Prevalence of control groups in cardiovascular clinical trials: An analysis of ClinicalTrials.gov from 2009 through 2019.

Clinical trials provide the foundational evidence that guide many patient-facing decisions; however, the therapeutic effect and safety of an intervention is best evaluated when compared to a control group. We used ClinicalTrials.gov to describe the proportion of registered Phase III and IV cardiovascular clinical trials that contain a control group from 2009 through 2019. Of 1,677 registered Phase III and IV cardiovascular clinical trials, 81.2% contain a control group, and the annual prevalence remained unchanged between 2009 and 2019.

Characteristics of Ophthalmology Trials Registered in ClinicalTrials.gov, 2007-2018.

PURPOSE: To perform a comprehensive analysis of characteristics of ophthalmology trials registered in ClinicalTrials.gov. DESIGN: Cross-sectional study. METHODS: All 4,203 ophthalmologic clinical trials registered on ClinicalTrials.gov between October 1, 2007, and April 30, 2018, were identified by using medical subject headings (MeSH). Disease condition terms were verified by manual review. Trial characteristics were assessed through frequency calculations. Hazard ratios and 95% confidence intervals were determined for characteristics associated with early discontinuation. RESULTS: The majority of trials were multiarmed (73.6%), single-site (69.4%), randomized (64.8%), and had <100 enrollees (66.3%). A total of 33% used a data-monitoring committee (DMC), and 50.6% incorporated blinding. Other groups (51.6%) were funded by industry, whereas 2.6% were funded by the US National Institutes of Health (NIH). NIH trials were significantly more likely to address oncologic (NIH = 15.5%, Other = 3%, Industry = 1.5%; P < 0.001) or pediatric disease (NIH = 20.9%, Other = 5.9%, Industry = 1.4%; P < 0.001). Industry-sponsored trials (69.6% of phase 3 trials) were significantly more likely to be randomized (Industry = 68.7%, NIH = 58.9%, Other = 60.8%; P < 0.001) and blinded (Industry = 57.2%, NIH = 42.7%, Other = 43.5%; P < 0.001). A total of 359 trials (8.5%) were discontinued early, and 530 trials (12.6%) had unknown status. Trials were less likely to be discontinued if funded by sources other than industry (hazard ratio [HR], 0.72; 95% confidence interval [CI], 0.55-0.95; P = 0.021) and/or had a DMC (HR, 0.71; 95% CI, 0.55-0.92; P = 0.010). CONCLUSIONS: Ophthalmology trials in the past decade reveal heterogeneity across study funding sources. NIH trials were more likely to support historically underfunded subspecialties, whereas Industry trials were more likely to face early discontinuation. These trends emphasize the importance of carefully monitored and methodologically sound trials with deliberate funding allocation.

Do Brief Educational Sessions Increase Electronic Health Literacy of Low-Income Persons Living With HIV/AIDS?

This research explored whether participating in a brief educational intervention using the National Library of Medicine video, Evaluating Health Information: A Tutorial From the National Library of Medicine, would increase electronic health literacy. A quasi-experimental longitudinal design was used in two randomly selected settings of a treatment program for low-income persons living with HIV/acquired immune deficiency syndrome (N = 100). Individuals in both intervention groups watched the video and completed an at-home assignment brought to the second session 1 week later; one group received an additional 15 minutes with an HIV nurse clinician who reinforced video content. Generalized linear models were used in order to account for the longitudinal nature of the data; a full model was fitted first that included age, gender, race, ethnicity, education, acquired immune deficiency syndrome diagnosis, time, group, and the interaction of time by intervention group with electronic health literacy as the dependent variable. Group means were not significantly different, and the overall group pattern were the same; the only significant variable was older age, which is consistent with the findings of other literature. Electronic health literacy can be increased by viewing a free video; making this video available in a variety of settings and encouraging clients to use the Internet as a source of health information may improve self-management strategies of persons living with chronic illnesses.

The pediatric surgeon's road to research independence: utility of mentor-based National Institutes of Health grants.

