Advancing Translational Science through Real-World Data and Real-World Evidence

Editorial

Advancing Regulatory Science through Real-World Data and Real-World Evidence

Pablo Cure, Joshua P. Fessel, Christopher M. Hartshorn and Scott J. Steele

Published online by Cambridge University Press: 21 May 2024

Research Article

Case Study of Semaglutide and Cardiovascular Outcomes: An Application of the Causal Roadmap to a Hybrid Design for Augmenting an RCT Control Arm with Real-World Data

Lauren E. Dang, Edwin Fong, Jens Magelund Tarp, Kim Katrine Bjerring Clemmensen, Henrik Ravn, Kajsa Kvist, John B. Buse, Mark van der Laan and Maya Petersen

Published online by Cambridge University Press: 23 October 2023

Review Article

A Causal Roadmap for Generating High-Quality Real-World Evidence

Lauren E. Dang, Susan Gruber, Hana Lee, Issa J. Dahabreh, Elizabeth A. Stuart, Brian D. Williamson, Richard Wyss, Iván Díaz, Debashis Ghosh, Emre Kıcıman, Demissie Alemayehu, Katherine L. Hoffman, Carla Y. Vossen, Raymond A. Huml, Henrik Ravn, Kajsa Kvist, Richard Pratley, Mei-Chiung Shih, Gene Pennello, David Martin, Salina P. Waddy, Charles E. Barr, Mouna Akacha, John B. Buse, Mark van der Laan and Maya Petersen

Published online by Cambridge University Press: 22 September 2023

Research Article

COVID-19 Vaccination and Venous Thromboembolism Risk in Older Veterans

Peter L. Elkin, Steven H. Brown, Skyler Resendez ,Wilmon McCray, Melissa Resnick, Kendria Hall, Gillian Franklin, Jean M. Connors and Mary Cushman

Published online by Cambridge University Press: 01 February 2023

Antibiotic prescribing by age, sex, race, and ethnicity for patients admitted to the hospital with community-acquired bacterial pneumonia (CABP) in the All of Us database

Corbyn M. Gilmore, Grace C. Lee, Susanne Schmidt, and Christopher R. Frei

Published online by Cambridge University Press: 26 May 2023

Brief Report

COVID-19 in hospitalized adult patients with sickle cell disease: A 2020 United States cohort using Cerner Real-World Data™ (CRWD)

Stephanie Howe Guarino, Kimberly D. Williams, Richard J. Caplan, Mitch Fawcett and Sophie Lanzkron

Published online by Cambridge University Press: 16 June 2023

Research Article

Educational Video While “waiting-to-be-seen” in a Cardiology Outpatient Clinic Promotes Opt-in Self-consent for Biobanking of Remnant Clinical Biospecimens: A Randomized-Controlled Trial

Javier E. López, Andrew Kyle, Armon J. Hosseini, Machelle Wilson and Stephanie Soares

Published online by Cambridge University Press: 11 April 2023

Electronic Health Record Data Quality Variability Across a Multistate Clinical Research Network

Yahia Mohamed, Xing Song, Tamara M. McMahon, Suman Sahil, Meredith Zozus, Zhan Wang, Lemuel R. Waitman and Greater Plains Collaborative

Published online by Cambridge University Press: 15 May 2023

The Use of N-of-1 Trials to Generate Real-world Evidence for Optimal Treatment of Individuals and Populations

Harry P. Selker, Dorothy Dulko, David J. Greenblatt, Marisha Palm, and Ludovic Trinquart

Published online by Cambridge University Press: 06 September 2023

Identification of delirium from real-world electronic health record clinical notes

Jennifer St. Sauver, Sunyang Fu, Sunghwan Sohn, Susan Weston, Chun Fan, Janet Olson, Bjoerg Thorsteinsdottir, Nathan LeBrasseur, Sandeep Pagali, Walter Rocca and Hongfang Liu

Published online by Cambridge University Press: 24 August 2023

Special Communications

"Applying Real-World Data from Expanded-Access (“Compassionate Use”) Patients to Drug Development"

June S. Wasser and David J. Greenblatt

Published online by Cambridge University Press: 07 August 2023

Research Article

An Application of the Causal Roadmap in Two Safety Monitoring Case Studies: Causal Inference and Outcome Prediction using Electronic Health Record Data

Brian D. Williamson, Richard Wyss, Elizabeth A. Stuart, Lauren E. Dang, Andrew N. Mertens, Romain S. Neugebauer, Andrew Wilson and Susan Gruber

Published online by Cambridge University Press: 21 September 2023

Sensitivity analysis for causality in observational studies for regulatory science

Iván Díaz, Hana Lee, Emre Kıcıman, Edward J. Schenck, Mouna Akacha, Dean Follman and Debashis Ghosh

Published online by Cambridge University Press: 05 December 2023

Real World Data to Evaluate Effects of a Multi-Level Dissemination Strategy on Access, Outcomes, and Equity of Monoclonal Antibodies for COVID-19

Mika K. Hamer, Chelsea Sobczak, Lindsey Whittington, Rachel L. Bowyer, Ramona Koren, Joel A. Begay, Hillary D. Lum, Adit A. Ginde, Matthew K. Wynia and Bethany M. Kwan

