Validation of the German version of the Family Reported Outcome Measure (FROM-16) to assess the impact of disease on the partner or family member

Abstract

Background The Family Reported Outcome Measure (FROM-16) assesses the impact of a patient’s chronic illness on the quality of life (QoL) of the patient’s partner or family members. The aim of the study was to translate, explore the structure of and validate the FROM-16. Methods The questionnaire was translated from English into German (forward, backward, four independent translators). Six interviews with family members were conducted to confirm the questionnaire for linguistic, conceptual, semantic and experiential equivalence and its practicability. The final German translation was tested for internal consistency, reproducibility and test validity. Criterion validity was tested by correlating the scores of the FROM-16 and the Global Health Scale (GHS). Principal component analysis, factor analysis, and confirmatory factor analysis was used to assess the questionnaire’s structure and its domains. Reliability and reproducibility were tested computing the intraclass correlation coefficient (ICC) using one sample t-test for testing the hypothesis that the difference between the scores was not different from zero. Results Overall, 83 family members (61% female, median age: 61 years) completed the questionnaire at two different times (mean interval: 22 days). Internal consistency was good for the FROM-16 scores (Cronbach’s α for total score = 0.86). In those with stable GHS, the ICC for the total score was 0.87 and the difference was not different from zero (p = 0.262) indicating reproducible results. A bi-factor model with a general factor including all items, and two sub-factors comprising the items from the original 2-factor construct had the best fit. Conclusions The German FROM-16 has good reliability, test validity and practicability. It can be considered as an appropriate and generic tool to measure QoL of a patient’s partner or family member. Due to the presence of several cross-loadings we do not recommend the reporting of the scores of the two domains proposed for the original version of FROM-16 when using the German version. Thus, in reporting the results emphasis should be put on the total score. Trial registration: Retrospectively registered: DRKS00021070.

Feasibility Study Protocol: Investigating Family Reported Outcome Measures (FROMs) in the Estimation of Societal Value of Advanced Therapy Medicinal Products (ATMPs)

“…The reliability and validity of the FROM-16 has been widely demonstrated: it has shown high internal consistency (Cronbach's α = 0.80-0.92), high reproducibility (intraclass correlation = 0.85-0.92) and strong construct validity [34,36,[39][40][41]. There is excellent correlation both between the FROM-16 and Abbreviated World Health Organisation Quality of Life questionnaire (WHOQOL-BREF) total scores (p < 0.001), which is a longer, more in-depth quality of life questionnaire and the patient's overall health score (p < 0.001) [39].…”

“…These data will be compared to data from previously published studies to give comparative meaning to the scores, such as the recent study applying the FROM-16 to myalgic encephalomyelitis [37]. The strength of any relationship found between GHS and FROM-16 scores will be compared to previously published data [39,40], to assess if the perceived severity of disease impacts on the family member's reported outcomes.…”

“…The scores can be examined as a total for all items, within a domain or as individual items, with a higher score indicating greater impact on the family member's life. It is also applicable cross-culturally and has been translated into multiple languages [34,36,[39][40][41].…”

Feasibility Study Protocol: Investigating Family Reported Outcome Measures (FROMs) in the Estimation of Societal Value of Advanced Therapeutic Medicinal Products (ATMPs)

“…These data will be compared to data from previously published studies to give comparative meaning to the scores, such as the recent study applying the FROM-16 to myalgic encephalomyelitis (Brittain et al 2021). The strength of any relationship found between GHS and FROM-16 scores will be compared to previously published data (Elsner et al 2021;Golics et al 2014), to assess if the perceived severity of disease impacts on the family member's reported outcomes.…”

Meaning of Family Reported Outcome Measure (FROM-16) severity score bands: a cross-sectional online study in the UK

“…The FROM-16 has been translated and validated in various languages, indicating the high interest in its use across many parts of the world. [3][4][5][6][7] Although a higher score indicates a greater impact on family members' QoL, for FROM-16 to be useful in a clinical or research setting, there is a need for scores to have practical meaning. The utility of QoL questionnaires can be maximised if a clinical meaning is assigned to the questionnaire scores.…”