Benjamin Lebwohl, Christopher Ma, Stephen M Lagana, Rish K Pai, K Adam Baker, Alexa Zayadi, Malcolm Hogan, Gerd Bouma, Christophe Cellier, Jeffrey D Goldsmith, Knut E A Lundin, Maria I Pinto-Sanchez, Marie E Robert, Alberto Rubio-Tapia, David S Sanders, David F Schaeffer, Carol E Semrad, Jocelyn A Silvester, Elena F Verdú, Ritu Verma, Tsung-Teh Wu, Brian G Feagan, Eileen Crowley, Vipul Jairath, Joseph A Murray
BACKGROUND & AIMS: There is a need to develop safe and effective pharmacologic options for the treatment of celiac disease (CeD); however, consensus on the appropriate design and configuration of randomized controlled trials (RCTs) in this population is lacking. METHODS: A 2-round modified Research and Development/University of California Los Angeles Appropriateness Method study was conducted. Eighteen gastroenterologists (adult and pediatric) and gastrointestinal pathologists voted on statements pertaining to the configuration of CeD RCTs, inclusion and exclusion criteria, gluten challenge, and trial outcomes...
September 11, 2023: Gastroenterology