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Background: Breastfeeding provides many short- and long-term health benefits for mothers and their infants and is a particularly relevant strategy for women who experience Gestational Diabetes Mellitus (GDM) during pregnancy. However, breastfeeding rates are generally lower amongst this group of women than the general population. This review's objective is to identify the factors that influence breastfeeding by exploring the experiences and outcomes of women in in high-income health care contexts when there is a history of GDM in the corresponding pregnancy. Methods: A comprehensive search strategy explored the electronic databases Medline, CINAHL, Web of Science and Scopus for primary studies exploring breastfeeding practices for papers published between January 2011 and June 2023. All papers were screened independently by two researchers with included papers assessed using the Crowe Critical Appraisal tool. Findings were analysed using a narrative synthesis framework. Results: From an initial search result of 1037 papers, 16 papers representing five high-income nations were included in this review for analysis – the United States of America (n = 10), Australia (n = 3), Finland (n = 1), Norway (n = 1), and Israel (n = 1). Fifteen papers used a quantitative design, and one used a qualitative design. The total number of participants represented in the papers is 963,718 of which 812,052 had GDM and 151,666 did not. Women with an immediate history of GDM were as likely to initiate breastfeeding as those without it. However, they were more likely to have the first feed delayed, be offered supplementation, experience delayed lactogenesis II and or a perception of low supply. Women were less likely to exclusively breastfeed and more likely to completely wean earlier than the general population. Maternity care practices, maternal factors, family influences, and determinants of health were contextual and acted as either a facilitator or barrier for this group. Conclusion: Breastfeeding education and support need to be tailored to recognise the individual needs and challenges of women with a history of GDM. Interventions, including the introduction of commercial milk formula (CMF) may have an even greater impact and needs to be very carefully considered. Supportive strategies should encompass the immediate and extended family who are major sources of influence. [ABSTRACT FROM AUTHOR]

Background: Cough is one of the most common presenting problems for patients in primary care and is largely managed in primary care clinical settings. Family physicians' familiarity with chronic cough guidelines and the extent to which these guidelines translate into everyday practice have not been well described. The objective of this study was to characterize current diagnosis, treatment, and referral practices among family physicians and to identify potentially impactful strategies to optimize chronic cough management in primary care. Methods: We conducted a cross-sectional survey of 5,000 family physicians to explore diagnosis, treatment, and referral practices related to chronic cough management in adults in primary care. Respondents completed the survey via paper or online. The outcome measures were self-reported numeric ratings and responses related to the survey elements. Results: 588 surveys were completed (11.8% response rate). About half (49.6%) of respondents defined chronic cough in a manner consistent with the American College of Chest Physicians (ACCP) chronic cough guidelines, with the rest differing in opinion primarily regarding duration of symptom presentation. Respondents reported trying to rule out most common causes of chronic cough themselves before referring (mean 3.41 on a 4-point scale where 4 is "describes me completely") and indicated a desire for more resources to help them manage and treat chronic cough. Years in practice and rural/urban setting influenced diagnosis and referral practices. Conclusions: Family physicians see chronic cough as a complicated condition that can be and is often diagnosed and treated entirely in a primary care setting. They also value the ability to refer in complex cases. Our results support that family physicians provide evidence-based management of chronic cough. [ABSTRACT FROM AUTHOR]

The emergence of the COVID-19 pandemic significantly changed the prenatal care experience, specifically regarding medical appointments and social opportunities. It is critical to capture this change through the narratives of pregnant people, particularly those of marginalized populations, whose voices may often be underrepresented in the literature. This mixed-methods paper summarizes the experiences of 40 pregnant Black/African American (AA) women during the COVID-19 pandemic. A cross-sectional, online survey was administered between 2020 and 2021 to assess prenatal health and the impacts of the COVID-19 pandemic on patients' pregnancy experience. Coping behaviors during the pandemic were self-reported using the COPE-IS. Univariate analyses were conducted. An additional analysis of participants (n = 4) was explored through a week-long qualitative exercise using a photo documentation procedure. Photo-Elicitation Interviews (PEI) were conducted to capture and center their pandemic pregnancy experiences. Sources of stress during the pandemic varied, with the most common being financial concerns (n = 19, 47.5%). Over half of the sample (n = 18, 54.5%) self-reported increases in their positive coping behaviors during the pandemic, such as communicating with friends and family, talking to healthcare providers, listening to music, and engaging in spiritual practices–such as prayer. The four PEI study participants reflected on the impacts of social distancing on their prenatal experience and mentioned hospital and provider-related weariness due to their race. The findings of this study suggest that during the COVID-19 pandemic, Black/AA pregnant women in Charlotte, NC used social support, mindfulness practices, self-advocacy, and health literacy to navigate challenges present during their prenatal health experience. This paper highlights the personal, social, and structural experiences of pregnant women during a public health crisis so that responsive and effective programs or policies can be planned in the future. [ABSTRACT FROM AUTHOR]

Background: Human communities suffered a vast socioeconomic burden in dealing with the pandemic of coronavirus disease 2019 (COVID-19) globally. Real-word data about these burdens can inform governments about evidence-based resource allocation and prioritization. The aim of this scoping review was to map the cost-of-illness (CoI) studies associated with COVID-19. Methods: This scoping review was conducted from January 2019 to December 2021. We searched cost-of-illness papers published in English within Web of Sciences, PubMed, Google Scholar, Scopus, Science Direct and ProQuest. For each eligible study, extracted data included country, publication year, study period, study design, epidemiological approach, costing method, cost type, cost identification, sensitivity analysis, estimated unit cost and national burden. All of the analyses were applied in Excel software. Results: 2352 records were found after the search strategy application, finally 28 articles met the inclusion criteria and were included in the review. Most of the studies were done in the United States, Turkey, and China. The prevalence-based approach was the most common in the studies, and most of studies also used Hospital Information System data (HIS). There were noticeable differences in the costing methods and the cost identification. The average cost of hospitalization per patient per day ranged from 101$ in Turkey to 2,364$ in the United States. Among the studies, 82.1% estimated particularly direct medical costs, 3.6% only indirect costs, and 14.3% both direct and indirect costs. Conclusion: The economic burden of COVID-19 varies from country to country. The majority of CoI studies estimated direct medical costs associated with COVID-19 and there is a paucity of evidence for direct non-medical, indirect, and intangible costs, which we recommend for future studies. To create homogeneity in CoI studies, we suggest researchers follow a conceptual framework and critical appraisal checklist of cost-of-illness (CoI) studies. [ABSTRACT FROM AUTHOR]

Background: PRO-CTCAE is a library of items that measure cancer treatment-related symptomatic adverse events (NCI Contracts: HHSN261201000043C and HHSN 261201000063C). The objective of this study is to examine the equivalence and acceptability of the three data collection modes (Web-enabled touchscreen tablet computer, Interactive voice response system [IVRS], and paper) available within the US National Cancer Institute (NCI) Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measurement system.Methods: Participants (n = 112; median age 56.5; 24 % high school or less) receiving treatment for cancer at seven US sites completed 28 PRO-CTCAE items (scoring range 0-4) by three modes (order randomized) at a single study visit. Subjects completed one page (approx. 15 items) of the EORTC QLQ-C30 between each mode as a distractor. Item scores by mode were compared using intraclass correlation coefficients (ICC); differences in scores within the 3-mode crossover design were evaluated with mixed-effects models. Difficulties with each mode experienced by participants were also assessed.Results: 103 (92 %) completed questionnaires by all three modes. The median ICC comparing tablet vs IVRS was 0.78 (range 0.55-0.90); tablet vs paper: 0.81 (0.62-0.96); IVRS vs paper: 0.78 (0.60-0.91); 89 % of ICCs were ≥0.70. Item-level mean differences by mode were small (medians [ranges] for tablet vs. IVRS = -0.04 [-0.16-0.22]; tablet vs paper = -0.02 [-0.11-0.14]; IVRS vs paper = 0.02 [-0.07-0.19]), and 57/81 (70 %) items had bootstrapped 95 % CI around the effect sizes within +/-0.20. The median time to complete the questionnaire by tablet was 3.4 min; IVRS: 5.8; paper: 4.0. The proportion of participants by mode who reported "no problems" responding to the questionnaire was 86 % tablet, 72 % IVRS, and 98 % paper.Conclusions: Mode equivalence of items was moderate to high, and comparable to test-retest reliability (median ICC = 0.80). Each mode was acceptable to a majority of respondents. Although the study was powered to detect moderate or larger discrepancies between modes, the observed ICCs and very small mean differences between modes provide evidence to support study designs that are responsive to patient or investigator preference for mode of administration, and justify comparison of results and pooled analyses across studies that employ different PRO-CTCAE modes of administration.Trial Registration: NCT Clinicaltrials.gov identifier: NCT02158637. [ABSTRACT FROM AUTHOR]

