National Headlines

JAMA | Guidelines for Reporting Outcomes in Trial Protocols

By on
Special Communication
December 13, 2022

Citation

Butcher NJ, Monsour A, Mew EJ, et al. Guidelines for Reporting Outcomes in Trial Protocols: The SPIRIT-Outcomes 2022 Extension. JAMA. 2022;328(23):2345–2356. doi:10.1001/jama.2022.21243

Guidelines for Reporting Outcomes in Trial ProtocolsThe SPIRIT-Outcomes 2022 Extension

Nancy J. Butcher, PhD1,2; Andrea Monsour, MPH1; Emma J. Mew, MPH, MPhil1,3; et al An-Wen Chan, MD, DPhil4; David Moher, PhD5,6; Evan Mayo-Wilson, DPhil7; Caroline B. Terwee, PhD8,9; Alyssandra Chee-A-Tow, MPH1; Ami Baba, MRes1; Frank Gavin, MA10; Jeremy M. Grimshaw, MBCHB, PhD11,12; Lauren E. Kelly, PhD13,14; Leena Saeed, BSc, BEd1; Lehana Thabane, PhD15; Lisa Askie, PhD16; Maureen Smith, MEd17; Mufiza Farid-Kapadia, MD, PhD1; Paula R. Williamson, PhD18; Peter Szatmari, MD19,20; Peter Tugwell, MD6,12,21,22; Robert M. Golub, MD23; Suneeta Monga, MD2,20; Sunita Vohra, MD24; Susan Marlin, MSc25,26; Wendy J. Ungar, PhD1,27; Martin Offringa, MD, PhD1,27,28
Author Affiliations Article Information
JAMA. 2022;328(23):2345-2356. doi:10.1001/jama.2022.21243
Key PointsQuestion  What outcome-specific information should be included in a clinical trial protocol?

Findings  Using an evidence-based and international consensus–based approach that applied methods from the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework, 9 outcome-specific reporting items to be addressed in clinical trial protocols were identified.

Meaning  Inclusion of these items in clinical trial protocols may enhance trial utility, replicability, and transparency and may help limit selective nonreporting of trial results.

Categories: National Headlines