BACKGROUND: The current research environment for academic surgeons demands that extramural funding be obtained. Financial support from the National Institutes of Health (NIH) is historically the gold standard for funding in the biomedical research community, with the R01 funding mechanism viewed as indicator of research independence. The NIH also supports a mentor-based career development mechanism (K-series awards) in order to support early-stage investigators. The goal of this study was to investigate the grants successfully awarded to pediatric surgeon-scientists and then determine the success of the K-series award recipients at achieving research independence. METHODS: In July 2012, all current members of the American Pediatric Surgery Association (APSA) were queried in the NIH database from 1988-2012 through the NIH Research Portfolio Online Reporting Tools. The following factors were analyzed: type of grant, institution, amount of funding, and funding institute or center. RESULTS: Among current APSA members, there have been 83 independent investigators receiving grants, representing 13% of the current APSA membership, with 171 independent grants funded through various mechanisms. Six percent currently have active NIH funding, with $7.2 million distributed in 2012. There have been 28 K-series grants awarded. Of the recipients of expired K08 awards, 39% recipients were subsequently awarded an R01 grant. A total of 63% of these K-awarded investigators transitioned to an independent NIH award mechanism. CONCLUSIONS: Pediatric surgeon-scientists successfully compete for NIH funding. Our data suggest that although the K-series funding mechanism is not the only path to research independence, over half of the pediatric surgeons who receive a K-award are successful in the transition to independent investigator.

Knowledge and utilization of the United States National Library of Medicine's biomedical information products and services among African health sciences librarians.

The United States National Library of Medicine (NLM) has the largest collection of biomedical information products and services in the world. Little is known of the extent to which librarians in sub-Saharan Africa are aware of and use these resources. The study's aim was to assess knowledge and frequency of use of NLM's biomedical information products and services among African librarians. Forty-three of the 50 delegates at the 11th biannual Congress of the Association of Health Information and Libraries in Africa (AHILA) participated in the study. The findings showed that participants' knowledge of NLM information products and services was low and that there is a need for increased awareness and training in the use of NLM's information products and services in order for users on the African continent to effectively benefit from them.

Laws, leaders, and legends of the modern National Library of Medicine.

PURPOSE: The paper is an expanded version of the 2007 Joseph Leiter National Library of Medicine (NLM)/Medical Library Association Lecture presented at MLA '07, the Medical Library Association annual meeting in Philadelphia in May 2007. It presents an historical accounting of four major pieces of legislation, beginning with the NLM Act of 1956 up through the creation of the National Center for Biotechnology Information. BRIEF DESCRIPTION: The transition from the United States Armed Forces Medical Library to the United States National Library of Medicine in 1956 was a major turning point in NLM's history, scope, and direction. The succeeding landmark legislative achievements--namely, the 1965 Medical Library Assistance Act, the 1968 Joint Resolution forming the Lister Hill National Center for Biomedical Communications, and the 1988 authorization for the National Center for Biotechnology Information--transformed the library into a major biomedical communications institution and a leader and supporter of an effective national network of libraries of medicine. The leaders of the library and its major advocates--including Dr. Michael DeBakey, Senator Lister Hill, and Senator Claude Pepper-together contributed to the creation of the modern NLM.

Interlibrary loan in US and Canadian health sciences libraries 2005: update on journal article use.

PURPOSE: The authors analyzed 2.48 million interlibrary loan (ILL) requests entered in the National Library of Medicine's (NLM's) DOCLINE system from 3,234 US and Canadian medical libraries during fiscal year (FY) 2005 to study their distribution and nature and the journals in which requested articles were published. METHODS: Data from DOCLINE and NLM's indexing system and online catalog were used to analyze all DOCLINE ILL transactions acted on from October 2004 to September 2005. The authors compared results from this analysis to previous data collected in FY 1992. RESULTS: Overall ILL volume in the United States and Canada is at about the same level as FY 1992 despite marked growth in online searching, knowledge discovery tools, and journals available online. Over 21,000 unique journal titles and 1.4 million unique articles were used to fill 2.2 million ILL requests in FY 2005. Over 1 million of the articles were requested only once by any network library. Fifty-two percent (11,022) of journals had 5 or fewer requests for articles from all the years of a journal by all libraries in the network. Fifty-two percent of the articles requested were published within the most recent 5 years. CONCLUSION: The overall ILL profile in the libraries studied has changed little since FY 1992, notable given other changes in publishing. Small changes, however, may reveal developing trends. Total ILL traffic has been declining in recent years following a peak in 2002, and fewer of the articles requested were published in the most recent five years compared to requests from 1992.

