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.

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.

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.

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.

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.

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.

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.

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

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

Grant funding among underrepresented minority and women urologists at academic institutions.

INTRODUCTION: Grant funding to Urology has decreased over the last decade. Documented lack of gender and race diversity at the faculty level raises concerns for funding disparities. This study sought to characterize disparities based upon race and gender in National Institutes of Health (NIH) funding data to Urologic faculty. METHODS AND MATERIALS: Data from 145 ACGME accredited Urology residency programs incorporating faculty gender and underrepresented in medicine (URiM) status was utilized. The NIH Research Portfolio Online Report Tool was queried between 1985 and 2023 for grants related to current Urology faculty. URiM status, gender, years of practice, academic rank, and Doximity residency program rank were factors in multivariable analysis. RESULTS: A total of 2,131 faculty were included. Three hundred one Urologists received 793 urologic grants for a total of $993,919,052 in funding. By race, grants were awarded to: White 72.9%, Asian 21.8%, Hispanic 3.0%, Black 2.1%. Men received 708 grants (89.3%) worth $917,083,475 total. Women received 85 grants (10.7%) worth $76,835,577 total. Likelihood of being awarded a grant was significantly associated with non-URiM status (p < 0.001) and men (p < 0.0001). On multivariable analysis, Doximity rank (p < 0.001) and academic rank (p < 0.001) were significant predictors of receiving a grant; male gender, URiM status, and years of practice were not. Academic rank was also a significant predictor of number of grants received (p = 0.04) and total funding (p = 0.04); years of practice, Doximity rank, URiM status, and gender were not. CONCLUSIONS: NIH grants were more likely awarded to higher ranked faculty from higher Doximity ranked institutions with no differences based on URiM status or gender.

NIH megastudy analyzes first 250,000 genomes.

All of Us finds new DNA variants and refines genetic risk scores in diverse groups.

NSF DARE-transforming modeling in neurorehabilitation: perspectives and opportunities from US funding agencies.

In recognition of the importance and timeliness of computational models for accelerating progress in neurorehabilitation, the U.S. National Science Foundation (NSF) and the National Institutes of Health (NIH) sponsored a conference in March 2023 at the University of Southern California that drew global participation from engineers, scientists, clinicians, and trainees. This commentary highlights promising applications of computational models to understand neurorehabilitation ("Using computational models to understand complex mechanisms in neurorehabilitation" section), improve rehabilitation care in the context of digital twin frameworks ("Using computational models to improve delivery and implementation of rehabilitation care" section), and empower future interdisciplinary workforces to deliver higher-quality clinical care using computational models ("Using computational models in neurorehabilitation requires an interdisciplinary workforce" section). The authors describe near-term gaps and opportunities, all of which encourage interdisciplinary team science. Four major opportunities were identified including (1) deciphering the relationship between engineering figures of merit-a term commonly used by engineers to objectively quantify the performance of a device, system, method, or material relative to existing state of the art-and clinical outcome measures, (2) validating computational models from engineering and patient perspectives, (3) creating and curating datasets that are made publicly accessible, and (4) developing new transdisciplinary frameworks, theories, and models that incorporate the complexities of the nervous and musculoskeletal systems. This commentary summarizes U.S. funding opportunities by two Federal agencies that support computational research in neurorehabilitation. The NSF has funding programs that support high-risk/high-reward research proposals on computational methods in neurorehabilitation informed by theory- and data-driven approaches. The NIH supports the development of new interventions and therapies for a wide range of nervous system injuries and impairments informed by the field of computational modeling. The conference materials can be found at https://dare2023.usc.edu/ .

Trends in NIH-funding to schools of nursing in the last 17 years.

BACKGROUND: Growing clinical demands, faculty retirements, fewer PhD-prepared graduates, and funding instability are challenges for nursing science. PURPOSE: The purpose of this analysis was to investigate National Institutes of Health (NIH) funding patterns in schools of nursing (SONs). METHODS: Data were extracted from the Blue Ridge Institute for Medical Research between 2006 and 2022. Growth modeling examined changes in funding over time between private and public SONs. DISCUSSION: In the last 17 years, NIH funding for SONs has risen nearly 25% but remains only 1% of the total NIH budget for extramural research. Overall, 109 (75%) of the SONs were public and 36 (25%) were private institutions. Regarding geography, 90% of the States received NIH funding except six: ID, ME, MS, NH, VT, and WY. Private SONs consistently received more funding than public SONs but the difference was only statistically significant in 2022. CONCLUSION: NIH funding has significantly increased to SONs, there is better geographic distribution but a funding disparity exists between public and private SONs.

