Yokoi Kensuke, Tanaka Atsushi, Yoshioka Goro, Hara Masahiko, Kamohara Keiji, Node Koichi
Department of Cardiovascular Medicine, Saga University, Saga, Japan.
Department of Clinical Investigation, Japan Society of Clinical Research, Osaka, Japan.
Mayo Clin Proc Innov Qual Outcomes. 2024 Oct 8;8(6):502-504. doi: 10.1016/j.mayocpiqo.2024.08.006. eCollection 2024 Dec.
Long-term outcome ascertainment can be affected by the follow-up performance and needs to use a different data source for more comprehensive data capture. However, a universal tracking system is absent in Japan, and long-term outcomes are often ascertained through electronic medical records (EMRs), the reliability of which is uncertain. In this study, we compared EMR-based and direct outreach-based collections on outcome ascertainment accuracy in 500 patients who underwent coronary artery bypass grafting. Mortality data for all patients were extracted from the EMR, as standard data collection. When patient death was not confirmed in the EMR, we enhanced to collect updated mortality information by direct outreach to patients, their family, or their physicians, as enhanced direct outreach data. As a result, the Kaplan-Meier curves found a notable separation between different data sources analyzed. Interestingly, mortality events in the latter half of the follow-up period (median, 6.5 years) were overestimated in the EMR-based data collection analysis because of the reduced number of actively tracked cases, highlighting a potential bias in the EMR-based data collection on long-term prognoses. Our findings suggest that an active follow-up strategy with better adherence will enhance the accuracy of long-term outcome ascertainment and be helpful to build more reliable real-world evidence.
长期结局的确定可能会受到随访工作的影响,并且需要使用不同的数据源以更全面地收集数据。然而,日本缺乏通用的追踪系统,长期结局通常通过电子病历(EMR)来确定,但其可靠性尚不确定。在本研究中,我们比较了基于电子病历和基于直接外联的两种方式在500例行冠状动脉旁路移植术患者结局确定准确性方面的差异。所有患者的死亡率数据均从电子病历中提取,作为标准数据收集。当电子病历中未确认患者死亡时,我们通过直接联系患者、其家属或医生来加强收集最新的死亡率信息,作为强化直接外联数据。结果,Kaplan-Meier曲线显示,所分析的不同数据源之间存在显著差异。有趣的是,在基于电子病历的数据收集分析中,由于积极追踪的病例数量减少,随访期后半段(中位数为6.5年)的死亡事件被高估,这突出了基于电子病历的数据收集在长期预后方面存在潜在偏差。我们的研究结果表明,积极的随访策略以及更好的依从性将提高长期结局确定的准确性,并有助于建立更可靠的真实世界证据。