Thoma Achilleas, Chew Roderick T, Sprague Sheila, Veltri Karen
Department of Surgery, Division of Plastic and Reconstructive Surgery, St Joseph's Healthcare, Hamilton, Ontario.
Can J Plast Surg. 2006 Winter;14(4):205-10. doi: 10.1177/229255030601400401.
The CONSORT (Consolidated Standards of Reporting Trials) statement was developed by a group of clinical trialists, biostatisticians, epidemiologists and biomedical editors as a means to improve the quality of reports of randomized controlled trials (RCTs). The purpose of the present study is to assess the reporting quality of published RCTs that compare endoscopic carpal tunnel release (ECTR) with open carpal tunnel release (OCTR) using the CONSORT statement.
A computerized literature search was conducted to identify all RCTs published from January 1989 to November 2004 that compared ECTR with OCTR. Foreign language studies were also included, and translated versions of these studies were obtained. Two investigators independently reviewed each eligible article and determined whether the authors reported on each of the 22 items of the CONSORT statement. Disagreements were resolved by consensus. The mean scores for studies published before the introduction of the CONSORT statement and those published afterward were compared. Similarly, a comparison was made between foreign language studies and those published in English.
Eighteen RCTs comparing ECTR with OCTR met the inclusion criteria. The total scores on the CONSORT checklist ranged from 3 to 20, with a mean score of 9.83+/-3.79 (the maximum possible score was 22). The six studies published in foreign language journals had a statistically significantly lower mean score than the studies published in English language journals (7.00+/-2.76 versus 11.25+/-3.49, respectively; P<0.05). The mean score was higher for studies published after 1996 than for those published in 1996 or earlier (12.14+/-3.80 versus 8.36+/-3.11, respectively; P<0.05).
The quality of reporting improved over time, but no study met all 22 criteria of the CONSORT statement. The CONSORT scores were higher for studies published after 1996 and for studies published in English language journals. Despite the improvement after 1996, most of these RCTs only reported one-half of the items listed on the CONSORT statement. Future investigators of surgical RCTs should make an effort to comply with the CONSORT checklist.
CONSORT（试验报告统一标准）声明由一组临床试验专家、生物统计学家、流行病学家和生物医学编辑共同制定，旨在提高随机对照试验（RCT）报告的质量。本研究的目的是使用CONSORT声明评估比较内镜下腕管松解术（ECTR）与开放性腕管松解术（OCTR）的已发表RCT的报告质量。
进行计算机文献检索，以识别1989年1月至2004年11月发表的所有比较ECTR与OCTR的RCT。还纳入了外语研究，并获取了这些研究的翻译版本。两名研究者独立审查每篇符合条件的文章，并确定作者是否报告了CONSORT声明的22项内容中的每一项。分歧通过协商解决。比较了在CONSORT声明引入之前和之后发表的研究的平均得分。同样，对外语研究和以英语发表的研究进行了比较。
18项比较ECTR与OCTR的RCT符合纳入标准。CONSORT清单的总分在3至20分之间，平均得分为9.83±3.79（最高可能得分为22分）。发表在外语期刊上的6项研究的平均得分在统计学上显著低于以英语期刊发表的研究（分别为7.00±2.76和11.25±3.49；P<0.05）。1996年以后发表的研究的平均得分高于1996年或更早发表的研究（分别为12.14±3.80和8.36±3.11；P<0.05）。
报告质量随时间有所提高，但没有研究符合CONSORT声明的所有22条标准。1996年以后发表的研究以及以英语发表的研究的CONSORT得分更高。尽管1996年以后有所改进，但这些RCT中的大多数仅报告了CONSORT声明中列出项目的一半。未来外科RCT的研究者应努力遵守CONSORT清单。
