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Objectives: The objectives of this paper is to conduct a bibliometric analysis to examine the research status and development trend of anterior cruciate ligament injury and reconstruction in children and adolescents over the past 20 years. Design: Descriptive Research. Methods: This study obtained information regarding studies on Anterior Cruciate Ligament Reconstruction in Children and Adolescents from the Web of Science Core Collection database. Visual and bibliometric analysis were conducted using VOSviewer, Origin 2022, Pajek64 5.18and Excel 2019. These analytic tools facilitated the analysis of various aspects, including countries/regions, institutions, authors, journals and keywords related to the research. Results: From 2003 to 2023, a total of 1328 articles were retrieved in WOS, and 637 articles were selected by two authors. The most productive institutions are Childrens Hosp Philadelphia, Kocher, ms. Their articles have the highest number of publications and citations. The American journal of sports medicine is the most frequently cited journal for articles on anterior cruciate ligament reconstruction in children and adolescents. The most common keywords used in these articles were "anterior cruciate ligament reconstruction", "injury, children, adolescent", and "skeletally immature patients". Conclusions: This study provides valuable insights into the research focus of anterior cruciate ligament reconstruction in children and adolescents. In recent years, there has been significant attention paid to areas of "the return to sport, re-repture rate and functional recovery after anterior cruciate ligament reconstruction" in this specific population. These aspects have emerged as key directions for future research in this field. [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: 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]

Background: An increasing number of HIV cure trials involve combining multiple potentially curative interventions. Until now, considerations for designing and implementing complex combination HIV cure trials have not been thoroughly considered. Methods: We used a purposive method to select key informants for our study. Informants included biomedical HIV cure researchers, regulators, policy makers, bioethicists, and community members. We used in-depth interviews to generate ethical and practical considerations to guide the design and implementation of combination HIV cure research. We analyzed the qualitative data using conventional content analysis focused on inductive reasoning. Results: We interviewed 11 biomedical researchers, 4 community members, 2 regulators, 1 policy researcher, and 1 bioethicist. Informants generated considerations for designing and implementing combination interventions towards an HIV cure, focused on ethical aspects, as well as considerations to guide trial design, benefit/risk determinations, regulatory requirements, prioritization and sequencing and timing of interventions, among others. Informants also provided considerations related to combining specific HIV cure research modalities, such as broadly neutralizing antibodies (bNAbs), cell and gene modification products, latency-reversing agents and immune-based interventions. Finally, informants provided suggestions to ensure meaningful therapeutic improvements over standard antiretroviral therapy, overcome challenges of designing combination approaches, and engage communities around combination HIV cure research. Conclusion: The increasing number of combination HIV cure trials brings with them a host of ethical and practical challenges. We hope our paper will inform meaningful stakeholder dialogue around the use of combinatorial HIV cure research approaches. To protect the public trust in HIV cure research, considerations should be periodically revisited and updated with key stakeholder input as the science continues to advance. [ABSTRACT FROM AUTHOR]

Background: Self-rated health (SRH) is one of the most commonly used summary measures of overall health and well-being available to population scientists due to its ease of administration in large-scale surveys and to its efficacy in predicting mortality. This paper assesses the extent to which SRH is affected by its placement before or after questions about bodyweight on a survey, and whether differences in placement on the questionnaire affects SRH's predictive validity. Methods: I assessed the validity of SRH in predicting the risk of mortality by comparing outcomes of sample members who were asked to rate their health before reporting on their bodyweight (the control group) and sample members who were asked to rate their health after reporting on their bodyweight (the treatment group). Both the control and treatment group were randomly assigned via an experiment administered as a module in a nationally representative sample of adults in the USA in 2019 (N = 2523). Results: The odds of reporting a more favorable appraisal of health are 30% lower for sample members who were in the treatment group when compared with the control group. Additionally, the SRH of treatment group members is significantly associated with their risk of mortality, while the SRH of control group members is not. Conclusion: The findings from this study suggest that for researchers to maximize the utility of SRH, closer attention needs to be paid to the context of the survey within which it asked. SRH is highly sensitive to the questions that precede it, and this sensitivity may in turn mischaracterize the true health of the population that the survey is intending to measure. [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: 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: While research has emphasized the importance of parental support for LGBTQIA + youth wellbeing, there remains limited understanding of parental experiences with nonbinary children, particularly those prepubescent. This study aimed to explore how parents of nonbinary children ages 5–8 learn to support their child's identity, examining initial reactions, emotional processes, supportive behaviors, societal responses, and associated challenges and rewards. Methods: A qualitative study was conducted using Reflexive Thematic Analysis (RTA) within a framework of ontological relativism and epistemological constructivism. Nine parents of nonbinary children aged 5–8 from the Northeastern United States participated in semi-structured interviews lasting 60–80 min. Questions explored various aspects of parenting nonbinary children, including the child's gender identity, parental feelings, experiences sharing the child's identity, and challenges and rewards of raising a gender-diverse child. The research team, comprising individuals who identify as trans, genderqueer, and nonbinary, employed collaborative coding and thematic development. Results: Four main themes were constructed: (1) Parents hear and support their child's nonbinary identity, this theme highlights immediate acceptance and efforts parents make to affirm their child's gender; (2) Parents learn about ways cisnormative society harms their child, here, parents recognize the societal pressures and barriers their children face; (3) Parents take significant and proactive steps to affirm their child, this theme documents the actions parents take to support their child in environments that invalidate their identity; and (4) Gender is just one aspect of who my child is, this theme reflects on parental insights of gender as just one part of their child's overall personhood. Conclusions: This study provides insights into the experiences of parents supporting young nonbinary children, emphasizing the importance of affirming expressed identity, the parent-child relationship, and proactive support in navigating cisnormative societal structures. Findings highlight the transformative experience of parenting nonbinary children, with parents often challenging their own preconceptions of gender and coming to more nuanced understandings. These results can inform supportive interventions and policies for nonbinary children and their families, and we hope to contribute to a growing body of research that shifts narratives towards joy, resilience, and community in trans and nonbinary experiences. [ABSTRACT FROM AUTHOR]

