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Background: The purpose of this paper is to describe the Juvenile Justice-Translational Research on Interventions for Adolescents in the Legal System (JJ-TRIALS) study, a cooperative implementation science initiative involving the National Institute on Drug Abuse, six research centers, a coordinating center, and Juvenile Justice Partners representing seven US states. While the pooling of resources across centers enables a robust implementation study design involving 36 juvenile justice agencies and their behavioral health partner agencies, co-producing a study protocol that has potential to advance implementation science, meets the needs of all constituencies (funding agency, researchers, partners, study sites), and can be implemented with fidelity across the cooperative can be challenging. This paper describes (a) the study background and rationale, including the juvenile justice context and best practices for substance use disorders, (b) the selection and use of an implementation science framework to guide study design and inform selection of implementation components, and (c) the specific study design elements, including research questions, implementation interventions, measurement, and analytic plan.Methods/design: The JJ-TRIALS primary study uses a head-to-head cluster randomized trial with a phased rollout to evaluate the differential effectiveness of two conditions (Core and Enhanced) in 36 sites located in seven states. A Core strategy for promoting change is compared to an Enhanced strategy that incorporates all core strategies plus active facilitation. Target outcomes include improvements in evidence-based screening, assessment, and linkage to substance use treatment.Discussion: Contributions to implementation science are discussed as well as challenges associated with designing and deploying a complex, collaborative project.Trial Registration: NCT02672150 . [ABSTRACT FROM AUTHOR]

Background: Lone parents and their children experience higher than average levels of adverse health and social outcomes, much of which are explained by high rates of poverty. Many high income countries have attempted to address high poverty rates by introducing employment requirements for lone parents in receipt of welfare benefits. However, there is evidence that employment may not reduce poverty or improve the health of lone parents and their children.Methods: We conducted a systematic review of qualitative studies reporting lone parents' accounts of participation in welfare to work (WtW), to identify explanations and possible mechanisms for the impacts of WtW on health and wellbeing. Twenty one bibliographic databases were searched. Two reviewers independently screened references and assessed study quality. Studies from any high income country that met the criteria of focussing on lone parents, mandatory WtW interventions, and health or wellbeing were included. Thematic synthesis was used to investigate analytic themes between studies.Results: Screening of the 4703 identified papers and quality assessment resulted in the inclusion of 16 qualitative studies of WtW in five high income countries, USA, Canada, UK, Australia, and New Zealand, covering a variety of welfare regimes. Our synthesis found that WtW requirements often conflicted with child care responsibilities. Available employment was often poorly paid and precarious. Adverse health impacts, such as increased stress, fatigue, and depression were commonly reported, though employment and appropriate training was linked to increased self-worth for some. WtW appeared to influence health through the pathways of conflict and control, analytical themes which emerged during synthesis. WtW reduced control over the nature of employment and care of children. Access to social support allowed some lone parents to manage the conflict associated with employment, and to increase control over their circumstances, with potentially beneficial health impacts.Conclusion: WtW can result in increased conflict and reduced control, which may lead to negative impacts on mental health. Availability of social support may mediate the negative health impacts of WtW. [ABSTRACT FROM AUTHOR]

Background: Incorporating evidence-based integrated treatment for dual disorders into typical care settings has been challenging, especially among those serving Veterans who are homeless. This paper presents an evaluation of an effort to incorporate an evidence-based, dual disorder treatment called Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking-Veterans Edition (MISSION-Vet) into case management teams serving Veterans who are homeless, using an implementation strategy called Getting To Outcomes (GTO).Methods: This Hybrid Type III, cluster-randomized controlled trial assessed the impact of GTO over and above MISSION-Vet Implementation as Usual (IU). Both conditions received standard MISSION-Vet training and manuals. The GTO group received an implementation manual, training, technical assistance, and data feedback. The study occurred in teams at three large VA Medical Centers over 2 years. Within each team, existing sub-teams (case managers and Veterans they serve) were the clusters randomly assigned. The trial assessed MISSION-Vet services delivered and collected via administrative data and implementation barriers and facilitators, via semi-structured interview.Results: No case managers in the IU group initiated MISSION-Vet while 68% in the GTO group did. Seven percent of Veterans with case managers in the GTO group received at least one MISSION-Vet session. Most case managers appreciated the MISSION-Vet materials and felt the GTO planning meetings supported using MISSION-Vet. Case manager interviews also showed that MISSION-Vet could be confusing; there was little involvement from leadership after their initial agreement to participate; the data feedback system had a number of difficulties; and case managers did not have the resources to implement all aspects of MISSION-Vet.Conclusions: This project shows that GTO-like support can help launch new practices but that multiple implementation facilitators are needed for successful execution of a complex evidence-based program like MISSION-Vet.Trial Registration: ClinicalTrials.gov NCT01430741. [ABSTRACT FROM AUTHOR]

Background: The scale and scope of medical tourism have expanded rapidly over the last few decades. Turkey is becoming an important player in this market because of its relatively better service quality and large comparative cost advantage.Methods: This paper compares cost, quality and effectiveness of in-vitro fertilization (IVF) in the USA and in Turkey. The data from Turkey were obtained from a hospital specializing in IVF services and the US data came from secondary sources. Package price offered by the dominant IVF-service provider to international patients in Turkey was used as a measure of cost for Turkey while IVF-specific service prices were used to estimate the cost for USA. To compare quality and effectiveness of IVF services, a number of general clinical quality indicators and IVF success rate were used.Results: Indicators of quality, cost and success rate in the Turkish hospital were found to be better than the corresponding indicators in US hospitals. The cost difference of IVF services between USA and Turkey is so significant that the overall cost of obtaining the service from Turkey remains lower even with additional expenses for travel and accommodation.Conclusions: Cost-effectiveness ratio of IVF treatment per successful clinical pregnancy was much lower in Turkey than in the USA. It appears that cost and quality are the two most important factors affecting demand for health care services by international patients in Turkey. Like other important players in the medical tourism market, Turkey should be able to take advantage of its success in IVF, a highly specialized niche market, to transform its health system into an important exporter of general health services. [ABSTRACT FROM AUTHOR]

Background: Prevalence of multiple health risk behaviors is growing, and obesity and smoking are costly. Weight gain associated with quitting smoking is common and can interfere with quit success. Efficacy of adding weight management to tobacco cessation treatment has been tested with women in group sessions over an extended period of time, but has never been tested in real-world settings with men and women seeking help to quit. This paper describes the Best Quit study which tests the effectiveness of delivering tobacco and weight control interventions via existing quitline infrastructures.Methods: Eligible and consenting smokers (n = 2550) who call a telephone quitline will be randomized to one of three groups; the standard quitline or standard quitline plus a weight management program added either simultaneously or sequentially to the tobacco program. The study aims to test: 1) the effectiveness of the combined intervention on smoking cessation and weight, 2) the cost-effectiveness of the combined intervention on cessation and weight and 3) theoretically pre-specified mediators of treatment effects on cessation: reduced weight concerns, increased outcome expectancies about quitting and improved self-efficacy about quitting without weight gain. Baseline, 6 month and 12 month data will be analyzed using multivariate statistical analyses and groups will be compared on treatment adherence, quit rates and change in weight among abstinent participants. To determine if the association between group assignment and primary outcomes (30-day abstinence and change in weight at 6 months) is moderated by pre-determined baseline and process measures, interaction terms will be included in the regression models and their significance assessed.Discussion: This study will generate information to inform whether adding weight management to a tobacco cessation intervention delivered by phone, mail and web for smokers seeking help to quit will help or harm quit rates and whether a simultaneous or sequential approach is better at increasing abstinence and reducing weight gain post quit. If proven effective, the combined intervention could be disseminated across the U.S. through quitlines and could encourage additional smokers who have not sought cessation treatment for fear of gaining weight to make quit attempts.Trial Registration: Clinicaltrials.gov NCT01867983 . Registered: May 30, 2013. [ABSTRACT FROM AUTHOR]

Background: Health care organizations need to be responsive to the needs of increasingly diverse patient populations. We compared the contents of six publicly available approaches to organizational responsiveness to diversity. The central questions addressed in this paper are: what are the most consistently recommended issues for health care organizations to address in order to be responsive to the needs of diverse groups that differ from the majority population? How much consensus is there between various approaches?Methods: We purposively sampled six approaches from the US, Australia and Europe and used qualitative textual analysis to categorize the content of each approach into domains (conceptually distinct topic areas) and, within each domain, into dimensions (operationalizations). The resulting classification framework was used for comparative analysis of the content of the six approaches.Results: We identified seven domains that were represented in most or all approaches: organizational commitment, empirical evidence on inequalities and needs, a competent and diverse workforce, ensuring access for all users, ensuring responsiveness in care provision, fostering patient and community participation, and actively promoting responsiveness. Variations in the operationalization of these domains related to different scopes, contexts and types of diversity. For example, approaches that focus on ethnic diversity mostly provide recommendations to handle cultural and language differences; approaches that take an intersectional approach and broaden their target population to vulnerable groups in a more general sense also pay attention to factors such as socio-economic status and gender.Conclusions: Despite differences in labeling, there is a broad consensus about what health care organizations need to do in order to be responsive to patient diversity. This opens the way to full scale implementation of organizational responsiveness in healthcare and structured evaluation of its effectiveness in improving patient outcomes. [ABSTRACT FROM AUTHOR]

Background: In the United States, home-based primary care (HBPC) is increasingly proposed as a means of enabling frail elders to remain at home for as long as possible, while still receiving needed medical care. However, there are relatively few studies of either the medical outcome effects or cost benefits of HBPC. In this paper, we examine medical cost and mortality outcomes for enrollees in the HBPC program offered by Spectrum Health/Priority Health (SH/PH), a not-for-profit integrated health care/health insurance system located in Grand Rapids, MI, USA.Methods: We perform a concurrent matched cohort study. SH/PH HBPC enrollees during 2012-2014 are matched for prior costs, age, sex and comorbidities against controls selected from unenrolled insurance plan members. Twelve and twenty four-month medical costs are compared between HBPC participants and matched controls, overall and conditional on mortality status. Mortality rates of HBPC participants are studied on their own and in comparison to controls.Results: At 12 and 24 months, in comparison to matched controls HBPC participants show higher ($2933) and lower ($8620) costs respectively. Relative costs and savings of HBPC participants are a function of short term increased costs upon entry into the program (enrollees who survive the first year cost $5866 more than controls); substantial savings at end-of-life (approximately $37,037 in savings relative to controls are realized); and the overall mortality of HBPC participants (mean residual lifespan is 37.75 months from the time of enrollment). We project the present value of lifetime medical cost savings due to enrollment in the HBPC program to be at least $14,336.Conclusions: The SH/PC HBPC program reduces healthcare costs while enabling frail elders to remain at home. Reduction in costs is obtained at end-of-life and is offset with a smaller initial increase in costs upon enrollment. [ABSTRACT FROM AUTHOR]