Background: Cigarettes are marketed in a wide array of packaging and product configurations, and these may impact consumers' perceptions of product health effects and attractiveness. Filtered cigarettes are typically perceived as less hazardous and white tipping paper (as opposed to cork) often conveys 'lightness'.Methods: This study examined cigarette-related perceptions among 1220 young adult (age 18-35) current, ever, and never smokers recruited from three eastern U.S. cities (Buffalo NY, Columbia SC, Morgantown WV). Participants rated three cigarette sticks: two filtered cigarettes 85 mm in length, differing only in tipping paper color (cork versus white), and an unfiltered 70 mm cigarette.Results: Overall, the cork-tipped cigarette was most commonly selected on taste and attractiveness, the white-tipped on least dangerous, and the unfiltered on most dangerous. Current smokers were more likely to select white-tipped (OR = 1.98) and cork-tipped (OR = 3.42) cigarettes, while ever smokers more commonly selected the cork-tipped (OR = 1.96), as most willing to try over the other products. Those willing to try the filtered white-tipped cigarette were more likely to have rated that cigarette as best tasting (OR = 11.10), attracting attention (OR = 17.91), and lowest health risk (OR = 1.94). Similarly, those willing to try cork tipped or unfiltered cigarettes rated those as best testing, attracting attention, and lowest health risk, respectively.Conclusions: Findings from this study demonstrate that consumer product perceptions can be influenced by elements of cigarette design, such as the presence and color of the filter tip. [ABSTRACT FROM AUTHOR]

Background: Primary healthcare services have principal responsibility for providing child and youth wellbeing and mental health services, but have lacked appropriate measurement instruments to assess the wellbeing of Indigenous children and youth or to evaluate the effectiveness of programs and services designed to meet their needs. This review assesses the availability and characteristics of measurement instruments that have been applied in primary healthcare services in Canada, Australia, New Zealand and the United States (CANZUS countries) to assess the wellbeing of Indigenous children and youth. Methods: Fifteen databases and 12 websites were searched in December 2017 and again in October 2021. Pre-defined search terms pertained to Indigenous children and youth, CANZUS country names, and wellbeing or mental health measures. PRISMA guidelines were followed, with eligibility criteria guiding screening of titles and abstracts, and selected full-text papers. Results are presented based on the characteristics of documented measurement instruments assessed according to five desirability criteria: development for Indigenous youth populations, adherence to relational strength-based constructs, administration by child and or youth self-report, reliability and validity, and usefulness for identifying wellbeing or risk levels. Results: Twenty-one publications were found that described the development and or use by primary healthcare services of 14 measurement instruments, employed across 30 applications. Four of the 14 measurement instruments were developed specifically for Indigenous youth populations, four focused solely on strength-based wellbeing concepts but none included all Indigenous wellbeing domains. Conclusion: There is a diversity of measurement instruments available, but few fit our desirability criteria. Although it is possible that we missed relevant papers and reports, this review clearly supports the need for further research to develop, refine or adapt instruments cross-culturally to measure the wellbeing of Indigenous children and youth. [ABSTRACT FROM AUTHOR]

Background: Advances in health equity rely on representation of diverse groups in population health research samples. Despite progress in the diversification of research samples, continued expansion to include systematically excluded groups is needed to address health inequities. One such group that is infrequently represented in population health research are adults with intellectual disability. Individuals with intellectual disability experience pervasive health disparities. Representation in population health research is crucial to determine the root causes of inequity, understand the health of diverse populations, and address health disparities. The purpose of this paper was to develop recommendations for researchers to increase the accessibility of university health research and to support the inclusion of adults with intellectual disability as participants in health research. Methods: A comprehensive literature review, consultation with the university ethics review board, and review of United States federal regulations was completed to identify barriers to research participation for individuals with intellectual disability. A collaborative stakeholder working group developed recommendations and products to increase the accessibility of university research for participants with intellectual disability. Results: Eleven key barriers to research participation were identified including gaps in researchers' knowledge, lack of trust, accessibility and communication challenges, and systematic exclusion among others. Together the stakeholder working group compiled seven general recommendations for university health researchers to guide inclusion efforts. Recommendations included: 1) address the knowledge gap, 2) build community partnerships, 3) use plain language, 4) simplify consent and assent processes, 5) establish research capacity to consent, 6) offer universal supports and accommodations, and 7) practice accessible dissemination. In addition, four products were created as part of the stakeholder working group to be shared with researchers to support the inclusion of participants with intellectual disability. 1) Supports I Need Checklist, 2) Plain language glossary of health and research terms, 3) Understanding Consent and Assent in Plain Language, 4) Easy-Read Paper Template. Conclusion: Community members and individuals with intellectual disability want to be included in research and are eager to engage as research participants. It is the responsibility of the researcher to open the door to university health research. The recommendations discussed in this paper could increase accessibility for a broader range of research participants and, in particular, promote the inclusion of individuals with intellectual disability to advance health equity in population health research. [ABSTRACT FROM AUTHOR]

Background: With the development of digital pathology and the renewal of deep learning algorithm, artificial intelligence (AI) is widely applied in tumor pathology. Previous researches have demonstrated that AI-based tumor pathology may help to solve the challenges faced by traditional pathology. This technology has attracted the attention of scholars in many fields and a large amount of articles have been published. This study mainly summarizes the knowledge structure of AI-based tumor pathology through bibliometric analysis, and discusses the potential research trends and foci.Methods: Publications related to AI-based tumor pathology from 1999 to 2021 were selected from Web of Science Core Collection. VOSviewer and Citespace were mainly used to perform and visualize co-authorship, co-citation, and co-occurrence analysis of countries, institutions, authors, references and keywords in this field.Results: A total of 2753 papers were included. The papers on AI-based tumor pathology research had been continuously increased since 1999. The United States made the largest contribution in this field, in terms of publications (1138, 41.34%), H-index (85) and total citations (35,539 times). We identified the most productive institution and author were Harvard Medical School and Madabhushi Anant, while Jemal Ahmedin was the most co-cited author. Scientific Reports was the most prominent journal and after analysis, Lecture Notes in Computer Science was the journal with highest total link strength. According to the result of references and keywords analysis, "breast cancer histopathology" "convolutional neural network" and "histopathological image" were identified as the major future research foci.Conclusions: AI-based tumor pathology is in the stage of vigorous development and has a bright prospect. International transboundary cooperation among countries and institutions should be strengthened in the future. It is foreseeable that more research foci will be lied in the interpretability of deep learning-based model and the development of multi-modal fusion model. [ABSTRACT FROM AUTHOR]

