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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

Ward, Denham S., MD, PhD*,†; Williams, Mark R., MBBS, BSc; Berkenbosch, John W., MD§; Bhatt, Maala, MD; Carlson, Douglas, MD¶,#; Chappell, Phillip, MD, MBA**; Clark, Randall M., MD††; Constant, Isabelle, MD, PhD‡‡; Conway, Aaron, RN, PhD§§; Cravero, Joseph, MD‖‖; Dahan, Albert, MD, PhD¶¶; Dexter, Franklin, MD, PhD##; Dionne, Raymond, DDS, PhD***; Dworkin, Robert H., PhD†††; Gan, Tong J., MBA, MHS, FRCA‡‡‡; Gozal, David, MD§§§; Green, Steven, MD‖‖‖; Irwin, Michael G., MBChB, MD¶¶¶; Karan, Suzanne, MD###; Kochman, Michael, MD****; Lerman, Jerrold, MD, FRCPC, FANZCA††††; Lightdale, Jenifer R., MD, MPH‡‡‡‡; Litman, Ronald S., DO§§§§; Mason, Keira P., MD‖‖; Miner, James, MD‖‖‖‖,¶¶¶¶; O’Connor, Robert E., MD, MPH####; Pandharipande, Pratik, MD*****; Riker, Richard R., MD†††††,‡‡‡‡‡; Roback, Mark G., MD‖‖‖‖; Sessler, Daniel I., MD§§§§§; Sexton, Anne, MD‖‖‖‖‖; Tobin, Joseph R., MD¶¶¶¶¶; Turk, Dennis C., PhD#####; Twersky, Rebecca S., MD, MPH******; Urman, Richard D., MD, MBA, CPE††††††; Weiss, Mark, MD‡‡‡‡‡‡; Wunsch, Hannah, MD, MSc§§§§§§,‖‖‖‖‖‖; Zhao-Wong, Anna, MD, PhD¶¶¶¶¶¶

doi: 10.1213/ANE.0000000000003409
Patient Safety: Special Article

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.

From the *Department of Anesthesiology and Perioperative Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York

Department of Anesthesiology, Tufts School of Medicine, Boston, Massachusetts

Department of Anesthesiology and Perioperative Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York

§Department of Pediatrics, University of Louisville School of Medicine, Norton Children’s Hospital, Louisville, Kentucky

Department of Pediatrics, Children’s Hospital of Eastern Ontario, University of Ottawa, Ottawa, Ontario, Canada

Department of Pediatrics, Southern Illinois University School of Medicine, Springfield, Illinois

#Department of Pediatrics, St John’s Children’s Hospital, Springfield, Illinois

**CNS Clinical Affairs, Pfizer Inc, Groton, Connecticut

††Department of Anesthesiology, University of Colorado School of Medicine, Denver, Colorado

‡‡Department of Anesthesiology, Hôpital Armand Trousseau, APHP, UPMC Université, Paris, France

§§School of Nursing, Queensland University of Technology, Brisbane, Queensland, Australia

‖‖Department of Anesthesia, Harvard Medical School, Department of Anesthesiology, Critical Care & Pain, Boston Children’s Hospital, Boston, Massachusetts

¶¶Department of Anesthesiology, Leiden University, Leiden University Medical Center, Leiden, the Netherlands

##Division of Management Consulting, Department of Anesthesia, The University of Iowa, Iowa City, Iowa

***Department of Pharmacology and Foundational Sciences, East Carolina University, Greenville, North Carolina

†††Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, New York

‡‡‡Department of Anesthesiology, Stony Brook University, Stony Brook, New York

§§§Division of Anesthesiology and Critical Care Medicine, Hadassah University Hospital, The Hebrew University of Jerusalem School of Medicine, Jerusalem, Israel

‖‖‖Department of Emergency Medicine, Loma Linda University, Loma Linda, California

¶¶¶Department of Anesthesiology, University of Hong Kong, Hong Kong, China

###Department of Anesthesiology and Perioperative Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York

****Department of Medicine, University of Pennsylvania Health System, Philadelphia, Pennsylvania

††††Department of Anesthesia, John R. Oishei Children's Hospital Jacobs School of Medicine and Biomedical Sciences, Buffalo, New York

‡‡‡‡Department of Pediatrics, University of Massachusetts Memorial Children’s Medical Center, University of Massachusetts Medical School, Worcester, Massachusetts

§§§§Department of Anesthesiology & Critical Care, The Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania

‖‖‖‖Department of Emergency, University of Minnesota Medical School, Minneapolis, Minnesota

¶¶¶¶Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota

####Department of Emergency Medicine, University of Virginia School of Medicine, Charlottesville, Virginia

*****Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee

†††††Department of Medicine, Tufts University School of Medicine, Boston, Massachusetts

‡‡‡‡‡ Department of Critical Care Medicine and Neuroscience Institute, Maine Medical Center, Portland, Maine

§§§§§Department of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, Ohio

‖‖‖‖‖CNS Clinical Affairs, Pfizer Inc, Groton, Connecticut

¶¶¶¶¶Department of Anesthesiology, Wake Forest School of Medicine, Winston-Salem, North Carolina

#####Department of Anesthesiology & Pain Medicine, University of Washington, Seattle, Washington

******Department of Anesthesiology & Critical Care Medicine, Memorial Sloan Kettering Cancer Center, Josie Robertson Surgery Center, New York, New York

††††††Department of Anesthesiology, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts

‡‡‡‡‡‡Department of Anesthesiology and Critical Care, University of Pennsylvania, Philadelphia, Pennsylvania

§§§§§§Department of Anesthesia, University of Toronto, Toronto, Ontario, Canada

‖‖‖‖‖‖Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

¶¶¶¶¶¶Maintenance and Support Services Organization, MedDRA, McLean, Virginia.

Published ahead of print May 17, 2018.

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.

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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