Evaluating Patient-Centered Outcomes in Clinical Trials of Procedural Sedation, Part 1 Efficacy: Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations

Mark R. Williams, Denham S. Ward, Douglas Carlson, Joseph Cravero, Franklin Dexter, Jenifer R. Lightdale, Keira P. Mason, James Miner, John J. Vargo, John W. Berkenbosch, Randall M. Clark, Isabelle Constant, Raymond Dionne, Robert H. Dworkin, David Gozal, David Grayzel, Michael G. Irwin, Jerrold Lerman, Robert E. O'Connor, Pratik PandharipandeBob A. Rappaport, Richard R. Riker, Joseph R. Tobin, Dennis C. Turk, Rebecca S. Twersky, Daniel I. Sessler

Research output: Contribution to journalArticlepeer-review

16 Scopus citations

Abstract

The Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research, established by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks public-private partnership with the US Food and Drug Administration, convened a meeting of sedation experts from a variety of clinical specialties and research backgrounds with the objective of developing recommendations for procedural sedation research. Four core outcome domains were recommended for consideration in sedation clinical trials: (1) safety, (2) efficacy, (3) patient-centered and/or family-centered outcomes, and (4) efficiency. This meeting identified core outcome measures within the efficacy and patient-centered and/or family-centered domains. Safety will be addressed in a subsequent meeting, and efficiency will not be addressed at this time. These measures encompass depth and levels of sedation, proceduralist and patient satisfaction, patient recall, and degree of pain experienced. Consistent use of the recommended outcome measures will facilitate the comprehensive reporting across sedation trials, along with meaningful comparisons among studies and interventions in systematic reviews and meta-analyses.

Original languageEnglish (US)
Pages (from-to)821-830
Number of pages10
JournalAnesthesia and analgesia
Volume124
Issue number3
DOIs
StatePublished - Mar 1 2017

Bibliographical note

Funding Information:
The views expressed in this article are those of the authors, none of whom have financial conflicts of interest specifically related to the issues discussed in this article. At the time of the meeting (April 4-5, 2014) on which this article is based, several authors were employed by a pharmaceutical company or had received consulting fees or honoraria from one or more pharmaceutical or device companies. Authors of this article who were not employed by industry at the time of the meeting received (or their universities received) travel stipends, hotel accommodations, and meals during the meeting from the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public- private partnership. No official endorsement by the Food and Drug Administration (FDA) or the pharmaceutical and device companies that have provided unrestricted grants to support the activities of ACTTION should be inferred. Financial support for this project was provided by ACTTION, which has received research contracts, grants, or other revenue from the FDA, multiple pharmaceutical and device companies, and other sources.

Publisher Copyright:
Copyright © 2016 International Anesthesia Research Society.

Copyright:
Copyright 2018 Elsevier B.V., All rights reserved.

Fingerprint

Dive into the research topics of 'Evaluating Patient-Centered Outcomes in Clinical Trials of Procedural Sedation, Part 1 Efficacy: Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations'. Together they form a unique fingerprint.

Cite this