Efficacy and Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children on Antibiotics (PLAY ON).

Context: Probiotics are live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. One of the most common indications for probiotic treatment is the prevention of antibiotic-associated diarrhea (AAD). Unfortunately, many probiotic products used for AAD are not supported by rigorous independent research, and often results in non-evidence-based usage. The overarching objective is to move research forward for the most well-studied Bifidobacterium strain. Objectives: The primary aim is to test the efficacy of high dose, BB-12-supplemented yogurt in preventing AAD, compared to yogurt without BB-12, in children receiving antibiotics. Other aims are to further assess the safety of yogurt supplemented with BB-12, and to carry out longitudinal community structure and gene expression analysis of fecal microbiota to evaluate the impact of high dose BB-12 in a pediatric population receiving antibiotics. The microbiota includes hundreds of species, and its disruption is hypothesized to be an important factor in the development of AAD. AIM 1: To test the efficacy of high dose, BB-12-supplemented yogurt in preventing AAD, compared to yogurt without BB-12, in children receiving antibiotics. Hypothesis: Children receiving antibiotics who receive the yogurt with BB-12 will demonstrate less diarrhea than those receiving a control yogurt without BB-12. This is a Phase II trial that requires additional safety evaluation of high dose BB-12. Hypotheses 3: Administration of antibiotics will alter the composition and gene expression profile of the gut microbiota in pediatric patients, and concomitant ingestion of BB-12 in yogurt will mitigate the antibiotic-induced disturbance in the gut microbiota, as identified using 16S rRNA and metatranscriptomic profiling. Study Design and Analysis: We will finish in the June 2023 a Phase II, randomized, doubleblinded controlled trial with allocation concealment. Setting: Capital Areal Primary Care Practice Based Research Network. Population Studied: 270 patients, ages 3-12 years, clinically diagnosed with a respiratory infection requiring 7-10 days of antibiotics. Interventions: The two arms are, BB-12-supplemented yogurt and non-supplemented control yogurt, in a 1:1 randomized allocation. Participants of all ages will be asked to consume the same dose, 100 ml, of product per day. The 100 ml serving of probiotic yogurt will deliver ≥1010 CFU of BB-12. The BB-12 probiotic was not be added.

Variations of pain medication use for patients with acute extremity pain in an emergency department: A quality improvement project.

OBJECTIVE: The opioid epidemic continues to take over 50,000 lives annually. At least 75 percent of patients present to an emergency department (ED) for pain. The objective of this study is to describe the characteristic(s) for receiving opioid, non-opioid, and combination analgesics in an ED for acute extremity pain. METHODS: A single-site, retrospective chart audit was conducted at a community-based teaching hospital. Patients ≥ 18 years old who were discharged from the ED with acute extremity pain and received at least one analgesic were included. Primary goal included determining characteristics associated with the prescribing of analgesics. Secondary goals included amount of pain score reduction, frequency of prescribing, and discharge prescription patterns among each group. Analyses consisted of univariate and multivariate general linear models analyses. RESULTS: There were 878 patients identified as having acute extremity pain between February and April 2019. A total of 335 patients met inclusion criteria and were separated into three groups: nonopioids (n = 200), opioids (n = 97), and combination analgesics (n = 38). The individual characteristics showing statistical differences (p < 0.05) between the groups were (1) an allergy to specific analgesics, (2) diastolic blood pressure > 90 mmHg, (3) heart rate > 100 bpm, (4) opioid use prior to ED admission, (5) prescriber level, and (6) discharge diagnosis. Multivariate analyses showed combination therapy (regardless of which two analgesics were administered) had a significant difference in mean pain score reduction compared to nonopioids (p < 0.05). CONCLUSION: There are patient, prescriber, and environment-specific characteristics that are associated with analgesic selection in an ED. Combination therapy had the greatest reduction in pain regardless of the two medications received.

Treatment of Acute Bronchitis and its Impact on Return Emergency Department Visits.

