Department of Emergency and Critical Care Medicine, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan.
Pediatric Intensive Care Unit, University of Tsukuba Hospital, Tsukuba, Ibaraki, Japan.
PLoS One. 2018 Mar 13;13(3):e0194094. doi: 10.1371/journal.pone.0194094. eCollection 2018.
Pediatric patients, especially in the preverbal stage, cannot self-report intensity of pain therefore several validated observational tools, including the Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale, have been used as a benchmark to evaluate pediatric pain. Unfortunately, this scale is currently unavailable in Japanese, precluding its widespread use in Japanese hospitals.
To translate and verify the validity and reliability of the Japanese version of the FLACC Behavioral Scale.
Back-translation was first conducted by eight medical researchers, then an available sample of patients at the University of Tsukuba Pediatric Intensive Care Unit (from May 2017 to August 2017) was enrolled in a clinical study. Two researchers evaluated the validity of the translated FLACC Behavioral Scale by weighted kappa coefficient and intraclass correlation coefficients (ICC). Observational pain was simultaneously measured by the visual analog scale (VAS obs) and reliability was evaluated by correlation analysis.
The original author approved the translation. For the clinical study, a total of 121 observations were obtained from 24 pediatric patients. Agreement between observers was highly correlated for each of the FLACC categories (Face: κ = 0.85, Leg: κ = 0.74, Activity: κ = 0.89, Cry: κ = 0.93, Consolability: κ = 0.93) as well as the total score (Total: κ = 0.95,). Correlation analysis demonstrated a good criterion validation between the FLACC scale and the VAS obs. (r = 0.96).
Our Japanese version of the FLACC Behavioral Scale shows high validity and reliability.
儿科患者，尤其是在言语前期，无法自我报告疼痛强度，因此已经使用了几种经过验证的观察工具，包括面部、腿部、活动、哭声、可安慰性（FLACC）行为量表，作为评估儿科疼痛的基准。不幸的是，该量表目前没有日文版本，这限制了它在日本医院的广泛使用。
翻译并验证日本版 FLACC 行为量表的有效性和可靠性。
首先由 8 名医学研究人员进行回译，然后在筑波大学儿科重症监护病房（2017 年 5 月至 2017 年 8 月）招募了一个可用的患者样本进行临床研究。两名研究人员通过加权kappa 系数和组内相关系数（ICC）评估翻译后的 FLACC 行为量表的有效性。同时通过视觉模拟量表（VAS obs）测量观察性疼痛，并通过相关分析评估可靠性。
原始作者批准了翻译。在临床研究中，从 24 名儿科患者中总共获得了 121 次观察结果。观察者在每个 FLACC 类别（面部：κ=0.85，腿部：κ=0.74，活动：κ=0.89，哭声：κ=0.93，可安慰性：κ=0.93）以及总分（总评分：κ=0.95）上的一致性都高度相关。相关性分析表明，FLACC 量表与 VAS obs 之间存在良好的标准验证。（r=0.96）。
我们的日本版 FLACC 行为量表具有较高的有效性和可靠性。
