临床试验中的电子健康记录出版偏倚。
Publication bias in clinical trials of electronic health records.
机构信息
Department of Biomedical Informatics, Columbia University, New York, NY 10032, United States.
出版信息
J Biomed Inform. 2013 Feb;46(1):139-41. doi: 10.1016/j.jbi.2012.08.007. Epub 2012 Sep 10.
Abstract
OBJECTIVE
To measure the rate of non-publication and assess possible publication bias in clinical trials of electronic health records.
METHODS
We searched ClinicalTrials.gov to identify registered clinical trials of electronic health records and searched the biomedical literature and contacted trial investigators to determine whether the results of the trials were published. Publications were judged as positive, negative, or neutral according to the primary outcome.
RESULTS
Seventy-six percent of trials had publications describing trial results; of these, 74% were positive, 21% were neutral, and 4% were negative (harmful). Of unpublished studies for which the investigator responded, 43% were positive, 57% were neutral, and none were negative; the lower rate of positive results was significant (p<0.001).
CONCLUSION
The rate of non-publication in electronic health record studies is similar to that in other biomedical studies. There appears to be a bias toward publication of positive trials in this domain.
摘要
目的
测量电子病历临床试验中未发表的比例，并评估可能存在的发表偏倚。
方法
我们在 ClinicalTrials.gov 上搜索了电子病历的注册临床试验，并搜索了生物医学文献，同时联系了试验研究者以确定这些试验的结果是否已经发表。根据主要结局，出版物被判断为阳性、阴性或中性。
结果
76%的试验有描述试验结果的出版物；其中，74%为阳性，21%为中性，4%为阴性（有害）。对于研究者回复的未发表的研究，43%为阳性，57%为中性，没有负面的结果；阳性结果的比例较低，差异具有统计学意义（p<0.001）。
结论
电子病历研究的未发表率与其他生物医学研究相似。在这个领域，似乎存在发表阳性试验的偏倚。
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