BACKGROUND: Antibiotics are not recommended in healthy, uncomplicated adults for the treatment of acute bronchitis, yet are still often prescribed. No randomized studies have examined whether prescribing antibiotics in the emergency department (ED) impacts hospital return rates. OBJECTIVE: Our aim was to compare hospital return rates between those who were prescribed an antibiotic vs. those who were not prescribed an antibiotic for the treatment of acute bronchitis. METHODS: A retrospective cohort study was completed evaluating patients aged 18-64 years who presented to a community teaching hospital ED with acute bronchitis between January 2017 and December 2019. The primary outcomes were 30-day ED return and hospital admissions from initial ED visit. The rates of ED return or readmitted were compared for patients prescribed an antibiotic for treatment of acute bronchitis vs. those patients who were not prescribed an antibiotic. RESULTS: Of the 752 patients included, 311 (41%) were prescribed antibiotics. Baseline demographics were similar between both groups. Of those prescribed an antibiotic, 26 of 311 (8.4%) returned to the hospital within 30 days compared with 33 of 441 patients (7.5%) who were not prescribed an antibiotic (odds ratio 1.13; 95% confidence interval 0.66-1.92). CONCLUSIONS: There was no association found between antibiotic therapy for treatment of acute bronchitis and return to the hospital.

Resident Remediation in Family Medicine Residency Programs: A CERA Survey of Program Directors.

BACKGROUND AND OBJECTIVES: Identifying underperforming residents and helping them become fully competent physicians is an important faculty responsibility. The process to identify and remediate these learners varies greatly between programs. The objective of this study was to evaluate the remediation landscape in family medicine residency programs by investigating resident remediation characteristics, tools to improve the process, and remediation challenges. METHODS: This study analyzed responses from the Council of Academic Family Medicine Educational Research Alliance (CERA) national survey of family medicine program directors in 2017. Survey questions included topics on faculty remediation training, remediation prevalence, tools for remediation, and barriers to remediation. RESULTS: Two hundred sixty-seven of 503 program directors completed our survey (53% response rate). Most residency programs (245/264, 93%) had at least one resident undergoing remediation in the last 3 years. A majority (242/265, 91%) of residents undergoing remediation were successful within 12 months. The three most important tools to improve remediation were an accessible remediation toolkit (50%), formal remediation recommendations from national family medicine organizations (20%), and on-site faculty development and training (19%). The top-two challenges to the remediation process were a lack of documented evaluations to trigger remediation and a lack of faculty knowledge and skills with effective remediation strategies. CONCLUSIONS: Residents needing remediation are common, but most were successfully remediated within 12 months. Program directors wanted access to a standardized toolkit to help guide the remediation process.

Safety and efficacy of direct oral anticoagulants across body mass index groups in patients with venous thromboembolism: a retrospective cohort design.

Current literature on the safety and efficacy of direct oral anticoagulants (DOACs) in patients of extreme weights are limited, however, they are still being prescribed in these populations. The objective of this study is to describe the safety and efficacy of DOAC therapy in patients of extreme weights for the treatment of venous thromboembolism (VTE) using body mass index (BMI) groups. A multi-site, retrospective cohort design at four hospitals was performed. Patients who experienced an initial VTE between November 2012 and August 2017 and placed on a DOAC were included. Patients were defined as: extremely obese (EO) if BMI ≥ 40 kg/m2, obese if BMI 30-39.9 kg/m2, normal/overweight if BMI 18.5-29.9 kg/m2, and underweight if BMI < 18.5 kg/m2. The primary efficacy outcome of recurrent VTE and primary safety outcome of major bleeding (MB) within 12 months were compared between weights. Univariate statistical tests and multivariate logistic regression analyses were performed. Rates of recurrent VTE showed no significant differences (p = 0.58) across groups; 7.8% (11/142) EO, 4.7% (18/383) obese, 5.2% (27/517) normal/overweight, and 5.9% (1/17) underweight. Proportions of MB were overall significantly different (p = 0.026); 6.3% (9/142) EO, 10.4% (40/383) obese, 10.1% (52/517) normal/overweight, and 29.4% (5/17) underweight. EO and obese patients had similar odds of MB compared to normal/overweight (OR 0.61, 95% CI [0.29, 1.26] and OR 1.04, 95% CI [0.67, 1.61]). Underweight patients showed larger odds of MB compared to normal/overweight (OR 3.73, 95% CI [1.26, 11.0]). This study found that recurrence of VTE was not associated with BMI. However, the proportions of major bleeding were statistically different among the BMI categories.

Predictors of Insufficient Preconception Multivitamin Use: An IMPLICIT Network Study.

