Search

EU-US data transfers for health research remain a particularly thorny issue in view of the stringent rules of the EU General Data Protection Regulation (GDPR) and the challenges related to US mass surveillance programs, particularly the manner in which US law enforcement and national security agencies can access personal data originating from the EU. Since the entry into force of the GDPR, evidence of impeded collaborations is increasing, particularly in the case of sharing data with US public institutions. The adoption of a new EU-US adequacy decision in July 2023 does not hold the promise for a long-lasting solution due to the risks of being challenged and invalidated – yet again – at the Court of Justice of the EU. As the research community is calling for answers, the new proposal for a European Health Data Space regulation may hold a key to solving some of the existing issues. In this paper, we critically discuss the current rules and outline a possible way forward for transfers between public bodies. [ABSTRACT FROM AUTHOR]

Introduction: The emergence of artificial intelligence (AI) chat programs has opened two distinct paths, one enhancing interaction and another potentially replacing personal understanding. Ethical and legal concerns arise due to the rapid development of these programs. This paper investigates academic discussions on AI in medicine, analyzing the context, frequency, and reasons behind these conversations. Methods: The study collected data from the Web of Science database on articles containing the keyword "ChatGPT" published from January to September 2023, resulting in 786 medically related journal articles. The inclusion criteria were peer-reviewed articles in English related to medicine. Results: The United States led in publications (38.1%), followed by India (15.5%) and China (7.0%). Keywords such as "patient" (16.7%), "research" (12%), and "performance" (10.6%) were prevalent. The Cureus Journal of Medical Science (11.8%) had the most publications, followed by the Annals of Biomedical Engineering (8.3%). August 2023 had the highest number of publications (29.3%), with significant growth between February to March and April to May. Medical General Internal (21.0%) was the most common category, followed by Surgery (15.4%) and Radiology (7.9%). Discussion: The prominence of India in ChatGPT research, despite lower research funding, indicates the platform's popularity and highlights the importance of monitoring its use for potential medical misinformation. China's interest in ChatGPT research suggests a focus on Natural Language Processing (NLP) AI applications, despite public bans on the platform. Cureus' success in publishing ChatGPT articles can be attributed to its open-access, rapid publication model. The study identifies research trends in plastic surgery, radiology, and obstetric gynecology, emphasizing the need for ethical considerations and reliability assessments in the application of ChatGPT in medical practice. Conclusion: ChatGPT's presence in medical literature is growing rapidly across various specialties, but concerns related to safety, privacy, and accuracy persist. More research is needed to assess its suitability for patient care and implications for non-medical use. Skepticism and thorough review of research are essential, as current studies may face retraction as more information emerges. [ABSTRACT FROM AUTHOR]

Introduction: This study presents a global research scenario in the broad domain of osteoarthritis (OA) research, using quantitative and qualitative publication and citation indicators. Methods: The study is based on 45,368 global publications, sourced from the Scopus bibliographical database, covering three decades (1994–2023). We studied the performance of the top 12 developed and top 12 developing countries. The key countries, organizations and authors at national and international levels were identified. The broad subject areas and key journals contributing to global OA research were delineated, besides identifying the broad characteristics of highly cited papers in the field. Results: The United States and China were the most productive countries, while the Netherlands and Canada made the largest citation impact. Harvard Medical School and the University of Sydney made the most contribution, while Boston University and Pfizer Inc., USA registered the highest citation impact. Hunter DJ and Guermazi A were the most productive authors, while Lohmander LS, and Hochberg MC registered the highest citation impact. Osteoarthritis and Cartilage (n = 4879) and Annals of the Rheumatic Diseases (n = 786) published the maximum papers, while Arthritis and Rheumatism and Nature Reviews Rheumatology registered the largest citation impact. The highly cited papers with 100 or more citations constituted 6.25% of the total publications. Conclusions: There has been a systematic growth of publications on OA. The research on OA was mainly done in developed countries, with the maximum publications coming from the United States of America, China and Canada. The most impactful publications on OA were from the Netherlands, Canada and the United States of America. [ABSTRACT FROM AUTHOR]

Background: Interleukin17 (IL17) is an important cytokine in host defense at mucosal surfaces and also mediates many autoimmune diseases, including rheumatoid arthritis (RA). In recent years, many types of research relevant to the structure and function of IL17 have been identified. However, there is no bibliometric analysis in this research field. This study aims to explore the history, research hotspots, and emerging trends of IL17 from the perspective of the structure and function dynamics. Methods: Articles relevant to IL17 in the last two decades were retrieved through the Web of Science Core Collection (WoSCC) database. The bibliometric analysis was performed by VOSview. Results: A total of 882 papers in this research were analyzed from 65 countries, and the rate of published articles has increased from 2008 annually, with the USA, China, and Germany leading the research effort. Frontiers in Immunology has significantly impacted research in this field and the University of Pittsburgh was the leading institution. Gaffen, Sarah L. from the University of Pittsburgh was the most productive researcher in this field and Papp Ka from the Probity Medical Research Incorporate of Canada is the most co-cited author. The analysis of keywords showed that inflammation, expression, Th17 cells, and cytokines were the main hotspots and frontier directions of IL17. The trend of clinical application in the future is the development of new therapy drugs based on the structure of IL17 or IL17 signaling pathway molecular. Conclusions: Our research summarized the developments and research trends of IL17 and would help researchers understand the research status of IL17 and provide a reference for future researchers as soon as possible. [ABSTRACT FROM AUTHOR]

