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临床医生与患者报告癌症临床试验中不良事件评估的基线和基线后症状。

Clinician vs Patient Reporting of Baseline and Postbaseline Symptoms for Adverse Event Assessment in Cancer Clinical Trials.

机构信息

Memorial Sloan Kettering Cancer Center, New York, New York.

Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, Arizona.

出版信息

JAMA Oncol. 2020 Mar 1;6(3):437-439. doi: 10.1001/jamaoncol.2019.5566.

DOI:10.1001/jamaoncol.2019.5566
PMID:31876902
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6990818/
Abstract

This retrospective analysis of clinical trials compares clinician reporting of adverse events and patient reporting of analogous symptoms.

摘要

本回顾性临床试验分析比较了临床医生报告的不良事件和患者报告的类似症状。

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本文引用的文献

1
Patient-reported outcomes: an essential component of oncology drug development and regulatory review.患者报告的结局：肿瘤药物研发与监管审评的重要组成部分。
Lancet Oncol. 2018 May;19(5):595-597. doi: 10.1016/S1470-2045(18)30141-4.
2
Patient-Reported Outcomes - Harnessing Patients' Voices to Improve Clinical Care.患者报告结局——利用患者声音改善临床护理。
N Engl J Med. 2017 Jan 12;376(2):105-108. doi: 10.1056/NEJMp1611252.
3
Methods for Implementing and Reporting Patient-reported Outcome (PRO) Measures of Symptomatic Adverse Events in Cancer Clinical Trials.癌症临床试验中有症状不良事件的患者报告结局（PRO）测量的实施与报告方法
Clin Ther. 2016 Apr;38(4):821-30. doi: 10.1016/j.clinthera.2016.03.011. Epub 2016 Apr 2.
4
Missing Patients' Symptoms in Cancer Care Delivery--The Importance of Patient-Reported Outcomes.癌症护理中患者症状的遗漏——患者报告结局的重要性。
JAMA Oncol. 2016 Apr;2(4):433-4. doi: 10.1001/jamaoncol.2015.4719.
5
Note on the sampling error of the difference between correlated proportions or percentages.关于相关比例或百分比差异的抽样误差说明。
Psychometrika. 1947 Jun;12(2):153-7. doi: 10.1007/BF02295996.