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Introduction: COVID-19 pandemic negatively influenced the entire life globally including various aspects of patients' care. Its effect on medical research production is not known. The aim of this study is to assess the impact of COVID-19 pandemic on medical research reporting trend. Methods: Advanced search on PubMed was performed over 2011- August, 2021. Monthly comparison was done for the years 2019, 2020, and 2021. Kruskal Wallis test was used to compare continuous distributions. Results: The total publication count showed constant increment over the study period. Faster rise was noticed on 2020 (15.7%). A steady growth in publications over the years and through the pandemic was also seen in seven studied countries with variable, both in total and also after exclusion of COVID-19 related papers. Italy and India have the highest proportions of COVID-19 related publications in comparison to the total papers in 2020, but USA has the highest quantity. Statistically significant differences exist between the first eight months of the last three years with and without counting COVID-19 related publications (p-values=0.0003907 and 0.001084, respectively). Conclusion: Our results reflect that investigators world-wide succeeded to reconfigure their work style and utilize the spared time induced by the lockdown to enrich the medical research platform. [ABSTRACT FROM AUTHOR]

Background: Ever since alexithymia was defined in the 1970s, robust associations have been observed between alexithymia and a variety of symptoms of psychopathology. Alexithymia is now widely regarded as an important transdiagnostic risk factor, and it is frequently assessed in clinical and research settings. However, despite this strong interest, it remains unclear exactly why (i.e., by which mechanisms) alexithymia is linked to psychopathology. In this paper, we hypothesise that alexithymia is linked to affective disorder symptoms because alexithymia impairs people's ability to regulate their emotions, and we empirically test this hypothesis.Method: We administered a battery of psychometric measures to 501 adults in the United States, and examined the direct and indirect effects between alexithymia (Perth Alexithymia Questionnaire), emotion regulation ability (Perth Emotion Regulation Competency Inventory), and affective disorder symptoms (Depression Anxiety Stress Scales-21).Results: In the Pearson bivariate correlation matrix, alexithymia, emotion regulation difficulties, and affective disorder symptoms were all significantly correlated. In the modelling of direct and indirect effects, alexithymia was indirectly associated with affective disorder symptoms through emotion regulation difficulties (no significant direct effect).Limitations: Our online survey data were all self-report data and cross-sectional. Future longitudinal work would be beneficial.Conclusions: Our findings support contemporary theorising that alexithymia is linked to affective disorder symptoms via emotion regulation difficulties. These results help to clarify the mechanisms by which alexithymia may predispose people to affective disorder symptoms, and highlight the importance of considering the roles of alexithymia and emotion regulation in case conceptualisations and treatment planning. [ABSTRACT FROM AUTHOR]

Background: Increasing knowledge on suicide prevention has been shown to be important for suicide prevention. This paper exams the accomplishment of research on suicide and examine how those research activities contribute to the change of suicide rates.Methods: Data of the publications relating to suicide from 1990 to 2018 were retrieved from the Web of Science and Scopus. Bibliographic information was analyzed and the relationships between suicide rates with the number of publications per million population and the average article citations per year were examined.Results: From 1990 to 2018, globally, publications on suicide have increased significantly. The United States ("USA") had the greatest number of publications. Research collaborations among different countries/regions have been flourishing and multinational centers have become more common than ever. Nonetheless, in some countries/regions with high rates of suicide, suicide research was scarce. It was found that the number of publications per million population and the average article citations per year were negatively correlated with the suicide rates at the global level (r = - 0.96, p < 0.001; r = -0.91, p < 0.001, respectively), but not in the higher SDI regions (r = -0.05, p = 0.81; r = 0.02, p = 0.91, respectively). Furthermore, research focusing on suicide intervention was also relatively limited.Limitation: The origins of the publications were only based on the corresponding authors' regions.Conclusions: There is significant imbalance in the amount of research effort especially in the regions with high suicide rates. In the higher socioeconomic level regions, the quantity and quality of publications sometimes do not transpire in the reduction of suicide rates. A better connection between the fundamental and practical suicide research should be established. More resources should be made available to the low- and middle-income countries/regions with higher suicide risks, then the effect of suicide prevention might be much more significant. [ABSTRACT FROM AUTHOR]