Cross sectional study of Twitter (X) use among academic anesthesiology departments in the United States.

Twitter (recently renamed X) is used by academic anesthesiology departments as a social media platform for various purposes. We hypothesized that Twitter (X) use would be prevalent among academic anesthesiology departments and that the number of tweets would vary by region, physician faculty size, and National Institutes of Health (NIH) research funding rank. We performed a descriptive study of Twitter (X) use by academic anesthesiology departments (i.e. those with a residency program) in 2022. Original tweets were collected using a Twitter (X) analytics tool. Summary statistics were reported for tweet number and content. The median number of tweets was compared after stratifying by region, physician faculty size, and NIH funding rank. Among 166 academic anesthesiology departments, there were 73 (44.0%) that had a Twitter (X) account in 2022. There were 3,578 original tweets during the study period and the median number of tweets per department was 21 (25th-75th = 0, 75) with most tweets (55.8%) announcing general departmental news and a smaller number highlighting social events (12.5%), research (11.1%), recruiting (7.1%), DEI activities (5.2%), and trainee experiences (4.1%). There was no significant difference in the median number of tweets by region (P = 0.81). The median number of tweets differed significantly by physician faculty size (P<0.001) with larger departments tweeting more and also by NIH funding rank (P = 0.005) with highly funded departments tweeting more. In 2022, we found that less than half of academic anesthesiology departments had a Twitter (X) account, and the median number of annual tweets per account was relatively low. Overall, Twitter (X) use was less common than anticipated among academic anesthesiology departments and most tweets focused on promotion of departmental activities or individual faculty. There may be opportunities for more widespread and effective use of Twitter (X) by academic anesthesiology departments including education about anesthesiology as a specialty.

Analysis of the health economics portfolio funded by the National Institutes of Health in response to published guidance.

Health services, economics, and outcomes research (referred to as health economics research hereinafter) is one of the interdisciplinary sciences that the National Institutes of Health (NIH) supports in order to pursue its overall mission to improve health. In 2015, NIH guidance was published to clarify the type of health economics research that NIH would continue to fund. This analysis aimed to determine if there were changes in the number of health economics applications received and funded by NIH after the release of the guidance. Health economics applications submitted to NIH both before and after publication of the guidance were identified using a machine learning approach with input from subject matter experts. Application and funding trends were examined by fiscal year, method of application (solicited vs. unsolicited), and activity code. This study found that application and funding rates of health economics research were decreasing prior to guidance. Following publication of this guidance, the application and funding rate of health economics applications increased.

National Institutes of Health Funding for Surgeon-Scientists in the US-An Update and an Expanded Landscape.

Importance: Current reports suggest that the surgeon-scientist phenotype is significantly threatened. However, a significant increase in the proportion of surgeons in the workforce funded by the National Institutes of Health (NIH) from 2010 (0.5%) to 2020 (0.7%) was recently reported and showed that surgeons primarily performed basic science research (78% in 2010; 73% in 2020) rather than clinical research. Objective: To provide an update on the status of surgeons funded by the NIH for fiscal year (FY) 2022. Evidence Review: NIH-funded surgeons were identified in FY2012 and FY2022, including those who were awarded grants with more than 1 principal investigator (PI) by querying the internal database at the NIH. The main outcome for this study was the total number of NIH-funded surgeons in FY2012 and FY2022, including total grant costs and number of grants. The secondary analysis included self-reported demographic characteristics of the surgeons in FY2022. The research type (basic science vs clinical) of R01 grants was also examined. Findings: Including multiple PI grants, 1324 surgeon-scientists were awarded $1.3 billion in FY2022. Women surgeons increased to 31.3% (339 of 1084) of the population of surgeon PIs in FY2022 compared with 21.0% (184 of 876) in FY2012. Among surgeon PIs awarded grants, a total of 200 (22.8%) were Asian, 35 (4.0%) were Black or African American, 18 (2.1%) were another race (including American Indian or Alaska Native, Native Hawaiian or Other Pacific Islander, and more than 1 race), and 623 (71.1%) were White. A total of 513 of 689 R01 grants (74.5%) were for basic science, 131 (19.0%) were for clinical trials, and 45 (6.5%) were for outcomes research. Conclusions and Relevance: NIH-funded surgeons are increasing in number and grant costs, including the proportion of women surgeon PIs, and are representative of the diversity among US academic surgical faculty. The results of this study suggest that despite the many obstacles surgeon-scientists face, their research portfolio continues to grow, they perform a myriad of mostly basic scientific research as both independent PIs and on multidisciplinary teams.