Background: International and migrant students face specific challenges which may impact their mental health, well-being and academic outcomes, and these may be gendered experiences. The purpose of this scoping review was to map the literature on the challenges, coping responses and supportive interventions for international and migrant students in academic nursing programs in major host countries, with a gender lens. Methods: We searched 10 databases to identify literature reporting on the challenges, coping responses and/or supportive interventions for international and migrant nursing students in college or university programs in Canada, the United-States, Australia, New Zealand or a European country. We included peer-reviewed research (any design), discussion papers and literature reviews. English, French and Spanish publications were considered and no time restrictions were applied. Drawing from existing frameworks, we critically assessed each paper and extracted information with a gender lens. Results: One hundred fourteen publications were included. Overall the literature mostly focused on international students, and among migrants, migration history/status and length of time in country were not considered with regards to challenges, coping or interventions. Females and males, respectively, were included in 69 and 59% of studies with student participants, while those students who identify as other genders/sexual orientations were not named or identified in any of the research. Several papers suggest that foreign-born nursing students face challenges associated with different cultural roles, norms and expectations for men and women. Other challenges included perceived discrimination due to wearing a hijab and being a 'foreign-born male nurse', and in general nursing being viewed as a feminine, low-status profession. Only two strategies, accessing support from family and other student mothers, used by women to cope with challenges, were identified. Supportive interventions considering gender were limited; these included matching students with support services' personnel by sex, involving male family members in admission and orientation processes, and using patient simulation as a method to prepare students for care-provision of patients of the opposite-sex. Conclusion: Future work in nursing higher education, especially regarding supportive interventions, needs to address the intersections of gender, gender identity/sexual orientation and foreign-born status, and also consider the complexity of migrant students' contexts. [ABSTRACT FROM AUTHOR]

Background: The US Veterans Administration (VA) has developed a robust and mature computational infrastructure in support of its electronic health record (EHR). Web technology offers a powerful set of tools for structuring clinical decision support (CDS) around clinical care. This paper describes informatics challenges and design issues that were confronted in the process of building three Web-based CDS systems in the context of the VA EHR.Methods: Over the course of several years, we implemented three Web-based CDS systems that extract patient data from the VA EHR environment to provide patient-specific CDS. These were 1) the VACS (Veterans Aging Cohort Study) Index Calculator which estimates prognosis for HIV+ patients, 2) Neuropath/CDS which assists in the medical management of patients with neuropathic pain, and 3) TRIM (Tool to Reduce Inappropriate Medications) which identifies potentially inappropriate medications in older adults and provides recommendations for improving the medication regimen.Results: The paper provides an overview of the VA EHR environment and discusses specific informatics issues/challenges that arose in the context of each of the three Web-based CDS systems. We discuss specific informatics methods and provide details of approaches that may be useful within this setting.Conclusions: Informatics issues and challenges relating to data access and data availability arose because of the particular architecture of the national VA infrastructure and the need to link to that infrastructure from local Web-based CDS systems. Idiosyncrasies of VA patient data, especially the medication data, also posed challenges. Other issues related to specific functional needs of individual CDS systems. The goal of this paper is to describe these issues so that our experience may serve as a useful foundation to assist others who wish to build such systems in the future. [ABSTRACT FROM AUTHOR]

Background: Chronic musculoskeletal pain (MSP) affects more than 40% of adults aged 50 years and older and is the leading cause of disability in the USA. Older adults with chronic MSP are at risk for analgesic-related side effects, long-term opioid use, and functional decline. Recognizing the burden of chronic MSP, reducing the transition from acute to chronic pain is a public health priority. In this paper, we report the protocol for the Brief EducaTional Tool to Enhance Recovery (BETTER) trial. This trial compares two versions of an intervention to usual care for preventing the transition from acute to chronic MSP among older adults in the emergency department (ED).Methods: Three hundred sixty patients from the ED will be randomized to one of three arms: full intervention (an interactive educational video about pain medications and recovery-promoting behaviors, a telecare phone call from a nurse 48 to 72 h after discharge from the ED, and an electronic communication containing clinical information to the patient's primary care provider); video-only intervention (the interactive educational video but no telecare or primary care provider communication); or usual care. Data collection will occur at baseline and at 1 week and 1, 3, 6, and 12 months after study enrollment. The primary outcome is a composite measure of pain severity and interference. Secondary outcomes include physical function, overall health, opioid use, healthcare utilization, and an assessment of the economic value of the intervention.Discussion: This trial is the first patient-facing ED-based intervention aimed at helping older adults to better manage their MSP and reduce their risk of developing chronic pain. If effective, future studies will examine the effectiveness of implementation strategies.Trial Registration: ClinicalTrials.gov NCT04118595 . Registered on 8 October 2019. [ABSTRACT FROM AUTHOR]

Background: Synthesis of psychometric properties of substance use measures to identify patterns of use and substance use disorders remains limited. To address this gap, we sought to systematically evaluate the psychometric properties of measures to detect substance use and misuse.Methods: We conducted a systematic review and meta-analysis of literature on measures of substance classes associated with HIV risk (heroin, methamphetamine, cocaine, ecstasy, alcohol) that were published in English before June 2016 that reported at least one of the following psychometric outcomes of interest: internal consistency (alpha), test-retest/inter-rater reliability (kappa), sensitivity, specificity, positive predictive value, and negative predictive value. We used meta-analytic techniques to generate pooled summary estimates for these outcomes using random effects and hierarchical logistic regression models.Results: Findings across 387 paper revealed that overall, 65% of pooled estimates for alpha were in the range of fair-to-excellent; 44% of estimates for kappa were in the range of fair-to-excellent. In addition, 69, 97, 37 and 96% of pooled estimates for sensitivity, specificity, positive predictive value, and negative predictive value, respectively, were in the range of moderate-to-excellent.Conclusion: We conclude that many substance use measures had pooled summary estimates that were at the fair/moderate-to-excellent range across different psychometric outcomes. Most scales were conducted in English, within the United States, highlighting the need to test and validate these measures in more diverse settings. Additionally, the majority of studies had high risk of bias, indicating a need for more studies with higher methodological quality. [ABSTRACT FROM AUTHOR]

Background: This paper discusses best practices for estimating fractions of mortality attributable to health exposures in survey data that are biased by observed confounders and unobserved endogenous selection. Extant research has shown that estimates of population attributable fractions (PAF) from the formula using the proportion of deceased that is exposed (PAFpd) can attend to confounders, whereas the formula using the proportion of the entire sample exposed (PAFpe) is biased by confounders. Research has not explored how PAFpd and PAFpe equations perform when both confounding and selection bias are present. Methods: We review equations for calculating PAF based on either the proportion of deceased (pd) or the proportion of the entire sample (pe) that receives the exposure. We explore how estimates from each equation are affected by confounding bias and selection bias using hypothetical data and real-world survey data from the National Health Interview Survey–Linked Mortality Files, 1987–2011. We examine the association between cigarette smoking and all-cause mortality risk in the US adult population as an example. Results: We show that both PAFpd and PAFpe calculate the true PAF in the presence of confounding bias if one uses the "weighted-sum" approach. We further show that both the PAFpd and PAFpe calculate biased PAFs in the presence of collider bias, but that the bias is more severe in the PAFpd formula. Conclusion: We recommend that researchers use the PAFpe formula with the weighted-sum approach when estimates of the exposure-outcome relationship are biased by endogenous selection. [ABSTRACT FROM AUTHOR]

Background: Over the past few decades, numerous forecasting methods have been proposed in the field of epidemic forecasting. Such methods can be classified into different categories such as deterministic vs. probabilistic, comparative methods vs. generative methods, and so on. In some of the more popular comparative methods, researchers compare observed epidemiological data from the early stages of an outbreak with the output of proposed models to forecast the future trend and prevalence of the pandemic. A significant problem in this area is the lack of standard well-defined evaluation measures to select the best algorithm among different ones, as well as for selecting the best possible configuration for a particular algorithm.Results: In this paper we present an evaluation framework which allows for combining different features, error measures, and ranking schema to evaluate forecasts. We describe the various epidemic features (Epi-features) included to characterize the output of forecasting methods and provide suitable error measures that could be used to evaluate the accuracy of the methods with respect to these Epi-features. We focus on long-term predictions rather than short-term forecasting and demonstrate the utility of the framework by evaluating six forecasting methods for predicting influenza in the United States. Our results demonstrate that different error measures lead to different rankings even for a single Epi-feature. Further, our experimental analyses show that no single method dominates the rest in predicting all Epi-features when evaluated across error measures. As an alternative, we provide various Consensus Ranking schema that summarize individual rankings, thus accounting for different error measures. Since each Epi-feature presents a different aspect of the epidemic, multiple methods need to be combined to provide a comprehensive forecast. Thus we call for a more nuanced approach while evaluating epidemic forecasts and we believe that a comprehensive evaluation framework, as presented in this paper, will add value to the computational epidemiology community. [ABSTRACT FROM AUTHOR]

