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Background Cigarette smoking among adults in the USA is a leading cause of preventable death worldwide, even though there has been a decline in prevalence since 2005. The addictive nature of nicotine is the chief reason smokers continue to use tobacco. Although the majority of smokers report a desire to quit smoking, a small minority who attempt to quit achieve long-term cessation. Combined, smoking cessation best practices include coordinated medication and behavioral treatments. However, these treatments are not currently adequately delivered to Medi-Cal beneficiaries in the publicly funded patient-centered medical homes (PCMHs) and community mental health clinics operated by Los Angeles County (LAC)-Department of Health Services (LACDHS) and LAC-Department of Mental Health (LACDMH). Methods This is a 5-year implementation, cluster-randomized comparative effectiveness trial that will support the implementation of smoking cessation services delivered in LAC-LACDHS-operated outpatient primary care clinics and in LAC-LACDMH-operated community mental health clinics. We will enroll 1000 participants from clinics that will offer smoking cessation services and 200 from clinics that will offer treatment as usual. Participants will be asked to complete assessments at baseline, 3 months, 6 months, and 12 months. The assessments will include self-reports on smoking history, anxiety, stress, quality of life, and participant satisfaction. Participants who are assigned to clinics that provide smoking cessation services will also be asked about the frequency of their participation in the smoking cessation services during the 12-month period. Discussion This study will evaluate the effectiveness and feasibility of implementing smoking cessation services in outpatient primary care and community mental health clinics. It will also determine if there will be higher rates of smoking cessation in the implementation sites as compared to the sites with treatment as usual. If the implementation proves to be effective, the plan is to sustain these services using a workflow we will develop in the LAC-operated sites. This would lead to ameliorating the significant smoking cessation treatment gaps among those served within the LAC Health Agency departments. Trial registration ClinicalTrials.gov NCT04717544 “Embedding comprehensive smoking cessation programs into community clinics.” Registered on January 22, 2021

Predictable and sustainable engraftment of live biotherapeutic products into the human gut microbiome is being explored as a promising way to modulate the human gut microbiome. We utilize a synbiotic approach pairing the infant gut microbe Bifidobacterium longum subspecies infantis (B. infantis) and human milk oligosaccharides (HMO). B. infantis, which is typically absent in adults, engrafts into healthy adult microbiomes in an HMO-dependent manner at a relative abundance of up to 25% of the bacterial population without antibiotic pretreatment or adverse effects. Corresponding changes in metabolites are detected. Germ-free mice transplanted with dysbiotic human microbiomes also successfully engraft with B. infantis in an HMO-dependent manner, and the synbiotic augments butyrate levels both in this in vivo model and in in vitro cocultures of the synbiotic with specific Firmicutes species. Finally, the synbiotic inhibits the growth of enteropathogens in vitro. Our findings point to a potential safe mechanism for ameliorating dysbioses characteristic of numerous human diseases.

Microvascular disease is an important cause of morbidity in patients with T2DM. Total VLDL concentrations is associated with increased BV, a major determinant of microvascular flow in patients with T2DM. Measurement of VLDL concentration may provide insight into lipoprotein associated microvascular complications of diabetes.

The goal of this study is to determine the cost-effectiveness of MIRISK VP, a next generation coronary heart disease risk assessment score, in correctly reclassifying and appropriately treating asymptomatic, intermediate risk patients.A Markov model was employed with simulated subjects based on the Multi-Ethnic Study of Atherosclerosis (MESA). This study evaluated three treatment strategies: (i) practice at MESA enrollment, (ii) current guidelines, and (iii) MIRISK VP in MESA.The model assessed patient healthcare costs and outcomes, expressed in terms of life years and quality-adjusted life years (QALYs), over the lifetime of the cohort from the provider and payer perspective. A total of 50,000 hypothetical individuals were used in the model. A sensitivity analysis was conducted (based on the various input parameters) for the entire cohort and also for individuals aged 65 and older.Guiding treatment with MIRISK VP leads to the highest net monetary benefits when compared to the 'Practice at MESA Enrollment' or to the 'Current Guidelines' strategies. MIRISK VP resulted in a lower mortality rate from any CHD event and a modest increase in QALY of 0.12-0.17 years compared to the other two approaches.This study has limitations of not comparing performance against strategies other than the FRS, the results are simulated as with all models, the model does not incorporate indirect healthcare costs, and the impact of patient or physician behaviors on outcomes were not taken into account.MIRISK VP has the potential to improve patient outcomes compared to the alternative strategies. It is marginally more costly than both the 'Practice at MESA Enrollment' and the 'Current Guidelines' strategies, but it provides increased effectiveness, which leads to positive net monetary benefits over either strategy.