INTRODUCTION: Adequate maternal nutrition before pregnancy is important to reduce the risk of poor birth outcomes. However, patients report suboptimal intake of multivitamins with folic acid (MVIs). METHODS: We conducted a quality improvement study to identify predictors of insufficient multivitamin use in women of childbearing age at five University of Pittsburgh Medical Center (UPMC) family health centers that implemented the IMPLICIT interconception care (ICC) model of maternal health screenings during well-child visits (WCVs). We derived this analysis from a retrospective chart review of patient-reported demographic information and physician documented maternal behaviors of 758 women who accompanied their children to 2,706 total well-child visits. Insufficient multivitamin use was defined as having one or more visits where the mother reported that she was not taking multivitamins. RESULTS: Insufficient multivitamin use at these health centers was associated with younger age (OR 0.96, 95% CI 0.92, 0.98), less than high school education (OR 3.3, 95% CI 1.56-6.80), public insurance (OR 1.56, 95% CI 1.05-2.34), and increased number of well-child visits attended (OR 1.46, 95% CI 1.31-1.61). CONCLUSION: Among women who received screening, younger, low-income, and less educated women are likely to benefit from targeted interventions to improve multivitamin use during the interconception period. Findings also suggest that WCVs are a viable access point to assess and address multivitamin use and other desired maternal health behaviors.

Soft-bottom community responses in a marine area influenced by recurrent dumping activities and freshwater discharges.

The results of a 3 years monitoring program to assess the effects associated with recurrent dredged spoil disposal activity in a naturally stressed subtidal coastal area subjected to estuarine inputs are described. Changes observed through time in environmental and anthropogenic variables have been analyzed using cumulated sums and compared to macrobenthic community structure. Results revealed a scarce impact of the recurrent dumping activities, with faunal assemblages derived from the main "Tellina-venus community". The magnitude of estuarine influence appeared indeed greater on the soft-bottom community than the putative changes due to anthropogenic activities. Through a combination of high energetic conditions, structural changes were observed and ascribed to a flushing action of the highly channeled estuary. Finally, an exceptional flood was recorded over the monitoring period, resulting in a short-term spatial homogenization of the benthic community with an abundance burst of A. alba. Origins of this main new species are discussed.

Improving Pain Reassessment and Documentation Rates: A Quality Improvement Project in a Teaching Hospital's Emergency Department.

INTRODUCTION: ED pain score reassessment and documentation rates were drastically low according to sampled data from the St. Margaret Hospital Emergency Department, leading to difficult pain management encounters for clinicians. The purpose of this project was to improve pain score reassessment rates in ED patients who were discharged with extremity pain. METHODS: This project was an 8-month, pre-postinterventional (preintervention: September-November 2018, intervention: December 2018-January 2019, and postintervention: February-April 2019) quality improvement project that took place in a community hospital emergency department. Emergency nurses participated in 6 focus groups, allowing for the creation of focus group-themed interventions at the request of the nursing staff. Daily audits of pain reassessment and documentation rates for individual nurses took place during the month of January 2019. In addition, a weekly newsletter was created and reported the ED pain reassessment and documentation rates. RESULTS: All patient encounters (581) were reviewed over the 8-month period. Baseline pain score reassessment and documentation rates were 36.2% (confidence interval, 30.3%-42.3%) in the emergency department. Pain reassessment and documentation rates increased to 62.3% (confidence interval, 56.8%-67.6%) during the 3-month postintervention period. DISCUSSION: Implementing daily audits and weekly newsletters that created transparency of individual and group performances increased pain score reassessment and documentation rates.

Spatially balanced sampling designs for environmental surveys.

Some environmental studies use non-probabilistic sampling designs to draw samples from spatially distributed populations. Unfortunately, these samples can be difficult to analyse statistically and can give biased estimates of population characteristics. Spatially balanced sampling designs are probabilistic designs that spread the sampling effort evenly over the resource. These designs are particularly useful for environmental sampling because they produce good-sample coverage over the resource, they have precise design-based estimators and they can potentially reduce the sampling cost. The most popular spatially balanced design is Generalized Random Tessellation Stratified (GRTS), which has many desirable features including a spatially balanced sample, design-based estimators and the ability to select spatially balanced oversamples. This article considers the popularity of spatially balanced sampling, reviews several spatially balanced sampling designs and shows how these designs can be implemented in the statistical programming language R. We hope to increase the visibility of spatially balanced sampling and encourage environmental scientists to use these designs.

