Infant Serum and Maternal Milk Vitamin B-12 Are Positively Correlated in Kenyan Infant-Mother Dyads at 1-6 Months Postpartum, Irrespective of Infant Feeding Practice.

BackgroundVitamin B-12 is an essential nutrient required for many functions including DNA synthesis, erythropoiesis, and brain development. If maternal milk vitamin B-12 concentrations are low, infants may face elevated risks of deficiency when exclusively breastfed.ObjectiveWe evaluated cross-sectional associations between infant serum vitamin B-12 concentrations and maternal milk vitamin B-12 concentrations at 1-6 mo postpartum among an unsupplemented population in rural western Kenya, and assessed biological demographic, and dietary characteristics associated with adequate infant serum vitamin B-12.MethodsWe modeled 1) infant serum vitamin B-12 using maternal milk vitamin B-12 concentration with linear regression; and 2) adequate (>220 pmol/L) infant serum vitamin B-12 using hypothesized biological, demographic, and dietary predictors with logistic regression. In both models, we used generalized estimating equations to account for correlated observations at the cluster-level.ResultsThe median (quartile 1, quartile 3) infant serum vitamin B-12 concentration was 276 pmol/L (193, 399 pmol/L) and approximately one-third of infants had serum vitamin B-12 ≤220 pmol/L, indicating that they were vitamin B-12 depleted or deficient. There was a positive correlation between maternal milk and infant serum vitamin B-12 (r = 0.36, P < 0.001) and in multivariable analyses, maternal milk vitamin B-12 concentration was significantly associated with infant serum vitamin B-12 adequacy (P-trend = 0.03).ConclusionsDespite a high prevalence (90%) of maternal milk vitamin B-12 concentrations below the level used to establish the Adequate Intake (<310 pmol/L), there was a low prevalence of infant vitamin B-12 deficiency. We found few factors that were associated with infant vitamin B-12 adequacy in this population, including infant feeding practices, although maternal vitamin B-12 status was not measured. The contribution of maternal milk to infant vitamin B-12 status remains important to quantify across populations, given that maternal milk vitamin B-12 concentration is modifiable with supplementation. This trial was registered at clinicaltrials.gov as NCT01704105

Correction to: Putting genome-wide sequencing in neonates into perspective

The original version of this Article contained an error in the spelling of the author Pleuntje J. van der Sluijs, which was incorrectly given as Eline (P. J.) van der Sluijs. This has now been corrected in both the PDF and HTML versions of the Article

A Qualitative Study to Assess US Patient Preferences between new Transdermal System and Injectable Anabolic Therapies for Osteoporosis Treatment

US patients with osteoporosis included in three focus groups identified efficacy, safety, cost, and convenience as important attributes of treatment when choosing between anabolic therapies with high stated preference for the solid Microstructured Transdermal System. OBJECTIVE: The current study evaluated patient perspective and relative importance of treatment attributes of in-home daily self-administration of abaloparatide-solid Microstructured Transdermal System (sMTS) compared with other anabolic agents (i.e. in-home daily subcutaneous self-injections, and monthly subcutaneous injections at doctor office) among a group of US patients with osteoporosis. METHODS: The current study included systematic literature reviews, experts' consultation and three online patients focus groups (n=27), including patients ≥50 years of age at high risk for fracture. Nominal Group Technique was used by asking patients to (1) Individually identify characteristics that would be important for them when choosing between anabolic treatments, (2) Share ideas and discuss perspectives with other patients, (3) Review additional attributes generated from a systematic literature review, (4) Select and rank individually the 7 most important characteristics from the list and (5) Report their acceptability and stated preference ranking between the three treatment options. RESULTS: Twenty women and 7 men with a mean age of 65 (range 51-85 years) participated in the focus groups. Twenty-four treatment characteristics were identified through focus groups and literature review. Efficacy, safety, out-of-pocket costs, strength of evidence and the option to self-administer were ranked as the most important attributes. The majority of patients stated preference for a daily sMTS if prescribed by their doctor. CONCLUSIONS: This study revealed that efficacy, safety, costs, and convenience are important attributes of osteoporosis treatment for US patients at high risk for fractures when choosing between anabolic therapies, with a high stated preference for sMTS

