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Background: Nazi Germany surrendered to the Allies on May 8, 1945. Six months later, the Allies tried the surviving leaders of Nazi Germany at the first Nuremberg trial. Later, the United States conducted 12 additional trials. The first one, The Unites States of America versus Karl Brandt et al., has been dubbed the Doctors' Trial. During the trial, the prosecution relied on the testimony of Dr. Andrew Ivy and Dr. Leo Alexander. At the end of the trial, Judge Sebring enunciated 10 principles needed to conduct human subject research-the Nuremberg Code. Authorship of the Code has been the subject of dispute, with both Ivy and Alexander claiming sole authorship.Methods: In the summer of 2017, I visited Duke University Medical Center's Archives and surveyed the contents of boxes labeled "Alexander's papers." I also explored online databases with information on the Doctors' Trial. Pertinent documents were compared across collections, and against scholarly works on the topic.Results: Box 3 of Alexander's papers at Duke University Medical Center's Archives contains a three-page document with six principles that, nearly word for word, were included in what is known as the Nuremberg Code. Alexander's name and appointment are typed at the end of the document.Conclusions: Although the Nuremberg Code is likely to have been an unplanned collaboration among members of the prosecuting team and the judges, I present evidence suggesting that Alexander drafted the blueprint and was the main contributor to the final version of the Code. [ABSTRACT FROM AUTHOR]

• Black men are significantly underrepresented in family-based research. • Children experience positive outcomes when they experience male caregiver-child relationships. • Strategies to engage Black male caregivers in family-based programming are presented. • Cultural sensitivity, highlighting the value and empowerment of Black men were effective. • Implementing strategies may reduce disparities and promote a positive representation of Black men. Black men are less likely to participate in research studies due to historical abuses and mistrust, which has consequences for various health issues, including research to improve the sexual health and well-being of young girls and women. This paper aims to present strategies from research staff on how to engage Black male caregivers in family-based research. After our five Black research team members (i.e., researchers, recruiters, facilitators, and community liaisons) recruited 30 Black male caregivers into one-on-one interviews, ten into focus groups, six into theatre testing of an intervention, and 20 more into the pilot intervention, interviews explored their experiences engaging the targeted population in research. Interview questions included asking what strategies were successful, what challenges occurred, and future recommendations to engage Black male caregivers in research. Audio recordings and written response data were analyzed using thematic analysis. Themes included: 1) empowering Black communities through fatherhood initiatives, 2) utlizing culturally sensitive and respectful recruiters, 3) highlighting the value of Black men, and 4) implementing study materials enhancing positive representations of Black men. Implementing strategies to include Black men in family-based health research has the potential to reduce health disparities in the United States and increase their representation across the literature. These strategies will equip researchers to engage in research with minority and structurally-systemically disadvantaged groups. [ABSTRACT FROM AUTHOR]

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

In 1999, a cooperative tripartite cancer research and training agreement was signed between Ireland (IE), Northern Ireland (NI) and the United States (US) National Cancer Institute, giving rise to the All-Ireland Cancer Consortium (AICC). We wished to consider if AICC increased the amount/impact of cancer research on the island of Ireland and what effect this enhanced research activity had on cancer services and cancer outcomes. As comparator, we chose the city regions of Copenhagen and Lund & Malmö, whose physical connection was greatly improved following construction of bridges between Denmark and Sweden around the time AICC was established. We analysed cancer research outputs from all four geographical regions in the Web of Science (1988–2017), with a particular focus on citations and journal impact factors. We evaluated disability-adjusted life years (DALYs) as an indicator of change in health status. Research outputs increased in all four regions, but more in IE/NI than in the Scandinavian cities, while collaboration between IE and NI and both the US and the Rest of Europe increased even more substantially. Citation scores also showed a greater improvement for IE and NI. Journal citation impact factors indicated that IE/NI papers were increasingly being published in more highly cited journals. Research-enabled cancer service provision improved on the island of Ireland, with concomitant increases in cancer survival. The AICC collaborative agreement delivered significant additionality on the island of Ireland, promoting transnational cooperation, enhancing cancer research activity, and underpinning improved cancer services and better cancer outcomes. • The All-Ireland Cancer Consortium led to: ○ Increased research outputs on the island of Ireland. ○ Enhanced collaboration. ○ Improved citations and enhanced impact. ○ Improved cancer services and increased cancer survival. [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]

