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| 1 | 随机对照试验中的患者报告结局:CONSORT PRO扩展版显示文摘临床试验报告规范CONSORT(Consolidated Standards of Reporting Trials,CONSORT)声明旨在提高随机对照试验(randomized controlled trail,RCT)的报告质量,然而该声明却缺少专门关于患者报告结局(patient-reported outcomes,PROs)的指引,而这部分内容恰恰也是临床试验经常报告不足的内容。患者报告结局指标数据的缺失影响了临床试验结果的价值。本文报告了依据'提高医疗卫生研究的质量和透明度协作网'(EQUATOR Network)所提出的报告规范研发方法学框架制定的临床试验报告规范—CONSORT患者报告结局扩展版(CONSORT PROs)。最终推荐5个CONSORT患者报告结局清单条目,用于以患者报告结局为主要或关键的次要结局指标的随机对照试验。这些推荐条目强烈要求:(1)在摘要中需明确说明将患者报告结局作为主要或次要结局指标;(2)提供针对患者报告结局指标及其相关适用范畴的假设(如是否使用了多维度患者报告结局指标的检测工具);(3)提供或引用患者报告结局测量工具效度和信度的证据;(4)明确说明处理缺失数据的统计学方法;(5)讨论以患者报告结局指标为研究结果指标的特定局限性和结果对其他人群和临床实践的影响。本文还提供了相关条目的示例和附有患者报告结局的CONSORT流程图。建议在报告以患者报告结局作为主要结局指标或关键的次要结局指标时,以CONSORT患者报告结局扩展版与原版的CONSORT报告规范相互参考进行报告。改进后的患者报告结局试验数据将大大促进对随机对照试验结果的全面解释,并较好指导患者的治疗。 | 陈泽(翻译) 陈珏璇(翻译) 段玉婷(翻译) 张弛(回译) 陈耀龙(审校) 卞兆祥(翻译) Calvert M Blazeby J Altman DG | 2021 | 中国循证医学杂志2021，21，3： | 5 |
| 2 | Removal of organic foulants from feed waters by dynamic membranes 显示文摘 | Altman M Semiat R Hasson D | 1999 | Desalination1999，125，13： | 1 |
| 3 | An integrated pricing model for defaultable loans and bonds 显示文摘 | Onorato M Altman E I | 2005 | European Journal of Operational Research2005，，163： | 1 |
| 4 | Determination of digestibility, tissue deposition, and metabolism of omega-3 fatty acid content of kdll protein concentrate in growing rats显示文摘 | BRIDGES K M GIGLIOTrI J C ALTMAN S | 2010 | Journal of Agricul- tural and Food Chemistry2010，58，5： | 1 |
| 5 | Assessing the quality of controlled clinical trials显示文摘 | Juni P Altman DG Egger M | 2001 | British Medical Journal2001，323，7303： | 1 |
| 6 | Genome se-quencing in microfabricated high-density picolitre reactors显示文摘 | Margulies M Egholm M Altman W | 2005 | Nature2005，437，： | 1 |
| 7 | An empirical equation for penetration depth of ogive-nose projectiles into concrete targets显示文摘 | Forrestal M J Altman B S Cargile J D | 1994 | International Journal of Impact Engineering1994，15，4： | 1 |
| 8 | Effect of C02 on succinate production in dual-phase Escherichia coli fer- mentations 显示文摘 | LU S EITEMAN M A ALTMAN E | 2009 | J Biotechnol2009，143，： | 1 |
| 9 | Advances and future challenges in binary translation and optimization显示文摘 | E R Altman K Ebcioglu M Gschwind | 2001 | Proc of the IEEE2001，89，11： | 1 |
| 10 | pH and base coun- terion affect succinate production in dual-phase Esche- richia coli fermentations 显示文摘 | LU S EITEMAN M A ALTMAN E | 2009 | J Ind Microbiol Biotechnol2009，36，： | 1 |
| 11 | Automated lung nodule classification following automated nodule detection on CT:A serial ap-proach 显示文摘 | Armato III S G Altman M B Wilkie J | 2003 | Medical Physics2003，30，6： | 1 |
| 12 | How I treat acute promyelo- cytic leukemia 显示文摘 | Tallman M S Altman J K | 2009 | Blood2009，114，25： | 1 |
| 13 | Agreed statistics: measurement method comparison显示文摘 | BLAND J M ALTMAN D G | 2012 | Anesthesiology2012，116，1： | 1 |
| 14 | The objectives, design and implementation of the INTERGROWTH 21st Project 显示文摘 | VILLARJ ALTMAN DG PURWAR M | 2013 | BJOG2013，120，2： | 1 |
| 15 | Conformational behavior of ionic self-complementary peptides显示文摘 | ALTMAN M LEE P ZHANG S | 2000 | Protein Sci2000，9，： | 1 |
| 16 | Removal of organic foulants from feed waters by dynamic membranes显示文摘 | Altman M Semiat R Hasson D | 1999 | Desalination1999，125，： | 1 |
| 17 | Analysis of serial measurements in medical research显示文摘 | Matthews J N S Altman D G CamPell M J | 1990 | BMJ1990，300，6719： | 1 |
| 18 | Repeatability of measurement of fetal nuchal translucency thickness 显示文摘 | Pandya P P Altman D G Brizot M L | 1995 | Ultrasound Obstet Gynecol1995，5，5： | 1 |
| 19 | Almost everything you always wanted to know about recoveries on defaulted bonds显示文摘 | Altman E Kishore M | 1996 | Financial Analysts Journal1996，，52： | 1 |
| 20 | Genome sequencing in microfabricated high-density picolitre reactors显示文摘 | Margulies M Egholm M Altman W E | 2005 | Nature2005，437，7057： | 1 |
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