To evaluate community screening using HbA1c levels in high risk African Americans and Latinos in those not known to have diabetes.HbA1c levels were measured in 1542 African Americans and Latinos agedor = 40 years with one or more of the following risk factors: family history in first degree relatives, waist circumferenceor = 40 inches in males oror = 35 inches in females, and hypertension, either treatment for or a measured BP ofor = 140/ 90 mm Hg. Oral glucose tolerance tests (OGTT) were offered to those meeting the HbA1c criterion for pre-diabetes.Churches, community health fares, senior citizen sites.People without known diabetes.Proportion of people meeting the HbA1c criteria for prediabetes (5.8-6.4%) and diabetes (or = 6.5%).32% had one, 50% had two and 18% had three risk factors. By HbA1c criteria, 40% had pre-diabetes and 25% had diabetes. Increased waist circumference was the most common risk factor followed by a positive family history, and lastly, hypertension. Each individual risk factor was significantly (P.001) and progressively more common as glycemia increased. Each additional risk factor increased the odds of pre-diabetes or diabetes by 2- to 4-fold. In individuals with pre-diabetes who underwent an OGTT, 59% were normal, 35% had pre-diabetes and only 6% had diabetes.Community screening of high risk African Americans and Latinos with HbA1c levels identifies a large proportion of people with pre-diabetes and diabetes. Those identified with pre-diabetes are unlikely to meet the OGTT criteria for diabetes.

To analyze whether types of providers and frequency of encounters are associated with higher quality of care within a coordinated dementia care management (CM) program for patients and caregivers.Secondary analysis of intervention-arm data from a dementia CM cluster-randomized trial, where intervention participants interacted with healthcare organization care managers (HOCMs), community agency care managers (CACMs), and/ or healthcare organization primary care providers (HOPCPs) over 18 months.Encounters of 238 patient/caregivers (dyads) with HOCMs, CACMs, and HOPCPs were abstracted from care management electronic records. The quality domains of assessment, treatment, education/support, and safety were measured from medical record abstractions and caregiver surveys. Mean percentages of met quality indicators associated with exposures to each provider type and frequency were analyzed using multivariable regression, adjusting for participant characteristics and baseline quality.As anticipated, for all 4 domains, the mean percentage of met dementia quality indicators was 15.5 to 47.2 percentage points higher for dyads with HOCM--only exposure than for dyads with none (all P.008); not anticipated were higher mean percentages with increasing combinations of provider-type exposure-up to 73.7 percentage points higher for safety (95% confidence interval 65.2%-82.1%) with exposure to all 3 provider types compared with no exposure. While greater frequency of HOCM-dyad encounters was associated with higher quality (P.04), this was not so for other provider types.HOCMs' interactions with dyads was essential for dementia care quality improvement. Additional coordinated interactions with primary care and community agency staff yielded even higher quality.

To evaluate the impact of a locally adapted evidence-based quality improvement (EBQI) approach to implementation of smoking cessation guidelines into routine practice.We used patient questionnaires, practice surveys, and administrative data in Veterans Health Administration (VA) primary care practices across five southwestern states.In a group-randomized trial of 18 VA facilities, matched on size and academic affiliation, we evaluated intervention practices' abilities to implement evidence-based smoking cessation care following structured evidence review, local priority setting, quality improvement plan development, practice facilitation, expert feedback, and monitoring. Control practices received mailed guidelines and VA audit-feedback reports as usual care.To represent the population of primary care-based smokers, we randomly sampled and screened 36,445 patients to identify and enroll eligible smokers at baseline (n=1,941) and follow-up at 12 months (n=1,080). We used computer-assisted telephone interviewing to collect smoking behavior, nicotine dependence, readiness to change, health status, and patient sociodemographics. We used practice surveys to measure structure and process changes, and administrative data to assess population utilization patterns.Intervention practices adopted multifaceted EBQI plans, but had difficulty implementing them, ultimately focusing on smoking cessation clinic referral strategies. While attendance rates increased (p.0001), we found no intervention effect on smoking cessation.EBQI stimulated practices to increase smoking cessation clinic referrals and try other less evidence-based interventions that did not translate into improved quit rates at a population level.