Background: People who inject drugs (PWID) constitute 60% of the approximately 5 million people in the U.S. infected with hepatitis C virus (HCV). Treatment of PWID is complex due to addiction, mental illness, poverty, homelessness, lack of positive social support, poor adherence-related skills, low motivation and knowledge, and poor access to and trust in the health care system. New direct-acting antiviral medications are available for HCV with high cure rates and few side effects. The life expectancy and economic benefits of new HCV treatments will not be realized unless we determine optimal models of care for the majority of HCV-infected patients. The purpose of this study is to evaluate the effectiveness of directly observed therapy and group treatment compared with self-administered individual treatment in a large, urban opioid agonist therapy clinic setting in the Bronx, New York.Methods/design: In this randomized controlled trial 150 PWID with chronic HCV were recruited from opioid agonist treatment (OAT) clinics and randomized to one of three models of onsite HCV treatment in OAT: 1) modified directly observed therapy; 2) group treatment; or 3) control - self-administered individual treatment. Participants were age 18 or older, HCV genotype 1, English or Spanish speaking, treatment naïve (or treatment experienced after 12/3/14), willing to receive HCV treatment onsite, receiving methadone or buprenorphine at the medication window at least once per week, and able to provide informed consent. Outcomes of interest include adherence (as measured by self-report and electronic blister packs), HCV treatment completion, sustained virologic response, drug resistance, and cost-effectiveness.Discussion: This paper describes the design and rationale of a randomized controlled trial comparing three models of care for HCV therapy delivered in an opioid agonist treatment program. Our trial will be critical to rigorously identify models of care that result in high adherence and cure rates. Use of blister pack technology will help us determine the role of adherence in successful cure of HCV. Moreover, the trial methodology outlined here can serve as a template for the development of future programs and studies among HCV-infected drug users receiving opioid agonist therapy, as well as the cost-effectiveness of such programs.Trial Registration: This trial was registered with ClinicalTrials.gov ( NCT01857245 ). Trial registration was obtained prospectively on May 20th, 2013. [ABSTRACT FROM AUTHOR]

Background: Hazardous environmental exposures are recognized risk factors for falls among older adults. However, the gender differences in the associations of falls with indoor and outdoor environmental hazards are scarce. This study examined the indoor and outdoor environmental risk factors for falls and compared the data for men and women among U.S. older adults using nationally representative data.Methods: We used the 2011 National Health and Aging Trends Study (NHATS) for a cross-sectional analysis of 6680 community-dwelling adults aged ≥65 years in the United States. A series of logistic regressions was used to identify the indoor and outdoor environmental hazards associated with falls stratified by gender after adjusting for sociodemographic, health, and behaviors. We also tested for significant interactions with gender.Results: Compared to men, women had a higher prevalence of falls. In the model adjusted for sociodemographic, health, and behavioral conditions, there were gender differences in the association of falls with the presence of indoor and outdoor environmental hazards. Gender-specific analyses showed that women with the presence of indoor environmental hazards (OR = 1.37, 95% CI = 1.04.-1.79) had higher odds of falls, whereas for men, the presence of outdoor environmental hazards (OR = 1.34, 95% CI = 1.02-1.75) was associated with falls. We also found a significant interaction term between outdoor environmental hazards and gender (OR = 0.65, 95% CI = 0.47-0.90). The interaction plot indicated that the presence of outdoor environmental hazards increased the risks of falling in men but not in women.Conclusions: Significant gender differences exist in the association of falls with indoor and outdoor environmental hazards among older men and women. Our findings suggest that gender-tailored prevention programs to increase awareness of the environmental hazards and gender-specific environmental interventions are needed to help prevent falls. [ABSTRACT FROM AUTHOR]

Objectives: The patent linkage system upgraded patent challenges to an important factor in granting timely market approval for generic drugs. We aim to understand patent challenges and identify the factors that are associated with successful patent challengers under the patent linkage system in South Korea.Methods: We constructed a novel dataset that combined information on manufacturers with detailed data about their patent challenges after introduction of the patent linkage system. Based on the number of successful patent challenges, manufacturers were categorized into non-challengers, passive challengers, and aggressive challengers. Then, two types of logistic models were applied to identify the factors associated with successful and aggressive challengers.Findings: Only 39 active ingredients were challenged by 77 manufacturers from March 2015 to December 2019. Of 171 manufacturers, 94 (55 %) were non-challengers, 58 (34 %) were passive challengers who had succeeded in fewer than 4 patent challenges, and 19 (11 %) were aggressive challengers who had succeeded in 4 or more patent challenges. Higher sales, more employees, and a greater number of reimbursed drugs were associated with being a patent challenger, while a greater number of reimbursed drugs was associated with being an aggressive challenger.Conclusion: Some manufacturers utilize patent challenges to strengthen their product portfolios in the market. However, under the patent linkage system, the frequency of patent challenges is limited in South Korea compared to the United States. In particular, patent challenges against drugs in injection form and biologics are very rare. [ABSTRACT FROM AUTHOR]

Background: The inclusion of self-reported differential treatment by race/ethnicity in population-based public health surveillance and monitoring systems may provide an opportunity to address long-standing health inequalities. While there is a growing trend towards decreasing response rates and selective non-response in health surveys, research examining the magnitude of non-response related to self-reported discrimination warrants greater attention. This study examined the distribution of sociodemographic variables among respondents and non-respondents to the South Carolina Behavioral Risk Factor Surveillance System (SC-BRFSS) Reactions to Race module (6-question optional module capturing reports of race-based treatment).Methods: Using data from SC-BRFSS (2016, 2017), we examined patterns of non-response to the Reactions to Race module and individual items in the module. Logistic regression models were employed to examine sociodemographic factors associated with non-response and weighted to account for complex sampling design.Results: Among 21,847 respondents, 15.3% were non-responders. Significant differences in RTRM non-response were observed by key sociodemographic variables (e.g., age, race/ethnicity, labor market participation, and health insurance status). Individuals who were younger, Hispanic, homemakers/students, unreported income, and uninsured were over-represented among non-respondents. In adjusted analyses, Hispanics and individuals with unreported income were more likely to be non-responders in RTRM and across item, while retirees were less likely to be non-responders. Heterogeneity in levels of non-responses were observed across RTRM questions, with the highest level of non-response for questions assessing differential treatment in work (54.8%) and healthcare settings (26.9%).Conclusions: Non-responders differed from responders according to some key sociodemographic variables, which could contribute to the underestimation of self-reported discrimination and race-related differential treatment and health outcomes. While we advocate for the use of population-based measures of self-reported racial discrimination to monitor and track state-level progress towards health equity, future efforts to estimate, assess, and address non-response variations by sociodemographic factors are warranted to improve understanding of lived experiences impacted by race-based differential treatment. [ABSTRACT FROM AUTHOR]

Background: With the increasing changes in tobacco use patterns, "current use" definition and the survey used may have important implications for monitoring population use trends.Methods: Using three US surveys (2014/15 TUS-CPS, NHIS and PATH), we compared the adult (age 18+) prevalence of four product groups (cigarettes, other combustibles, smokeless tobacco, and e-cigarettes) based on three past 30-day frequency of use thresholds: 1+, 10+, and 25+ days. We also examined mutually exclusive single, dual, and polytobacco users as a percentage of total users for each product group.Results: Regardless of threshold or product, the prevalence was higher in PATH followed by NHIS and TUS-CPS, in some cases by large percentages. The differences in cigarette and smokeless tobacco use prevalence in going from the 1+ to 10+ days and to the 25+ days threshold were minimal. Applying different frequency thresholds had the largest impact on other combustibles prevalence, with a 60% reduction with the 10+ days threshold and a 80% reduction with the 25+ days threshold, compared to the 1+ days threshold, followed by e-cigarettes with 40 and 60% reductions, respectively. The proportion of dual and polytobacco users decreased considerably when using the 10+ vs. the 1+ days threshold and polytobacco use was almost non-existent with the 25+ days threshold.Conclusion: The estimated prevalence of each tobacco product use depends largely on the survey and frequency of use threshold adopted. The choice of survey and frequency threshold merits serious consideration when monitoring patterns of tobacco use. [ABSTRACT FROM AUTHOR]

Background: The patient ranking process for donor lung allocation in the United States is carried out by a classification-based, computerized algorithm, known as the match system. Experts have suggested that a continuous, points-based allocation framework would better serve waiting list candidates by removing hard boundaries and increasing transparency into the relative importance of factors used to prioritize candidates. We applied discrete choice modeling to match run data to determine the feasibility of approximating current lung allocation policy by one or more composite scores. Our study aimed to demystify the points-based approach to organ allocation policy; quantify the relative importance of factors used in current policy; and provide a viable policy option that adapts the current, classification-based system to the continuous allocation framework.Methods: Rank ordered logistic regression models were estimated using 6466 match runs for 5913 adult donors and 534 match runs for 488 pediatric donors from 2018. Four primary attributes are used to rank candidates and were included in the models: (1) medical priority, (2) candidate age, (3) candidate's transplant center proximity to the donor hospital, and (4) blood type compatibility with the donor.Results: Two composite scores were developed, one for adult and one for pediatric donor allocation. Candidate rankings based on the composite scores were highly correlated with current policy rankings (Kendall's Tau ~ 0.80, Spearman correlation > 90%), indicating both scores strongly reflect current policy. In both models, candidates are ranked higher if they have higher medical priority, are registered at a transplant center closer to the donor hospital, or have an identical blood type to the donor. Proximity was the most important attribute. Under a points-based scoring system, candidates in further away zones are sometimes ranked higher than more proximal candidates compared to current policy.Conclusions: Revealed preference analysis of lung allocation match runs produced composite scores that capture the essence of current policy while removing rigid boundaries of the current classification-based system. A carefully crafted, continuous version of lung allocation policy has the potential to make better use of the limited supply of donor lungs in a manner consistent with the priorities of the transplant community. [ABSTRACT FROM AUTHOR]

Background: Previous studies have reported a high prevalence of excessive gestational weight gain (GWG) in women with prepregnancy BMI classified as overweight and obese. However, the joint evidence regarding GWG and prepregnancy BMI in the worldwide population has not been synthesized. Thus, this systematic review and meta-analysis aimed to estimate global and regional mean GWG and the prevalence of GWG above, within and below 2009 Institute of Medicine (IOM) guidelines. Second, we aimed to estimate global and regional prepregnancy BMI and the prevalence of BMI categories according to World Health Organization (WHO) classification.Methods: We searched Medline, Embase, the Cochrane Library and Web of Science to identify observational studies until 9 May 2018. We included studies published from 2009 that used 2009 IOM guidelines, reporting data from women in general population with singleton pregnancies. The 2009 IOM categories for GWG and the WHO categories for prepregnancy BMI were used. DerSimonian and Laird random effects methods were used to estimate the pooled and their respective 95% confidence intervals (95% CIs) of the mean and by category rates of GWG and prepregnancy BMI, calculated by global and regions.Results: Sixty-three published studies from 29 countries with a total sample size of 1,416,915 women were included. The global prevalence of GWG above and below the 2009 IOM guidelines, was 27.8% (95% CI; 26.5, 29.1) and 39.4% (95% CI; 37.1, 41.7), respectively. Furthermore, meta-regression analyses showed that the mean GWG and the prevalence of GWG above guidelines have increased. The global prevalence of overweight and obesity, was 23.0% (95% CI; 22.3, 23.7) and 16.3% (95% CI; 15.4, 17.4), respectively. The highest mean GWG and prepregnancy BMI were in North America and the lowest were in Asia.Conclusions: Considering the high prevalence of GWG above the 2009 IOM guidelines and women with overweight/obesity and their continuously increasing trend in most regions, clinicians should recommend lifestyle interventions to improve women's weight during reproductive age. Due to regional variability, these interventions should be adapted to each cultural context.Trial Registration: Prospectively registered with PROSPERO ( CRD42018093562 ). [ABSTRACT FROM AUTHOR]

