Süt Necdet, Senocak Mustafa, Uysal Omer, Köksalan Hilal
Department of Biostatistics, Trakya University Medical Faculty, Edirne, Turkey.
Hematol Oncol Stem Cell Ther. 2008 Jan-Mar;1(1):38-43. doi: 10.1016/s1658-3876(08)50059-8.
No study has been conducted on the scientific quality of randomized controlled trials (RCTs) in the cancer field. Our objective was to determine whether adherence to the Consolidated Standards for Reporting Trials (CONSORT) statement is associated with scientific properties of RCT reports from two leading cancer journals.
We conducted an observational study of RCTs published between 2002 and 2004 in two leading cancer journals that did not endorse the CONSORT statement during that period. We determined the adherence rates with confidence intervals of 33 RCTs according to the 19 methodological items of the CONSORT statement. Each RCT was blindly assessed by three independent evaluators; then the evaluators examined all judgments sequentially and obtained a consensus regarding each methodological item of the CONSORT statement.
The average adherence of these 33 RCTs to the 19 methodological items of the CONSORT statement was 79.3% (95% CI, 75.3-83.4%). Most descriptors from the checklist were determined to be methodologically adequate except sequence generation (56.1%; 95% CI, 40.9-71.3%), allocation concealment (27.3%; 95% CI, 13.2-41.4%), implementation (7.6%; 95% CI, 0.0-15.4%), blinding (30.3%; 95% CI, 14.4-46.3%) and sample size (74.2%; 95% CI, 59.5-89.0%). Of all CONSORT checklist items, randomization implementation was the most often omitted.
Some key methodological items of the CONSORT statement seem poorly addressed in RCTs from these leading cancer journals. Thus researchers should be urged to conform to the CONSORT statement when reporting on RCTs, and the poorly addressed items of the CONSORT statement should be reevaluated for RCTs already reported.
尚未对癌症领域随机对照试验（RCT）的科学质量进行研究。我们的目的是确定是否遵守《报告试验的统一标准》（CONSORT）声明与来自两份领先癌症期刊的RCT报告的科学属性相关。
我们对2002年至2004年期间在两份领先癌症期刊上发表的RCT进行了一项观察性研究，这两份期刊在该期间未认可CONSORT声明。我们根据CONSORT声明的19项方法学项目确定了33项RCT的依从率及其置信区间。每项RCT由三名独立评估者进行盲法评估；然后评估者依次检查所有判断，并就CONSORT声明的每个方法学项目达成共识。
这33项RCT对CONSORT声明的19项方法学项目的平均依从率为79.3%（95%CI，75.3 - 83.4%）。检查表中的大多数描述符在方法学上被确定为充分，但序列产生（56.1%；95%CI，40.9 - 71.3%）、分配隐藏（27.3%；95%CI，13.2 - 41.4%）、实施（7.6%；95%CI，0.0 - 15.4%）、盲法（30.3%；95%CI，14.4 - 46.3%）和样本量（74.2%；95%CI，59.5 - 89.0%）除外。在所有CONSORT检查表项目中，随机化实施是最常被遗漏的。
在这些领先癌症期刊的RCT中，CONSORT声明的一些关键方法学项目似乎未得到充分处理。因此，应敦促研究人员在报告RCT时遵守CONSORT声明，并且应对已报告的RCT中CONSORT声明未充分处理的项目进行重新评估。