Importance: Recent discussion has focused on questions related to the repeal and replacement of portions of the Affordable Care Act (ACA). However, issues central to the future of health and health care in the United States transcend the ACA provisions receiving the greatest attention. Initiatives directed to certain strategic and infrastructure priorities are vital to achieve better health at lower cost.Objectives: To review the most salient health challenges and opportunities facing the United States, to identify practical and achievable priorities essential to health progress, and to present policy initiatives critical to the nation's health and fiscal integrity.Evidence Review: Qualitative synthesis of 19 National Academy of Medicine-commissioned white papers, with supplemental review and analysis of publicly available data and published research findings.Findings: The US health system faces major challenges. Health care costs remain high at $3.2 trillion spent annually, of which an estimated 30% is related to waste, inefficiencies, and excessive prices; health disparities are persistent and worsening; and the health and financial burdens of chronic illness and disability are straining families and communities. Concurrently, promising opportunities and knowledge to achieve change exist. Across the 19 discussion papers examined, 8 crosscutting policy directions were identified as vital to the nation's health and fiscal future, including 4 action priorities and 4 essential infrastructure needs. The action priorities-pay for value, empower people, activate communities, and connect care-recurred across the articles as direct and strategic opportunities to advance a more efficient, equitable, and patient- and community-focused health system. The essential infrastructure needs-measure what matters most, modernize skills, accelerate real-world evidence, and advance science-were the most commonly cited foundational elements to ensure progress.Conclusions and Relevance: The action priorities and essential infrastructure needs represent major opportunities to improve health outcomes and increase efficiency and value in the health system. As the new US administration and Congress chart the future of health and health care for the United States, and as health leaders across the country contemplate future directions for their programs and initiatives, their leadership and strategic investment in these priorities will be essential for achieving significant progress. [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]

Purpose: Building research capacity and increasing scholarly productivity are identified needs of the specialty of family medicine. The Accreditation Council for Graduate Medical Education (ACGME) has increased the scholarly requirements for residency programs, placing even more pressure on faculty to be productive in the scholarly realm. The Council of Academic Family Medicine Educational Research Alliance (CERA) was created by volunteer members of the specialty with shared interests in overcoming barriers and increasing scholarly production.Methods: CERA has developed the infrastructure and expertise to regularly conduct omnibus surveys of key family medicine educational leaders. Proposals are centrally collected and competitively chosen. The omnibus survey process includes collaboration with experienced mentors, centralized institutional review board clearance, pilot testing, and centralized data collection. The survey results are disseminated back to research teams for presentation and publication of the findings.Results: To date, over 115 research teams have had their projects included in CERA omnibus surveys. Projects have been led by research teams from across the country and with a wide variety of research experience. This collaborative work has resulted in more than 75 scientific presentations and over 55 peer-reviewed papers in the medical literature. The raw data are now available online and serve as a repository for future secondary analysis and as an educational resource.Conclusions: The CERA infrastructure has allowed a large number of research teams to conduct meaningful scholarship at a fraction of the typical cost in terms of time and energy. CERA has expanded family medicine research by removing barriers for teams with limited experience or resources. [ABSTRACT FROM AUTHOR]

Rising rates of childhood obesity over the past 2 decades have spurred a number of public- and private-sector initiatives aimed at halting or even reversing this trend. Recognizing common interests in this issue, the Centers for Disease Control and Prevention, NIH, and the Robert Wood Johnson Foundation began conversations about creating a formal collaboration aimed at accelerating efforts to address childhood obesity by coordinating research agendas and providing support for evidence-building activities. The National Collaborative on Childhood Obesity Research (NCCOR) was launched in February 2009, and the U.S. Department of Agriculture joined in 2010. Using the model provided by other previously successful collaborations, such as the Youth Tobacco Cessation Collaborative, NCCOR has emphasized several principles suggested by Petrovich as key elements for successful partnerships: (1) delineate a common purpose by identifying key knowledge gaps in the field; (2) create a shared identity around that common purpose; (3) develop structures for democratic and respectful collaboration so as to strategically coordinate efforts for maximum national impact; (4) identify effective leaders capable of articulating challenges in the field and inspiring a commitment of minds and the resolve to address identified needs; (5) facilitate continuous knowledge exchange and synthesis to keep the field informed; and (6) support assessment of progress and feedback loops for ensuring continual progress. This paper examines how NCCOR has used these principles to help build the field of research, evaluation, and surveillance for childhood obesity prevention and management. [ABSTRACT FROM AUTHOR]