Background: Promoting uptake of evidence-based innovations in healthcare systems requires attention to how innovations are adapted to enhance their fit with a given setting. Little is known about real-world variation in how programs are delivered over time and across multiple populations and contexts, and what motivates adaptations.Methods: As part of the BeneFIT study of mailed fecal immunochemical tests (FIT) to increase colorectal cancer screening, we interviewed 9 leaders from two participating Medicaid/Medicare health insurance plans to examine adaptations to their health plan-initiated mailed FIT outreach programs in the second year of implementation. We applied an adaptation and modification model developed by Stirman and colleagues to document content and context modifications made to the two programs.Results: Both health plans made substantial changes to their programs in the second year; adaptations differed substantially across health plans. In Health Plan Oregon, adaptations generally targeted health centers and member populations, most content adaptations involved tailoring program components, and the program was expanded to four additional health centers. In contrast, Health Plan Washington's second-year content adaptations were primarily at the level of members, and generally involved adding program components. Moreover, Health Plan Washington undertook large-scale context adaptations to the setting where the program was led (local vs. national), the personnel who administered the program (vendor and staffing), and the population selected for outreach (limiting outreach to dual-eligible members).Conclusions: Both programs implemented a variety of adaptations that reflected the values and incentives of the broader health plan contexts. Financial incentives for screening allowed Health Plan Oregon to expand but led Health Plan Washington to offer more targeted outreach to a subset of eligible enrollees. The breadth of changes made by each health system reflects the necessity of evaluating programs in context and adjusting to specific challenges as they are identified. Further research is needed to understand the effects of these types of adaptations on program efficiency and enrollee and health system outcomes. [ABSTRACT FROM AUTHOR]

Background: The majority of participants in weight loss trials are non-Hispanic White women, while men and women of color are underrepresented. This study presents data obtained from non-targeted and targeted recruitment approaches in a trial of behavioral weight loss programs to (1) describe the yields from each approach and (2) compare the demographics, weight control histories, and study involvement of samples recruited by each approach.Methods: Data for this observational study include source of recruitment, demographic information, weight loss experiences (e.g., lifetime weight loss, current weight loss behaviors), and completion of the 6-month assessment visit.Results: Men comprised 14.2% of participants who responded to non-targeted recruitment efforts, while targeted efforts yielded 50.4% men. Similarly, people of color comprised 12.8% of those who responded to non-targeted approaches, whereas targeted recruitment methods yielded 47.2% people of color. Men recruited through targeted methods were younger (p = 0.01) than men recruited through non-targeted means but were otherwise similar. Women of color recruited through targeted methods reported use of fewer weight loss strategies relative to women of color recruited through non-targeted means (p = 0.006) but were otherwise similar. There were no differences by recruitment method on retention to the study.Conclusions: Using targeted recruitment methods increased the ethnic and gender diversity of the recruited sample without reducing study retention. This targeting also increased the enrollment of women with less weight loss experience who may not have otherwise sought out a weight loss program. Developing and implementing a targeted recruitment plan should be considered early in the clinical trial development process.Trial Registration: Clinicaltrials.gov, NCT02368002. Registered on 20 February 2015. [ABSTRACT FROM AUTHOR]

Background: Implementation theories, models and frameworks offer guidance when implementing and sustaining healthcare evidence-based interventions. However, selection can be challenging given the myriad of potential options. We propose to inform a decision support tool to facilitate the appropriate selection of an implementation theory, model or framework in practice. To inform tool development, this study aimed to explore barriers and facilitators to identifying and selecting implementation theories, models and frameworks in research and practice, as well as end-user preferences for features and functions of the proposed tool.Methods: We used an interpretive descriptive approach to conduct semi-structured interviews with implementation researchers and practitioners in Canada, the United States and Australia. Audio recordings were transcribed verbatim. Data were inductively coded by a single investigator with a subset of 20% coded independently by a second investigator and analyzed using thematic analysis.Results: Twenty-four individuals participated in the study. Categories of barriers/facilitators, to inform tool development, included characteristics of the individual or team conducting implementation and characteristics of the implementation theory, model or framework. Major barriers to selection included inconsistent terminology, poor fit with the implementation context and limited knowledge about and training in existing theories, models and frameworks. Major facilitators to selection included the importance of clear and concise language and evidence that the theory, model or framework was applied in a relevant health setting or context. Participants were enthusiastic about the development of a decision support tool that is user-friendly, accessible and practical. Preferences for tool features included key questions about the implementation intervention or project (e.g., purpose, stage of implementation, intended target for change) and a comprehensive list of relevant theories, models and frameworks to choose from along with a glossary of terms and the contexts in which they were applied.Conclusions: An easy to use decision support tool that addresses key barriers to selecting an implementation theory, model or framework in practice may be beneficial to individuals who facilitate implementation practice activities. Findings on end-user preferences for tool features and functions will inform tool development and design through a user-centered approach. [ABSTRACT FROM AUTHOR]

Background: Infection is the most common cause of mortality within the first year after lung transplantation (LTx). The management of perioperative antibiotic therapy is a major issue, but little is known about worldwide practices.Methods: We sent by email a survey dealing with 5 daily clinical vignettes concerning perioperative antibiotic therapy to 180 LTx centers around the world. The invitation and a weekly reminder were sent to lung transplant specialists for a single consensus answer per center during a 3-month period.Results: We received a total of 99 responses from 24 countries, mostly from Western Europe (n = 46) and the USA (n = 34). Systematic screening for bronchial recipient colonization before LTx was mostly performed with sputum samples (72%), regardless of the underlying lung disease. In recipients without colonization, antibiotics with activity against gram-negative bacteria resistant strains (piperacillin / tazobactam, cefepime, ceftazidime, carbapenems) were reported in 72% of the centers, and antibiotics with activity against methicillin-resistant Staphylococcus aureus (mainly vancomycin) were reported in 38% of the centers. For these recipients, the duration of antibiotics reported was 7 days (33%) or less (26%) or stopped when cultures of donor and recipients were reported negatives (12%). In recipients with previous colonization, antibiotics were adapted to the susceptibility of the most resistant strain and given for at least 14 days (67%).Conclusion: Practices vary widely around the world, but resistant bacterial strains are mostly targeted even if no colonization occurs. The antibiotic duration reported was longer for colonized recipients. [ABSTRACT FROM AUTHOR]

Background: Heart disease is the leading cause of death in the United States. The U.S. Food and Drug Administration approved the health claim that 1.5 oz (42.5 g) of nut intake may reduce the risk of cardiovascular disease. Previous studies have focused on the cost-effectiveness of other foods or dietary factors on primary cardiovascular disease prevention, yet not in almond consumption. This study aimed to examine the cost-effectiveness of almond consumption in cardiovascular disease primary prevention.Perspective& Setting: This study assessed the cost-effectiveness of consuming 42.5 g of almond from the U.S. healthcare sector perspective.Methods: A decision model was developed for 42.5 g of almond per day versus no almond consumption and cardiovascular disease in the U.S.Population: Parameters in the model were derived from the literature, which included the probabilities of increasing low-density lipoprotein cholesterol, developing acute myocardial infarction and stroke, treating acute myocardial infarction, dying from the disease and surgery, as well as the costs of the disease and procedures in the U.S. population, and the quality-adjusted life years. The cost of almonds was based on the current price in the U.S. market. Sensitivity analyses were conducted for different levels of willingness-to-pay, the probabilistic sensitivity analysis, ten-year risk prevention, different costs of procedures and almond prices, and patients with or without cardiovascular disease.Results: The almond strategy had $363 lower cost and 0.02 higher quality-adjusted life years gain compared to the non-almond strategy in the base-case model. The annual net monetary benefit of almond consumption was $1421 higher per person than no almond consumption, when the willingness to pay threshold was set at $50,000 for annual health care expenditure. Almond was more cost-effective than non-almond in cardiovascular disease prevention in all the sensitivity analyses.Conclusion: Consuming 42.5 g of almonds per day is a cost-effective approach to prevent cardiovascular disease in the short term and potentially in the long term. [ABSTRACT FROM AUTHOR]

Background: Endotoxin is ubiquitous in the environment, but its clustering with indoor allergens is not well characterized. This study examined the clustering patterns of endotoxin with allergens in house dust and their association with asthma outcomes.Methods: We analyzed data from 6963 participants of the 2005-2006 National Health and Nutrition Examination Survey. House dust sampled from bedroom floor and bedding was evaluated for endotoxin and allergens from fungi, cockroach, dog, cat, mites, and rodents. Two-step cluster analysis and logistic regressions were performed to identify the clustering patterns and their associations with current asthma and wheeze in the past 12 months, adjusting for covariates.Results: Of the homes, 17.8% had low endotoxin and allergen levels in house dust (Cluster 1). High endotoxin level clustered with Alternaria and pet allergens in the homes of participants with a high socioeconomic status who own pets (Cluster 2) (48.9%). High endotoxin clustered with Aspergillus, dust mites, cockroach, and rodent allergens in the homes of participants with low socioeconomic status (Cluster 3) (33.3%). Compared to Cluster 1, Cluster 2 was associated with higher asthma prevalence (OR 1.42, 95% CI: 1.06-1.91) and wheeze (OR 1.32, 95% CI: 1.07-1.63). Cluster 3 was positively associated with wheeze only in participants sensitized to inhalant allergens (OR 1.42, 95% CI: 1.06-1.91) or exposed to tobacco smoke (OR 1.72, 95% CI: 1.15-2.60).Conclusions: The clustering of endotoxin with allergens in dust from homes with pets or of people with low socioeconomic status is associated with asthma and wheeze. [ABSTRACT FROM AUTHOR]

Background: Perinatal depression is a prevalent public health concern. Although preventive interventions exist, there is limited literature on the acceptability and appropriateness of these interventions, especially those delivered by paraprofessionals. The Mothers and Babies Program (MB) is a group-based perinatal depression preventive intervention delivered prenatally. A cluster-randomized controlled trial examined the acceptability, appropriateness, and effectiveness of MB delivered by mental health professionals compared to paraprofessional staff from home visiting programs.Methods: The full study enrolled 874 pregnant women. Fifty-three facilitators were trained and delivered the MB intervention to women in one of seven states in the United States. Semi-structured interviews were attempted with a randomly-selected subset of the full sample of pregnant women who received the MB intervention and with all facilitators. Specifically, interviews were conducted with 88 women who received the MB group intervention (45 in the paraprofessional-led arm and 43 in the mental health professional-led arm) and 46 women who facilitated the groups (27 home visiting staff and 19 mental health professionals). Interviews were conducted over the phone in English or Spanish and audio recorded. The recordings were translated into English, as needed, and transcribed. Thematic analysis was conducted using NVIVO to identify key themes related to intervention acceptability and appropriateness. Similarities and differences between study arms were explored.Results: Clients and facilitators found the MB content and group format acceptable. Challenges included maintaining group attendance, transportation issues, and managing group discussion. Overall, facilitators found the intervention appropriate for pregnant clients with some challenges presented for clients in crisis situations, experiencing housing instability, and with literacy and learning challenges. Participants provided suggestions for improvement, both for the course content and implementation. There were no significant differences found between study arms.Conclusions: Overall, clients and facilitators enjoyed MB irrespective of study arm, and facilitators found the intervention appropriate for the population. These findings add to the qualitative literature on perinatal depression preventive interventions, specifically those delivered by paraprofessionals.Trial Registration: This trial is registered on ClinicalTrials.gov (Initial post: December 1, 2016; identifier: NCT02979444). [ABSTRACT FROM AUTHOR]

