Department of Hand Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan.
Department of Rheumatology, AP-HP, Hospital Saint-Antoine, Paris, France.
BMC Musculoskelet Disord. 2020 Mar 16;21(1):173. doi: 10.1186/s12891-020-03193-6.
Hand osteoarthritis (OA) has a wide spectrum of clinical presentations and physical function is one of the core domains where patients suffer. The Functional Index for Hand Osteoarthritis (FIHOA) is a leading assessment tool for hand OA-related functional impairment. Our objective was to make a Japanese version of FIHOA (J-FIHOA) and validate it among Japanese hand OA patients.
Forward and backward translation processes were completed to create a culturally adapted J-FIHOA. A prospective, observational multicenter study was undertaken for the validation process. Seventeen collaborating hospitals recruited Japanese hand OA patients who met the American College of Rheumatology criteria. A medical record review and responses to the following patient-rated questionnaires were collected: J-FIHOA, Hand20, Health Assessment Questionnaire (HAQ), numerical rating scale for pain (NRS pain) and Short Form 36 Health Survey (SF-36). We explored the structure of J-FIHOA using factor analysis. Cronbach's alpha coefficients and item-total correlations were calculated. Correlations between J-FIHOA and other questionnaires were evaluated for construct validity. Participants in clinically stable conditions repeated J-FIHOA at a one- to two-week interval to assess test-retest reliability. To evaluate responsiveness, symptomatic patients who started new pharmacological treatments had a 1-month follow-up visit and completed the questionnaires twice. Effect size (ES) and standardized response mean (SRM) were calculated with pre- and post-treatment data sets. We assessed responsiveness, comparing ES and SRM of J-FIHOA with other questionnaires (construct approach).
A total of 210 patients participated. J-FIHOA had unidimensional structure. Cronbach's alphas (0.914 among females and 0.929 among males) and item-total correlations (range, 0.508 to 0.881) revealed high internal consistency. Hand20, which measures upper extremity disability, was strongly correlated with J-FIHOA (r = 0.82) while the mental and role-social components of SF-36 showed no correlations (r = - 0.24 and - 0.26, respectively). Intraclass correlation coefficient for test-retest reliability was 0.83 and satisfactory. J-FIHOA showed the highest ES and SRM (- 0.68 and - 0.62, respectively) among all questionnaires, except for NRS pain.
Our results showed J-FIHOA had good measurement properties to assess physical function in Japanese hand OA patients both for ambulatory follow-up in clinical practice, and clinical research and therapeutic trials.
手骨关节炎（OA）具有广泛的临床表现，而身体机能是患者受影响的核心领域之一。手部骨关节炎功能指数（FIHOA）是评估手部 OA 相关功能障碍的主要工具。我们的目的是制作日文版 FIHOA（J-FIHOA）并在日本手部 OA 患者中验证其有效性。
通过正向和反向翻译过程创建文化适应性强的 J-FIHOA。进行了前瞻性、观察性多中心研究以验证该方法。17 家合作医院招募了符合美国风湿病学会标准的日本手部 OA 患者。通过病历回顾和以下患者自评问卷的回答收集数据：J-FIHOA、手部 20 项问卷（Hand20）、健康评估问卷（HAQ）、疼痛数字评分量表（NRS 疼痛）和简明健康状况调查问卷 36 项（SF-36）。我们使用因子分析探讨了 J-FIHOA 的结构。计算了 Cronbach's alpha 系数和条目总分相关性。评估了 J-FIHOA 与其他问卷之间的结构效度相关性。在临床稳定条件下，参与者在 1 至 2 周的时间间隔内重复进行 J-FIHOA 评估以测试重测信度。为了评估反应度，开始新的药物治疗的症状患者在 1 个月时进行了随访并两次完成了问卷。使用治疗前后的数据计算效应量（ES）和标准化反应均值（SRM）。我们通过与其他问卷（结构方法）比较 J-FIHOA 的 ES 和 SRM 来评估反应度。
共有 210 名患者参与了研究。J-FIHOA 具有单一维度结构。女性的 Cronbach's alpha 系数为 0.914，男性为 0.929，条目总分相关性为 0.508 至 0.881，表明具有较高的内部一致性。测量上肢残疾的 Hand20 与 J-FIHOA 高度相关（r=0.82），而 SF-36 的心理和角色-社会成分则无相关性（r=-0.24 和-0.26）。重测信度的组内相关系数为 0.83，结果满意。除了 NRS 疼痛外，J-FIHOA 在所有问卷中具有最高的 ES 和 SRM（分别为-0.68 和-0.62）。
我们的研究结果表明，J-FIHOA 具有良好的测量性能，可用于评估日本手部 OA 患者的身体机能，无论是在临床实践中的门诊随访，还是在临床研究和治疗试验中。
