Search

Abstract Background While the Affordable Care Act’s Medicaid expansion improved healthcare coverage and access for millions of uninsured Americans, less is known about its effects on the overall accessibility and quality of care across all payers. Rapid volume increases of newly enrolled Medicaid patients might have unintentionally strained accessibility or quality of care. We assessed changes in physician office visits and high- and low-value care associated with Medicaid expansion across all payers. Methods Prespecified, quasi-experimental, difference-in-differences analysis pre and post Medicaid expansion (2012–2015) in 8 states that did and 5 that did not choose to expand Medicaid. Physician office visits sampled from the National Ambulatory Medical Care Survey, standardized with U.S. Census population estimates. Outcomes included visit rates per state population and rates of high or low-value service composites of 10 high-value measures and 7 low-value care measures respectively, stratified by year and insurance. Results We identified approximately 143 million adults utilizing 1.9 billion visits (mean age 56; 60% female) during 2012–2015. Medicaid visits increased in expansion states post-expansion compared to non-expansion states by 16.2 per 100 adults (p = 0.031 95% CI 1.5–31.0). New Medicaid visits increased by 3.1 per 100 adults (95% CI 0.9–5.3, p = 0.007). No changes were observed in Medicare or commercially-insured visit rates. High or low-value care did not change for any insurance type, except high-value care during new Medicaid visits, which increased by 4.3 services per 100 adults (95% CI 1.1–7.5, p = 0.009). Conclusions Following Medicaid expansion, the U.S. healthcare system increased access to care and use of high-value services for millions of Medicaid enrollees, without observable reductions in access or quality for those enrolled in other insurance types. Provision of low-value care continued at similar rates post-expansion, informing future federal policies designed to improve the value of care.

Objectives Low-value esophagogastroduodenoscopies (EGDs) for uncomplicated gastro-oesophageal reflux disease (GERD) can harm patients and raise patient and payer costs. We developed an electronic health record (EHR) ‘eMeasure’ to detect low-value EGDs.Design Retrospective cohort of 518 adult patients diagnosed with GERD who underwent initial EGD between 1 January 2019 and 31 December 2019.Setting Outpatient primary care and gastroenterology clinics at a large, urban, academic health centre.Participants Adult primary care patients at the University of California Los Angeles who underwent initial EGD for GERD in 2019.Main outcome measures EGD appropriateness criteria were based on the American College of Gastroenterology 2012 guidelines. An initial EGD was considered low-value if it lacked a documented guideline-based indication, including alarm symptoms (eg, iron-deficiency anaemia); failure of an 8-week proton pump inhibitor trial or elevated Barrett’s oesophagus risk. We performed manual chart review on a random sample of 204 patients as a gold standard of the eMeasure’s validity. We estimated EGD costs using Medicare physician and facility fee rates.Results Among 518 initial EGDs performed (mean age 53 years; 54% female), the eMeasure identified 81 (16%) as low-value. The eMeasure’s sensitivity was 42% (95% CI 22 to 61) and specificity was 93% (95% CI 89 to 96). Stratifying across clinics, 62 (74.6%) low-value EGDs originated from 2 (12.5%) out of 16 clinics. Total cost for 81 low-value EGDs was approximately US$75 573, including US$14 985 in patients’ out-of-pocket costs.Conclusions We developed a highly specific eMeasure that showed that low-value EGDs occurred frequently in our healthcare system and were concentrated in a minority of clinics. These results can inform future QI efforts at our institution, such as best practice alerts for the ordering physician. Moreover, this open-source eMeasure has a much broader potential impact, as it can be integrated into any EHR and improve medical decision-making at the point of care.

Introduction We tested the hypotheses that depression diagnoses influence racial and ethnic disparities in diabetes control and that mental health treatment moderates that relationship.Research design and methods We created a national cohort of Veterans Health Administration (VHA) patients with diabetes using administrative data (n=815 067). Cross-sectional linear mixed effects regression models tested the hypothesized indirect effect of depression on poor diabetes control (glycosylated hemoglobin >9%) and tested whether mental health treatment (visits or antidepressant prescriptions) moderated the effect of depression (α=0.05). Results represent the percentage point difference in probability of poor diabetes control. Covariates included primary care visits, sex, age, and VHA facility.Results Overall, 20% of the cohort had poor diabetes control and 22% had depression. Depression was more common among racial and ethnic minoritized groups. The probability of poor diabetes control was higher for most minoritized groups compared with White patients (largest difference: American Indian or Alaska Native patients, 5.2% (95% CI 4.3%, 6.0%)). The absolute value of the proportion of racial and ethnic disparities accounted for by depression ranged from 0.2% (for Hispanic patients) to 2.0% (for Asian patients), with similar effects when accounting for the moderating effect of mental health treatment. Patients with depression and 5+ mental health visits had a lower probability of poor diabetes control compared with those with fewer visits, regardless of antidepressant prescription status.Conclusions The influence of depression on disparities in diabetes control was small. High rates of depression among people with diabetes, especially among those from racial and ethnic minoritized groups, highlight a need to ensure equitable and coordinated care for both conditions, as the effects of mental health treatment may extend to the control of physical health conditions.

