醫療異常事件人為因素分類系統中譯之信效度分析

Analysis of the Reliability and Validity of Human Factors Analysis and Classification System in Medical Adverse Events

目的：中譯使用於航空界的人為因素分析與分類系統HFACS（Human Factor Analysis Classification System，HFACS），並測試此架構的信度與效度；修正使之可為醫療界應用，檢視影響病人安全事件的人為因素（Human Factors）。材料與方法：邀請專家對HFACS中譯版進行審視並計算其內容效度指數（content validity index，CVI），再利用此中譯版請6名分析員回溯2011年至2016年間進行根本原因分析之病人安全事件，進行案例評核與信度分析，計算其內部一致性。另外，運用Cohen´s Kappa Coefficient計算分析員間評分的一致性。結果：此中譯版CVI為0.98，具高效度。有各層內部一致性（Cronbach´sα）皆達在0.7以上，信度佳；分析員間對於各子階層的內在一致性介於0.4-1.0之間，顯示結果為中等到強。結論：人為因素與病安事件發生的原因息息相關，本研究中譯HFACS架構並檢視其信效度，期望未來能將此架構運用於醫療業進行根本原因分析，且以人為因素角度去思考醫療不良事件，以預防性的角度促進病人安全。 Objective: This study translated and validated the Human Factors Analysis and Classification System (HFACS) for aviation and investigated the feasibility of implementing this system in the healthcare industry. Methods: Five patient safety experts translated the HFACS into Mandarin Chinese and tested the validity of the translated HFACS. Six analysts calculated the content validity index (CVI) based on 40 patient safety incident reports from 2011 to 2016. Cronbach's α and Cohen'skappa coefficient were used to test internal consistency and interrater agreement. Results: The content validity of the Mandarin Chinese version of the HFACS was excellent (CVI=0.98). Furthermore, the internal consistency of each layer (Cronbach's α) was above 0.7, and reliability was high. The internal consistency scores in the analysis of all subitems were between 0.4 to 1.0, representing medium to strong outcomes. Conclusion: Human factors are closely related to patient safety incidents. This study translated the HFACS architecture into Mandarin Chinese and examined the reliability and validity of the translated version. The proposed framework can be implemented in the health care industry to analyze root causes, thereby enabling adverse medical events to be considered from the perspective of human factors. Thus, the proposed framework may enhance patient safety.