Núcleo de Avaliação de Tecnologias em Saúde, Instituto René Rachou, Fundação Oswaldo Cruz, Belo Horizonte, State of Minas Gerais, Brazil.
Departamento de Fisioterapia, Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, State of Minas Gerais, Brazil.
PLoS One. 2024 Feb 23;19(2):e0298988. doi: 10.1371/journal.pone.0298988. eCollection 2024.
To evaluate the performance of the Cutaneous Leishmaniasis Impact Questionnaire (CLIQ) using the EuroQol-5 Dimension (EQ-5D-3L) as a reference standard (criterion validation); to evaluate the responsiveness of the instruments and estimate a cut-off point for the CLIQ to be able to discriminate between high and low impacts of cutaneous leishmaniasis on patients.
Between 2020 and 2022, a longitudinal validation study was conducted at a reference centre for leishmaniasis in Brazil. The EQ-5D-3L and CLIQ questionnaires were administered before, during and after treatment for cutaneous leishmaniasis. The correlation between the instruments was assessed using Spearman's correlation coefficient, responsiveness was assessed using the Wilcoxon test, and CLIQ cut-off points were proposed based on results of the EQ-5Q-3L, dichotomized between patients reporting no problems' and 'some or extreme problems'.
There were satisfactory correlation coefficients between the two instruments before (-0.596) and during treatment (-0.551) and a low correlation between the instruments after the end of treatment (-0.389). In general, the responsiveness of the instruments was satisfactory. The CLIC scores that maximized sensitivity and specificity for recognizing impaired health status before and during treatment were 7 points and 17 points, respectively. However, at the end of treatment, based on the results for the EQ-5D-3L, the CLIC was not able to discriminate between individuals with high and low impacts of the disease.
The CLIQ corresponds well with the EQ-5D-3L when applied before and during treatment but does not seem to be appropriate for follow-up evaluations after the end of treatment.
使用欧洲五维健康量表（EQ-5D-3L）作为参考标准（准则验证），评估皮肤利什曼病影响问卷（CLIQ）的性能；评估工具的反应能力，并估计 CLIQ 的截止值，以便能够区分皮肤利什曼病对患者的高影响和低影响。
2020 年至 2022 年，在巴西利什曼病参考中心进行了一项纵向验证研究。在皮肤利什曼病治疗前后，分别使用 EQ-5D-3L 和 CLIQ 问卷进行评估。使用斯皮尔曼相关系数评估两种工具之间的相关性，使用 Wilcoxon 检验评估反应能力，并根据 EQ-5Q-3L 的结果提出 CLIQ 截止值，将患者报告的“无问题”和“有些或极端问题”分为两类。
两种工具在治疗前（-0.596）和治疗期间（-0.551）之间的相关性良好，而在治疗结束后两者之间的相关性较低（-0.389）。一般来说，两种工具的反应能力都令人满意。CLIC 评分在治疗前和治疗期间识别健康状况受损的最佳敏感度和特异性的分数分别为 7 分和 17 分。然而，在治疗结束时，根据 EQ-5D-3L 的结果，CLIC 无法区分疾病高影响和低影响的个体。
CLIQ 在治疗前和治疗期间与 EQ-5D-3L 相关性良好，但在治疗结束后似乎不适合用于随访评估。
