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Interpretation of “the guidelines for inclusion of patient-reported outcomes in clinical trial protocols: the SPIRIT-PRO extension”
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Hui ZHOU1, 2, Mi YAO3, Jie CHEN2, Xiao CHEN2, Yi-li CHEN1, Wei CHEN4, Gang YUAN1
Chinese Journal of New Drugs | 2021, 30(14) : 1296 - 1301
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Chinese Journal of New Drugs | 2021, 30(14): 1296-1301
Interpretation of “the guidelines for inclusion of patient-reported outcomes in clinical trial protocols: the SPIRIT-PRO extension”
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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
Published: 2021-07-30
Outline
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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 .
Year 2021 volume 30 Issue 14
49
9
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  • Online Date:2026-10-28
  • Published:2021-07-30
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  • Accepted:2020-07-15
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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
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表12种不同金属材料的力学参数
科
Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
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属
Genus
种数
Number of
species
占总种数比例
Percentage of total
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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