# Development and validation of the Pediatrics Functional Living Index—Emesis scale

## TL;DR

This study created and tested a new tool called PFLIE to measure how chemotherapy-induced nausea and vomiting affect the quality of life of children with cancer.

## Contribution

The PFLIE is a novel, validated patient-reported outcome measure specifically designed for pediatric cancer patients experiencing CINV.

## Key findings

- The PFLIE has strong reliability with Cronbach’s alpha coefficients above 0.92 for both domains.
- The PFLIE demonstrated high content validity with a CVI of 0.933 for both nausea and vomiting domains.
- The PFLIE showed acceptable construct and concurrent validity for assessing CINV impact in pediatric patients.

## Abstract

Assessing the impact of chemotherapy-induced nausea and vomiting (CINV) on the quality of life (QoL) of cancer patients is critical. However, there is a dearth of specialized assessment tools designed specifically for pediatric cancer patients. The aim of this study was to develop and validate the Pediatrics Functional Living Index-Emesis (PFLIE) as a patient-reported outcome measure (PROM) to assess the impact of CINV on QoL in pediatric patients. This study was approved by the Institutional Review Board of Sun Yat-sen University Cancer Center (Approval No. B2021-113-01) and was conducted in accordance with the Declaration of Helsinki.​

The reliability, content validity, structural validity, and concurrent validity of the PFLIE were assessed through two rounds of Delphi expert consultation and a questionnaire survey of 90 pediatric cancer patients receiving chemotherapy at a tertiary care hospital cancer center in China.

The PFLIE consists of two domains: nausea (10 items) and vomiting (10 items). The content validity index (CVI) for both the nausea and vomiting domains was 0.933. The Cronbach’s alpha coefficients for the total scale, nausea domain, and vomiting domain were 0.964, 0.928, and 0.943, respectively. Item-domain correlations were stronger for the PFLIE (r = 0.678-0.882) across domains compared to across-domain correlations (r = 0.493-0.780), suggesting that the PFLIE has acceptable construct validity. In addition, the PFLIE demonstrated acceptable concurrent validity.

The validity and reliability of the Chinese version of the PFLIE are reliable and valid. The tool can help healthcare providers effectively identify and manage CINV symptoms, thereby improving the QoL of pediatric cancer patients. In low- and middle-income countries (LMICs) with limited resources, PFLIE can be used to improve the management of CINV and to ensure that pediatric cancer patients receive adequate care despite inadequate healthcare infrastructures. The tool can be used to improve the management of CINV and to ensure that pediatric cancer patients receive adequate care despite inadequate healthcare infrastructures.​