Impact of Electronic Physician Order-Set on Antibiotic Ordering Time in Septic Patients in the Emergency Department.

BACKGROUND: Sepsis is a serious medical condition that can lead to organ dysfunction and death. Research shows that each hour delay in antibiotic administration increases mortality. The Surviving Sepsis Campaign Bundles created standards to assist in the timely treatment of patients with suspected sepsis to improve outcomes and reduce mortality. OBJECTIVE: This article determines if the use of an electronic physician order-set decreases time to antibiotic ordering for patients with sepsis in the emergency department (ED). METHODS: A retrospective chart review was performed on adult patients who presented to the ED of four community hospitals from May to July 2016. Patients with severe sepsis and/or septic shock were included. Primary outcome was the difference in time to antibiotic ordering in patients whose physicians utilized the order-set versus those whose physicians did not. Secondary outcomes included differences in time to antibiotic administration, time to lactate test, hospital length of stay, and posthospitalization disposition. The institution's Quality Improvement Committee approved the project. RESULTS: Forty-five of 123 patients (36.6%) with sepsis had physicians who used the order-set. Order-set utilization reduced the mean time to ordering antibiotics by 20 minutes (99 minutes, 95% confidence interval [CI]: 69-128 vs. 119 minutes, 95% CI: 91-147), but this finding was not statistically significant. Mean time to antibiotic administration (145 minutes, 95% CI: 108-181 vs. 182 minutes, 95% CI: 125-239) and median time to lactate tests (12 minutes, 95% CI: 0-20 vs. 19 minutes, 95% CI: 8-34), although in the direction of the hypotheses, were not significantly different. CONCLUSION: Utilization of the order-set was associated with a potentially clinically significant, but not statistically significant, reduced time to antibiotic ordering in patients with sepsis. Electronic order-sets are a promising tool to assist hospitals with meeting the Centers for Medicare and Medicaid Services core measure.

A cost-minimization analysis of dalbavancin compared to conventional therapy for the outpatient treatment of acute bacterial skin and skin-structure infections.

INTRODUCTION: Acute bacterial skin and skin-structure infections (ABSSSI) are common infectious diseases (ID) that often require intravenous (IV) antibiotics. Dalbavancin is a novel lipoglycopeptide antibiotic administered once that is FDA-approved for the treatment of ABSSSI. No literature is available for real-world cost-comparability relative to conventional therapy. METHODS: This retrospective chart review examined adults diagnosed with ABSSSI and treated with IV antibiotics at an outpatient ID clinic after hospital discharge from January 2015 to August 2016. Patients received either dalbavancin or conventional therapy. In-hospital baseline demographics as well as outpatient clinical variables and outcomes were assessed. The primary outcome was the total ID-related cost of care per patient. A Monte Carlo probalistic sensitivity analysis was conducted. RESULTS: One hundred and fifty-eight patients were included: 64 received dalbavancin and 94 received conventional therapy. The total ID-related cost of care per patient was greater with dalbavancin (mean $4,561) vs conventional (mean $1,668), p < 0.01. In the subset of patients treated with daptomycin, the total ID-related cost (mean $5,218) was comparable to dalbavancin (mean $4,561). CONCLUSIONS: Dalbavancin was more costly than conventional therapy for the outpatient treatment of ABSSSI. This greater overall cost was likely driven by the higher acquisition cost of dalbavancin. Dalbavancin may be comparable to the daily use of daptomycin for ABSSSI.

Comparison of haloperidol, non-haloperidol antipsychotics, and no pharmacotherapy for the management of delirium in an inpatient geriatric palliative care population.

Antipsychotics are frequently used for treatment of delirium, although little evidence exists that they improve delirium outcomes. Our objective was to evaluate haloperidol (HAL) compared to non-haloperidol antipsychotics (NHAP) or no pharmacologic treatment (NP) in the management of delirium in older adults under the care of a palliative care consult service across a large, integrated health care system. A retrospective chart review examined data from September 2014-September 2015. All hospitalized patients ≥65 years old with a diagnosis of delirium during palliative care consultation were included (n = 304). Primary outcome was length of stay after delirium diagnosis. Secondary outcomes included delirium symptom length, sedation, and QTc prolongation. Univariate statistical tests, analysis of covariance, and multiple regression methods were used to compare groups. Post-delirium length of stay in the HAL, NHAP, and NP groups were 8.5, 7.0, and 6.8 days, respectively (p = 0.19). Delirium duration in the HAL, NHAP, and NP groups were 6.7, 6.0, and 4.9 days, respectively (p = 0.05). Safety outcomes were statistically different than the reference group (NHAP). Congruent with existing literature in other generalized patient populations, no significant difference in post-delirium length of stay existed in geriatric, palliative care population.

