Browsing by Subject "Biomedical research"

Now showing 1 - 10 of 16
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    A common language for Gulf War Illness (GWI) research studies: GWI common data elements
    (Elsevier, 2022) Cohen, Devra E.; Sullivan, Kimberly A.; McNeil, Rebecca B.; Gulf War Illness Common Data Elements Working Group; Symptoms Assessment Working Group; McNeil, Rebecca B.; Ashford, Wes; Bested, Alison; Bunker, James; Cheema, Amanpreet; Cohen, Devra E.; Cook, Dane; Cournoyer, Jeffrey; Craddock, Travis; Golier, Julia; Hardie, Anthony; Helmer, Drew; Lindheimer, Jacob B.; Janulewicz Lloyd, Patricia; Kerr, Kathleen; Krengel, Maxine; Nadkarni, Shree; Nugent, Shannon; Paris, Bonnie; Reinhard, Matthew; Rumm, Peter; Schneiderman, Aaron; Sims, Kellie J.; Steele, Lea; Turner, Marsha; Systems Assessment Working Group; Sullivan, Kimberly A.; Abdullah, Laila; Abreu, Maria; Abu-Donia, Mohamed; Aenlle, Kristina; Arocho, Jimmy; Balbin, Elizabeth; Baraniuk, James; Block, Karen; Block, Michelle; DeBeer, Bryann; Engdahl, Brian; Filipov, Nikolay; Fletcher, Mary Ann; Kalasinsky, Victor; Kokkotou, Efi; Lidie, Kristy; Little, Deborah; Loging, William; Morris, Marianna; Nathanson, Lubov; Nichols, Montra Denise; Pasinetti, Giulio; Shungu, Dikoma; Waziry, Paula; VanLeeuwen, Jon; Younger, Jarred; Pharmacology and Toxicology, School of Medicine
    Aims: The Gulf War Illness programs (GWI) of the United States Department of Veteran Affairs and the Department of Defense Congressionally Directed Medical Research Program collaborated with experts to develop Common Data Elements (CDEs) to standardize and systematically collect, analyze, and share data across the (GWI) research community. Main methods: A collective working group of GWI advocates, Veterans, clinicians, and researchers convened to provide consensus on instruments, case report forms, and guidelines for GWI research. A similar initiative, supported by the National Institute of Neurologic Disorders and Stroke (NINDS) was completed for a comparative illness, Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), and provided the foundation for this undertaking. The GWI working group divided into two sub-groups (symptoms and systems assessment). Both groups reviewed the applicability of instruments and forms recommended by the NINDS ME/CFS CDE to GWI research within specific domains and selected assessments of deployment exposures. The GWI CDE recommendations were finalized in March 2018 after soliciting public comments. Key findings: GWI CDE recommendations are organized in 12 domains that include instruments, case report forms, and guidelines. Recommendations were categorized as core (essential), supplemental-highly recommended (essential for specified conditions, study types, or designs), supplemental (commonly collected, but not required), and exploratory (reasonable to use, but require further validation). Recommendations will continually be updated as GWI research progresses. Significance: The GWI CDEs reflect the consensus recommendations of GWI research community stakeholders and will allow studies to standardize data collection, enhance data quality, and facilitate data sharing.
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    A New Era of Data-Driven Cancer Research and Care: Opportunities and Challenges
    (American Association for Cancer Research, 2024) Gomez, Felicia; Danos, Arpad M.; Del Fiol, Guilherme; Madabhushi, Anant; Tiwari, Pallavi; McMichael, Joshua F.; Bakas, Spyridon; Bian, Jiang; Davatzikos, Christos; Fertig, Elana J.; Kalpathy-Cramer, Jayashree; Kenney, Johanna; Savova, Guergana K.; Yetisgen, Meliha; Van Allen, Eliezer M.; Warner, Jeremy L.; Prior, Fred; Griffith, Malachi; Griffith, Obi L.; Pathology and Laboratory Medicine, School of Medicine
    People diagnosed with cancer and their formal and informal caregivers are increasingly faced with a deluge of complex information, thanks to rapid advancements in the type and volume of diagnostic, prognostic, and treatment data. This commentary discusses the opportunities and challenges that the society faces as we integrate large volumes of data into regular cancer care.