Aims: Individuals with Limited English Proficiency (LEP) represent a growing percentage of the U.S. population yet face inequities in health outcomes and barriers to routine care. Despite these disparities, LEP populations are often excluded from clinical research studies. The aim of this study was to assess for the inclusion of LEP populations in published acute care stroke research in the U.S. Methods: A systematic review was conducted of publications from three databases using acute care and stroke specific Medical Subject Heading key terms. The primary outcome was whether language was used as inclusion or exclusion criteria for study participation and the secondary outcome was whether the study explored outcomes by language. Results: A total of 167 studies were included. Twenty-two studies (13.2%) indicated the use of language as inclusion/exclusion criteria within the manuscript or dataset/registry and only 17 studies (10.2%) explicitly included LEP patients either in the study or dataset/registry. Only four papers (2%) include language as a primary variable. Conclusions: As LEP populations are not routinely incorporated in acute care stroke research, it is critical that researchers engage in language-inclusive research practices to ensure all patients are equitably represented in research studies and ultimately evidence-based practices. [ABSTRACT FROM AUTHOR]

Taoism and Confucianism both exited simultaneously as philosophies of living in dynastic China. Although there has been an increasing popularity in scientometric studies, religion and health (R&H) literature lacks a holistic evaluation investigating articles relevant to Taoism and Confucianism. All publications produced in Taoism and Confucianism literature and indexed in Web of Science (WoS) databases between 1975 and 2018 were included in this study. Database search on health and Taoism literature retrieved 199 documents from WoS databases. Main research areas were Psychology, Religion and Behavioral Sciences (24.121, 21.608 and 20.603, respectively). The USA ranked first with 38 papers followed China, Taiwan and the UK (n = 35, 20 and 6 documents, respectively). Hong Kong Polytechnic University from China was the most contributor institution in health and Taoism literature. A total of 448 documents were published in health and Confucianism literature between 1975 and 2018, and original articles covered 93.08% of all literature. China was leading country with 126 articles followed by the USA, South Korea and Taiwan (n = 97, 35 and 35 items, respectively). The most productive institutions were City University of Hong Kong (China), Karolinska Institute (Sweden) and University of Hong Kong (China). Researchers from developing and least developed countries should be encouraged to carry out novel scientometric studies in R&H literature. [ABSTRACT FROM AUTHOR]

Background: Tremendous progress has been made in the field of cartilage repair and regeneration, particularly with tissue-engineering approaches. This study aims to estimate the global status and current trends in the field of cartilage tissue engineering. Methods: Publications from 2011 to 2020 on tissue engineering for cartilage repair and regeneration were retrieved from Web of Science Core Collection database. The source data were statistically evaluated based on the bibliometrics. In terms of visualized analysis, some bibliometric indicators such as bibliographic coupling, co-citation, co-authorship and co-occurrence analysis were performed by VOSviewer software, to investigate the research trends in tissue engineering for cartilage repair and regeneration. Results: In total, 3715 papers were included. Since 2011, the amount of issued papers and relative research interest (RRI) have grown by leaps and bounds globally. The United States was the biggest contributor to the research in this field, due to the greatest citation frequency, the highest H index and the strongest total link strength. Romania had the highest average citation for each. The journal Tissue Engineering Part A published most articles in this field. For institutions, the largest contributors were Shanghai Jiaotong University, University of California System and Sichuan University. Studies could all be grouped into four main clusters: study of biomaterial scaffolds, study of seeding cells and growth factors, experimental animal model and clinical study, and mechanism research. Conclusion: Great efforts should be put into the study of biomaterial scaffolds, seeding cells and growth factors, considered to be the next hot topics in cartilage tissue engineering. This findings provide collaborative insights and research orientation for academic researchers, surgeons and healthcare practitioners to a certain extent. [ABSTRACT FROM AUTHOR]

An increase in the number of identified therapeutic cancer targets achieved through recent biomedical research has resulted in the generation of a large number of molecules that need to be tested further. Current development of (anticancer) drugs is a rather inefficient process that for an average new molecule takes around 10–15 years. It is also a challenging process as it is associated with high costs and a low rate of approval. It is known that less than 10% of new molecular entities entering clinical Phase I testing progress beyond the investigational programme and reach the market; this probability is even lower for anticancer agents. In 2003, the US Food and Drug Administration (US FDA) declared the urgent need for new toolkits to improve the critical development path that leads from scientific discovery to the patient. In this scenario, Phase 0 (zero) trials should allow an early evaluation in humans of pharmacokinetic and pharmacodynamic profiles of test compounds through administration of sub-pharmacological doses and for a short time period to a low number of humans. Typically, Phase 0 studies have no therapeutic or diagnostic intent. Owing to the low doses administered and the low risk of toxicity, shorter preclinical packages to support these studies are required. Phase 0 trials have been proposed to help in making an early selection of promising candidates for further evaluation in Phase I–III trials, providing a potentially useful instrument for drug discovery, particularly in the field of oncology. Phase 0 studies are expected to reduce costs of drug development, and to limit the preclinical in vitro and in vivo testing and the time period of drug development. However, there are also concerns about the utility and feasibility of Phase 0 studies. In January 2006, guidelines on exploratory investigational new drug studies in humans have been published by the US FDA, and currently a Phase 0 programme is ongoing at the National Cancer Institute to evaluate the impact (feasibility and utility) of Phase 0 studies on drug development. In Europe, a Position Paper produced by the Evaluation of Medicinal Products (EMEA) in 2004 raised the possibility of a reduced preclinical safety package to support early microdose clinical studies, and, as announced by a recent Concept Paper on medicinal products published by the committee for medicinal products for human use of the EMEA, EMEA's guidelines on Phase 0 studies are expected shortly. The true impact of Phase 0 studies on the drug development process as well as on the safety needs to be carefully explored.British Journal of Cancer (2007) 97, 577–581. doi:10.1038/sj.bjc.6603925 www.bjcancer.com Published online 28 August 2007 [ABSTRACT FROM AUTHOR]

Longitudinal qualitative research can provide rich understanding of the life circumstances of vulnerable groups who experience health inequities, of whether, how and why these circumstances change, and of how these circumstances and processes of change impact health. But, this rich understanding is not automatic and requires systematic and thoughtful approaches to data collection and analysis. The purpose of this paper is to describe two longitudinal qualitative studies embedded in mixed-methods studies of social determinants of HIV in the United States and the Dominican Republic. We compare these two studies to critically reflect on specific techniques that facilitate longitudinal and iterative data collection, management, and analysis, in particular the use of participant-specific matrices and analytic summaries across the distinct phases of the research. We conclude that combining cross-sectional and longitudinal analysis that engages with both themes and processes of change can contribute to improved contextualization and understanding of social determinants of HIV. [ABSTRACT FROM AUTHOR]