Objective: To examine the association between the medical imaging utilization and information related to patients' socioeconomic, demographic and clinical factors during the patients' ED visits; and to develop predictive models using these associated factors including natural language elements to predict the medical imaging utilization at pediatric ED.Methods: Pediatric patients' data from the 2012-2016 United States National Hospital Ambulatory Medical Care Survey was included to build the models to predict the use of imaging in children presenting to the ED. Multivariable logistic regression models were built with structured variables such as temperature, heart rate, age, and unstructured variables such as reason for visit, free text nursing notes and combined data available at triage. NLP techniques were used to extract information from the unstructured data.Results: Of the 27,665 pediatric ED visits included in the study, 8394 (30.3%) received medical imaging in the ED, including 6922 (25.0%) who had an X-ray and 1367 (4.9%) who had a computed tomography (CT) scan. In the predictive model including only structured variables, the c-statistic was 0.71 (95% CI: 0.70-0.71) for any imaging use, 0.69 (95% CI: 0.68-0.70) for X-ray, and 0.77 (95% CI: 0.76-0.78) for CT. Models including only unstructured information had c-statistics of 0.81 (95% CI: 0.81-0.82) for any imaging use, 0.82 (95% CI: 0.82-0.83) for X-ray, and 0.85 (95% CI: 0.83-0.86) for CT scans. When both structured variables and free text variables were included, the c-statistics reached 0.82 (95% CI: 0.82-0.83) for any imaging use, 0.83 (95% CI: 0.83-0.84) for X-ray, and 0.87 (95% CI: 0.86-0.88) for CT.Conclusions: Both CT and X-rays are commonly used in the pediatric ED with one third of the visits receiving at least one. Patients' socioeconomic, demographic and clinical factors presented at ED triage period were associated with the medical imaging utilization. Predictive models combining structured and unstructured variables available at triage performed better than models using structured or unstructured variables alone, suggesting the potential for use of NLP in determining resource utilization. [ABSTRACT FROM AUTHOR]

Background: Even though in situ breast cancer (BCIS) accounts for a large proportion of the breast cancers diagnosed, few studies have investigated potential risk factors for BCIS. Their results suggest that some established risk factors for invasive breast cancer have a similar impact on BCIS risk, but large population-based studies on lifestyle factors and BCIS risk are lacking. Thus, we investigated the association between lifestyle and BCIS risk within the European Prospective Investigation into Cancer and Nutrition cohort.Methods: Lifestyle was operationalized by a score reflecting the adherence to the World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) cancer prevention recommendations. The recommendations utilized in these analyses were the ones pertinent to healthy body weight, physical activity, consumption of plant-based foods, energy-dense foods, red and processed meat, and sugary drinks and alcohol, as well as the recommendation on breastfeeding. Cox proportional hazards regression was used to assess the association between lifestyle score and BCIS risk. The results were presented as hazard ratios (HR) and corresponding 95% confidence intervals (CI).Results: After an overall median follow-up time of 14.9 years, 1277 BCIS cases were diagnosed. Greater adherence to the WCRF/AICR cancer prevention recommendations was not associated with BCIS risk (HR = 0.98, 95% CI 0.93-1.03; per one unit of increase; multivariable model). An inverse association between the lifestyle score and BCIS risk was observed in study centers, where participants were recruited mainly via mammographic screening and attended additional screening throughout follow-up (HR = 0.85, 95% CI 0.73-0.99), but not in the remaining ones (HR = 0.99, 95% CI 0.94-1.05).Conclusions: While we did not observe an overall association between lifestyle and BCIS risk, our results indicate that lifestyle is associated with BCIS risk among women recruited via screening programs and with regular screening participation. This suggests that a true inverse association between lifestyle habits and BCIS risk in the overall cohort may have been masked by a lack of information on screening attendance. The potential inverse association between lifestyle and BCIS risk in our analyses is consistent with the inverse associations between lifestyle scores and breast cancer risk reported from previous studies. [ABSTRACT FROM AUTHOR]

Background: Interventions to improve fecal testing for colorectal cancer (CRC) exist, but are not yet routine practice. We conducted this systematic review to determine how implementation strategies and contextual factors influenced the uptake of interventions to increase Fecal Immunochemical Tests (FIT) and Fecal Occult Blood Testing (FOBT) for CRC in rural and low-income populations in the United States.Methods: We searched Medline and the Cochrane Library from January 1998 through July 2016, and Scopus and clinicaltrials.gov through March 2015, for original articles of interventions to increase fecal testing for CRC. Two reviewers independently screened abstracts, reviewed full-text articles, extracted data and performed quality assessments. A qualitative synthesis described the relationship between changes in fecal testing rates for CRC, intervention components, implementation strategies, and contextual factors. A technical expert panel of primary care professionals, health system leaders, and academicians guided this work.Results: Of 4218 citations initially identified, 27 unique studies reported in 29 publications met inclusion criteria. Studies were conducted in primary care (n = 20, 74.1%), community (n = 5, 18.5%), or both (n = 2, 7.4%) settings. All studies (n = 27, 100.0%) described multicomponent interventions. In clinic based studies, components that occurred most frequently among the highly effective/effective study arms were provision of kits by direct mail, use of a pre-addressed stamped envelope, client reminders, and provider ordered in-clinic distribution. Interventions were delivered by clinic staff/community members (n = 10, 37.0%), research staff (n = 6, 22.2%), both (n = 10, 37.0%), or it was unclear (n = 1, 3.7%). Over half of the studies lacked information on training or monitoring intervention fidelity (n = 15, 55.6%).Conclusions: Studies to improve FIT/FOBT in rural and low-income populations utilized multicomponent interventions. The provision of kits through the mail, use of pre-addressed stamped envelopes, client reminders and in-clinic distribution appeared most frequently in the highly effective/effective clinic-based study arms. Few studies described contextual factors or implementation strategies. More robust application of guidelines to support reporting on methods to select, adapt and implement interventions can help end users determine not just which interventions work to improve CRC screening, but which interventions would work best in their setting given specific patient populations, clinical settings, and community characteristics.Trial Registration: In accordance with PRISMA guidelines, our systematic review protocol was registered with PROSPERO, the international prospective register of systematic reviews, on April 16, 2015 (registration number CRD42015019557 ). [ABSTRACT FROM AUTHOR]

Food and beverage marketing contributes to poor dietary choices among adults and children. As consumers spend more time on the Internet, food and beverage companies have increased their online marketing efforts. Studies have shown food companies' online promotions use a variety of marketing techniques to promote mostly energy-dense, nutrient-poor products, but no studies have compared the online marketing techniques and nutritional quality of products promoted on food companies' international websites. For this descriptive study, we developed a qualitative codebook to catalogue the marketing themes used on 18 international corporate websites associated with the world's three largest fast food and beverage companies (i.e. Coca-Cola, McDonald's, Kentucky Fried Chicken). Nutritional quality of foods featured on those websites was evaluated based on quantitative Nutrient Profile Index scores and food category (e.g. fried, fresh). Beverages were sorted into categories based on added sugar content. We report descriptive statistics to compare the marketing techniques and nutritional quality of products featured on the company websites for the food and beverage company websites in two high-income countries (HICs), Germany and the United States, two upper-middle-income countries (UMICs), China and Mexico, and two lower-middle-income countries (LMICs), India and the Philippines. Of the 406 screenshots captured from company websites, 67·8% depicted a food or beverage product. HICs' websites promoted diet food or beverage products/healthier alternatives (e.g. baked chicken sandwich) significantly more often on their pages (25%), compared to LMICs (14·5%). Coca-Cola featured diet products significantly more frequently on HIC websites compared to LMIC websites. Charities were featured more often on webpages in LMICs (15·4%) compared to UMICs (2·6%) and HICs (2·3%). This study demonstrates that companies showcase healthier products in wealthier countries and advertise their philanthropic activities in lower income countries, which is concerning given the negative effect of nutrition transition (double burden of overnutrition and undernutrition) on burden of non-communicable diseases and obesity in lower income countries. [ABSTRACT FROM AUTHOR]

Background: To determine the impact of preoperative Liver Dysfunction (LD) on outcomes after elective Coronary Artery Bypass Grafting (CABG) and Valvular surgery (VS).Methods: The Nationwide Inpatient Sample (2002-2010) was queried to identify patients with LD who had elective CABG or VS utilizing ICD-9-CM diagnosis and procedure codes. These patients were matched with the similar patients without LD (controls) by propensity score matching. Chi-square and Wilcoxon rank sum tests were used for analysis.Results: We identified 1197 patients with LD (CABG = 755; VS = 442) who were matched to 2394 controls. LD significantly increased hospital mortality after both CABG (OR = 5.19; 95%CI = 2.93-9.20) and VS (OR = 7.49; 95%CI = 3.12-17.96). Overall rates of complications after CABG with LD were greater than in non-complicated cases (OR = 1.73; 95%CI = 1.46-2.05). Among them, there was an increase in bleeding (OR = 1.81;95%CI = 1.44-2.28), respiratory (OR = 2.33;95%CI = 1.86-2.93), renal (OR = 2.79;95%CI = 2.04-3.81), and infectious (OR = 2.93;95%CI = 2.14-4.01) complications. In general, the rates of complications after VS with LD were also greater than in non-complicated cases (OR = 2.77;95%CI = 2.13-3.60), specifically for bleeding (OR = 3.07;95%CI = 2.17-4.34), respiratory (OR = 3.57;95%CI = 2.51-5.07), renal (OR = 4.40;95%CI = 2.80-6.92), and infectious (OR = 4.63;95%CI = 2.85-7.51) complications. The development of LD significantly increased mean hospital length of stay (LOS) and total hospital charges after both CABG (from7.0 ± 4.0 to 9.2 ± 9.1 days and from $100,265 ± 87,107 to $117,756 ± 99,320, respectively; P < 0.0001 for both) and VS (from 7.9 ± 5.0 to 11.4 ± 9.9 days and from $134,306 ± 114,216 to $176,620 ± 147,049, respectively; P < 0.0001 for both).Conclusions: LD worsened the outcomes after cardiac surgery. It increased rates of complications, hospital mortality, length of stay and total hospital charges after both procedures. [ABSTRACT FROM AUTHOR]

