Search

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]

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]

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]

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]

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]

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]

In this paper the need for review (ethical) committees is elaborated to include a discussion of their composition and function. In some institutions more than one such committee may be set up, a departmental ethical committee and one which studies the projects of all the departments concerned. By considering proposed research before it is started patients or volunteers are protected from injury, discomfort, and inconvenience, and the scientific validity of a clinical experiment can be scrutinized. A list of possible criteria for the work of ethical committees is given. [ABSTRACT FROM PUBLISHER]

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]

Background: Osteochondritis dissecans (OCD) occurs most commonly in the knees of young individuals. This condition is known to cause pain and discomfort in the knee and can lead to disability and early knee osteoarthritis. The cause is not well understood, and treatment plans are not well delineated. The Research in Osteochondritis Dissecans of the Knee (ROCK) group established a multicenter, prospective cohort to better understand this disease. Purpose: To provide a baseline report of the ROCK multicenter prospective cohort and present a descriptive analysis of baseline data for patient characteristics, lesion characteristics, and clinical findings of the first 1000 cases enrolled into the prospective cohort. Study Design: Cross-sectional study; Level of evidence, 3. Methods: Patients were recruited from centers throughout the United States. Baseline data were obtained for patient characteristics, sports participation, patient-reported measures of functional capabilities and limitations, physical examination, diagnostic imaging results, and initial treatment plan. Descriptive statistics were completed for all outcomes of interest. Results: As of November 2020, a total of 27 orthopaedic surgeons from 17 institutions had enrolled 1004 knees with OCD, representing 903 patients (68.9% males; median age, 13.1 years; range, 6.3-25.4 years), into the prospective cohort. Lesions were located on the medial femoral condyle (66.2%), lateral femoral condyle (18.1%), trochlea (9.5%), patella (6.0%), and tibial plateau (0.2%). Most cases involved multisport athletes (68.1%), with the most common primary sport being basketball for males (27.3% of cases) and soccer for females (27.6% of cases). The median Pediatric International Knee Documentation Committee (Pedi-IKCD) score was 59.9 (IQR, 45.6-73.9), and the median Pediatric Functional Activity Brief Scale (Pedi-FABS) score was 21.0 (IQR, 5.0-28.0). Initial treatments were surgical intervention (55.4%) and activity restriction (44.0%). When surgery was performed, surgeons deemed the lesion to be stable at intraoperative assessment in 48.1% of cases. Conclusion: The multicenter ROCK group has been able to enroll the largest knee OCD cohort to date. This information is being used to further understand the pathology of OCD, including its cause, associated comorbidities, and initial presentation and symptoms. The cohort having been established is now being followed longitudinally to better define and elucidate the best treatment algorithms based on these presenting signs and symptoms. [ABSTRACT FROM AUTHOR]

Objective: Women are broadly underrepresented in scientific leadership positions and their accomplishments are not provided equal recognition compared with those of men, but the imbalance in the field of diabetes is unknown. Hence, we analyzed multiple aspects of historical and present-day female representation in the diabetes field.Research Design and Methods: We quantified gender representation at annual American Diabetes Association (ADA) meetings; editorial board service positions for ADA and the European Association for the Study of Diabetes (EASD) journals; principal investigators for ADA, JDRF, and National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases P30 grant funding; and ADA, JDRF, and EASD award recipients.Results: There are many women in the field of diabetes: registration for the ADA Scientific Sessions has been 43% female since 2016, and for over five decades, women comprised 83% of ADA Presidents of Health Care and Education. Yet, only 9% of ADA Presidents of Medicine and Science have been women. Women were well represented on editorial boards for journals focused on diabetes education (Diabetes Spectrum, 89% female) and primary care (Clinical Diabetes, 49% female) but not for the more academically targeted Diabetes Care (34% female), Diabetes (21% female), and Diabetologia (30% female). Only one-third of ADA Pathway to Stop Diabetes and JDRF grants have been awarded to women, and females only lead 2 of 18 (11%) of the P30-supported Diabetes Research Centers. Finally, only 2-12% of major ADA, JDRF, and EASD awards were given to women, without significant change over time.Conclusions: Despite increasing recognition of gender imbalance in research and medicine, many disparities in the field of diabetes persist. We call for decreasing barriers for advancement of female investigators and creating environments that promote their retention and equitable recognition for their contributions to the field. [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]

