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)