptability curves. Analyses were performed from the perspective of the UK's National Health Service (NHS). SETTING: Twenty-eight UK NHS early pregnancy units. SAMPLE: A cohort of 711 women aged 16-39 years with ultrasound evidence of a missed miscarriage. METHODS: Treatment with mifepristone and misoprostol or with matched placebo and misoprostol tablets. MAIN OUTCOME MEASURES: Cost per additional successfully managed miscarriage and quality-adjusted life years (QALYs). RESULTS: For the within-trial analysis, MifeMiso intervention resulted in an absolute effect difference of 6.6% (95% CI 0.7-12.5%) per successfully managed miscarriage and a QALYs difference of 0.04% (95% CI -0.01 to 0.1%). The average cost per successfully managed miscarriage was lower in the MifeMiso arm than in the placebo and misoprostol arm, with a cost saving of £182 (95% CI £26-£338). Hence, the MifeMiso intervention dominated the use of misoprostol alone. The model-based analysis showed that the MifeMiso intervention is preferable, compared with expectant management, and this is the current medical management strategy. However, the model-based evidence suggests that the intervention is a less effective but less costly strategy than surgical management. CONCLUSIONS: The within-trial analysis found that based on cost-effectiveness grounds, the MifeMiso intervention is likely to be recommended by decision makers for the medical management of women presenting with a missed miscarriage. TWEETABLE ABSTRACT: The combination of mifepristone and misoprostol is more effective and less costly than misoprostol alone for the management of missed miscarriages.

Ethnic Variations in Serum 25(OH)D Levels and Bone Ultrasound Attenuation Measurements in Blacks and Whites.

Vitamin D deficiency is more common in Blacks, yet Blacks have lower prevalence of bone fragility fractures or osteoporosis than Whites. Broadband ultrasound attenuation (BUA) has been used to explore the association between serum 25(OH)D levels and bone quality in White and non-white populations. We investigated serum 25(OH)D status with corresponding BUA measurements assessed cross sectionally in a cohort of 232 Blacks and 260 Whites, aged 30-95 years who were part of the calibration study of the large Adventist Health Study-2 (AHS-2). At the calibration clinics, calcaneal BUA was measured and blood drawn for serum 25(OH)D assessment. In multivariable analyses, BUA was negatively associated with age (ß-coefficient = -0.38; p < 0.0001) and positively associated with body mass index (BMI) (p (trend) < 0.0001) and positively, but non-significantly, associated with serum 25(OH)D levels. Also, as expected, females had lower BUA (ß-coefficient = -5.19; p < 0.05) and Blacks had higher BUA (ß-coefficient = 4.26; p < 0.05). Gender and race modified the relationship of serum 25(OH)D on BUA with a positive association in males (p (trend) ≤ 0.05), but no significant association in females after also controlling for menopausal status and hormone therapy. After also controlling for serum 25(OH)D levels, Black males had higher BUA than White men, but such differences were not found among the females. When stratifying on race, a positive association between serum 25(OH)D levels and BUA (p (trend) ≤ 0.05) was found in Blacks, but not among Whites. Further studies are needed to understand how racial/ethnic differences in serum 25(OH)D levels influence bone health.

Hydrolysis of phytate to its lower esters can influence the growth performance and nutrient utilization of broilers with regular or super doses of phytase.

The aim of the study was to observe the effects of dietary available phosphorus (aP) and calcium (Ca), with regular or super doses of phytase, on phytate hydrolysis and subsequent influences on broiler growth performance and nutrient utilization. In a 2 × 3 factorial design, 384 Ross-308 broilers were allocated to one of 6 dietary treatments with 8 replicates in a randomized complete block design for 21 days. Diets were nutritionally adequate (positive control, PC) or marginally deficient in aP and Ca (negative control, NC), with 0, 500 or 1,500 FTU/kg phytase. Bird and feed weights were recorded on d 0 and 21, excreta were collected on d 19 and 20, and gizzard and ileal contents were collected on d 21. Body weight gain (P < 0.01) increased linearly with phytase in the PC and quadratically in the NC. There was an interactive effect on ileal DM, N, and P utilization, increasing quadratically with phytase supplementation in the NC, but there was no phytase influence in the PC (P < 0.05). Phytase linearly increased copper (P < 0.001) and linearly decreased Ca (P < 0.05) utilization in the ileum. Phytase decreased ileal (IPx, inositol x-phosphate) IP6 and IP5 and increased inositol (quadratic, P < 0.001) but had no effect on IP4 or IP3. The influence of the dietary aP was more apparent on the hydrolysis of phytate and phytate esters after the ileum, with increasing (linear and quadratic, P < 0.05) IP4 and IP3 content in the excreta of birds fed the NC or PC when phytase was added. Phytate hydrolysis improves the growth potential of birds fed NC diets, allowing them to match the growth performance of birds fed PC diets and improve nutrient utilization. These results indicate that dietary Ca and aP concentrations can be reduced when phytase is supplemented. It also may be beneficial to apply the enzyme nutrient matrix to other nutrients in the diet to maintain an optimal balance of nutrients in the digesta.