A Qualitative Study to Assess US Patient Preferences between new Transdermal System and Injectable Anabolic Therapies for Osteoporosis Treatment

US patients with osteoporosis included in three focus groups identified efficacy, safety, cost, and convenience as important attributes of treatment when choosing between anabolic therapies with high stated preference for the solid Microstructured Transdermal System. OBJECTIVE: The current study evaluated patient perspective and relative importance of treatment attributes of in-home daily self-administration of abaloparatide-solid Microstructured Transdermal System (sMTS) compared with other anabolic agents (i.e. in-home daily subcutaneous self-injections, and monthly subcutaneous injections at doctor office) among a group of US patients with osteoporosis. METHODS: The current study included systematic literature reviews, experts' consultation and three online patients focus groups (n=27), including patients ≥50 years of age at high risk for fracture. Nominal Group Technique was used by asking patients to (1) Individually identify characteristics that would be important for them when choosing between anabolic treatments, (2) Share ideas and discuss perspectives with other patients, (3) Review additional attributes generated from a systematic literature review, (4) Select and rank individually the 7 most important characteristics from the list and (5) Report their acceptability and stated preference ranking between the three treatment options. RESULTS: Twenty women and 7 men with a mean age of 65 (range 51-85 years) participated in the focus groups. Twenty-four treatment characteristics were identified through focus groups and literature review. Efficacy, safety, out-of-pocket costs, strength of evidence and the option to self-administer were ranked as the most important attributes. The majority of patients stated preference for a daily sMTS if prescribed by their doctor. CONCLUSIONS: This study revealed that efficacy, safety, costs, and convenience are important attributes of osteoporosis treatment for US patients at high risk for fractures when choosing between anabolic therapies, with a high stated preference for sMTS

Cost-effectiveness of sequential treatment with abaloparatide vs. teriparatide for United States women at increased risk of fracture.

Objectives: There is emerging evidence supporting sequential therapy with an osteoanabolic followed by an antiresorptive in patients at high-risk of fragility fractures. This study assessed the cost-effectiveness of sequential treatment with abaloparatide (ABL) followed by alendronate (ALN) [(ABL/ALN)] compared with teriparatide (TPTD) followed by ALN (TPTD/ALN). Methods: A previously validated Markov microsimulation model was adapted to estimate the cost-effectiveness of sequential ABL/ALN compared with sequential TPTD/ALN and no treatment with a lifetime horizon from the US payer perspective. Patients were assumed to receive ABL or TPTD for 18 months followed by 5 years of ALN in line with clinical recommendations. The effects of ABL on fracture risk were derived from the ACTIVExtend trial. The effects of TPTD were assumed to be maintained during subsequent ALN treatment, consistent with ACTIVExtend findings for ABL. Evaluation was completed for patients, aged 50 80 years with a BMD T-score ¡3.5 or with a T-score between ¡2.5 and ¡3.5 and a history of one osteoporotic fracture. Results: In all simulated populations, sequential ABL/ALN therapy was dominant (lower costs, D14X X higher QALYs) compared with sequential TPTD/ALN therapy, resulting from the improved efficacy and lower drug price of ABL. Probabilistic sensitivity analyses suggested that ABL/ALN was dominant in at least 99% of the simulations. Compared to no treatment, the cost per QALY gained of ABL/ALN D15X X was always below $130,000. Conclusions: Sequential ABL/ALN therapy is a D16X X cost-effective (dominant) strategy compared with sequential TPTD/ALN therapy for the treatment of US women at increased risk of fractures

Validation of an administrative claims-based diagnostic code for pneumonia in a Us-based commercially insured COPD population

