News Item
Multidisciplinary Sciences
McKenzie Prillaman
Summary: Researchers are cautiously optimistic about the positive results of lecanemab announced by companies.
News Item
Multidisciplinary Sciences
Zeeya Merali
Summary: Scientists awarded for the development of combination treatment Trikafta.
Article
Pharmacology & Pharmacy
Lingshan Wang, Kimberly Maxfield, Daphne Guinn, Rajanikanth Madabushi, Issam Zineh, Robert N. Schuck
Summary: The study suggests that early interactions between FDA and sponsors can support dose studies in efficacy trials that may lead to individualized dosing strategies in labeling.
CLINICAL PHARMACOLOGY & THERAPEUTICS
(2021)
Article
Pharmacology & Pharmacy
Lisette Pregelj, Damian C. Hine, Aaron S. Kesselheim, Jonathan J. Darrow
Summary: The study found that the Breakthrough Therapy designation had limited impact on clinical trial design, and early designation may lead to shorter trial durations.
CLINICAL PHARMACOLOGY & THERAPEUTICS
(2021)
Review
Oncology
R. Angelo de Claro, Jennifer J. Gao, Tamy Kim, Paul G. Kluetz, Marc R. Theoret, Julia A. Beaver, Richard Pazdur
Summary: The Real-Time Oncology Review (RTOR) pilot project by the FDA Oncology Center of Excellence aimed to expedite drug application submissions and provide faster approvals. The project supported the submission and review of 20 oncology drug applications, with the majority being supplemental approvals and two being new molecular entity (NME) drug approvals. All applications received priority review, and innovative regulatory processes like RTOR are crucial for efficient FDA product reviews.
CLINICAL CANCER RESEARCH
(2021)
Article
Pharmacology & Pharmacy
Ying Zhang, Li Ran, Yongchao Liang, Yanqiu Zhang, Zhuoling An
Summary: This study investigated the safety of pemigatinib through data-mining of the US FDA Adverse Event Reporting System. The results revealed significant associations between pemigatinib use and adverse events. Some adverse events signals were stronger with pemigatinib compared to other drugs, and certain adverse events were not mentioned in the drug label.
FRONTIERS IN PHARMACOLOGY
(2023)
Article
Nutrition & Dietetics
Lindsey Smith Taillie, Christina Chauvenet, Anna H. Grummon, Marissa G. Hall, Wilma Waterlander, Carmen E. Prestemon, Lindsay M. Jaacks
Summary: Warnings did not have a significant effect on item preference in the choice experiment, but combined and health warnings performed better than the environment warning across a variety of warning label reaction measures.
INTERNATIONAL JOURNAL OF BEHAVIORAL NUTRITION AND PHYSICAL ACTIVITY
(2021)
Review
Medicine, General & Internal
Phoebe Clark, Jayne Kim, Yindalon Aphinyanaphongs
Summary: A systematic review of FDA-approved AI- or ML-enabled medical devices found that one-fifth of the devices surveyed had discrepancies between their clearance documentation and marketing material. The inconsistencies were more prominent in radiological and cardiovascular devices.
Article
Parasitology
Harouna M. Soumare, Edgard Diniba Dabira, Muhammed M. Camara, Lamin Jadama, Pa Modou Gaye, Sainey Kanteh, Ebrima A. Jawara, Amie Kolleh Njie, Fatou Sanneh, Mamadou Ousman Ndiath, Steven W. Lindsay, Bakary Conteh, Sainey Ceesay, Nuredin Mohammed, Michael Ooko, John Bradley, Chris Drakeley, Annette Erhart, Teun Bousema, Umberto D'Alessandro
Summary: This study evaluated the entomological impact of mass drug administration (MDA) with combined drugs on mosquito density, entomological inoculation rate, and vector parity through a cluster-randomized trial. The results showed that MDA can decrease mosquito density and entomological inoculation rate, but its effect on vector parity is not clear.
PARASITES & VECTORS
(2022)
Article
Medicine, General & Internal
Samuel J. Lee, Lauren Cho, Eyal Klang, James Wall, Stefano Rensi, Benjamin S. Glicksberg
Summary: This study identified a gap in both quantity and diversity of high-risk devices indicated for the pediatric population through analyzing PMA statements. The scarcity of pediatric devices limits therapeutic possibilities for children, and efforts should be made to address this gap and prioritize clinical specialties in need of pediatric device innovation.
Article
Multidisciplinary Sciences
Daniel Fatori, Pedro Fonseca Zuccolo, Elizabeth Shephard, Helena Brentani, Alicia Matijasevich, Alexandre Archanjo Ferraro, Lislaine Aparecida Fracolli, Anna Maria Chiesa, James Leckman, Euripedes Constantino Miguel, Guilherme V. Polanczyk
Summary: This study investigated the effects of a nurse home visiting program on child development, maternal and environmental outcomes in adolescent mothers. The results showed that Primeiros Lacos had significant positive effects on child expressive language development, maternal emotional/verbal responsivity, and opportunities for variety in daily stimulation. The intervention showed small to moderate standardized effect sizes in improving outcomes for low-income adolescent mothers.