Effects of exogenous proteases without or with carbohydrases on nutrient digestibility and disappearance of non-starch polysaccharides in broiler chickens.

The objective of the current study was to evaluate the effect of a subtilisin protease, without or with inclusion of carbohydrases, on digestibility and retention of energy and protein, as well as the solubilization and disappearance of non-starch polysaccharides (NSP) from corn-soybean meal based diets fed to broiler chickens. Two hundred eighty-eight Ross 308 male broiler chickens were used for the experiment. On d 14, the birds were weighed and allocated to 6 treatments and 8 replicates per treatment with 6 birds per replicate. Treatments were: 1) corn-soybean meal based control diet; 2) control diet plus supplemental protease at 5,000 (P5000) protease units (PU)/kg); 3) control plus 10,000 PU/kg protease (P10000); or control plus an enzyme combination containing xylanase, amylase, and protease (XAP) added to achieve protease activity of: 4) 2,500 PU/kg (XAP2500); 5) 5,000 PU/kg (XAP5000); or 6) 10,000 PU/kg (XAP10000). The enzymes in XAP were combined at fixed ratios of 10:1:25 of xylanase:amylase:protease. Data were analyzed by ANOVA and specific orthogonal contrasts between treatments were performed. Addition of xylanase and amylase increased (P < 0.05) the ileal digestibility of protein by 4.2% and 2.1% at XAP5000 and XAP10000, respectively (relative to P5000 and P10000, respectively), exhibiting a plateau after the XAP5000 dose. Increment (P < 0.05) in AME due to protease was evident, particularly in P10000. At the ileal level, XAP reduced (P < 0.05) the flow of insoluble xylose and arabinose, which indicates an increase in the solubilization of arabinoxylan polymers in the small intestine. Protease on its own reduced (P < 0.05) the flow of insoluble arabinose but did not affect the flow of insoluble xylose. XAP reduced (P < 0.05) the pre-cecal flow of insoluble and total glucose and galactose. It was concluded that whereas protease by itself improved nutrient utilization and increased solubilization of NSP components, at the lower dose, a combination of xylanase, amylase, and protease produced effects greater than those of protease alone.

Effect of the EnBalance, a culturally and language-sensitive diabetes education program, on dietary changes and plasma lipid profile in Hispanic diabetics.

OBJECTIVE: To assess the effects of a language-sensitive diabetes education program on dietary changes and plasma lipid profiles. METHOD: Hispanic participants (n=13 males and 18 females, mean age = 54.00 + 10.68 years) participated in a 3-month health education study. Spearman correlation coefficients were used to evaluate correlations between dietary intake and laboratory measurements. RESULTS: There were significant decreases in serum total cholesterol (-16.07 mg/dl, P= 0.035), HDL cholesterol (-3.23 mg/dl, P = 0.01), LDL cholesterol (-11.71 mg/dl, P = 0.013) and dietary cholesterol (-79.22 mg, P = 0.03). No significant mean change was observed in triglyceride and total cholesterol/HDL ratio. There was also a reduction in body mass index (BMI) (-0.15 kg/m(2), P = 0.40), fasting glucose (-3.90 mg/dl, P = 0.43) and dual energy X-ray absorptiometry (DXA) total fat (-0.50, P = 0.97). Although not statistically significant, saturated fatty acids (-4.90 g, P = 0.19), polyunsaturated fatty acids (-3.31g, P = 0.11), and carbohydrate (-44.82 g, P = 0.22), decreased after three months. CONCLUSION: There were significant improvements in dietary intake and serum lipids after a three-month culture-specific diabetes education program.

Pooled analysis of prospective cohort studies on height, weight, and breast cancer risk.