New approaches to universal eating disorders prevention and interventions targeting macro-environmental change are greatly needed, and research-to-policy translation efforts hold promise for advancing both of these goals. This paper describes as a policy-translation case example an academic-community-government partnership of the Strategic Training Initiative for the Prevention of Eating Disorders, Multi-Service Eating Disorders Association, and the office of Massachusetts Representative Kay Khan, all based in Massachusetts, USA. The partnership's research-to-policy translation project focused on dietary supplements sold for weight loss and muscle building, which have been linked with serious injury and death in consumers. Youth and people of all ages with eating disorders and body dysmorphic disorder may be especially vulnerable to use these products due to deceptive promises of fast and safe weight loss and muscle gain. The research-to-policy translation project was informed by a triggers-to-action framework to establish the evidentiary base of harm to consumers, operationalize policy solutions to mitigate harm through legislation, and generate political will to support action through legislation introduced in the Massachusetts legislature to restrict sales of weight-loss and muscle-building dietary supplements. The paper concludes with lessons learned from this unique policy translation effort for the prevention of disordered weight and shape control behaviors and offers recommendations for next steps for the field to advance research and practice for universal, macro-environmentally targeted prevention. [ABSTRACT FROM AUTHOR]

Objective: The objective of this study was to conduct a survey of the academic contribution and influence of Chinese scholars in the field of burns.Method: The PubMed database was searched to obtain literature items originating from various countries and Chinese provinces from 1985 to 2014. The citation data were collected through the Google Scholar engine.Results: A total of 1037 papers published in 256 journals were included in this survey. China was second only to the USA in the number of publications on burns since 2010. In addition, the annual number of papers has increased significantly since 2001. The journal Burns published the most number of articles, but its proportion has been decreasing. Of the papers included in the survey, 58.34% were published in journals with a 5-year impact factor between 1 and 2, whereas only 3.66% were published in journals with an impact factor >5. Both total citations and citations per paper have decreased in the past decade. Randomized controlled trials or systematic reviews merely accounted for a small proportion. Twenty-nine provinces including 64 cities contributed one paper at least. The publications from Taiwan, Beijing, Chongqing, Shanghai, and Guangdong were high in both quantity and quality.Conclusion: The Chinese academic contribution to the field of burns is now on a rise. Although the quality of papers is lagging behind quantity, scholars and academies are dedicated to improving China's academic level. [ABSTRACT FROM AUTHOR]

The article examines the role and challenges of scientific self-governance and standardization in inter-continental clinical research partnerships in stem cell medicine. The paper shows that – due to a high level of regulatory diversity – the enactment of internationally recognized standards in multi-country stem cell trials is a complex and highly situation-specific achievement. Standardization is imposed on a background of regulatory, institutional and epistemic-cultural heterogeneity, and implemented exclusively in the context of select clinical projects. Based on ethnographic data from the first trans-continental clinical trial infrastructure in stem cell medicine between China and the USA, the article demonstrates that locally evolved and international forms of experimental clinical research practices often co-exist in the same medical institutions. Researchers switch back and forth between these schemas, depending on the purposes of their research, the partners they work with, the geographic scale of research projects, and the contrasting demands for regulatory review, that result from these differences. Drawing on Birch's analysis of the role of standardization in international forms of capital production in the biosciences, the article argues that the integration of local knowledge institutions into the global bioeconomy does not necessarily result in the shutting down of localized forms of value production. In emerging fields of medical research, that are regulated in highly divergent ways across geographical regions, the coexistence of distinct modes of clinical translation allows also for the production of multiple forms of economic value, at varying spatial scales. This is especially so in countries with lenient regulations. As this paper shows, the long-standing absence of a regulatory framework for clinical stem cell applications in China, permits the situation-specific adoption of internationally recognized standards in some contexts, while enabling the continuation of localized forms of value production in others. [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]

Abstract: Purpose: Ethical and legal requirements for healthcare providers in the United States, stipulate that patients sign a consent form prior to undergoing medical treatment or participating in a research study. Currently, the majority of the hospitals obtain these consents using paper-based forms, which makes patient preference data cumbersome to store, search and retrieve. To address these issues, Health Sciences of South Carolina (HSSC), a collaborative of academic medical institutions and research universities in South Carolina, is developing an electronic consenting system, the Research Permissions Management System (RPMS). This article reports the findings of a study conducted to investigate the efficacy of the two proposed interfaces for this system – an iPad-based and touchscreen-based by comparing them to the paper-based and Topaz-based systems currently in use. Methods: This study involved 50 participants: 10 hospital admission staff and 40 patients. The four systems were compared with respect to the time taken to complete the consenting process, the number of errors made by the patients, the workload experienced by the hospital staff and the subjective ratings of both patients and staff on post-test questionnaires. Results: The results from the empirical study indicated no significant differences in the time taken to complete the tasks. More importantly, the participants found the new systems more usable than the conventional methods with the registration staff experiencing the least workload in the iPad and touchscreen-based conditions and the patients experiencing more privacy and control during the consenting process with the proposed electronic systems. In addition, they indicated better comprehension and awareness of what they were signing using the new interfaces. Discussion: The results indicate the two methods proposed for capturing patient consents are at least as effective as the conventional methods, and superior in several important respects. While more research is needed, these findings suggest the viability of cautious adoption of electronic consenting systems, especially because these new systems appear to address the challenge of identifying the participants required for the complex research being conducted as the result of advances in the biomedical sciences. [Copyright &y& Elsevier]