[Elizabeth Fee: a historian reaching out to wider audiences]. / Elizabeth Fee: uma historiadora em busca de audiências mais amplas.

To what activities and topics does a historian in health and medicine, whose articles and books have become fundamental references for scholars of the area, devote her time? Feminism, counter-culture, medical education, global health, the role of international health organizations, and knowledge sharing in the health history are some of the subjects Elizabeth Fee addresses in this interview given at Fiocruz in April where she presented the 2006 inaugural class to the Graduate Program in History of Health Sciences at Casa de Oswaldo Cruz. The topic of her lecture was "The World Health Organization and AIDS: what can we learn from history?"

The National Library of Medicine's Native American outreach portfolio: a descriptive overview.

OBJECTIVES: This paper provides the most complete accounting of the National Library of Medicine's (NLM's) Native outreach since 1995, when there were only a few scattered projects. METHOD: The descriptive overview is based on a review of project reports, inventories, and databases and input from the NLM Specialized Information Services Division, National Network Office of the Library Operations Division, National Network of Libraries of Medicine, and Office of Health Information Programs Development of the Office of the NLM Director. The overview focuses on NLM-supported or sponsored outreach initiatives involving Native peoples: American Indians, Alaska Natives, and Native Hawaiians. RESULTS: The review of NLM's relevant activities resulted in a portfolio of projects that clustered naturally into the following areas: major multisite projects: Tribal Connections and related, Native American Information Internship Project: Sacred Root, tribal college outreach and tribal librarianship projects, collaboration with inter-tribal and national organizations, participation in Native American Powwows, Native American Listening Circle Project, Native American Health Information, and other Native American outreach projects. IMPLICATIONS: NLM's Native American Outreach reached programmatic status as of late 2004. The companion paper identifies several areas of possible new or enhanced Native outreach activities. Both papers highlight the importance of solid reporting and evaluation to optimize project results and programmatic balance and priorities.

Treatment and management of the Chiari II malformation: an evidence-based review of the literature.

OBJECTIVE: Multiple surgical strategies exist for the management of the symptomatic Chiari II malformation. To date, no comprehensive analysis of this medical literature in an attempt to seek out standards or guidelines has been performed, thus serving as the impetus for this present review. METHODS: A computerized search of the database of the National Library of Medicine was performed on the English-language medical literature between 1966 and 2003. Terms searched for included hindbrain hernia, Chiari II, Arnold-Chiari, surgery, decompression, syringomyelia, and CSF shunts. All literature found was reviewed with associated references from these sources. Each piece of literature reviewed was scrutinized and guidelines developed utilizing the methodology used by the Guidelines for the Management of Acute Cervical Spine and Spinal Cord Injuries. RESULTS: All data reviewed were deemed to be Class III in nature. No standards or guidelines could be established from the available literature. There is significant debate and variable results in the current neurosurgical literature regarding the evaluation of shunt function vs. Chiari II decompression in patients with symptomatic hindbrain herniation. CONCLUSIONS: Multi-institutional prospective randomized trials are needed before any conclusions can be drawn regarding symptomatic Chiari II and its treatment paradigm. Until this time, clinical practice will be based on individual surgeons' experience, training, and personal beliefs.

Information needs of rural health professionals: a review of the literature.

This review analyzes the existing research on the information needs of rural health professionals and relates it to the broader information-needs literature to establish whether the information needs of rural health professionals differ from those of other health professionals. The analysis of these studies indicates that rural health practitioners appear to have the same basic needs for patient-care information as their urban counterparts, and that both groups rely on colleagues and personal libraries as their main sources of information. Rural practitioners, however, tend to make less use of journals and online databases and ask fewer clinical questions; a difference that correlates with geographic and demographic factors. Rural practitioners experience pronounced barriers to information access including lack of time, isolation, inadequate library access, lack of equipment, lack of skills, costs, and inadequate Internet infrastructure. Outreach efforts to this group of underserved health professionals must be sustained to achieve equity in information access and to change information-seeking behaviors.

Transitioning to the Internet: results of a National Library of Medicine user survey.

