Predicting Brain Amyloid Status Using the National Institute of Health Toolbox (NIHTB) for Assessment of Neurological and Behavioral Function.

BACKGROUND: Amyloid-beta (Aß) plaque is a neuropathological hallmark of Alzheimer's disease (AD). As anti-amyloid monoclonal antibodies enter the market, predicting brain amyloid status is critical to determine treatment eligibility. OBJECTIVE: To predict brain amyloid status utilizing machine learning approaches in the Advancing Reliable Measurement in Alzheimer's Disease and Cognitive Aging (ARMADA) study. DESIGN: ARMADA is a multisite study that implemented the National Institute of Health Toolbox for Assessment of Neurological and Behavioral Function (NIHTB) in older adults with different cognitive ability levels (normal, mild cognitive impairment, early-stage dementia of the AD type). SETTING: Participants across various sites were involved in the ARMADA study for validating the NIHTB. PARTICIPANTS: 199 ARMADA participants had either PET or CSF information (mean age 76.3 ± 7.7, 51.3% women, 42.3% some or complete college education, 50.3% graduate education, 88.9% White, 33.2% with positive AD biomarkers). MEASUREMENTS: We used cognition, emotion, motor, sensation scores from NIHTB, and demographics to predict amyloid status measured by PET or CSF. We applied LASSO and random forest models and used the area under the receiver operating curve (AUROC) to evaluate the ability to identify amyloid positivity. RESULTS: The random forest model reached AUROC of 0.74 with higher specificity than sensitivity (AUROC 95% CI:0.73 - 0.76, Sensitivity 0.50, Specificity 0.88) on the held-out test set; higher than the LASSO model (0.68 (95% CI:0.68 - 0.69)). The 10 features with the highest importance from the random forest model are: picture sequence memory, cognition total composite, cognition fluid composite, list sorting working memory, words-in-noise test (hearing), pattern comparison processing speed, odor identification, 2-minutes-walk endurance, 4-meter walk gait speed, and picture vocabulary. Overall, our model revealed the validity of measurements in cognition, motor, and sensation domains, in associating with AD biomarkers. CONCLUSION: Our results support the utilization of the NIH toolbox as an efficient and standardizable AD biomarker measurement that is better at identifying amyloid negative (i.e., high specificity) than positive cases (i.e., low sensitivity).

NIH funding and journal selection: trends in dermatology publication models across tiers from 2021 to 2023.

This study examines the influence of National Institutes of Health (NIH) funding on the publication choices of dermatologists, particularly in terms of journal tiers and pay-to-publish (P2P) versus free-to-publish (F2P) models. Utilizing k-means clustering for journal ranking based on SCImago Journal Rank, h-index, and Impact Factor, journals were categorized into three tiers and 54,530 dermatology publications from 2021 to 2023 were analyzed. Authors were classified as Top NIH Funded or Non-Top NIH Funded according to Blue Ridge Institute for Medical Research rankings. The study finds significant differences in publication patterns, with Top NIH Funded researchers in Tier I journals demonstrating a balanced use of P2P and F2P models, while they preferred F2P models in Tier II and III journals. Non-Top NIH Funded authors, however, opted for P2P models more frequently across all tiers. These data suggest NIH funding allows researchers greater flexibility to publish in higher-tier journals despite publication fees, while prioritizing F2P models in lower-tier journals. Such a pattern indicates that funding status plays a critical role in strategic publication decisions, potentially impacting research visibility and subsequent funding. The study's dermatology focus limits broader applicability, warranting further research to explore additional factors like geographic location, author gender, and research design.

A/B Testing of User Enrollment Forms to Enhance Diversity in the Biomedical Workforce via the National Research Mentoring Network: User-Centered Design Case Study.