Background: Transgender, non-binary, and/or gender expansive (TNG) individuals experience disproportionately high rates of mental illness and unique barriers to accessing psychiatric care. Integrating TNG-specific psychiatric care with other physical health services may improve engagement, but little published literature describes patient and clinician perspectives on such models of care. Here we present a formative evaluation aiming to inform future projects integrating psychiatric care with physical health care for TNG individuals. Methods: In this qualitative pre-implementation study, semi-structured interview guides were developed informed by the Consolidated Framework for Implementation Research to ensure uniform inclusion and sequencing of topics and allow for valid comparison across interviews. We elicited TNG patient (n = 11) and gender-affirming care clinician (n = 10) needs and preferences regarding integrating psychiatric care with other gender-affirming clinical services. We conducted a rapid analysis procedure, yielding a descriptive analysis for each participant group, identifying challenges of and opportunities in offering integrated gender-affirming psychiatric care. Results: Participants unanimously preferred integrating psychiatry within primary care instead of siloed service models. All participants preferred that patients have access to direct psychiatry appointments (rather than psychiatrist consultation with care team only) and all gender-affirming care clinicians wanted increased access to psychiatric consultations. The need for flexible, tailored care was emphasized. Facilitators identified included taking insurance, telehealth, clinician TNG-competence, and protecting time for clinicians to collaborate and obtain consultation. Conclusions: This health equity pre-implementation project engaged TNG patients and gender-affirming care clinicians to inform future research exploring integration of mental health care with primary care for the TNG community and suggests utility of such a model of care. [ABSTRACT FROM AUTHOR]

Background: About 30 million individuals in the United States are living with a rare disease, which by definition have a prevalence of 200,000 or fewer cases in the United States ([National Organization for Rare Disorders], [About NORD], [2016]). Disease heterogeneity and geographic dispersion add to the difficulty of completing robust studies in small populations. Improving the ability to conduct research on rare diseases would have a significant impact on population health. The purpose of this paper is to raise awareness of methodological approaches that can address the challenges to conducting robust research on rare diseases.Approach: We conducted a landscape review of available methodological and analytic approaches to address the challenges of rare disease research. Our objectives were to: 1. identify algorithms for matching study design to rare disease attributes and the methodological approaches applicable to these algorithms; 2. draw inferences on how research communities and infrastructure can contribute to the efficiency of research on rare diseases; and 3. to describe methodological approaches in the rare disease portfolio of the Patient-Centered Outcomes Research Institute (PCORI), a funder promoting both rare disease research and research infrastructure.Results: We identified three algorithms for matching study design to rare disease or intervention characteristics (Gagne, et.al, BMJ 349:g6802, 2014); (Gupta, et.al, J Clin Epidemiol 64:1085-1094, 2011); (Cornu, et. al, Orphet J Rare Dis 8:48,2012) and summarized the applicable methodological and analytic approaches. From this literature we were also able to draw inferences on how an effective research infrastructure can set an agenda, prioritize studies, accelerate accrual, catalyze patient engagement and terminate poorly performing studies. Of the 24 rare disease projects in the PCORI portfolio, 11 are randomized controlled trials (RCTs) using standard designs. Thirteen are observational studies using case-control, prospective cohort, or natural history designs. PCORI has supported the development of 9 Patient-Powered Research Networks (PPRNs) focused on rare diseases.Conclusion: Matching research design to attributes of rare diseases and interventions can facilitate the completion of RCTs that are adequately powered. An effective research infrastructure can improve efficiency and avoid waste in rare disease research. Our review of the PCORI research portfolio demonstrates that it is feasible to conduct RCTs in rare disease. However, most of these studies are using standard RCT designs. This suggests that use of a broader array of methodological approaches to RCTs --such as adaptive trials, cross-over trials, and early escape designs can improve the productivity of robust research in rare diseases. [ABSTRACT FROM AUTHOR]

Background: Values are broadly understood to have implications for how individuals make decisions and cope with serious illness stressors, yet it remains uncertain how patients and their family and friend caregivers discuss, reflect upon, and act on their values in the post-left ventricular assist device (LVAD) implantation context. This study aimed to explore the values elicitation experiences of patients with an LVAD in the post-implantation period. Methods: Qualitative descriptive study of LVAD recipients. Socio-demographics and patient resource use were analyzed using descriptive statistics and semi-structured interview data using thematic analysis. Adult (> 18 years) patients with an LVAD receiving care at an outpatient clinic in the Southeastern United States. Results: Interviewed patients (n = 27) were 30–76 years, 59% male, 67% non-Hispanic Black, 70% married/living with a partner, and 70% urban-dwelling. Three broad themes of patient values elicitation experiences emerged: 1) LVAD implantation prompts deep reflection about life and what is important, 2) patient values are communicated in various circumstances to convey personal goals and priorities to caregivers and clinicians, and 3) patients leverage their values for strength and guidance in navigating life post-LVAD implantation. LVAD implantation was an impactful experience often leading to reevaluation of patients' values; these values became instrumental to making health decisions and coping with stressors during the post-LVAD implantation period. Patient values arose within broad, informal exchanges and focused, decision-making conversations with their caregiver and the healthcare team. Conclusions: Clinicians should consider assessing the values of patients post-implantation to facilitate shared understanding of their goals/priorities and identify potential changes in their coping. [ABSTRACT FROM AUTHOR]

