Department of Radiation Oncology, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre of Cancer Medicine, Guangzhou, People's Republic of China.
Department of Clinical Oncology, The University of Hong Kong-Shenzhen Hospital, Shenzhen, People's Republic of China.
Int J Radiat Oncol Biol Phys. 2017 May 1;98(1):170-176. doi: 10.1016/j.ijrobp.2017.01.214. Epub 2017 Jan 29.
To comprehensively assess the reporting quality of randomized, controlled trials (RCTs) in nasopharyngeal carcinoma (NPC), and to identify significant predictors of quality.
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.
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.
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.
全面评估鼻咽癌（NPC）随机对照试验（RCT）的报告质量，并确定质量的显著预测因素。
两名调查员检索了 MEDLINE 和 EMBASE 数据库，以查找发表于 1988 年 1 月至 2015 年 12 月间评估 NPC 联合放化疗效果的 RCT。根据 2010 年 CONSORT 声明，使用 28 分总体质量评分（OQS）评估每份报告的总体质量。为了进一步评估提供基线数据，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。
我们检索到 24 项相关 RCT，包括 6591 例患者。中位数 2010 OQS 为 15.5（范围 10-24）。2010 OQS 的一半项目在至少 40%的试验中报告不佳。多变量回归模型显示，2010 年后发表和高影响因子是 2010 OQS 改善的显著预测因素。此外，我们认为重要的许多问题没有得到充分报告。
尽管 CONSORT 声明发表已有十多年，但 NPC RCT 的总体报告质量仍不尽如人意。此外，某些关键问题的报告存在明显的选择性和异质性。这项调查首次促使 NPC 试验研究者根据 CONSORT 声明提高报告质量；编辑和同行评审者也需要更加严格的审查和审查。
