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Article(id=1322181154980086361, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322181102488375822, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1594742400000, acceptedDateStr=2020-07-15, onlineDate=1793162152285, onlineDateStr=2026-10-28, pubDate=1627574400000, pubDateStr=2021-07-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793162152285, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793162152284, creator=13701087609, updateTime=1793162152284, updator=13701087609, issue=Issue{id=1322181102488375822, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='14', pageStart='1249', pageEnd='1344', issueExtLink='null', onlineDate='null', pubDate='1627574400000', pubDateStr='2021-07-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1793162139770, creator='13701087609', updateTime=1793162209831, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322181396408419308, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322181102488375822, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322181396408419309, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322181102488375822, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1296, endPage=1301, ext={EN=ArticleExt(id=1322181155164635738, articleId=1322181154980086361, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Interpretation of “the guidelines for inclusion of patient-reported outcomes in clinical trial protocols: the SPIRIT-PRO extension”, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Patient-reported outcome (PRO) data from clinical trials is strong evidence which can inform shared decision-making, labeling claims, clinical guidelines, and health policy; however, those data is often not given enough emphasis to in current clinical trial protocols. The “Standard Protocol Items: Recommendations for Interventional Trials” (SPIRIT) statement, using the most concise items by providing evidence-based medicine, aims to improve the completeness of trial protocols. However, it does not provide guidance on PRO content. The SPIRIT-PRO Extension provides minimum requirements for PRO which will be used as the primary or key secondary study endpoint in clinical trials. Improved design of clinical trials including PRO could help ensure high-quality data that may inform patient-centered care. We interpreted the key contents of this extension, including the normative methods for the management, collection and analysis of PRO data, in order to provide references for clinical trial researchers.

, authors=Hui ZHOU1, 2, Mi YAO3, Jie CHEN2, Xiao CHEN2, Yi-li CHEN1, Wei CHEN4, Gang YUAN1, authorsList=Hui ZHOU, Mi YAO, Jie CHEN, Xiao CHEN, Yi-li CHEN, Wei CHEN, Gang YUAN, authorCompany=null, correspAuthors=Gang YUAN, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1322181155403711067, articleId=1322181154980086361, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=《临床试验方案纳入患者报告结局的指南-扩展声明》解读, columnId=1236331741447778310, journalTitle=中国新药杂志, columnName=药物临床试验规范与进展专栏, runingTitle=null, highlight=null, articleAbstract=

临床试验的患者报告结局（patient-reported outcome，PRO）可为医患共同决策、药品标示说明、临床指南和卫生政策提供有价值的参考，然而目前的临床试验方案对PRO重视度仍不足。《规范临床试验方案内容声明》（Standard Protocol Items：Recommendations for Interventional Trials，SPIRIT）依据循证医学原理，通过简洁指引条目提高临床试验方案的完整性。然而，该声明并未提供PRO相关的详细内容。新的SPIRIT-PRO指南为临床试验方案中PRO提供详细指引。这些指引将PRO作为主要研究终点或关键的次要研究终点。在临床研究方案设计中纳入PRO，可以提高研究质量，也有助于以患者为中心的治疗。本文对《临床试验方案中纳入患者报告结局的指南-扩展声明》重点内容进行分析和解读，包括临床试验中PRO数据的管理、收集、分析的规范性方法等内容，以期为临床试验工作者提供参考。

, authors=周慧1, 2, 姚弥3, 陈杰2, 陈孝2, 陈艺莉1, 陈崴4, 元刚1, authorsList=周慧, 姚弥, 陈杰, 陈孝, 陈艺莉, 陈崴, 元刚, authorCompany=null, correspAuthors=元刚, authorNote=

周慧，女，硕士研究生，主要从事药物早期临床试验。联系电话：（020）87608941，E-mail：。

, correspAuthorsNote=
元刚，男，博士，副主任医师，主要从事药物早期临床试验研究、药物临床试验管理。联系电话：（020）87608941，E-mail：。
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周慧，女，硕士研究生，主要从事药物早期临床试验。联系电话：（020）87608941，E-mail：。

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周慧，女，硕士研究生，主要从事药物早期临床试验。联系电话：（020）87608941，E-mail：。

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《临床试验方案纳入患者报告结局的指南-扩展声明》解读
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周慧 1, 2 , 姚弥 3 , 陈杰 2 , 陈孝 2 , 陈艺莉 1 , 陈崴 4 , 元刚 1
中国新药杂志 | 药物临床试验规范与进展专栏 2021,30(14): 1296-1301
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中国新药杂志 |药物临床试验规范与进展专栏 2021 , 30 (14) : 1296 -1301
《临床试验方案纳入患者报告结局的指南-扩展声明》解读
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周慧，女，硕士研究生，主要从事药物早期临床试验。联系电话：（020）87608941，E-mail：。

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周慧，女，硕士研究生，主要从事药物早期临床试验。联系电话：（020）87608941，E-mail：。