Objective: Qualitative research methods are based on the analysis of words rather than numbers; they encourage self-reflection on the investigator's part; they are attuned to social interaction and nuance; and they incorporate their subjects' thoughts and feelings as primary sources. Despite appearing well suited for research in child and adolescent psychiatry (CAP), qualitative methods have had relatively minor uptake in the discipline. We conducted a qualitative study of CAPs involved in qualitative research to learn about these investigators' lived experiences, and to identify modifiable factors to promote qualitative methods within the field of youth mental health. Methods: We conducted individual, semi-structured 1-h long interviews through Zoom. Using purposive sample, we selected 23 participants drawn from the US (n = 12) and from France (n = 11), and equally divided in each country across seniority level. All participants were current or aspiring CAPs and had published at least one peer-reviewed qualitative article. Ten participants were women (44%). We recorded all interviews digitally and transcribed them for analysis. We coded the transcripts according to the principles of thematic analysis and approached data analysis, interpretation, and conceptualization informed by an interpersonal phenomenological analysis (IPA) framework. Results: Through iterative thematic analysis we developed a conceptual model consisting of three domains: (1) Becoming a qualitativist: embracing a different way of knowing (in turn divided into the three themes of priming factors/personal fit; discovering qualitative research; and transitioning in); (2) Being a qualitativist: immersing oneself in a different kind of research (in turn divided into quality: doing qualitative research well; and community: mentors, mentees, and teams); and (3) Nurturing: toward a higher quality future in CAP (in turn divided into current state of qualitative methods in CAP; and advocating for qualitative methods in CAP). For each domain, we go on to propose specific strategies to enhance entry into qualitative careers and research in CAP: (1) Becoming: personalizing the investigator's research focus; balancing inward and outward views; and leveraging practical advantages; (2) Being: seeking epistemological flexibility; moving beyond bibliometrics; and the potential and risks of mixing methods; and (3) Nurturing: invigorating a quality pipeline; and building communities. Conclusions: We have identified factors that can support or impede entry into qualitative research among CAPs. Based on these modifiable findings, we propose possible solutions to enhance entry into qualitative methods in CAP (pathways), and to foster longer-term commitment to this type of research (identity). [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: The paper examines the role of community-based participatory research (CBPR) within the context of social justice literature and practice. Methods: Two CBPR case studies addressing health inequities related to Type 2 Diabetes and Cardiovascular disease were selected from a national cross-site study assessing effective academic-community research partnerships. One CBPR partnership works with African Americans in rural Pemiscot County, Missouri and the other CBPR partnership works with African American and Latinos in urban South Bronx, New York City. Data collection included semi-structured key informant interviews and focus groups. Analysis focused on partnerships' context/ history and their use of multiple justice-oriented strategies to achieve systemic and policy changes in order to address social determinants of health in their communities. Results: Community context and history shaped each partnership's strategies to address social determinants. Four social justice approaches (identity/recognition, procedural, distributive, and structural justice) used by both partnerships were identified. These social justice approaches were employed to address underlying causes of inequitable distribution of resources and power structures, while remaining within a scientific research framework. Conclusion: CBPR can bridge the role of science with civic engagement and political participation, empowering community members to become political agents who integrate evidence into their social justice organizing strategies. [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: In the United States, Latinos face a wide array of cultural and structural barriers to accessing and utilizing mental health care. Latino men specifically are at high risk of receiving inadequate mental health care, possibly due to additional obstacles they experience that are related to masculinity. Among men more generally, greater adherence to emotional control and self-reliance is associated with higher depression severity and less depression help-seeking. Men experience more stigma toward depression and help-seeking and are less likely to be diagnosed with depression than women. However, Latino men's barriers and facilitators to depression care remain largely unexplored. The objective of this study was to examine barriers and facilitators to depression care that are related to masculinity among English- and Spanish-speaking Latino men in a primary care setting. Methods: We used convenience and purposive sampling to recruit primary care patients who self-identified as Latino men, spoke English or Spanish, and screened positive for depressive symptoms on the Patient Health Questionnaire-2 or had a history of depression. Semi-structured interviews were conducted between December 2020 and August 2021. The interview guide examined views and experiences of depression, masculinity, and barriers and facilitators to engaging in depression care. Utilizing consensual qualitative research and thematic analysis informed by modified grounded theory, barriers and facilitators to depression care were identified. Results: We interviewed thirteen participants who varied in English proficiency, education, income, and country of origin. Barriers and facilitators were placed into three domains—Self-Recognition of Depression, Seeking Help for Depression, and Depression Diagnosis and Treatment. Participants described aspects of masculinity as barriers (emotional control and pressure to provide), facilitators (honesty, courage, collaboration, practicality, and responsibility), or both (self-reliance and autonomy). Conclusions: Masculinity influences barriers and facilitators for depression care among Latino men at the levels of self-recognition, seeking help, and diagnosis and treatment. Clinicians may promote Latino men's engagement in depression care by understanding patients' values and framing depression care as affirming masculinity. Providing education to primary care physicians and other healthcare professionals on gender and depression and addressing structural barriers are essential to providing access to all who need depression care. [ABSTRACT FROM AUTHOR]

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

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

In the United States (US), the Surveillance, Epidemiology, and End Results (SEER) program is the only comprehensive source of population-based information that includes stage of cancer at the time of diagnosis and patient survival data. This program aims to provide a database about cancer incidence and survival for studies of surveillance and the development of analytical and methodological tools in the cancer field. Currently, the SEER program covers approximately half of the total cancer patients in the US. A growing number of clinical studies have applied the SEER database in various aspects. However, the intrinsic features of the SEER database, such as the huge data volume and complexity of data types, have hindered its application. In this review, we provided a systematic overview of the commonly used methodologies and study designs for retrospective epidemiological research in order to illustrate the application of the SEER database. Therefore, the goal of this review is to assist researchers in the selection of appropriate methods and study designs for enhancing the robustness and reliability of clinical studies by mining the SEER database. [ABSTRACT FROM AUTHOR]

Background A Drug Influence Evaluation (DIE) is a formal assessment of an impaired driving suspect, performed by a trained law enforcement officer who uses circumstantial facts, questioning, searching, and a physical exam to form an unstandardized opinion as to whether a suspect's driving was impaired by drugs. This paper first identifies the scientific studies commonly cited in American criminal trials as evidence of DIE accuracy, and second, uses the QUADAS tool to investigate whether the methodologies used by these studies allow them to correctly quantify the diagnostic accuracy of the DIEs currently administered by US law enforcement. Results Three studies were selected for analysis. For each study, the QUADAS tool identified biases that distorted reported accuracies. The studies were subject to spectrum bias, selection bias, misclassification bias, verification bias, differential verification bias, incorporation bias, and review bias. The studies quantified DIE performance with prevalence-dependent accuracy statistics that are internally but not externally valid. Conclusion The accuracies reported by these studies do not quantify the accuracy of the DIE process now used by US law enforcement. These studies do not validate current DIE practice. [ABSTRACT FROM AUTHOR]