Introduction Smoking remains the leading preventable cause of death in the USA. Low utilisation of treatments for smoking cessation remains a major barrier for reducing smoking rates. Financial incentives represent an innovative approach to increasing use of therapies for smoking cessation. This paper will describe the rationale and design of the Financial Incentives for Smoking Treatment II (FIESTA II) study, a randomised controlled trial to evaluate the effectiveness and feasibility of goal-directed and outcome-based financial incentives to promote smoking cessation among hospitalised smokers.Methods and analysis We are recruiting adult participants who smoked tobacco in the 30 days prior to initial interview and are contemplating quitting smoking. These participants will come from two hospitals in underserved communities in New York City and Los Angeles. They will be randomised into one of three arms. The first arm consists of goal-directed financial incentives plus enhanced usual care, which includes hospital-directed information about quitting smoking, nicotine replacement therapy and referral to a Quitline. The second arm involves outcome-based financial incentives plus enhanced usual care. The third arm consists of enhanced usual care alone. Multiple phone interviews with the participants will be completed after randomisation to assess smoking cessation. Participants will earn $20 for each follow-up interview completed and $30 for each smoking cessation test completed. Those who are randomised to the financial incentive groups can earn an additional $700. The participants in the outcome-based group will receive payments solely for exhibiting cessation, whereas the participants in the goal-based group are also eligible for receiving payments after meeting milestones such as speaking with a helpline coach.Ethics Human research protection committees at New York University School of Medicine and the University of California Los Angeles (UCLA) David Geffen School of Medicine granted ethics approval.Protocol number: IRB#19-000 084.Trial registration number NCT03979885.

BackgroundAlthough suicide is a leading cause of death among children, the optimal approach for using health care data sets to detect suicide-related emergencies among children is not known. ObjectiveThis study aimed to assess the performance of suicide-related International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes and suicide-related chief complaint in detecting self-injurious thoughts and behaviors (SITB) among children compared with clinician chart review. The study also aimed to examine variations in performance by child sociodemographics and type of self-injury, as well as develop machine learning models trained on codified health record data (features) and clinician chart review (gold standard) and test model detection performance. MethodsA gold standard classification of suicide-related emergencies was determined through clinician manual review of clinical notes from 600 emergency department visits between 2015 and 2019 by children aged 10 to 17 years. Visits classified with nonfatal suicide attempt or intentional self-harm using the Centers for Disease Control and Prevention surveillance case definition list of ICD-10-CM codes and suicide-related chief complaint were compared with the gold standard classification. Machine learning classifiers (least absolute shrinkage and selection operator–penalized logistic regression and random forest) were then trained and tested using codified health record data (eg, child sociodemographics, medications, disposition, and laboratory testing) and the gold standard classification. The accuracy, sensitivity, and specificity of each detection approach and relative importance of features were examined. ResultsSITB accounted for 47.3% (284/600) of the visits. Suicide-related diagnostic codes missed nearly one-third (82/284, 28.9%) and suicide-related chief complaints missed more than half (153/284, 53.9%) of the children presenting to emergency departments with SITB. Sensitivity was significantly lower for male children than for female children (0.69, 95% CI 0.61-0.77 vs 0.84, 95% CI 0.78-0.90, respectively) and for preteens compared with adolescents (0.66, 95% CI 0.54-0.78 vs 0.86, 95% CI 0.80-0.92, respectively). Specificity was significantly lower for detecting preparatory acts (0.68, 95% CI 0.64-0.72) and attempts (0.67, 95% CI 0.63-0.71) than for detecting ideation (0.79, 95% CI 0.75-0.82). Machine learning–based models significantly improved the sensitivity of detection compared with suicide-related codes and chief complaint alone. Models considering all 84 features performed similarly to models considering only mental health–related ICD-10-CM codes and chief complaints (34 features) and models considering non–ICD-10-CM code indicators and mental health–related chief complaints (53 features). ConclusionsThe capacity to detect children with SITB may be strengthened by applying a machine learning–based approach to codified health record data. To improve integration between clinical research informatics and child mental health care, future research is needed to evaluate the potential benefits of implementing detection approaches at the point of care and identifying precise targets for suicide prevention interventions in children.