Importance: Convalescent plasma is a potential therapeutic option for patients with coronavirus disease 2019 (COVID-19), but further data from randomized clinical trials are needed.Objective: To evaluate the efficacy and adverse effects of convalescent plasma therapy for patients with COVID-19.Design, Setting, and Participants: Open-label, multicenter, randomized clinical trial performed in 7 medical centers in Wuhan, China, from February 14, 2020, to April 1, 2020, with final follow-up April 28, 2020. The trial included 103 participants with laboratory-confirmed COVID-19 that was severe (respiratory distress and/or hypoxemia) or life-threatening (shock, organ failure, or requiring mechanical ventilation). The trial was terminated early after 103 of a planned 200 patients were enrolled.Intervention: Convalescent plasma in addition to standard treatment (n = 52) vs standard treatment alone (control) (n = 51), stratified by disease severity.Main Outcomes and Measures: Primary outcome was time to clinical improvement within 28 days, defined as patient discharged alive or reduction of 2 points on a 6-point disease severity scale (ranging from 1 [discharge] to 6 [death]). Secondary outcomes included 28-day mortality, time to discharge, and the rate of viral polymerase chain reaction (PCR) results turned from positive at baseline to negative at up to 72 hours.Results: Of 103 patients who were randomized (median age, 70 years; 60 [58.3%] male), 101 (98.1%) completed the trial. Clinical improvement occurred within 28 days in 51.9% (27/52) of the convalescent plasma group vs 43.1% (22/51) in the control group (difference, 8.8% [95% CI, -10.4% to 28.0%]; hazard ratio [HR], 1.40 [95% CI, 0.79-2.49]; P = .26). Among those with severe disease, the primary outcome occurred in 91.3% (21/23) of the convalescent plasma group vs 68.2% (15/22) of the control group (HR, 2.15 [95% CI, 1.07-4.32]; P = .03); among those with life-threatening disease the primary outcome occurred in 20.7% (6/29) of the convalescent plasma group vs 24.1% (7/29) of the control group (HR, 0.88 [95% CI, 0.30-2.63]; P = .83) (P for interaction = .17). There was no significant difference in 28-day mortality (15.7% vs 24.0%; OR, 0.59 [95% CI, 0.22-1.59]; P = .30) or time from randomization to discharge (51.0% vs 36.0% discharged by day 28; HR, 1.61 [95% CI, 0.88-2.95]; P = .12). Convalescent plasma treatment was associated with a negative conversion rate of viral PCR at 72 hours in 87.2% of the convalescent plasma group vs 37.5% of the control group (OR, 11.39 [95% CI, 3.91-33.18]; P < .001). Two patients in the convalescent plasma group experienced adverse events within hours after transfusion that improved with supportive care.Conclusion and Relevance: Among patients with severe or life-threatening COVID-19, convalescent plasma therapy added to standard treatment, compared with standard treatment alone, did not result in a statistically significant improvement in time to clinical improvement within 28 days. Interpretation is limited by early termination of the trial, which may have been underpowered to detect a clinically important difference.Trial Registration: Chinese Clinical Trial Registry: ChiCTR2000029757. [ABSTRACT FROM AUTHOR]

The second recorded case of sesquizygotic (SQZ) twins is summarized. It is suspected that SQZ twins result from the fertilization of an egg by two separate spermatozoa, followed by division of the fertilized ovum. Next, recent studies examining how differences in parental affection affect co-twins' personality profiles, the prenatal demise of fetuses during twin pregnancy, a forensic case of heteropaternal superfecundation and selective feticide in dichorionic twins are reviewed. Finally, summaries of newsworthy items featuring an identical twin Oscar winner, a case of 'superfecundated' twins born to a gay couple, identical twins who try partly living apart and new molecular techniques to distinguish an innocent identical twin from his or her guilty co-twin are presented. [ABSTRACT FROM AUTHOR]

Background: The World Health Organization (WHO) recommends that women wait at least 24 months after a livebirth before attempting a subsequent pregnancy to reduce the risk of adverse maternal, perinatal, and infant health outcomes. However, the applicability of the WHO recommendations for women in the United States is unclear, as breast feeding, nutrition, maternal age at first birth, and total fertility rate differs substantially between the United States and the low- and middle-resource countries upon which most of the evidence is based.Methods: To inform guideline development for birth spacing specific to women in the United States, the Office of Population Affairs (OPA) convened an expert work group meeting in Washington, DC, on 14-15 September 2017 among reproductive, perinatal, paediatric, social, and public health epidemiologists; obstetrician-gynaecologists; biostatisticians; and experts in evidence synthesis related to women's health.Results: Presentations and discussion topics included the methodological quality of existing studies, evaluation of the evidence for causal effects of short interpregnancy intervals on adverse perinatal and maternal health outcomes, good practices for future research, and identification of research gaps and priorities for future work.Conclusions: This report provides an overview of the presentations, discussions, and conclusions from the expert work group meeting. [ABSTRACT FROM AUTHOR]