In late 1995, several months prior to the introduction of Internet Grateful Med, the National Library of Medicine (NLM) conducted a customer survey as part of its efforts to make a transition from Grateful Med to new forms of electronic information access and retrieval. A questionnaire survey was mailed to a sample of 2,500 online users randomly selected from domestic users (excluding fixed-fee users) who searched NLM databases during the second quarter of 1995. The final response rate was nearly 83% of eligible respondents. About 70% of NLM customers responding already had access to the Internet, and of those, more than 90% had access to the World Wide Web. However, only 26% of customers with Internet access were using the Internet to access NLM databases. Health care providers account for about 46% of NLM customers but, as a group, search NLM databases relatively infrequently even though they have higher-end equipment. Librarians and information professionals represent about one-fifth of NLM customers and are by far the most intensive users, but tend to have lower-end equipment. Overall, the survey results provide a strong basis for the transition to Internet-based delivery of NLM online database services, including Internet Grateful Med and the NLM family of World Wide Web sites. However, Internet access is uneven, especially in rural areas and at hospitals. This reinforces the need for continuing special outreach efforts directed at improving access for rural and hospital-based users and rural libraries, upgrading computer equipment for medical librarians, and training health care providers in more effective use of Internet-based biomedical information resources.

Interlibrary loan in U.S. health sciences libraries: journal article use.

Health sciences libraries in the United States use the National Library of Medicine (NLM) DOCLINE system to request more than two million items annually through interlibrary loan (ILL). Ninety-seven percent of all ILL requests are for journal articles. In this study, NLM analyzed four million ILL requests entered into the DOCLINE system during two twelve-month periods ending September 30, 1992. The requests were analyzed at both the journal title level and article level. Data for the two years were found to be remarkably similar. Results showed that a large number of journals are required to fill ILL requests and that there is a relatively low number of repeat requests for most journal articles. Seventy-six percent of journal articles analyzed were requested only once, and fewer than 1% were requested more than ten times. About 39% of journals used to fill ILL requests were indexed in MEDLINE at some time, while 84% of the articles supplied were indexed in MEDLINE. Ninety-two percent of articles supplied were from English-language journals. Sixty-seven percent of articles were published in the most recent five years, and 85% in the most recent ten years. The 100 most frequently requested articles for each of the two years were examined to determine characteristics such as language, where they were indexed, and the subject matter. This study has provided valuable information for planning of NLM's interlibrary document delivery services and also should have significance for libraries and other organizations involved in document delivery.

Growth patterns in the National Library of Medicine's serials collection and in Index Medicus journals, 1966-1985.

Data from the National Library of Medicine (NLM) automated Master Serials System and its MEDLINE database were used to chart the growth of NLM's serials collection and of the journals indexed in Index Medicus from 1966 to 1985. The number of live serial titles in the subset of NLM's collection examined increased 30% in the twenty years. The average number of articles per Index Medicus journal increased 56%. The average number of articles in U.S. Index Medicus journals grew more rapidly than the average number in journals published elsewhere. The NLM data provide clear evidence that the years from 1966 to 1985 saw a substantial increase in the percentage of the biomedical serial literature published in English. The period from 1966 to 1985 saw substantial but uneven growth in the number of serial titles in the NLM collection and in the average number of articles in Index Medicus journals. Although data on the number of articles published in Index Medicus journals is unlikely to reflect the number of articles in other journals, the pattern of growth in the number of serials held by NLM probably reflects trends in the universe of all biomedical serials.

Reaching NLM through the Internet.

Currently, many of the electronic services are still new, and there may be a need for further fine-tuning and changes. Having separate electronic addresses for each service rather than having one centralized address will make it easier for NLM to identify and isolate questions or problems. The Appendix summarizes the commands and addresses mentioned in this article.

Redes de información biomédica: experiencia de la Biblioteca Nacional de Medicina de Estados Unidos de América / Biomedical information networking: the experience of the National Library of Medicine of the United States

Se analiza el concepto de una red de información y de servicios cooperativos entre bibliotecas médicas y bancos de datos regionales, nacionales e internacionales. Como ejemplo se describen los antecedentes de la Biblioteca Nacional de Medicina de Estados Unidos y se destaca el éxito de BIREME en América Latina (AU)