Background: Racial/ethnic inequities along the HIV care continuum persist in the United States despite substantial federal investment. Numerous studies highlight individual and social-level impediments in HIV, but fewer foreground systemic barriers. The present qualitative study sought to uncover and describe systemic barriers to the HIV care continuum from the perspectives of African American/Black and Latino persons living with HIV (PLWH) with unsuppressed HIV viral load, including how barriers operated and their effects. Methods: Participants were African American/Black and Latino PLWH with unsuppressed HIV viral load (N = 41). They were purposively sampled for maximum variability on key indices from a larger study. They engaged in semi-structured in-depth interviews that were audio-recorded and professionally transcribed. Data were analyzed using directed content analysis. Results: Participants were 49 years old, on average (SD = 9), 76% were assigned male sex at birth, 83% were African American/Black and 17% Latino, 34% were sexual minorities (i.e., non-heterosexual), and 22% were transgender/gender-nonbinary. All had indications of chronic poverty. Participants had been diagnosed with HIV 19 years prior to the study, on average (SD = 9). The majority (76%) had taken HIV medication in the six weeks before enrollment, but at levels insufficient to reach HIV viral suppression. Findings underscored a primary theme describing chronic poverty as a fundamental cause of poor engagement. Related subthemes were: negative aspects of congregate versus private housing settings (e.g., triggering substance use and social isolation); generally positive experiences with health care providers, although structural and cultural competency appeared insufficient and managing health care systems was difficult; pharmacies illegally purchased HIV medication from PLWH; and COVID-19 exacerbated barriers. Participants described mitigation strategies and evidenced resilience. Conclusions: To reduce racial/ethnic inequities and end the HIV epidemic, it is necessary to understand African American/Black and Latino PLWH's perspectives on the systemic impediments they experience throughout the HIV care continuum. This study uncovers and describes a number of salient barriers and how they operate, including unexpected findings regarding drug diversion and negative aspects of congregate housing. There is growing awareness that systemic racism is a core determinant of systemic barriers to HIV care continuum engagement. Findings are interpreted in this context. [ABSTRACT FROM AUTHOR]

Introduction: Hospital chaplains aid patients confronting challenges related to palliative and end-of-life care, but relatively little is known about how chaplains view and respond to such needs among Muslim patients, and how well. Methods: Telephone qualitative interviews of ~ 1 h each were conducted with 23 chaplains and analyzed. Results: Both Muslim and non-Muslim chaplains raised issues concerning Islam among chaplains, doctors and patients, particularly challenges and misunderstandings between non-Muslim providers and Muslim patients, especially at the end-of-life, often due to a lack of knowledge of Islam, and misunderstanding and differences in perspectives. Due to broader societal Islamophobia, Muslim patients may fear or face discrimination, and thus not disclose their religion in the hospital. Confusion can arise among Muslim patients and families about what their faith permits regarding end-of-life care and pain management, and how to interpret and apply their religious beliefs in hospitals. Muslims hail from different countries, but providers may not fully grasp how these patients' cultural practices may also vary. Chaplains can help address these challenges, playing key roles in mediating tensions and working to counteract Muslim patients' fears, and express support. Yet many Muslim immigrants don't know what "chaplaincy" is and/or prefer a chaplain of their own faith. Muslim chaplains can play vital roles, having expertise that can heighten trust, and educating non-Muslim colleagues, providing in-depth understanding of Islam (e.g., highlighting how Islam is related to Judaism and Christianity) and correcting misconceptions among colleagues. Hospitals without a Muslim chaplain can draw on local community imams. Conclusions: These data highlight how mutual sets of misunderstandings, especially concerning patients' and families' decisions about end-of-life care and pain management, can emerge among Muslim patients and non-Muslim staff that chaplains can help mediate. Non-Muslim chaplains and providers should seek to learn more about Islam. Muslim patients and families may also benefit from enhanced education and awareness of chaplains' availability and scope, and of pain management and end-of-life options. These data thus have several critical implications for future practice, education, and research. [ABSTRACT FROM AUTHOR]

Background: Our aims were to examine themes of the most difficult or distressing events reported by healthcare workers during the first wave of COVID-19 pandemic in two US health care systems in order to identify common themes and then to relate them to both behavioral theory and measures of anxiety and depression. Methods: We conducted a cross-sectional survey of nurses and physicians during the early phases of the COVID-19 pandemic in the US. An emailed recruitment letter was sent, with about half choosing to supply open-ended responses relevant to thematic analysis. We measured symptoms of anxiety and depression separately, captured demographics, and asked two open-ended questions regarding events that were the most difficult or stressful, and reinforced pride. We reported descriptive statistics and coded thematic categories for their continuum "pride" and "distress" the factors related to fostering well-being according to the Self-Determination Theory. Results: Themes that emerged from these narratives were congruent with prediction of Self-Determination theory that autonomy-supportive experiences will foster pride, while autonomy-thwarting experiences will cause distress. Those who reported distressful events were more anxious and depressed compared to those who did not. Among those who reported incidences that reinforced pride in the profession, depression was rarer compared to those who did not. These trends were evident after allowing for medical history and other covariates in logistic regressions. Conclusion: Causal claims from our analysis should be made with caution due to the cross-sectional research design. Understanding perceptions of the pandemic by nurses and physicians may help identify and manage sources of distress, and suggest means of mitigating the risk of mental health distress through autonomy-supportive policies. [ABSTRACT FROM AUTHOR]