Background: The National Research Mentoring Network (NRMN) is a National Institutes of Health-funded program for diversifying the science, technology, engineering, math, and medicine research workforce through the provision of mentoring, networking, and professional development resources. The NRMN provides mentoring resources to members through its online platform-MyNRMN. Objective: MyNRMN helps members build a network of mentors. Our goal was to expand enrollment and mentoring connections, especially among those who have been historically underrepresented in biomedical training and the biomedical workforce. Methods: To improve the ease of enrollment, we implemented the split testing of iterations of our user interface for platform registration. To increase mentoring connections, we developed multiple features that facilitate connecting via different pathways. Results: Our improved user interface yielded significantly higher rates of completed registrations (P<.001). Our analysis showed improvement in completed enrollments that used the version 1 form when compared to those that used the legacy form (odds ratio 1.52, 95% CI 1.30-1.78). The version 2 form, with its simplified, 1-step process and fewer required fields, outperformed the legacy form (odds ratio 2.18, 95% CI 1.90-2.50). By improving the enrollment form, the rate of MyNRMN enrollment completion increased from 57.3% (784/1368) with the legacy form to 74.5% (2016/2706) with the version 2 form. Our newly developed features delivered an increase in connections between members. Conclusions: Our technical efforts expanded MyNRMN's membership base and increased connections between members. Other platform development teams can learn from these efforts to increase enrollment among underrepresented groups and foster continuing, successful engagement.

National Institutes of Health Designates Disabled People a Health Disparity Population.

This Viewpoint examines watershed moments in improving health care for people with disabilities in the US.

Trajectories of biomedical research leading to Nobel Prize-winning discoveries.

Significant advancements in public health come from scientific discoveries, but more are needed to meet the ever-growing societal needs. Examining the best practices of outstanding scientists may help develop future researchers and lead to more discoveries. This study compared the comprehensive work of 49 Nobel laureates in Physiology or Medicine from 2000 to 2019 to a matched control of National Institutes of Health (NIH)-funded biomedical investigators. Our unique data set, comprising 11,737 publications, 571 US patents, and 1693 NIH research awards produced by pre-Nobel laureates, was compared to a similar data set of control researchers. Compared to control researchers, pre-Nobel laureates produce significantly more publications annually (median = 5.66; interquartile range [IQR] = 5.16); significantly fewer coauthors per publication (median = 3.32; IQR = 1.95); consistently higher Journal Impact Factor publications (median = 12.04; IQR = 6.83); and substantially more patents per researcher (median = 5; IQR = 14). Such differences arose from nearly identical cumulative NIH award budgets of pre-Nobel laureates (median $25.3 M) and control researchers. Nobel laureates are neither hyper-prolific (>72 papers per year) nor hyper-funded (>$100 M cumulative). An academic age-specific trajectory graph allows aspiring researchers to compare their productivity and collaboration patterns to those of pre-Nobel laureates.

Postdoctoral T32 training is correlated with obtaining an academic primarily research faculty position.

The mission of NIH-sponsored institutional training programs such as the T32 is to provide strong research and career training for early career scientists. One of the main avenues to pursuing health-related research is becoming research faculty at an academic institution. It is therefore important to know whether these programs are succeeding in this mission, or, if barriers exist that prevent trainees from pursuing these careers. Our institution currently trains ~ 2400 post-doctoral scholars per year, approximately 5% of whom are enrolled in one of our 33 T32 programs. In this study, we 1) compare the proximal professional career trajectories of T32 trainees with non-T32 trainees at our institution, 2) compare proximal career trajectories of trainees in a subset of cardiovascular T32 programs based on their previous training backgrounds, and 3) survey past and current T32 trainees in a subset of cardiovascular T32 programs about the barriers and enablers they experienced to pursuing research-oriented careers. We find that former T32 trainees are significantly more likely to attain appointments as primarily research faculty members, compared to other trainees. Trainees report a perceived lack of stability, the paucity of open positions, and the 'publish or perish' mentality of academia as the top barriers to pursuing careers in academia. However, they were still more likely to choose research over clinical careers after participating in a dedicated T32 program. Our results support the conclusion that structured training programs strengthen the pipeline of young scientists pursuing careers in academic research, including those from underrepresented backgrounds. However, T32 postdoctoral researchers are held back from pursuing academic careers by a perceived lack of stability and high competition for faculty positions.

