• Alyson Takaoka, Nicole Zytaruk, Megan Davis, Andrea Matte, Jennie Johnstone, François Lauzier, John Marshall, Neill Adhikari, France J Clarke, Bram Rochwerg, François Lamontagne, Lori Hand, Irene Watpool, Rebecca K Porteous, Marie-Hélène Masse, Frédérick D'Aragon, Daniel Niven, Diane Heels-Ansdell, Erick Duan, Joanna Dionne, Shane English, Charles St-Arnaud, Tina Millen, Deborah J Cook, and PROSPECT Investigators and the Canadian Critical Care Trials Group.
• Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada. Electronic address: takaokam@mcmaster.ca.
• J Crit Care. 2022 Oct 1; 71: 154094.

PurposeTo categorize, quantify and interpret findings documented in feedback letters of monitoring or auditing visits for an investigator-initiated, peer-review funded multicenter randomized trial testing probiotics for critically ill patients.Materials & MethodsIn 37 Canadian centers, monitoring and auditing visits were performed by 3 trained individuals; findings were reported in feedback letters. At trial termination, we performed duplicate content analysis on letters, categorizing observations first into unique findings, followed by 10 pre-determined trial quality management domains. We further classified each observation into a) missing operational records, b) errors in process, and potential threats to c) data integrity, d) patient privacy or e) safety.ResultsAcross 37 monitoring or auditing visits, 75 unique findings were categorized into 10 domains. Most frequently, observations were in domains of training documentation (180/566 [32%]) and the informed consent process (133/566 [23%]). Most observations were missing operational records (438/566 [77%]) rather than errors in process (128/566 [23%]). Of 75 findings, 13 (62/566 observations [11%]) posed a potential threat to data integrity, 1 (1/566 observation [0.18%]) to patient privacy, and 9 (49/566 observations [8.7%]) to patient safety.ConclusionsMonitoring and auditing findings predominantly concerned missing documentation with minimal threats to data integrity, patient privacy or safety.Trial RegistrationPROSPECT (Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial): NCT02462590.Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.

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