TY - JOUR
T1 - Design of Clinical Trials Evaluating Sedation in Critically Ill Adults Undergoing Mechanical Ventilation
T2 - Recommendations From Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research (SCEPTER) Recommendation III
AU - Ward, Denham S
AU - Absalom, Anthony R
AU - Aitken, Leanne M
AU - Balas, Michele C
AU - Brown, David L
AU - Burry, Lisa
AU - Colantuoni, Elizabeth
AU - Coursin, Douglas
AU - Devlin, John W
AU - Dexter, Franklin
AU - Dworkin, Robert H
AU - Egan, Talmage D
AU - Elliott, Doug
AU - Egerod, Ingrid
AU - Flood, Pamela
AU - Fraser, Gilles L
AU - Girard, Timothy D
AU - Gozal, David
AU - Hopkins, Ramona O
AU - Kress, John
AU - Maze, Mervyn
AU - Needham, Dale M
AU - Pandharipande, Pratik
AU - Riker, Richard
AU - Sessler, Daniel I
AU - Shafer, Steven L
AU - Shehabi, Yahya
AU - Spies, Claudia
AU - Sun, Lena S
AU - Tung, Avery
AU - Urman, Richard D
N1 - Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the Society of Critical Care Medicine and Wolters Kluwer Health, Inc.
PY - 2021/10/1
Y1 - 2021/10/1
N2 - OBJECTIVES: Clinical trials evaluating the safety and effectiveness of sedative medication use in critically ill adults undergoing mechanical ventilation differ considerably in their methodological approach. This heterogeneity impedes the ability to compare results across studies. The Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations convened a meeting of multidisciplinary experts to develop recommendations for key methodologic elements of sedation trials in the ICU to help guide academic and industry clinical investigators.DESIGN: A 2-day in-person meeting was held in Washington, DC, on March 28-29, 2019, followed by a three-round, online modified Delphi consensus process.PARTICIPANTS: Thirty-six participants from academia, industry, and the Food and Drug Administration with expertise in relevant content areas, including two former ICU patients attended the in-person meeting, and the majority completed an online follow-up survey and participated in the modified Delphi process.MEASUREMENTS AND MAIN RESULTS: The final recommendations were iteratively refined based on the survey results, participants' reactions to those results, summaries written by panel moderators, and a review of the meeting transcripts made from audio recordings. Fifteen recommendations were developed for study design and conduct, subject enrollment, outcomes, and measurement instruments. Consensus recommendations included obtaining input from ICU survivors and/or their families, ensuring adequate training for personnel using validated instruments for assessments of sedation, pain, and delirium in the ICU environment, and the need for methodological standardization.CONCLUSIONS: These recommendations are intended to assist researchers in the design, conduct, selection of endpoints, and reporting of clinical trials involving sedative medications and/or sedation protocols for adult ICU patients who require mechanical ventilation. These recommendations should be viewed as a starting point to improve clinical trials and help reduce methodological heterogeneity in future clinical trials.
AB - OBJECTIVES: Clinical trials evaluating the safety and effectiveness of sedative medication use in critically ill adults undergoing mechanical ventilation differ considerably in their methodological approach. This heterogeneity impedes the ability to compare results across studies. The Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations convened a meeting of multidisciplinary experts to develop recommendations for key methodologic elements of sedation trials in the ICU to help guide academic and industry clinical investigators.DESIGN: A 2-day in-person meeting was held in Washington, DC, on March 28-29, 2019, followed by a three-round, online modified Delphi consensus process.PARTICIPANTS: Thirty-six participants from academia, industry, and the Food and Drug Administration with expertise in relevant content areas, including two former ICU patients attended the in-person meeting, and the majority completed an online follow-up survey and participated in the modified Delphi process.MEASUREMENTS AND MAIN RESULTS: The final recommendations were iteratively refined based on the survey results, participants' reactions to those results, summaries written by panel moderators, and a review of the meeting transcripts made from audio recordings. Fifteen recommendations were developed for study design and conduct, subject enrollment, outcomes, and measurement instruments. Consensus recommendations included obtaining input from ICU survivors and/or their families, ensuring adequate training for personnel using validated instruments for assessments of sedation, pain, and delirium in the ICU environment, and the need for methodological standardization.CONCLUSIONS: These recommendations are intended to assist researchers in the design, conduct, selection of endpoints, and reporting of clinical trials involving sedative medications and/or sedation protocols for adult ICU patients who require mechanical ventilation. These recommendations should be viewed as a starting point to improve clinical trials and help reduce methodological heterogeneity in future clinical trials.
KW - Congresses as Topic
KW - Consensus
KW - Delphi Technique
KW - District of Columbia
KW - Humans
KW - Hypnotics and Sedatives/pharmacokinetics
KW - Respiration, Artificial/instrumentation
KW - Time Factors
UR - http://www.scopus.com/inward/record.url?scp=85110474286&partnerID=8YFLogxK
U2 - 10.1097/CCM.0000000000005049
DO - 10.1097/CCM.0000000000005049
M3 - Journal article
C2 - 33938718
SN - 0090-3493
VL - 49
SP - 1684
EP - 1693
JO - Critical Care Medicine
JF - Critical Care Medicine
IS - 10
ER -