Analysis of NIH K99/R00 awards and the career progression of awardees.

Many postdoctoral fellows and scholars who hope to secure tenure-track faculty positions in the United States apply to the National Institutes of Health (NIH) for a Pathway to Independence Award. This award has two phases (K99 and R00) and provides funding for up to 5 years. Using NIH data for the period 2006-2022, we report that ~230 K99 awards were made every year, representing up to ~$250 million annual investment. About 40% of K99 awardees were women and ~89% of K99 awardees went on to receive an R00 award annually. Institutions with the most NIH funding produced the most recipients of K99 awards and recruited the most recipients of R00 awards. The time between a researcher starting an R00 award and receiving a major NIH award (such as an R01) ranged between 4.6 and 7.4 years, and was significantly longer for women, for those who remained at their home institution, and for those hired by an institution that was not one of the 25 institutions with the most NIH funding. Shockingly, there has yet to be a K99 awardee at a historically Black college or university. We go on to show how K99 awardees flow to faculty positions, and to identify various factors that influence the future success of individual researchers and, therefore, also influence the composition of biomedical faculty at universities in the United States.

Meaningful Endpoints for Idiopathic Pulmonary Fibrosis (IPF) Clinical Trials: Emphasis on 'Feels, Functions, Survives'. Report of a Collaborative Discussion in a Symposium with Direct Engagement from Representatives of Patients, Investigators, the National Institutes of Health, a Patient Advocacy Organization, and a Regulatory Agency.

Background: Idiopathic pulmonary fibrosis (IPF) carries significant mortality and unpredictable progression, with limited therapeutic options. Designing trials with patient-meaningful endpoints, enhancing the reliability and interpretability of results, and streamlining the regulatory approval process are of critical importance to advancing clinical care in IPF. Methods: A landmark in-person symposium in June 2023 assembled 43 participants from the US and internationally, including patients with IPF, investigators, and regulatory representatives, to discuss the immediate future of IPF clinical trial endpoints. Patient advocates were central to discussions, which evaluated endpoints according to regulatory standards and the FDA's 'feels, functions, survives' criteria. Results: Three themes emerged: 1) consensus on endpoints mirroring the lived experiences of patients with IPF; 2) consideration of replacing forced vital capacity (FVC) as the primary endpoint, potentially by composite endpoints that include 'feels, functions, survives' measures or FVC as components; 3) support for simplified, user-friendly patient-reported outcomes (PROs) as either components of primary composite endpoints or key secondary endpoints, supplemented by functional tests as secondary endpoints and novel biomarkers as supportive measures (FDA Guidance for Industry (Multiple Endpoints in Clinical Trials) available at: https://www.fda.gov/media/162416/download). Conclusions: This report, detailing the proceedings of this pivotal symposium, suggests a potential turning point in designing future IPF clinical trials more attuned to outcomes meaningful to patients, and documents the collective agreement across multidisciplinary stakeholders on the importance of anchoring IPF trial endpoints on real patient experiences-namely, how they feel, function, and survive. There is considerable optimism that clinical care in IPF will progress through trials focused on patient-centric insights, ultimately guiding transformative treatment strategies to enhance patients' quality of life and survival.

Understanding risk and causal mechanisms for developing obesity in infants and young children: A National Institutes of Health workshop.

Obesity in children remains a major public health problem, with the current prevalence in youth ages 2-19 years estimated to be 19.7%. Despite progress in identifying risk factors, current models do not accurately predict development of obesity in early childhood. There is also substantial individual variability in response to a given intervention that is not well understood. On April 29-30, 2021, the National Institutes of Health convened a virtual workshop on "Understanding Risk and Causal Mechanisms for Developing Obesity in Infants and Young Children." The workshop brought together scientists from diverse disciplines to discuss (1) what is known regarding epidemiology and underlying biological and behavioral mechanisms for rapid weight gain and development of obesity and (2) what new approaches can improve risk prediction and gain novel insights into causes of obesity in early life. Participants identified gaps and opportunities for future research to advance understanding of risk and underlying mechanisms for development of obesity in early life. It was emphasized that future studies will require multi-disciplinary efforts across basic, behavioral, and clinical sciences. An exposome framework is needed to elucidate how behavioral, biological, and environmental risk factors interact. Use of novel statistical methods may provide greater insights into causal mechanisms.