Evidence-based HMO care for prostate specific antigen testing.

BACKGROUND: There is pressure in the U.S. system to move away from fee-for-service models to a more pre-paid system, which may result in decreased costs, but the impact on evidence-based care is unclear. We examined a large pre-paid Health Maintenance Organizations (HMO) in Israel to see if evidence-based guidelines are followed for prostate specific antigen (PSA) testing. METHODS: A retrospective cohort of ambulatory visits from 2002 to 2011 of patients age >75 receiving care from Clalit Health Services was conducted. Historically reported U.S. cohorts were used for comparison. The main measure was the percent of patients who had at least one PSA after age 75. RESULTS: In each of the 10 years of follow-up, 22% of the yearly Israeli cohort, with no known malignancy or benign prostatic hyperplasia, had at least one PSA, while for the total 10 years, 30% of the men had at least one PSA. These rates are considerably lower than previously reported U.S. rates. CONCLUSIONS: In a pre-paid system in which physicians have no incentive to order tests, they appear to order PSA tests at a lower rate than has been observed in the U.S. system. Additional quality of measures should continue to be examined as the U.S. shifts away from a fee-for-service model. Copyright © 2016 John Wiley & Sons, Ltd.

Lactobacillus reuteri to Treat Infant Colic: A Meta-analysis.

CONTEXT: Lactobacillus reuteri DSM17938 has shown promise in managing colic, but conflicting study results have prevented a consensus on whether it is truly effective. OBJECTIVE: Through an individual participant data meta-analysis, we sought to definitively determine if L reuteri DSM17938 effectively reduces crying and/or fussing time in infants with colic and whether effects vary by feeding type. DATA SOURCES: We searched online databases (PubMed, Medline, Embase, the Cumulative Index to Nursing and Allied Health Literature, the Database of Abstracts of Reviews of Effects, and Cochrane), e-abstracts, and clinical trial registries. STUDY SELECTION: These were double-blind randomized controlled trials (published by June 2017) of L reuteri DSM17398 versus a placebo, delivered orally to infants with colic, with outcomes of infant crying and/or fussing duration and treatment success at 21 days. DATA EXTRACTION: We collected individual participant raw data from included studies modeled simultaneously in multilevel generalized linear mixed-effects regression models. RESULTS: Four double-blind trials involving 345 infants with colic (174 probiotic and 171 placebo) were included. The probiotic group averaged less crying and/or fussing time than the placebo group at all time points (day 21 adjusted mean difference in change from baseline [minutes] -25.4 [95% confidence interval (CI): -47.3 to -3.5]). The probiotic group was almost twice as likely as the placebo group to experience treatment success at all time points (day 21 adjusted incidence ratio 1.7 [95% CI: 1.4 to 2.2]). Intervention effects were dramatic in breastfed infants (number needed to treat for day 21 success 2.6 [95% CI: 2.0 to 3.6]) but were insignificant in formula-fed infants. LIMITATIONS: There were insufficient data to make conclusions for formula-fed infants with colic. CONCLUSIONS: L reuteri DSM17938 is effective and can be recommended for breastfed infants with colic. Its role in formula-fed infants with colic needs further research.

Developing a Clinician Friendly Tool to Identify Useful Clinical Practice Guidelines: G-TRUST.

