评估程序性镇静临床试验中的以患者为中心的结局：镇静终点和治疗、教育及研究建议协作组。
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.
机构信息
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.
出版信息
Anesth Analg. 2017 Mar;124(3):821-830. doi: 10.1213/ANE.0000000000001566.
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.
镇静学终点和治疗、教育、研究程序联盟由镇痛、麻醉和成瘾临床试验转化、创新、机会和网络公私合作伙伴关系与美国食品和药物管理局共同成立，召集了来自不同临床专业和研究背景的镇静学专家会议，旨在为镇静研究制定建议。四项核心结局领域被推荐用于镇静临床试验的考虑：（1）安全性，（2）疗效，（3）以患者为中心和/或以家庭为中心的结局，以及（4）效率。本次会议确定了疗效和以患者为中心和/或以家庭为中心领域的核心结局指标。安全性将在随后的会议中讨论，而此时不会讨论效率。这些措施包括镇静深度和水平、术者和患者满意度、患者回忆和体验到的疼痛程度。推荐的结局指标的一致使用将有助于镇静试验的全面报告，并在系统评价和荟萃分析中对研究和干预措施进行有意义的比较。
Zotero 插件