Background: The goal of Lean Enterprise Transformation (LET) is to go beyond simply using Lean tools and instead embed Lean principles and practices in the system so that it becomes a fundamental, collective mindset of the entire enterprise. The Veterans Engineering Resource Center (VERC) launched the Veterans Affairs (VA) LET pilot program to improve quality, safety, and the Veteran's experience. A national evaluation will examine the pilot program sites' implementation processes, outcomes and impacts, and abilities to improve LET adoption and sustainment. This paper describes the evaluation design for the VA LET national evaluation and describes development of a conceptual framework to evaluate LET specifically in healthcare settings.Methods: A targeted literature review of Lean evaluation frameworks was performed to inform the development of the conceptual framework. Key domains were identified by a multidisciplinary expert group and then validated with key stakeholders. The national evaluation design will examine LET implementation using qualitative, survey, and quantitative methods at ten VA facilities. Qualitative data include site visits, interviews, and field observation notes. Survey data include an employee engagement survey to be administered to front-line staff at all pilot sites. Quantitative data include site-level quality improvement metrics collected by the Veterans Services Support Center. Qualitative, quantitative, and mixed-methods analyses will be conducted to examine implementation of LET strategic initiatives and variations in implementation success across sites.Discussion: This national evaluation of a large-scale LET implementation effort will provide insights helpful to other systems interested in embarking on a Lean journey. Additionally, we created a multi-faceted conceptual framework to capture the specific features of a Lean healthcare organization. This framework will guide this evaluation and may be useful as an assessment tool for other organizations interested in implementing Lean principles at an enterprise level. [ABSTRACT FROM AUTHOR]

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: This paper chronicles attempts in the United States over the past 20 years to fully represent women in clinical trials and ensure the study of sex and gender in biomedical research. We maintain that productive science with the aim of serving the public health requires examining the influence of sex and gender on health outcomes.Discussion: This section provides a historical perspective on the changes in recommendations and requirements of both the National Institutes of Health - the world's largest single funder of biomedical research - and the U.S. Food and Drug Administration - the world's most influential regulator of drugs and medical devices - for the acceptable conduct of research as it relates to sex and gender. We also cite all reports by the U.S. Institute of Medicine and the U.S. Congress' General Accountability Office issued from 1990 to the present on the inclusion of sex and gender in research, and selected high-impact published studies that illustrate and document the paucity of, yet the need for, inclusion of females and consideration of sex and gender in research across an array of biomedical disciplines. The key message of this paper is that it has been 20 years since the first requirements to include women as well as men in clinical trials and analyze results by sex were mandated by a U.S. federal law, yet not nearly enough progress has been made. Recent signs of potential change in both policy and practice of scientific inquiry suggest much more progress may be within reach. However, awaiting a cultural shift to allow the study of sex and gender to be embraced is not seen as an effective strategy for change. Rather, specific instrumental recommendations are offered for how to include the study of sex and gender in research so as to increase our understanding and promotion of health for the benefit of all. [ABSTRACT FROM AUTHOR]

Background: Theories, models, and frameworks used by implementation science, including Diffusion of Innovations, tend to focus on the adoption of one innovation, when often organizations may be facing multiple simultaneous adoption decisions. For instance, despite evidence that care management practices (CMPs) are helpful in managing chronic illness, there is still uneven adoption by physician organizations. This exploratory paper leverages this natural variation in uptake to describe inter-organizational patterns in adoption of CMPs and to better understand how adoption choices may be related to one another.Methods: We assessed a cross section of national survey data from physician organizations reporting on the use of 20 CMPs (5 each for asthma, congestive heart failure, depression, and diabetes). Item response theory was used to explore patterns in adoption, first considering all 20 CMPs together and then by subsets according to disease focus or CMP type (e.g., registries, patient reminders). Mokken scale analysis explored whether adoption choices were linked by disease focus or CMP type and whether a consistent ordering of adoption choices was present.Results: The Mokken scale for all 20 CMPs demonstrated medium scalability (H = 0.43), but no consistent ordering. Scales for subsets of CMPs sharing a disease focus had medium scalability (0.4 < H < 0.5), while subsets sharing a CMP type had strong scalability (H > 0.5). Scales for CMP type consistently ranked diabetes CMPs as most adoptable and depression CMPs as least adoptable. Within disease focus scales, patient reminders were ranked as the most adoptable CMP, while clinician feedback and patient education were ranked the least adoptable.Conclusions: Patterns of adoption indicate that innovation characteristics may influence adoption. CMP dissemination efforts may be strengthened by encouraging traditionally non-adopting organizations to focus on more adoptable practices first and then describing a pathway for the adoption of subsequent CMPs. Clarifying why certain CMPs are "less adoptable" may also provide insights into how to overcome CMP adoption constraints. [ABSTRACT FROM AUTHOR]

Background: While dissemination and implementation (D&I) science has grown rapidly, there is an ongoing need to understand how to build and sustain capacity in individuals and institutions conducting research. There are three inter-related domains for capacity building: people, settings, and activities. Since 2008, Washington University in St. Louis has dedicated significant attention and resources toward building D&I research capacity. This paper describes our process, challenges, and lessons with the goal of informing others who may have similar aims at their own institution.Activities: An informal collaborative, the Washington University Network for Dissemination and Implementation Research (WUNDIR), began with a small group and now has 49 regular members. Attendees represent a wide variety of settings and content areas and meet every 6 weeks for half-day sessions. A logic model organizes WUNDIR inputs, activities, and outcomes. A mixed-methods evaluation showed that the network has led to new professional connections and enhanced skills (e.g., grant and publication development). As one of four, ongoing, formal programs, the Dissemination and Implementation Research Core (DIRC) was our first major component of D&I infrastructure. DIRC's mission is to accelerate the public health impact of clinical and health services research by increasing the engagement of investigators in later stages of translational research. The aims of DIRC are to advance D&I science and to develop and equip researchers with tools for D&I research. As a second formal component, the Washington University Institute for Public Health has provided significant support for D&I research through pilot projects and a small grants program. In a third set of formal programs, two R25 training grants (one in mental health and one in cancer) support post-doctoral scholars for intensive training and mentoring in D&I science. Finally, our team coordinates closely with D&I functions within research centers across the university. We share a series of challenges and potential solutions.Conclusion: Our experience in developing D&I research at Washington University in St. Louis shows how significant capacity can be built in a relatively short period of time. Many of our ideas and ingredients for success can be replicated, tailored, and improved upon by others. [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: Limited evidence exists to inform physical activity (PA) and sedentary behavior guidelines for older people, especially women. Rigorous evidence on the amounts, intensities, and movement patterns associated with better health in later life is needed.Methods/design: The Objective PA and Cardiovascular Health (OPACH) Study is an ancillary study to the Women's Health Initiative (WHI) Program that examines associations of accelerometer-assessed PA and sedentary behavior with cardiovascular and fall events. Between 2012 and 2014, 7048 women aged 63-99 were provided with an ActiGraph GT3X+ (Pensacola, Florida) triaxial accelerometer, a sleep log, and an OPACH PA Questionnaire; 6489 have accelerometer data. Most women were in their 70s (40%) or 80s (46%), while approximately 10% were in their 60s and 4% were age 90 years or older. Non-Hispanic Black or Hispanic/Latina women comprise half of the cohort. Follow-up includes 1-year of falls surveillance with monthly calendars and telephone interviews of fallers, and annual follow-up for outcomes with adjudication of incident cardiovascular disease (CVD) events through 2020. Over 63,600 months of calendar pages were returned by 5,776 women, who reported 5,980 falls. Telephone interviews were completed for 1,492 women to ascertain the circumstances, injuries and medical care associated with falling. The dataset contains extensive information on phenotypes related to healthy aging, including inflammatory and CVD biomarkers, breast and colon cancer, hip and other fractures, diabetes, and physical disability.Discussion: This paper describes the study design, methods, and baseline data for a diverse cohort of postmenopausal women who wore accelerometers under free-living conditions as part of the OPACH Study. By using accelerometers to collect more precise and complete data on PA and sedentary behavior in a large cohort of older women, this study will contribute crucial new evidence about how much, how vigorous, and what patterns of PA are necessary to maintain optimal cardiovascular health and to avoid falls in later life.Clinical Trials Registration: ClinicalTrials.gov identifier NCT00000611 . Registered 27 October 1999. [ABSTRACT FROM AUTHOR]

