Cross-cultural translation, adaptation and validation of a Japanese version of the functional index for hand osteoarthritis (J-FIHOA)

Cross-cultural translation, adaptation and validation of a Japanese version of the functional index for hand osteoarthritis (J-FIHOA)
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DOI:
10.1186/s12891-020-03193-6
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发表时间:
2020-03-16
影响因子:
2.3
通讯作者:
Hirata, Hitoshi
Hirata, Hitoshi
中科院分区:
医学3区
文献类型:
--
作者:
Nakagawa, Yasunobu;Kurimoto, Shigeru;Hirata, Hitoshi

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背景手骨关节炎(OA)临床表现多样,而身体功能是患者受累的核心领域之一。手部骨关节炎功能指数(FIHOA)是手部OA相关功能障碍的主要评估工具。我们的目标是使日本版的FIHOA(J-FIHOA)和日本手OA patients.MethodsForward和向后的翻译过程中验证它完成创建一个文化适应的J-FIHOA。在验证过程中进行了一项前瞻性、观察性多中心研究。17家合作医院招募了符合美国流变学学会标准的日本手OA患者。收集病历审查和对以下患者评定问卷的答复:J-FIHOA、Hand 20、健康评估问卷(HAQ)、疼痛数字评定量表(NRS疼痛)和简明健康调查表36(SF-36)。采用因子分析法对J-FIHOA的结构进行了探讨。计算Cronbach α系数和项目-总相关。J-FIHOA和其他问卷之间的相关性进行了结构效度评价。在临床稳定条件下的参与者重复J-FIHOA在一至两周的时间间隔,以评估重测信度。为了评价反应性,开始新药物治疗的症状性患者进行了1个月的随访,并完成了两次问卷调查。使用治疗前和治疗后的数据集计算效应量(ES)和标准化反应均值(SRM)。我们评估反应,比较ES和SRM的J-FIHOA与其他问卷(结构的方法)。J-FIHOA具有一维结构。Cronbach的α(0.914之间的女性和0.929之间的男性)和项目总的相关性(范围,0.508至0.881)显示出较高的内部一致性。测量上肢残疾的Hand 20与J-FIHOA密切相关(r =0.82),而SF-36的精神和角色社会成分无相关性(r =-0.24和-0.26)。重测信度的组内相关系数为0.83,令人满意。J-FIHOA表现出最高的ES和SRM(-0.68和-0.62,分别)在所有的问卷调查,除了NRS pain.ConclusionsOur结果显示,J-FIHOA有良好的测量性能,以评估日本手OA患者的身体功能,无论是门诊随访的临床实践,临床研究和治疗试验。
BackgroundHand 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.MethodsForward 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).ResultsA 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.ConclusionsOur 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.