Background: Evaluation of repetitive transcranial magnetic stimulation (rTMS) for treatment-resistant major depression (TRMD) in Veterans offers unique clinical trial challenges. Here we describe a randomized, double-blinded, intent-to-treat, two-arm, superiority parallel design, a multicenter study funded by the Cooperative Studies Program (CSP No. 556) of the US Department of Veterans Affairs.Methods: We recruited medical providers with clinical expertise in treating TRMD at nine Veterans Affairs (VA) medical centers as the trial local investigators. We plan to enroll 360 Veterans diagnosed with TRMD at the nine VA medical centers over a 3-year period. We will randomize participants into a double-blinded clinical trial to left prefrontal rTMS treatment or to sham (control) rTMS treatment (180 participants each group) for up to 30 treatment sessions. All participants will meet Diagnostic and statistical manual of mental disorders, 4 th edition (DSM-IV) criteria for major depression and will have failed at least two prior pharmacological interventions. In contrast with other rTMS clinical trials, we will not exclude Veterans with posttraumatic stress disorder (PTSD) or history of substance abuse and we will obtain detailed history regarding these disorders. Furthermore, we will maintain participants on stable anti-depressant medication throughout the trial. We will evaluate all participants on a wide variety of potential predictors of treatment response including cognitive, psychological and functional parameters.Discussion: The primary dependent measure will be remission rate (Hamilton Rating Scale for Depression (HRSD24) ≤ 10), and secondary analyses will be conducted on other indices. Comparisons between the rTMS and the sham groups will be made at the end of the acute treatment phase to test the primary hypothesis. The unique challenges to performing such a large technically challenging clinical trial with Veterans and potential avenues for improvement of the design in future trials will be described.Trial Registration: ClinicalTrials.gov, NCT01191333 . Registered on 26 August 2010. This report is based on the protocol version 4.6 amended in February 2016. All items from the World Health Organization Trial Registration Data Set are listed in Appendix A. [ABSTRACT FROM AUTHOR]

Background: Overuse of antibiotics is a major public health problem, contributing to growing antibiotic resistance. Procalcitonin has been reported to be commonly elevated in bacterial, but not viral infection. Multiple European trials found procalcitonin-guided care reduced antibiotic use in lower respiratory tract infection, with no apparent harm. However, applicability to US practice is limited due to trial design features impractical in the US, between-country differences, and residual safety concerns.Methods: The Procalcitonin Antibiotic Consensus Trial (ProACT) is a multicenter randomized trial to determine the impact of a procalcitonin antibiotic prescribing guideline, implemented with basic reproducible strategies, in US patients with lower respiratory tract infection.Discussion: We describe the trial methods using the Consolidated Standards of Reporting Trials (CONSORT) framework, and the rationale for key design decisions, including choice of eligibility criteria, choice of control arm, and approach to guideline implementation.Trial Registration: ClinicalTrials.gov NCT02130986 . Registered May 1, 2014. [ABSTRACT FROM AUTHOR]

Background: The NEI VFQ-25 has undergone psychometric evaluation in patients with varying ocular conditions and the general population. However, important limitations which may affect the interpretation of clinical trial results have been previously identified, such as concerns with reliability and validity. The purpose of this study was to evaluate the National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) and make recommendations for a revised scoring structure, with a view to improving its psychometric performance and interpretability.Methods: Rasch Measurement Theory analyses were conducted in two stages using pooled baseline NEI VFQ-25 data for 2487 participants with retinal diseases enrolled in six clinical trials. In stage 1, we examined: scale-to-sample targeting; thresholds for item response options; item fit statistics; stability; local dependence; and reliability. In stage 2, a post-hoc revision of the scoring structure (VFQ-28R) was created and psychometrically re-evaluated.Results: In stage 1, we found that the NEI VFQ-25 was mis-targeted to the sample, and had disordered response thresholds (15/25 items) and mis-fitting items (8/25 items). However, items appeared to be stable (differential item functioning for three items), have minimal item dependency (one pair of items) and good reliability (person-separation index, 0.93). In stage 2, the modified Rasch-scored NEI VFQ-28-R was assessed. It comprised two broad domains: Activity Limitation (19 items) and Socio-Emotional Functioning (nine items). The NEI VFQ-28-R demonstrated improved performance with fewer disordered response thresholds (no items), less item misfit (three items) and improved population targeting (reduced ceiling effect) compared with the NEI VFQ-25.Conclusions: Compared with the original version, the proposed NEI VFQ-28-R, with Rasch-based scoring and a two-domain structure, appears to offer improved psychometric performance and interpretability of the vision-related quality of life scale for the population analysed. [ABSTRACT FROM AUTHOR]

Background: The long-term downward national U.S. trend in heart disease-related mortality slowed substantially during 2011-2014 before turning upward in 2015. Examining mortality trends in the major subgroups of heart disease may provide insight into potentially more targeted and effective prevention and treatment approaches to promote favorable trajectories. We examined national trends between 2000 and 2015 in mortality attributed to major heart disease subgroups including ischemic heart disease, heart failure, and all other types of heart disease.Methods: Using the Centers for Disease Control and Prevention Wide-ranging Online Data for Epidemiologic Research (WONDER) data system, we determined national trends in age-standardized mortality rates attributed to ischemic heart disease, heart failure, and other heart diseases from January 1, 2000, to December 31, 2011, and from January 1, 2011, to December 31, 2015. Annual rate of changes in mortality attributed to ischemic heart disease, heart failure, and other heart diseases for 2000-2011 and 2011-2015 were compared.Results: Death attributed to ischemic heart disease declined from 2000 to 2015, but the rate of decline slowed from 4.96% (95% confidence interval 4.77%-5.15%) for 2000-2011 to 2.66% (2.00%-3.31%) for 2011-2015. In contrast, death attributed to heart failure and all other causes of heart disease declined from 2000 to 2011 at annual rates of 1.94% (1.77%-2.11%) and 0.64% (0.44%-0.82%) respectively, but increased from 2011 to 2015 at annual rates of 3.73% (3.21% 4.26%) and 1.89% (1.33-2.46%). Differences in 2000-2011 and 2011-2015 decline rates were statistically significant for all 3 endpoints overall, by sex, and all race/ethnicity groups except Asian/Pacific Islanders (heart failure only significant) and American Indian/Alaskan Natives.Conclusions: While the long-term decline in death attributed to heart disease slowed between 2011 and 2014 nationally before turning upward in 2015, heterogeneity existed in the trajectories attributed to heart disease subgroups, with ischemic heart disease mortality continuing to decline while death attributed to heart failure and other heart diseases switched from a downward to upward trend. While systematic efforts to prevent and treat ischemic heart disease continue to be effective, urgent attention is needed to address the challenge of heart failure. [ABSTRACT FROM AUTHOR]

Background: The use of analgesic antipyretics (ANAP) in children have long been a matter of controversy. Data on their practical use on an individual level has, however, been scarce. There are indications of possible effects on glucose homeostasis and immune function related to the use of ANAP. The aim of this study was to analyze patterns of analgesic antipyretic use across the clinical centers of The Environmental Determinants of Diabetes in the Young (TEDDY) prospective cohort study and test if ANAP use was a risk factor for islet autoimmunity.Methods: Data were collected for 8542 children in the first 2.5 years of life. Incidence was analyzed using logistic regression with country and first child status as independent variables. Holm's procedure was used to adjust for multiplicity of intercountry comparisons. Time to autoantibody seroconversion was analyzed using a Cox proportional hazards model with cumulative analgesic use as primary time dependent covariate of interest. For each categorization, a generalized estimating equation (GEE) approach was used.Results: Higher prevalence of ANAP use was found in the U.S. (95.7%) and Sweden (94.8%) compared to Finland (78.1%) and Germany (80.2%). First-born children were more commonly given acetaminophen (OR 1.26; 95% CI 1.07, 1.49; p = 0.007) but less commonly Non-Steroidal Anti-inflammatory Drugs (NSAID) (OR 0.86; 95% CI 0.78, 0.95; p = 0.002). Acetaminophen and NSAID use in the absence of fever and infection was more prevalent in the U.S. (40.4%; 26.3% of doses) compared to Sweden, Finland and Germany (p < 0.001). Acetaminophen or NSAID use before age 2.5 years did not predict development of islet autoimmunity by age 6 years (HR 1.02, 95% CI 0.99-1.09; p = 0.27). In a sub-analysis, acetaminophen use in children with fever weakly predicted development of islet autoimmunity by age 3 years (HR 1.05; 95% CI 1.01-1.09; p = 0.024).Conclusions: ANAP use in young children is not a risk factor for seroconversion by age 6 years. Use of ANAP is widespread in young children, and significantly higher in the U.S. compared to other study sites, where use is common also in absence of fever and infection. [ABSTRACT FROM AUTHOR]

Background: Hepatitis C virus (HCV) is a common and highly morbid illness. New medications that have much higher cure rates have become the new evidence-based practice in the field. Understanding the implementation of these new medications nationally provides an opportunity to advance the understanding of the role of implementation strategies in clinical outcomes on a large scale. The Expert Recommendations for Implementing Change (ERIC) study defined discrete implementation strategies and clustered these strategies into groups. The present evaluation assessed the use of these strategies and clusters in the context of HCV treatment across the US Department of Veterans Affairs (VA), Veterans Health Administration, the largest provider of HCV care nationally.Methods: A 73-item survey was developed and sent to all VA sites treating HCV via electronic survey, to assess whether or not a site used each ERIC-defined implementation strategy related to employing the new HCV medication in 2014. VA national data regarding the number of Veterans starting on the new HCV medications at each site were collected. The associations between treatment starts and number and type of implementation strategies were assessed.Results: A total of 80 (62%) sites responded. Respondents endorsed an average of 25 ± 14 strategies. The number of treatment starts was positively correlated with the total number of strategies endorsed (r = 0.43, p < 0.001). Quartile of treatment starts was significantly associated with the number of strategies endorsed (p < 0.01), with the top quartile endorsing a median of 33 strategies, compared to 15 strategies in the lowest quartile. There were significant differences in the types of strategies endorsed by sites in the highest and lowest quartiles of treatment starts. Four of the 10 top strategies for sites in the top quartile had significant correlations with treatment starts compared to only 1 of the 10 top strategies in the bottom quartile sites. Overall, only 3 of the top 15 most frequently used strategies were associated with treatment.Conclusions: These results suggest that sites that used a greater number of implementation strategies were able to deliver more evidence-based treatment in HCV. The current assessment also demonstrates the feasibility of electronic self-reporting to evaluate ERIC strategies on a large scale. These results provide initial evidence for the clinical relevance of the ERIC strategies in a real-world implementation setting on a large scale. This is an initial step in identifying which strategies are associated with the uptake of evidence-based practices in nationwide healthcare systems. [ABSTRACT FROM AUTHOR]

Background: An array of risk factors has been associated with cardiovascular diseases, and developing nations are becoming disproportionately affected by such diseases. Cardiovascular diseases have been reported to be highly prevalent in the Mexican population, but local mortality data is poor. The Mexican side of the US-Mexico border has a culture that is closely related to a developed nation and therefore may share the same risk factors of cardiovascular diseases. We wanted to explore if there was higher cardiovascular mortality in the border region of Mexico compared to the rest of the nation.Methods: We conducted a population based cross-sectional time series analysis to estimate the effects of education, insurance and municipal size in Mexican border (n = 38) and non-border municipalities (n = 2360) and its association with cardiovascular age-adjusted mortality rates between the years 1998-2012. We used a mixed effect linear model with random effect estimation and repeated measurements to compare the main outcome variable (mortality rate), the covariates (education, insurance and population size) and the geographic delimiter (border/non-border).Results: Mortality due to cardiovascular disease was consistently higher in the municipalities along the US-Mexico border, showing a difference of 78 · 5 (95% CI 58 · 7-98 · 3, p < 0 · 001) more cardiovascular deaths after adjusting for covariates. Larger municipal size and higher education levels showed a reduction in cardiovascular mortality of 12 · 6 (95% CI 11 · 4-13 · 8, p < 0 · 001) deaths and 8 · 6 (95% CI 5 · 5-11 · 8, p < 0 · 001) deaths respectively. Insurance coverage showed an increase in cardiovascular mortality of 3 · 6 (95% CI 3 · 1-4 · 0, p < 0 · 001) deaths per decile point increase. There was an increase in cardiovascular mortality of 0 · 3 (95% CI -0 · 001-0 · 6, p = 0 · 050) deaths per year increase in the non-border but a yearly reduction of 2 · 9 (95% CI 0 · 75-5.0, p = 0 · 008) deaths in the border over the time period of 1998-2012.Conclusion: We observed that the Mexican side of the US-Mexico border region is disproportionately affected by cardiovascular disease mortality as compared to the non-border region of Mexico. This was not explained by education, population density, or insurance coverage. Proximity to the US culture and related diet and habits can be explanations of the increasing mortality trend. [ABSTRACT FROM AUTHOR]