Background: The most pervasive form of female genital mutilation/cutting--infibulation--involves the almost complete closure of the vaginal orifice by cutting and closing the labia to create a skin seal. A small opening remains for the passage of urine and menstrual blood. This physical closure has to be re-opened--defibulated--later in life. When they marry, a partial opening is made to enable sexual intercourse. The husband commonly uses his penis to create this opening. In some settings, a circumciser or traditional midwife opens the infibulated scar with a knife or razor blade. Later, during childbirth, a further opening is necessary to make room for the child's passage. In Norway, public health services provide surgical defibulation, which is less risky and painful than traditional forms of defibulation. This paper explores the perceptions and experiences of surgical defibulation among migrants in Norway and investigates whether surgical defibulation is an accepted medicalization of a traditional procedure or instead challenges the cultural underpinnings of infibulation. Methods: Data derived from in-depth interviews with 36 women and men of Somali and Sudanese origin and with 30 service providers, as well as participant observations in various settings from 2014-15, were thematically analyzed. Results: The study findings indicate that, despite negative attitudes towards infibulation, its cultural meaning in relation to virility and sexual pleasure constitutes a barrier to the acceptance of medicalized defibulation. Conclusions: As sexual concerns regarding virility and male sexual pleasure constitute a barrier to the uptake of medicalized defibulation, health care providers need to address sexual concerns when discussing treatment for complications in infibulated women. Furthermore, campaigns and counselling against this practice also need to tackle these sexual concerns. [ABSTRACT FROM AUTHOR]

Background: This paper contributes to research on the education-health association by extending the scope of inquiry to adult inmates. Not only are inmates excluded from most nationally representative studies of health but they also represent a highly select group in terms of both education and health. As such, our study provides new information about the health of incarcerated populations and it extends the generalizability of the education-health association beyond the non-institutionalized population.Methods: We use a prison-level fixed-effects regression model with the 2004 Survey of Inmates in State Correctional Facilities (n = 287 facilities) to evaluate the effects of education on a standardized morbidity scale of 11 lifetime and current health conditions among incarcerated men (n = 10,493) and women (n = 2,797).Results: Education prior to incarceration is negatively associated with lifetime health problems for both women and men and the association is stronger among women. Among inmates who enter prison with less than a GED level of education, attaining a GED in prison is associated with better current health outcomes for men, but not women.Conclusions: The generalization of the education-health association among prisoners further highlights the fundamental nature of education as a health promotive resource. Discussed are the implications for the education-health literature in general and health promotion efforts among incarcerated adults specifically. [ABSTRACT FROM AUTHOR]

Background: Adaptive designs have been increasingly used in the pharmaceutical and device industries, but adoption within the academic setting has been less widespread - particularly for confirmatory phase trials. We sought to understand perceptions about understanding, acceptability, and scientific validity of adaptive clinical trials (ACTs).Methods: We used a convergent mixed methods design using survey and mini-focus group data collection procedures to elucidate attitudes and opinions among "trial community" stakeholders regarding understanding, acceptability, efficiency, scientific validity, and speed of discovery with adaptive designs. Data were collected about various aspects of ACTs using self-administered surveys (paper or Web-based) with visual analog scales (VASs) with free text responses and with mini-focus groups of key stakeholders. Participants were recruited as part of an ongoing NIH/FDA-funded research project exploring the incorporation of ACTs into an existing NIH network that focuses on confirmatory phase clinical trials in neurological emergencies. "Trial community" representatives, namely, clinical investigators, biostatisticians, NIH officials, and FDA scientists involved in the planning of four clinical trials, were eligible to participate. In addition, recent and current members of a clinical trial-oriented NIH study section were also eligible.Results: A total of 76 stakeholders completed the survey (out of 91 who were offered it, response rate 84 %). While the VAS attitudinal data showed substantial variability across respondents about acceptability and understanding of ACTs by various constituencies, respondents perceived clinicians to be less likely to understand ACTs and that ACTs probably would increase the efficiency of discovery. Textual and focus group responses emerged into several themes that enhanced understanding of VAS attitudinal data including the following: acceptability of adaptive designs depends on constituency and situation; there is variable understanding of ACTs (limited among clinicians, perceived to be higher at FDA); views about the potential for efficiency depend on the situation and implementation. Participants also frequently mentioned a need for greater education within the academic community. Finally, the empiric, non-quantitative selection of treatments for phase III trials based on limited phase II trials was highlighted as an opportunity for improvement and a potential explanation for the high number of neutral confirmatory trials.Conclusions: These data show considerable variations in attitudes and beliefs about ACTs among trial community representatives. For adaptive trials to be fully considered when appropriate and for the research enterprise to realize the full potential of adaptive designs will likely require extensive experience and trust building within the trial community. [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 associated transmission of Mycobacterium tuberculosis (TB) is well described. A previous survey of infection control (IC) practices at clinical research sites in low and middle income countries (LMIC) funded by the National Institute of Allergy and Infectious Diseases (NIAID) conducting HIV research identified issues with respiratory IC practices. A guideline for TB IC based on international recommendations was developed and promulgated. This paper reports on adherence to the guideline at sites conducting or planning to conduct TB studies with the intention of supporting improvement.Methods: A survey was developed that assessed IC activities in three domains: facility level measures, administrative control measures and environmental measures. An external site monitor visited each site in 2013-2014, to complete the audit. A central review committee evaluated the site-level survey and results were tabulated. Fisher's exact test was performed to determine whether there were significant differences in practices at sites that had IC officers versus sites that did not have IC officers. Significance was assessed at p

Background: Since the 1970s, the dominant model for U.S. federal housing policy has shifted from unit-based programs to tenant-based vouchers and certificates. Because housing vouchers allow recipients to move to apartments and neighborhoods of their choice, such programs were designed to improve the ability of poor families to move into neighborhoods with less concentrated poverty. However, little research has examined whether housing voucher recipients live in less distressed neighborhoods than those without housing vouchers. There is much reason to believe that drug users may not be able to access or keep federal housing subsidies due to difficulties drug users, many of whom may have criminal histories and poor credit records, may have in obtaining free market rental housing. In response to these difficulties, permanent supportive housing was designed for those who are chronically homeless with one or more disabling condition, including substance use disorders. Little research has examined whether residents of permanent supportive housing units live in more or less economically distressed neighborhoods compared to low-income renters.Methods: This paper uses survey data from 337 low-income residents of Hartford, CT and geospatial analysis to determine whether low-income residents who receive housing subsidies and supportive housing live in neighborhoods with less concentrated poverty than those who do not. We also examine the relationships between receiving housing subsidies or supportive housing and housing satisfaction. Finally, we look at the moderating effects of drug use and race on level of neighborhood distress and housing satisfaction.Results: Results show that low-income residents who receive housing subsidies or supportive housing were not more or less likely to live in neighborhoods with high levels of distress, although Black residents with housing subsidies lived in more distressed neighborhoods. Regarding housing satisfaction, those with housing subsidies perceived significantly more choice in where they were living while those in supportive housing perceived less choice. In addition, those with rental subsidies or supportive housing reported living closer to needed services, unless they also reported heavy drug use.Conclusions: Housing subsidies and supportive housing have little impact on the level of neighborhood distress in which recipients live, but some effects on housing satisfaction. [ABSTRACT FROM AUTHOR]