Research on human cadavers is an important mechanism of scientific progress and comprises a large industry in the United States. However, despite its importance and influence, there is little ethical or regulatory oversight of cadaver-based research. This lack of transparency raises important ethical questions. Thus, this paper serves as a call for ethicists and regulators to pay increased attention to cadaver research. I argue that cadaver research ought to be considered a subset of human subjects research and held accountable to higher ethical standards. After describing current practices, I argue that oversight of cadaver research as a form of human subjects research is appropriate because cadaver research is similar to other types of human research, participants in cadaver research incur risks of harm, and a current lack of oversight has allowed the cadaver industry to entice research participation through ethically questionable practices. This paper urges greater dialogue among human subjects research ethicists and regulators about what constitutes appropriate protections for participants in cadaver research. [ABSTRACT FROM AUTHOR]

An important health policy issue is the low rate of patient enrollment into clinical trials, which may slow down the process of clinical trials and discourage their supply, leading to delays in innovative life-saving drug treatments reaching the general population. In the US, patients' cost of participating in a clinical trial is considered to be a major barrier to patient enrollment. In order to reduce this barrier, some states in the US have implemented policies requiring health insurers to cover routine care costs for patients enrolled in clinical trials. This paper evaluates empirically how effective these policies were in increasing the supply of clinical trials and speeding up their completion, using data on cancer clinical trials initiated in the US between 2001 and 2007. Our analysis indicates that the policies did not lead to an increased supply in the number of clinical trials conducted in mandate states compared to non-mandate states. However, we find some evidence that once clinical trials are initiated, they are more likely to finish their patient recruitment in a timely manner in mandate states than in non-mandate states. As a result, the overall length to completion was significantly shorter in mandate states than in non-mandate states for cancer clinical trials in certain phases. The findings hint at the possibility that these policies might encourage drug innovation in the long run. [ABSTRACT FROM AUTHOR]

Fraud and abuse have led to significant additional expense in the health care system of the United States. This paper aims to provide a comprehensive survey of the statistical methods applied to health care fraud detection, with focuses on classifying fraudulent behaviors, identifying the major sources and characteristics of the data based on which fraud detection has been conducted, discussing the key steps in data preprocessing, as well as summarizing, categorizing, and comparing statistical fraud detection methods. Based on this survey, some discussion is provided about what has been lacking or under-addressed in the existing research, with the purpose of pinpointing some future research directions. [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]

Attempts to document changing HIV incidence rates among MSM are compromised by issues of generalizability and statistical power. To address these issues, this paper reports annualized mean HIV incidence rates from the entire published incidence literature on MSM from Europe, North America and Australia for the period 1995–2005. Publications that met the entry criteria were coded for region of the world, sampling method and year of study. From these reports, we calculated a mean incidence rate with confidence intervals for these variables. Although no differences in mean incidence rates were found for MSM from 1995 to 2005, HIV incidence rates are lower in Australia than either North America or Europe. We calculated a mean incidence rate of 2.39% for MSM in the United States, which if sustained within a cohort of MSM, would yield HIV prevalence rate of approximately 40% at age 40. These extrapolations overlap published HIV prevalence rates for MSM younger than age 40 in the United States. HIV incidence rates in the 2–3% range will adversely affect the health of gay male communities for decades to come. This analysis suggests that greater attention should be devoted to the question of how best to design prevention interventions that will lower HIV incidence rates among gay men. [ABSTRACT FROM AUTHOR]

Objectives: The objective of this paper was to describe primary care prescribers' perspectives on electronic prescribing drug alerts at the point of prescribing.Design: We used a mixed-method study which included clinician surveys (web-based and paper) and focus groups with prescribers and staff.Participants: Prescribers (n = 157) working in one of 64 practices using 1 of 6 e-prescribing technologies in 6 US states completed the quantitative survey and 276 prescribers and staff participated in focus groups.Measurements: The study measures self-reported frequency of overriding of drug alerts; open-ended responses to: "What do you think of the drug alerts your software generates for you?"Results: More than 40% of prescribers indicated they override drug-drug interactions most of the time or always (range by e-prescribing system, 25% to 50%). Participants indicated that the software and the interaction alerts were beneficial to patient safety and valued seeing drug-drug interactions for medications prescribed by others. However, they noted that alerts are too sensitive and often unnecessary. Participant suggestions included: (1) run drug alerts on an active medication list and (2) allow prescribers to set the threshold for severity of alerts.Conclusions: Primary care prescribers recognize the patient safety value of drug prescribing alerts embedded within electronic prescribing software. Improvements to increase specificity and reduce alert overload are needed. [ABSTRACT FROM AUTHOR]

Hospitals and other health-care providers today are being pressed more than ever to use technologies for reducing medical errors. Particularly, medication errors are likely to increase fast as Americans age. This paper intends to provide a starting point for understanding information technologies and database systems supporting such technologies as Computerized Physician Order Entry (CPOE), Automated Dispensing System (ADS), and Bar Coding System designed to reduce medication errors in hospitals. Although vendors provide the necessary communication software and applications, actions involving governments, technology vendors, pharmaceutical companies, and clinical researchers are needed to put to actual use the applications with a massive potential to significantly reduce medication-related errors. [ABSTRACT FROM AUTHOR]

Tailored programs to diversify the pool of HIV/AIDS investigators and provide sufficient training and support for minority investigators to compete successfully are uncommon in the US and abroad. This paper encourages a shift in the HIV/AIDS training and research paradigm to effectively train and mentor Latino researchers in the US, Latin America and the Caribbean. We suggest three strategies to accomplish this: (1) coaching senior administrative and academic staff of HIV/AIDS training programs on the needs, values, and experiences unique to Latino investigators; (2) encouraging mentors to be receptive to a different set of research questions and approaches that Latino researchers offer due to their life experiences and perspectives; and (3) creating a virtual infrastructure to share resources and tackle challenges faced by minority researchers. Shifts in the research paradigm to include, retain, and promote Latino HIV/AIDS researchers will benefit the scientific process and the patients and communities who await the promise of HIV/AIDS research. [ABSTRACT FROM AUTHOR]