Background: Over 1100 Veterans work in the Veterans Health Administration (VHA) as peer specialists (PSs). PSs are Veterans with formal training who provide support to other Veterans with similar diagnoses, primarily in mental health settings. A White House Executive Action mandated the pilot reassignment of VHA PSs from mental health to 25 primary care Patient Aligned Care Teams (PACT) in order to broaden the provision of wellness services that can address many chronic illnesses. An evaluation of this initiative was undertaken to assess the impact of outside assistance on the deployment of PS in PACT, as implementation support is often needed to prevent challenges commonly experienced when first deploying PSs in VHA settings. We present the protocol for this cluster-randomized hybrid type II trial to test the impact of standard implementation (receive minimal assistance) vs. facilitated implementation (receive outside assistance) on the deployment of VHA PSs in PACT.Methods: A VHA Office of Mental Health Services work group is recruiting 25 Veterans Affairs Medical Centers to reassign a mental health PSs to provide wellness-oriented care in PACT. Sites in three successive cohorts (n = 8, 8, 9) beginning over 6-month blocks will be matched and randomized to either standard or facilitated implementation. In facilitated implementation, an outside expert works with site stakeholders through a site visit, regular calls, and performance data to guide the planning and address challenges. Standard implementation sites will receive a webinar and access the Office of Mental Health Services work group. The two conditions will be compared on PS workload data, fidelity to the PS model of service delivery, team functioning, and Veteran measures of activation, satisfaction, and functioning. Qualitative interviews will collect information on implementation barriers and facilitators.Discussion: This evaluation will provide critical data to guide administrators and VHA policy makers on future deployment of PSs, as their role has been expanding beyond mental health. In addition, development of novel implementation strategies (facilitation tailored to PSs) and the use of new tools (peer fidelity) can be models for monitoring and supporting deployment of PSs throughout VHA.Trial Registration: ClinicalTrials.gov, NCT02732600 (URL: https://clinicaltrials.gov/ct2/show/NCT02732600 ). [ABSTRACT FROM AUTHOR]

Background: Involuntary exposure to secondhand smoke (SHSe) is an important cause of morbidity in children who present to the pediatric emergency department (PED) and urgent care (UC). SHSe interventions delivered in the PED and UC would benefit both the smoker and child, but there have been no large trials testing the efficacy of such interventions. The Healthy Families program is the first randomized controlled trial to test whether a screening, brief intervention, and referral to treatment (SBIRT) intervention delivered in the PED and UC will be effective in decreasing SHSe in children and increasing cessation in smokers.Methods/design: This trial uses a randomized, two-group design in which caregiver-smokers of children 0-17 years old are recruited from the PED and UC. Eligible caregiver-smokers are randomized to either the: 1) SBIRT Condition with face-to-face, tailored counseling that focuses on the child's illness, the importance of reducing child SHSe, caregiver smoking cessation, and the option to receive nicotine replacement therapy; or 2) Healthy Habits Control Condition which includes face-to-face, tailored attention control "5-2-1-0" counseling that focuses on improving the child's health. Dyadic assessments are conducted in-person at baseline, and via email, phone, or in-person at 6-weeks and 6-months. The primary outcomes are biochemically-verified, 7-day point prevalence and prolonged smoking abstinence. Secondary outcomes are cigarettes smoked per week, 24 h quit attempts, and biochemically validated child SHSe at each time point. The costs of this intervention will also be analyzed.Discussion: This study will test an innovative, multilevel intervention designed to reduce child SHSe and increase smoking cessation in caregivers. If effective and routinely used, this SBIRT model could reach at least one million smokers a year in the U.S., resulting in significant reductions in caregivers' tobacco use, SHSe-related pediatric illness, and healthcare costs in this population of children.Trial Registration: ClinicalTrials.gov Identifier: NCT02531594. Date of registration: August 4, 2015. [ABSTRACT FROM AUTHOR]

There is extensive health and public health literature on the 'evidence-policy gap', exploring the frustrating experiences of scientists trying to secure a response to the problems and solutions they raise and identifying the need for better evidence to reduce policymaker uncertainty. We offer a new perspective by using policy theory to propose research with greater impact, identifying the need to use persuasion to reduce ambiguity, and to adapt to multi-level policymaking systems.We identify insights from secondary data, namely systematic reviews, critical analysis and policy theories relevant to evidence-based policymaking. The studies are drawn primarily from countries such as the United States, United Kingdom, Canada, Australia and New Zealand. We combine empirical and normative elements to identify the ways in which scientists can, do and could influence policy.We identify two important dilemmas, for scientists and researchers, that arise from our initial advice. First, effective actors combine evidence with manipulative emotional appeals to influence the policy agenda - should scientists do the same, or would the reputational costs outweigh the policy benefits? Second, when adapting to multi-level policymaking, should scientists prioritise 'evidence-based' policymaking above other factors? The latter includes governance principles such the 'co-production' of policy between local public bodies, interest groups and service users. This process may be based primarily on values and involve actors with no commitment to a hierarchy of evidence.We conclude that successful engagement in 'evidence-based policymaking' requires pragmatism, combining scientific evidence with governance principles, and persuasion to translate complex evidence into simple stories. To maximise the use of scientific evidence in health and public health policy, researchers should recognise the tendency of policymakers to base judgements on their beliefs, and shortcuts based on their emotions and familiarity with information; learn 'where the action is', and be prepared to engage in long-term strategies to be able to influence policy; and, in both cases, decide how far you are willing to go to persuade policymakers to act and secure a hierarchy of evidence underpinning policy. These are value-driven and political, not just 'evidence-based', choices. [ABSTRACT FROM AUTHOR]

Background: Electromagnetic navigation bronchoscopy (ENB) is an image-guided, minimally invasive approach that uses a flexible catheter to access pulmonary lesions.Methods: NAVIGATE is a prospective, multicenter study of the superDimension™ navigation system. A prespecified 1-month interim analysis of the first 1,000 primary cohort subjects enrolled at 29 sites in the United States and Europe is described. Enrollment and 24-month follow-up are ongoing.Results: ENB index procedures were conducted for lung lesion biopsy (n = 964), fiducial marker placement (n = 210), pleural dye marking (n = 17), and/or lymph node biopsy (n = 334; primarily endobronchial ultrasound-guided). Lesions were in the peripheral/middle lung thirds in 92.7%, 49.7% were <20 mm, and 48.4% had a bronchus sign. Radial EBUS was used in 54.3% (543/1,000 subjects) and general anesthesia in 79.7% (797/1,000). Among the 964 subjects (1,129 lesions) undergoing lung lesion biopsy, navigation was completed and tissue was obtained in 94.4% (910/964). Based on final pathology results, ENB-aided samples were read as malignant in 417/910 (45.8%) subjects and non-malignant in 372/910 (40.9%) subjects. An additional 121/910 (13.3%) were read as inconclusive. One-month follow-up in this interim analysis is not sufficient to calculate the true negative rate or diagnostic yield. Tissue adequacy for genetic testing was 80.0% (56 of 70 lesions sent for testing). The ENB-related pneumothorax rate was 4.9% (49/1,000) overall and 3.2% (32/1,000) CTCAE Grade ≥2 (primary endpoint). The ENB-related Grade ≥2 bronchopulmonary hemorrhage and Grade ≥4 respiratory failure rates were 1.0 and 0.6%, respectively.Conclusions: One-month results of the first 1,000 subjects enrolled demonstrate low adverse event rates in a generalizable population across diverse practice settings. Continued enrollment and follow-up are required to calculate the true negative rate and delineate the patient, lesion, and procedural factors contributing to diagnostic yield.Trial Registration: ClinicalTrials.gov NCT02410837 . Registered 31 March 2015. [ABSTRACT FROM AUTHOR]

Background: Childhood obesity persists in the United States and is associated with serious health problems. Higher rates of obesity among children from disadvantaged households may be, in part, attributable to disparities in access to healthy foods such as fruits and vegetables. Community supported agriculture can improve access to and consumption of fresh produce, but the upfront payment structure, logistical barriers, and unfamiliarity with produce items may inhibit participation by low-income families. The aim of this project is to assess the impact of subsidized, or "cost-offset," community supported agriculture participation coupled with tailored nutrition education for low-income families with children.Methods/design: The Farm Fresh Foods for Healthy Kids community-based, randomized intervention trial will build on formative and longitudinal research to examine the impact of cost-offset community supported agriculture on diet and other health behaviors as well as the economic impacts on local economies. The intervention will involve reduced-price community supported agriculture shares which can be paid for on a weekly basis, nine skill-based and seasonally-tailored healthy eating classes, and the provision of basic kitchen tools. Low income families with at least one child aged 2-12 years will be recruited to join existing community supported agriculture programs in New York, North Carolina, Vermont, and Washington. In each program, families will be randomized 1:1 to intervention or delayed intervention groups. Data will be collected at baseline, and in the fall and spring for 3 years. The primary outcomes are children's intake of fruits and vegetables and foods high in sugar and/or (solid) fat, as well as diet quality; secondary outcomes include physical, behavioral, psychosocial, and environmental variables. Cost-effectiveness and economic impact at the farm and community levels also will be assessed.Discussion: This integrated project will provide important information and contribute to the evidence base regarding the use of local agricultural interventions to improve children's dietary behaviors and weight maintenance. Findings also will inform the development of a toolkit for farmers and education modules related to local food system innovations for undergraduate and graduate students.Trial Registration: ClinicalTrials.gov NCT02770196 . Registered 5 April 2016. [ABSTRACT FROM AUTHOR]

Background: Homeless veterans often have multiple health care and psychosocial needs, including assistance with access to housing and health care, as well as support for ongoing treatment engagement. The Department of Veterans Affairs (VA) developed specialized Homeless Patient Alignment Care Teams (HPACT) with the goal of offering an integrated, "one-stop program" to address housing and health care needs of homeless veterans. However, while 70% of HPACT's veteran enrollees have co-occurring mental health and substance use disorders, HPACT does not have a uniform, embedded treatment protocol for this subpopulation. One wraparound intervention designed to address the needs of homeless veterans with co-occurring mental health and substance use disorders which is suitable to be integrated into HPACT clinic sites is the evidence-based practice called Maintaining Independence and Sobriety through Systems Integration, Outreach, and Networking-Veterans Edition, or MISSION-Vet. Despite the promise of MISSION-Vet within HPACT clinics, implementation of an evidence-based intervention within a busy program like HPACT can be difficult. The current study is being undertaken to identify an appropriate implementation strategy for MISSION-Vet within HPACT. The study will test the implementation platform called Facilitation and compared to implementation as usual (IU). The aims of this study are as follows: (1) Compare the extent to which IU or Facilitation strategies achieve fidelity to the MISSION-Vet intervention as delivered by HPACT homeless provider staff. (2) Compare the effects of Facilitation and IU strategies on the National HPACT Performance Measures. (3) Compare the effects of IU and Facilitation on the permanent housing status. (4) Identify and describe key stakeholders' (patients, providers, staff) experiences with, and perspectives on, the barriers to, and facilitators of implementing MISSION.Design: Type III Hybrid modified stepped wedge implementation comparing IU to Facilitation across seven HPACT teams in three sites in the greater Los Angeles VA system. This is a cluster randomized trial.Discussion: Integrating MISSION-Vet within HPACT has the potential to improve the health of thousands of veterans, but it is crucial to implement the intervention appropriately in order for it to succeed. The lessons learned in this protocol could assist with a larger roll-out of MISSION within HPACT. This protocol is registered with clinicaltrials.gov and was assigned the number NCT 02942979. [ABSTRACT FROM AUTHOR]

