五种中华医学会系列杂志的论著中科研设计类型的分析

目的评价５种中华医学会系列杂志发表的科研论文中各种设计类型应用情况及其近十年来的变迁。方法系统地评阅了１９８５年和１９９５年５种中华医学会系列杂志６４０篇和９５４篇论著,对其所报道的研究设计类型、存在的问题和１０年来的变迁进行现况调查。结果在１９８５年和１９９５年发表的１５９４篇论著中,横断面研究和病例报道所占的比例都超过５０％,纵向研究的比例约占１／３。与１９８５年相比,临床试验所占的比例从５６％增加到１１３％,特别是临床对照试验（ＲＣＴ）的比例从１３％增加到４２％;前瞻性研究的比例从３９％上升到６０％;回顾性研究的比例从２５０％降至１３９％,病例报告的比例更是由１７３％降至５９％。在１９８５年和１９９５年的论著中研究设计明显存在问题的比例各为３８０％和３６８％。纵向研究存在的问题比例最高。５种最常见的科研设计问题依次为缺乏必要的对照或对照选择不合理、样本无代表性、结论依据不足、分组不随机及未考虑混杂偏倚。这五类问题占所有错误的６６９％。结论近十年来医学研究中选择论证力较强的设计类型的比例有所提高,但总的比例仍然很低,同时在应用中存在不少问题,应引起足够的重视。

Research reports in Chinese medical journals

Objective To assess research designs employed in Chinese medical journals over the last decade. Method The types of study design used in all original articles published in five leading journals (sponsored by the Chinese Medical Association) in 1985 ( n =640) and 1995 ( n =954) were evaluated. Results Of 1 594 articles, over 50% were case reports and cross sectional studies, and one third were longitudinal studies. Compared with 1985, the proportion of clinical trials increased from 5.6% to 11.3%, especially that of RCT increased from 1.3% to 4.2%. The proportion of prospective studies also increased from 3.9% to 6.0% and that of retrospective studies decreased from 25.0% to 13.9%, particularly, that of case series decreased from 17.3% to 5.9%. The inappropriate use of research design was frequent, the proportion of this problem was 38.0% and 36 8% for 1985 and 1995 respectively. The longitudinal studies were most liable to have this problem. The five commonly problems were the lack or inappropriateness of control, non representativeness of sample, unbelievable conclusion, no randomization, and no consideration of confounders. They accounted for 66.9%. Conclusion The quality of research designs used in Chinese medical research is gradually improving in the last decade, but the lack or inappropriate use remains a serious problem.