The article focuses on the dramatic increase in autism research recently in the United States. The Federal Government in the United States has greatly increased financial support for autism research and this has resulted in a new wave of exciting papers and the addition of many talented new investigators. The Journal of Autism and Developmental Disorders has doubled the number of papers it receives annually in just four short years. This surge in interest and productivity will undoubtedly lead to important gains in our knowledge about Autism Spectrum Disorders. Although these gains are important and exciting, the number of these additional studies that are focused on intervention are disappointingly small.

This commentary provides a response to the rejoinder by Paal et al. (Journal of Religion and Health. https://doi.org/10.1007/s10943-022-01726-y, 2023), regarding the research of Otaiku (Journal of Religion and Health. https://doi.org/10.1007/s10943-022-01603-8, 2022) "Religiosity and risk of Parkinson's disease in England and the USA." After providing a brief overview of Otaiku's work, the commentary then addresses each of Paal et al.'s arguments. While agreeing that more research needs to be undertaken, this commentary concludes that Otaiku's research findings are well founded, suggesting that greater religiosity may lower the risk of PD. [ABSTRACT FROM AUTHOR]

This rejoinder refers to the research of Otaiku (J Religion Health 1–17, 2022), which concluded that low religiosity in adulthood is associated with an increased risk of developing Parkinson's disease. Although Otaiku points to a number of limitations of their own research and thus clearly qualifies that further work is needed to verify the findings, a number of concerns still need to be raised about this research. Five points are highlighted in this article, namely (1) it is not clear why and how the variables of religiosity and spirituality were combined; (2) it is not reported whether other variables were tested; (3) they refer to the four different groups of how religiosity plays a role, which include extremely small samples of 11, 16, 25, 22 participants, (4) the final conclusion is based only on the two extreme groups with Parkinson's disease, (5) it remains unclear whether all patients had Parkinson's disease. Consequently, we are of opinion that Otaiku's findings and conclusions are questionable, but agree that future studies are warranted that require state-of-the-art research. [Note: A detailed response to this rejoinder has been provided in a subsequent commentary; Koenig (Journal Religion Health 62, 2023)]. [ABSTRACT FROM AUTHOR]

The number of articles published in open access journals (OAJs) has increased dramatically in recent years. Simultaneously, the quality of publications in these journals has been called into question. Few studies have explored the retraction rate from OAJs. The purpose of the current study was to determine the reasons for retractions of articles from OAJs in biomedical research. The Medline database was searched through PubMed to identify retracted publications in OAJs. The journals were identified by the Directory of Open Access Journals. Data were extracted from each retracted article, including the time from publication to retraction, causes, journal impact factor, and country of origin. Trends in the characteristics related to retraction were determined. Data from 621 retracted studies were included in the analysis. The number and rate of retractions have increased since 2010. The most common reasons for retraction are errors (148), plagiarism (142), duplicate publication (101), fraud/suspected fraud (98) and invalid peer review (93). The number of retracted articles from OAJs has been steadily increasing. Misconduct was the primary reason for retraction. The majority of retracted articles were from journals with low impact factors and authored by researchers from China, India, Iran, and the USA. [ABSTRACT FROM AUTHOR]

Numerous reports indicate that the incidence of posttraumatic stress disorder (PTSD) in returning OEF/OIF military personnel is creating a significant healthcare challenge. These findings have served to motivate research on how to better develop and disseminate evidence-based treatments for PTSD. Virtual Reality delivered exposure therapy for PTSD has been previously used with reports of positive outcomes. This article details how virtual reality applications are being designed and implemented across various points in the military deployment cycle to prevent, identify and treat combat-related PTSD in OIF/OEF Service Members and Veterans. The summarized projects in these areas have been developed at the University of Southern California Institute for Creative Technologies, a U.S. Army University Affiliated Research Center, and this paper will detail efforts to use virtual reality to deliver exposure therapy, assess PTSD and cognitive function and provide stress resilience training prior to deployment. [ABSTRACT FROM AUTHOR]

The National Institutes of Health sponsored Patient-Reported Outcome Measurement Information System (PROMIS) aimed to create item banks and computerized adaptive tests (CATs) across multiple domains for individuals with a range of chronic diseases. Web-based software was created to enable a researcher to create study-specific Websites that could administer PROMIS CATs and other instruments to research participants or clinical samples. This paper outlines the process used to develop a user-friendly, free, Web-based resource (Assessment CenterSM) for storage, retrieval, organization, sharing, and administration of patient-reported outcomes (PRO) instruments. Joint Application Design (JAD) sessions were conducted with representatives from numerous institutions in order to supply a general wish list of features. Use Cases were then written to ensure that end user expectations matched programmer specifications. Program development included daily programmer “scrum” sessions, weekly Usability Acceptability Testing (UAT) and continuous Quality Assurance (QA) activities pre- and post-release. Assessment Center includes features that promote instrument development including item histories, data management, and storage of statistical analysis results. This case study of software development highlights the collection and incorporation of user input throughout the development process. Potential future applications of Assessment Center in clinical research are discussed. [ABSTRACT FROM AUTHOR]

In the United States, men who have sex with men (MSM) currently represent more than 50% of those living with HIV and over 70% of HIV+ men (CDC 2007, ). Male-to-male sexual contact has been identified as the predominant route of transmission among this sub-group, which underscores the need for research that targets risk factors associated with risky sex-related HIV acquisition. Along these lines, research has shown that one potentially important predictor variable for risky sex among MSM is alcohol use. The major aim of this paper is to review and integrate empirical evidence on the association of alcohol use and risky sex among MSM. A summary of the quantitative research is provided first, followed by a critique of the reviewed literature, a discussion of the consistency of the existing empirical evidence with predictions of current theories, and finally, recommendations for future research designed to evaluate alcohol-related sexual risk in MSM. [ABSTRACT FROM AUTHOR]

