德语眼科期刊中的随机对照试验和对照临床试验

[Randomized controlled and controlled clinical trials in German-language ophthalmological journals].

作者信息

Schmucker C, Blümle A, Antes G, Lagrèze W

机构信息

Universitäts-Augenklinik Freiburg, Freiburg, Deutschland.

出版信息

Ophthalmologe. 2008 Mar;105(3):255-61. doi: 10.1007/s00347-007-1618-6.

DOI:10.1007/s00347-007-1618-6

PMID:17899115

Abstract

BACKGROUND

The medical database MEDLINE contains only a part of all published randomized controlled (RCTs) and controlled clinical (CCTs) trials. The validity of a systematic review depends on the complete consideration of all studies pertaining to a clinical question. Therefore, a manual systematic search in medical journals is mandatory.

METHODS

The last 30 years of the three peer-reviewed German-language ophthalmological journals Der Ophthalmologe, Klinische Monatsblätter für Augenheilkunde, and Spektrum der Augenheilkunde were retrospectively searched for controlled trials. All identified RCTs and CCTs were classified according to their ophthalmological subspecialty. The quality of the studies was evaluated using the CONSORT Statement. Moreover, a comparison was made of how many of the studies identified by hand searching are registered in MEDLINE and correctly classified as RCTs/CCTs.

RESULTS

In total 984 RCTs and CCTs were identified; 62% of the trials were from the subspecialty anterior eye segment, 14% belonged to the subspecialty posterior eye segment, and 18% belonged to glaucoma. A sample size calculation was reported in less than 2% of the full-text publications and 34% reported a blinded study design. A randomization process was described in 23% of the RCTs. Most controlled trials were published in the 1990s in all three journals. From 1998 onward, there was a decrease in the number of published controlled trials in the reviewed German literature. About 63% of the studies registered in MEDLINE are correctly classified.

CONCLUSION

In the specialty of ophthalmology there are many important studies which provide basic information for compilation of systematic reviews and clinical guidelines. However, many of the identified clinical trials in German-language journals show deficiencies in the study quality. Only a part of the identified controlled trials are correctly classified in MEDLINE. Therefore, a retrospective registration is essential to complete the electronic database in ophthalmology.

摘要

背景

医学数据库MEDLINE仅包含所有已发表的随机对照试验（RCT）和对照临床试验（CCT）的一部分。系统评价的有效性取决于对与临床问题相关的所有研究的全面考量。因此，必须对医学期刊进行手动系统检索。

方法

对德语同行评审的三本眼科期刊《Der Ophthalmologe》《Klinische Monatsblätter für Augenheilkunde》和《Spektrum der Augenheilkunde》过去30年的内容进行回顾性检索，以查找对照试验。所有识别出的RCT和CCT均根据其眼科亚专业进行分类。使用CONSORT声明评估研究质量。此外，还比较了通过手工检索识别出的研究中有多少在MEDLINE中注册并被正确分类为RCT/CCT。

结果

共识别出984项RCT和CCT；62%的试验来自眼前节亚专业，14%属于眼后节亚专业，18%属于青光眼亚专业。不到2%的全文出版物报告了样本量计算，34%报告了盲法研究设计。23%的RCT描述了随机化过程。大多数对照试验在20世纪90年代发表于这三本期刊。从1998年起，德语文献中发表的对照试验数量有所减少。在MEDLINE中注册的研究约63%被正确分类。