Background: Few studies, if any, have examined cardiovascular outcomes in patients with diabetes and gout. Both diabetes and gout are risk factors for cardiovascular disease. The objective of this study was to examine the effect of allopurinol on the risk of incident acute cardiovascular events in patients with gout and diabetes.Methods: We used the 2007-2010 Multi-Payer Claims Database (MPCD) that linked health plan data from national commercial and governmental insurances, representing beneficiaries with United Healthcare, Medicare, or Medicaid coverage. In patients with gout and diabetes, we assessed the current allopurinol use, defined as a new filled prescription for allopurinol, as the main predictor of interest. Our outcome of interest was the occurrence of the first Incident hospitalized myocardial infarction (MI) or stroke (composite acute cardiovascular event), after which observations were censored. We employed multivariable-adjusted Cox proportional hazards models that simultaneously adjusted for patient demographics, cardiovascular risk factors and other medical comorbidities. We calculated hazard ratios [HR] (95% confidence intervals [CI]) for incident composite (MI or stroke) acute cardiovascular events. We performed sensitivity analyses that additionally adjusted for the presence of immune diseases and colchicine use, as potential confounders.Results: There were 2,053,185 person days (5621.3 person years) of current allopurinol use and 1,671,583 person days (4576.5 person years) of prior allopurinol use. There were 158 incident MIs or strokes in current and 151 in prior allopurinol users, respectively. Compared to previous allopurinol users, current allopurinol users had significantly lower adjusted hazard of incident acute cardiovascular events (incident stroke or MI), with an HR of 0.67 (95% CI, 0.53, 0.84). Sensitivity analyses, additionally adjusted for immune diseases or colchicine use, confirmed this association.Conclusions: Current allopurinol use protected against the occurrence of acute cardiovascular events in patients with gout and diabetes. The underlying mechanisms for this potential cardio-protective effect of allopurinol need further exploration. [ABSTRACT FROM AUTHOR]

Background: The future of notifiable condition reporting in the United States is undergoing a transformation with the increasing development of Health Information Exchanges which support electronic data-sharing and -transfer networks and the wider adoption of electronic laboratory reporting. Communicable disease report forms originating in clinics are an important source of surveillance data for public health agencies. However, problems of poor data quality and delayed submission of reports to public health agencies are common. In addition, studies of barriers and facilitators to reporting have assumed that the primary reporter is the treating physician, although the extent to which a provider is involved in the reporting workflow is unclear. We sought to better understand the barriers to and burden of notifiable condition reporting from the perspectives of the three primary groups involved in reporting workflow: providers, clinic staff who bear the principal responsibility for reporting, and the public health workers who receive and process reports from clinics. In addition, we sought to situate these findings within the context of the future of notifiable disease reporting and the potential impacts of electronic lab and medical records on the surveillance system.Methods: Seven ambulatory care clinics and 3 public health agencies that are part of a Health Information Exchange in the state of Indiana, USA, participated in the study. Data were obtained from a survey of clinic physicians (N = 29), interviews with clinic reporters (N = 11), and interviews with public health workers (N = 9). Survey data were summarized descriptively and interview transcripts underwent qualitative analysis.Results: In both clinics and public health agencies, the laboratory report initiates reporting workflow. Provider involvement with reporting primarily revolves around ordering medications to treat a condition confirmed by the lab result. In clinics, reporting is typically the responsibility of clinic reporters who vary in frequency of reporting. We found an association between frequency of reporting, reporting knowledge and perceptions of reporting burden. In both clinics and public health agencies, interruptions and delays in reporting workflow are encountered due to inaccurate or missing information and impact reporting timeliness, data quality and report completeness. Both providers and clinic reporters lack clarity regarding how data submitted by their reports are used by public health agencies. It is possible that the value of reporting may be diminished when those responsible do not perceive receiving benefit in return. This may account for the low awareness of or recollection of public health communications with clinics that we observed. Despite the high likelihood that public health advisories and guidance are based, in part, on data submitted by clinics, a direct concordance may not be recognized.Conclusions: Unlike most studies of notifiable condition reporting, this study included the clinic reporters who bear primary responsibility for completing and submitting reports to public health agencies. A primary barrier to this reporting is timely and easy access to data. It is possible that expanded adoption of electronic health record and laboratory reporting systems will improve access to this data and reduce reporting the burden. However, a complete reliance on automatic electronic extraction of data requires caution and necessitates continued interfacing with clinic reporters for the foreseeable future-particularly for notifiable conditions that are high-impact, uncommon, prone to false positive readings by labs, or are hard to verify. An important finding of this study is the association between frequency of reporting, reporting knowledge and perceptions of reporting burden. Increased automation could result in even lower reporting knowledge and familiarity with reporting requirements which could actually increase reporters' perception of notifiable condition reporting as burdensome. Another finding was of uncertainty regarding how data sent to public health agencies is used or provides clinical benefit. A strong recommendation generated by these findings is that, given their central role in reporting, clinic reporters are a significant target audience for public health outreach and education that aims to alleviate perceived reporting burden and improve reporting knowledge. In particular, communicating the benefits of public health's use of the data may reduce a perceived lack of information reciprocity between clinical and public health organizations. [ABSTRACT FROM AUTHOR]

Background: Large-scale implementation of evidence-based psychotherapies (EBPs) such as cognitive processing therapy (CPT) for posttraumatic stress disorder can have a tremendous impact on mental and physical health, healthcare utilization, and quality of life. While many mental health systems (MHS) have invested heavily in programs to implement EBPs, few eligible patients receive EBPs in routine care settings, and clinicians do not appear to deliver the full treatment protocol to many of their patients. Emerging evidence suggests that when CPT and other EBPs are delivered at low levels of fidelity, clinical outcomes are negatively impacted. Thus, identifying strategies to improve and sustain the delivery of CPT and other EBPs is critical. Existing literature has suggested two competing strategies to promote sustainability. One emphasizes fidelity to the treatment protocol through ongoing consultation and fidelity monitoring. The other focuses on improving the fit and effectiveness of these treatments through appropriate adaptations to the treatment or the clinical setting through a process of data-driven, continuous quality improvement. Neither has been evaluated in terms of impact on sustained implementation.Methods: To compare these approaches on the key sustainability outcomes and provide initial guidance on sustainability strategies, we propose a cluster randomized trial with mental health clinics (n = 32) in three diverse MHSs that have implemented CPT. Cohorts of clinicians and clinical managers will participate in 1 year of a fidelity oriented learning collaborative or 1 year of a continuous quality improvement-oriented learning collaborative. Patient-level PTSD symptom change, CPT fidelity and adaptation, penetration, and clinics' capacity to deliver EBP will be examined. Survey and interview data will also be collected to investigate multilevel influences on the success of the two learning collaborative strategies. This research will be conducted by a team of investigators with expertise in CPT implementation, mixed method research strategies, quality improvement, and implementation science, with input from stakeholders in each participating MHS.Discussion: It will have broad implications for supporting ongoing delivery of EBPs in mental health and healthcare systems and settings. The resulting products have the potential to significantly improve efforts to ensure ongoing high quality implementation and consumer access to EBPs.Trial Registration: NCT02449421 . Registered 02/09/2015. [ABSTRACT FROM AUTHOR]

Background: Under the Affordable Care Act, States have obtained Medicaid waivers to overhaul their behavioral health service systems to improve quality and reduce costs. Critical to implementation of broad service delivery reforms has been the preparation of organizations responsible for service delivery. This study focused on one large-scale initiative to overhaul its service system with the goal of improving service quality and reducing costs. The study examined the participation of behavioral health organizations in technical assistance efforts and the extent to which organizational factors related to their participation.Methods: This study matched two datasets to examine the organizational characteristics and training participation for 196 behavioral health organizations. Organizational characteristics were drawn from the Substance Abuse and Mental Health Services Administration National Mental Health Services Survey (N-MHSS). Training variables were drawn from the Clinical Technical Assistance Center's master training database. Chi-square analyses and multivariate logistic regression models were used to examine the proportion of organizations that participated in training, the organizational characteristics (size, population served, service quality, infrastructure) that predicted participation in training, and for those who participated, the type (clinical or business) and intensity of training (webinar, learning collaborative, in-person) they received.Results: Overall 142 (72. 4%) of the sample participated in training. Organizations who pursued training were more likely to be large in size (p = .02), serve children in addition to adults (p < .01), provide child evidence-based practices (p = .01), and use computerized scheduling (p = .01). Of those trained, 95% participated in webinars, 64% participated in learning collaboratives and 35% participated in in-person trainings. More organizations participated in business trainings than clinical (63.8 vs. 59.2%). Organizations serving children had higher odds of participating in both clinical training (OR = 5.91, p < .01) and business training (OR = 4.24, p < .01) than those that did not serve children.Conclusions: The majority of organizations participated in trainings indicating desire for technical assistance to prepare for health care reform. Larger organizations and organizations serving children were more likely to participate potentially indicating increased interest in preparation. Over half participated in business trainings highlighting interest in learning to improve efficiency. Further understanding is needed to support organizational readiness for health care reform initiatives among behavioral health organizations. [ABSTRACT FROM AUTHOR]

Background: As the emphasis in health reform shifts to value-based payments, especially through multi-payer initiatives supported by the U.S. Center for Medicare & Medicaid Innovation, and with the increasing availability of statewide all-payer claims databases, the need for an all-payer, "whole-population" approach to facilitate the reporting of utilization, cost, and quality measures has grown. However, given the disparities between the different populations served by Medicare, Medicaid, and commercial payers, risk-adjustment methods for addressing these differences in a single measure have been a challenge.Methods: This study evaluated different levels of risk adjustment for primary care practice populations - from basic adjustments for age and gender to a more comprehensive "full model" risk-adjustment method that included additional demographic, payer, and health status factors. It applied risk adjustment to populations attributed to patient-centered medical homes (283,153 adult patients and 78,162 pediatric patients) in the state of Vermont that are part of the Blueprint for Health program. Risk-adjusted expenditure and utilization outcomes for calendar year 2014 were reported in 102 adult and 56 pediatric primary-care comparative practice profiles.Results: Using total expenditures as the dependent variable for the adult population, the r2 for the model adjusted for age and gender was 0.028. It increased to 0.265 with the additional adjustment for 3M Clinical Risk Groups and to 0.293 with the full model. For the adult population at the practice level, the no-adjustment model had the highest variation as measured by the coefficient of variation (18.5) compared to the age and gender model (14.8); the age, gender, and CRG model (13.0); and the full model (11.7). Similar results were found for the pediatric population practices.Conclusions: Results indicate that more comprehensive risk-adjustment models are effective for comparing cost, utilization, and quality measures across multi-payer populations. Such evaluations will become more important for practices, many of which do not distinguish their patients by payer type, and for the implementation of incentive-based or alternative payment systems that depend on "whole-population" outcomes. In Vermont, providers, accountable care organizations, policymakers, and consumers have used Blueprint profiles to identify priorities and opportunities for improving care in their communities. [ABSTRACT FROM AUTHOR]