Background: Prostate cancer is the third most prevalent cancer in the American population. Furthermore, the prognosis is worse in African American as there is increased morbidity and mortality associated with it.Purpose: The purpose of this study is to evaluate the effectiveness of a new online method to educate the patient population regarding prostate cancer risk, diagnosis, treatments, and their decisions about whether to be screened for the early detection of prostate cancer.Methods: Two hundred Black male patients are recruited from different clinical sites and randomized to either the control arm (usual care) or the intervention arm (educational program). We will compare the effectiveness of the intervention to see if patients are discussing the need of getting a prostate-specific antigen (PSA) test, and the possible benefits and harms that may result of having or not having the test, with their primary care providers.Discussion: Shared decision-making (SDM) is the current standard in most cancer-screening guidelines and also a standard of person-centered care. However, there is a lack of evidence-based approaches to improve decision quality in clinical settings and an increased ambiguity of applying SDM for PSA-based screening among Black men in primary care. Our proposal to evaluate a decisional-aid intervention and measure the actual application of SDM during clinical encounters has a high potential to advance the translation path of implementing shared decision-making in clinical settings and provide evidence of the applicability of the guideline in general.Innovation and Overall Impact: Given the 2018 USPSTF updated guidelines recommending shared decision-making about PSA-based screening, the increased risk of prostate cancer mortality in Black men, the challenges of evidence-based decision-making due to the underrepresentation of Blacks in major randomized clinical trials, and implicit racial bias among primary care providers, the time is ripe for interventions to improve shared decision-making about prostate cancer screening in Black men. In this study, we address communication and knowledge gaps between Black men and their primary care providers. The intervention, if proven effective, can be readily scaled across primary care practices across the U.S. and may be adapted to other types of cancer where guidelines have included shared decision-making as well. Early detection of prostate cancer may decrease mortality and morbidity in the long term. [ABSTRACT FROM AUTHOR]

Background: Ethiopia's government and civil society have driven crosscutting initiatives in the last 15 years to improve sexual and reproductive health outcomes, including passing a 2005 abortion law that facilitated reduced rates of maternal death due to unsafe abortion. However, both the government and nongovernmental organizations have relied on external funding for sexual and reproductive health and rights, particularly from the U.S. government, which has been Ethiopia's largest global health donor. This article explores how the implementation and expansion of the 2017–2021 U.S. foreign policy "Protecting Life in Global Health Assistance," also known as the Global Gag Rule—which attached itself to a nongovernmental organization's funding—impacted sexual and reproductive health and rights, including safe abortion care, in Ethiopia. Methods: This article is based on research conducted by PAI staff in Ethiopia in 2018 with follow-up in 2019. PAI held in-depth semistructured interviews with representatives of 30 organizations in Ethiopia's capital, Addis Ababa. Among these groups were U.S.-based and non-U.S. nongovernmental organizations, including community-based organizations, non-U.S. government donors, and Ethiopian government officials. Results: Nongovernmental organizations have been essential to sexual and reproductive health service provision and advocacy in Ethiopia. Because of the sector's reliance on U.S. global health assistance, these organizations; their activities; and, consequently, the wider health system were negatively impacted by the Global Gag Rule. Certain vulnerable groups, particularly adolescents and youth, have traditionally relied on the private sector for sexual and reproductive health services. PAI's research demonstrates that U.S. policy disrupted activities and service delivery, threatened the closure of private clinics, stalled mobile outreach, and impacted safe abortion training of health personnel. Additionally, the Global Gag Rule dismantled partnerships, affected non-U.S. government donors' investments, and caused confusion that limited activities permissible under the policy. Conclusions: The Trump administration's Global Gag Rule forced non-U.S. organizations to choose between providing comprehensive care or losing U.S. global health assistance, ultimately impacting populations in need of services. Ethiopia provides a clear example of how the Global Gag Rule can threaten a country's domestic health agenda by targeting nongovernmental organizations that are vital to health service delivery and safe abortion care. Plain language summary: In 2005, Ethiopia's government, health advocates, and service providers secured a more liberal abortion law that has been instrumental in reducing maternal deaths due to unsafe abortion. However, these fragile gains are vulnerable because the in-country sexual and reproductive health sector has relied heavily on external funding. The U.S. government has been an important development partner to Ethiopia for global health and, in particular, reproductive health and family planning. As a result, the Global Gag Rule, reimposed and expanded by the Trump administration in 2017, impacted sexual and reproductive health and rights in Ethiopia. U.S. agencies and departments attached this policy to U.S. global health assistance for nongovernmental organizations that were critical partners in service delivery and advocacy. In a country like Ethiopia with a progressive environment for sexual and reproductive health, including safe abortion care, it remains important to examine the impacts of the Global Gag Rule, despite being rescinded in January 2021 by the Biden administration, as the policy has still not yet been permanently repealed and could be reinstated by future administrations. PAI's research sought to document the impacts of the expanded Global Gag Rule on sexual and reproductive health in Ethiopia, with a focus on safe abortion care. Study participants reported that nongovernmental organizations serving rural populations, adolescents and youth, sex workers, and people living with HIV/AIDS were impacted by the loss of U.S. government funding due to noncompliance with the policy. Organizations that chose to comply with the policy were forced to stop critical activities like training on safe abortion care. Outcomes also included self-censorship out of fear of the policy and dismantled partnerships between compliant and noncompliant organizations. [ABSTRACT FROM AUTHOR]

Background: The COVID-19 lockdown in March 2020 had a significant consequence for nursing students worldwide including limited access to learning situations in clinical rotation. Therefore, this study aims to explore how an innovative redesign of a clinical course in a time of pandemic supported nursing students in learning the fundamentals of care in their first year. The redesign involved the transformation of a traditional hands-on clinical course into a technology-enhanced learning environment. Design: This was an explorative convergent mixed-methods study using both quantitative and qualitative methods. Methods: Twenty-four first-year nursing students responded to an online questionnaire with open-ended questions. Two nursing students and one faculty member participated in individual online interviews, and three faculty members participated in an online focus group interview. All the data were collected in June 2020. The quantitative data were analyzed using descriptive statistics and the qualitative data using content analysis. The GRAMMS guideline was applied. Results: The students achieved the learning outcomes regarding fundamental care, basic physical assessment skills, and clinical reasoning with the help of academic assignments, multimedia learning resources, and virtual patients. Further, six central aspects of the facilitator role in the virtual simulation were identified. The aspect that was considered most valuable involved uncovering the "red thread" between different areas of knowledge in the first year of nursing education; this supported the students to better understand how to think and talk like a nurse. Conclusion: This study offers insight into how a technology-enhanced clinical course can foster the learning of fundamental nursing care, basic physical assessment skills, and clinical reasoning skills; enhancing students' preparedness for clinical hours. Virtual patients' scenarios contributed to integrating different types of knowledge and skills that are important when providing nursing care for patients in clinical practice. This study also highlighted a gap in pedagogical competence among faculty members with regards to facilitating learning in a technology-enhanced learning environment. Study findings suggest promising pedagogical strategies that should be further developed post-pandemic, in response to the call for a renewal of nursing education using more technologically supported learning designs. [ABSTRACT FROM AUTHOR]