Objective: The Affordable Care Act and Medicare Access and CHIP Reauthorization Act are changing access to, and delivery of, health care in the United States, with potential implications for the field of health services research (HSR). We therefore investigated employers' perceptions of demand for individuals to conduct HSR, the competencies required for success, and implications for HSR training programs.Data Source: Interviews conducted in August 2016 with 21 key informants at a range of U.S.-based HSR organizations.Study Design: We conducted a semistructured, qualitative, telephone interview study to explore relevant topics.Data Collection/extraction Methods: Interviews with respondents were transcribed from recordings and then synthesized by respondent organization type and topic area.Principal Findings: Most respondents reported recently hiring health services researchers, and most anticipated hiring additional such researchers in the future. Most respondents emphasized the abilities to analyze data, work in teams, and engage with stakeholders. Finally, most respondents recommended that potential recruits gain real-world experience during their academic training.Conclusions: Our interviews indicated that current and future demand for health services researchers is strong. They also suggested that, as a field, HSR will continue to draw together individuals from a variety of backgrounds to inform a diverse array of decision makers. [ABSTRACT FROM AUTHOR]

Objective: To determine if there is a significant difference in the predictive abilities of left ventricular hypertrophy (LVH) detected by ECG-LVH versus LVH ascertained by cardiac MRI-LVH in a model similar to the Framingham Heart Failure Risk Score (FHFRS).Methods: This study included 4745 (mean age 61±10 years, 53.5% women, 61.7% non-whites) participants in the Multi-Ethnic Study of Atherosclerosis. ECG-LVH was defined using Cornell voltage product while MRI-LVH was derived from left ventricular mass. Cox proportional hazard regression was used to examine the association between ECG-LVH and MRI-LVH with incident heart failure (HF). Harrell's concordance C-index was used to estimate the predictive ability of the model when either ECG-LVH or MRI-LVH was included as one of its components.Results: ECG-LVH was present in 291 (6.1%), while MRI-LVH was present in 499 (10.5%) of the participants. Both ECG-LVH (HR 2.25, 95% CI 1.38 to 3.69) and MRI-LVH (HR 3.80, 95% CI 1.56 to 5.63) were predictive of HF. The absolute risk of developing HF was 8.81% for MRI-LVH versus 2.26% for absence of MRI-LVH with a relative risk of 3.9. With ECG-LVH, the absolute risk of developing HF 6.87% compared with 2.69% for absence of ECG-LVH with a relative risk of 2.55. The ability of the model to predict HF was better with MRI-LVH (C-index 0.871, 95% CI 0.842 to 0.899) than with ECG-LVH (C-index 0.860, 95% CI 0.833 to 0.888) (p<0.0001).Conclusions: ECG-LVH and MRI-LVH are predictive of HF. Substituting MRI-LVH for ECG-LVH improves the predictive ability of a model similar to the FHFRS. [ABSTRACT FROM AUTHOR]

Objective: This article chronicles the building of individual student capacity as well as faculty and institutional capacity, within the context of a population-based, longitudinal study of African Americans and cardiovascular disease. The purpose of this article is to present preliminary data documenting the results of this approach.Design: The JHS Scholars program is designed, under the organizational structure of the Natural Sciences Division at Tougaloo College, to provide solid preparation in quantitative skills through: good preparation in mathematics and the sciences; a high level of reading comprehension; hands-on learning experiences; and mentoring and counseling to sustain the motivation of the students to pursue further studies.Setting: This program is on the campus of a private Historically Black College in Mississippi.Participants: The participants in the program are undergraduate students.Main Outcome Measures: Data, which included information on major area of study, institution attended, degrees earned and position in the workforce, were analyzed using STATA 14.Results: Of 167 scholars, 46 are currently enrolled, while 118 have graduated. One half have completed graduate or professional programs, including; medicine, public health, pharmacy, nursing, and biomedical science; approximately one-fourth (25.4 %) are enrolled in graduate or professional programs; and nearly one tenth (9.3%) completed graduate degrees in law, education, business or English.Conclusions: These data could assist other institutions in understanding the career development process that helps underrepresented minority students in higher education to make career choices on a path toward public health, health professions, biomedical research, and related careers. [ABSTRACT FROM AUTHOR]

