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.

Cuts to high-profile NIH efforts leave researchers reeling.

Drop in 21st Century Cures Act funding will slow BRAIN and All of Us projects.

The impact of US-China tensions on US science: Evidence from the NIH investigations.

Amid the discourse on foreign influence investigations in research, this study examines the impact of NIH-initiated investigations starting in 2018 on U.S. scientists' productivity, focusing on those collaborating with Chinese peers. Using publication data from 2010 to 2021, we analyze over 113,000 scientists and find that investigations coincide with reduced productivity for those with China collaborations compared to those with other international collaborators, especially when accounting for publication impact. The decline is particularly pronounced in fields that received greater preinvestigation NIH funding and engaged more in U.S.-China collaborations. Indications of scientist migration and broader scientific progress implications also emerge. We also offer insights into the underlying mechanisms via qualitative interviews.

Ending "domestic helicopter research".

"Helicopter research" refers to a practice where researchers from wealthier countries conduct studies in lower-income countries with little involvement of local researchers or community members. This practice also occurs domestically. In this Commentary, we outline strategies to curb domestic helicopter research and to foster equity-centered collaborations.

Mapping of Alzheimer's disease related data elements and the NIH Common Data Elements.

BACKGROUND: Alzheimer's Disease (AD) is a devastating disease that destroys memory and other cognitive functions. There has been an increasing research effort to prevent and treat AD. In the US, two major data sharing resources for AD research are the National Alzheimer's Coordinating Center (NACC) and the Alzheimer's Disease Neuroimaging Initiative (ADNI); Additionally, the National Institutes of Health (NIH) Common Data Elements (CDE) Repository has been developed to facilitate data sharing and improve the interoperability among data sets in various disease research areas. METHOD: To better understand how AD-related data elements in these resources are interoperable with each other, we leverage different representation models to map data elements from different resources: NACC to ADNI, NACC to NIH CDE, and ADNI to NIH CDE. We explore bag-of-words based and word embeddings based models (Word2Vec and BioWordVec) to perform the data element mappings in these resources. RESULTS: The data dictionaries downloaded on November 23, 2021 contain 1,195 data elements in NACC, 13,918 in ADNI, and 27,213 in NIH CDE Repository. Data element preprocessing reduced the numbers of NACC and ADNI data elements for mapping to 1,099 and 7,584 respectively. Manual evaluation of the mapping results showed that the bag-of-words based approach achieved the best precision, while the BioWordVec based approach attained the best recall. In total, the three approaches mapped 175 out of 1,099 (15.92%) NACC data elements to ADNI; 107 out of 1,099 (9.74%) NACC data elements to NIH CDE; and 171 out of 7,584 (2.25%) ADNI data elements to NIH CDE. CONCLUSIONS: The bag-of-words based and word embeddings based approaches showed promise in mapping AD-related data elements between different resources. Although the mapping approaches need further improvement, our result indicates that there is a critical need to standardize CDEs across these valuable AD research resources in order to maximize the discoveries regarding AD pathophysiology, diagnosis, and treatment that can be gleaned from them.

Elements of successful NIH grant applications.

Is there a formula for a competitive NIH grant application? The Serenity Prayer may provide one: "Grant me the serenity to accept the things I cannot change, the ability to change the things I can, and the wisdom to know the difference." But how to tell the difference? In this Perspective, we provide an inclusive roadmap-elements of NIH funding. Collectively, we have over 30 y of peer review experience as NIH Scientific Review Officers in addition to over 30 y of program experience as NIH Program Officers. This article distills our NIH experience. We use Euclid's 13-book landmark, The Elements, as our template to humbly share what we learned. We have three specific aims: inform, guide, and motivate prospective applicants. We also address ways that support diversity and inclusion among applicants and young investigators in biomedical research. The elements we describe come from a wide range of sources. Some themes will be general. Some will be specific. All will be candid. The ultimate goal is a competitive application, serenity, and hopefully both.