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    Advances in understanding Alzheimer's disease, and the contributions of current Alzheimer research: ten years on and beyond
    (Bentham Science Publishers, 2014-02) Greig, Nigel H.; Lahiri, Debomoy K.; Department of Psychiatry, IU School of Medicine
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    Best practices to evaluate the impact of biomedical research software-metric collection beyond citations
    (Oxford University Press, 2024) Afiaz, Awan; Ivanov, Andrey A.; Chamberlin, John; Hanauer, David; Savonen, Candace L.; Goldman, Mary J.; Morgan, Martin; Reich, Michael; Getka, Alexander; Holmes, Aaron; Pati, Sarthak; Knight, Dan; Boutros, Paul C.; Bakas, Spyridon; Caporaso, J. Gregory; Del Fiol, Guilherme; Hochheiser, Harry; Haas, Brian; Schloss, Patrick D.; Eddy, James A.; Albrecht, Jake; Fedorov, Andrey; Waldron, Levi; Hoffman, Ava M.; Bradshaw, Richard L.; Leek, Jeffrey T.; Wright, Carrie; Pathology and Laboratory Medicine, School of Medicine
    Motivation: Software is vital for the advancement of biology and medicine. Impact evaluations of scientific software have primarily emphasized traditional citation metrics of associated papers, despite these metrics inadequately capturing the dynamic picture of impact and despite challenges with improper citation. Results: To understand how software developers evaluate their tools, we conducted a survey of participants in the Informatics Technology for Cancer Research (ITCR) program funded by the National Cancer Institute (NCI). We found that although developers realize the value of more extensive metric collection, they find a lack of funding and time hindering. We also investigated software among this community for how often infrastructure that supports more nontraditional metrics were implemented and how this impacted rates of papers describing usage of the software. We found that infrastructure such as social media presence, more in-depth documentation, the presence of software health metrics, and clear information on how to contact developers seemed to be associated with increased mention rates. Analysing more diverse metrics can enable developers to better understand user engagement, justify continued funding, identify novel use cases, pinpoint improvement areas, and ultimately amplify their software's impact. Challenges are associated, including distorted or misleading metrics, as well as ethical and security concerns. More attention to nuances involved in capturing impact across the spectrum of biomedical software is needed. For funders and developers, we outline guidance based on experience from our community. By considering how we evaluate software, we can empower developers to create tools that more effectively accelerate biological and medical research progress. Availability and implementation: More information about the analysis, as well as access to data and code is available at https://github.com/fhdsl/ITCR_Metrics_manuscript_website.
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    Call for papers: A special issue on tackling emerging infectious diseases
    (Elsevier, 2021-08-04) Frederickson, Robert M.; Herzog, Roland W.; Pediatrics, School of Medicine
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    Mendelian randomisation and experimental medicine approaches to interleukin-6 as a drug target in pulmonary arterial hypertension
    (European Respiratory Society, 2022-03-10) Toshner, Mark; Church, Colin; Harbaum, Lars; Rhodes, Christopher; Villar Moreschi, Sofia S.; Liley, James; Jones, Rowena; Arora, Amit; Batai, Ken; Desai, Ankit A.; Coghlan, John G.; Gibbs, J. Simon R.; Gor, Dee; Gräf, Stefan; Harlow, Louise; Hernandez-Sanchez, Jules; Howard, Luke S.; Humbert, Marc; Karnes, Jason; Kiely, David G.; Kittles, Rick; Knightbridge, Emily; Lam, Brian; Lutz, Katie A.; Nichols, William C.; Pauciulo, Michael W.; Pepke-Zaba, Joanna; Suntharalingam, Jay; Soubrier, Florent; Trembath, Richard C.; Schwantes-An, Tae-Hwi L.; Wort, S. John; Wilkins, Martin R.; Gaine, Sean; Morrell, Nicholas W.; Corris, Paul A.; Uniphy Clinical Trials Network; Medicine, School of Medicine
    Background: Inflammation and dysregulated immunity are important in the development of pulmonary arterial hypertension (PAH). Compelling preclinical data supports the therapeutic blockade of interleukin-6 (IL-6) signalling. Methods: We conducted a phase 2 open-label study of intravenous tocilizumab (8 mg·kg-1) over 6 months in patients with group 1 PAH. Co-primary end-points were safety, defined by incidence and severity of adverse events, and change in pulmonary vascular resistance. Separately, a mendelian randomisation study was undertaken on 11 744 individuals with European ancestry including 2085 patients with idiopathic/heritable disease for the IL-6 receptor (IL6R) variant (rs7529229), known to associate with circulating IL-6R levels. Results: We recruited 29 patients (male/female 10/19; mean±sd age 54.9±11.4 years). Of these, 19 had heritable/idiopathic PAH and 10 had connective tissue disease-associated PAH. Six were withdrawn prior to drug administration; 23 patients received at least one dose of tocilizumab. Tocilizumab was discontinued in four patients owing to serious adverse events. There were no deaths. Despite evidence of target engagement in plasma IL-6 and C-reactive protein levels, both intention-to-treat and modified intention-to-treat analyses demonstrated no change in pulmonary vascular resistance. Inflammatory markers did not predict treatment response. Mendelian randomisation did not support an effect of the lead IL6R variant on risk of PAH (OR 0.99, p=0.88). Conclusion: Adverse events were consistent with the known safety profile of tocilizumab. Tocilizumab did not show any consistent treatment effect.
