Verifying the validity and reliability of the Japanese version of the Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale

PLOS ONE, Nov 2019

Background 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. Objectives To translate and verify the validity and reliability of the Japanese version of the FLACC Behavioral Scale. Method 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. Result 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) Conclusion Our Japanese version of the FLACC Behavioral Scale shows high validity and reliability.

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Verifying the validity and reliability of the Japanese version of the Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale

March Verifying the validity and reliability of the Japanese version of the Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale Yujiro Matsuishi 0 1 Haruhiko Hoshino 0 1 Nobutake Shimojo 0 1 Yuki Enomoto 0 1 Takahiro Kido 0 1 Tetsuya Hoshino 0 1 Masahiko Sumitani 1 Yoshiaki Inoue 0 1 0 Department of Emergency and Critical Care Medicine, Faculty of Medicine, University of Tsukuba , Tsukuba, Ibaraki , Japan , 2 Pediatric Intensive Care Unit, University of Tsukuba Hospital , Tsukuba, Ibaraki , Japan , 3 University of Tsukuba Hospital, Department of Pediatrics , Tsukuba, Ibaraki , Japan , 4 Department of Anesthesiology and Pain Relief Center, University of Tokyo Hospital , Tokyo , Japan 1 Editor: Kazutaka Ikeda, Tokyo Metropolitan Institute of Medical Science , JAPAN 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. - Data Availability Statement: All relevant data are within the paper and its Supporting Information files. Funding: This study was supported by the Health Labour Science Research Grant from the Japanese Ministry of Health, Labour and Welfare (H26Kakushintekigan-ippan-060) to MS. The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Background Objectives Method Result 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) Competing interests: The authors have declared that no competing interests exist. Conclusion Our Japanese version of the FLACC Behavioral Scale shows high validity and reliability. Introduction Relief of pain is a basic human right regardless of expressive ability and, in a concerning trend, several studies have reported that patients in the pediatric intensive care unit (PICU) [ 1,2 ] require more invasive procedures compared to the general ward. Additionally, painful procedures such as heel sticks and venous arterial punctures are frequently performed in PICU which would logically indicate higher pain levels in these settings [2]. However, pediatric nurses are often challenged to identify pain at the preverbal development stage and efforts to do so are further complicated in critically ill patients undergoing sedation and mechanical ventilation. To solve this situation, several validated observational tools, including the Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale [3], have been developed for pediatric patients in intensive care settings. The FLACC Behavioral Scale has the advantages of both wide recognition and distribution (it is available in several languages) and previous studies have reported high reliability and validity in assessing acute pain for pediatric patients [ 3,4 ]. However, to this point in time, reliable assessment tools for detecting pediatric pain, such as the FLACC Behavioral Scale, have been unavailable in Japanese hospitals due to language barriers. Thus, the aims of the present study are to translate the FLACC Behavioral Scale using the back-translation method and to analyze the reliability and validity of this new Japanese version. Methods Translation Prior to the beginning of the study, written permission to translate the FLACC Behavioral Scale was obtained from the developer (Ms. Sandra Merkel) and we received an Academic/ Non-Profit license from the University of Michigan. Translation was conducted using the back-translation method. This method is a widely accepted method that maintains the overall literature and meaning between the original and translated versions. The translation process of the FLACC Behavioral Scale was as follows (Fig 1). (...truncated)


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Yujiro Matsuishi, Haruhiko Hoshino, Nobutake Shimojo, Yuki Enomoto, Takahiro Kido, Tetsuya Hoshino, Masahiko Sumitani, Yoshiaki Inoue. Verifying the validity and reliability of the Japanese version of the Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale, PLOS ONE, 2018, Volume 13, Issue 3, DOI: 10.1371/journal.pone.0194094