# Psychometric validation of the Spanish for Ecuador Family Reported Outcome Measure (FROM-16) and its application to measure impact on family members of patients with skin diseases

## TL;DR

This study validates a Spanish version of the FROM-16 tool to measure how skin diseases affect the quality of life of patients' family members in Ecuador.

## Contribution

The study provides a validated Spanish (Ecuadorian) version of the FROM-16, a tool to assess the impact of skin diseases on family members' quality of life.

## Key findings

- The Ecuadorian Spanish FROM-16 has strong psychometric properties with a Cronbach’s alpha of 0.89 and a two-factor model.
- Nearly one-third of family members reported a very large or extremely large impact on their quality of life due to the patient's skin condition.
- Adult children caring for non-cohabiting parents and those of patients with inflammatory skin diseases experienced the highest burden.

## Abstract

The Family Reported Outcome Measure (FROM-16) is a generic tool to measure the impact of health conditions on patients’ family members and partners (FMs). This study aimed to translate, validate, evaluate, and implement FROM-16 in Ecuadorian Spanish and to assess the quality of life (QoL) of FMs of patients with skin diseases.

A cross-sectional study of patients and their FMs was performed using FROM-16 and a five-point-Likert scale to evaluate patient´s skin health by the FM and physician. Construct validity, confirmatory factor analysis and item response modelling of FROM-16 were assessed.

195 FMs completed Ecuadorian FROM-16. Inter-item correlation was 0.40 and factor analysis confirmed the original two-factor model: Cronbach’s alpha 0.89, with factor loadings of 0.44–0.76. Mean age of patients = 41.8 ± 31.1 years and of FMs = 47.3 ± 7; diseases were classified as inflammatory (n = 88) or non-inflammatory (n = 107). The mean FROM-16 score was 12.5 ± 7 meaning “a moderate effect on QoL;” however, scores of 29.2% (57 of 195) indicated a “very large” (n = 47) or “extremely large” (n = 10) effect. Populations with the highest burden were adult children main carers, not cohabiting with their sick parents (mean FROM-16 = 17 ± 7.7, n = 8, p = 0.05 versus those cohabiting), and FM of patients with inflammatory conditions (mean = 14 ± 6.9, n = 88, p = 0.006 versus those with non-inflammatory dermatoses).

The FROM-16 is a succinct, well-structured two-domain instrument. It can be used to identify the largely overlooked impact on FMs of dermatology patients. Understanding this impact may contribute to better holistic care, inform physicians’ decisions, and encourage further support for families.

The online version contains supplementary material available at 10.1186/s41687-025-00866-5.

This study is needed to address the lack of information on the impact of dermatoses on family members (FMs) and the absence of validated, generic quality of life (QoL) tools to assess this impact. The key issue addressed is whether the Spanish for Ecuador version of FROM-16, a family-reported outcome measure, can reliably assess the QoL impact on FMs of patients with skin diseases. This study examines the psychometric validity of FROM-16 and assesses if the translated tool maintains consistency with the original version. Results show that the Ecuadorian FROM-16 achieves a robust inter-item correlation (0.40) and a strong two-factor model with a Cronbach’s alpha of 0.89, confirming its reliability. The findings reveal that nearly one-third of FMs experience a significant decline in QoL, particularly adult children caring for parents and those FMs of patients suffering from inflammatory skin conditions. These results underscore the substantial QoL impact on FMs and suggest that clinicians consider these effects when designing holistic care approaches.

The online version contains supplementary material available at 10.1186/s41687-025-00866-5.