Evaluating Patient-Centered Outcomes in Clinical Trials of Procedural Sedation, Part 2 Safety: Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations

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, a public–private partnership with the US Food and Drug Administration, convened a second meeting of sedation experts from a variety of clinical specialties and research backgrounds to develop recommendations for procedural sedation research. The previous meeting addressed efficacy and patient- and/or family-centered outcomes. This meeting addressed issues of safety, which was defined as "the avoidance of physical or psychological harm." A literature review identified 133 articles addressing safety measures in procedural sedation clinical trials. After basic reporting of vital signs, the most commonly measured safety parameter was oxygen saturation. Adverse events were inconsistently defined throughout the studies. Only 6 of the 133 studies used a previously validated measure of safety. The meeting identified methodological problems associated with measuring infrequent adverse events. With a consensus discussion, a set of core and supplemental measures were recommended to code for safety in future procedural clinical trials. When adopted, these measures should improve the integration of safety data across studies and facilitate comparisons in systematic reviews and meta-analyses. Accepted for publication March 5, 2018. Funding: None. The authors declare no conflicts of interest. Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's website (https://ift.tt/KegmMq). The views expressed in this article are those of the authors, none of whom has financial conflicts of interest specifically related to the issues discussed. At the time of the meeting (November 17–19, 2016) on which this article is based, several authors were employed by a pharmaceutical company or had received consulting fees or honoraria from 1 or more pharmaceutical or device companies. The 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 US Food and Drug Administration 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 US Food and Drug Administration, multiple pharmaceutical and device companies, philanthropy, and other sources. Reprints will not be available from the authors. Address correspondence to Denham S. Ward, MD, PhD, Department of Anesthesiology and Perioperative Medicine, University of Rochester School of Medicine and Dentistry, 601 Elmwood Ave, Box 604, Rochester, NY 14642. Address e-mail to Denham_Ward@URMC.Rochester.edu. © 2018 International Anesthesia Research Society

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