Division of Biomedical Informatics, Cincinnati Children's Hospital Medical Center, Cincinnati, USA.
Department of Anesthesia, Cincinnati Children's Hospital Medical Center, Cincinnati, USA.
Int J Med Inform. 2018 Mar;111:45-50. doi: 10.1016/j.ijmedinf.2017.12.014. Epub 2017 Dec 17.
Many clinical research studies claim to collect data that are also captured in the electronic medical record (EMR). We evaluate the potential for EMR data to replace prospective research data collection.
Using a dataset of 358 surgical patients enrolled in a prospective study, we examined the completeness and agreement of EMR and study entries for several variables, including the patient's stay in the post-operative care unit (PACU), surgical pain relief and pain medication side effects.
For all variables with a completeness percentage, values were greater than 96%. For the adverse event variables, we found slight to substantial agreement (Cohen's kappa), ranging from 0.19 (nausea) to 0.48 (respiratory depression) to 0.73 (emesis).
The potential to use EMR data as a replacement for prospective research data collection shows promise, but for now, should be evaluated on a variable-by-variable basis.
许多临床研究声称收集了电子病历(EMR)中也捕获的数据。我们评估了 EMR 数据替代前瞻性研究数据收集的潜力。
使用前瞻性研究中纳入的 358 名手术患者的数据集,我们检查了 EMR 和研究记录中几个变量的完整性和一致性,包括患者在术后护理单元(PACU)中的停留时间、手术疼痛缓解和疼痛药物副作用。
对于所有完整性百分比的变量,值均大于 96%。对于不良事件变量,我们发现存在轻微到实质性的一致性(Cohen's kappa),范围从 0.19(恶心)到 0.48(呼吸抑制)到 0.73(呕吐)。
使用 EMR 数据替代前瞻性研究数据收集的潜力有希望,但目前,应根据变量逐个进行评估。