The anti-gender threat: An ethical, democratic, and scientific imperative for NIH research/ers.

Anti-gender campaigns in the United States and globally have promoted policies and legislation that significantly limit bodily autonomy for women, transgender, and nonbinary people. This attack on the human rights of women and gender-diverse communities not only reflects implicit and explicit bias but also detrimentally impacts population health and well-being. We outline the domestic and global rise of anti-gender campaigns and their deep historical connections to broader forms of discrimination and inequality to argue that there is an ethical, democratic, and scientific imperative to more critically center and contextualize gender in health research. While the inclusion of gender as a complex concept in research design, implementation, and dissemination is important, we emphasize that gender inequities must be understood as inextricable from other systems of discrimination and exclusion. To that end, this commentary outlines two actions: for researchers to advance critical approaches to gender as part of a broader landscape of discrimination, and for the US National Institutes of Health to integrate both sex and gender into funded research.

Workshop summary: National Institutes of Health (NIH) 2022 scientific workshop on gender and health.

In this manuscript, we summarize the goals, content, and impact of the Gender and Health: Impacts of Structural Sexism, Gender Norms, Relational Power Dynamics, and Gender Inequities workshop held by the National Institutes of Health (NIH) Office of Research on Women's Health (ORWH) in collaboration with 10 NIH Institutes, Centers, and Offices. Specifically, we outline the key points emerging from the workshop presentations, which are the focus of the collection of articles in this supplement. The overarching goals of the workshop were to convene NIH staff, the external scientific community, and the public to discuss methods, measurement, modifiable factors, interventions, and best practices in health research on gender as a social and cultural variable and to identify opportunities to advance research and foster collaborations on these key topics. Themes emerging from the workshop include the need for intersectional measures in research on gender and health, the role of multilevel interventions and analyses, and the importance of considering gender as a social and structural determinant of health. Careful, nuanced, and rigorous integration of gender in health research can contribute to knowledge about and interventions to change the social and structural forces that lead to disparate health outcomes and perpetuate inequities.

Gender(ed) science: How the institutionalization of gender continues to shape the conduct and content of women's health research.

Gender refers to the socially constructed roles, behaviors, and attributes that a particular society considers appropriate for men and women based on assumptions about biological sex. It also operates as a major social organizing principle that confers unequal power, status, and resources to men and women, with direct consequences for health. Historic patriarchal and misogynistic beliefs and values are reinforced through social institutions, including health science, which reify gender inequities. This commentary examines two key domains in which the social organization and institutionalization of gender in scientific research affect the conduct of women's health research and, by extension, women's health outcomes. These domains are: 1) decisions about which topics are prioritized, researched, and funded and 2) the dissemination of research findings. Using the National Institutes of Health (NIH) as a case study to illustrate broader patterns in scientific research, we present evidence of gender-based inequities in what is prioritized, deemed fundable, and disseminated, and how this affects knowledge production and attention to women's health. We highlight efforts and progress made by the NIH and call for additional attention to further address gender-based inequities and their impact on women's health research. We conclude with a call for critical social science analyses-ideally supported by the NIH-of the social organization of health science research to identify points of intervention for redressing deep-seated obstacles to advancing research on women's health.

Republicans float plan to overhaul NIH.

Lawmakers propose reducing 27 institutes to 15.

Settlement over China funding puts institutions on notice.

Cleveland Clinic fined $7.6 million for alleged mismanagement of NIH grants.

Trends in financial payments from industry to US cancer centers, 2014-2021.