Published online by Cambridge University Press: 13 November 2023

Brief Report

Disparities in Maternal Mortality

Phuong Tran, Barbara Jreij, Farideh Sistani and Fadia T. Shaya

Published online by Cambridge University Press: 20 April 2023

Research Article

Telemedicine and Health Disparities: Association between the Area Deprivation Index and Primary Care Telemedicine Utilization during the COVID-19 Pandemic

Mina Ostovari, Zugui Zhang, Vishal Patel and Claudine Jurkovitz

Published online by Cambridge University Press: 10 July 2023

Letter

Preoperative mental illness and postoperative atrial fibrillation in cardiac surgery patients: Identifying a vulnerable population

Natalie K. Kolba, Byungho Lee, Henry J. Tannous, Thomas V. Bilfinger and Annie L. Shroyer

Published online by Cambridge University Press: 15 November 2022

Research Article

Evidence of Housing Instability Identified by Addresses, Clinical Notes, and Diagnostic Codes in a Real-world Population with Substance Use Disorders

Daniel R. Harris, Nicholas Anthony, Dana Quesinberry and Chris Delcher

Published online by Cambridge University Press: 04 September 2023

Feasibility and Anticipated Acceptability of Community Health Worker-facilitated HPV Self-sampling for Cervical Cancer Screening around Lake County, Indiana

Tiwaladeoluwa B. Adekunle, Alyssa Arreola, Sathveka Sembian, Raquel Castro, Layla Claure, Lara Balian and Natalia M. Rodriguez

Published online by Cambridge University Press: 23 June 2023

Use of population health data to promote equitable recruitment for a primary care practice implementation trial addressing unhealthy alcohol use

Alex H. Krist, Alison N. Huffstetler, Gabriela Villalobos, Michelle S. Rockwell, Alicia Richards, Adam Funk, Roy T. Sabo, Beth Bortz, Ben Webel, Jong Hyung Lee, Kyle Russel, Anton Kuzel, Jaqueline B. Britz and F. Gerard Moeller

Published online by Cambridge University Press: 14 April 2023

Special Communications

Clinical and Translational Science Personas: Expansion and Use Cases

Sara Gonzales, Robin Champieux, Nicole Contaxis, Andrea H. Denton, Mohammad Hosseini, Alisa Surkis, Annie Wescott, and Kristi Holmes

Published online by Cambridge University Press: 08 June 2023

Research Article

Clinical Applications of Contactless Photoplethysmography for Vital Signs Monitoring in Paediatrics: A Systematic Review and Meta-Analysis

Melissa Bautista, Daniel Cave, Candice Downey, James R. Bentham and David Jayne

Published online by Cambridge University Press: 25 May 2023

Clinical applications of contactless photoplethysmography for monitoring in adults: A systematic review and meta-analysis

Melissa Joanne Bautista, Mikolaj Kowal, Daniel G. W. Cave, Candice Downey and David G. Jayne

Published online by Cambridge University Press: 15 May 2023

Brief Report

A Pilot Study: Comparing a Novel Noninvasive Measure of Cerebrovascular Stability Index with an Invasive Measure of Cerebral Autoregulation in Neonates with Congenital Heart Disease

Carlin A. Merkel, Kenneth M. Brady, Jodie K. Votava-Smith and Nhu N. Tran

Published online by Cambridge University Press: 10 July 2023

Research Article

A Survey of United States Adult Privacy Perspectives and Willingness to Share Real-World Data

Rachele M. Hendricks-Sturrup, and Christine Y. Lu

Published online by Cambridge University Press: 01 February 2023

Review Article

FAIR Enough: Building an Academic Data Core to Make Real World Data Available for Research

Isabella Chu, Rebecca Miller, Ian Mathews, Ayin Vala, Lesley Sept, Ruth O’Hara and David H. Rehkopf

Published online by Cambridge University Press: 02 May 2024

Perspective

Real-World Data for 21st Century Medicine: The Clinical and Translational Science Awards Program Perspective

Pablo Cure, Sanae ElShourbagy Ferreira, Joshua P. Fessel, Deborah Ossip, Martin S. Zand, Scott J. Steele, Kenneth Gersing, and Christopher M. Hartshorn

Published online by Cambridge University Press: 11 September 2023

Special Communications

The Evolve to Next-Gen ACT Network: An evolving open-access, real-world data resource primed for real-world evidence research across the Clinical and Translational Science Award Consortium

Elaine H. Morrato, Lindsay A. Lennox, James W. Dearing, Anne T. Coughlan, Elaina S. Gano, Doug McFadden, Nallely Mora, Harold Alan Pincus, Gary S. Firestein, Robert Toto and Steven E. Reis

Published online by Cambridge University Press: 29 September 2023

Research Article

A Framework for Future National Pediatric Pandemic Respiratory Disease Severity Triage: The HHS Pediatric COVID-19 Data Challenge

Timothy Bergquist, Marie Wax, Tellen D. Bennett, Richard A. Moffitt, Jifan Gao, Guanhua Chen, Amalio Telenti, M. Cyrus Maher, Istvan Bartha, Lorne Walker, Benjamin E. Orwoll, Meenakshi Mishra, Joy Alamgir, Bruce L. Cragin, Christopher H. Ferguson, Hui-Hsing Wong, Anne Deslattes Mays, Leonie Misquitta, Kerry A. DeMarco, Kimberly L. Sciarretta and Sandeep A. Patel

Published online by Cambridge University Press: 10 July 2023