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随机临床试验方案中计划的亚组分析评估。

Evaluation of Planned Subgroup Analysis in Protocols of Randomized Clinical Trials.

机构信息

Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Basel, Switzerland.

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.

出版信息

JAMA Netw Open. 2021 Oct 1;4(10):e2131503. doi: 10.1001/jamanetworkopen.2021.31503.

DOI:10.1001/jamanetworkopen.2021.31503
PMID:34705015
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8552052/
Abstract

This cross-sectional study compares randomized clinical trial protocols to assess the prevalence and reporting quality of planned subgroup analyses over time.

摘要

本横断面研究比较了随机临床试验方案，以评估随时间变化的计划亚组分析的流行程度和报告质量。

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Evaluation of Planned Subgroup Analysis in Protocols of Randomized Clinical Trials.随机临床试验方案中计划的亚组分析评估。
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本文引用的文献

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Rationale and design of repeated cross-sectional studies to evaluate the reporting quality of trial protocols: the Adherence to SPIrit REcommendations (ASPIRE) study and associated projects.重复横断面研究评估试验方案报告质量的原理与设计：遵循《渥太华小组声明》建议（ASPIRE）研究及相关项目
Trials. 2020 Oct 28;21(1):896. doi: 10.1186/s13063-020-04808-y.
2
Development of the Instrument to assess the Credibility of Effect Modification Analyses (ICEMAN) in randomized controlled trials and meta-analyses.随机对照试验和荟萃分析中效应修饰分析可信度评估工具（ICEMAN）的开发。
CMAJ. 2020 Aug 10;192(32):E901-E906. doi: 10.1503/cmaj.200077.
3
A systematic survey identified 36 criteria for assessing effect modification claims in randomized trials or meta-analyses.一项系统调查确定了 36 项标准，用于评估随机试验或荟萃分析中关于效应修饰的主张。
J Clin Epidemiol. 2019 Sep;113:159-167. doi: 10.1016/j.jclinepi.2019.05.014. Epub 2019 May 24.
4
Afatinib versus cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): analysis of overall survival data from two randomised, phase 3 trials.阿法替尼对比基于顺铂的化疗用于 EGFR 突变阳性肺腺癌（LUX-Lung 3 和 LUX-Lung 6）：两项随机、III 期临床试验总生存数据的分析。
Lancet Oncol. 2015 Feb;16(2):141-51. doi: 10.1016/S1470-2045(14)71173-8. Epub 2015 Jan 12.
5
Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications.随机对照试验的亚组分析：基于试验方案和期刊文献的队列研究。
BMJ. 2014 Jul 16;349:g4539. doi: 10.1136/bmj.g4539.
6
Panitumumab-FOLFOX4 treatment and RAS mutations in colorectal cancer.帕尼单抗联合 FOLFOX4 治疗与结直肠癌的 RAS 突变。
N Engl J Med. 2013 Sep 12;369(11):1023-34. doi: 10.1056/NEJMoa1305275.