Objective To measure univariate and covariate‐adjusted trends in children's mental health‐related emergency department (MH‐ED) use across geographically diverse areas of the U.S. during the first wave of the Coronavirus‐2019 (COVID‐19) pandemic. Method This is a retrospective, cross‐sectional cohort study using electronic health records from four academic health systems, comparing percent volume change and adjusted risk of child MH‐ED visits among children aged 3–17 years, matched on 36‐week (3/18/19–11/25/19 vs. 3/16/20–11/22/20) and 12‐week seasonal time intervals. Adjusted incidence rate ratios (IRR) were calculated using multivariate Poisson regression. Results Visits declined during spring‐fall 2020 (n = 3892 vs. n = 5228, −25.5%) and during spring (n = 1051 vs. n = 1839, −42.8%), summer (n = 1430 vs. n = 1469, −2.6%), and fall (n = 1411 vs. n = 1920, −26.5%), compared with 2019. There were greater declines among males (28.2% vs. females −22.9%), children 6–12‐year (−28.6% vs. −25.9% for 3–5 years and −22.9% for 13–17 years), and Black children (−34.8% vs. −17.7% to −24.9%). Visits also declined for developmental disorders (−17.0%) and childhood‐onset disorders (e.g., attention deficit and hyperactivity disorders; −18.0%). During summer‐fall 2020, suicide‐related visits rose (summer +29.8%, fall +20.4%), but were not significantly elevated from 2019 when controlling for demographic shifts. In contrast, MH‐ED use during spring‐fall 2020 was significantly reduced for intellectual disabilities (IRR 0.62 [95% CI 0.47–0.86]), developmental disorders (IRR 0.71 [0.54–0.92]), and childhood‐onset disorders (IRR 0.74 [0.56–0.97]). Conclusions The early pandemic brought overall declines in child MH‐ED use alongside co‐occurring demographic and diagnostic shifts. Children vulnerable to missed detection during instructional disruptions experienced disproportionate declines, suggesting need for future longitudinal research in this population.

Aims: The progression of prediabetes to T2DM can be delayed through diet modification and weight management. However, the intensive lifestyle program is often not covered by medical insurance. This retrospective analysis evaluates the association of a patient self-paid weight management program on an improvement of blood sugar in overweight and obese patients with impaired fasting glucose (IFG). Methods: The medical records of 4634 patients who participated in the self-pay UCLA Weight Management Program were reviewed and 2572 patients met the criteria for this retrospective analysis to examine whether this program was associated with the reversal of IFG over 3 months among 1396 patients with normal fasting glucose (NFG) and 1176 with IFG. Results: The patients with IFG lost comparable amounts of weight (10.5 ± 1.3 kg) at three months, as did the subjects with NFG (10.1 ± 1.3 kg). Fasting blood glucose in the IFG group decreased from 108.49 ± 6.4 to 101.8 ± 9.41 mg/dL (p < 0.0001) after three months. There were also significant reductions in triglycerides, and both systolic and diastolic blood pressure in both groups in association with weight loss. Conclusion: Our medically supervised self-pay multidisciplinary weight management program was associated with reduced fasting blood glucose levels in patients with IFG over three months with comparable weight loss to patients with NFG.

Statin medications reduce cardiovascular events, but many patients never start taking their prescribed statin (primary nonadherence). Limited knowledge exists about the attitudes and beliefs of those with primary nonadherence. In this study, patients with primary nonadherence to statin medications (n = 173) completed a self-administered cross-sectional survey that assessed their attitudes and beliefs related to primary nonadherence and to potential motivators for statin use. Patients were recruited in 2019 from two academic health systems and nationwide internet advertisements. Only 49 of 173 (28.3%) patients with primary nonadherence reported having cardiovascular disease (CVD). Ninety-nine patients (57.2%) never filled their prescription, and 74 (42.8%) filled but never took any statin. Over half failed to initially inform their prescriber they might not take the statin. Patients strongly or somewhat agreed that they desired alternate treatment plans such as diet and/or exercise (n = 134; 77.4%) or natural remedies/dietary supplements (n = 125; 72.3%). Ninety-eight (56.6%) stronglyor somewhat worried about the possibility of statin dependence or addiction. Twenty-seven (15.6%) patients noted that they would not take a statin based solely on CVD risk estimates; 50 (28.9%) selected a CVD risk threshold of >20%; and 23 (13.3%) a threshold of >50% as motivating factors to take statins. Patients with primary nonadherence have attitudes about taking statins based on CVD risk that differ from scientific recommendations, may not tell providers about their hesitation to take statins, and likely prefer alternative initial approaches to cholesterol lowering. Early shared decision-making and assessment of patient attitudes about statins could potentially better align initial approaches for CVD risk reduction.

