摘要
临床评价指标的选择与测量是临床研究的关键问题。由上海交通大学医学院附属第九人民医院牵头,联合多所国际口腔知名高校,历时两年制订了《口腔种植临床评价核心指标的国际共识》,于2023年5月联合发布于Journal of Clinical Periodontology和Clinical Oral Implants Research。该共识确定了口腔种植试验、骨增量试验和软组织增量试验必须报告的系列临床评价指标,旨在全面、规范、标准化地评价口腔种植治疗的风险与收益。本文详述该共识的制订流程及关键内容,以帮助国内学者理解并使用此临床评价核心指标,提高我国口腔种植临床研究质量。
Selection and measurement of clinical outcome are key components of clinical research in implant dentistry.Shanghai Ninth People′s Hospital,Shanghai Jiao Tong University School of Medicine took the lead and collaborated with multiple internationally renowned colleges of stomatology to develop an international consensus on the core outcome set and measurement in implant dentistry,which took two years and was published in May,2023 in Journal of Clinical Periodontology and Clinical Oral Implants Research simultaneously.The consensus,aiming at identifying the full spectrum of benefits and harms of interventions,provides a comprehensive,agreed,and standardized set of outcomes that should be measured and reported as a minimum in clinical trials relating with implant dentistry,bone augmentation,and soft tissue augmentation.The present review describes the methodology and key elements of the consensus to help Chinese clinical researchers fully understand and appropriately apply the core outcome set and improve the overall quality of Chinese clinical research in implant dentistry.
作者
史俊宇
刘蓓蕾
伍昕宇
赖红昌
Shi Junyu;Liu Beilei;Wu Xinyu;Lai Hongchang(Department of Oral Implantology,Shanghai Ninth People′s Hospital,Shanghai Jiao Tong University School of Medicine&College of Stomatology,Shanghai Jiao Tong University&National Center for Stomatology&National Clinical Research Center for Oral Diseases&Shanghai Key Laboratory of Stomatology&Shanghai Research Institute of Stomatology,Shanghai 200011,China)
出处
《中华口腔医学杂志》
CAS
CSCD
北大核心
2023年第12期1227-1234,共8页
Chinese Journal of Stomatology
基金
国家自然科学基金(82171005)
上海市科学技术委员会科技支撑计划(19411950100)
上海市高水平大学创新研究团队(SHSMU-ZDCX202125000)
国家口腔疾病临床医学研究中心上海交通大学医学院附属第九人民医院临床研究项目(JYLJ201909)
欧洲牙周病学研究小组。
关键词
牙种植
临床试验
临床评价核心指标
专家共识
Dental implantation
Clinical trial
Core outcome set and measurement
Expert consensus