National Institutes of Health Stroke Scale Reporting in Medicare Claims Data: Reporting in the First 3 Years.

BACKGROUND: Since 2016, hospitals have been able to document International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes for the National Institutes of Health Stroke Scale (NIHSS). As of 2023, the Centers for Medicare & Medicaid Services uses NIHSS as a risk adjustment variable. We assessed associations between patient- and hospital-level variables and contemporary NIHSS reporting. METHODS: We performed a retrospective cross-sectional analysis of 2019 acute ischemic stroke admissions using deidentified, national 100% inpatient Medicare Fee-For-Service data sets. We identified index acute ischemic stroke admissions using the ICD-10-CM code I63.x and abstracted demographic information, medical comorbidities, hospital characteristics, and NIHSS. We linked Medicare and Mount Sinai Health System (New York, NY) registry data from 2016 to 2019. We calculated NIHSS documentation at the patient and hospital levels, predictors of documentation, change over time, and concordance with local data. RESULTS: There were 231 383 index acute ischemic stroke admissions in 2019. NIHSS was documented in 44.4% of admissions and by 66.5% of hospitals. Hospitals that documented ≥1 NIHSS were more commonly teaching hospitals (39.0% versus 5.5%; standardized mean difference score, 0.88), stroke certified (37.2% versus 8.0%; standardized mean difference score, 0.75), higher volume (mean, 80.8 [SD, 92.6] versus 6.33 [SD, 14.1]; standardized mean difference score, 1.12), and had intensive care unit availability (84.9% versus 23.2%; standardized mean difference score, 1.57). Adjusted odds of documentation were lower for patients with inpatient mortality (odds ratio, 0.64 [95% CI, 0.61-0.68]; P<0.0001), in nonmetropolitan areas (odds ratio, 0.49 [95% CI, 0.40-0.61]; P<0.0001), and male sex (odds ratio, 0.95 [95% CI, 0.93-0.97]; P<0.0001). NIHSS was documented for 52.9% of Medicare cases versus 93.1% of registry cases, and 74.7% of Medicare NIHSS scores equaled registry admission NIHSS. CONCLUSIONS: Missing ICD-10-CM NIHSS data remain widespread 3 years after the introduction of the ICD-10-CM NIHSS code, and there are systematic differences in reporting at the patient and hospital levels. These findings support continued assessment of NIHSS reporting and caution in its application to risk adjustment models.

Underfunding for Research Training and Career Development: The Impact on Family Medicine Research.

BACKGROUND AND OBJECTIVES: The National Institutes of Health and related federal awards for research training (RT) and research career development (RCD) are designed to prepare applicants for research careers. We compared funding rates for RT and RCD for anesthesiology, dermatology, emergency medicine, family medicine, internal medicine, neurology, obstetrics-gynecology, pathology, pediatrics, and psychiatry. METHODS: We estimated the denominator using the number of residency graduates from different specialties from 2001 to 2010 from the Association of American Medical Colleges data. For the numerator, we used published data on federally funded awards by specialty from 2011 to 2020. We also examined the correlation between RCD funding and overall research funding. RESULTS: Family medicine had the lowest rate per graduating resident for RT (0.01%) and RCD (0.77%) awards among 10 specialties and was lower than the mean/median for the other nine specialties, ranging from 2.15%/1.19% and 9.83%/8.74%. We found a strong correlation between rates of RCD awards and mean federal funding per active physician, which was statistically significant (ρ=0.77, P=.0098). CONCLUSIONS: Comparatively low rates for family medicine awards for RT and RCD plausibly contribute to poor federal funding for family medicine research, underscoring the need to bolster the research career pathway in family medicine.

Citizenship status and career self-efficacy: An intersectional study of biomedical trainees in the United States.