Background Context: Over the course of the last decade, interest in the use of large data repositories for clinical research in orthopedic and spine surgery has grown substantially. Detractors maintain that the clinical relevance of research conducted using large registries is limited, and that the academic influence of such studies is minimal. Such contentions have not been empirically evaluated.Purpose: This study sought to perform a systematic review of spinal research conducted using the National Surgical Quality Improvement Program (NSQIP).Study Design: This is a systematic review.Outcome Measures: Impact factor (IF) of the journal of publication and number of citations of published articles conducted using the NSQIP.Methods: Orthopedic and spine-specific NSQIP articles published from January 1, 2007 to July 31, 2015, were identified through a query of PubMed or Medline, Embase, Web of Science, and Scopus. Articles were classified by journal of publication, year of publication, study topic, study purpose, and method of statistical analysis. Spine surgical publications were compared with other orthopedic research conducted using the NSQIP. The primary dependent variables for the purposes of statistical testing were IF of the journal in which the article was published and the number of citations for each publication. Negative binomial regression was used to evaluate the characteristics of papers associated with increased IF and number of citations.Results: Of the 1,525 articles identified in the initial search, 114 studies were considered eligible for inclusion in the systematic review. The average IF for the journals publishing orthopedic NSQIP articles was 2.75 (standard deviation [SD] 1.22, range 0-5.28), whereas it was 2.52 (SD 0.81, range 1.38-5.28) for spinal research. The average number of citations per article was 6.08 (SD 10.9, range 0-69) and 6.4 (SD 12.0, range 0-69) for spine-specific studies. Following negative binomial regression, only IF (regression coefficients [RC] 0.31; 95% confidence intervals [CI] 0.08, 0.55) and the year of publication (RC -1.29; 9% CI -1.64, -0.95) were found to have a statistically significant association with number of citations. Among spine-specific research articles, only the year of publication was found to influence the number of citations (RC -1.29; 95% CI -1.94, -0.64).Conclusions: Our findings indicate that the academic impact of orthopedic and spine surgical research conducted using NSQIP is highly variable, with most publications found to have relatively low impact. As our evaluation of study characteristics associated with high-impact publications and increased citations were unable to uncover factors that are likely translatable, we suggest following research design guidelines that highlight best practices when using large datasets for orthopedic research. [ABSTRACT FROM AUTHOR]

The mission of the Veterans Health Administration's (VHA) quality enhancement research initiative (QUERI) is to enhance the quality of VHA health care by implementing clinical research findings into routine care. This paper presents lessons that QUERI investigators have learned through their initial attempts to pursue the QUERI mission. The lessons in this paper represent those that were common across multiple QUERI projects and were mutually agreed on as having substantial impact on the success of implementation. While the lessons are consistent with commonly recognized ingredients of successful implementation efforts, the examples highlight the fact that, even with a thorough knowledge of the literature and thoughtful planning, unexpected circumstances arise during implementation efforts that require flexibility and adaptability. The findings stress the importance of utilizing formative evaluation techniques to identify barriers to successful implementation and strategies to address these barriers. [ABSTRACT FROM AUTHOR]

As interest in comparative effectiveness research grows, questions have emerged regarding whether it is ever acceptable to alter informed consent requirements for research when patients are randomly assigned to widely-used therapies. This paper reports on interviews with Institutional Review Board members and researchers and on focus groups with patients from Geisinger and Johns Hopkins health systems. The objective was to elicit participants' views of the acceptability of four different disclosure and authorization models for low-risk pragmatic comparative effectiveness trials of widely-used therapies. Results suggest that although participants valued autonomous choice, many also believed that it was acceptable to streamline information disclosure and to use an opt-out process for eligible individuals who would prefer not to participate. This provides some preliminary evidence that relevant stakeholders find alternatives to traditional informed consent acceptable for low-risk pragmatic comparative effectiveness trials of widely-used therapies as long as a sufficient amount of choice is preserved. [ABSTRACT FROM AUTHOR]

Nearly four in ten American use complementary or alternative medicine (CAM) each year. Even with a large number of patients, CAM practitioners face scrutiny from physicians and biomedical researchers who, in an era of evidence-based medicine, argue there is little evidence to support CAM treatments. Examining how CAM has or has not been integrated into American health care is crucial in understanding the contemporary boundaries of healthcare systems. An analytical tool from science and technology studies, boundary objects, can help scholars of medicine understand which practices become integrated into these systems. Using a comparative analysis based on archival and interview data, this paper examines the use of boundary objects in two alternative medical practices – acupuncture and Christian Science. While boundary objects alone cannot explain what health practices succeed or fail, juxtaposing the use of boundary objects by different CAM groups identifies the work boundary objects do to facilitate integration and the conditions under which they “work.” I find that acupuncturists' use of sterile needles as a boundary objects assists in their effective integration into U.S. healthcare because needles are both a symbol of biomedical prowess and a potentially unsafe device requiring regulation. Christian Scientists' use of the placebo effect as a boundary object has not succeeded because they fail to acknowledge the different contextual definitions of the placebo effect in biomedical communities. This comparative analysis highlights how context affects which boundary objects “work” for CAM practices and theorizes why alternative health practices succeed or fail to become integrated into healthcare systems. [ABSTRACT FROM AUTHOR]