The association between anthropometric indices and the risk of breast cancer was analyzed using pooled data from seven prospective cohort studies. Together, these cohorts comprise 337,819 women and 4,385 incident invasive breast cancer cases. In multivariate analyses controlling for reproductive, dietary, and other risk factors, the pooled relative risk (RR) of breast cancer per height increment of 5 cm was 1.02 (95% confidence interval (CI): 0.96, 1.10) in premenopausal women and 1.07 (95% CI: 1.03, 1.12) in postmenopausal women. Body mass index (BMI) showed significant inverse and positive associations with breast cancer among pre- and postmenopausal women, respectively; these associations were nonlinear. Compared with premenopausal women with a BMI of less than 21 kg/m2, women with a BMI exceeding 31 kg/m2 had an RR of 0.54 (95% CI: 0.34, 0.85). In postmenopausal women, the RRs did not increase further when BMI exceeded 28 kg/m2; the RR for these women was 1.26 (95% CI: 1.09, 1.46). The authors found little evidence for interaction with other breast cancer risk factors. Their data indicate that height is an independent risk factor for postmenopausal breast cancer; in premenopausal women, this relation is less clear. The association between BMI and breast cancer varies by menopausal status. Weight control may reduce the risk among postmenopausal women.

Cohort studies of fat intake and the risk of breast cancer--a pooled analysis.

BACKGROUND: Experiments in animals, international correlation comparisons, and case-control studies support an association between dietary fat intake and the incidence of breast cancer. Most cohort studies do not corroborate the association, but they have been criticized for involving small numbers of cases, homogeneous fat intake, and measurement errors in estimates of fat intake. METHODS: We identified seven prospective studies in four countries that met specific criteria and analyzed the primary data in a standardized manner. Pooled estimates of the relation of fat intake to the risk of breast cancer were calculated, and data from study-specific validation studies were used to adjust the results for measurement error. RESULTS: Information about 4980 cases from studies including 337,819 women was available. When women in the highest quintile of energy-adjusted total fat intake were compared with women in the lowest quintile, the multivariate pooled relative risk of breast cancer was 1.05 (95 percent confidence interval, 0.94 to 1.16). Relative risks for saturated, monounsaturated, and polyunsaturated fat and for cholesterol, considered individually, were also close to unity. There was little overall association between the percentage of energy intake from fat and the risk of breast cancer, even among women whose energy intake from fat was less than 20 percent. Correcting for error in the measurement of nutrient intake did not materially alter these findings. CONCLUSIONS: We found no evidence of a positive association between total dietary fat intake and the risk of breast cancer. There was no reduction in risk even among women whose energy intake from fat was less than 20 percent of total energy intake. In the context of the Western lifestyle, lowering the total intake of fat in midlife is unlikely to reduce the risk of breast cancer substantially.

Condition of toothbrushes in use: correlation with behavioral and socio-economic factors.

Toothbrushes and questionnaires from 94 adult dentate individuals were analyzed. More than 97% of respondents said they brushed their teeth at least once a day, while 48% used more than one toothbrush (such as one at home and another at work). Only 47% said they preferred a soft nylon bristle, while 41% preferred medium and 10% a hard nylon bristle. More than 73% of subjects said they used their brushes for 3 months or longer. Examination of collected brushes by both objective and subjective criteria revealed a wide variation in wear; however, the majority of brushes did not appear to be 'worn-out'. No significant correlation was found between objective wear-index and the educational level of the user, annual household income of the user, or reported time in use of the brush. A significant (p less than 0.01) correlation was found between brush wear-index and the ability of the user to judge toothbrush wear.

Estimating cumulative ambient concentrations of air pollutants: description and precision of methods used for an epidemiological study.

Methods for estimating cumulative ambient air pollution concentrations for individuals enrolled in an epidemiological cohort study are described and studied. Monthly interpolations from fixed-site monitoring stations in California to zip code centroids were used. The precision of the interpolation methods for total suspended particulates and ozone was assessed, and fixed-site monitoring stations were used in turn as receptor sites. Actual versus interpolated 2-y mean concentrations did not differ significantly and were correlated with a Pearson correlation coefficient of .78 for total suspended particulates and .87 for ozone. The impact of the change from monitoring total oxidants to ozone on oxidant/ozone cumulations was evaluated, and monthly mean concentrations for total oxidants were compared with ozone for 435 station months during which both pollutants were measured simultaneously. Average concentrations did not differ significantly and were highly correlated (r = 0.94). Exceedance frequency statistics, which averaged slightly higher for ozone than for total oxidants, were also highly correlated.