Background: Use of HIV PrEP (pre-exposure prophylaxis) is a strategic tool in the effort to end the HIV epidemic. 20% of new HIV infections in the US are among cis-gender women, yet they comprise only 5% of all PrEP users. Black women disproportionately bear the burden of new HIV acquisition and accounted for almost 60% of new HIV diagnoses among women in 2018. Increasing understanding and uptake of PrEP among women at risk of HIV acquisition in alignment with their reproductive values and preferences is key to increasing PrEP uptake and decreasing HIV burden in this population. Objective: This study examines how experiences with contraception among women of color shape their perceptions and preferences regarding HIV PrEP to inform counseling that aligns with their reproductive values. Methods: Women aged 18–45 who self-identified as Black or Latina were recruited at an academic medical center in the Bronx from June 2018 to July 2019. We enrolled 30 participants seeking family planning care (10), prenatal care (10), or care for sexually transmitted infections (10). Participants completed a brief written survey assessing their risk of HIV acquisition. Semi-structured, face-to-face interviews were then audio-recorded, transcribed, and entered into Dedoose. Grounded theory and constant comparison approaches were used to analyze the data. Results: Twenty-one participants (70%) screened positive for HIV acquisition risk. Four had received information on PrEP from a medical provider prior to the interview. Three themes emerged from the qualitative analysis: (1) Similar to oral contraception, women conceptualized PrEP as a "daily pill" to support their reproductive health; (2) Women perceived PrEP as a tool to support autonomy and pleasure in their sexual health; (3) Like birth control, women desired multiple delivery options for HIV prophylaxis. Conclusions: Contraception may serve as a frame of reference when counseling about PrEP among cis-women at risk of acquiring HIV. Our study suggests that this approach re-contextualizes counseling on PrEP within a sex-positive framework that prioritizes pleasure, safety, and autonomy as integral to sexual and reproductive wellness. Consideration of historically marginalized women's experiences with contraception and reproductive values may facilitate their use of PrEP. Plain Language Summary: PrEP (pre-exposure prophylaxis) is a medicine taken daily by people at risk of getting HIV from sex or injection drug use. Although PrEP is a safe and effective medication for women, the use of PrEP remains exceedingly low among cis-gender women at risk of HIV in the US. This study examines how experiences with contraception among women of color, who disproportionately bear the burden of HIV acquisition, shape their perceptions and preferences regarding PrEP. We interviewed 30 women who self-identified as Black or Latina at an academic medical center in the Bronx. Similar to oral contraception, women in this study conceptualized PrEP as a "daily pill" to support their reproductive health. This report details how women's experiences with contraception may serve as the foundation to re-contextualize conversations on PrEP within a sex-positive framework that prioritizes pleasure, safety, and autonomy as integral to sexual and reproductive wellness. [ABSTRACT FROM AUTHOR]

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

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

Background: Our objectives were to describe both the development, and content, of a charitable food dataset that includes geographic information for food pantries in 12 American states.Methods: Food pantries were identified from the foodpantries.org website for 12 states, which were linked to state-, county-, and census-level demographic information. The publicly available 2015 Food Access Research Atlas and the 2010 US Census of Population and Housing were used to obtain demographic information of each study state. We conducted a descriptive analysis and chi-square tests were used to test for differences in patterns of food pantries according to various factors.Results: We identified 3777 food pantries in 12 US states, providing an estimated 4.84 food pantries per 100,000 people, but ranged from 2.60 to 7.76 within individual states. The majority of counties (61.2%) had at least one food pantry. In contrast, only 15.7% of all census tracts in the study states had at least one food pantry. A higher proportion of urban census tracts had food pantries compared to rural tracts. We identified 2388 (63.2%) as being faith-based food pantries. More than a third (34.4%) of food pantries did not have information on their days of operation available. Among the food pantries displaying days of operation, 78.1% were open at least once per week. Only 13.6% of food pantries were open ≤1 day per month.Conclusions: The dataset developed in this study may be linked to food access and food environment data to further examine associations between food pantries and other aspects of the consumer food system (e.g. food deserts) and population health from a systems perspective. Additional linkage with the U.S. Religion Census Data may be useful to examine associations between church communities and the spatial distribution of food pantries. [ABSTRACT FROM AUTHOR]

