de Keizer N F, Ammenwerth E
Department of Medical Informatics, J1b-114, Academic Medical Centre, Universiteit van Amsterdam, P.O. Box 22700, 1100 DE Amsterdam, The Netherlands.
Int J Med Inform. 2008 Jan;77(1):41-9. doi: 10.1016/j.ijmedinf.2006.11.009. Epub 2007 Jan 5.
To obtain an overview of study designs and study methods used in research evaluating IT in health care, to present a list of quality criteria by which all kinds of reported evaluation studies on IT systems in health care can be assessed, and to assess the quality of reported evaluation studies on IT in health care and its development over time (1982-2005).
A generic 10-item list of quality indicators was developed based on existing literature on quality of medical and medical informatics publications. It is applicable to all kind of IT evaluation papers and not restricted to randomized controlled trials. One hundred and twenty explanatory papers evaluating the effects of an IT system in health care published between 1982 and 2005 were randomly selected from PubMed, the study designs and study methods were extracted, and the quality indicators were used to assess the quality of each paper by two independent raters.
The inter-rater variability of scoring the 10 quality indicators as assessed by a pre-test with nine papers was good (K=0.87). There was a trend towards more multi-centre studies and authors coming more frequently from various departments. About 70% of the studies used a design other than a randomized controlled trial (RCT). Forty percent of the studies combined at least two different data acquisition methods. The quality of IT evaluation papers, as defined by the quality indicators, was only slightly improving in time (Spearman correlation coefficient [rs]=0.19). The quality of RCTs publications was significantly higher than the quality of non-RCT studies (p<0.001).
The continuous and dominant number of non-RCT studies reflects the various approaches applicable to evaluate IT systems in health care. Despite the increasing discussion on evidence-based health informatics, the quality of published evaluation studies on IT interventions in health care is still insufficient in some aspects. Journal editors and referees should take care that reports of evaluation on IT systems contain all aspects needed for a sufficient understanding and reproducibility of a paper. Publication guidelines should be developed to support more complete and better publications of IT evaluation papers.
全面了解医疗保健领域中评估信息技术(IT)的研究设计和研究方法,列出一系列质量标准,据此可对各类已报道的医疗保健领域IT系统评估研究进行评估,并评估1982年至2005年间已报道的医疗保健领域IT评估研究的质量及其随时间的发展情况。
基于关于医学和医学信息学出版物质量的现有文献,制定了一份包含10项质量指标的通用列表。该列表适用于各类IT评估论文,不限于随机对照试验。从PubMed中随机选取1982年至2005年间发表的120篇评估医疗保健领域IT系统效果的解释性论文,提取其研究设计和研究方法,并由两名独立评分者使用质量指标评估每篇论文的质量。
通过对9篇论文进行预测试评估10项质量指标时,评分者间的变异性良好(K = 0.87)。多中心研究有增加趋势且作者来自不同部门的频率更高。约70%的研究采用了随机对照试验(RCT)以外的设计。40%的研究至少结合了两种不同的数据采集方法。根据质量指标定义,IT评估论文的质量随时间仅略有提高(斯皮尔曼相关系数[rs] = 0.19)。RCT出版物的质量显著高于非RCT研究(p < 0.001)。
非RCT研究持续且占主导地位,反映了适用于评估医疗保健领域IT系统的多种方法。尽管关于循证健康信息学的讨论日益增多,但已发表的医疗保健领域IT干预评估研究的质量在某些方面仍不足。期刊编辑和审稿人应确保IT系统评估报告包含充分理解和重现论文所需的所有方面。应制定出版指南以支持IT评估论文更完整和更好的发表。