SCIENTIFIC REPORTS
(2021)
Letter
Medicine, General & Internal
Mark P. Lythgoe, Paul Middleton
Summary: This qualitative improvement study examines COVID-19 vaccine approvals by medicine regulatory agencies in the US, EU, and Canada, comparing regulatory review times and analyzing clinical evidence supporting authorization.
Article
Medicine, General & Internal
Alene Kennedy-Hendricks, Emma E. McGinty, Amber Summers, Susan Krenn, Michael Fingerhood, Colleen L. Barry
Summary: This study examined the impact of different messengers delivering messages about opioid use disorder (OUD) on stigma and attitudes toward people with OUD among healthcare professionals. The results showed that delivering messages about non-stigmatizing language and medication treatment reduced stigma among healthcare professionals.
Letter
Medicine, General & Internal
Huseyin Naci, Xiaodong Guan, Steven Woloshin, Ziyue Xu, Anita K. Wagner
Summary: This study examines how information on overall survival benefits of novel cancer drug indications is communicated in labeling.
JAMA INTERNAL MEDICINE
(2021)
Article
Immunology
Jessica M. Fogel, Ethan A. Wilson, Estelle Piwowar-Manning, Autumn Breaud, William Clarke, Christos Petropoulos, Ayana Moore, Christophe Fraser, Barry Kosloff, Kwame Shanaube, Gert van Zyl, Michelle Scheepers, Sian Floyd, Peter Bock, Helen Ayles, Sarah Fidler, Richard Hayes, Deborah Donnell, Susan H. Eshleman
Summary: The study suggests that universal HIV testing and treatment (UTT) did not lead to an increase in drug resistance. The findings showed that non-seroconverters had higher rates of drug resistance and multi-class resistance compared to seroconverters.
JOURNAL OF THE INTERNATIONAL AIDS SOCIETY
(2022)
Article
Obstetrics & Gynecology
Marlyse F. Haward, John M. Lorenz, Annie Janvier, Baruch Fischhoff
Summary: This study explores the experiences of extremely preterm infant loss in the delivery room and the perspectives on antenatal consultation. The interactions between participants and healthcare providers strongly influence their experiences, well-being, and healing. Personalized information, individualized approaches, and emotional support are considered key elements to enhance antenatal consultation.
AMERICAN JOURNAL OF PERINATOLOGY
(2023)
Article
Behavioral Sciences
Tiffany Wang, Tamar Krishnamurti, Miriam Bernard, Samia Lopa, Beth Quinn, Hyagriv Simhan
Summary: The study investigates the perceptions and knowledge of obstetric healthcare workers (HCWs) regarding the COVID-19 vaccine. The findings show that both vaccinated and non-vaccinated obstetric HCWs had accurate knowledge about the vaccine, but vaccinated HCWs tended to endorse beliefs regarding herd immunity and the safety of the vaccine for pregnant and lactating individuals. Additional education and outreach may be needed to help obstetric individuals make informed decisions about receiving the COVID-19 vaccine.
BEHAVIORAL MEDICINE
(2023)
Article
Environmental Studies
Caitlin Drummond Otten, Baruch Fischhoff
Summary: The study found that research funded by NSF generally satisfied both NSF's and Smith's criteria, with explicit references to societal impacts slightly improving ratings. However, noting NSF support specifically did not improve ratings.
SCIENCE AND PUBLIC POLICY
(2022)
Article
Medicine, Research & Experimental
Emily N. Grayek, Baruch Fischhoff, Alexander L. Davis, Tamar Krishnamurti
Summary: This study proposes a method to evaluate the cost-effectiveness of adherence monitoring methods in clinical trials. The results show that the most cost-effective method depends on trial participant adherence and drug forgiveness. The study also estimates the effects of evaluable patient analysis.
Article
Behavioral Sciences
Ryan Kenny, Baruch Fischhoff, Alex Davis, Kathleen M. Carley, Casey Canfield
Summary: The study found that individuals have limited ability to detect social bots, with lower sensitivity to mistaking bots for humans. Participants with more social media experience, stronger bias, and less analytical reasoning ability performed worse in detecting bots.
Article
Geosciences, Multidisciplinary
Dana Rose Garfin, E. Alison Holman, Baruch Fischhoff, Gabrielle Wong-Parodi, Roxane Cohen Silver
Summary: This study examined media exposure, psychological fear and worry, risk perceptions, and health protective behaviors during the 2014 Ebola virus outbreak. Findings showed that more hours and more graphic media exposure were associated with higher levels of fear and worry, as well as higher perceived risk. Higher risk perceptions and fear and worry were linked to more health protective behaviors. The amount and content of media exposure had indirect effects on behaviors performed and intentions.
