普通内分泌学文献中随机对照试验的报告质量

Quality of reporting of randomized controlled trials in general endocrinology literature.

作者信息

Rios Lorena P, Odueyungbo Adefowope, Moitri Misha O, Rahman Mohammed O, Thabane Lehana

机构信息

Father Sean O'Sullivan Research Centre, St. Joseph's Healthcare, Hamilton, Ontario, L8N 4A6 Canada.

出版信息

J Clin Endocrinol Metab. 2008 Oct;93(10):3810-6. doi: 10.1210/jc.2008-0817. Epub 2008 Jun 26.

Abstract

CONTEXT

The reporting quality of randomized controlled trials (RCTs) is poor in general medicine and several areas of specialization but unknown in endocrinology.

OBJECTIVE

Our aim was to assess the reporting quality of RCTs in general endocrinology. A secondary objective was to identify predictors for better reporting quality.

DESIGN AND SETTING

We systematically reviewed RCTs published in three general endocrinology journals between January 2005 and December 2006.

PARTICIPANTS

We included parallel-design RCTs that addressed a question of treatment or prevention. Article selection and data abstraction were conducted by two reviewers independently, and disagreements were resolved by consensus.

MAIN OUTCOMES

There were two main outcomes: 1) a 15-point overall reporting quality score (OQS) based on the Consolidated Standards for Reporting Trials (CONSORT); and 2) a 3-point key score, based on allocation concealment, blinding, and use of intention-to-treat analysis.

RESULTS

Eighty nine RCTs were included. The median OQS was 10 (interquartile range = 2). Allocation concealment, blinding, and analysis by intention to treat were reported in 10, 20, and 16 of the 89 RCTs, respectively. A multivariable regression analysis showed that complete industrial funding [incidence rate ratio (IRR) = 1.014; 95% confidence interval (CI), 1.010-1.018], journal of publication (IRR = 1.068; 95% CI, 1.007-1.132), and sample size (IRR = 1.048; 95% CI, 1.026-1.070) were significantly associated with a slightly better OQS.

CONCLUSIONS

The quality of RCT reporting in general endocrine literature is suboptimal. We discuss our results, highlight the areas where improvements are needed, and provide some recommendations.

摘要

背景

在普通医学及多个专科领域,随机对照试验(RCT)的报告质量普遍较差,但在内分泌学领域情况未知。

目的

我们的目的是评估普通内分泌学领域RCT的报告质量。次要目的是确定报告质量更好的预测因素。

设计与环境

我们系统回顾了2005年1月至2006年12月期间在三本普通内分泌学杂志上发表的RCT。

参与者

我们纳入了针对治疗或预防问题的平行设计RCT。文章选择和数据提取由两名审稿人独立进行,分歧通过协商解决。

主要结果

有两个主要结果:1)基于《报告试验的统一标准》(CONSORT)的15分总体报告质量评分(OQS);2)基于分配隐藏、盲法和意向性分析使用情况的3分关键评分。

结果

纳入了89项RCT。OQS的中位数为10(四分位间距 = 2)。89项RCT中,分别有10项、20项和16项报告了分配隐藏、盲法和意向性分析。多变量回归分析显示,完全由产业资助[发病率比(IRR) = 1.014;95%置信区间(CI),1.010 - 1.018]、发表杂志(IRR = 1.068;95%CI,1.007 - 1.132)和样本量(IRR = 1.048;95%CI,1.026 - 1.070)与略高的OQS显著相关。

结论

普通内分泌学文献中RCT报告的质量欠佳。我们讨论了结果,强调了需要改进的领域,并提供了一些建议。

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