Background: Emergency department (ED) visits among older adults are common near the end of life. Palliative care has been shown to reduce ED visits and to increase quality of life among patients, but recruitment into these programs is often challenging. This descriptive analysis explores the barriers to enrolling seriously ill patients scheduled for discharge from the ED into palliative care research. Methods: This descriptive sub-study aims to assess the reasons why patients with advanced illness scheduled for discharge home from 11 EDs across the United States decline to participate in Emergency Medicine Palliative Care Access (EMPallA), a Phase IV randomized controlled trial (RCT) comparing two modes of palliative care delivery. Our aim was to understand why patients decline to enroll to improve future recruitment rates and expand care for patients discharged home from the ED. Research coordinators documented reasons that patients declined to enroll in the larger EMPallA trial; reasons for refusing participation were independently analyzed by two researchers to identify overarching themes. Results: Enrollment rate across all sites was 45%; of the 504 eligible patients who declined participation, 47% (n = 237) declined for reasons related to illness severity. 28% of refusals (n = 143) were related to the mode of palliative care delivery, while 24% (n = 123) were due to misconceptions or stigma related to palliative care. Less commonly, patients refused due to general research barriers (16.5%), family/caregiver barriers (11.7%), and physician-related barriers (< 1%). Conclusions: Patients with advanced illnesses presenting to the ED often refuse to participate in palliative care research due to the severity of their illness, the mode of care delivery, and misconceptions about palliative care. In contrast with other studies, our study found minimal physician gatekeeping, which may be the result of both changing attitudes toward palliative care and the nature of the ED setting. Robust training programs are crucial to overcome these misconceptions and to educate patients and providers about the role of palliative care. Future palliative care programs and study designs should recognize the burden this vulnerable population endures and consider alternative modes of care delivery in an effort to increase participation and enrollment. Clinical trials registration: NCT03325985, October 30, 2017. [ABSTRACT FROM AUTHOR]

Background: Suboptimal human papillomavirus (HPV) vaccination rates persist among adolescents in the United States (U.S.). New Jersey (NJ), among the top, most racially/ethnically diverse states in the U.S., had among the lowest HPV vaccine initiation rates, prior to 2018. This study examined parental HPV vaccine knowledge and adolescent HPV vaccine initiation among multiethnic parents in NJ, where access to language concordant HPV vaccine information and vaccination services may differ, for immigrant parents.Methods: We surveyed parents of adolescents (ages 11-18) at community events in NJ to examine parental HPV vaccine knowledge and adolescent HPV vaccine uptake. Vaccine knowledge was assessed using an 11-item question stem that covered vaccine efficacy, gender recommendation, vaccine protection, and myths. Multivariable models assessed the association of parent nativity on HPV vaccine knowledge scores and adolescent HPV vaccine initiation, controlling for sociodemographic factors.Results: Of the 77 parents, most parents (84%) were aware of the HPV vaccine. However, knowledge scores were low and differed by parent nativity. Non-U.S. born parents had significantly lower knowledge scores - 1.7 [- 3.1, - 0.4] and lower odds of adolescent children initiating the HPV vaccine 0.3 [0.1, 0.9] compared to U.S.-born parents after adjusting demographic characteristics.Conclusions: Our findings reveal that parental HPV vaccine knowledge remains low among suburban dwelling, immigrant parents, even though they have higher education and access to health care. Multilevel strategies to reduce missed opportunities for HPV vaccine education among parents and HPV vaccination for adolescents are needed, including for suburban, immigrant communities. [ABSTRACT FROM AUTHOR]

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

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

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

Background: More than 30 states have either expanded Medicaid or are actively considering expansion. The coverage gains from this policy are well documented, however, the impacts of its increasing coverage on poverty disparity are unclear at the national level. Method: American Community Survey (2012–2018) was used to examine the effects of Medicaid expansion on poverty disparity in insurance coverage for nonelderly adults in the United States. Differences-in-differences-in-differences design was used to analyze trends in uninsured rates by poverty levels: (1) < 138 %, (2) 138–400 % and (3) > 400 % federal poverty level (FPL). Results: Compared with uninsured rates in 2012, uninsured rates in 2018 decreased by 10.75 %, 6.42 %, and 1.11 % for < 138 %, 138–400 %, and > 400 % FPL, respectively. From 2012 to 2018, > 400 % FPL group continuously had the lowest uninsured rate and < 138 % FPL group had the highest uninsured rate. Compared with ≥ 138 % FPL groups, there was a 2.54 % reduction in uninsured risk after Medicaid expansion among < 138 % FPL group in Medicaid expansion states versus control states. After eliminating the impact of the ACA market exchange premium subsidy, 3.18 % decrease was estimated. Conclusion: Poverty disparity in uninsured rates improved with Medicaid expansion. However, < 138 % FPL population are still at a higher risk for being uninsured. [ABSTRACT FROM AUTHOR]

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

Background: Rapid implementation of Medical Assistance in Dying (MAiD) across care settings has challenged providers and organizations, including hospices, to develop and implement new modes of practice. The aim of this study was to examine the effects that legalization of MAiD has had on hospice care provider roles within the non-provider context. Methods: Eight in-depth semi-structured interviews were conducted and a qualitative descriptive approach used to examine hospice care providers experiences in a small western Canadian city. In the study context, patients who choose MAiD are cared for until immediately prior to the procedure when they are transferred off-site to undergo MAiD. Inductive and thematic analyses were undertaken. Results: Participants experienced practical, philosophical, and professional challenges. Despite the overwhelming desire to support patient autonomy and decision-making, some interpreted patient choice for MAiD as rejection of the natural death experience at the hospice. Patient choice for MAiD initiated a new and different pathway of end-of-life care. While participants felt uncertain how best to support patients undergoing MAiD, they shared mixed optimism on how their care provider roles were evolving as their level of experience broadened. While implementation of MAiD was rapid, the introduction of practical and professional supports has remained slow to materialize, leaving many providers to navigate their own personal and professional positions and practices. Conclusion: Care providers require a multi-faceted range of clinical, legal, and logistical supports at the practice, organizational, and health system levels, to facilitate care delivery to those requesting and undergoing MAiD and to promote coordinated and holistic patient-centered care. The different pathway for those who chose MAiD may lead care providers to struggle with relational challenges and interpersonal unease. Further research may address how to support those undergoing MAiD within the hospice context. [ABSTRACT FROM AUTHOR]

