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.

Is it time to reduce the length of postgraduate training for physician-scientists in internal medicine?

Physician-scientists play a crucial role in advancing medical knowledge and patient care, yet the long periods of time required to complete training may impede expansion of this workforce. We examined the relationship between postgraduate training and time to receipt of NIH or Veterans Affairs career development awards (CDAs) for physician-scientists in internal medicine. Data from NIH RePORTER were analyzed for internal medicine residency graduates who received specific CDAs (K08, K23, K99, or IK2) in 2022. Additionally, information on degrees and training duration was collected. Internal medicine residency graduates constituted 19% of K awardees and 28% of IK2 awardees. Of MD-PhD internal medicine-trained graduates who received a K award, 92% received a K08 award; of MD-only graduates who received a K award, a majority received a K23 award. The median time from medical school graduation to CDA was 9.6 years for K awardees and 10.2 years for IK2 awardees. The time from medical school graduation to K or IK2 award was shorter for US MD-PhD graduates than US MD-only graduates. We propose that the time from medical school graduation to receipt of CDAs must be shortened to accelerate training and retention of physician-scientists.

Putting science to work for women's health.

The Office of Research on Women's Health (ORWH)'s whole health paradigm expands the scope of women's health research, incorporating a life-course perspective that recognizes the profound influences of sex and gender on health. From childhood through adulthood, external and societal factors along with internal factors and biology shape women's health and influence access to quality healthcare. This comprehensive approach integrates data-driven sex- and gender-aware strategies to prevent, diagnose, and treat disease, focusing on the unique needs of women. Acknowledging the historical lack of timely research and data on women's health, an initiative led by First Lady Dr. Jill Biden and the White House Gender Policy Council, ushers in a new era of women's health research that offers unprecedented opportunities to enhance the health of women through biomedical and behavioral research. The initiative fosters interdisciplinary collaboration, supporting research on autoimmune diseases, menopause, oral health, and chronic pain conditions. ORWH serves as the focal point for National Institutes of Health (NIH) women's health research. With a commitment to advancing holistic outcomes, ORWH engages in partnerships, outreach, and educational initiatives to disseminate critical research findings and support women's health researchers. Here we describe the convergence of this initiative with the National Institute of Dental and Craniofacial Research's work to advance the understanding of sex as a biological variable for conditions such as Sjogren's disease and temporomandibular disorder. This transformative approach to women's health research propels the United States toward innovative solutions, ensuring that science works for the health and well-being of every woman.

Cuts to high-profile NIH efforts leave researchers reeling.

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

Barriers to care and health-related quality of life among US adults with several common chronic inflammatory skin diseases: a cross-sectional analysis of the NIH All of Us Research Program.

Research investigating the impact of barriers to care on health-related quality of life (HRQoL) among US adults with chronic inflammatory skin diseases (CISDs) is limited. In this study, we utilize multivariable-adjusted logistic regression to analyze the associations between cost barriers (e.g., delaying specialist and mental health care due to cost) and non-cost barriers (e.g., delaying care due to transportation issues and the lack of provider diversity) with HRQoL among US adults with several common CISDs in the National Institutes of Health's All of Us Research Program (AoURP). Among the 19,208 adults with CISDs included in our analysis, the prevalence of poorer HRQoL(i.e., "fair" or "poor" HRQoL) was significantly higher among adults with CISDs who experienced cost (aOR, 2.39;95% CI, 2.10-2.73) and non-cost barriers (aOR, 2.52; 95% CI, 2.20-2.88) than those with CISDs who did not experience those barriers. Since dermatologists are often the only physician caring for patients with CISDs, this study reinforces the critical role dermatologists have in addressing social determinants of health and advocating to reduce cost and non-cost barriers for their patients with CISDs.

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.

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.

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.

The enhanced reliability of higher national institute of health stroke scale thresholds over the conventional 6-point scale.

INTRODUCTION: It is still uncertain if higher thresholds on National Institute of Health Stroke Scale (NIHSS) are better predictors of large infarctions than the conventional 6-point cutoff. METHODS: We used 6-point and higher NIHSS thresholds including 8, 9, and 10-point to predict relative infarct areas, expressed as percentage of the affected hemisphere on axial brain computed tomography images, beginning at 5% with 5% increments each time until reaching the 40% cutoff for large infarctions, or achieving 100% sensitivity. Results were compared using area under the receiver operating characteristic curves (AUROC). RESULTS: We enrolled 151 patients of acute ischemic stroke (Mean age: 62.88 years ± 12.71; Female: 48.34%). 77 patients (50.99%) exhibited left hemisphere strokes, while 74 (49%) had right hemisphere involvement. Sensitivity values of the 6-point for infarcts measuring 5%, 10%, 20%, 30%, and 40% were 62%, 64%, 77%, 82%, and 100%, respectively. At 40% infarct-size, 8-point achieved comparable results (52%, 55%, 69%, 76%, 100%), closely aligning with the 9-point (50%, 53%, 69%, 76%, 100%). The10-point was slightly trailing behind in sensitivity at 40% infarct-core (96%). Moreover, higher thresholds exhibited improved false-positive rates (FPR). At 40% infarct size, the FPRs of 6, 8, 9, and 10 points were 39%, 27%, 27%, and 21% respectively. Higher thresholds had augmented AUROC values (0.86, 0.86, 0.89) as compared to the 6-point (0.80). Logistic regression identified 14-point as definitive cutoff for large infarctions. CONCLUSION: Higher thresholds can better differentiate small and medium infarcts as true-negatives and substantially reduce false-positive referrals for mechanical thrombectomy.

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.

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.

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.

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.

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.