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

被引：18

作者：

Ward, Denham S. ^{[1
,2
]}

Williams, Mark R. ^{[1
]}

Berkenbosch, John W. ^{[3
]}

Bhatt, Maala ^{[4
]}

Carlson, Douglas ^{[5
,6
]}

Chappell, Phillip ^{[7
]}

Clark, Randall M. ^{[8
]}

Constant, Isabelle ^{[9
]}

Conway, Aaron ^{[10
]}

Cravero, Joseph ^{[11
]}

Dahan, Albert ^{[12
]}

Dexter, Franklin ^{[13
]}

Dionne, Raymond ^{[14
]}

Dworkin, Robert H. ^{[15
]}

Gan, Tong J. ^{[16
]}

Gozal, David ^{[17
]}

Green, Steven ^{[18
]}

Irwin, Michael G. ^{[19
]}

Karan, Suzanne ^{[1
]}

Kochman, Michael ^{[20
]}

Lerman, Jerrold ^{[21
]}

Lightdale, Jenifer R. ^{[22
]}

Litman, Ronald S. ^{[23
]}

Mason, Keira P. ^{[11
]}

Miner, James ^{[24
,25
]}

O'Connor, Robert E. ^{[26
]}

Pandharipande, Pratik ^{[27
]}

Riker, Richard R. ^{[28
,29
,30
]}

Roback, Mark G. ^{[24
]}

Sessler, Daniel I. ^{[31
]}

Sexton, Anne ^{[7
]}

Tobin, Joseph R. ^{[32
]}

Turk, Dennis C. ^{[33
]}

Twersky, Rebecca S. ^{[34
]}

Urman, Richard D. ^{[35
]}

Weiss, Mark ^{[36
]}

Wunsch, Hannah ^{[37
,38
]}

Zhao-Wong, Anna ^{[39
]}

机构：

[1] Univ Rochester, Sch Med & Dent, Dept Anesthesiol & Perioperat Med, 601 Elmwood Ave,Box 604, Rochester, NY 14642 USA

[2] Tufts Sch Med, Dept Anesthesiol, Boston, MA USA

[3] Univ Louisville, Norton Childrens Hosp, Sch Med, Dept Pediat, Louisville, KY 40292 USA

[4] Univ Ottawa, Childrens Hosp Eastern Ontario, Dept Pediat, Ottawa, ON, Canada

[5] Southern Illinois Univ, Sch Med, Dept Pediat, Springfield, IL USA

[6] St Johns Childrens Hosp, Dept Pediat, Springfield, IL USA

[7] Pfizer Inc, CNS Clin Affairs, Groton, CT 06340 USA

[8] Univ Colorado, Sch Med, Dept Anesthesiol, Denver, CO 80202 USA

[9] UPMC Univ, Hop Armand Trousseau, AP HP, Dept Anesthesiol, Paris, France

[10] Queensland Univ Technol, Sch Nursing, Brisbane, Qld, Australia

[11] Harvard Med Sch, Boston Childrens Hosp, Dept Anesthesiol Crit Care & Pain, Dept Anesthesia, Boston, MA USA

[12] Leiden Univ, Med Ctr, Dept Anesthesiol, Leiden, Netherlands

[13] Univ Iowa, Dept Anesthesia, Div Management Consulting, Iowa City, IA 52242 USA

[14] East Carolina Univ, Dept Pharmacol & Foundat Sci, Greenville, NC USA

[15] Univ Rochester, Sch Med & Dent, Dept Anesthesiol, Rochester, NY USA

[16] SUNY Stony Brook, Dept Anesthesiol, Stony Brook, NY 11794 USA

[17] Hebrew Univ Jerusalem, Sch Med, Hadassah Univ Hosp, Div Anesthesiol & Crit Care Med, Jerusalem, Israel

[18] Loma Linda Univ, Dept Emergency Med, Loma Linda, CA 92350 USA

[19] Univ Hong Kong, Dept Anesthesiol, Hong Kong, Hong Kong, Peoples R China

[20] Univ Penn Hlth Syst, Dept Med, Philadelphia, PA USA

[21] John R Oishei Childrens Hosp, Jacobs Sch Med & Biomed Sci, Dept Anesthesia, Buffalo, NY USA

[22] Univ Massachusetts, Med Sch, Mem Childrens Med Ctr, Dept Pediat, Worcester, MA 01605 USA

[23] Childrens Hosp Philadelphia, Dept Anesthesiol & Crit Care, Philadelphia, PA 19104 USA

[24] Univ Minnesota, Med Sch, Dept Emergency, Minneapolis, MN USA

[25] Hennepin Cty Med Ctr, Dept Emergency Med, Minneapolis, MN 55415 USA

[26] Univ Virginia, Sch Med, Dept Emergency Med, Charlottesville, VA 22908 USA

[27] Vanderbilt Univ, Med Ctr, Dept Anesthesiol, 221 Kirkland Hall, Nashville, TN 37235 USA

[28] Tufts Univ, Sch Med, Dept Med, Boston, MA 02111 USA

[29] Maine Med Ctr, Dept Crit Care Med, Portland, ME 04102 USA

[30] Maine Med Ctr, Neurosci Inst, Portland, ME 04102 USA

[31] Cleveland Clin, Anesthesiol Inst, Dept Outcomes Res, Cleveland, OH 44106 USA

[32] Wake Forest Sch Med, Dept Anesthesiol, Winston Salem, NC USA

[33] Univ Washington, Dept Anesthesiol & Pain Med, Seattle, WA 98195 USA

[34] Mem Sloan Kettering Canc Ctr, Josie Robertson Surg Ctr, Dept Anesthesiol & Crit Care Med, 1275 York Ave, New York, NY 10021 USA

[35] Harvard Med Sch, Brigham & Womens Hosp, Dept Anesthesiol, Boston, MA USA

[36] Univ Penn, Dept Anesthesiol & Crit Care, Philadelphia, PA 19104 USA

[37] Univ Toronto, Dept Anesthesia, Toronto, ON, Canada

[38] Sunnybrook Hlth Sci Ctr, Dept Crit Care Med, Toronto, ON, Canada

[39] MedDRA, Maintenance & Support Serv Org, Mclean, VA USA

来源：

ANESTHESIA AND ANALGESIA | 2018年 / 127卷 / 05期

关键词：

UPPER AIRWAY COLLAPSIBILITY; ADVERSE EVENTS; OPERATING-ROOM; PEDIATRIC SEDATION/ANESTHESIA; POSTOPERATIVE NAUSEA; VENTILATORY RESPONSE; VALIDATION; ANESTHESIA; ANALGESIA; PROPOFOL;

D O I：

10.1213/ANE.0000000000003409

中图分类号：

R614 [麻醉学];

学科分类号：

100217 ;

摘要：

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.

引用

页码：1146 / 1154

页数：9

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