Background: Many children with serious illnesses are receiving palliative and end-of-life care from pediatric palliative and hospice care teams at home (PPHC@Home). Despite the growth in PPHC@Home, no standardized measures exist to evaluate whether PPHC@Home provided in the U.S. meets the needs and priorities of children and their families. Methods: We developed and conducted a preliminary evaluation of a family-reported measure of PPHC@Home experiences using a multi-method, multi-stakeholder approach. Our instrument development process consisted of four phases. Item identification and development (Phase 1) involved a comprehensive literature search of existing instruments, guidelines, standards of practice, and PPHC@Home outcome studies, as well as guidance from a PPHC stakeholder panel. Phase 2 involved the initial item prioiritization and reduction using a discrete choice experiment (DCE) with PPHC professionals and parent advocates. Phase 3 involved a second DCE with bereaved parents and parents currently receiving care for their child to further prioritize and winnow the items to a set of the most highly-valued items. Finally, we conducted cognitive interviews with parents to provide information about the content validity and clarity of the newly-developed instrument (Phase 4). Results: Items were compiled predominantly from three existing instruments. Phase 2 participants included 34 PPHC providers, researchers, and parent advocates; Phase 3 participants included 47 parents; and Phase 4 participants included 11 parents. At the completion of Phase 4, the Experiences of Palliative and Hospice Care for Children and Caregivers at Home (EXPERIENCE@Home) Measure contains 22 of the most highly-valued items for evaluating PPHC@Home. These items include "The care team treats my child's physical symptoms so that my child has as good a quality of life as possible", "I have regular access to on-call services from our care team", and "The nurses have the knowledge, skills, and experience to support my child's palliative or hospice care at home." Conclusions: The EXPERIENCE@Home Measure is the first known to specifically measure family-reported experiences with PPHC@Home in the U.S. Future work will include formal psychometric evaluation with a larger sample of parents, as well as evaluation of the clinical utility of the instrument with PPHC@Home teams. [ABSTRACT FROM AUTHOR]

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

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

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

Background: Sedentary behavior (SB) is linked to negative health outcomes in older adults. Most studies use summary values, e.g., total sedentary minutes/day. Diurnal timing of SB accumulation may further elucidate SB-health associations. Methods: Six thousand two hundred four US women (mean age = 79 ± 7; 50% White, 34% African-American) wore accelerometers for 7-days at baseline, yielding 41,356 person-days with > 600 min/day of data. Annual follow-up assessments of health, including physical functioning, were collected from participants for 6 years. A novel two-phase clustering procedure discriminated participants' diurnal SB patterns: phase I grouped day-level SB trajectories using longitudinal k-means; phase II determined diurnal SB patterns based on proportion of phase I trajectories using hierarchical clustering. Mixed models tested associations between SB patterns and longitudinal physical functioning, adjusted for covariates including total sedentary time. Effect modification by moderate-vigorous-physical activity (MVPA) was tested. Results: Four diurnal SB patterns were identified: p1 = high-SB-throughout-the-day; p2 = moderate-SB-with-lower-morning-SB; p3 = moderate-SB-with-higher-morning-SB; p4 = low-SB-throughout-the-day. High MVPA mitigated physical functioning decline and correlated with better baseline and 6-year trajectory of physical functioning across patterns. In low MVPA, p2 had worse 6-year physical functioning decline compared to p1 and p4. In high MVPA, p2 had similar 6-year physical functioning decline compared to p1, p3, and p4. Conclusions: In a large cohort of older women, diurnal SB patterns were associated with rates of physical functioning decline, independent of total sedentary time. In particular, we identified a specific diurnal SB subtype defined by less SB earlier and more SB later in the day, which had the steepest decline in physical functioning among participants with low baseline MVPA. Thus, diurnal timing of SB, complementary to total sedentary time and MVPA, may offer additional insights into associations between SB and physical health, and provide physicians with early warning of patients at high-risk of physical function decline. [ABSTRACT FROM AUTHOR]

Objective: This research note aimed to analyze the scientific productivity trends 2015–2019, focusing on the top 30 universities in Europe and United States and on the top 30 private companies—as classified in the SCImago Institutions Ranking. Our hypothesis is that private companies are gaining an increasingly prominent role in the research field, while academia is losing its predominance. Results: From 2015 to 2019, all universities in Europe and the United States lost positions in the scientific production ranking, while private companies gained positions. These trends seem to be driven mainly by the scientific productivity sub-indicator "Innovation". These data suggest that the role private companies will play in the future will not be limited to support research economically or influence it from "outside". Private companies have taken a path that may lead them to directly control all stages of production/communication of knowledge, including research—a role once bestowed on universities. Our data, although preliminary, seem to suggest that, at present, academia risks losing its predominance in the research field. This scenario deserves attention because of the threats it may pose to the independence of research and its role in supporting human equity and sustainable health for all. [ABSTRACT FROM AUTHOR]

Background: Ending the HIV epidemic requires that women living with HIV (WLWH) have access to structurally competent HIV-related and other health care. WLWH may not regularly engage in care due to inadequate quality; however, women's perspectives on the quality of care they receive are understudied. Methods: We conducted 12 focus groups and three in-depth interviews with Black (90%) and Latina (11%) WLWH enrolled in the Women's Interagency HIV Study in Atlanta, GA, Birmingham, AL, Brooklyn, NY, Chapel Hill, NC, Chicago, IL, and Jackson, MS from November 2017 to May 2018 (n = 92). We used a semi-structured format to facilitate discussions about satisfaction and dissatisfaction with health care engagement experiences, and suggestions for improvement, which were audio-recorded, transcribed, and coded using thematic analysis. Results: Themes emerged related to women's health care satisfaction or dissatisfaction at the provider, clinic, and systems levels and across Institute of Medicine-defined quality of care domains (effectiveness, efficiency, equity, patient-centeredness, safety and timeliness). Women's degree of care satisfaction was driven by: 1) knowledge-based care resulting in desired outcomes (effectiveness); 2) coordination, continuity and necessity of care (efficiency); 3) perceived disparities in care (equity); 4) care delivery characterized by compassion, nonjudgment, accommodation, and autonomous decision-making (patient-centeredness); 5) attention to avoiding side effects and over-medicalization (safety); and 6) limited wait time (timeliness). Conclusions: Quality of care represents a key changeable lever affecting engage in care among WLWH. The communities most proximally affected by HIV should be key stakeholders in HIV-related quality assurance. Findings highlight aspects of the health care experience valued by WLWH, and potential participatory, patient-driven avenues for improvement. [ABSTRACT FROM AUTHOR]

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

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