精神心理疾病临床研究中量表电子化的实践指导  

Practical guide on electronic application of scales in clinical research of mental and psychological diseases

作　　者：沈一峰[1] 黄丽霞 覃龙 苏泉宇 李华芳[1] SHEN Yi-feng;HUANG Li-xia;QIN Long;SU Quan-yu;LI Hua-fang(Shanghai Mental Health Center,Shanghai Jiao Tong University School of Medicine/Shanghai Clinical Research Center for Mental Health/Shanghai Key Laboratory of Psychotic Disorders,SHANGHAI 200032,China;EClinCloud(Ningbo)Technology Co.,Ltd,Ningbo ZHEJIANG 315336,China)

机构地区：[1]上海交通大学医学院附属精神卫生中心/上海市精神心理疾病临床医学研究中心/上海市重性精神病重点实验室,上海200032 [2]一临云(宁波)科技有限公司,浙江宁波315336

出　　处：《中国新药与临床杂志》2024年第10期721-727,共7页Chinese Journal of New Drugs and Clinical Remedies

基　　金：上海市精神卫生中心示范性研究型病房项目(SHDC2023CRW007);徐汇区院地合作项目生命健康领域(23XHYD-15);中国精神药物临床试验协作网、上海市药学会药物临床研究专业委员会支持。

摘　　要：量表是精神卫生领域诊断和评估患者的重要工具。去中心化临床试验的大力发展,促进了量表电子化的兴起。量表电子化是指将传统的纸质量表或调查问卷等临床结局评估工具通过电子化技术转换为数字格式的过程,使量表的填报更便捷、及时、准确,收集到的数据更完整、合规、安全。本文对量表电子化迁移的流程进行梳理并提出相应注意事项,旨在为中国精神心理疾病临床研究中量表的电子化提供指导和建议。A scale is an important tool for diagnosing and evaluating patients in the field of mental health.The vigorous development of decentralized clinical trials has promoted the rise of electronic scales.The electronization of scales refers to the process of converting clinical outcome assessment tools such as traditional paper scales or questionnaire survey tools into digital formats through electronic technology,making the administration of scales more convenient,timely,and accurate,and data-collecting more complete,regular,and secure.This article outlined the process of electronic migration of scales and proposed corresponding precautions,aiming to provide guidance and suggestions for the electronization of scales in clinical research on mental and psychological diseases in China.

关 键 词：精神心理疾病 量表 临床结局评估 患者报告结局 电子化临床结局评估 

分 类 号：R749[医药卫生—神经病学与精神病学]