Kober Thilo, Trelle Sven, Engert Andreas
Competence Network Malignant Lymphomas, Department I of Internal Medicine, University of Cologne, Germany.
J Natl Cancer Inst. 2006 May 3;98(9):620-5. doi: 10.1093/jnci/djj160.
Randomized controlled trials (RCTs) are the best tool to evaluate the effectiveness of clinical interventions. The Consolidated Standards for Reporting Trials (CONSORT) statement was introduced in 1996 to improve reporting of RCTs. We aimed to determine the extent of ambiguity and reporting quality as assessed by adherence to the CONSORT statement in published reports of RCTs involving patients with Hodgkin lymphoma from 1966 through 2002.
We analyzed 242 published full-text reports of RCTs in patients with Hodgkin lymphoma. Quality of reporting was assessed using a 14-item questionnaire based on the CONSORT checklist. Reporting was studied in two pre-CONSORT periods (1966-1988 and 1989-1995) and one post-CONSORT period (1996-2002).
Only six of the 14 items were addressed in 75% or more of the studies in all three time periods. Most items that are necessary to assess the methodologic quality of a study were reported by fewer than 20% of the studies. Improvements over time were seen for some items, including the description of statistics methods used, reporting of primary research outcomes, performance of power calculations, method of randomization and concealment allocation, and having performed intention-to-treat analysis.
Despite recent improvements, reporting levels of CONSORT items in RCTs involving patients with Hodgkin lymphoma remain unsatisfactory. Further concerted action by journal editors, learned societies, and medical schools is necessary to make authors even more aware of the need to improve the reporting RCTs in medical journals to allow assessment of validity of published clinical research.
随机对照试验（RCT）是评估临床干预效果的最佳工具。1996年引入了《报告试验的统一标准》（CONSORT）声明，以改善随机对照试验的报告。我们旨在确定1966年至2002年发表的涉及霍奇金淋巴瘤患者的随机对照试验报告中，按照CONSORT声明评估的模糊程度和报告质量。
我们分析了242篇已发表的霍奇金淋巴瘤患者随机对照试验的全文报告。使用基于CONSORT清单的14项问卷评估报告质量。在CONSORT声明发布前的两个时期（1966 - 1988年和1989 - 1995年）以及发布后的一个时期（1996 - 2002年）对报告进行了研究。
在所有三个时间段的75%或更多研究中，14项内容中只有6项得到了阐述。评估研究方法学质量所需的大多数项目，报告的研究不足20%。随着时间推移，部分项目有改进，包括所用统计方法的描述、主要研究结果的报告、效能计算的执行情况、随机化方法和分配隐藏以及是否进行意向性分析。
尽管最近有所改进，但涉及霍奇金淋巴瘤患者的随机对照试验中CONSORT项目的报告水平仍不令人满意。期刊编辑、学术团体和医学院校需要进一步共同采取行动，使作者更加意识到有必要改进医学期刊中随机对照试验的报告，以便评估已发表临床研究的有效性。