BACKGROUND: Clinicians are faced with a plethora of guidelines. To rate guidelines, they can select from a number of evaluation tools, most of which are long and difficult to apply. The goal of this project was to develop a simple, easy-to-use checklist for clinicians to use to identify trustworthy, relevant, and useful practice guidelines, the Guideline Trustworthiness, Relevance, and Utility Scoring Tool (G-TRUST). METHODS: A modified Delphi process was used to obtain consensus of experts and guideline developers regarding a checklist of items and their relative impact on guideline quality. We conducted 4 rounds of sampling to refine wording, add and subtract items, and develop a scoring system. Multiple attribute utility analysis was used to develop a weighted utility score for each item to determine scoring. RESULTS: Twenty-two experts in evidence-based medicine, 17 developers of high-quality guidelines, and 1 consumer representative participated. In rounds 1 and 2, items were rewritten or dropped, and 2 items were added. In round 3, weighted scores were calculated from rankings and relative weights assigned by the expert panel. In the last round, more than 75% of experts indicated 3 of the 8 checklist items to be major indicators of guideline usefulness and, using the AGREE tool as a reference standard, a scoring system was developed to identify guidelines as useful, may not be useful, and not useful. CONCLUSION: The 8-item G-TRUST is potentially helpful as a tool for clinicians to identify useful guidelines. Further research will focus on its reliability when used by clinicians.

Methodological Standards for Meta-Analyses and Qualitative Systematic Reviews of Cardiac Prevention and Treatment Studies: A Scientific Statement From the American Heart Association.

Meta-analyses are becoming increasingly popular, especially in the fields of cardiovascular disease prevention and treatment. They are often considered to be a reliable source of evidence for making healthcare decisions. Unfortunately, problems among meta-analyses such as the misapplication and misinterpretation of statistical methods and tests are long-standing and widespread. The purposes of this statement are to review key steps in the development of a meta-analysis and to provide recommendations that will be useful for carrying out meta-analyses and for readers and journal editors, who must interpret the findings and gauge methodological quality. To make the statement practical and accessible, detailed descriptions of statistical methods have been omitted. Based on a survey of cardiovascular meta-analyses, published literature on methodology, expert consultation, and consensus among the writing group, key recommendations are provided. Recommendations reinforce several current practices, including protocol registration; comprehensive search strategies; methods for data extraction and abstraction; methods for identifying, measuring, and dealing with heterogeneity; and statistical methods for pooling results. Other practices should be discontinued, including the use of levels of evidence and evidence hierarchies to gauge the value and impact of different study designs (including meta-analyses) and the use of structured tools to assess the quality of studies to be included in a meta-analysis. We also recommend choosing a pooling model for conventional meta-analyses (fixed effect or random effects) on the basis of clinical and methodological similarities among studies to be included, rather than the results of a test for statistical heterogeneity.

FitwitsTM Leads to Improved Parental Recognition of Childhood Obesity and Plans to Encourage Change.

INTRODUCTION: Brief tools are needed to help physicians and parents reach consensus on body mass index (BMI) categories for children and to discuss health-improving behaviors. This study tested the FitwitsTM intervention with interactive flashcards and before and- after surveys to improve parents' perceptions of children's BMI status. METHODS: We enrolled 140 parents and their 9- to 12-year-old children presenting for well child care, regardless of BMI status, scheduled with 53 Fitwits-trained physicians. The Fitwits tool guided a conversation with all parent-child dyads regarding understanding BMI, nutrition, activity, and portion sizes. A survey addressed BMI category perceptions before and after the intervention, requested 2 goal selections, and included open-ended comment areas. RESULTS: Fifty-three percent of children were overweight or obese. The primary outcome variable was the rate of correct parental identification of their child's weight status (underweight, healthy, overweight, or obese). The survey before the intervention resulted in 50.0% correct BMI category designations. This changed to 60.6% correct perceptions after the intervention, with movement between correct overweight (34.5% to 51.7%) and obese (4.4% to 24.4%) categories. Secondary outcome variables included specific behavior change goals and the qualitative responses of parents, children, and physicians to the intervention. Parent-child dyads predominantly commented favorably and chose (75.8%) goals corresponding to Fitwits card suggestions. CONCLUSIONS: An improvement was observed in parental ability to identify the correct BMI category after the intervention during a preadolescent well child visit. Parent underrecognition of overweight/obese children was also observed. Most parent comments were appreciative of the physician interaction, Fitwits flashcards, and health improvement exchange.

Training Family Medicine Residents to Perform Home Visits: A CERA Survey.