Background: Since 2006, the genetic testing company 23andMe has collected biological samples, self-reported information, and consent documents for biobanking and research from more than 1,000,000 individuals (90% participating in research), through a direct-to-consumer (DTC) online genetic-testing service providing a genetic ancestry report and a genetic health report. However, on November 22, 2013, the Food and Drug Administration (FDA) halted the sale of genetic health testing, on the grounds that 23andMe was not acting in accordance with federal law, by selling tests of undemonstrated reliability as predictive tests for medical risk factors. Consumers could still obtain the genetic ancestry report, but they no longer had access to the genetic health report in the United States (US). However, this did not prevent the company from continuing its health research, with previously obtained and future samples, provided that consent had been obtained from the consumers concerned, or with health reports for individuals from other countries. Furthermore, 23andMe was granted FDA authorization on February 19, 2015, first to provide reports about Bloom syndrome carrier status, and, more recently, to provide consumers with "carrier status" information for 35 genes known (with high levels of confidence) to cause disease.Discussion: In this Debate, we highlight the likelihood that the primary objective of the company was probably two-fold: promoting itself within the market for predictive testing for human genetic diseases and ancestry at a low cost to consumers, and establishing a high-value database/biobank for research (one of the largest biobanks of human deoxyribonucleic acid (DNA) and personal information). By dint of this marketing approach, a two-sided market has been established between the consumer and the research laboratories, involving the establishment of a database/DNA biobank for scientific and financial gain. We describe here the profound ethical issues raised by this setup. [ABSTRACT FROM AUTHOR]

Background and Objectives: Multi-institutional quality improvement registries (QI registries) are a promising approach to quality improvement. They are also used for clinical research, public quality reporting and other valuable purposes. The aim of this study was to identify elements and outcomes of national policies to promote registries in Sweden and to compare them with recent policies in the USA.Methods: This case study draws on previous studies of Swedish registries and on interviews, observations and document studies conducted in Sweden and the USA.Results: In Sweden, registries are fostered by favourable patient data regulation and an indirect control approach combining government funding with soft regulation and professional self-governance. This enables the development of high-quality QI registries which are used for improvements by engaged clinicians, for clinical research and for decision support for practitioners and stakeholders. For example, Riks-HIA/Swedeheart achieved improved outcomes in cardiac intensive care, SCAAR/Swedeheart was used in a unique registry-based randomized trial, and the Swedish Rheumatology Quality Register provides a Web interface for patient encounters and clarifies adverse effects of biologic drugs. Still, the system has persistent limitations, especially the administrative burden on participants. In the USA, Medicare's programme for qualified clinical data registries and other recent changes mirror Swedish policies. Automated data capture is a US advantage, but uncertain funding and complex data regulations stall registry development in the USA.Conclusion: The findings of this study indicate that tailor-made data regulation and a soft regulatory policy approach foster high-quality QI registries with multiple meaningful uses. These findings offer a framework for further cross-country comparative study to evaluate registry policies. [ABSTRACT FROM AUTHOR]

Objective: Previous research has found that physicians are divided on whether they are obligated to provide a treatment to which they object and whether they should refer patients in such cases. The present study compares several possible scenarios in which a physician objects to a treatment that a patient requests, in order to better characterise physicians' beliefs about what responses are appropriate.Design: We surveyed a nationally representative sample of 1504 US primary care physicians using an experimentally manipulated vignette in which a patient requests a clinical intervention to which the patient's physician objects. We used multivariate logistic regression models to determine how vignette and respondent characteristics affected respondent's judgements.Results: Among eligible respondents, the response rate was 63% (896/1427). When faced with an objection to providing treatment, referring the patient was the action judged most appropriate (57% indicated it was appropriate), while few physicians thought it appropriate to provide treatment despite one's objection (15%). The most religious physicians were more likely than the least religious physicians to support refusing to accommodate the patient's request (38% vs 22%, OR=1.75; 95% CI 1.06 to 2.86).Conclusions: This study indicates that US physicians believe it is inappropriate to provide an intervention that violates one's personal or professional standards. Referring seems to be physicians' preferred way of responding to requests for interventions to which physicians object. [ABSTRACT FROM AUTHOR]

