Institute for Social Medicine and Epidemiology, University of Luebeck, Ratzeburger Allee 160, 23562, Luebeck, Germany.
School of Life and Medical Sciences, University of Hertfordshire, Hatfield, AL10 9AB, UK.
Health Qual Life Outcomes. 2021 Mar 24;19(1):106. doi: 10.1186/s12955-021-01738-4.
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.
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.
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.
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.
Retrospectively registered: DRKS00021070.
家庭报告结局测量（FROM-16）评估患者慢性疾病对患者伴侣或家庭成员生活质量（QoL）的影响。本研究的目的是翻译、探索 FROM-16 的结构并验证其有效性。
该问卷从英语翻译成德语（正向、反向、四位独立翻译）。对六名家庭成员进行了六次访谈，以确认问卷在语言、概念、语义和经验方面的等效性及其实用性。对最终的德文翻译进行了内部一致性、可重复性和测试有效性的检验。标准效度通过 FROM-16 评分与全球健康量表（GHS）的相关性来检验。使用主成分分析、因子分析和验证性因子分析来评估问卷的结构及其领域。使用单样本 t 检验检验假设，即分数之间的差异无显著差异，计算组内相关系数（ICC）以检验可靠性和可重复性。
共有 83 名家庭成员（61%为女性，中位数年龄：61 岁）在两个不同时间点完成了问卷（平均间隔：22 天）。FROM-16 评分的内部一致性良好（总评分的 Cronbach's α 为 0.86）。在 GHS 稳定的患者中，总评分的 ICC 为 0.87，差异无显著差异（p=0.262），表明结果可重复。具有包含所有项目的一般因子和由原始 2 因子结构的项目组成的两个子因子的双因子模型具有最佳拟合度。
德文版 FROM-16 具有良好的可靠性、测试有效性和实用性。它可以被认为是一种合适的通用工具，用于测量患者伴侣或家庭成员的 QoL。由于存在多个交叉负荷，因此当使用德文版时，我们不建议报告 FROM-16 原始版本中提出的两个领域的分数。因此，在报告结果时，应重点关注总分。
回顾性注册：DRKS00021070。
