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

被引：33

作者：

Williams, Mark R. ^{[1
]}

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

Carlson, Douglas ^{[3
,4
]}

Cravero, Joseph ^{[5
,6
]}

Dexter, Franklin ^{[7
]}

Lightdale, Jenifer R. ^{[8
]}

Mason, Keira P. ^{[9
]}

Miner, James ^{[10
,11
]}

Vargo, John J. ^{[12
]}

Berkenbosch, John W. ^{[13
]}

Clark, Randall M. ^{[14
]}

Constant, Isabelle ^{[15
]}

Dionne, Raymond ^{[16
]}

Dworkin, Robert H. ^{[1
]}

Gozal, David ^{[17
]}

Grayzel, David ^{[18
]}

Irwin, Michael G. ^{[19
]}

Lerman, Jerrold ^{[20
]}

O'Connor, Robert E. ^{[21
]}

Pandharipande, Pratik ^{[22
]}

Rappaport, Bob A. ^{[23
]}

Riker, Richard R. ^{[24
,25
,26
]}

Tobin, Joseph R. ^{[27
]}

Turk, Dennis C. ^{[28
]}

Twersky, Rebecca S. ^{[29
]}

Sessler, Daniel I. ^{[30
]}

机构：

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

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

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

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

[5] Harvard Med Sch, Dept Anesthesia, Boston, MA USA

[6] Boston Childrens Hosp, Dept Anesthesiol, Boston, MA USA

[7] Univ Iowa, Dept Anesthesia, Iowa City, IA 52242 USA

[8] Univ Massachusetts, Med Ctr, Sch Med, Pediat Gastroenterol, Worcester, MA 01655 USA

[9] Harvard Med Sch, Boston Childrens Hosp, Dept Anesthesiol, Boston, MA USA

[10] Univ Minnesota, Sch Med, Dept Emergency Med, Minneapolis, MN 55455 USA

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

[12] Case Western Univ, Cleveland Clin, Dept Gastroenterol & Hepatol, Lerner Coll Med, Cleveland, OH USA

[13] Univ Louisville, Sch Med, Pediat Crit Care, Kosair Childrens Hosp, Louisville, KY 40292 USA

[14] Univ Colorado, Sch Med, Sect Profess Stand, Amer Soc Anesthesiologists Childrens Hosp Colorad, Denver, CO USA

[15] Hop Armand Trousseau, Dept Anesthesiol, Paris, France

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

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

[18] Annovat BioPharma, Cambridge, MA USA

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

[20] SUNY Buffalo, Dept Anesthesiol, Women & Childrens Hosp Buffalo, Buffalo, NY USA

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

[22] Vanderbilt Univ, Dept Anesthesiol, 221 Kirkland Hall, Nashville, TN 37235 USA

[23] Analges Concepts LLC, Arlington, VA USA

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

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

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

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

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

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

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

来源：

ANESTHESIA AND ANALGESIA | 2017年 / 124卷 / 03期

关键词：

MONITORED ANESTHESIA CARE; ADVERSE EVENTS; MODERATE SEDATION; DOUBLE-BLIND; PEDIATRIC SEDATION/ANESTHESIA; FOSPROPOFOL DISODIUM; IOWA SATISFACTION; CRITICALLY-ILL; OPERATING-ROOM; PAIN SCALE;

D O I：

10.1213/ANE.0000000000001566

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 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.

引用

页码：821 / 830

页数：10

共 55 条

[41]

Merkel S I, 1997, Pediatr Nurs, V23, P293

[42] Procedural sedation and analgesia research: State of the art [J].

Miner, James R. ;

Krauss, Baruch .

ACADEMIC EMERGENCY MEDICINE, 2007, 14 (02) :170-178

[43]

Schulz Kenneth F, 2010, Open Med, V4, pe60, DOI [10.1136/bmj.c869, 10.1016/j.jclinepi.2010.03.004, 10.1016/j.ijsu.2011.10.001]

[44] Assessing pain in critically ill sedated patients by using a behavioral pain scale [J].

Payen, JF ;

Bru, O ;

Bosson, JL ;

Lagrasta, A ;

Novel, E ;

Deschaux, I ;

Lavagne, P ;

Jacquot, C .

CRITICAL CARE MEDICINE, 2001, 29 (12) :2258-2263

[45] Development and validation of a nurse-assessed patient comfort score for colonoscopy [J].

Rostom, Alaa ;

Ross, Erin D. ;

Dube, Catherine ;

Rutter, Matthew D. ;

Lee, Thomas ;

Valori, Roland ;

Bridges, Ronald J. ;

Pontifex, Darlene ;

Webbink, Veronica ;

Rees, Colin ;

Brown, Carly ;

Whetter, Deborah H. ;

Kelsey, Susan G. ;

Hilsden, Robert J. .

GASTROINTESTINAL ENDOSCOPY, 2013, 77 (02) :255-261

[46] Validation of the bispectral index monitor for measuring the depth of sedation in children [J].

Sadhasivam, S ;

Ganesh, A ;

Robison, A ;

Kaye, R ;

Watcha, MF .

ANESTHESIA AND ANALGESIA, 2006, 102 (02) :383-388

[47] Pediatric patients with disabilities - assessment of satisfaction with anesthesia [J].

Schiff, Jan-H. ;

Russ, Nicolai ;

Ihringer, Katja ;

Heal, Clare ;

Martin, Eike ;

Walther, Andreas .

PEDIATRIC ANESTHESIA, 2012, 22 (11) :1117-1123

[48]

Schulz K.F., 2010, J PHARMACOL PHARMACO, V340, pc332, DOI DOI 10.4103/0976-500X.72352

[49] A Phase 3, Randomized, Double-Blind Study To Assess the Efficacy and Safety of Fospropofol Disodium Injection for Moderate Sedation in Patients Undergoing Flexible Bronchoscopy [J].

Silvestri, Gerard A. ;

Vincent, Brad D. ;

Wahidi, Momen M. ;

Robinette, Emory ;

Hansbrough, James R. ;

Downie, Gordon H. .

CHEST, 2009, 135 (01) :41-47

[50] Adherence to CONSORT harms-reporting recommendations in publications of recent analgesic clinical trials: An ACTTION systematic review [J].

Smith, Shannon M. ;

Chang, R. Daniel ;

Pereira, Anthony ;

Shah, Nirupa ;

Gilron, Ian ;

Katz, Nathaniel P. ;

Lin, Allison H. ;

McDermott, Michael P. ;

Rappaport, Bob A. ;

Rowbotham, Michael C. ;

Sampaio, Cristina ;

Turk, Dennis C. ;

Dworkin, Robert H. .

PAIN, 2012, 153 (12) :2415-2421

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