INTERNATIONAL JOURNAL OF DISASTER RISK REDUCTION
(2022)
Article
Public, Environmental & Occupational Health
Victor L. Rodriguez, Baruch Fischhoff, Alexander L. Davis
Summary: The movie industry developed guidelines for returning to operation after the COVID-19 pandemic and used heatmaps to communicate the risks to workers. The study found that these heatmaps effectively conveyed complex risk information to lay audiences, but faced challenges when applied to complex settings.
Article
Psychology, Applied
Caitlin Drummond Otten, Baruch Fischhoff
Summary: Scientific reasoning ability can help individuals use scientific evidence in making judgments and decisions. This study found that individuals with greater scientific reasoning ability are better calibrated with respect to their ability. Additionally, scientific reasoning ability is associated with success in avoiding negative decision outcomes and holding beliefs consistent with the scientific consensus.
JOURNAL OF BEHAVIORAL DECISION MAKING
(2023)
Article
Obstetrics & Gynecology
Marlyse F. F. Haward, John M. M. Lorenz, Annie Janvier, Baruch Fischhoff
Summary: This study aims to analyze and compare perspectives on antenatal consultation and decision-making from participants with different levels of prematurity experience and clinician experts. Open-ended interviews were conducted and mixed methods analysis was used. The results showed that non-clinician participants had different views on the amount and content of desired information, decision-making strategies, and who should direct consultations, parents or clinicians.
JOURNAL OF PERINATOLOGY
(2023)
Article
Health Care Sciences & Services
Waendi Bruine de Bruin, Yasmina Okan, Tamar Krishnamurti, Mark D. Huffman
Summary: This study found that patients with hypertension may lack confidence in their understanding of normal/healthy blood pressure, which may affect their willingness to seek necessary care. Patients who are confident are more likely to take action against high blood pressure. Therefore, improving patients' confidence in blood pressure knowledge can improve hypertension management behavior.
MEDICAL DECISION MAKING
(2023)
Article
Health Care Sciences & Services
Kristin N. Ray, Samuel R. Wittman, Sarah Burns, Tran Doan, Kelsey A. Schweiberger, Jonathan G. Yabes, Janel Hanmer, Tamar Krishnamurti
Summary: During the COVID-19 pandemic, telemedicine provided by primary care practices became widely accessible for children. This study aimed to identify the factors associated with the use of primary care telemedicine among children with a usual source of care. Factors such as having a chronic medical condition, living in a metropolitan area, internet connectivity concerns, and higher health literacy were found to be associated with the use of primary care telemedicine.
JOURNAL OF MEDICAL INTERNET RESEARCH
(2023)
Article
Biochemistry & Molecular Biology
Steven Woloshin, Yanran Yang, Baruch Fischhoff
Summary: Well-designed visual displays have the power to effectively convey health messages to non-experts, while poorly designed ones can confuse and alienate recipients. This Perspective proposes a structured framework for effective visual communication of health information, using case examples and practical evaluation methods. The framework is grounded in research and experience in health risk communication, visualization, and decision science.
Article
Computer Science, Artificial Intelligence
Kristen C. Allen, Alex Davis, Tamar Krishnamurti
Summary: During the perinatal period, psychosocial health risks are associated with serious adverse health outcomes. Stigma often prevents people from disclosing relevant information, hindering healthcare professionals from identifying those at risk. This research utilizes short diary entries to indirectly elicit information and examines patterns in the language of individuals at risk. The findings suggest that diary entries exhibit consistent themes and emotional perspectives, which can be used to predict screening measures for depression and psychological aggression by an intimate partner.
IEEE TRANSACTIONS ON AFFECTIVE COMPUTING
(2023)
Article
Economics
Hanzelle Kleeman, Baruch Fischhoff, Daniel Erian Armanios
Summary: Researchers modified a behavior change model to understand decision-making of low-income residents regarding energy efficiency programs, and developed a more informative communication framework. Testing the framework by redesigning web pages, the study found that the change improved low-income respondents' assessment, increased their intentions to apply for and complete the program. These findings have practical implications for organizations and policymakers aiming to increase participation in energy efficiency programs.
Review
Health Care Sciences & Services
Emily Grayek, Tamar Krishnamurti, Lydia Hu, Olivia Babich, Katherine Warren, Baruch Fischhoff
Summary: This systematic review examines adherence and engagement metrics in clinical trials of software as a medical device (SaMD) apps. The study finds inconsistencies in how researchers measure adherence and address the risk of bias, leading to potential inaccuracies in effectiveness estimates. The review suggests using consistent metrics, reliable adherence measures, and less biased efficacy analysis methods to improve future SaMD trials and studies.
JMIR MHEALTH AND UHEALTH
(2023)