Background: For several years there has been a vigorous policy debate on comparative effectiveness research (CER). This debate has focused on whether more evidence should be gathered, and who should be doing the funding and developing of evidence. There has been less emphasis on implementation of CER findings, and examining whether CER has or will have an impact on prescribing patterns, reimbursement, health outcomes, and health care spending. Objective: This paper addresses both empirical and normative aspects of CER in terms of its impact on prescribing, reimbursement, cost-containment, and health outcomes. Results: A significant gap persists between the best available evidence on therapeutic effectiveness and toler-ability and typical patterns of prescribing care, as well as patient choices. Consequently, there is room for building a more systematic evidence base in the United States, so that policymakers are better equipped to understand variation in clinical outcomes while promoting appropriate prescribing and reimbursement patterns. Methods: The author carried out a non-systematic literature review of both empirical and normative aspects pertaining to CER and its policy implications. Keywords for the Medline search were "comparative effectiveness research" and "policy implications." Conclusion: CER has a modest impact on prescribing, reimbursement, cost- containment, and health outcomes. This impact will likely intensify as funding increases and novel models to steer prescribing and reimbursement choices incorporate comparative-effectiveness evidence. [ABSTRACT FROM AUTHOR]

Since the early work of RA Fisher, exact methods have been recognized as important tools in data analysis because they provide valid statistical inference even with small sample sizes, or with sparse or skewed data. With the recent advance of computational power and the availability of commercial software packages, exact methods have gained substantial popularity over the past two decades. However, most of these exact methods have been devoted to testing classical null hypotheses of no differences, and until recently little was known about exact methods dealing with non-inferiority or equivalence hypotheses. The presence of nuisance parameters in testing non-inferiority/equivalence hypotheses presents a special challenge for exact methods because of the intense computational requirement. In this paper, we review exact methods available for proving non-inferiority or equivalence of two treatments with a dichotomous endpoint. First, we present the general methodology for conducting exact tests for non-inferiority or equivalence; we then discuss several unconditional and conditional methods available for constructing hypothesis tests and confidence intervals based on three commonly used measures, namely, the difference, relative risk, and odds ratio of two independent proportions or rates. Finally, we illustrate with several examples the application of these exact methods in analysing and planning non-inferiority or equivalence trials. [ABSTRACT FROM AUTHOR]

This paper examines the objectives for performing sensitivity analysis in medical cost-effectiveness analysis and the implications of expected utility maximization for methods to perform such analyses. The analysis suggests specific approaches for optimal decision making under uncertainty and specifying such decisions for subgroups based on the ratio of expected costs to expected benefits, and for valuing research using value of information calculations. Though ideal value of information calculations may be difficult, certain approaches with less stringent data requirements may bound the value of information. These approaches suggest methods by which the vast cost-effectiveness literature may help inform priorities for medical research. [ABSTRACT FROM AUTHOR]

Context: The professional integrity of scientists is important to society as a whole and particularly to disciplines such as medicine that depend heavily on scientific advances for their progress.Objective: To characterize the professional norms of active scientists and compare them with those of individuals with institutional responsibility for the conduct of research.Design: A mailed survey consisting of 12 scenarios in 4 domains of research ethics. Respondents were asked whether an act was unethical and, if so, the degree to which they considered it unethical and to select responses and punishments for the act.Participants: A total of 924 National Science Foundation research grantees in 1993 or 1994 in molecular or cellular biology and 140 representatives from the researchers' institutions to the US Department of Health and Human Services Office of Research Integrity.Main Outcome Measures: Percentage of respondents considering an act unethical and the mean malfeasance rating on a scale of 1 to 10.Results: A total of 606 research grantees and 91 institutional representatives responded to the survey (response rate of 69% of those who could be contacted). Respondents reported a hierarchy of unethical research behaviors. The mean malfeasance rating was unrelated to the characteristics of the investigator performing the hypothetical act or to its consequences. Fabrication, falsification, and plagiarism received malfeasance ratings higher than 8.6, and virtually all thought they were unethical. Deliberately misleading statements about a paper or failure to give proper attribution received ratings between 7 and 8. Sloppiness, oversights, conflicts of interest, and failure to share were less serious still, receiving malfeasance ratings between 5 and 6. Institutional representatives proposed more and different interventions and punishments than the scientists.Conclusions: Surveyed scientists and institutional representatives had strong and similar norms of professional behavior, but differed in their approaches to an unethical act. INSET: Scenario. [ABSTRACT FROM AUTHOR]