Muntéis Olivas E, Navarro Mascarell G, Meca Lallana J, Maestre Martínez A, Pérez Sempere Á, Gracia Gil J, Pato Pato A
Hospital del Mar, Barcelona, España.
Hospital Virgen de la Macarena, Sevilla, España.
Neurologia. 2017 Jan-Feb;32(1):29-39. doi: 10.1016/j.nrl.2014.12.011. Epub 2015 Feb 16.
Although subcutaneous treatments for multiple sclerosis (MS) have been shown to be effective, adverse reactions and pain may adversely affect treatment satisfaction and adherence. This study presents an adapted and validated Spanish version of the Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ), which evaluates satisfaction with the injection device (ID) across 4 domains: injection system (A), side effects (B) (flu-like symptoms, reactions, and satisfaction), experience with treatment (C) and benefits (D).
Two study phases: 1) Cultural adaptation process with input from experts (n=6) and patients (n=30). 2) Validation obtained by means of an observational, cross-sectional, multi-centre study evaluating 143 adult MS patients using an ID. Tools employed: MSTCQ, Patient-Reported Indices for Multiple Sclerosis (PRIMUS), and Treatment Satisfaction Questionnaire for Medication (TSQM). Psychometric properties: Feasibility (percentage of valid cases and floor/ceiling effects); Reliability (Cronbach α) and test-retest correlation (n=41, intraclass correlation coefficient, ICC); and construct validity (factor analysis of domains A and B) and convergent validity (Spearman rank-order correlation for MSTCQ vs TSQM).
Mean age (SD) was 41.94 (10.47) years, 63% of the group were women, and 88.11% presented relapsing-remitting MS. Mean (SD) EDSS score was 2.68 (1.82) points. MSTCQ completion was high (0%-2.80% missing data). Internal consistency was high at α=0.89 for the total score (A+B) and α=0.76, 0.89, and 0.92 for domains A, B, and C, respectively. The version demonstrated excellent test-retest reliability for the total (ICC=0.98) and for domains A, B, and C: ICC=0.82, 0.97, and 0.89, respectively. Factor analysis corroborated the internal structure of the original questionnaire. The association between total and domain scores on both the MSTCQ and the TSQM was moderately strong (Rho=0.42-0.74) and significant (P<.05 and P<.01).
The Spanish version of MSTCQ demonstrates appropriate psychometric properties.
尽管已证明用于治疗多发性硬化症（MS）的皮下治疗方法有效，但不良反应和疼痛可能会对治疗满意度和依从性产生不利影响。本研究展示了一份经过改编和验证的西班牙语版多发性硬化症治疗问题问卷（MSTCQ），该问卷从4个领域评估对注射装置（ID）的满意度：注射系统（A）、副作用（B）（类流感症状、反应及满意度）、治疗体验（C）和益处（D）。
研究分两个阶段：1）在专家（n = 6）和患者（n = 30）的参与下进行文化适应性调整。2）通过一项观察性、横断面、多中心研究进行验证，该研究评估了143名使用ID的成年MS患者。使用的工具：MSTCQ、多发性硬化症患者报告指数（PRIMUS）和药物治疗满意度问卷（TSQM）。心理测量学特性：可行性（有效病例百分比及地板/天花板效应）；信度（克朗巴哈α系数）和重测相关性（n = 41，组内相关系数，ICC）；以及结构效度（对领域A和B进行因子分析）和收敛效度（MSTCQ与TSQM的斯皮尔曼等级相关）。
平均年龄（标准差）为41.94（10.47）岁，该组63%为女性，88.11%表现为复发缓解型MS。平均（标准差）扩展残疾状态量表（EDSS）评分为2.68（1.82）分。MSTCQ的完成率很高（缺失数据为0% - 2.80%）。总分（A + B）的内部一致性较高，α = 0.89，领域A、B和C的α分别为0.76、0.89和0.92。该版本在总分（ICC = 0.98）以及领域A、B和C方面均表现出出色的重测信度：ICC分别为0.82、0.97和0.89。因子分析证实了原始问卷的内部结构。MSTCQ和TSQM的总分及各领域得分之间的关联中等强度（Rho = 0.42 - 0.74）且具有显著性（P <.05和P <.01）。
西班牙语版MSTCQ展示了适当的心理测量学特性。
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