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周慧1, 2 , 姚弥3, 陈杰2, 陈孝2, 陈艺莉1, 陈崴4, 元刚1
作者信息
  • 1中山大学附属第一医院Ⅰ期临床试验中心，广州　510080
  • 2中山大学附属第一医院药学部，广州　510080
  • 3英国伯明翰大学应用卫生研究院，伯明翰　B15 2TT
  • 4中山大学附属第一医院肾内科，广州　510080
通讯作者:
元刚，男，博士，副主任医师，主要从事药物早期临床试验研究、药物临床试验管理。联系电话：（020）87608941，E-mail：。
作者简介:

周慧，女，硕士研究生，主要从事药物早期临床试验。联系电话：（020）87608941，E-mail：。

Interpretation of “the guidelines for inclusion of patient-reported outcomes in clinical trial protocols: the SPIRIT-PRO extension”
Hui ZHOU1, 2 , Mi YAO3, Jie CHEN2, Xiao CHEN2, Yi-li CHEN1, Wei CHEN4, Gang YUAN1
Affiliations
  • 1Phase Ⅰ Clinical Trial Center, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou 510080, China
  • 2Department of Pharmacy, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou 510080, China
  • 3Institute of Applied Health Research, University of Birmingham, Birmingham B15 2TT, UK
  • 4Nephrology Department, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou 510080, China
出版时间: 2021-07-30
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摘要
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临床试验的患者报告结局（patient-reported outcome，PRO）可为医患共同决策、药品标示说明、临床指南和卫生政策提供有价值的参考，然而目前的临床试验方案对PRO重视度仍不足。《规范临床试验方案内容声明》（Standard Protocol Items：Recommendations for Interventional Trials，SPIRIT）依据循证医学原理，通过简洁指引条目提高临床试验方案的完整性。然而，该声明并未提供PRO相关的详细内容。新的SPIRIT-PRO指南为临床试验方案中PRO提供详细指引。这些指引将PRO作为主要研究终点或关键的次要研究终点。在临床研究方案设计中纳入PRO，可以提高研究质量，也有助于以患者为中心的治疗。本文对《临床试验方案中纳入患者报告结局的指南-扩展声明》重点内容进行分析和解读，包括临床试验中PRO数据的管理、收集、分析的规范性方法等内容，以期为临床试验工作者提供参考。

临床试验  /  临床试验方案  /  患者报告结局  /  指南

Patient-reported outcome (PRO) data from clinical trials is strong evidence which can inform shared decision-making, labeling claims, clinical guidelines, and health policy; however, those data is often not given enough emphasis to in current clinical trial protocols. The “Standard Protocol Items: Recommendations for Interventional Trials” (SPIRIT) statement, using the most concise items by providing evidence-based medicine, aims to improve the completeness of trial protocols. However, it does not provide guidance on PRO content. The SPIRIT-PRO Extension provides minimum requirements for PRO which will be used as the primary or key secondary study endpoint in clinical trials. Improved design of clinical trials including PRO could help ensure high-quality data that may inform patient-centered care. We interpreted the key contents of this extension, including the normative methods for the management, collection and analysis of PRO data, in order to provide references for clinical trial researchers.

clinical trial  /  clinical trial protocol  /  patient-reported outcome  /  guideline
周慧, 姚弥, 陈杰, 陈孝, 陈艺莉, 陈崴, 元刚. 《临床试验方案纳入患者报告结局的指南-扩展声明》解读. 中国新药杂志, 2021 , 30 (14) : 1296 -1301 .
Hui ZHOU, Mi YAO, Jie CHEN, Xiao CHEN, Yi-li CHEN, Wei CHEN, Gang YUAN. Interpretation of “the guidelines for inclusion of patient-reported outcomes in clinical trial protocols: the SPIRIT-PRO extension”[J]. Chinese Journal of New Drugs, 2021 , 30 (14) : 1296 -1301 .
基金
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  • 国家自然科学基金面上资助项目(81772699)
  • 广东省自然科学基金资助项目(2018A030313138)
  • 广东省药学会医院药学研究基金资助项目(2018HS06)
文献
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参考文献 引证文献
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2021年第30卷第14期
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  • 首发时间：2026-10-28
  • 出版时间：2021-07-30
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  • 录用日期：2020-07-15
基金
国家自然科学基金面上资助项目(81772699)
广东省自然科学基金资助项目(2018A030313138)
广东省药学会医院药学研究基金资助项目(2018HS06)
作者信息
    1中山大学附属第一医院Ⅰ期临床试验中心，广州　510080
    2中山大学附属第一医院药学部，广州　510080
    3英国伯明翰大学应用卫生研究院，伯明翰　B15 2TT
    4中山大学附属第一医院肾内科，广州　510080

通讯作者:

元刚，男，博士，副主任医师，主要从事药物早期临床试验研究、药物临床试验管理。联系电话：（020）87608941，E-mail：。
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Number of
species		 占总种数比例
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total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
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species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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