Service d'Oncologie Médicale, Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon, 165 chemin du grand Revoyet, Pierre-Bénite, France.
J Natl Cancer Inst. 2012 Jul 3;104(13):982-9. doi: 10.1093/jnci/djs259.
The Consolidated Standards of Reporting Trials (CONSORT) guidelines were developed in the mid-1990s for the explicit purpose of improving clinical trial reporting. However, there is little information regarding the adherence to CONSORT guidelines of recent publications of randomized controlled trials (RCTs) in oncology.
All phase III RCTs published between 2005 and 2009 were reviewed using an 18-point overall quality score for reporting based on the 2001 CONSORT statement. Multivariable linear regression was used to identify features associated with improved reporting quality. To provide baseline data for future evaluations of reporting quality, RCTs were also assessed according to the 2010 revised CONSORT statement. All statistical tests were two-sided.
A total of 357 RCTs were reviewed. The mean 2001 overall quality score was 13.4 on a scale of 0-18, whereas the mean 2010 overall quality score was 19.3 on a scale of 0-27. The overall RCT reporting quality score improved by 0.21 points per year from 2005 to 2009. Poorly reported items included method used to generate the random allocation (adequately reported in 29% of trials), whether and how blinding was applied (41%), method of allocation concealment (51%), and participant flow (59%). High impact factor (IF, P = .003), recent publication date (P = .008), and geographic origin of RCTs (P = .003) were independent factors statistically significantly associated with higher reporting quality in a multivariable regression model. Sample size, tumor type, and positivity of trial results were not associated with higher reporting quality, whereas funding source and treatment type had a borderline statistically significant impact.
The results show that numerous items remained unreported for many trials. Thus, given the potential impact of poorly reported trials, oncology journals should require even stricter adherence to the CONSORT guidelines.
《统一报告临床试验标准》（CONSORT）指南是在 20 世纪 90 年代中期制定的，其明确目的是提高临床试验报告的质量。然而，关于肿瘤学领域近期发表的随机对照试验（RCT）是否符合 CONSORT 指南的信息却很少。
根据 2001 年 CONSORT 声明，我们使用 18 点整体报告质量评分，对 2005 年至 2009 年期间发表的所有 III 期 RCT 进行了回顾性审查。采用多元线性回归分析确定与提高报告质量相关的特征。为了为未来的报告质量评估提供基线数据，我们还根据 2010 年修订的 CONSORT 声明对 RCT 进行了评估。所有统计检验均为双侧检验。
共回顾了 357 项 RCT。2001 年的平均总质量评分为 0-18 分制的 13.4 分，而 2010 年的平均总质量评分为 0-27 分制的 19.3 分。2005 年至 2009 年，RCT 报告质量总评分每年提高 0.21 分。报告较差的项目包括生成随机分配的方法（仅 29%的试验中充分报告）、是否以及如何应用盲法（41%）、分配隐藏方法（51%）和参与者流程（59%）。高影响因子（IF，P=0.003）、近期发表日期（P=0.008）和 RCT 的地理来源（P=0.003）是多变量回归模型中与更高报告质量相关的独立因素。样本量、肿瘤类型和试验结果的阳性率与更高的报告质量无关，而资金来源和治疗类型具有统计学意义上的边界。
结果表明，许多试验仍有许多项目未报告。因此，鉴于报告质量差的试验可能产生的影响，肿瘤学期刊应要求更严格地遵守 CONSORT 指南。
