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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 | Randomized crossover study comparing efficacy of transnasal endoscopy with that of standard endoscopy to detect Barrett’s esophagus显示文摘 | M. Kareem Shariff Elizabeth L. Bird-Lieberman Maria O'Donovan Zarah Abdullahi Xinxue Liu Jane Blazeby Rebecca Fitzgerald | 2012 | Gastrointestinal Endoscopy2012，，5： | 2 |
| 3 | Decision-Making about PSA Testing and Prostate Biopsies: A Qualitative Study Embedded in a Primary Care Randomised Trial显示文摘 | Kerry N.L. Avery Jane M. Blazeby J. Athene Lane David E. Neal Freddie C. Hamdy Jenny L. Donovan | 2007 | European Urology2007，，6： | 1 |
| 4 | The prognostic value of quality of life scores during treatment for oesophageal cancer显示文摘 | Blazeby JM Brookes ST Alderson D | 2001 | Gut2001，49，2： | 1 |
| 5 | Reporting quality of life in clinical trials:a CONSORT extension显示文摘 | Calvert M Blazeby J Revicki D | 2011 | Lancet2011，378，9804： | 1 |
| 6 | Quality of life in patients with oesophagea lcancer显示文摘 | Blazeby JM Alderson D Farndon JR | 2000 | Recent Results Cancer Res2000，155，： | 1 |
| 7 | Health-related quality of life measurement in randomized clinical trials in surgical oncology显示文摘 | Blazeby J M AveryK Sprangers M | 2006 | J Clin Oncol2006，24，19： | 1 |
| 8 | Clinical and psychomet ric validation of an EORTC questionnaire module,the EORTC QLQ2OES18,to assess quality of life in patient s wit hoesophageal cancer显示文摘 | Blazeby JM Conroy T Hammerlid E | 2003 | Eur J Cancer2003，39，10： | 1 |
| 9 | Development of an EORTC disease-specific quality of life module for use in pa- tients with gastric cancer 显示文摘 | Vickery CW Blazeby JM Conroy T | 2001 | Eur J Cancer2001，37，8： | 1 |
| 10 | Analysis of clinical decision-making in multi-disciplinary cancer teams显示文摘 | Blazeby JM Wilson L Metcalfe C | 2006 | Ann Oncol2006，17，3： | 1 |
| 11 | Analysis of clinical deci- sion-making in multi-disciplinary cancer teams 显示文摘 | Blazeby JM Wilson L Metcalfe C | 2006 | Ann Oncol2006，17，3： | 1 |
| 12 | Randomized clinical trial comparing laparoscopic and open surgery for colorectal cancer within an enhanced recovery programme显示文摘 | King PM Blazeby JM Ewings P | 2006 | Br J Surg2006，93，3： | 1 |
| 13 | Prospective longitudinal study examining the quality of life of patients with esophageal carcinoma显示文摘 | Blazeby JM Farndon JR Donovan JA | 2000 | Cancer2000，88，8： | 1 |
| 14 | Demonstration of the IDEAL recommendations for evaluating and reporting surgical innovation in minimally invasive oesophagectomy显示文摘 | Blazeby JM Blencowe NS Titcomb DR | | 0，，4： | 1 |
| 15 | Quality of life in patients with oesophagea lcancer显示文摘 | Blazeby JM Alderson D Farndon JR | 2000 | Recent Results Cancer Res2000，155，： | 1 |
| 16 | Guidelines for the management of oesophageal and gastric cancer 显示文摘 | Allure WH Blazeby JM Griffin SM | 2011 | Gut2011，60，11： | 1 |
| 17 | Clinical and psyehometric validation of an EORTC questionnaire module,the EORTCQLQ-OES18,to assess quality of life in patients with oesophageal cancer显示文摘 | Blazeby JM Conroy T Hammerlid E | 2003 | Eur J Caneer2003，39，10： | 1 |
| 18 | The prognostic value of quality of life scores during treatment for oesophageal cancer显示文摘 | Blazeby JM Brookes ST Alderson D | 2001 | Gut2001，49，2： | 1 |
| 19 | Development of a questionnaire module to supplement the EORTC QLQ-C30to assess quality of life in patients with hepatocellular carcinoma,the EORTC QLQ-HCC18显示文摘 | Blazeby JM | 2004 | Eur J Cancer2004，40，16： | 1 |
| 20 | Randomized clini- cal trial comparing laparoscopic and open surgery for colorectal cancer within an enhanced recovery programme 显示文摘 | King PM Blazeby JM Ewings P | 2006 | Br J Surg2006，93，3： | 1 |
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