Academic health centers (ACHs) represent the pinnacle of health care by providing innovative clinical care, cutting-edge research, and premier education. However, recent changes in health care put their tripartite mission at risk. The coming years will bring immense change to AHCs as they adjust to new market conditions impacting the 3 distinct elements of their mission. Fundamental adaptations are required for AHCs to survive, let alone thrive and continue to represent the best of medical research, education, and health. This paper evaluates the missions and strengths of AHCs, describes the challenges to these missions, and proposes adaptations for future success. [ABSTRACT FROM AUTHOR]

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

Beginning in 1868, the United States Army Medical Museum issued a request to Army medical personnel situated in ‘Indian country’ for specimens of skulls from Native Americans. The purpose of this collection was to promote the study of craniometry, a branch of racial science commonly used to delineate the different varieties of mankind and to rank them according to their perceived intellectual attributes. Yet, as this paper argues, the efforts of Army surgeons in amassing hundreds of crania for the Army Medical Museum were not matched by a similar level of commitment on the part of racial researchers. In examining why this seemingly impressive collection fell rapidly into disuse, this paper explores the creation and abandonment of one of the largest craniological collections formed in the United States in relation to the trajectory of craniometrical studies during this period. It also questions the link between the interests of racial researchers in the late nineteenth century and those of government policy makers, arguing that the two might not have been particularly closely aligned in the case of craniological research in Washington. [Copyright &y& Elsevier]

Cancer survivors, the medical community, public health professionals, researchers, and policymakers all need information about newly diagnosed cancer cases and deaths to better understand and address the disease burden. CDC collects cancer data on 96% of the U.S. population through the National Program of Cancer Registries. The National Program of Cancer Registries routinely collects data on all cancer occurrences, deaths, and the types of initial treatment received by the patients, and recently CDC has made advances in its cancer surveillance activities that have direct applicability to cancer survivorship research and care. This article examines CDC's innovative uses of the National Program of Cancer Registries infrastructure and data as a recruitment source for survivorship research studies and behavioral interventions; comparative effectiveness and patient-centered outcomes research; and the collection, consolidation, and dissemination of treatment summaries for cancer survivors and their providers. This paper also discusses long-term, idealistic plans for additional data linkages and sharing among public health, providers, and the cancer survivor through innovative concepts such as patient portals and rapid-learning health care. [ABSTRACT FROM AUTHOR]

As medicine continues to advance, fragmentation problems in care delivery – and the promise of care integration to solve them – will remain central. But focused research over the past thirty years has yet to uncover the key factors that enable integrated care. In their paper, Burns and colleagues offer a path to new discovery in this well-trodden area: drawing on network theory to better understand the social processes through which integrated care is produced. Social processes are a vital and understudied aspect of integration, and applying network theory may help to refocus integration in a more comprehensive way. However, to transform our understanding of integrated care – and to enable impact in practice – will require expansion beyond the usual network approaches to also capture the communication and work processes that occur among entities. This is no small endeavor. It will take considerable humility, open-mindedness, and focus. [ABSTRACT FROM AUTHOR]

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

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

Summary: Objective: The purpose of this paper is to give an overview about the state of the art in research on home telehealth in an international perspective. Method: The study is based on a review of the scientific literature published between 1990 and 2003 and retrieved via Medline in January/February 2004. All together, the abstracts of 578 publications have been analyzed. Results: The majority of publications (44%) comes from the United States, followed by UK and Japan. Most publications deal with vital sign parameter (VSP) measurement and audio/video consultations (“virtual visits”). Publications about IT tools for improved information access and communication as well as decision support for staff, patients and relatives are relatively sparse. Clinical application domains are mainly chronic diseases, the elderly population and paediatrics. Conclusions: Internationally, we observe a trend towards tools and services not only for professionals but also for patients and citizens. However, their impact on the patient–provider relationship and their design for special user groups, such as elderly and/or disabled needs to be further explored. In general, evaluation studies are rare and further research is critical to determine the impacts and benefits, and limitations, of potential solutions and to overcome a number of hinders and restrictions, such as [-] the lack of standards to combine incompatible information systems; [-] the lack of an evaluation framework considering legal, ethical, organisational, clinical, usability and technical aspects; [-] the lack of proper guidelines for practical implementation of home telehealth solutions. [Copyright &y& Elsevier]

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]