Background: An estimated 20-50% of patients do not take medications as recommended. Accepting a doctor's recommendation is the first step in medication adherence, yet little is known about patients' beliefs and preferences about how medications are prescribed.Objective: To explore patients' beliefs and preferences about medication prescribing to understand factors that might affect medication adherence.Methods: Fifty members from 2 health plans in Massachusetts participated in in-depth telephone interviews. Participants listened to an audio-vignette of a doctor prescribing a medication to a patient and were asked a series of questions related to the vignette. Responses were reviewed in an iterative process to identify themes related to participants' beliefs and preferences about medication prescribing.Results: Participants' beliefs and preferences about medication prescribing encompassed 3 major areas: patient-doctor relationships, outside influences, and professional expertise. Important findings included participants' concerns about the pharmaceutical industry's influence on doctors' prescribing practices and beliefs that there is a clear "best" medication for most health problems.Conclusions: Patients' beliefs and preferences about medication prescribing may affect medication adherence. Additional empiric studies that explore whether doctors' relationships with pharmaceutical representatives impact medication adherence by affecting trust are indicated. In addition, it would be worthwhile to explore whether discussions between patients and doctors regarding equipoise (no clear scientific evidence for 1 treatment choice over another) affect medication adherence. [ABSTRACT FROM AUTHOR]

Applications of saddlepoint approximations to distribution functions are reviewed. Calculations are provided for marginal distributions and conditional distributions. These approximations are applied to problems of testing and generating confidence intervals, particularly in canonical exponential families. [ABSTRACT FROM AUTHOR]

Objective: To describe barriers to participation of African Americans in research.Design: Focus group interviews conducted in 1997.Patients: Thirty-three African-American adults presenting to an urban public hospital for outpatient medical care participated in one of five focus groups.Measurements and Main Results: African-American patients' attitudes toward medical research were measured. Mistrust of doctors, scientists, and the government was reported consistently by the participants. Many participants described concerns about the ethical conduct of clinicians and investigators when poor or minority patients are involved and cited examples of exploitation as supporting evidence for their mistrust of the medical establishment. While participants were clear about the violation of human rights in the Tuskegee Syphilis Study, all were misinformed of the historical facts of the study. Few participants understood the concept of informed consent. Participants saw signing the document as relinquishing their autonomy and as a legal protection for physicians. Despite these concerns, participants gave recommendations to improve minority participation in research.Conclusions: African-American participants in this study described distrust of the medical community as a prominent barrier to participation in clinical research. Participants described real and perceived examples of exploitation to support their distrust of researchers. The goal of the consent process, to inform patients of risks and benefits so as to facilitate self-determination, was misinterpreted by these participants. Understanding the importance of interpersonal trust within the clinical relationship may prove to be a significant factor in enhancing participation in clinical trials. [ABSTRACT FROM AUTHOR]

Context: Increased competitive pressures on academic health centers may result in reduced discretionary funds from patient care revenues to support the performance of unsponsored research, including institutionally funded and faculty-supported activities.Objective: To measure the amount and distribution of unsponsored research activities and their outcomes.Design and Setting: Survey conducted in academic year 1996-1997 of 2336 research faculty in 117 medical schools. Responses were weighted to provide national estimates.Main Outcome Measures: Institutionally funded research as a proportion of total direct costs of research was compared across stages of market competition. Logistic regression was used to assess the relationship of performing unsponsored research to faculty characteristics and market stage.Results: Overall, 43% of faculty received institutional funding for research. Young faculty were more likely than others to receive institutional support (adjusted odds ratio [OR], 1.4; 95% confidence interval [CI], 1.1-1.9; P = .004). The amount of institutional support as a proportion of total funding was more than twice as high in less competitive markets (6.1%) compared with the most competitive markets (2.5%; P = .05). Most faculty (55%) performed faculty-supported research. Clinical researchers (OR, 1.6; 95% CI, 1.1-2.3), principal investigators (OR, 4.3; 95% CI, 2.8-7.0), faculty with high levels of research effort (OR, 6.2; 95% CI, 4.0-9.5) or institutional funding (OR, 1.9; 95% CI, 1.4-2.6), and faculty in the most competitive markets (OR, 1.9; 95% CI, 1.4-2.5) were more likely than others to conduct faculty-supported research. When undertaken by clinical researchers, these activities were supported by clinical income, extra hours worked, and discretionary funds, and often led to publications (76%) or grant awards (51%).Conclusions: Many academic health center faculty receive institutional support to conduct their research or fund the research themselves. Market pressures may be affecting the level of institutional funding available to faculty. [ABSTRACT FROM AUTHOR]

A decade after the dawn of the Internet Age, are people who seek health information better off than they used to be? The current study by Arora and colleagues examines a small slice of the massive Health Information National Trends Survey dataset and attempts to understand the experiences of those US adults who have sought cancer information at any point in their lives from any source. One third reported that the information they encountered was hard to understand, and one half questioned the quality of the information they found. Several research questions regarding how individuals successfully find information on the Internet remain to be answered. [ABSTRACT FROM AUTHOR]