Reporting Quality of Randomized, Controlled Trials Evaluating Combined Chemoradiotherapy in Nasopharyngeal Carcinoma
Reporting Quality of Randomized, Controlled Trials Evaluating Combined Chemoradiotherapy in Nasopharyngeal Carcinoma
复制标题
DOI：
10.1016/j.ijrobp.2017.01.214
复制
发表时间：
2017-05-01
影响因子：
7
通讯作者：
Ma, Jun
中科院分区：
文献类型：
--
作者：
Chen, Yu-Pei;Chen, Lei;Ma, Jun
目的：综合评价鼻咽癌（NPC）随机对照试验（RCTs）的报告质量，并寻找影响报告质量的重要因素。方法和材料：两位研究者在MEDLINE和EMBASE检索1988年1月至2015年12月期间发表的评估鼻咽癌联合放化疗效果的随机对照试验。每个报告的总体质量是根据2010年报告试验综合标准（CONSORT）声明使用28分的总体质量分数（OQS）进行评估的。为了提供进一步评估的基线数据，我们还详细调查了某些重要问题的报告质量，包括关键的方法学项目（分配隐藏、盲法、意向治疗原则）、终点、随访、亚组分析和不良事件。结果：我们检索到24项相关rct，包括6591例患者。2010年OQS中位数为15.5（范围：10-24）。2010年OQS中有一半的项目在至少40%的试验中报告不佳。多变量回归模型显示，2010年以后发表论文和高影响因子是2010年OQS提高的显著预测因子。此外，许多我们认为重要的问题没有得到充分的报告。结论：尽管CONSORT声明在十多年前就发表了，但NPC随机对照试验的总体报告质量并不令人满意。此外，在某些关键问题的报告中存在大量的选择性和异质性。这项调查为人大审判调查员提供了第一个提示，即根据CONSORT声明提高报告质量；编辑和同行审稿人也需要加强审查和勤奋。(C) 2017爱思唯尔公司版权所有。
Purpose: To comprehensively assess the reporting quality of randomized, controlled trials (RCTs) in nasopharyngeal carcinoma (NPC), and to identify significant predictors of quality.Methods and Materials: Two investigators searched MEDLINE and EMBASE for RCTs published between January 1988 and December 2015 that assessed the effect of combined chemoradiotherapy for NPC. The overall quality of each report was assessed using a 28-point overall quality score (OQS) based on the 2010 Consolidated Standards of Reporting Trials (CONSORT) statement. To provide baseline data for further evaluation, we also investigated the reporting quality of certain important issues in detail, including key methodologic items (allocation concealment, blinding, intention-to-treat principle), endpoints, follow-up, subgroup analyses, and adverse events.Results: We retrieved 24 relevant RCTs including 6591 patients. Median 2010 OQS was 15.5 (range, 10-24). Half of the items in the 2010 OQS were poorly reported in at least 40% of trials. Multivariable regression models revealed that publication after 2010 and high impact factor were significant predictors of improved 2010 OQS. Additionally, many issues that we consider significant were not reported adequately.Conclusions: Despite publication of the CONSORT statement more than a decade ago, overall reporting quality for RCTs in NPC was unsatisfactory. Additionally, substantial selectivity and heterogeneity exists in reporting of certain crucial issues. This survey provides the first prompt for NPC trial investigators to improve reporting quality according to the CONSORT statement; increased scrutiny and diligence by editors and peer reviewers is also required. (C) 2017 Elsevier Inc. All rights reserved.