This study examines the intersectional role of citizenship and gender with career self-efficacy amongst 10,803 doctoral and postdoctoral trainees in US universities. These biomedical trainees completed surveys administered by 17 US institutions that participated in the National Institutes of Health Broadening Experiences in Scientific Training (NIH BEST) Programs. Findings indicate that career self-efficacy of non-citizen trainees is significantly lower than that of US citizen trainees. While lower career efficacy was observed in women compared with men, it was even lower for non-citizen female trainees. Results suggest that specific career interests may be related to career self-efficacy. Relative to US citizen trainees, both male and female non-citizen trainees showed higher interest in pursuing a career as an academic research investigator. In comparison with non-citizen female trainees and citizen trainees of all genders, non-citizen male trainees expressed the highest interest in research-intensive (and especially principal investigator) careers. The authors discuss potential causes for these results and offer recommendations for increasing trainee career self-efficacy which can be incorporated into graduate and postdoctoral training.

Sarcopenia in subjects with Alzheimer's disease: prevalence and comparison of agreement between EGWSOP1, EGWSOP2, and FNIH criteria.

BACKGROUND: Sarcopenia is an age-related clinical syndrome characterized by the progressive loss of muscle mass and muscle strength. It appears to be closely linked to dementia, particularly Alzheimer's disease (AD); however, its prevalence among AD patients remains unclear. In this study, we assessed differences in sarcopenia prevalence between non-demented individuals and AD patients. Moreover, we assessed sex-specific differences in sarcopenia prevalence and explored the diagnostic value of the Muscle Quality Index (MQI) for diagnosing sarcopenia among AD patients. METHOD: Cross-sectional study including 145 patients with probable AD and 51 older adults with normal cognition. Sarcopenia was diagnosed according to the criteria of the European Working Group on Sarcopenia in Older People (EWGSOP1 and EWGSOP2) and of the Foundation for the National Institutes of Health (FNIH). The MQI was computed as the ratio of handgrip strength to skeletal muscle mass. RESULTS: No significant difference in sarcopenia prevalence was observed between AD patients and controls. Prevalence ranged from 3.4 to 23.4% in AD patients and from 2 to 11.8% in controls, depending on diagnostic criteria. Prevalence was higher using EWGSOP1 and decreased using EWGSOP2 and FNIH. Prevalence was higher in males than in females with AD. The MQI was lower in AD patients than in controls (95%CI: - 0.23, - 0.05, p < 0.001), but displayed poor diagnostic accuracy in identifying sarcopenia cases. CONCLUSIONS: AD patients and controls show comparable sarcopenia prevalence. Sarcopenia prevalence is higher in males than females among AD patients and higher when using EWGSOP1 compared to FNIH and EWGSOP2 criteria.

Examining who is conducting and leading National Institute of Health-funded research in U.S. schools of nursing.

BACKGROUND: Nursing science is essential for generating a unique body of knowledge that is foundational to the academic discipline of nursing. PURPOSE: The goal of this analysis is to detail the education and licensing of faculty and leadership in research-intensive schools of nursing and to present the current data on the National Institute of Health (NIH) funding patterns in schools of nursing. METHODS: The faculty composition analysis focused on the 40 U.S. schools of nursing receiving the most NIH funding through faculty serving as PIs on grants awarded in 2023. For the NIH funding patterns analysis, data were extracted from the NIH RePORTER database. DISCUSSION: Of the top 30 NIH-funded Schools of Nursing, all the Deans and Associate Deans of Academic Affairs are educated or licensed as nurses; whereas only 55% of Associate Deans of Research are educated or licensed as nurses. In 2022, nearly half of the top-ranked schools of nursing had less than half of their NIH funding awarded to faculty who are trained and licensed as nurses CONLUSION: The current trends in the research enterprise in schools of nursing implore us to assess if we are adequately training nurses to advance nursing science and more importantly to serve as leaders of nursing science.

Efficacy of Centers of Biomedical Research Excellence (CoBRE) grants to build research capacity in underrepresented states.