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    Modernizing Clinical Trial Eligibility Criteria: Recommendations of the ASCO-Friends of Cancer Research Performance Status Work Group
    (American Association for Cancer Research, 2021-05-01) Magnuson, Allison; Bruinooge, Suanna S.; Singh, Harpreet; Wilner, Keith D.; Jalal, Shadia; Lichtman, Stuart M.; Kluetz, Paul G.; Lyman, Gary H.; Klepin, Heidi D.; Fleury, Mark E.; Hirsch, Brad; Melemed, Allen; Arnaldez, Fernanda I.; Roy, Upal Basu; Schenkel, Caroline; Sherwood, Shimere; Garrett-Mayer, Elizabeth; Medicine, School of Medicine
    Purpose: Performance status (PS) is one of the most common eligibility criteria. Many trials are limited to patients with high-functioning PS, resulting in important differences between trial participants and patient populations with the disease. In addition, existing PS measures are subjective and susceptible to investigator bias. Experimental design: A multidisciplinary working group of the American Society of Clinical Oncology and Friends of Cancer Research evaluated how PS eligibility criteria could be more inclusive. The working group recommendations are based on a literature search, review of trials, simulation study, and multistakeholder consensus. The working group prioritized inclusiveness and access to investigational therapies, while balancing patient safety and study integrity. Results: Broadening PS eligibility criteria may increase the number of potentially eligible patients for a given clinical trial, thus shortening accrual time. It may also result in greater participant diversity, potentially reduce trial participant and patient disparities, and enable clinicians to more readily translate trial results to patients with low-functioning PS. Potential impact on outcomes was explored through a simulation trial demonstrating that when the number of Eastern Cooperative Oncology Group PS2 participants was relatively small, the effect on the estimated HR and power was modest, even when PS2 patients did not derive a treatment benefit. Conclusions: Expanding PS eligibility criteria to be more inclusive may be justified in many cases and could result in faster accrual rates and more representative trial populations.
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    Molecular Therapy’s growing impact
    (Elsevier, 2022) Herzog, Roland W.; Frederickson, Robert M.; Pediatrics, School of Medicine
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    Opportunities for Prevention of Concussion and Repetitive Head Impact Exposure in College Football Players: A Concussion Assessment, Research, and Education (CARE) Consortium Study
    (American Medical Association, 2021) McCrea, Michael A.; Shah, Alok; Duma, Stefan; Rowson, Steven; Harezlak, Jaroslaw; McAllister, Thomas W.; Broglio, Steven P.; Giza, Christopher C.; Goldman, Joshua; Cameron, Kenneth L.; Houston, Megan N.; McGinty, Gerald; Jackson, Jonathan C.; Guskiewicz, Kevin; Mihalik, Jason P.; Brooks, M. Alison; Pasquina, Paul; Stemper, Brian D.; Psychiatry, School of Medicine
    Importance: Concussion ranks among the most common injuries in football. Beyond the risks of concussion are growing concerns that repetitive head impact exposure (HIE) may increase risk for long-term neurologic health problems in football players. Objective: To investigate the pattern of concussion incidence and HIE across the football season in collegiate football players. Design, setting, and participants: In this observational cohort study conducted from 2015 to 2019 across 6 Division I National Collegiate Athletic Association (NCAA) football programs participating in the Concussion Assessment, Research, and Education (CARE) Consortium, a total of 658 collegiate football players were instrumented with the Head Impact Telemetry (HIT) System (46.5% of 1416 eligible football players enrolled in the CARE Advanced Research Core). Players were prioritized for instrumentation with the HIT System based on their level of participation (ie, starters prioritized over reserves). Exposure: Participation in collegiate football games and practices from 2015 to 2019. Main outcomes and measures: Incidence of diagnosed concussion and HIE from the HIT System. Results: Across 5 seasons, 528 684 head impacts recorded from 658 players (all male, mean age [SD], 19.02 [1.25] years) instrumented with the HIT System during football practices or games met quality standards for analysis. Players sustained a median of 415 (interquartile range [IQR], 190-727) recorded head impacts (ie, impacts) per season. Sixty-eight players sustained a diagnosed concussion. In total, 48.5% of concussions (n = 33) occurred during preseason training, despite preseason representing only 20.8% of the football season (0.059 preseason vs 0.016 regular-season concussions per team per day; mean difference, 0.042; 95% CI, 0.020-0.060; P = .001). Total HIE in the preseason occurred at twice the proportion of the regular season (324.9 vs 162.4 impacts per team per day; mean difference, 162.6; 95% CI, 110.9-214.3; P < .001). Every season, HIE per athlete was highest in August (preseason) (median, 146.0 impacts; IQR, 63.0-247.8) and lowest in November (median, 80.0 impacts; IQR, 35.0-148.0). Over 5 seasons, 72% of concussions (n = 49) (game proportion, 0.28; 95% CI, 0.18-0.40; P < .001) and 66.9% of HIE (262.4 practices vs 137.2 games impacts per player; mean difference, 125.3; 95% CI, 110.0-140.6; P < .001) occurred in practice. Even within the regular season, total HIE in practices (median, 175.0 impacts per player per season; IQR, 76.0-340.5) was 84.2% higher than in games (median, 95.0 impacts per player per season; IQR, 32.0-206.0). Conclusions and relevance: Concussion incidence and HIE among college football players are disproportionately higher in the preseason than regular season, and most concussions and HIE occur during football practices, not games. These data point to a powerful opportunity for policy, education, and other prevention strategies to make the greatest overall reduction in concussion incidence and HIE in college football, particularly during preseason training and football practices throughout the season, without major modification to game play. Strategies to prevent concussion and HIE have important implications to protecting the safety and health of football players at all competitive levels.