This paper describes (1) the design, methods and baseline data of the first smoking cessation clinical trial for Chinese Americans with medical conditions - Chinese Community Smoking Cessation Project (CCSCP); (2) the collaborative process between researchers and the Chinese community; and (3) the barriers and facilitators of implementing the study. CCSCP was a culturally tailored, randomized, smoking cessation trial testing the efficacy of an intensive (physician advice, in-person counseling with nicotine replacement therapy, 5 telephone calls) compared to a minimal (physician advice and self-help manual) intervention. The study applied a community-sensitive research method involving community members in all phases of the research process in San Francisco Bay Area during 2001–2007. CCSCP recruited 464 smokers from health care facilities (79%) located in Chinese neighborhoods and through Chinese language media (21%). Baseline assessments and interventions were conducted in-person using translated and tested questionnaire and intervention materials. The majority of the participants were men (91%) with a mean age of 58.3 years, foreign born (98%), with less than high school education (58%), spoke no English (42%) and in non-skilled or semi-skilled occupations (60%) with <$20,000 household income (51%). Participants smoked regularly on an average 38.6 ± 17 years, smoked 9.1 ± 8 cigarettes per day and 85% smoked daily. Cultural tailoring of recruitment methods and intervention design led to successful enrollment and retention of participants, overcoming barriers faced by the participants. Community sensitive collaborative process facilitated implementation of study protocol in community health care settings. [ABSTRACT FROM AUTHOR]

Recently, several pharmaceutical companies have been shown to have withheld negative clinical trial results from the public. These incidents have resulted in a concerted global effort to register all trials at inception, so that all subsequent results can be tracked regardless of whether they are positive or negative. These trial registration policies have been driven in large part by concern about the pharmaceutical sector. The medical device industry is much smaller, and different from the pharmaceutical industry in some fundamental ways. This paper examines the issues surrounding registration of device trials and argues that these differences with pharmaceutical should not exempt device trials from registration. [ABSTRACT FROM AUTHOR]

Many of the same fundamental principles and regulations that govern civilian biomedical research also apply to research conducted by the US Military. Despite these similarities, the conduct of research by the US Military has additional requirements designed to preserve service members’ informed consent rights, ethical standards and information that may be deemed classified. Furthermore, there are also additional rules and regulations associated with potential research to be done in a combat setting. Before conducting battlefield research, many unique circumstances must be considered to include: (1) the current legal and regulatory requirements for advanced informed consent (2) the tactical situations, and the ability to adequately document in the “austere” environment (3) the need to provide improved drugs and devices for combat casualty care and (4) the special nature of the superior-subordinate relationship. This paper discusses historical background, regulatory oversight, ethical implications and release of information as it pertains to research conducted by the US Military. [ABSTRACT FROM AUTHOR]

Many of the Institutes, Agencies and Centers that make up the US Department of Health and Human Services (DHHS) have recognized the need for better instrumentation in health outcomes research, and provide support, both internally and externally, for research utilizing advances in measurement theory and computer technology (informatics). In this paper, representatives from several DHHS agencies and institutes will discuss their need for better instruments within their discipline and describe current or future initiatives for exploring the benefits of these technologies. Together, the perspectives underscore the importance of developing valid, precise, and efficient measures to capture the full burden of disease and treatment on patients. Initiatives, like the Patient-Reported Outcomes Measurement Information System (PROMIS) to create health-related quality of life item banks, represent a trans-DHHS effort to develop a standard set of measures for informing decision making in clinical research, practice, and health policy. [ABSTRACT FROM AUTHOR]

In 2002, the National Institutes of Health sponsored a meeting concerning methodological challenges of research in psychosocial interventions in Autism Spectrum Disorders. This paper provides a summary of the presentations and the discussions that occurred during this meeting. Recommendations to federal and private agencies included the need for randomized clinical trials of comprehensive interventions for autism as the highest, but not the sole priority. Ongoing working groups were proposed to address psychosocial interventions with a focus on relevant statistics, standardized documentation and methods of diagnosis, development of outcome measures, establishment of standards in research; and the need for innovative treatment designs, including application of designs from other research areas to the study of interventions in ASD. [ABSTRACT FROM AUTHOR]

Cites several research papers on the quality of medical care in the U.S., published in the April 2003 supplement I of 'Journal of General Internal Medicine.' Factors associated with adequate pain relief among patients hospitalized in a teaching hospital; Incidence of medication errors in a county teaching hospital; Medical treatment of diabetes.

Millions of people cross political borders yearly without having the proper documents. This has led to increased detention and deportation practices in destination countries for reasons related to security and sovereignty. The objective of the current study was to analyze and visualize research publications on the detention and deportation of migrants to identify current research hotspots, research gaps, and potential future research in the field. Relevant research articles were obtained from the Scopus database for the study period from 1900 to December 31, 2022. The analysis included presentations of key contributors to the field and visualization of topics, themes, and international collaboration. In total, 906 articles were found. The earliest was in 1982. The majority of articles were published in journals within the subject areas of social sciences and humanities. The number of publications showed a steep rise from 2011 to 2022. The Journal of Ethnic and Migration Studies was the most prolific, but publications in the Citizenship Studies journal received the highest number of citations per article. Researchers from the United States contributed the most. Mexico ranked fifth in the number of publications. Oxford University was the most prolific institution, followed by three universities in Australia. The majority of articles were single-authored, indicative of limited author-author collaboration. Research hotspots in the field were "human rights" and "mental health". The detention and deportation of Mexican and other Latino migrants in the United States constituted a distinct research theme in the field. International research collaboration was limited by geographical proximity (e.g., the United States and Mexico) or common language (e.g., the United Kingdom and Australia). Future research topics should focus on alternatives to detention, family separation, and healthcare services for detained migrants. Research activity on detention and deportation is required from all world regions, including the source countries of migrants. Future research should promote alternatives to traditional detentions. The contribution of countries in Africa, the Middle East, and South-Eastern Asian regions needs to be encouraged. Future research on the detention and deportation of non-Latino migrants is highly required. [ABSTRACT FROM AUTHOR]