BACKGROUND: Home visits have been shown to improve quality of care, save money, and improve outcomes. Primary care physicians are in an ideal position to provide these visits; of note, the Accreditation Council for Graduate Medical Education no longer requires home visits as a component of family medicine residency training. OBJECTIVE: To investigate changes in home visit numbers and expectations, attitudes, and approaches to training among family medicine residency program directors. METHODS: This research used the Council of Academic Family Medicine Educational Research Alliance (CERA) national survey of family medicine program directors in 2015. Questions addressed home visit practices, teaching and evaluation methods, common types of patient and visit categories, and barriers. RESULTS: There were 252 responses from 455 possible respondents, representing a response rate of 55%. At most programs, residents performed 2 to 5 home visits by graduation in both 2014 (69% of programs, 174 of 252) and 2015 (68%, 172 of 252). The vast majority (68%, 172 of 252) of program directors expect less than one-third of their graduates to provide home visits after graduation. Scheduling difficulties, lack of faculty time, and lack of resident time were the top 3 barriers to residents performing home visits. CONCLUSIONS: There appeared to be no decline in resident-performed home visits in family medicine residencies 1 year after they were no longer required. Family medicine program directors may recognize the value of home visits despite a lack of few formal curricula.

Safety of Bifidobacterium animalis Subsp. Lactis (B. lactis) Strain BB-12-Supplemented Yogurt in Healthy Children.

OBJECTIVES: Probiotics are live microorganisms that may provide health benefits to the individual when consumed in sufficient quantities. For studies conducted on health or disease endpoints on probiotics in the United States, the Food and Administration has required those studies to be conducted as investigational new drugs. This phase I, double-blinded, randomized, controlled safety study represents the first requirement of this pathway. The purpose of the study was to determine the safety of Bifidobacterium animalis subsp. lactis (B lactis) strain BB-12 (BB-12)-supplemented yogurt when consumed by a generally healthy group of children. The secondary aim was to assess the effect of BB-12-supplemented yogurt on the gut microbiota of the children. METHODS: Sixty children ages 1 to 5 years were randomly assigned to consume 4 ounces of either BB-12-supplemented yogurt or nonsupplemented control yogurt daily for 10 days. The primary outcome was to assess safety and tolerability, as determined by the number of reported adverse events. RESULTS: A total of 186 nonserious adverse events were reported, with no significant differences between the control and BB-12 groups. No significant changes due to probiotic treatment were observed in the gut microbiota of the study cohort. CONCLUSIONS: BB-12-supplemented yogurt is safe and well-tolerated when consumed by healthy children. The present study will form the basis for future randomized clinical trials investigating the potential effects of BB-12-supplemented yogurt in different disease states.

Melatonin-micronutrients Osteopenia Treatment Study (MOTS): a translational study assessing melatonin, strontium (citrate), vitamin D3 and vitamin K2 (MK7) on bone density, bone marker turnover and health related quality of life in postmenopausal osteopenic women following a one-year double-blind RCT and on osteoblast-osteoclast co-cultures.

This one-year double blind randomized control trial assessed the effects of nightly melatonin, strontium (citrate), vitamin D3 and vitamin K2 (MK7; MSDK) on bone mineral density (BMD) and quality of life (QOL) in postmenopausal osteopenic women (ages 49-75). Compared to placebo, MSDK treatment increased BMD in lumbar spine (4.3%) and left femoral neck (2.2%), with an upward trend for total left hip (p=0.069). MSDK increased serum P1NP levels and reduced bone turnover (CTx:P1NP). Psychometric analyses indicated that mood and sleep quality improved for the MSDK group. MSDK-exposed human mesenchymal stem cells (hMSCs) and human peripheral blood monocytes (hPBMCs) plated in transwells or layered demonstrated increases in osteoblastogenesis, decreases in osteoclastogenesis, increases in OPG (TNFRSF11B) and decreases in RANKL (TNFSF11) levels. In transwell osteoblasts, MSDK increased pERK1/2 (MAPK1/MAPK3) and RUNX2 levels; decreased ERK5 (MAPK7); and did not affect the expression of NFκB (NFKB1) and ß1integrin (ITGB1). In layered osteoblasts, MSDK also decreased expression of the metabolic proteins PPARγ (PPARG) and GLUT4 (SLC2A4). In adipose-derived human MSCs, MSDK induced osteoblastogenesis. These findings provide both clinical and mechanistic support for the use of MSDK for the prevention or treatment of osteopenia, osteoporosis or other bone-related diseases.