Department of Physical Medicine and Rehabilitation, Oslo University Hospital, Ullevål, Postboks 4956, Nydalen, 0242, Oslo, Norway.
Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Postboks 1078, Blindern, 0316, Oslo, Norway.
BMC Musculoskelet Disord. 2022 May 3;23(1):416. doi: 10.1186/s12891-022-05374-x.
Foot disorders affect up to one quarter of the adult population. Plantar fasciopathy is a common cause of foot pain associated with decreased activity level and quality of life. Patient-reported outcome measures are important in assessing the burden of a condition as well as in research on the effects of interventions. The Foot Function Index revised short form (FFI-RS) is a region specific questionnaire frequently used in research. This study aimed to cross-culturally adapt the FFI-RS into Norwegian and to test its psychometric properties.
The FFI-RS was translated into Norwegian (FFI-RSN) following international guidelines. 139 patients with foot disorders (88% with plantar fasciopathy) were included at baseline to measure internal consistency, explorative factor analysis, construct validity and floor and ceiling effects. 54 patients were included after 1 week for test-retest reliability and smallest detectable change analyses. 100 patients were included for responsiveness and minimal important change at 3 months.
Cronbach's alpha for internal consistency was 0.97 and factor analysis supported the use of the total score of the FFI-RSN. Two out of three predefined hypotheses were confirmed by assessing the construct validity with Spearman's correlation coefficient. Quadratic weighted Kappa for test-retest reliability showed 0.91 (95% CI 0.86-0.96) and the smallest detectable change was 6.5%. The minimal important change was 8.4% and the area under the receiver operating characteristic curve for responsiveness was 0.78 (95% CI 0.69-0.87). We found no floor or ceiling effects on the total score of the FFI-RSN.
The present study showed excellent reliability of the FFI-RSN and supports the use of the total score of the questionnaire. Furthermore, we found the FFI-RSN to have acceptable responsiveness in relation to change in general health. Smallest detectable change, minimal important change and responsiveness were presented as novel results of the total score of the FFI-RS. FFI-RSN can be used to evaluate global foot health in clinical or research settings with Norwegian patients suffering from plantar fasciopathy.
Clinical Trials.gov NCT04207164 . Initial release 01.11.19.
足部疾病影响了多达四分之一的成年人。足底筋膜炎是一种常见的足部疼痛原因,与活动水平和生活质量下降有关。患者报告的结果测量在评估疾病负担以及研究干预措施的效果方面非常重要。足部功能指数修订简表(FFI-RS)是一种常用于研究的特定区域问卷。本研究旨在将 FFI-RS 进行跨文化适应转化为挪威语,并测试其心理测量特性。
根据国际指南,FFI-RS 被翻译为挪威语(FFI-RSN)。在基线时纳入 139 名足部疾病患者(88%患有足底筋膜炎),以测量内部一致性、探索性因子分析、结构有效性以及地板和天花板效应。1 周后纳入 54 名患者进行测试-重测信度和最小可检测变化分析。3 个月时纳入 100 名患者进行反应性和最小重要变化分析。
内部一致性的克朗巴赫α系数为 0.97,因子分析支持使用 FFI-RSN 的总分。通过 Spearman 相关系数评估结构有效性,验证了三个预定假设中的两个。测试-重测信度的二次加权 Kappa 为 0.91(95%CI 0.86-0.96),最小可检测变化为 6.5%。最小重要变化为 8.4%,反应性的受试者工作特征曲线下面积为 0.78(95%CI 0.69-0.87)。我们在 FFI-RSN 的总分上没有发现地板或天花板效应。
本研究表明 FFI-RSN 具有良好的可靠性,并支持使用问卷的总分。此外,我们发现 FFI-RSN 在一般健康状况变化方面具有可接受的反应性。最小可检测变化、最小重要变化和反应性作为 FFI-RS 总分的新结果呈现。FFI-RSN 可用于评估挪威足底筋膜炎患者的临床或研究环境中的整体足部健康。
ClinicalTrials.gov NCT04207164。初始发布日期 2019 年 11 月 1 日。