TY - JOUR
T1 - Evaluating Patient-Centered Outcomes in Clinical Trials of Procedural Sedation, Part 1 Efficacy
T2 - Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations
AU - Williams, Mark R.
AU - Ward, Denham S.
AU - Carlson, Douglas
AU - Cravero, Joseph
AU - Dexter, Franklin
AU - Lightdale, Jenifer R.
AU - Mason, Keira P.
AU - Miner, James
AU - Vargo, John J.
AU - Berkenbosch, John W.
AU - Clark, Randall M.
AU - Constant, Isabelle
AU - Dionne, Raymond
AU - Dworkin, Robert H.
AU - Gozal, David
AU - Grayzel, David
AU - Irwin, Michael G.
AU - Lerman, Jerrold
AU - O'Connor, Robert E.
AU - Pandharipande, Pratik
AU - Rappaport, Bob A.
AU - Riker, Richard R.
AU - Tobin, Joseph R.
AU - Turk, Dennis C.
AU - Twersky, Rebecca S.
AU - Sessler, Daniel I.
PY - 2017/3/1
Y1 - 2017/3/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84987624229&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84987624229&partnerID=8YFLogxK
U2 - 10.1213/ANE.0000000000001566
DO - 10.1213/ANE.0000000000001566
M3 - Article
C2 - 27622720
AN - SCOPUS:84987624229
VL - 124
SP - 821
EP - 830
JO - Anesthesia and Analgesia
JF - Anesthesia and Analgesia
SN - 0003-2999
IS - 3
ER -