Abstract Objective This study aimed to assess the minimal clinically important differences (MCIDs) for the modified Rodnan skin score (mRSS) using combined data from the Scleroderma Lung Studies (I and II). Methods MCID estimates for the mRSS at 12 months were calculated using three anchors: change in scores on the Health Assessment Questionnaire- Disability Index from baseline to 12 months, change in scores on the Patient Global Assessment from baseline to 12 months, and answer at 12 month for the Short Form-36 health transition question “Compared to one year ago, how would you rate your health in general now?” We determined the mRSS MCID estimates for all participants and for those with diffuse cutaneous systemic sclerosis (dcSSc). We then assessed associations between MCID estimates of mRSS improvement and patient-reported outcomes, using Student’s t test to compare the mean differences in patient outcomes between those who met the MCID improvement criteria versus those who did not meet the improvement criteria. Results The mean (SD) mRSS at baseline was 14.75 (10.72) for all participants and 20.93 (9.61) for those with dcSSc. The MCID estimate for mRSS improvement at 12 months ranged from 3 to 4 units for the overall group (improvement of 20–27% from baseline) and was 5 units for those with dcSSc (improvement of 24% from baseline). Those who met the mRSS MCID improvement criteria had statistically significant improvements in scores on the Short Form-36 Physical Component Summary, the Transition Dyspnea Index, and joint contractures at 12 months. Conclusion MCID estimates for the mRSS were 3–4 units for all participants and 5 units for those with dcSSc. These findings are consistent with previously reported MCID estimates for systemic sclerosis.

Abstract Background Smoking is the leading preventable cause of death in the United States, but evidence-based smoking cessation therapy is underutilized. Financial incentive strategies represent an innovative approach for increasing the use of counseling and pharmacotherapy. If effective, they could supplement or supplant resource-intensive policy options, particularly in populations for whom smoking has substantial societal costs. FIESTA (Financial IncEntives for Smoking TreAtment) will randomize hospitalized smokers to receive usual smoking cessation care alone or usual smoking care augmented with financial incentives. We aim to compare the impact of these two strategies on 1) smoking abstinence, 2) use of counseling and nicotine replacement therapy, and 3) quality of life of participants. We also will evaluate the short-term and long-term return on the investment of incentives. The FIESTA Oral Microbiome Substudy will compare the oral microbiome of smokers and nonsmokers to longitudinally assess whether smoking cessation changes oral microbiome composition. Methods We will enroll 182 inpatient participants from the Manhattan campus of the Veterans Affairs New York Harbor Healthcare System. All participants receive enhanced usual care, including screening for tobacco use, counseling while hospitalized, access to nicotine replacement therapy, and referral to a state Quitline. Patients in the financial incentive arm receive enhanced usual care and up to $550 for participating in the New York Smoker’s Quitline, using nicotine replacement therapy (NRT), and achieving biochemically confirmed smoking cessation at 2 months and 6 months. In the microbiome substudy, we enroll nonsmoking control participants matched to each recruited smoker’s hospital ward, sex, age, diabetes status, and antibiotic use. After discharge, participants are asked to complete periodic phone interviews at 2 weeks, 2 months, 6 months, and 12 months and provide expired carbon monoxide and saliva samples at 2 months, 6 months, and 12 months for cotinine testing and oral microbiome analysis. Discussion The incentive interventions of FIESTA may benefit hospitalized smokers, an objective made all the more critical because smoking rates among hospitalized patients are higher than those in the general population. Moreover, the focus of FIESTA on evidence-based therapy and bioconfirmed smoking cessation can help guide policy efforts to reduce smoking-related healthcare costs in populations with high rates of tobacco use and costly illnesses. Trial registration ClinicalTrials.gov, NCT02506829. Registered on 1 July 2014.

Previous studies have found that alkylated polycyclic aromatic hydrocarbons (alkyl-PAHs) were more abundant in petrogenic sources (e.g., crude oil and its refined products) than pyrogenic sources of incomplete combustion. While urinary hydroxylated metabolites of unsubstituted PAHs have been widely used as biomarkers of PAHs exposures, little information is available as to the occurrence of alkyl-PAH metabolites. In this study, we have detected carboxylic acid metabolites of alkyl-naphthalene (2-NAPCA) and alkyl-phenanthrene (2-PHECA) in 314 urine samples repeatedly collected from 45 Los Angeles residents before, during, and after they spent ten weeks in Beijing in summers of 2014–2017. We found that traveling from Los Angeles to Beijing led to 348% (95% CI: 243 to 485%) and 209% (95% CI: 149 to 282%) increases in 2-NAPCA and 2-PHECA concentrations, respectively, which returned to baseline levels after participants came back to Los Angeles. The concentration ratio between 2-PHECA and hydroxy-phenanthrenes was significantly (p