The rarity of primary hyperoxaluria (PH) challenges our understanding of the disease. The purpose of our study was to describe the course of clinical care in a United States cohort of PH pediatric patients, highlighting health service utilization. We performed a retrospective cohort study of PH patients < 18 years old in the PEDSnet clinical research network from 2009 to 2021. Outcomes queried included diagnostic imaging and testing related to known organ involvement of PH, surgical and medical interventions specific to PH-related renal disease, and select PH-related hospital service utilization. Outcomes were evaluated relative to cohort entrance date (CED), defined as date of first PH-related diagnostic code. Thirty-three patients were identified: 23 with PH type 1; 4 with PH type 2; 6 with PH type 3. Median age at CED was 5.0 years (IQR 1.4, 9.3 years) with the majority being non-Hispanic white (73%) males (70%). Median follow-up between CED and most recent encounter was 5.1 years (IQR 1.2, 6.8). Nephrology and Urology were the most common specialties involved in care, with low utilization of other sub-specialties (12%-36%). Most patients (82%) had diagnostic imaging used to evaluate kidney stones; 11 (33%) had studies of extra-renal involvement. Stone surgery was performed in 15 (46%) patients. Four patients (12%) required dialysis, begun in all prior to CED; four patients required renal or renal/liver transplant. Conclusion: In this large cohort of U.S. PH children, patients required heavy health care utilization with room for improvement in involving multi-disciplinary specialists. What is Known: • Primary hyperoxaluria (PH) is rare with significant implications on patient health. Typical involvement includes the kidneys; however, extra-renal manifestations occur. • Most large population studies describe clinical manifestations and involve registries. What is New: • We report the clinical journey, particularly related to diagnostic studies, interventions, multispecialty involvement, and hospital utilization, of a large cohort of PH pediatric patients in the PEDSnet clinical research network. • There are missed opportunities, particularly in that of specialty care, that could help in the diagnosis, treatment, and even prevention of known clinical manifestations. [ABSTRACT FROM AUTHOR]

The 1996 Physician Health Research Conference was the first conference to focus exclusively on research issues and methods for impaired physicians. The conference was initiated by James Shore, M.D., professor and chairman of the Department of Psychiatry in the School of Medicine at the University of Colorado Health Sciences Center and superintendent of the Colorado Psychiatric Hospital, and Stephen Dilts, M.D., Ph.D., medical director of the Colorado Physician Health Program and clinical professor of psychiatry at the University of Colorado Health Sciences Center. Forty participants represented a wide range of national organizations. The conference was supported by contributions from the American Medical Association, American Psychiatric Association, Colorado Physician Health Program, Colorado Physician Insurance Program, and the Department of Psychiatry and Colorado Psychiatric Hospital at the Health Sciences Center. In addition, the conference was cosponsored by the American Academy of Addiction Psychiatry, the American Society of Addiction Medicine, and the Federation of State Physician Health Programs. This paper summarizes the formal presentations of the conference. [ABSTRACT FROM AUTHOR]

An unexpected finding of the International Pilot Study of Schizophrenia, launched by the World Health Organization (WHO) in 1967, was that patients in countries outside Europe and the United States have a more favourable short- and medium-term course of the disease than those seen in developed countries. Since then, WHO has intensified its schizophrenia research programme and has initiated a set of international studies that have confirmed these initial findings and explored possible reasons for such differences in the course and outcome of schizophrenia. While such work has provided important findings and has generated additional pertinent hypotheses, it did not explain the differences in outcome. The present paper describes a new initiative in which approximately 2500 subjects involved in previous WHO multicentre schizophrenia studies are being followed up for between 15 and 25 years after initial examination. Nineteen research centres in 16 countries are taking part in this work. The research methodology is described. [ABSTRACT FROM AUTHOR]

Stated preference (SP) methods are increasingly being applied to HIV-related research and continuously provide researchers with health utility scores of select healthcare products or services that populations consider important. Following PRISMA guidelines, we sought to understand how SP methods have been applied in HIV-related research. We conducted a systematic review to identify studies meeting the following criteria: SP method is clearly stated, conducted in the United States, was published between 01/01/2012 and 02/12/2022, and included adults aged 18 and over. Study design and SP method application were also examined. We identified six SP methods (e.g., Conjoint Analysis, Discrete Choice Experiment) across 18 studies, which were categorized into one of two groups: HIV prevention and HIV treatment-care. Categories of attributes used in SP methods largely focused on: administration, physical/health effects, financial, location, access, and external influences. SP methods are innovative tools capable of informing researchers on what populations consider most beneficial when deciding on treatment, care, or prevention options for HIV. [ABSTRACT FROM AUTHOR]

Patients with limited English proficiency receive worse care due to communication barriers. Little is known about which cancer hospitals have written language access policies addressing bilingual clinicians. We conducted a cross-sectional survey of healthcare organizations, matching survey data to American Hospital Association Survey and American Community Survey data. We analyzed characteristics associated with hospitals having bilingual clinician policies. The response rate was 71% (127/178). Many hospitals (53 [42%]) did not have written policies on bilingual clinicians. Having bilingual clinicians available at the hospital was associated with having a written policy on bilingual clinicians, while being an NCORP site was associated with not having a written policy on bilingual clinicians. Patient demographic characteristics were not associated with hospitals having written policies on bilingual clinicians. A substantial proportion of cancer hospitals do not have policies that cover language use by bilingual clinicians, particularly at NCORP sites. Having written policies on bilingual clinicians has the potential to mitigate cancer disparities by facilitating accountability, improving communication, and reducing errors. [ABSTRACT FROM AUTHOR]