Federal funding for research has immediate and long-term economic impact. Since federal research funding is regionally concentrated and not geographically distributed, the benefits are not fully realized in some regions of the country. The Established (previously Experimental) Program to Stimulate Competitive Research (EPSCoR) programs at several agencies, for example, the National Science Foundation, and the Institutional Development Award (IDeA) program at the National Institutes of Health were created to increase competitiveness for funding in states with historically low levels of federal funding. The Centers of Biomedical Research Excellence (CoBRE) award program is a component of the IDeA program. The CoBRE grants support research core facilities to develop research infrastructure. These grants also support the research projects of junior investigators, under the guidance of mentoring teams of senior investigators, to develop human resources at these institutions. Few studies have assessed the effectiveness of these programs. This study examines the investment and outcomes of the CoBRE grants from 2000 through 2022. The maturation of junior investigators into independently funded principal investigators is comparable to other mentoring programs supported by NIH. The investment in research cores resulted in substantial research productivity, measured by publications. Despite the successes of individual investigators and increased research infrastructure and productivity, the geographic distribution of federal and NIH research dollars has not changed. These results will be informative in consideration of policies designed to enhance the geographic distribution of federal research dollars.

NIH's flat budget for 2024 will force 'very difficult decisions'.

Belated Senate and House compromise eliminates policy riders restricting certain studies.

Balancing best practice and reality in behavioral intervention development: A survey of principal investigators funded by the National Institutes of Health.

Preliminary studies play a prominent role in the development of large-scale behavioral interventions. Though recommendations exist to guide the execution and interpretation of preliminary studies, these assume optimal scenarios which may clash with realities faced by researchers. The purpose of this study was to explore how principal investigators (PIs) balance expectations when conducting preliminary studies. We surveyed PIs funded by the National Institutes of Health to conduct preliminary behavioral interventions between 2000 and 2020. Four hundred thirty-one PIs (19% response rate) completed the survey (November 2021 to January 2022, 72% female, mean 21 years post-terminal degree). Most PIs were aware of translational models and believed preliminary studies should precede larger trials but also believed a single preliminary study provided sufficient evidence to scale. When asked about the relative importance of preliminary efficacy (i.e. changes in outcomes) and feasibility (i.e. recruitment, acceptance/adherence) responses varied. Preliminary studies were perceived as necessary to successfully compete for research funding, but among PIs who had peer-reviewed federal-level grants applications (n = 343 [80%]), responses varied about what should be presented to secure funding. Confusion surrounding the definition of a successful, informative preliminary study poses a significant challenge when developing behavior interventions. This may be due to a mismatch between expectations surrounding preliminary studies and the realities of the research enterprise in which they are conducted. To improve the quality of preliminary studies and advance the field of behavioral interventions, additional funding opportunities, more transparent criteria in grant reviews, and additional training for grant reviewers are suggested.

Initial testing of behavioral interventions can provide valuable information about the methods of the intervention and whether it is effective. However, recommendations that provide researchers with guidance on how to best conduct pilot studies assume ideal circumstances. The mismatch between what can be realistically accomplished in a preliminary study, and what researchers expect from preliminary studies creates confusion. As a result, it is difficult for researchers to judge the quality, relevance, and potential of preliminary studies. This study suggests more research funding opportunities, clearer rules for reviewing grant applications, and more training for the people who review these applications could help improve preliminary studies and create more effective health behavior programs.

New approaches for challenging therapeutic targets.

Despite successes with new drug approvals over the past two decades through conventional drug development approaches, many human diseases remain intractable to current therapeutic interventions. Possible barriers may be that the complexity of the target, and disease biology, are impervious to such conventional drug development approaches. The US National Institutes of Health hosted a workshop with the goal of identifying challenges and opportunities with alternative modalities for developing treatments across diseases associated with historically undruggable targets. This report highlights key issues discussed during the workshop that, if addressed, could expand the pool of therapeutic approaches for treating various diseases.