The Probability of A1C Goal Attainment in Patients With Uncontrolled Type 2 Diabetes in a Large Integrated Delivery System: A Prediction Model.

OBJECTIVE: To assess patient characteristics and treatment factors associated with uncontrolled type 2 diabetes (T2D) and the probability of hemoglobin A1c (A1C) goal attainment. RESEARCH DESIGN AND METHODS: This was a retrospective cohort study using the electronic health record at Cleveland Clinic. Patients with uncontrolled T2D (A1C >9%) were identified on the index date of 31 December 2016 (n = 6,973) and grouped by attainment (n = 1,653 [23.7%]) or nonattainment (n = 5,320 [76.3%]) of A1C <8% by 31 December 2017, and subgroups were compared on a number of demographic and clinical variables. On the basis of these variables, a nomogram was created for predicting probability of A1C goal attainment. RESULTS: For the entire population, median age at index date was 57.7 years (53.3% male), and the majority were white (67.2%). Median A1C was 10.2%. Obesity (50.6%), cardiovascular disease (46.9%), and psychiatric disease (61.1%) were the most common comorbidities. Metformin (62.7%) and sulfonylureas (38.7%) were the most common antidiabetes medications. Only 1,653 (23.7%) patients achieved an A1C <8%. Predictors of increased probability of A1C goal attainment were older age, white/non-Hispanic race/ethnicity, Medicare health insurance, lower baseline A1C, higher frequency of endocrinology/primary care visits, dipeptidyl peptidase 4 inhibitor use, thiazolidinedione use, metformin use, glucagon-like peptide 1 receptor agonist use, and fewer classes of antidiabetes drugs. Factors associated with lower probability included insulin use and longer time in the T2D database (both presumed as likely surrogates for duration of T2D). CONCLUSIONS: A minority of patients with an A1C >9% achieved an A1C <8% at 1 year. While most identified predictive factors are nonmodifiable by the clinician, pursuit of frequent patient engagement and tailored drug regimens may help to improve A1C goal attainment.

Baby hamster kidney cell-derived recombinant factor VIII: a quarter century of learning and clinical experience.

INTRODUCTION: Management and care of individuals with hemophilia A advanced immensely with the introduction of recombinant factor VIII (rFVIII) replacement products. This review provides a historical overview of rFVIII development with a focus on Bayer's rFVIII (with albumin) and sucrose-formulated rFVIII (rFVIII-FS), the only rFVIII products cloned in baby hamster kidney (BHK) cells with >25 years of proven safety and efficacy. Areas covered: We review the advances in rFVIII technology and the efficacy and safety data for BHK-derived rFVIII/rFVIII-FS from clinical trials, investigator-initiated studies, and observational studies. Innovative products with new treatment potentials (eg, BAY 81-8973 and BAY 94-9027) built on this established safety and efficacy profile are also briefly discussed. The literature search strategy included targeted searches (PubMed) with manual article selection and other product-specific searches. Expert commentary: Development of rFVIII products and related improvements in viral safety and manufacturing efficiency have guaranteed an adequate supply of factor products worldwide and increased prophylaxis use. The net effects have been joint health preservation, reduction in morbidity and mortality, and quality-of-life enhancements. Current treatment challenges include lack of adherence to prophylaxis and inhibitor development; extended-half-life rFVIII products and non-FVIII replacement therapies in development may help overcome these challenges.

Lifestyle medicine curriculum for a preventive medicine residency program: implementation and outcomes.