Clinical studies and meta-analyses have supported the notion that consuming cinnamon spice long term can have beneficial effects in individuals with normal glucose homeostasis and varying degrees of glucose intolerance including type 2 diabetes. The objective of this study was to evaluate the acute effect of cinnamon on the post-prandial responses to a typical American breakfast in normal and overweight/obese participants (ClinicalTrials.gov registration No. NCT04686552). The consumption of a single dose of 6 g of cinnamon added to oatmeal prepared with milk resulted in a significant reduction of one of our primary outcomes post-prandial insulin response (niAUC0−180min) in overweight/obese participants compared to control consuming breakfast without cinnamon. We also performed exploratory analysis of secondary outcomes. In normal weight participants, we observed a decrease of post-prandial glucagon response (niAUC0−180min and glucagon levels at 60–120 min) and C-peptide response (30 min) comparing breakfast with to without cinnamon. Cinnamon consumption did not change post-prandial glycemic response in normal weight participants, but increased 60 min post-prandial glucose in overweight/obese participants compared to control. In summary, cinnamon consumption differentially affected post-prandial hormonal responses in normal and overweight/obese participants.

Recent studies suggested a significant downward trend in population’s exposure to bisphenol A (BPA) in the United States. However, the temporal trend of BPA exposure remains unclear in China - a populous country with substantial industrial activities but less efforts made to phase out BPA in consumer products. In addition, it is unclear to what extent a visit from the United States to China could affect human exposure to BPA. In this natural experiment, we measured the concentration of total BPA in 418 urine samples repeatedly collected from 55 Los Angeles residents before, during, and after they spent 10 weeks in Beijing from 2012 to 2017. We found that traveling from Los Angeles to Beijing led to a 2.91-fold (95% CI: 2.43 to 3.50) increase in urinary BPA levels, which fully returned to baseline after study participants came back to Los Angeles. From 2012 to 2017, urinary BPA concentrations decreased in Los Angeles by 25.5% per year (95% CI: −30.8% to −19.8%; p

Summary: Background: HIV self-testing increases testing uptake in sub-Saharan Africa but scale-up is challenging because of resource constraints. We evaluated an HIV self-testing intervention integrated into high-burden outpatient departments in Malawi. Methods: In this cluster-randomised trial, we recruited participants aged 15 years or older from 15 outpatient departments at high-burden health facilities (including health centres, mission hospitals, and district hospitals) in central and southern Malawi. The trial was clustered at the health facility level. We used constrained randomisation to allocate each cluster (1:1:1) to one of the following groups: standard provider-initiated testing and counselling with no intervention (provider offered during consultations), optimised provider-initiated testing and counselling (with additional provider training and morning HIV testing), and facility-based HIV self-testing (Oraquick HIV self-test, group demonstration and distribution, and private spaces for interpretation and counselling). The primary outcome was the proportion of outpatients tested for HIV on the day of enrolment, measured through exit surveys with a sample of outpatients. Analyses were on an intention-to-treat basis. The trial is registered with ClinicalTrials.gov, NCT03271307, and Pan African Clinical Trials, PACTR201711002697316. Findings: Between Sept 12, 2017, and Feb 23, 2018, 5885 outpatients completed an exit survey—2097 in the HIV self-testing group, 1951 in the standard provider-initiated testing and counselling group, and 1837 in the optimised provider-initiated testing and counselling group. 1063 (51%) of 2097 patients in the HIV self-testing group had HIV testing on the same day as enrolment, compared with 248 (13%) of 1951 in the standard provider-initiated testing and counselling group and 261 (14%) of 1837 in the optimised provider-initiated testing and counselling group. The odds of same-day HIV testing were significantly higher in the facility-based HIV self-testing group compared with either standard provider-initiated testing and counselling (adjusted odds ratio 8·52, 95% CI 3·98–18·24) or optimised provider-initiated testing and counselling (6·29, 2·96–13·38). Around 4% of those tested in the standard provider-initiated testing and counselling and optimised provider-initiated testing and counselling groups felt coerced to test, and around 1% felt coerced to share test results. No coercion was reported in the facility-based HIV self-testing group. Interpretation: Facility-based HIV self-testing increased HIV testing among outpatients in Malawi, with a minimal risk of adverse events. Facility-based HIV self-testing should be considered for scale-up in settings with a high unmet need for HIV testing. Funding: United States Agency for International Development.