While abduction remains a rare occurrence in the United States, many parents and caregivers have concerns about children's reactions to strangers and other safety-related behaviors. Abduction is a risk for all children, but may be of specific concern for people with disabilities due to social skill and communication deficits. Behavior analytic interventions can be used to address skill deficits that may leave children with disabilities vulnerable. Systematic searches of electronic databases, forward, and ancestral searches were conducted to find available research on interventions that address abduction-prevention skills for people with disabilities. Fifteen articles were found and summarized. Current interventions assessed in this research included: behavior skills training, in-situ training, video modeling, and social stories, which were used both alone and in combination. Lures were presented mostly by unknown strangers with some studies including responding to uniformed police officers and known individuals. Generalization and maintenance data were included in the majority of studies, and many studies assessed social validity. Research methods were assessed using the What Works Clearinghouse standards and data were assessed using standards for visual analysis. Limitations of the current research are discussed, and future research recommendations are presented. [ABSTRACT FROM AUTHOR]

Purpose: The HRSA-funded maternal and child health pipeline training programs (MCHPTPs) are a response to the critical need to diversify the MCH workforce, as a strategy to reduce health disparities in MCH populations. These MCHPTPs support students from undergraduate to graduate education and ultimately into the MCH workforce. Description: The models and components of training across the six MCHPTPs funded in 2016–2021 are summarized, to examine the design and delivery of undergraduate pipeline training and the insights gained across programs. Assessment: Strategies that emerged across training programs were organized into three themes: recruitment, support for student persistence (in education), and pipeline-to-workforce intentionality. Support for student persistence included financial support, mentoring, creating opportunity for students to develop a sense of belonging, and the use of research as a tool to promote learning and competitiveness for graduate education. Finally, the link to Maternal and Child Health Bureau (MCHB) long-term training and other MCHB opportunities for professional development contributed significant nuance to the pipeline-to-workforce objectives of these programs. Conclusions: The MCHPTPs not only increase the diversity of the MCH workforce, they also actively prepare the next generation of MCH leaders. The intentional connection of undergraduates to the infrastructure and continuum of MCH training, underscores the comprehensive impact of this funding. [ABSTRACT FROM AUTHOR]

Summary: Background. Previous research focused on the clinical evidence supporting new cancer drugs' initial US Food and Drug Administration (FDA) approval. However, targeted drugs are increasingly approved for supplementary indications of unknown evidence and benefit. Objectives. To examine the clinical trial evidence supporting new targeted cancer drugs' initial and supplementary indication approval in the US, EU, Canada, and Australia. Data and Methods. 25 cancer drugs across 100 indications were identified with FDA approval between 2009–2019. Data on regulatory approval and clinical trials were extracted from the FDA, European Medicines Agency (EMA), Health Canada (HC), Australian Therapeutic Goods Administration (TGA), and clinicaltrials.gov. Regional variations were compared with χ2-tests. Multivariate logistic regressions compared characteristics of initial and supplementary indication approvals, reporting adjusted odds ratios (AOR) with 95% confidence intervals (CI). Results. Out of 100 considered cancer indications, the FDA approved 96, the EMA 92, HC 86, and the TGA 83 (83%, p < 0.05). The FDA more frequently granted priority review, conditional approval, and orphan designations than other agencies. Initial approvals were more likely to receive conditional / accelerated approval (AOR: 2.69, 95%CI [1.07–6.77], p < 0.05), an orphan designation (AOR: 3.32, 95%CI [1.38–8.00], p < 0.01), be under priority review (AOR: 2.60, 95%CI [1.17–5.78], p < 0.05), and be monotherapies (AOR: 5.91, 95%CI [1.14–30.65], p < 0.05) than supplementary indications. Initial indications' pivotal trials tended to be shorter (AOR per month: 0.96, 95%CI [0.93–0.99], p < 0.05), of lower phase design (AOR per clinical phase: 0.28, 95%CI [0.09–0.85], p < 0.05), and enroll more patients (AOR per 100 patients: 1.19, 95%CI [1.01–1.39], p < 0.05). Conclusions. Targeted cancer drugs are increasingly approved for multiple indications of varying clinical benefit. Drugs are first approved as monotherapies in rare diseases with a high unmet need. Whilst expedited regulatory review incentivizes this prioritization, indication-specific safety, efficacy, and pricing policies are necessary to reflect each indication's differential clinical and economic value. [ABSTRACT FROM AUTHOR]

Objective: Crowdsourcing research allows investigators to engage thousands of people to provide either data or data analysis. However, prior work has not documented the use of crowdsourcing in health and medical research. We sought to systematically review the literature to describe the scope of crowdsourcing in health research and to create a taxonomy to characterize past uses of this methodology for health and medical research. Data sources: PubMed, Embase, and CINAHL through March 2013. Study eligibility criteria: Primary peer-reviewed literature that used crowdsourcing for health research. Study appraisal and synthesis methods: Two authors independently screened studies and abstracted data, including demographics of the crowd engaged and approaches to crowdsourcing. Results: Twenty-one health-related studies utilizing crowdsourcing met eligibility criteria. Four distinct types of crowdsourcing tasks were identified: problem solving, data processing, surveillance/monitoring, and surveying. These studies collectively engaged a crowd of >136,395 people, yet few studies reported demographics of the crowd. Only one (5 %) reported age, sex, and race statistics, and seven (33 %) reported at least one of these descriptors. Most reports included data on crowdsourcing logistics such as the length of crowdsourcing (n = 18, 86 %) and time to complete crowdsourcing task (n = 15, 71 %). All articles (n = 21, 100 %) reported employing some method for validating or improving the quality of data reported from the crowd. Limitations: Gray literature not searched and only a sample of online survey articles included. Conclusions and implications of key findings: Utilizing crowdsourcing can improve the quality, cost, and speed of a research project while engaging large segments of the public and creating novel science. Standardized guidelines are needed on crowdsourcing metrics that should be collected and reported to provide clarity and comparability in methods. [ABSTRACT FROM AUTHOR]

Surgicaltraining programs across the globe have the responsibility of preparing the future generation of surgeons while promoting quality and patient safety. Surgical training differs significantly between countries, which can be based on the requirements of local accrediting bodies, different patient populations, different healthcare delivery systems and cultural and traditional patterns unique to that particular training environment. In this article, we reviewed General surgery residency training in the USA, UK, and India to identify strengths and challenges. We also highlighted salient aspects of training, including duration of the training, resident work-hours, operative opportunities, rotation and supervision, essential skill development, research activity, assessment, and regulation. [ABSTRACT FROM AUTHOR]

The article highlights a research conducted by C. D. Glen and Y. E. Dubrova regarding the hereditary effects of exposure to anticancer therapy, wherein some cancer survivors do go on to have children, although infertility occurs following their chemotherapy or radiotherapy.