BACKGROUND: Industry payments to US cancer centers are poorly understood. METHODS: US National Cancer Institute (NCI)-designated comprehensive cancer centers were identified (n = 51). Industry payments to NCI-designated comprehensive cancer centers from 2014 to 2021 were obtained from Open Payments and National Institutes of Health (NIH) grant funding from NIH Research Portfolio Online Reporting Tools (RePORT). Given our focus on cancer centers, we measured the subset of industry payments related to cancer drugs specifically and the subset of NIH funding from the NCI. RESULTS: Despite a pandemic-related decline in 2020-2021, cancer-related industry payments to NCI-designated comprehensive cancer centers increased from $482 million in 2014 to $972 million in 2021. Over the same period, NCI research grant funding increased from $2 481  million to $2 724  million. The large majority of nonresearch payments were royalties and licensing payments. CONCLUSION: Industry payments to NCI-designated comprehensive cancer centers increased substantially more than NCI funding in recent years but were also more variable. These trends raise concerns regarding the influence and instability of industry payments.

Research with Refugee Populations in North America: Applying the NIH Guiding Principles for Ethical Research.

This article examines the ethics of research design and the initiation of a study (e.g., recruitment of participants) involving refugee participants. We aim to equip investigators and members of IRBs with a set of ethical considerations and pragmatic recommendations to address challenges in refugee-focused research as it is developed and prepared for IRB review. We discuss challenges including how refugees are being defined and identified; their vulnerabilities before, during, and following resettlement that impacts their research participation; recruitment; consent practices including assent and unaccompanied minors; and conflicts of interest. Ethical guidance and regulatory oversight provided by international bodies, federal governments, and IRBs are important for enforcing the protection of participants. We describe the need for additional ethical guidance and awareness, if not special protections for refugee populations as guided by the National Institutes of Health (NIH) Guiding Principles for Ethical Research.

Understanding enterprise data warehouses to support clinical and translational research: impact, sustainability, demand management, and accessibility.

OBJECTIVES: Healthcare organizations, including Clinical and Translational Science Awards (CTSA) hubs funded by the National Institutes of Health, seek to enable secondary use of electronic health record (EHR) data through an enterprise data warehouse for research (EDW4R), but optimal approaches are unknown. In this qualitative study, our goal was to understand EDW4R impact, sustainability, demand management, and accessibility. MATERIALS AND METHODS: We engaged a convenience sample of informatics leaders from CTSA hubs (n = 21) for semi-structured interviews and completed a directed content analysis of interview transcripts. RESULTS: EDW4R have created institutional capacity for single- and multi-center studies, democratized access to EHR data for investigators from multiple disciplines, and enabled the learning health system. Bibliometrics have been challenging due to investigator non-compliance, but one hub's requirement to link all study protocols with funding records enabled quantifying an EDW4R's multi-million dollar impact. Sustainability of EDW4R has relied on multiple funding sources with a general shift away from the CTSA grant toward institutional and industry support. To address EDW4R demand, institutions have expanded staff, used different governance approaches, and provided investigator self-service tools. EDW4R accessibility can benefit from improved tools incorporating user-centered design, increased data literacy among scientists, expansion of informaticians in the workforce, and growth of team science. DISCUSSION: As investigator demand for EDW4R has increased, approaches to tracking impact, ensuring sustainability, and improving accessibility of EDW4R resources have varied. CONCLUSION: This study adds to understanding of how informatics leaders seek to support investigators using EDW4R across the CTSA consortium and potentially elsewhere.

Common Data Elements Repository.

Created by the NIH in 2015, the Common Data Elements (CDE) Repository provides free online access to search and use Common Data Elements. This tool helps to ensure consistent data collection, saves time and resources, and ultimately improves the accuracy of and interoperability among datasets. The purpose of this column is to provide an overview of the database, discuss why it is important for researchers and relevant for health sciences librarians, and review the basic layout of the website, including sample searches that will demonstrate how it can be used.