Abstract Background Throughout sub-Saharan Africa HIV-testing rates remain low. Barriers to testing, such as inconvenient service hours and long wait times, lack of privacy, and fear of unwanted disclosure, continue to impede service utilization. HIV self-testing (HIVST) is one strategy that addresses these barriers and has been shown to increase use of HIV-testing when distributed through community-based settings. However, the scalability of HIVST is limited because it has yet to be fully integrated into existing health systems and routine care. To address this gap, we designed a study to test the effect of offering HIVST to routine outpatient department (OPD) clients on uptake of HIV-testing as compared to standard of care and optimized standard of care. Methods/design This is a non-blinded, multi-site, cluster-randomized control trial. The health facility is the unit of randomization (cluster). Fifteen facilities were randomized to one of three arms: (1) Standard of care using routine provider-initiated testing and counseling (PITC); (2) Optimized standard of care using optimized PITC defined by additional training, job aids, and monitoring of PITC strategies with OPD providers and support staff; and (3) HIVST defined by HIVST demonstrations for OPD clients, HIVST kit distribution, and private spaces for HIVST kit use and/or interpretation. The primary outcome is the proportion of OPD clients tested for HIV on the day that they accessed OPD services. Secondary outcome measures are the proportion of OPD clients newly identified as HIV-positive and antiretroviral therapy (ART) initiation. Costs and cost-effectiveness will be evaluated. Nested studies will determine the acceptability of facility-based HIVST among OPD clients and health care providers, the presence of adverse events, such as coercion to test or unwanted status disclosure, and a process evaluation to determine feasibility and scale-up of facility-based HIVST for the future. Discussion This study protocol tests whether facility-based HIVST can positively contribute to HIV-testing among OPD clients in resource-limited settings. This will be one of the first studies to test the integration of HIVST into facility-based, primary health services in sub-Saharan Africa. Trial registration ClinicalTrials.gov, ID: NCT03271307. Registered on 31 August 2017. Pan African Clinical Trials: PACTR201711002697316. Registered on 1 November 2017.

Patients exposed to pollutants are more likely to suffer from allergic rhinitis and may benefit from antioxidant treatment. Our study determined if patients diagnosed with grass-induced allergic rhinitis could benefit from broccoli sprout extract (BSE) supplementation. In total, 47 patients were confirmed with grass-induced allergic rhinitis and randomized to one of four groups: group 1 (nasal steroid spray + BSE), group 2 (nasal steroid spray + placebo tablet), group 3 (saline nasal spray + BSE) and group 4 (saline nasal spray + placebo tablet). Peak Nasal Inspiratory Flow (PNIF), Total Nasal Symptoms Scores (TNSS) and nasal mucus cytokine levels were analyzed in samples collected before and after the 3-week intervention. Comparing before and after the intervention, PNIF improved significantly when comparing Groups 1 and 2, vs. placebo, at various time points (p ≤ 0.05 at 5, 15, 60 and 240 min) following nasal challenge, while TNSS was only statistically significant at 5 (p = 0.03), 15 (p = 0.057) and 30 (p = 0.05) minutes. There were no statistically significant differences in various cytokine markers before and after the intervention. Combining nasal corticosteroid with BSE led to the most significant improvement in objective measures.

Mixed tree nuts (MTNs) are an excellent source of protein and healthy fat contributing to satiety. However, their relatively high caloric content might not be beneficial in a weight loss diet. The present study was designed to test whether including MTNs in a weight loss and maintenance program interferes with weight management compared to a refined carbohydrate pretzel snack (PS). We performed a randomized, controlled, two-arm study in 95 overweight individuals consuming 1.5 oz of MTNs or PS daily as part of a hypocaloric weight loss diet (−500 kcal) over 12 weeks followed by an isocaloric weight maintenance program for 12 weeks. Participants in both groups experienced significant weight loss (12 weeks: −1.6 and −1.9 and 24 weeks: −1.5 and −1.4 kg) compared to baseline in the MTN and PS groups, respectively. However, there was no difference in weight loss and other outcome parameters between the MTN and PS groups. The MTN group showed a significant increase in satiety at 24 weeks. Both groups had a decrease in diastolic blood pressure at 12 weeks. Participants in the MTN group showed significant decreases in heart rate at 4, 12, and 24 weeks. Plasma oleic acid was significantly increased at 12 and 24 weeks in the MTN group but only at 12 weeks in the PS group. Plasma MCP-1 was decreased significantly in the MTN group at 4 weeks. In summary, participants in both groups lost weight, but only the MTN intervention increased satiety at 24 weeks, enhanced retention, decreased heart rate, and increased serum oleic acid at 24 weeks.