Summary: George Washington Crile was a successful surgeon who lived at the end of the 19th century. He was born on 11 November 1864 on a farm near Chili, Ohio. He became interested in the study of shock after a close friend died from hemorrhage. Crile dedicated his research years to the study of shock, cardiac arrest, and the use of adrenaline. His research on shock and cardiac arrest led to treatment guidelines that are still used today. He also participated in the Spanish-American War and in World War I as a Navy Surgeon and saved the lives of many soldiers with his principles of blood transfusion and sanitation. He is also known in the surgical world as the grandfather of radical neck dissection and received the Gold Lannelongue Medal and prize. Having written over 400 papers and 24 books, George W. Crile died from complications of bacterial endocarditis on 7th January 1943. Although they were published a long time ago, his contributions to medicine remain fundamental to clinical practice in today’s operating rooms and critical care units. [Copyright &y& Elsevier]

The research into bioactive natural products originating from medicinal plants, fungi and other organisms has a long history, accumulating abundant and diverse publications. However no quantitative literature analysis has been conducted so far. Here we analyze the bibliometric data of ethnopharmacology literature and relate the semantic content to the publication and citation data so that the major research themes, contributors, and journals of different time periods could be identified and evaluated. Web of Science (WoS) was searched to identify relevant publications. The Analyze function of WoS and bibliometric software (VOSviewer) were utilized to perform the analyses. Until the end of November 2018, 59,576 publications -linked to 'ethnopharmacology' indexed by WoS, published since 1958 in more than 5600 journals, and contributed by over 20,600 institutions located in more than 200 countries/regions, were identified. The papers were published under four dominating WoS categories, namely pharmacology/pharmacy (34.4%), plant sciences (28.6%), medicinal chemistry (25.3%), and integrative complementary medicine (20.6%). India (14.6%) and China (13.2%) were dominating the publication space. The United States and Brazil also had more than 8.0% contribution each. The rest of the top ten countries/regions were mainly from Asia. There were around ten-fold more original articles (84.6%) than reviews (8.4%). Ethnopharmacological research has a consistent focus on food and plant sciences, (bio)chemistry, complementary medicine and pharmacology, with a more limited scientific acceptance in the socio-cultural sciences. Dynamic global contributions have been shifting from developed countries to economically and scientifically emerging countries in Asia, South America and the Middle East. Research on recording medicinal plant species used by traditional medicine continues, but the evaluation of specific properties or treatment effects of extracts and compounds has increased enormously. Moreover increasing attention is paid to some widely distributed natural products, such as curcumin, quercetin, and rutin. Image 1 [ABSTRACT FROM AUTHOR]

The article analyzes the paper, "Use of Existing PRO Instruments and their Modification: Good Research Practices for Evaluating and Documenting Content Validity," written by the Patient-Reported Outcomes (PRO) Task Force of International Society for Pharmacoeconomics & Outcomes Research (ISPOR). It describes a rigorous and practical approach to demonstrate the content validity of a PRO measure. It critically analyzes the steps taken by the U.S. Food and Drug Administration (FDA).

Purpose: The origins of the phrase ‘legacy of the Tuskegee Syphilis Study (TSS)’ lie in the widely held belief that Blacks are more reluctant than Whites to participate in biomedical research studies because of that infamous study. This paper is the first to address the validity of the ‘legacy’, a key issue in subject recruitment, in a multi-city, multi-racial, large-scale random survey using a detailed questionnaire. Methods: The Tuskegee Legacy Project (TLP) Questionnaire, which contains two validated scales, the Likelihood of Participation (LOP) Scale and the Guinea Pig Fear Factor (GPFF) Scale, was administered via random-digit dial telephone interviews to respondents aged 18 years and older in three U.S. cities: Tuskegee, AL; Birmingham, AL; and Hartford, CT. Awareness of the TSS was measured as a yes/no response to two separate questions asking if they had ‘ever heard of the TSS’ while detailed knowledge of the TSS was assessed by a set of seven questions. Results: Response rates, by city, ranged from 49–70% and yielded 327 Black and 499 White respondents. Awareness of the Tuskegee Syphilis Study was significantly higher in Blacks than Whites within each city, and ranged from a high of 93.3% for Blacks in Tuskegee, AL, to a low of 41.9% for Whites in Hartford, CT. While adjusted analyses (age, sex, education and income) revealed no association (p <0.05) between either general awareness or detailed knowledge of the Tuskegee Syphilis Study and willingness to participate (LOP Scale) in biomedical research either for Blacks or Whites, Blacks did show an direct association (p=0.02) between awareness and increased GPFF scores, indicating increased wariness. Conclusion: As these data show no association between awareness of TSS and willingness to participate (albeit in Blacks, awareness was associated with an increased wariness), the long-held belief about the ‘legacy’ of the Tuskegee Syphilis Study that Blacks would be less willing to participate in biomedical studies is not supported by this study. [Copyright &y& Elsevier]