Lai Yan See, Afseth Janyne Dawn
1 School of Health and Social Care, Edinburgh Napier University, Edinburgh, UK.
2 Research Clinic, Singapore Eye Research Institute, Singapore, Singapore.
Clin Trials. 2019 Apr;16(2):194-203. doi: 10.1177/1740774519829709. Epub 2019 Feb 15.
Recruitment is an important aspect of clinical research, as poor recruitment could undermine the scientific value of a trial or delay the development process of new treatments. The development of electronic medical records provides a new way to identify potential participants for trials by matching the eligibility criteria with patients' data within electronic medical records.
A literature search was performed to examine the effectiveness and efficiency of the electronic medical record recruitment method using MEDLINE, PubMed, PubMed Central, CINAHL Plus with Full Text, ScienceDirect and Cochrane Library databases. These searches generated 11 articles that met the eligibility criteria, and handsearching reference lists generated two additional articles bringing the total number of articles to 13. These articles were subjected to critical appraisal utilising the Effective Public Health Practice Project tool.
Out of the 13 included articles, 11 provided quantitative data on recruitment effectiveness while seven articles provided quantitative data on recruitment efficiency. The automation in screening and patient identification by using alerts, a notification system, to notify research staff of a potential participant, was observed to contribute to higher recruitment yield and reduced workload due to its specificity on participant screening. The use of electronic medical record alerts was found to be associated with better recruitment outcomes when they were sent to dedicated research staff rather than physicians. Using electronic medical records for recruitment was found to be effective due to its capability for patient identification outside working hours and fast processing time, which was particularly useful for clinical trials in acute conditions. Several challenges may hinder the impact of the electronic medical record recruitment method, including the lack of conformity of clinical trial eligibility criteria and electronic medical record data structure and missing data. 'Alert fatigue' could also impact on the effectiveness of this method in the long term.
The results from this review supports electronic medical record being an effective and efficient method for clinical trial recruitment. Recommendations were made in order to maximise the potential of the electronic medical record recruitment method and also for future research in order to improve the quality of evidence to support this strategy for recruitment.
招募是临床研究的一个重要方面，因为招募不佳可能会损害试验的科学价值或延迟新治疗方法的开发进程。电子病历的发展为通过将入选标准与电子病历中的患者数据进行匹配来识别试验的潜在参与者提供了一种新方法。
进行文献检索，以使用MEDLINE、PubMed、PubMed Central、CINAHL Plus with Full Text、ScienceDirect和Cochrane Library数据库来考察电子病历招募方法的有效性和效率。这些检索产生了11篇符合入选标准的文章，通过手工检索参考文献列表又增加了2篇文章，使文章总数达到13篇。使用有效公共卫生实践项目工具对这些文章进行了严格评估。
在纳入的13篇文章中，11篇提供了关于招募有效性的定量数据，7篇文章提供了关于招募效率的定量数据。通过使用警报（一种通知系统）来通知研究人员潜在参与者，从而实现筛选和患者识别自动化，由于其在参与者筛选方面的特异性，被观察到有助于提高招募产量并减少工作量。当电子病历警报发送给专门的研究人员而非医生时，发现其与更好的招募结果相关。由于能够在工作时间之外识别患者且处理时间快，利用电子病历进行招募被认为是有效的，这对于急性病症的临床试验尤为有用。若干挑战可能会阻碍电子病历招募方法的影响，包括临床试验入选标准与电子病历数据结构不一致以及数据缺失。从长远来看，“警报疲劳”也可能影响该方法的有效性。
本综述结果支持电子病历是一种用于临床试验招募的有效且高效的方法。提出了一些建议，以便最大限度地发挥电子病历招募方法的潜力，同时也为未来研究提供建议，以提高支持这种招募策略的证据质量。