Background: Most schools have not fully implemented wellness policies, and those that have rarely incorporate meaningful student participation. The aim of the Fuel Up to Play 60 (FUTP60) program is to help schools implement wellness policies by engaging students in activities to improve access to healthful, good tasting food and drinks, and increase the number and type of opportunities for students to be physically active. The aim of this paper is to present initial student-level results from an implementation of FUTP60 in 72 schools, grades 6-9. Methods: The study used a non-controlled pretest/posttest with serial cross-sectional data. School process data and student-level data were collected in fall 2009 (pre-intervention) and spring 2010 (post-intervention). School wellness practices were captured during a baseline needs assessment survey. Validated self-administered questionnaires assessing dietary and physical activity (PA) behaviors were administered to students in grades 6-9 in the 72 pilot schools. Mixed-effects logistic regression controlling for clustering of schools and demographics was used to calculate odds ratios and confidence intervals to evaluate changes pre- and post- intervention. Results: All 72 schools implemented FUTP60 during the 2009-2010 school year. Action strategies most frequently chosen by the schools included increasing breakfast participation and new activities before and after school. Positive and significant changes in students' behaviors (n = 32,482 at pretest and 29,839 at post-test) were noted for dairy, whole grains, fruit, and vegetable consumption and PA levels pre- and post-intervention (OR 1.05 to 1.27). Students aware of the program at post-test were significantly more likely to report healthier eating and PA behaviors than students unaware of the program (OR 1.1 to 1.34). Conclusions: FUTP60 pilot findings indicate that a low intensity program focused on wellness policy implementation is associated with small positive changes in student behaviors, especially when students were aware of the program. Although these initial results are promising, a more rigorous controlled study is warranted as a next step. [ABSTRACT FROM AUTHOR]

Background: A 2-day consensus working meeting, hosted by the United States National Institutes of Health and the Veterans Administration, focused on issues related to dissemination and implementation (D&I) research in measurement and reporting. Meeting participants included 23 researchers, practitioners, and decision makers from the USA and Canada who concluded that the field would greatly benefit from measurement resources to enhance the ease, harmonization, and rigor of D&I evaluation efforts. This paper describes the findings from an environmental scan and literature review of resources for D&I measures.Findings: We identified a total of 17 resources, including four web-based repositories and 12 static reviews or tools that attempted to synthesize and evaluate existing measures for D&I research. Thirteen resources came from the health discipline, and 11 were populated from database reviews. Ten focused on quantitative measures, and all were generated as a resource for researchers. Fourteen were organized according to an established D&I theory or framework, with the number of constructs and measures ranging from 1 to more than 450. Measure metadata was quite variable with only six providing information on the psychometric properties of measures.Conclusions: Additional guidance on the development and use of measures are needed. A number of approaches, resources, and critical areas for future work are discussed. Researchers and stakeholders are encouraged to take advantage of a number of funding mechanisms supporting this type of work. [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: About 35 % of non-elderly U.S. adult Medicaid enrollees have a behavioral health condition, such as anxiety, mood disorders, substance use disorders, and/or serious mental illness. Individuals with serious mental illness, in particular, have mortality rates that are 2 to 3 times higher as the general population, which are due to multiple factors including inactivity, poor nutrition, and tobacco use. 61 % of Medicaid beneficiaries with behavioral health conditions also have multiple other co-occurring chronic physical health conditions, which further contributes to morbidity and mortality. The Wellness Incentives and Navigation (WIN) project is one of 10 projects under the Centers for Medicare and Medicaid Services "Medicaid Incentives for the Prevention of Chronic Diseases" Initiative, to "test the effectiveness of providing incentives directly to Medicaid beneficiaries of all ages who participate in prevention programs, and change their health risks and outcomes by adopting healthy behaviors."Methods/design: WIN is a three-year randomized pragmatic clinical trial designed to examine the comparative effectiveness of the combined use of personal navigators, motivational interviewing, and a flexible wellness account on cardiovascular risk reduction among individuals in Medicaid with co-occurring physical and mental health conditions or serious mental illness alone relative to the usual care provided within Medicaid Managed Care. 1250 individuals, identified through Medicaid claims data, were recruited and randomly assigned to an intervention group or control group with outcomes tracked annually. A comparison group was also recruited to help assess the study's internal validity.Discussion: The primary outcomes are physical and mental health related quality-of-life as measured by the SF-12, and BMI, blood pressure, LDL-C, and Hba1c results for those who are diabetic measured clinically. The purpose of this paper is to present the unique design of the WIN trial prior to results becoming available in hopes of assisting other researchers in conducting community-based randomized pragmatic trials. Outcomes will be assessed through the linkage of patient reported outcomes, health care claims, and electronic health record data.Trial Registration: NCT02440906. [ABSTRACT FROM AUTHOR]

Background: Many families rely on child care outside the home, making these settings important influences on child development. Nearly 1.5 million children in the U.S. spend time in family child care homes (FCCHs), where providers care for children in their own residences. There is some evidence that children in FCCHs are heavier than those cared for in centers. However, few interventions have targeted FCCHs for obesity prevention. This paper will describe the application of the Intervention Mapping (IM) framework to the development of a childhood obesity prevention intervention for FCCHsMethods: Following the IM protocol, six steps were completed in the planning and development of an intervention targeting FCCHs: needs assessment, formulation of change objectives matrices, selection of theory-based methods and strategies, creation of intervention components and materials, adoption and implementation planning, and evaluation planningResults: Application of the IM process resulted in the creation of the Keys to Healthy Family Child Care Homes program (Keys), which includes three modules: Healthy You, Healthy Home, and Healthy Business. Delivery of each module includes a workshop, educational binder and tool-kit resources, and four coaching contacts. Social Cognitive Theory and Self-Determination Theory helped guide development of change objective matrices, selection of behavior change strategies, and identification of outcome measures. The Keys program is currently being evaluated through a cluster-randomized controlled trialConclusions: The IM process, while time-consuming, enabled rigorous and systematic development of intervention components that are directly tied to behavior change theory and may increase the potential for behavior change within the FCCHs. [ABSTRACT FROM AUTHOR]

Background: In 2007, the National Cancer Institute (NCI) launched the NCI Community Cancer Centers Program (NCCCP) as a public-private partnership with community hospitals with a goal of advancing cancer care and research. In order to leverage federal dollars in a time of limited resources, matching funds from each participating hospital were required. The purpose of this paper is to examine hospitals' level of and rationale for co-investment in this partnership, and whether there is an association between hospitals' co-investment and achievement of strategic goals.Methods: Analysis using a comparative case study and micro-cost data was conducted as part of a comprehensive evaluation of the NCCCP pilot to determine the level of co-investment made in support of NCI's goals. In-person or telephone interviews with key informants were conducted at 10 participating hospital and system sites during the first and final years of implementation. Micro-cost data were collected annually from each site from 2007 to 2010. Self-reported data from each awardee are presented on patient volume and physician counts, while secondary data are used to examine the local Medicare market share.Results: The rationale expressed by interviewees for participation in a public-private partnership with NCI included expectations of increased market share, higher patient volumes, and enhanced opportunities for cancer physician recruitment as a result of affiliation with the NCI. On average, hospitals invested resources into the NCCCP at a level exceeding $3 for every $1 of federal funds. Six sites experienced a statistically significant change in their Medicare market share. Cancer patient volume increased by as much as one-third from Year 1 to Year 3 for eight of the sites. Nine sites reported an increase in key cancer physician recruitment.Conclusions: Demonstrated investments in cancer care and research were associated with increases in cancer patient volume and perhaps in recruitment of key cancer physicians, but not in increased Medicare market share. Although the results reflect a small sample of hospitals, findings suggest that hospital executives believe there to be a strategic case for a public-private partnership as demonstrated through the NCCCP, which leveraged federal funds to support mutual goals for advancing cancer care and research. [ABSTRACT FROM AUTHOR]

