《骨质疏松症临床治疗生物制剂循证用药指南》推荐意见外审:一项横断面调查  

External review of the recommendations of the Guidelines for Evidence-based Use of Biological Agents for the Clinical Treatment of Osteoporosis:a cross-sectional survey

作　　者：余玲玲 刘爽 宋再伟 易秋莎 张玉[4] 缪丽燕[5] 章振林 宋纯理[7] 陈耀龙[8] 张伶俐[3] 赵荣生[1,2] YU Lingling;LIU Shuang;SONG Zaiwei;YI Qiusha;ZHANG Yu;MIAO Liyan;ZHANG Zhenlin;SONG Chunli;CHEN Yaolong;ZHANG Lingli;ZHAO Rongsheng(Dept.of Pharmacy,Peking University Third Hospital,Beijing 100191,China;Institute for Drug Evaluation,Peking University Health Science Center,Beijing 100191,China;Dept.of Pharmacy,West China Second University Hospital,Sichuan University,Chengdu 610041,China;Dept.of Pharmacy,Union Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430022,China;Dept.of Pharmacy,the First Affiliated Hospital of Soochow University,Jiangsu Suzhou 215006,China;Dept.of Osteoporosis and Bone Disease,Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,Shanghai 200233,China;Dept.of Orthopedics,Peking University Third Hospital,Beijing 100191,China;Evidencebased Medicine Center,School of Basic Medical Sciences,Lanzhou University,Lanzhou 730000,China)

机构地区：[1]北京大学第三医院药学部,北京100191 [2]北京大学医学部药物评价中心,北京100191 [3]四川大学华西第二医院药学部,成都610041 [4]华中科技大学同济医学院附属协和医院药学部,武汉430022 [5]苏州大学附属第一医院药学部,江苏苏州215006 [6]上海交通大学医学院附属第六人民医院骨质疏松和骨病专科,上海200233 [7]北京大学第三医院骨科,北京100191 [8]兰州大学基础医学院循证医学中心,兰州730000

出　　处：《中国药房》2025年第9期1025-1029,共5页China Pharmacy

基　　金：国家自然科学基金项目(No.72304007);北京市卫生健康科技成果和适宜技术推广项目(No.BHTPP2024007)。

摘　　要：目的对《骨质疏松症临床治疗生物制剂循证用药指南》(后文简称《指南》)的推荐意见进行科学性、明晰性和可行性的外部同行评估,以进一步修订和完善《指南》推荐意见。方法本研究采用横断面调查研究设计,通过方便抽样的方法选取骨质疏松症治疗领域一线医务工作者(临床医生、临床药师、护师)及患者或患者家属,并通过封闭式和开放式相结合的问卷调查方式开展外审工作,征求其对《指南》的32条推荐意见初稿的赞同程度、表达清晰程度和可行程度3个方面的反馈。结果本研究共收集到来自15家医院的90名外审对象的意见反馈,包括45名临床医生、15名临床药师、15名护师和15名患者或患者家属。推荐意见获得了高度认可,总体赞同程度达99.38%,总体表述清晰程度达98.92%,总体可行程度达99.65%。同时,收集到111条主观建议,为《指南》推荐意见的进一步完善提供了重要参考。基于上述反馈,《指南》指导委员会和核心专家组针对其中12条推荐意见初稿修订了表述,未进行删减,最终确定了32条推荐意见。结论本次外审为《指南》定稿提供了依据,进一步完善了推荐意见的科学性、明晰性和可行性,有利于提高《指南》的规范性、临床适用性与可实施性。OBJECTIVE To assess the scientific rigor,clarity and feasibility of the recommendations of the Guidelines for Evidence-based Use of Biological Agents for the Clinical Treatment of Osteoporosis(hereinafter referred to as the Guideline)through external review,in order to further revise and improve the Guideline recommendations.METHODS This study employed a cross-sectional survey research design,a convenience sampling method was adopted to select frontline medical workers in the field of osteoporosis(including clinical doctors,clinical pharmacists,and nurses)as well as patients or their family members.External review was conducted through a combination of closed-ended and open-ended electronic questionnaires to get feedback from them on the appreciation,clarity and feasibility of the 32 preliminary recommendations in the Guideline.RESULTS A total of 90 external review subjects from 15 hospitals were collected,including 45 clinical doctors,15 clinical pharmacists,15 nurses and 15 patients or their family members.The overall appreciation degree of recommendations was 99.38%,the overall clarity degree of recommendations was 98.92%,and the overall feasibility degree of recommendations was 99.65%.At the same time,111 subjective suggestions were collected,which provided an important reference for the further improvement of the Guideline recommendations.Based on the above feedback,the Guideline steering committee and core expert group revised the wording of 12 draft recommendations without deletion,and finally determined 32 recommendations.CONCLUSIONS The external review provides an important basis for the final formation of the Guideline,further improves the scientific rigor,clarity and feasibility of the recommendations,and ensures the standardization,practicality and implementability of the Guideline.

关 键 词：骨质疏松症 生物制剂 循证用药指南 外审 推荐意见 

分 类 号：R969.3[医药卫生—药理学]