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.

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.

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.

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.

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.

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.

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.

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.

Short-term, daily intake of yogurt containing Bifidobacterium animalis ssp. lactis Bf-6 (LMG 24384) does not affect colonic transit time in women.

The present study investigated the effect of Bifidobacterium animalis ssp. lactis Bf-6 (LMG 24 384) (Bf-6)-supplemented yogurt on colonic transit time (CTT). A triple-blinded, randomised, placebo-controlled, two-period cross-over trial was conducted with sixty-eight women with a self-reported history of straining during bowel movements or hard or lumpy stools in the past 2 years. As per regulatory requirements for probiotic studies, eligible women were generally healthy and not actively constipated at the time of enrolment. Participants consumed both Bf-6 and placebo yogurts for 14 d each in a randomised order, with a 6-week washout period between the treatments. The primary outcome, CTT, was assessed via Sitz marker X-rays. The average CTT was 42·1 h for the active period and 43·3 h for the control period (mean difference 1·2 h, 95 % CI - 4·9, 7·4). Since the statistical tests for the cross-over study implied that the mean CTT for the active and control periods in period 2 were biased, the standard protocol suggests examining the results of only period 1 as a traditional randomised controlled trial. This showed that the mean CTT was 35·2 h for the active period v. 52·9 h for the control period (P= 0·015). Bootstrapping demonstrated that both the mean and median differences remained significant (P= 0·016 and P= 0·045, respectively). Few adverse events were noted, with no differences among the active and control periods. The paired analysis showed no differences between the active and control periods during the cross-over trial. Further trials should be conducted in populations with underlying problems associated with disordered transit to determine the potential value of probiotic supplementation more accurately.

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.

Melatonin osteoporosis prevention study (MOPS): a randomized, double-blind, placebo-controlled study examining the effects of melatonin on bone health and quality of life in perimenopausal women.

The purpose of this double-blind study was to assess the effects of nightly melatonin supplementation on bone health and quality of life in perimenopausal women. A total of 18 women (ages 45-54) were randomized to receive melatonin (3mg, p.o., n=13) or placebo (n=5) nightly for 6months. Bone density was measured by calcaneal ultrasound. Bone turnover marker (osteocalcin, OC for bone formation and NTX for bone resorption) levels were measured bimonthly in serum. Participants completed Menopause-Specific Quality of Life-Intervention (MENQOL) and Pittsburgh Sleep Quality Index (PSQI) questionnaires before and after treatment. Subjects also kept daily diaries recording menstrual cycling, well-being, and sleep patterns. The results from this study showed no significant change (6-month-baseline) in bone density, NTX, or OC between groups; however, the ratio of NTX:OC trended downward over time toward a ratio of 1:1 in the melatonin group. Melatonin had no effect on vasomotor, psychosocial, or sexual MENQOL domain scores; however, it did improve physical domain scores compared to placebo (mean change melatonin: -0.6 versus placebo: 0.1, P<0.05). Menstrual cycling was reduced in women taking melatonin (mean cycles melatonin: 4.3 versus placebo: 6.5, P<0.05), and days between cycles were longer (mean days melatonin: 51.2 versus placebo: 24.1, P<0.05). No differences in duration of menses occurred between groups. The overall PSQI score and average number of hours slept were similar between groups. These findings show that melatonin supplementation was well tolerated, improved physical symptoms associated with perimenopause, and may restore imbalances in bone remodeling to prevent bone loss. Further investigation is warranted.

Lifestyle characteristics assessment of Japanese in Pittsburgh, USA.

Lifestyle-related chronic diseases such as cancer and cardiovascular disease are the greatest public health concerns. Evidence shows Japanese immigrants to a westernized environment have higher incidence of lifestyle-related diseases. However, little is known about lifestyle characteristics related to chronic diseases for Japanese in a westernized environment. This study is examining the gap in lifestyle by comparing the lifestyle prevalence for Japanese in the US with the Japanese National Data (the National Health and Nutrition Survey in Japan, J-NHANS) as well as the Japan National Health Promotion in the twenty-first Century (HJ21) goals. Japanese adults were surveyed in Pittsburgh, USA, regarding their lifestyle (e.g., diet, exercise, smoking, stress, alcohol, and oral hygiene). The prevalence was compared with J-NHANS and HJ21 goals. Ninety-three responded (response rate; 97.9%). Japanese men (n = 38) and women (n = 55) in Pittsburgh smoke less than Japanese in Japan (P < 0.001 for both genders). Japanese in Pittsburgh perform less physical activity in daily life and have lower prevalence of walking more than 1 h per day (P < 0.001 for both genders). Japanese women in Pittsburgh have significantly higher prevalence of stress than in Japan (P = 0.004). Japanese men in Pittsburgh do not reach HJ21 goal in weight management, BMI, use of medicine or alcohol to sleep, and sleep quality. Japanese women in Pittsburgh do not reach HJ21 goal in weight management and sleep quality. In conclusion, healthy lifestyle promotion including exercise and physical activity intervention for Japanese living in a westernized environment is warranted.

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.

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.

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.

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.

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.