To identify specific care management activities within a dementia care management intervention that are associated with 18-month change in caregiver mastery and relationship strain.Exploratory analysis, using secondary data (care management processes and caregiver outcomes) from the intervention arm of a clinic-level randomized, controlled trial of a dementia care management quality improvement program.Nine primary care clinics in three managed care and fee-for-service southern California healthcare organizations.Two hundred thirty-eight pairs: individuals with dementia and their informal, nonprofessional caregivers.Care management activity types extracted from an electronic database were used as predictors of caregiver mastery and relationship strain, which were measured through mailed surveys. Multivariable linear regression models were used to predict caregiver mastery and relationship strain.For each care manager home environment assessment, caregiver mastery increased 4 points (range 0-100, mean+/-standard deviation 57.1+/-26.6, 95% confidence interval (CI)=2.4-5.7; P=.001) between baseline and 18 months. For every action linking caregivers to community agencies for nonspecific needs, caregiver mastery decreased 6.2 points (95% CI=-8.5 to -3.9; P.001). No other care management activities were significantly associated with this outcome, and no specific activities were associated with a change in caregiver relationship strain.Home assessments for specific needs of caregivers and persons with dementia are associated with improvements in caregivers' sense of mastery. Future work is needed to determine whether this increase is sustained over time and decreases the need for institutionalization.

To describe the quality of dementia care within one U.S. metropolitan area and to investigate associations between variations in quality and patient, caregiver, and health system characteristics.Observational, cross-sectional.Three hundred eighty-seven patient-caregiver pairs from three healthcare organizationsUsing caregiver surveys and medical record abstraction to assess 18 dementia care processes drawn from existing guidelines, the proportion adherent to each care process was calculated, as well as mean percentages of adherence aggregated within four care dimensions: assessment (6 processes), treatment (6 processes), education and support (3 processes), and safety (3 processes). For each dimension, associations between adherence and patient, caregiver, and health system characteristics were investigated using multivariable models.Adherence ranged from 9% to 79% for the 18 individual care processes; 11 processes had less than 40% adherence. Mean percentage adherence across the four care dimensions was 37% for assessment, 33% for treatment, 52% for education and support, and 21% for safety. Higher comorbidity was associated with greater adherence across all four dimensions, whereas greater caregiver knowledge (in particular, one item) was associated with higher care quality in three of four care dimensions. For selected dimensions, greater adherence was also associated with greater dementia severity and with more geriatrics or neurologist visits.In general, dementia care quality has considerable room for improvement. Although greater comorbidity and dementia severity were associated with better quality, caregiver knowledge was the most consistent caregiver characteristic associated with better adherence. These findings offer opportunities for targeting low quality and suggest potential focused interventions.

Resistin induces insulin resistance in mice. In humans, recent data suggest that resistin functions as a proinflammatory cytokine. Here, we studied resistin up to 2 wks after admission in patients with septic shock and/or severe sepsis.Two prospective studies of patients with sepsis and in vitro studies of resistin interaction with monocytes.Intensive care unit at Karolinska University Hospital and Center for Infectious Medicine, Karolinska Institute, Huddinge, Sweden.Twenty-nine patients with severe sepsis and 66 with septic shock.None.Ninety-five patients were studied, 25 of whom died within 28 days. Resistin and cytokine levels and routine biochemistry were measured at three to six defined time points during the first 2 wks after admission and were correlated to other cytokines, glucose levels, body mass index, Acute Physiology and Chronic Health Evaluation II, and Sepsis-related Organ Failure Assessment scores. Serum resistin was significantly elevated compared with healthy controls (p.000001) and correlated with severity of disease as measured by Acute Physiology and Chronic Health Evaluation II and Sepsis-related Organ Failure Assessment scores, with an increasingly strong degree of correlation over time. Median levels were four- to eight-fold higher than controls and remained high up to 2 wks after admission to the intensive care unit. Levels correlated with interleukin-6, interleukin-8, interleukin-10, tumor necrosis factor-alpha, creatinine, D-dimer, and lactate, but not with p-glucose or body mass index. In vitro, resistin was released from monocytes after stimulation with either lipopolysaccharide or high mobility group box 1 protein. Recombinant resistin itself up-regulated intercellular adhesion molecule-1 on monocytes.This is the first study assessing systemic levels of resistin in patients with septic shock/severe sepsis. We show that resistin is a marker of severity of disease and possibly a mediator of the prolonged inflammatory state seen in infected critically ill patients. Further exploration of resistin as a therapeutic target and marker of disease is merited.

