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Full-Text Articles in Critical Care
Protocol Adherence For Continuously Titrated Interventions In Randomized Trials: An Overview Of The Current Methodology And Case Study., F Lauzier, N K Adhikari, A Seely, K K Y Koo, E P Belley-Côté, K E A Burns, D J Cook, F D'Aragon, B Rochwerg, M E Kho, S J W Oczkowksi, E H Duan, M O Meade, A G Day, F Lamontagne
Protocol Adherence For Continuously Titrated Interventions In Randomized Trials: An Overview Of The Current Methodology And Case Study., F Lauzier, N K Adhikari, A Seely, K K Y Koo, E P Belley-Côté, K E A Burns, D J Cook, F D'Aragon, B Rochwerg, M E Kho, S J W Oczkowksi, E H Duan, M O Meade, A G Day, F Lamontagne
Articles, Abstracts, and Reports
BACKGROUND: The standard definition for protocol adherence is the proportion of all scheduled doses that are delivered. In clinical research, this definition has several limitations when evaluating protocol adherence in trials that study interventions requiring continuous titration.
DISCUSSION: Building upon a specific case study, we analyzed a recent trial of a continuously titrated intervention to assess the impact of different definitions of protocol deviations on the interpretation of protocol adherence. The OVATION pilot trial was an open-label randomized controlled trial of higher (75-80 mmHg) versus lower (60-65 mmHg) mean arterial pressure (MAP) targets for vasopressor therapy in shock. In this …