Sedentary behaviour (SB) has emerged as a potential risk factor for metabolic health in youth. Knowledge on the determinants of SB in youth is necessary to inform future intervention development to reduce SB. A systematic review was conducted to identify predictors and determinants of SB in youth. Pubmed, Embase, CINAHL, PsycINFO and Web of Science were searched, limiting to articles in English, published between January 2000 and May 2014. The search strategy was based on four key elements and their synonyms: (a) sedentary behaviour, (b) determinants, (c) types of sedentary behaviours, (d) types of determinants. The full protocol is available from PROSPERO (PROSPERO 2014:CRD42014009823). Cross-sectional studies were excluded. The analysis was guided by the socio-ecological model. 37 studies were selected out of 2654 identified papers from the systematic literature search. Most studies were conducted in Europe (n = 13), USA (n = 11), and Australia (n = 10). The study quality, using the Qualsyst tool, was high with a median of 82 % (IQR: 74-91 %). Multiple potential determinants were studied in only one or two studies. Determinants were found at the individual, interpersonal, environmental and policy level but few studies examined a comprehensive set of factors at different levels of influences. Evidence was found for age being positively associated with total SB, and weight status and baseline assessment of screen time being positively associated with screen time (at follow-up). A higher playground density and a higher availability of play and sports equipment at school were consistently related to an increased total SB, although these consistent findings come from single studies. Evidence was also reported for the presence of safe places to cross roads and lengthening morning and lunch breaks being associated with less total SB. Future interventions to decrease SB levels should especially target children with overweight or obesity and should start at a young age. However, since the relationship of many determinants with SB remains inconsistent, there is still a need for more longitudinal research on determinants of SB in youth. [ABSTRACT FROM AUTHOR]

Background: Effective, low-cost approaches are needed to enhance dietary behavior change. While both video and tailoring technology have been effective interventions to improve diet, these approaches have never been combined to study the effectiveness of tailored videos. The purpose of this paper is to discuss the results of Good For You!, a randomized trial that tested the efficacy of innovative, individually tailored videos in helping worksite employees decrease dietary fat and increase fruit and vegetable (F&V) intake. Methods: Worksites were matched on approximate size, type of company and workforce composition and randomized to one of three experimental conditions: Non-Tailored written information (NT) (n = 14), Tailored Written information (TW) (n = 14), or Tailored Written + Tailored Video (TW + TV) (n =15). Evaluation was conducted at baseline, 4 and 7 months. We used the NCI Fat Screener and an adapted Food Habits Questionnaire (FHQ) to estimate fat intake and fat-related behaviors, the NCI F&V Screener and F&V Habits Questionnaire (FVHQ) to measure F&V intake and behaviors. Generalized linear models were examined for all outcome measurements. Results: 2525 worksite employees were recruited. At 4 months, dietary fat intake decreased significantly more for TW (-2.95 %) and TW + TV (-3.14 %) compared with NT (-2.42 %). FHQ scores decreased significantly more for TW + TV than the other two groups. Fruit intake increased the most for TW + TV compared to NT and TW. Both TW (1.30 cups) and TW + TV (1.59 cups) increased F&V intake significantly more than NT (0.78 cups). TW + TV showed the largest increase in F&V behaviors on the FVFQ. At 8 months, dietary fat change continued to be significantly better for TW + TV (-3.48 %) than NT (3.01 %). F&V intake increased significantly more for the TW + TV group (1.38 cups) compared to the NT group (1.04 cups) and FVHQ changes were significantly greater in TW + TV and TW than for NT. Conclusions: The tailored intervention participants were more likely to decrease fat and increase F&V intake. The TW + TV group was generally the stronger of the two tailored interventions, especially at the longer term follow-up, demonstrating the promise of tailored video as an intervention to change eating habits. Future studies should explore newer channels and technologies in addition to DVDs for delivering tailored video interventions such as the internet and smart phones. [ABSTRACT FROM AUTHOR]

Background: Annually since 2010, the University of Wisconsin Population Health Institute and the Robert Wood Johnson Foundation have produced the County Health Rankings--a "population health checkup" for the nation's over 3,000 counties. The purpose of this paper is to review the background and rationale for the Rankings, explain in detail the methods we use to create the health rankings in each state, and discuss the strengths and limitations associated with ranking the health of communities. Methods: We base the Rankings on a conceptual model of population health that includes both health outcomes (mortality and morbidity) and health factors (health behaviors, clinical care, social and economic factors, and the physical environment). Data for over 30 measures available at the county level are assembled from a number of national sources. Z-scores are calculated for each measure, multiplied by their assigned weights, and summed to create composite measure scores. Composite scores are then ordered and counties are ranked from best to worst health within each state. Results: Health outcomes and related health factors vary significantly within states, with over two-fold differences between the least healthy counties versus the healthiest counties for measures such as premature mortality, teen birth rates, and percent of children living in poverty. Ranking within each state depicts disparities that are not apparent when counties are ranked across the entire nation. Discussion: The County Health Rankings can be used to clearly demonstrate differences in health by place, raise awareness of the many factors that influence health, and stimulate community health improvement efforts. The Rankings draws upon the human instinct to compete by facilitating comparisons between neighboring or peer counties within states. Since no population health model, or rankings based off such models, will ever perfectly describe the health of its population, we encourage users to look to local sources of data to understand more about the health of their community. [ABSTRACT FROM AUTHOR]

Introduction: Accurate measurement of health inequities is indispensable to track progress or to identify needs for health equity policy interventions. A key empirical task is to measure the extent to which observed inequality in health -- a difference in health -- is inequitable. Empirically operationalizing definitions of health inequity has generated an important question not considered in the conceptual literature on health inequity. Empirical analysis can explain only a portion of observed health inequality. This paper demonstrates that the treatment of unexplained inequality is not only a methodological but ethical question and that the answer to the ethical question -- whether unexplained health inequality is unfair -- determines the appropriate standardization method for health inequity analysis and can lead to potentially divergent estimates of health inequity. Methods: We use the American sample of the 2002-03 Joint Canada/United States Survey of Health and measure health by the Health Utilities Index (HUI). We model variation in the observed HUI by demographic, socioeconomic, health behaviour, and health care variables using Ordinary Least Squares. We estimate unfair HUI by standardizing fairness, removing the fair component from the observed HUI. We consider health inequality due to factors amenable to policy intervention as unfair. We contrast estimates of inequity using two fairness-standardization methods: direct (considering unexplained inequality as ethically acceptable) and indirect (considering unexplained inequality as unfair). We use the Gini coefficient to quantify inequity. Results: Our analysis shows that about 75% of the variation in the observed HUI is unexplained by the model. The direct standardization results in a smaller inequity estimate (about 60% of health inequality is inequitable) than the indirect standardization (almost all inequality is inequitable). Conclusions: The choice of the fairness-standardization method is ethical and influences the empirical health inequity results considerably. More debate and analysis is necessary regarding which treatment of the unexplained inequality has the stronger foundation in equity considerations. [ABSTRACT FROM AUTHOR]

Introduction Accurate measurement of health inequities is indispensable to track progress or to identify needs for health equity policy interventions. A key empirical task is to measure the extent to which observed inequality in health - a difference in health - is inequitable. Empirically operationalizing definitions of health inequity has generated an important question not considered in the conceptual literature on health inequity. Empirical analysis can explain only a portion of observed health inequality. This paper demonstrates that the treatment of unexplained inequality is not only a methodological but ethical question and that the answer to the ethical question - whether unexplained health inequality is unfair - determines the appropriate standardization method for health inequity analysis and can lead to potentially divergent estimates of health inequity. Methods We use the American sample of the 2002-03 Joint Canada/United States Survey of Health and measure health by the Health Utilities Index (HUI). We model variation in the observed HUI by demographic, socioeconomic, health behaviour, and health care variables using Ordinary Least Squares. We estimate unfair HUI by standardizing fairness, removing the fair component from the observed HUI. We consider health inequality due to factors amenable to policy intervention as unfair. We contrast estimates of inequity using two fairness- standardization methods: direct (considering unexplained inequality as ethically acceptable) and indirect (considering unexplained inequality as unfair). We use the Gini coefficient to quantify inequity. Results Our analysis shows that about 75% of the variation in the observed HUI is unexplained by the model. The direct standardization results in a smaller inequity estimate (about 60% of health inequality is inequitable) than the indirect standardization (almost all inequality is inequitable). Conclusions The choice of the fairness-standardization method is ethical and influences the empirical health inequity results considerably. More debate and analysis is necessary regarding which treatment of the unexplained inequality has the stronger foundation in equity considerations. [ABSTRACT FROM AUTHOR]

