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.

Background: 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.

Methods: 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.

Results: 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).

Conclusion: 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.