OBJECTIVE: To estimate the accuracy of claims-based pneumonia diagnoses in COPD patients using clinical information in medical records as the reference standard. METHODS: Selecting from a repository containing members’ data from 14 regional United States health plans, this validation study identified pneumonia diagnoses within a group of patients initiating treatment for COPD between March 1, 2009 and March 31, 2012. Patients with ≥1 claim for pneumonia (International Classification of Diseases Version 9-CM code 480.xx–486.xx) were identified during the 12 months following treatment initiation. A subset of 800 patients was randomly selected to abstract medical record data (paper based and electronic) for a target sample of 400 patients, to estimate validity within 5% margin of error. Positive predictive value (PPV) was calculated for the claims diagnosis of pneumonia relative to the reference standard, defined as a documented diagnosis in the medical record. RESULTS: A total of 388 records were reviewed; 311 included a documented pneumonia diagnosis, indicating 80.2% (95% confidence interval [CI]: 75.8% to 84.0%) of claims-identified pneumonia diagnoses were validated by the medical charts. Claims-based diagnoses in inpatient or emergency departments (n=185) had greater PPV versus outpatient settings (n=203), 87.6% (95% CI: 81.9%–92.0%) versus 73.4% (95% CI: 66.8%–79.3%), respectively. Claims-diagnoses verified with paper-based charts had similar PPV as the overall study sample, 80.2% (95% CI: 71.1%–87.5%), and higher PPV than those linked to electronic medical records, 73.3% (95% CI: 65.5%–80.2%). Combined paper-based and electronic records had a higher PPV, 87.6% (95% CI: 80.9%–92.6%). CONCLUSION: Administrative claims data indicating a diagnosis of pneumonia in COPD patients are supported by medical records. The accuracy of a medical record diagnosis of pneumonia remains unknown. With increased use of claims data in medical research, COPD researchers can study pneumonia with confidence that claims data are a valid tool when studying the safety of COPD therapies that could potentially lead to increased pneumonia susceptibility or severity

Comparative Effectiveness of Budesonide-Formoterol Combination and Fluticasone-Salmeterol Combination for Asthma Management: A United States Retrospective Database Analysis

BackgroundComparative effectiveness of the budesonide–formoterol fumarate dihydrate combination (BFC) and the fluticasone propionate–salmeterol combination (FSC) therapy on asthma exacerbation has not been assessed in real-world settings in the United States.ObjectiveTo compare exacerbation rates and health care utilization for patients with asthma who initiate BFC versus FSC therapy.MethodsThis retrospective cohort comparative effectiveness study queried medical and pharmacy data for patients with asthma from a large managed care data repository that covers major US population centers. The patients were 12 to 64 years old, with ≥12 months of pre- and postindex enrollment and ≥1 pharmacy claim(s) for BFC or FSC initiated during June 1, 2007, and September 30, 2010; the first prescription fill date was defined as the index date. Patients with other respiratory diseases and/or cancer were excluded. Exacerbation was defined as asthma-related hospitalization, emergency department visit, and/or oral corticosteroid prescription fill. Cohorts were matched by using propensity scores.ResultsA total of 3043 patients per cohort were matched and balanced. During the 12 months following the initiation the BFC cohort had lower adjusted exacerbations per person year versus the FSC cohort (0.85 vs 0.93; RR 0.92, 95% CI [0.85-0.99]), lower oral corticosteroid fill rates, and fewer asthma-related emergency department visits but comparable asthma-related hospitalization.ConclusionsAsthma exacerbation was lower for BFC versus FSC initiators due to lower rates of oral corticosteroid use and asthma-related emergency department visits, which indicate better treatment effectiveness of those patients initiated with BFC compared with FSC

Comparative effectiveness of budesonide/formoterol combination and fluticasone/salmeterol combination among chronic obstructive pulmonary disease patients new to controller treatment: a US administrative claims database study