OBJECTIVES/SPECIFIC AIMS: Intensive lifestyle change (e.g., the Diabetes Prevention Program) and metformin reduce type 2 diabetes risk among patients with prediabetes. However, real-world uptake remains low. Shared decision-making (SDM) may increase awareness and help patients select and follow through with informed options for diabetes prevention that are aligned with their preferences.The objective was to test the effectiveness of a prediabetes SDM intervention. METHODS/STUDY POPULATION: This was a cluster-randomized controlled trial in 20 primary care clinics within a large regional health system. Participants were overweight/obese adults with prediabetes (BMI>24 kg/m2 and HbA1c 5.7-6.4%) were enrolled from 10 SDM intervention clinics. Propensity score matching was used to identify control patients from 10 usual care clinics.Intervention clinic patients were invited to participate in a face-to-face SDM visit with a pharmacist who used a decision aid (DA) to describe prediabetes and four possible options for diabetes prevention; DPP, DPP +/− metformin, metformin only, or usual care. RESULTS/ANTICIPATED RESULTS: Uptake of DPP and/or metformin was higher among SDM participants (n=351) than controls receiving usual care (n = 1,028; 38% vs. 2%, p

OBJECTIVES:Arachidonic acid metabolites (eicosanoids) reflect oxidative stress and vascular health and have been associated with anthropometric measures and sex differences in cross-sectional analyses of HIV-infected (HIV+) persons. Telmisartan is an angiotensin receptor blocker and PPAR-γ agonist with potential anti-inflammatory and metabolic benefits. We assessed telmisartan's effects on urine eicosanoids among HIV+ adults with central adiposity on suppressive antiretroviral therapy enrolled in a prospective clinical trial. METHODS:Thirty-five HIV+ adults (15 women; 20 men) completed 24 weeks of open-label oral telmisartan 40mg daily. Lumbar computed tomography quantified visceral (VAT) and subcutaneous (SAT) abdominal adipose tissue. Urine F2-isoprostane (F2-IsoP), prostaglandin E2 (PGE-M), prostacyclin (PGI-M), and thromboxane B2 (TxB-M) were quantified at baseline and 24 weeks using gas/liquid chromatography-mass spectroscopy. Mann-Whitney-U tests compared sub-group differences; Spearman's rho assessed correlations between clinical factors and eicosanoid levels. RESULTS:Median PGE-M increased on telmisartan (p5% VAT (+3.7 ng/mg cr, p5% SAT (+1.7 ng/mg cr, p = 0.04). Median baseline F2-IsoP and TxB-M were slightly higher in women (both between-group p = 0.08) and did not change on telmisartan. CONCLUSIONS:Urine PGE-M increased with 24 weeks of telmisartan in virally suppressed, HIV+ adults with central adiposity. Associations with favorable fat redistribution suggest increased PGE-M may reflect a beneficial response.

Background. Physical activity is associated with better physical health, possibly by changing biological markers of health such as waist circumference and inflammation, but these relationships are unclear and even less understood among older Latinos—a group with high rates of sedentary lifestyle. Methods. Participants were 120 sedentary older Latino adults from senior centers. Community-partnered research methods were used to recruit participants. Inflammatory (C-reactive protein) and metabolic markers of health (waist circumference, HDL-cholesterol, triglycerides, insulin, and glucose), physical activity (Yale physical activity survey), and physical performance (short physical performance NIA battery) were measured at baseline and 6-month followup. Results. Eighty percent of the sample was female. In final adjusted cross-sectional models, better physical activity indices were associated with faster gait speed (P

Visceral adiposity in the setting of HIV infection and antiretroviral therapy (ART) is not fully understood, and treatment options remain limited. Telmisartan, an angiotensin receptor blocker and partial PPAR-γ agonist, has been shown to decrease visceral fat and improve metabolic and inflammatory parameters in HIV-uninfected subjects.HIV-infected subjects with HIV-1 RNA 94/95 cm or waist: hip ratio >0.88/0.94 received open-label telmisartan 40 mg po daily for 24 weeks. Adipose tissue (AT) volumes were quantified by L4-L5 single slice computed tomography. Metabolic and inflammatory markers were obtained fasting. Thirty-five subjects provided 80% power to detect a 10% 24-week decrease in visceral AT (VAT, two-sided α = 0.05).Thirty-five subjects enrolled and completed the protocol. At entry (median or %): age 49 years, 43% female, 77% non-white, 91% non-smokers, CD4+ T cell count 590 cells/mm(3), BMI 31 kg/m(2). AT responses were heterogeneous, with statistically significant losses of median (IQR) total (TAT, 2.9% (-9.8, 0.7), p = 0.03) and subcutaneous (SAT, -2.7% (-9.8, 1.1), p = 0.03) AT, but not VAT (-2.7% (-20.5, 14.2), p = 0.53). Significant decreases in waist circumference and waist:hip ratio occurred (both p

An appropriate sample size is crucial for the success of many studies that involve a large number of comparisons. Sample size formulas for testing multiple hypotheses are provided in this paper. They can be used to determine the sample sizes required to provide adequate power while controlling familywise error rate or false discovery rate, to derive the growth rate of sample size with respect to an increasing number of comparisons or decrease in effect size, and to assess reliability of study designs. It is demonstrated that practical sample sizes can often be achieved even when adjustments for a large number of comparisons are made as in many genomewide studies.