Background: The U.S. Food and Drug Administration can set standards for cigarettes that could include reducing their nicotine content. Such a standard should improve public health without causing unintended serious consequences for sub-populations. This study evaluates the effect of progressive nicotine reduction in cigarettes on smoking behavior, toxicant exposure, and psychiatric symptoms in smokers with comorbid mood and/or anxiety disorders using a two-site, two-arm, double-blind, parallel group, randomized controlled trial (RCT) in four phases over 34 weeks.Methods: Adult smokers (N = 200) of 5 or more cigarettes per day will be randomized across two sites (Penn State and Massachusetts General). Participants must have not had a quit attempt in the prior month, nor be planning to quit in the next 6 months, meet criteria for a current or lifetime unipolar mood and/or anxiety disorder based on the structured Mini-International Neuropsychiatric Interview, and must not have an unstable medical or psychiatric condition. After a week of smoking their own cigarettes, participants receive two weeks of Spectrum research cigarettes with usual nicotine content (11.6 mg). After this baseline period, participants will be randomly assigned to continue smoking Spectrum research cigarettes that contain either (a) Usual Nicotine Content (11.6 mg); or (b) Reduced Nicotine Content: the nicotine content per cigarette is progressively reduced from approximately 11.6 mg to 0.2 mg in five steps over 18 weeks. At the end of the randomization phase, participants will be offered the choice to either (a) quit smoking with assistance, (b) continue smoking free research cigarettes, or (c) return to purchasing their own cigarettes, for the final 12 weeks of the study. The primary outcome measure is blood cotinine; key secondary outcomes are: exhaled carbon monoxide, urinary total NNAL- 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and 1-hydroxypyrene, oxidative stress biomarkers including 8-isoprostanes, measures of psychiatric symptoms (e.g., depression, anxiety), smoking behavior and dependence (e.g., cigarette consumption, quit attempts), and health effects (e.g., blood pressure, respiratory symptoms).Discussion: Results from this study will inform FDA on the potential effects of regulating the nicotine content of cigarettes and help determine whether smokers with mood and/or anxiety disorders can safely transition to significantly reduced nicotine content cigarettes.Trial Registration: TRN: NCT01928758 , registered August 21, 2013. [ABSTRACT FROM AUTHOR]

Background: Rates of chronic pain are rising sharply in the United States and worldwide. Presently, there is evidence of racial disparities in pain treatment and treatment outcomes in the United States but few interventions designed to address these disparities. There is growing consensus that chronic musculoskeletal pain is best addressed by a biopsychosocial approach that acknowledges the role of psychological and environmental factors, some of which differ by race.Methods/design: The primary aim of this randomized controlled trial is to test the effectiveness of a non-pharmacological, self-regulatory intervention, administered proactively by telephone, at improving pain outcomes and increasing walking among African American patients with hip, back and knee pain. Participants assigned to the intervention will receive a telephone counselor delivered pedometer-mediated walking intervention that incorporates action planning and motivational interviewing. The intervention will consist of 6 telephone counseling sessions over an 8-10 week period. Participants randomly assigned to Usual Care will receive an informational brochure and a pedometer. The primary outcome is chronic pain-related physical functioning, assessed at 6 months, by the revised Roland and Morris Disability Questionnaire, a measure recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT). We will also examine whether the intervention improves other IMMPACT-recommended domains (pain intensity, emotional functioning, and ratings of overall improvement). Secondary objectives include examining whether the intervention reduces health care service utilization and use of opioid analgesics and whether key contributors to racial/ethnic disparities targeted by the intervention mediate improvement in chronic pain outcomes Measures will be assessed by mail and phone surveys at baseline, three months, and six months. Data analysis of primary aims will follow intent-to-treat methodology.Discussion: We will tailor our intervention to address key contributors to racial pain disparities and examine the effects of the intervention on important pain treatment outcomes for African Americans with chronic musculoskeletal pain.Trial Registration: ClinicalTrials.gov: NCT01983228 . Registered 6 November 2013. [ABSTRACT FROM AUTHOR]

Background: Outcomes after total knee (TKA) and hip (THA) arthroplasty are often generalized internationally. Patient-dependent factors and preoperative symptom levels may differ across countries. We compared preoperative patient and clinical characteristics from two large cohorts, one in Switzerland, the other in the US.Methods: Patient characteristics were collected prospectively on all elective primary TKAs and THAs performed at a large Swiss hospital and in a US national sample. Data included age, sex, education level, BMI, diagnosis, medical co-morbidities, PROMs (WOMAC pain/function), global health (SF-12).Results: Six thousand six hundred eighty primary TKAs (US) and 823 TKAs (Swiss) were evaluated. US vs. Switzerland TKA patients were younger (mean age 67 vs. 72 years.), more obese (BMI ≥30 55% vs. 43%), had higher levels of education, more cardiac disease. Swiss patients had lower preoperative WOMAC pain scores (41 vs. 52) but pre-operative physical disability were comparable. 4,647 primary THAs (US) and 1,023 THAs (Swiss) were evaluated. US vs. Switzerland patients were younger (65 vs. 68 years.), more obese (BMI ≥30: 38% vs. 24%), had higher levels of education, more diabetes. Swiss patients had lower preoperative WOMAC pain scores (40 vs. 48 points). Physical disability was reported comparable, but Swiss patients indicated lower mental health scores.Conclusion: We found substantial differences between US and Swiss cohorts in pre-operative patient characteristics and pain levels, which has potentially important implications for cross-cultural comparison of TKA/THA outcomes. Reports from national registries lack detailed patient information while these data suggest the need for adequate risk adjustment of patient factors. [ABSTRACT FROM AUTHOR]

Background: Understanding immigrants' interactions with the United States (US) healthcare system will likely make it possible to meet their healthcare needs and improve their quality of life in the US. Although challenges to accessing and utilizing healthcare in the US have been identified, there is little information specific to Brazilian-born immigrants' experiences. Brazilians comprise a fast-growing immigrant population group in the US. The purpose of this study was to explore Brazilian immigrant women's perspectives and experiences with healthcare services in the US to gain insights into factors amenable to interventions that may contribute to disparities in access to and utilization of services.Methods: Five focus groups were conducted from April to May in 2015 using a purposeful sampling of Brazilian-born immigrant women living in Massachusetts, US.Results: Thirty-five women participated in this study. Although participants expressed their overall satisfaction with the US healthcare system, they noted several barriers to care, including sociocultural differences in delivery of care and communication barriers, including inconsistent quality of interpreting services.Conclusions: This study provides new information on the experiences and challenges faced by Brazilian immigrant women in accessing and utilizing healthcare services in the US and points out opportunities for improving services and the overall health of this immigrant population. Addressing noted sociocultural differences and communication barriers including inconsistent quality of hospital's interpreting services might enhance Brazilian-born immigrants' experiences with the healthcare system. [ABSTRACT FROM AUTHOR]

Background: This study forms part of the first complete characterization of the dose-response curve for glycopyrrolate (GP) delivered using Co-Suspension™ Delivery Technology via a metered dose inhaler (MDI). We examined the lower GP MDI dose range to determine an optimal dose for patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).Methods: This randomized, double-blind, chronic-dosing, balanced incomplete-block, placebo-controlled, crossover study compared six doses of GP MDI (18, 9, 4.6, 2.4, 1.2, and 0.6 μg, twice daily [BID]) with placebo MDI BID and open-label tiotropium dry powder inhaler (18 μg, once daily [QD]) in patients with moderate-to-severe COPD. Patients were randomized into 1 of 120 treatment sequences. Each sequence included 4 of 8 treatments administered for 14-day periods separated by 7- to 21-day washout periods. The primary efficacy endpoint was change from baseline in forced expiratory volume in 1 s area under the curve from 0 to 12 h (FEV1 AUC0-12) on Day 14. Secondary efficacy endpoints included peak change from baseline (post-dose) in FEV1 and inspiratory capacity (IC) on Days 1, 7, and 14; change from baseline in morning pre-dose trough FEV1 on Days 7 and 14; change from baseline in 12-h post-dose trough FEV1 on Day 14; time to onset of action (≥10 % improvement in mean FEV1) and the proportion of patients achieving ≥12 % improvement in FEV1 on Day 1; and pre-dose trough IC on Days 7 and 14. Safety and tolerability were also assessed.Results: GP MDI 18, 9, 4.6, and 2.4 μg demonstrated statistically significant and clinically relevant increases in FEV1 AUC0-12 compared with placebo MDI following 14 days of treatment (modified intent-to-treat population = 120). GP MDI 18 μg was non-inferior to open-label tiotropium for peak change in FEV1 on Day 1 and morning pre-dose trough FEV1 on Day 14. All doses of GP MDI were well tolerated with no unexpected safety findings.Conclusions: These efficacy and safety results support GP MDI 18 μg BID as the most appropriate dose for evaluation in Phase III trials in patients with moderate-to-severe COPD.Trial Registration: ClinicalTrials.gov NCT01566773 . Registered 27 March 2012. [ABSTRACT FROM AUTHOR]

Background: Recently released American College of Cardiology/American Heart Association (ACC/AHA) guideline recommends the Pooled Cohort equations for evaluating atherosclerotic cardiovascular risk of individuals. The impact of the clinical input variable uncertainties on the estimates of ten-year cardiovascular risk based on ACC/AHA guidelines is not known.Methods: Using a publicly available the National Health and Nutrition Examination Survey dataset (2005-2010), we computed maximum and minimum ten-year cardiovascular risks by assuming clinically relevant variations/uncertainties in input of age (0-1 year) and ±10 % variation in total-cholesterol, high density lipoprotein- cholesterol, and systolic blood pressure and by assuming uniform distribution of the variance of each variable. We analyzed the changes in risk category compared to the actual inputs at 5 % and 7.5 % risk limits as these limits define the thresholds for consideration of drug therapy in the new guidelines. The new-pooled cohort equations for risk estimation were implemented in a custom software package.Results: Based on our input variances, changes in risk category were possible in up to 24 % of the population cohort at both 5 % and 7.5 % risk boundary limits. This trend was consistently noted across all subgroups except in African American males where most of the cohort had ≥7.5 % baseline risk regardless of the variation in the variables.Conclusions: The uncertainties in the input variables can alter the risk categorization. The impact of these variances on the ten-year risk needs to be incorporated into the patient/clinician discussion and clinical decision making. Incorporating good clinical practices for the measurement of critical clinical variables and robust standardization of laboratory parameters to more stringent reference standards is extremely important for successful implementation of the new guidelines. Furthermore, ability to customize the risk calculator inputs to better represent unique clinical circumstances specific to individual needs would be highly desirable in the future versions of the risk calculator. [ABSTRACT FROM AUTHOR]