BACKGROUND: Inhaled corticosteroid/long-acting β(2)-agonist combinations (ICS/LABA) have emerged as first line therapies for chronic obstructive pulmonary disease (COPD) patients with exacerbation history. No randomized clinical trial has compared exacerbation rates among COPD patients receiving budesonide/formoterol combination (BFC) and fluticasone/salmeterol combination (FSC) to date, and only limited comparative data are available. This study compared the real-world effectiveness of approved BFC and FSC treatments among matched cohorts of COPD patients in a large US managed care setting. METHODS: COPD patients (≥40 years) naive to ICS/LABA who initiated BFC or FSC treatments between 03/01/2009-03/31/2012 were identified in a geographically diverse US managed care database and followed for 12 months; index date was defined as first prescription fill date. Patients with a cancer diagnosis or chronic (≥180 days) oral corticosteroid (OCS) use within 12 months prior to index were excluded. Patients were matched 1-to-1 on demographic and pre-initiation clinical characteristics using propensity scores from a random forest model. The primary efficacy outcome was COPD exacerbation rate, and secondary efficacy outcomes included exacerbation rates by event type and healthcare resource utilization. Pneumonia objectives included rates of any diagnosis of pneumonia and pneumonia-related healthcare resource utilization. RESULTS: Matching of the identified 3,788 BFC and 6,439 FSC patients resulted in 3,697 patients in each group. Matched patients were well balanced on age (mean = 64 years), gender (BFC: 52% female; FSC: 54%), prior COPD-related medication use, healthcare utilization, and comorbid conditions. During follow-up, no significant difference was seen between BFC and FSC patients for number of COPD-related exacerbations overall (rate ratio [RR] = 1.02, 95% CI = [0.96,1.09], p = 0.56) or by event type: COPD-related hospitalizations (RR = 0.96), COPD-related ED visits (RR = 1.11), and COPD-related office/outpatient visits with OCS and/or antibiotic use (RR = 1.01). The proportion of patients diagnosed with pneumonia during the post-index period was similar for patients in each group (BFC = 17.3%, FSC = 19.0%, odds ratio = 0.92 [0.81,1.04], p = 0.19), and no difference was detected for pneumonia-related healthcare utilization by place of service. CONCLUSION: This study demonstrated no difference in COPD-related exacerbations or pneumonia events between BFC and FSC treatment groups for patients new to ICS/LABA treatment in a real-world setting. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT01921127

Outcomes post fragility fracture among members of an integrated healthcare organization.

This study highlights an unmet need in osteoporosis management, suggesting that beyond bone mineral density and fracture history, gender, fracture type, and age should be considered for fracture risk assessment. Following fragility fracture, men, patients with a spine or hip fracture, and those aged ≥ 65 have a higher disease burden.IntroductionThe objective of this study was to characterize osteoporosis-related fracture incidence and identify predictors of subsequent fractures and mortality.MethodsThis retrospective cohort study, conducted within Kaiser Permanente Southern California, included patients aged ≥ 50 years with qualifying fractures from 1/1/2007 to 12/31/2016, identified from diagnosis/procedure codes. Rates for fracture incidence, mortality, and resource utilization in the year post-fracture are reported. Associations between index fracture types and demographic/clinical characteristics, and mortality, subsequent fracture, and rehospitalization outcomes were estimated.ResultsOf 63,755 eligible patients, 66.7% were ≥ 65 years and 69.1% female. Index fractures included nonhip/nonspine (64.4%), hip (25.3%), and spine (10.3%). Age-adjusted subsequent fracture rate/100 person-years was higher for those with an index spine (14.5) versus hip fracture (6.3). Hospitalization rate/100 person-years was highest for patients ≥ 65 (31.8) and for spine fractures (43.5). Men (vs women) had higher age-adjusted rates of hospitalization (19.4; 17.7), emergency room visits (73.8; 66.3), and use of rehabilitation services (31.7; 27.2). The 30-day age-adjusted mortality rate/100 person-years was 46.7, 32.4, and 15.5 for spine, hip, and nonspine/nonhip fractures. The 1-year age-adjusted mortality rate/100 person-years was 14.7 for spine and 15.6 for hip fractures. In multivariable analyses, spine and hip fractures (vs nonhip/nonspine fractures) were significant predictors of 1-year mortality, all-cause and osteoporosis-related hospitalization, and nursing home use (all P-values < 0.0001).ConclusionMorbidity is high in the year following a fragility fracture and men, patients with a spine or hip fracture, and those aged ≥ 65 have a greater disease burden

Discontinuation of Biologic Therapy in Rheumatoid Arthritis: Analysis from the Corrona RA Registry

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