BACKGROUND: The vast majority of the healthcare problems burdening our society today are caused by disease-promoting lifestyles (e.g., physical inactivity and unhealthy eating). Physicians report poor training and lack of confidence in counseling patients on lifestyle changes. OBJECTIVE: To evaluate a new curriculum and rotation in lifestyle medicine for preventive medicine residents. METHODS: Training included didactics (six sessions/year), distance learning, educational conferences, and newly developed lifestyle medicine rotations at the Institute of Lifestyle Medicine, the Yale-Griffin Prevention Research Center, and the Integrative Medicine Center. We used a number of tools to assess residents' progress including Objective Structured Clinical Examinations (OSCEs), self-assessments, and logs of personal health habits. RESULTS: A total of 20 residents participated in the lifestyle medicine training between 2010 and 2013. There was a 15% increase in residents' discussions of lifestyle issues with their patients based on their baseline and follow-up surveys. The performance of preventive medicine residents on OSCEs increased each year they were in the program (average OSCE score: PGY1 73%, PGY2 83%, PGY3 87%, and PGY4 91%, p=0.01). Our internal medicine and preliminary residents served as a control, since they did participate in didactics but not in lifestyle medicine rotations. Internal medicine and preliminary residents who completed the same OSCEs had a slightly lower average score (76%) compared with plural for resident, preventive medicine residents (80%). However, this difference did not reach statistical significance (p=0.11). CONCLUSION: Incorporating the lifestyle medicine curriculum is feasible for preventive medicine training allowing residents to improve their health behavior change discussions with patients as well as their own personal health habits.

Effect of multivitamin supplements on weight gain during pregnancy among HIV-negative women in Tanzania.

Multivitamin supplementation has been shown to reduce the risk of low birthweight. This effect could be mediated through gestational weight gain. However, the effect of multivitamin supplementation on weight gain during pregnancy has not been fully studied. The objective of this study was to examine the effects of multivitamins on pregnancy weight gain. We enrolled 8468 HIV-negative women from Dar es Salaam, Tanzania, in a randomised, placebo-controlled trial of multivitamins on birth outcomes. Women were randomly assigned to receive either a daily oral dose of multivitamin tablets or a placebo and were weighed every 4 weeks from enrolment until the last visit before delivery. Intent-to-treat analyses were carried out to examine the effects of multivitamins on pregnancy weight gain. Multivariate linear and binomial regression models with the log-link function were used to examine the association of weight gain during pregnancy to birthweight. The overall total weight gain was 253 g (SE: 69, P: 0.0003) more, while the overall 4 weekly weight gain was 59 g greater (SE: 18, P: 0.005) among women who received multivitamins compared to placebo. Women in the lowest quartile of gestational weight gain had babies with an average birthweight of 3030 g (SD: 524), while women in the highest quartile had babies weighing 3246 g (SD: 486), on average. Prenatal multivitamin supplements increased gestational weight gain, which was a significant predictor of birthweight.

Predictors of breastfeeding cessation among HIV-infected women in Dar es Salaam, Tanzania.

This paper examines predictors of breastfeeding cessation among a cohort of human immunodeficiency virus (HIV)-infected women. This was a prospective follow-up study of HIV-infected women who participated in a randomized micronutrient supplementation trial conducted in Dar es Salaam, Tanzania. 795 HIV-infected Tanzanian women with singleton newborns were utilized from the cohort for this analysis. The proportion of women breastfeeding declined from 95% at 12 months to 11% at 24 months. The multivariate analysis showed breastfeeding cessation was significantly associated with increasing calendar year of delivery from 1995 to 1997 [risk ratio (RR), 1.36; 95% confidence interval (CI) 1.13-1.63], having a new pregnancy (RR 1.33; 95% CI 1.10-1.61), overweight [body mass index (BMI) ≥25 kg m(-2) ; RR 1.37; 95% CI 1.07-1.75], underweight (BMI <18.5kg m(-2) ; RR 1.29; 95% CI 1.00-1.65), introduction of cow's milk at infant's age of 4 months (RR 1.30; 95% CI 1.04-1.63). Material and social support was associated with decreased likelihood of cessation (RR 0.83; 95% CI 0.68-1.02). Demographic, health and nutritional factors among women and infants are associated with decisions by HIV-infected women to cease breastfeeding. The impact of breastfeeding counselling programs for HIV-infected African women should consider individual maternal, social and health contexts.