The article reports on the two papers which demonstrates that specific microRNAs (miRNAs) also take part in the battle of the human immune system with two important viruses in the U.S. It states that specific interferon (IFN)- induced miRNAs are highly active against hepatitis C virus (HCV) and the human immunodeficiency virus (HIV) is even one step ahead using cellular miRNAs to maintain a reservoir of latently infected cells.

The article offers several news briefs concerning health and environment in the U.S. The Environment Protection Agency issued the first federal rule which allows manufacturers to dose people with pesticides as part of marketing strategies for approval of their products. The Bush administration is willing to fund for programs concerning abstinence-based HIV/AIDS prevention programs, while refusing to aid groups that is apathetic for prostitution. Studies revealed that biologists are secretive concerning their work which hinders progress of young scientist.

The National Institutes of Health sponsored Patient-Reported Outcome Measurement Information System (PROMIS) aimed to create item banks and computerized adaptive tests (CATs) across multiple domains for individuals with a range of chronic diseases. Web-based software was created to enable a researcher to create study-specific Websites that could administer PROMIS CATs and other instruments to research participants or clinical samples. This paper outlines the process used to develop a user-friendly, free, Web-based resource (Assessment CenterSM) for storage, retrieval, organization, sharing, and administration of patient-reported outcomes (PRO) instruments. Joint Application Design (JAD) sessions were conducted with representatives from numerous institutions in order to supply a general wish list of features. Use Cases were then written to ensure that end user expectations matched programmer specifications. Program development included daily programmer “scrum” sessions, weekly Usability Acceptability Testing (UAT) and continuous Quality Assurance (QA) activities pre- and post-release. Assessment Center includes features that promote instrument development including item histories, data management, and storage of statistical analysis results. This case study of software development highlights the collection and incorporation of user input throughout the development process. Potential future applications of Assessment Center in clinical research are discussed. [ABSTRACT FROM AUTHOR]

Biomedical research has never been more intellectually exciting or practically important to society. Ironically, pursuing a career as a biomedical scientist has never been more difficult. Here I provide unvarnished advice for young biomedical scientists on the difficulties that lie ahead and on how to find the right laboratories for training in the skills that you will need to succeed. Although my advice is geared towards succeeding in the United States, many aspects apply to other countries. [ABSTRACT FROM AUTHOR]

Objective:The cutoffs defining anaemia based on haemoglobin and haematocrit recommended by the World Health Organization (WHO) and the United States (US) are different. We compared the prevalences resulting from these definitions and explored the reasons for the variation observed.Design:A cross-sectional survey within a cohort study of children recruited at birth at Royal Darwin Hospital.Setting:Subjects were interviewed in their homes or other convenient location and had a blood sample drawn.Subjects:Five hundred and seventeen Australian Aboriginal children aged 9–13 years inclusive.Results:Depending on the criterion used, the prevalence of anaemia in the total group ranged between 6% (95% confidence interval: 4.1–8.4%) and 24.4% (20.7–28.3). Using the WHO criteria, girls aged 12–13 years were identified as a target group, having a two- to-six fold higher prevalence than the other groups. When compared to the US criteria, boys aged 12–13 years had the highest prevalence of anaemia, although this was not significant. Simulations show that the WHO cutoffs are based on inconsistent centiles of the age–sex haemoglobin and haematocrit distributions, and that this largely explains the discrepant results.Conclusions:This variability in definition could lead to inappropriate identification of target groups for intervention programmes.Sponsorship:National Health and Medical Research Council of Australia, the Colonial Foundation and the Channel 7 Children's Research Foundation of South Australia Inc.European Journal of Clinical Nutrition (2007) 61, 135–139. doi:10.1038/sj.ejcn.1602483; published online 19 July 2006 [ABSTRACT FROM AUTHOR]

The majority of biomedical research is funded by public, governmental, and philanthropic grants. These initiatives often shape the avenues and scope of research across disease areas. However, the prioritization of disease-specific funding is not always reflective of the health and social burden of each disease. We identify a prioritization disparity between lung and breast cancers, whereby lung cancer contributes to a substantially higher socioeconomic cost on society yet receives significantly less funding than breast cancer. Using search engine results and natural language processing (NLP) of Twitter tweets, we show that this disparity correlates with enhanced public awareness and positive sentiment for breast cancer. Interestingly, disease-specific venture activity does not correlate with funding or public opinion. We use outcomes from recent early-stage innovation events focused on lung cancer to highlight the complementary mechanism by which bottom-up "grass-roots" initiatives can identify and tackle under-prioritized conditions. [ABSTRACT FROM AUTHOR]

Copyright of AIDS & Behavior is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Persons of diminished capacity, especially those who are still legally competent but are de facto incompetent should still be able to participate in moderately risky research projects that benefit the class of persons with similar diseases. It is argued that this view can be supported with a modified communitarianism, a philosophy of medicine that holds that health care is a joint responsibility that meets foundational human needs. The mechanism for obtaining a substituted consent I call "community consent," and distinguish this from the usual family or surrogate consent for treatment. Care givers are included in the community that might consent for an individual who has no identifiable family members. [ABSTRACT FROM AUTHOR]