Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias-Instituto René Rachou-Fundação Oswaldo Cruz, Fiocruz, Belo Horizonte, Minas Gerais, Brazil.
PLoS One. 2018 Aug 30;13(8):e0203378. doi: 10.1371/journal.pone.0203378. eCollection 2018.
BACKGROUND: The impact of cutaneous leishmaniasis (CL) on the quality of life of patients has been neglected in research studies worldwide. The few reported studies have used non-specific questionnaires for the disease, which represents a limitation since generic instruments may not address specific aspects of the disease, compromising the evaluation of its real impact. The aim of this paper is to describe the development and the initial validation of an instrument for evaluating the impact of CL, named the Cutaneous Leishmaniasis Impact Questionnaire. METHODOLOGY: The formulation and validation of the instrument consisted of the following steps: (1) literature review; (2) conceptual framework construction and initial item generation; (3) tool analysis by health professionals (experts); (4) tool evaluation performed by the patients; and (5) a pilot study with 100 patients with localized CL, evaluated at a reference ambulatory facility in Belo Horizonte, in the state of Minas Gerais, Brazil. The structure of the proposed instrument was analyzed using hierarchical cluster analysis (ICLUST). RESULTS: Twenty-seven items were initially proposed by the researchers to compose the questionnaire. Content validity (evaluates if the instrument fully assesses the construct of interest) was evaluated by the panel of experts, while face validity (evaluates how potential participants interpret the items) was evaluated by the target population. In this step, some items were excluded, reformulated and/or included. After evaluating a factorial structure of the items in accordance with the cluster analysis, we assembled a questionnaire with 25 items (alpha = 0.86), with high reliability and homogeneity, which address the following: 1) the general impact of the disease (alpha = 0.91, beta = 0.67) and 2) the evaluation of the perception about the treatment and health services (alpha = 0.72, beta = 0.51). CONCLUSIONS: The Cutaneous Leishmaniasis Impact Questionnaire, developed with contributions from patients and experts, was confirmed, in this first validation, as a useful and reliable instrument.
背景：在全球范围内的研究中，皮肤利什曼病（CL）对患者生活质量的影响一直被忽视。少数已报道的研究使用了针对该疾病的非特异性问卷，这是一个局限性，因为通用工具可能无法解决疾病的具体方面，从而影响对其真实影响的评估。本文的目的是描述一种评估 CL 影响的工具的开发和初步验证，该工具命名为皮肤利什曼病影响问卷。
方法：该工具的制定和验证包括以下步骤：（1）文献回顾；（2）概念框架构建和初始项目生成；（3）健康专业人员（专家）对工具进行分析；（4）患者对工具进行评估；（5）在巴西米纳斯吉拉斯州贝洛奥里藏特的一个参考门诊进行了一项包含 100 例局限性 CL 患者的试点研究。提出的工具的结构使用层次聚类分析（ICLUST）进行分析。
结果：研究人员最初提出了 27 个项目来组成问卷。内容有效性（评估工具是否充分评估了感兴趣的结构）由专家组评估，而表面有效性（评估潜在参与者如何解释项目）由目标人群评估。在这一步，一些项目被排除、重新制定和/或包括在内。在根据聚类分析评估项目的因子结构后，我们组装了一个包含 25 个项目的问卷（α=0.86），具有高可靠性和同质性，可评估以下内容：1）疾病的一般影响（α=0.91，β=0.67）和 2）对治疗和卫生服务的感知评估（α=0.72，β=0.51）。
结论：皮肤利什曼病影响问卷是由患者和专家共同开发的，在首次验证中被证实是一种有用且可靠的工具。
Zotero 插件