Objective: To study the systemic release and kinetics of high mobility group box-1 protein (HMGB1) in relation to clinical features in a population of patients with severe sepsis or septic shock and to compare these with the kinetics of the cytokines interleukin-6, interleukin-8, interleukin-10, and tumor necrosis factor-. Design: Prospective study of two cohorts of patients. Setting: Intensive care unit and infectious disease clinic at Karolinska University Hospital Huddinge. Patients: Twenty-six patients with severe sepsis, 33 patients with septic shock, and a reference group of five patients with sepsis. Interventions: None. Measurements and Main Results: Sixty-four patients were included, ten of whom died within 28 days. Cytokine levels were measured at five time points during the first week after admission and were correlated to Acute Physiology and Chronic Health Evaluation II and Sepsis-related Organ Failure Assessment scores. Two HMGB1 assays were used. Both demonstrated delayed kinetics for HMGB1 with high levels on inclusion that remained high throughout the study period. Serum concentration at 144 hrs, the last sampling point, was 300 times higher, 34,000 76,000 pg/mL (mean SD), than any of the other cytokines. This study, however, found no predictable correlation between serum levels of HMGB1 and severity of infection. We did quite unexpectedly find significantly lower levels of HMGB1 in nonsurvivors compared with survivors as measured by our main assay, but the other showed no difference between the two groups. Levels of interleukin-6, interleukin-8, interleukin-10, and tumor necrosis factor- correlated significantly with severity of disease, and all were significantly higher in patients with septic shock compared with those with severe sepsis. Neither of these comparisons showed significant correlations for HMGB1. Conclusions: This is the first prospective study assessing the release over time of HMGB1 in a population of patients with sepsis, severe sepsis, or septic shock. Levels remained high in the majority of patients up to 1 wk after admittance, indicating that the cytokine indeed is a downstream and late mediator of inflammation. Further studies are required to fully define the relationship of HMGB1 to severity of disease. (Crit Care Med 2005; 33:564‐573)

Increasingly, primary care practices include nurse practitioners (NPs) in their staffing mix to contain costs and expand primary care. To achieve these aims in U.S. Department of Veterans Affairs medical centers (VAMCs), national policy endorsed involvement of NPs as primary care (PC) providers.To evaluate the degree to which VAMCs incorporated NPs into PC practices between 1996 and 1999, and to identify the internal and external practice environment features associated with NP use.We surveyed 131 PC directors of all VAMCs in 1996 and 1999 to ascertain the staffing and characteristics of the PC practice and parent organization (e.g., academic affiliation, level of physician staffing, use of managed care arrangements), and drew on previously published studies and HRSA State Health Workforce Profiles to characterize each practice's regional health care environment (e.g., geographic region, state NP practice laws, state managed care penetration). Using multivariate linear regression, we evaluate the contribution of these environmental and organizational factors on the number of NPs/10,000 PC patients in 1999, controlling for the rate of NP use in 1996.From 1996-1999, NP use increased from 75 percent to 90 percent in VA PC practices. The mean number of NPs per practice increased by about 60 percent (2.0 versus 3.2; p.001), while the rate of NPs/10,000 PC patients trended upward (2.2 versus 2.7; p=.09). Staffing of other primary care clinicians (e.g., physicians and physician assistants per practice) remained stable, while the NP-per-physician rate increased (0.2 versus 0.4; p.001). After multivariate adjustment, greater reliance on managed-care-oriented provider education programs (p=.02), the presence of NP training programs (p=.05), and more specialty-trained physicians/10,000 PC patients (p=.09) were associated with greater NP involvement in primary care.Staffing models in VA PC practices have, in fact, changed, with NPs having a greater presence. However, we found substantial practice-based variations in their use, suggesting that more research is needed to better understand how they have been integrated into practice and what impact their involvement has had on the VA's ability to achieve its restructuring goals.

Medication measurement is crucial in assessing quality for chronic conditions yet agreement of alternate data sources remains uncertain.To evaluate medication agreement between interviews, medical records, and pharmacy data; to assess data source contribution to attributing medication exposure; and to describe the impact of combining data sources on models that predict medication use.Prospective cohort study.Probability sample of HIV-infected participants in the HIV Cost and Services Utilization Study.Medications reported in 2267 interviews, 1936 medical records, and 457 pharmacy records were compared using crude agreement, kappa, and the proportion of average positive and negative agreement. The percent of medications reported in each source alone was used to assess their relative contribution to attributing exposure status. We performed weighted logistic regression in alternate data sources.Kappa varied from 0.38 for nucleoside reverse transcriptase inhibitors to 0.70 for protease inhibitors, when comparing drug classes in interview versus medical record, interview versus pharmacy data, and medical record versus pharmacy data. The percentage of medications reported in medical records was greater than that reported in interviews or pharmacy data. Pharmacy data contributed little to the attribution of medication exposure. Adding medication data to interview data did not appreciably change analytic models predicting medication use.For specific medications, agreement between alternative data sources is fair to substantial, but is lower for key drug classes. Relying on one data source may lead to misclassification of drug exposure status, but combining data sources does not change the results of analytic models predicting appropriate medication use.

The problem of demonstrating the equivalence of two treatments or drugs occurs fairly frequently in medicine, but is quite often misformulated. The common error is to assume equivalence is demonstrated if the usual null hypothesis of no difference is not rejected, which ignores the potential of a substantial beta-error. We describe here two procedures for testing equivalence when the data are paired and dichotomous, and provide sample size formulas. We give an example based on a clinical trial of haemophiliacs with inhibitor to Factor VIII.