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    Parental Factors Associated With the Decision to Participate in a Neonatal Clinical Trial
    (JAMA, 2021-01-04) Weiss, Elliott Mark; Olszewski, Aleksandra E.; Guttmann, Katherine F.; Magnus, Brooke E.; Li, Sijia; Shah, Anita R.; Juul, Sandra E.; Wu, Yvonne W.; Ahmad, Kaashif A.; Bendel-Stenzel, Ellen; Isaza, Natalia A.; Lampland, Andrea L.; Mathur, Amit M.; Rao, Rakesh; Riley, David; Russell, David G.; Salih, Zeynep N.I.; Torr, Carrie B.; Weitkamp, Joern-Hendrik; Anani, Uchenna E.; Chang, Taeun; Dudley, Juanita; Flibotte, John; Havrilla, Erin M.; Kathen, Charmaine M.; O'Kane, Alexandra C.; Perez, Krystle; Stanley, Brenda J.; Wilfond, Benjamin S.; Shah, Seema K.; Pediatrics, School of Medicine
    Importance: It remains poorly understood how parents decide whether to enroll a child in a neonatal clinical trial. This is particularly true for parents from racial or ethnic minority populations. Understanding factors associated with enrollment decisions may improve recruitment processes for families, increase enrollment rates, and decrease disparities in research participation. Objective: To assess differences in parental factors between parents who enrolled their infant and those who declined enrollment for a neonatal randomized clinical trial. Design, setting, and participants: This survey study conducted from July 2017 to October 2019 in 12 US level 3 and 4 neonatal intensive care units included parents of infants who enrolled in the High-dose Erythropoietin for Asphyxia and Encephalopathy (HEAL) trial or who were eligible but declined enrollment. Data were analyzed October 2019 through July 2020. Exposure: Parental choice of enrollment in neonatal clinical trial. Main outcomes and measures: Percentages and odds ratios (ORs) of parent participation as categorized by demographic characteristics, self-assessment of child's medical condition, study comprehension, and trust in medical researchers. Survey questions were based on the hypothesis that parents who enrolled their infant in HEAL differ from those who declined enrollment across 4 categories: (1) infant characteristics and parental demographic characteristics, (2) perception of infant's illness, (3) study comprehension, and (4) trust in clinicians and researchers. Results: Of a total 387 eligible parents, 269 (69.5%) completed the survey and were included in analysis. This included 183 of 242 (75.6%) of HEAL-enrolled and 86 of 145 (59.3%) of HEAL-declined parents. Parents who enrolled their infant had lower rates of Medicaid participation (74 [41.1%] vs 47 [55.3%]; P = .04) and higher rates of annual income greater than $55 000 (94 [52.8%] vs 30 [37.5%]; P = .03) compared with those who declined. Black parents had lower enrollment rates compared with White parents (OR, 0.35; 95% CI, 0.17-0.73). Parents who reported their infant's medical condition as more serious had higher enrollment rates (OR, 5.7; 95% CI, 2.0-16.3). Parents who enrolled their infant reported higher trust in medical researchers compared with parents who declined (mean [SD] difference, 5.3 [0.3-10.3]). There was no association between study comprehension and enrollment. Conclusions and relevance: In this study, the following factors were associated with neonatal clinical trial enrollment: demographic characteristics (ie, race/ethnicity, Medicaid status, and reported income), perception of illness, and trust in medical researchers. Future work to confirm these findings and explore the reasons behind them may lead to strategies for better engaging underrepresented groups in neonatal clinical research to reduce enrollment disparities.