The protective effect of family meals on unhealthy weight gain and diet has been shown across multiple age groups; however, it is unknown whether a similar effect is present among diverse immigrant populations. In addition, little research has focused on factors associated with the frequency of evening family meals, such as feeding styles (how parents interact with their child around feeding). Therefore the goals of this paper are to explore the 1) association between the frequency of evening family meals and child weight status among new immigrant families, and 2) influence of immigrant mothers’ feeding styles on the frequency of evening family meals. Baseline self-reported socio-demographic information and measured heights and weights were collected for both mother and child (age range: 3-12 years) among 387 mother-child dyads enrolled in Live Well, a community-based, participatory-research, randomized controlled lifestyle intervention to prevent excessive weight gain in recent (<10 years in the U.S.) immigrant mothers and children. For children, height and weight measurements were transformed into BMI z-scores using age-and sex-specific CDC standards and categorized as overweight (85th-94th percentile) and obese (≥95th percentile); mothers’ BMI was calculated. Frequency of evening family meals, eating dinner in front of the TV, acculturation and responses to the Caregiver’s Feeding Styles Questionnaire (CFSQ) were also obtained from the mother. Children were categorized as “eating evening family meals regularly” if they had an evening family meal ≥5 times per week. Overall, 20% of children were overweight and 25% were obese. Less than half (40.9%) of families had regular evening family meals. In multivariate analyses, adjusting for covariates, children who were overweight/obese were significantly less likely to have ≥5 evening family meals/week compared with normal weight children (OR = 0.51, 95% CI 0.32-0.82) . Mothers who had a low demanding/high responsive or a low demanding/low responsive feeding style, were less likely to have ≥5 evening family meals/week compared to mothers with a high demanding/high responsive feeding style (OR = 0.41, 95% CI 0.18-0.0.96, OR = 0.33, 95% CI 0.13-0.87, respectively). Future interventions and programs that seek to help parents establish healthy household routines, such as family meals, may consider tailoring to specific maternal feeding styles. [ABSTRACT FROM AUTHOR]

Background: Training investigators for the rapidly developing field of implementation science requires both mentoring and scientific collaboration. Using social network descriptive analyses, visualization, and modeling, this paper presents results of an evaluation of the mentoring and collaborations fostered over time through the National Institute of Mental Health (NIMH) supported by Implementation Research Institute (IRI).Methods: Data were comprised of IRI participant self-reported collaborations and mentoring relationships, measured in three annual surveys from 2012 to 2014. Network descriptive statistics, visualizations, and network statistical modeling were conducted to examine patterns of mentoring and collaboration among IRI participants and to model the relationship between mentoring and subsequent collaboration.Results: Findings suggest that IRI is successful in forming mentoring relationships among its participants, and that these mentoring relationships are related to future scientific collaborations. Exponential random graph network models demonstrated that mentoring received in 2012 was positively and significantly related to the likelihood of having a scientific collaboration 2 years later in 2014 (p = 0.001). More specifically, mentoring was significantly related to future collaborations focusing on new research (p = 0.009), grant submissions (p = 0.003), and publications (p = 0.017). Predictions based on the network model suggest that for every additional mentoring relationships established in 2012, the likelihood of a scientific collaboration 2 years later is increased by almost 7 %.Conclusions: These results support the importance of mentoring in implementation science specifically and team science more generally. Mentoring relationships were established quickly and early by the IRI core faculty. IRI fellows reported increasing scientific collaboration of all types over time, including starting new research, submitting new grants, presenting research results, and publishing peer-reviewed papers. Statistical network models demonstrated that mentoring was strongly and significantly related to subsequent scientific collaboration, which supported a core design principle of the IRI. Future work should establish the link between mentoring and scientific productivity. These results may be of interest to team science, as they suggest the importance of mentoring for future team collaborations, as well as illustrate the utility of network analysis for studying team characteristics and activities. [ABSTRACT FROM AUTHOR]

Background: Latinos are currently the largest and fastest growing racial/ethnic group in the United States and have the lowest rates nationally of regular sources of primary care. The changing demographics of Latino populations have significant implications for the future health of the nation, particularly with respect to chronic disease. Community-based agencies and clinics alike have a long history of engaging community health workers (CHWs) to provide a broad range of tangible and emotional support strategies for Latinos with chronic diseases. In this paper, we present the protocol for a community intervention designed to evaluate the impact of CHWs in a Community-Clinical Linkage model to address chronic disease through innovative utilization of electronic health records (EHRs) and application of mixed methodologies. Linking Individual Needs to Community and Clinical Services (LINKS) is a 3-year, prospective matched observational study designed to examine the feasibility and impact of CHW-led Community-Clinical Linkages in reducing chronic disease risk and promoting emotional well-being among Latinos living in three U.S.-Mexico border communities.Methods: The primary aim of LINKS is to create Community-Clinical Linkages between three community health centers and their respective county health departments in southern Arizona. Our primary analysis is to examine the impact of the intervention 6 to 12-months post program entry. We will assess chronic disease risk factors documented in the EHRs of participants versus matched non-participants. By using a prospective matched observational study design with EHRs, we have access to numerous potential comparators to evaluate the intervention effects. Secondary analyses include modeling within-group changes of extended research-collected measures. This approach enhances the overall evaluation with rich data on physical and emotional well-being and health behaviors of study participants that EHR systems do not collect in routine clinical practice.Discussion: The LINKS intervention has practical implications for the development of Community-Clinical Linkage models. The collaborative and participatory approach in LINKS illustrates an innovative evaluation framework utilizing EHRs and mixed methods research-generated data collection.Trial Registration: This study protocol was retrospectively registered, approved, and made available on Clinicaltrials.gov by NCT03787485 as of December 20, 2018. [ABSTRACT FROM AUTHOR]

Background: Audit and feedback has been shown to be instrumental in improving quality of care, particularly in outpatient settings. The mental model individuals and organizations hold regarding audit and feedback can moderate its effectiveness, yet this has received limited study in the quality improvement literature. In this study we sought to uncover patterns in mental models of current feedback practices within high- and low-performing healthcare facilities.Methods: We purposively sampled 16 geographically dispersed VA hospitals based on high and low performance on a set of chronic and preventive care measures. We interviewed up to 4 personnel from each location (n = 48) to determine the facility's receptivity to audit and feedback practices. Interview transcripts were analyzed via content and framework analysis to identify emergent themes.Results: We found high variability in the mental models of audit and feedback, which we organized into positive and negative themes. We were unable to associate mental models of audit and feedback with clinical performance due to high variance in facility performance over time. Positive mental models exhibit perceived utility of audit and feedback practices in improving performance; whereas, negative mental models did not.Conclusions: Results speak to the variability of mental models of feedback, highlighting how facilities perceive current audit and feedback practices. Findings are consistent with prior research  in that variability in feedback mental models is associated with lower performance.; Future research should seek to empirically link mental models revealed in this paper to high and low levels of clinical performance. [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: Understanding the social lives of South Asian immigrants in the United States (U.S) and their influence on health can inform interpersonal and community-level health interventions for this growing community. This paper describe the rationale, survey design, measurement, and network properties of 700 South Asian individuals in the Mediators of Atherosclerosis in South Asians Living in America (MASALA) social networks ancillary study.Methods: MASALA is a community-based cohort, established in 2010, to understand risk factors for cardiovascular disease among South Asians living in the U.S. Survey data collection on personal social networks occurred between 2014 and 2017. Network measurements included size, composition, density, and organizational affiliations. Data on participants' self-rated health and social support functions and health-related discussions among network members were also collected.Results: Participants' age ranged from 44 to 84 (average 59 years), and 57% were men. South Asians had large (size=5.6, SD=2.6), kin-centered (proportion kin=0.71, SD=0.28), and dense networks. Affiliation with religious and spiritual organizations was perceived as beneficial to health. Emotional closeness with network members was positively associated with participants' self-rated health (p-value <0.001), and networks with higher density and more kin were significantly associated with health-related discussions.Discussion: The MASALA networks study advances research on the cultural patterning of social relationships and sources of social support in South Asians living in the U.S. Future analyses will examine how personal social networks and organizational affiliations influence South Asians' health behaviors and outcomes.Trial Registration: ClinicalTrials.gov identifier: NCT02268513. [ABSTRACT FROM AUTHOR]