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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 | Focal distribution for superresolving toraldo filters显示文摘 | Sheppard C J R Calvert G Wheatland M | 1998 | J Opt Soc Am A1998，15，： | 1 |
| 3 | Determination of lincomycin and tylosin residues in honey using solid - phase ex- traction and liquid chromatography - atmospheric pressure chemi- cal ionization mass spectrometry 显示文摘 | Thompson S T Noot D K Calvert J | 2003 | Journal of Chromatogra- phy A2003，1020，2： | 1 |
| 4 | Preva-lence of placenta praevia by world region: a systematic reviewand meta-analysis显示文摘 | CRESSWELL J A RONSMANS C CALVERT C | 2013 | Trop Med Int Health2013，18，6： | 1 |
| 5 | Effect of hyperbaric oxygen on apoptosis in neonatal hypoxia-ischemia rat model显示文摘 | CALVERT J W ZHOU C NANDA A | 2003 | Appl Physiol2003，95，： | 1 |
| 6 | Evaluation of diabetes mellitus, serum glucose and thyroid function among United States workers exposed to 2,3,7,8-tetrachlorodibenzo-p--dioxin显示文摘 | Calvert GM Sweeney MH Deddens J | 1999 | Occupational and Environmental Medicine1999，56，4： | 1 |
| 7 | Using fMRI to study recovery from acquired dysphasia显示文摘 | Brammer M J Morris RG | 2000 | Brain Lang2000，71，： | 1 |
| 8 | Mechanisms of early brain injury after subarachnoid hemorrhage 显示文摘 | Cahill J Calvert JW Zhang JH | 2006 | J Cereb Blood Flow Metab2006，26，： | 1 |
| 9 | Factors affecting vocabulary acquisition at age 2 in children born between 23 and 28 weeks' gestation显示文摘 | Marston L Peacock J Calvert S | 2007 | Dev Med Child Neurol2007，49，8： | 1 |
| 10 | Role of β-adrenergic receptors and nitric oxide signaling in exercise-mediated cardioprotection显示文摘 | John W Calvert David J Lefer | 2013 | Physiology (Bethesda)2013，28，4： | 1 |
| 11 | Novel insights into hydrogen sulfide-mediated cytoprotection显示文摘 | Calvert J W Coetzee W A Lefer D J | 2010 | Antioxid Redox Signal2010，12，10： | 1 |
| 12 | 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 |
| 13 | CD163 expression confers susceptibility to porcine reproductive and respiratory syndrome viruses显示文摘 | Calvert J G Slade D E Shields S L | 2007 | J Virol2007，81，14： | 1 |
| 14 | A quantitative comparison of graph-based models for Intemet topology 显示文摘 | ZEGURA E W CALVERT K L DONAHOO M J | 1997 | IEEE/ ACM Trans on Networking1997，5，6： | 1 |
| 15 | The evolution of the midface lift in aesthetic plastic surgery显示文摘 | PAUL M D CALVERT J W EVANS G R | 2006 | Plast Reconstr Surg2006，117，6： | 1 |
| 16 | Predictors andtreatment response with cardiac resynchronization therapy in patientswith heart failure characterized by dyssynchrony显示文摘 | Richardson M Freemantle N Calvert M J | 2007 | Eur Heart J2007，28，15： | 1 |
| 17 | Mechanisms of early brain in- jury after subarachnoid hemorrhage 显示文摘 | Cahill J Calvert J W Zheng J H | 2006 | J Cereb Blood Flow Metab2006，26，11： | 1 |
| 18 | Effects of nitrogenfertilization and stalk position polyphenols andcarbohydrates in the fluecured leaf of three tobaccogenotypecan显示文摘 | Sheen S J Calvert J Rebagray G R | 1997 | Plant Science1997，，53： | 1 |
| 19 | Novel insights into hydrogen sulfide-mediated cytoprotection显示文摘 | CALVERT J W COETZEE W A LEFER D J | 2010 | Antioxid Redox Signal2010，12，： | 1 |
| 20 | Equivalence of the vir- tual- source method and wave-field deconvolution in seis- mic interferometry 显示文摘 | Snieder R Sheiman J Calvert R | 2006 | Physical Review2006，73，6： | 1 |
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