BACKGROUND:Current treatment regimens for pulmonary tuberculosis require at least 6 months of therapy. Immune adjuvant therapy with recombinant interferon-gamma1b (rIFN-gammab) may reduce pulmonary inflammation and reduce the period of infectivity by promoting earlier sputum clearance. METHODOLOGY/PRINCIPAL FINDINGS:We performed a randomized, controlled clinical trial of directly observed therapy (DOTS) versus DOTS supplemented with nebulized or subcutaneously administered rIFN-gamma1b over 4 months to 89 patients with cavitary pulmonary tuberculosis. Bronchoalveolar lavage (BAL) and blood were sampled at 0 and 4 months. There was a significant decline in levels of inflammatory cytokines IL-1beta, IL-6, IL-8, and IL-10 in 24-hour BAL supernatants only in the nebulized rIFN-gamma1b group from baseline to week 16. Both rIFN-gamma1b groups showed significant 3-fold increases in CD4+ lymphocyte response to PPD at 4 weeks. There was a significant (p = 0.03) difference in the rate of clearance of Mtb from the sputum smear at 4 weeks for the nebulized rIFN-gamma1b adjuvant group compared to DOTS or DOTS with subcutaneous rIFN-gamma1b. In addition, there was significant reduction in the prevalence of fever, wheeze, and night sweats at 4 weeks among patients receiving rFN-gamma1b versus DOTS alone. CONCLUSION:Recombinant interferon-gamma1b adjuvant therapy plus DOTS in cavitary pulmonary tuberculosis can reduce inflammatory cytokines at the site of disease, improve clearance of Mtb from the sputum, and improve constitutional symptoms. TRIAL REGISTRATION:ClinicalTrials.gov NCT00201123.

For psoriasis, an idiopathic inflammatory disorder of the skin, the microbial biota has not been defined using cultivation-independent methods. We used broad-range 16S rDNA PCR for archaea and bacteria to examine the microbiota of normal and psoriatic skin. From 6 patients, 19 cutaneous samples (13 from diseased skin and 6 from normal skin) were obtained. Extracted DNA was subjected to the broad range PCR, and 1,925 cloned products were compared with 2,038 products previously reported from healthy persons. Using 98% sequence identity as a species boundary, 1,841 (95.6%) clones were similar to known bacterial 16S rDNA, representing 6 phyla, 86 genera, or 189 species-level operational taxonomic unit (SLOTU); 84 (4.4%) clones with

Importance: Limited evidence supports kidney dysfunction as an indication for parathyroidectomy in asymptomatic primary hyperparathyroidism (PHPT). Objective: To investigate the natural history of kidney function in PHPT and whether parathyroidectomy alters renal outcomes. Design: Matched control study. Setting: A vertically integrated health care system serving 4.6 million patients in Southern California. Participants: 6058 subjects with PHPT and 16 388 matched controls, studied from 2000 to 2016. Exposures: Biochemically confirmed PHPT with varying serum calcium levels. Main outcomes: Estimated glomerular filtration rate (eGFR) trajectories were compared over 10 years, with cases subdivided by severity of hypercalcemia: serum calcium 2.62-2.74 mmol/L (10.5-11 mg/dL), 2.75-2.87 (11.1-11.5), 2.88-2.99 (11.6-12), and >2.99 (>12). Interrupted time series analysis was conducted among propensity-score-matched PHPT patients with and without parathyroidectomy to compare eGFR trajectories postoperatively. Results: Modest rates of eGFR decline were observed in PHPT patients with serum calcium 2.62-2.74 mmol/L (-1.0 mL/min/1.73 m²/year) and 2.75-2.87 mmol/L (-1.1 mL/min/1.73 m²/year), comprising 56% and 28% of cases, respectively. Compared with the control rate of -1.0 mL/min/1.73 m²/year, accelerated rates of eGFR decline were observed in patients with serum calcium 2.88-2.99 mmol/L (-1.5 mL/min/1.73 m²/year, P2.99 mmol/L (-2.1 mL/min/1.73 m²/year, P2.87 mmol/L exhibited mitigation of eGFR decline after parathyroidectomy (-2.0 [95% CI: -2.6, -1.5] to -0.9 [95% CI: -1.5, 0.4] mL/min/1.73 m²/year). Conclusions and relevance: Compared with matched controls, accelerated eGFR decline was observed in the minority of PHPT patients with serum calcium >2.87 mmol/L (11.5 mg/dL). Parathyroidectomy was associated with mitigation of eGFR decline in patients with serum calcium >2.87 mmol/L. [ABSTRACT FROM AUTHOR]