Iron status is an important cause of anemia in HIV-infected Tanzanian women but is not related to accelerated HIV disease progression.

In HIV-infected populations from developing countries, it is unclear what proportion of anemia is attributable to iron deficiency (ID) and whether high body iron stores worsen HIV disease progression. We therefore evaluated these research questions in 584 HIV-infected Tanzanian women. Hemoglobin (Hb), serum ferritin (SF), serum transferrin receptor (sTfR), and C-reactive protein (CRP) concentrations were evaluated between 13 and 43 wk after women gave birth. ID was defined as SF or sTfR outside normal ranges, and ID anemia (IDA) as ID plus low Hb. In multivariate Cox regression models, the association between SF and HIV disease progression was assessed. Participants received iron + folate supplements during pregnancy. Hb (r = -0.159; P = 0.0001), SF (r = 0.355; P < 0.0001), and sTfR/log SF index (r = -0.119; P = 0.004) were related to CRP, whereas sTfR (r = 0.029; P = 0.48) was not. Prevalence estimates were 39.7% for ID and 23.6% for IDA. ID was associated with 48.9% of anemia cases. Categories of SF were not significantly associated with HIV-related mortality or progression to stage 4. Nevertheless, SF > 150.0 microg/L was related to a nonsignificantly elevated risk of progression to stage 4 (rate ratio = 1.78; 95% CI = 0.68-4.64; P = 0.24) compared with SF < 12.0 microg/L. In HIV-infected, parous women from sub-Saharan Africa, ID is of moderately high prevalence and is an important underlying cause of anemia. High storage iron does not appear to be related to HIV disease progression in this population, but more research on the role of iron during HIV disease is needed.

Vitamins and perinatal outcomes among HIV-negative women in Tanzania.

BACKGROUND: Prematurity and low birth weight are associated with high perinatal and infant mortality, especially in developing countries. Maternal micronutrient deficiencies may contribute to these adverse outcomes. METHODS: In a double-blind trial in Dar es Salaam, Tanzania, we randomly assigned 8468 pregnant women (gestational age of fetus, 12 to 27 weeks) who were negative for human immunodeficiency virus infection to receive daily multivitamins (including multiples of the recommended dietary allowance) or placebo. All the women received prenatal supplemental iron and folic acid. The primary outcomes were low birth weight (<2500 g), prematurity, and fetal death. RESULTS: The incidence of low birth weight was 7.8% among the infants in the multivitamin group and 9.4% among those in the placebo group (relative risk, 0.82; 95% confidence interval [CI], 0.70 to 0.95; P=0.01). The mean difference in birth weight between the groups was modest (67 g, P<0.001). The rates of prematurity were 16.9% in the multivitamin group and 16.7% in the placebo group (relative risk, 1.01; 95% CI, 0.91 to 1.11; P=0.87), and the rates of fetal death were 4.3% and 5.0%, respectively (relative risk, 0.87; 95% CI, 0.72 to 1.05; P=0.15). Supplementation reduced both the risk of a birth size that was small for gestational age (<10th percentile; 10.7% in the multivitamin group vs. 13.6% in the placebo group; relative risk, 0.77; 95% CI, 0.68 to 0.87; P<0.001) and the risk of maternal anemia (hemoglobin level, <11 g per deciliter; relative risk, 0.88; 95% CI, 0.80 to 0.97; P=0.01), although the difference in the mean hemoglobin levels between the groups was small (0.2 g per deciliter, P<0.001). CONCLUSIONS: Multivitamin supplementation reduced the incidence of low birth weight and small-for-gestational-age births but had no significant effects on prematurity or fetal death. Multivitamins should be considered for all pregnant women in developing countries. (ClinicalTrials.gov number, NCT00197548 [ClinicalTrials.gov].).