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.
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.
From the *Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, New York; †Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, New York; ‡Department of Anesthesiology, Tufts School of Medicine, Boston, Massachusetts; §Department of Pediatrics, Southern Illinois University School of Medicine, Springfield, Illinois; ‖Department of Pediatrics, St John's Children's Hospital, Springfield, Illinois; ¶Department of Anesthesia, Harvard Medical School, Boston, Massachusetts; #Department of Anesthesiology, Boston Children's Hospital, Boston, Massachusetts; **Department of Anesthesia, University of Iowa, Iowa City; ††Pediatric Gastroenterology, University of Massachusetts Medical Center, University of Massachusetts Medical School, Worcester, Massachusetts; ‡‡Department of Anesthesiology, Harvard Medical School, Boston Children's Hospital, Boston, Massachusetts; §§Department of Emergency Medicine, University of Minnesota Medical School, Minneapolis, Minnesota; ‖‖Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota; ¶¶Department of Gastroenterology and Hepatology, Cleveland Clinic Lerner College of Medicine of Case Western University, Cleveland, Ohio; ##Pediatric Critical Care, Kosair Children's Hospital, University of Louisville School of Medicine, Louisville, Kentucky; ***Section for Professional Standards, American Society of Anesthesiologists Children's Hospital Colorado, University of Colorado School of Medicine, Denver, Colorado; †††Department of Anesthesiology, Hôpital Armand Trousseau, Paris, France; ‡‡‡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; ‖‖‖Division of Anesthesiology and CCM, Hadassah University Hospital, The Hebrew University of Jerusalem School of Medicine, Jerusalem, Israel; ¶¶¶Annovation BioPharma, Cambridge, Massachusetts; ###Department of Anesthesiology, University of Hong Kong, Hong Kong, China; ****Department of Anesthesiology, Women and Children's Hospital of Buffalo, SUNY at Buffalo, Buffalo, New York; ††††Department of Emergency Medicine, University of Virginia School of Medicine, Charlottesville, Virginia; ‡‡‡‡Department of Anesthesiology, Vanderbilt University, Nashville, Tennessee; §§§§Analgesic Concepts LLC, Arlington, Virginia; ‖‖‖‖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 Anesthesiology, Wake Forest School of Medicine, Winston-Salem, North Carolina; *****Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, Washington; †††††Department of Anesthesiology & Critical Care Medicine, Josie Robertson Surgery Center, Memorial Sloan Kettering Cancer Center, New York, New York; and ‡‡‡‡‡Department of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, Ohio.
Mark R
MR
Williams
Denham S
DS
Ward
Douglas
D
Carlson
Joseph
J
Cravero
Franklin
F
Dexter
Jenifer R
JR
Lightdale
Keira P
KP
Mason
James
J
Miner
John J
JJ
Vargo
John W
JW
Berkenbosch
Randall M
RM
Clark
Isabelle
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Constant
Raymond
R
Dionne
Robert H
RH
Dworkin
David
D
Gozal
David
D
Grayzel
Michael G
MG
Irwin
Jerrold
J
Lerman
Robert E
RE
O'Connor
Pratik
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Pandharipande
Bob A
BA
Rappaport
Richard R
RR
Riker
Joseph R
JR
Tobin
Dennis C
DC
Turk
Rebecca S
RS
Twersky
Daniel I
DI
Sessler
D000758:Anesthesia / Q000009:adverse effects / Q000592:standards; D035843:Biomedical Research / Q000379:methods / Q000592:standards*; D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards*; D003226:Congresses as Topic / Q000592:standards; D016292:Procedural Sedation / Q000379:methods / Q000592:standards; D004219:District of Columbia; D023381:Endpoint Determination / Q000379:methods / Q000592:standards*; D006801:Humans; D006993:Hypnotics and Sedatives / Q000009:adverse effects / Q000592:standards* / Q000627:therapeutic use; D061214:Patient Safety / Q000592:standards*; D017060:Patient Satisfaction; D018802:Patient-Centered Care / Q000379:methods / Q000592:standards*; D016896:Treatment Outcome
D006993:Hypnotics and Sedatives