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《药物治疗满意度问卷》(SATMED-Q)的编制与验证

Development and validation of the "Treatment Satisfaction with Medicines Questionnaire" (SATMED-Q).

作者信息

Ruiz Miguel A, Pardo Antonio, Rejas Javier, Soto Javier, Villasante Fernando, Aranguren José L

机构信息

Department of Methodology, School of Psychology, Madrid Autonomous University, Madrid, Spain.

出版信息

Value Health. 2008 Sep-Oct;11(5):913-26. doi: 10.1111/j.1524-4733.2008.00323.x. Epub 2008 May 20.

DOI:10.1111/j.1524-4733.2008.00323.x
PMID:18494753
Abstract

OBJECTIVE

To develop and validate a multidimensional generic questionnaire measuring satisfaction with treatment with medicines. The questionnaire was designed to be used in chronic patients undergoing pharmacological treatment for any disease.

METHODS

After a literature review and cognitive debriefing process with an expert panel of six members and 21 chronic patients in four focus groups, a preliminary instrument with 36 items grouped into six dimensions was developed. Three samples of patients were enrolled during the whole process: 1) 12 patients to assess feasibility and pertinence of items; 2) 150 patients for item reduction; and 3) 455 patients for psychometric properties assessment of the instrument. The latter two were stratified by gender, age, and main disease (type 2 diabetes, hypertension, osteoarthritis, benign prostate hyperplasia, chronic obstructive pulmonary disease/asthma, depression, and migraine). Additional measures were gathered for concept validity: clinical and treatment information, patient and clinician assessment of treatment tolerability and effectiveness, treatment satisfaction (Treatment Satisfaction Questionnaire for Medication [TSQM]), and therapeutic compliance (Morisky-Green). Feasibility, reliability, and validity (content, discriminant, construct, and concurrent) were assessed.

RESULTS

Factor analysis item reduction resulted in a 17-item questionnaire with six dimensions: treatment effectiveness, convenience of use, impact on daily activities, medical care, global satisfaction, and undesirable side effects. Unidimensional scales (Cronbach's alpha ranging 0.813-0.912) were correlated, and allowed computation of a summary composite score (alpha = 0.890). SATMED-Q dimensions showed moderate but significant correlations with TSQM dimensions (0.577-0.680). Differences between tolerability and effectiveness groups were found, depending on dimension and whether the clinician or the patient were informing. Therapeutic compliance groups showed differences in some treatment satisfaction dimensions.

CONCLUSIONS

The SATMED-Q is a reliable and valid measure of treatment satisfaction, structured in six dimensions, and a summary composite score. Additional work is needed to assess sensitivity to change.

摘要

目的

开发并验证一份用于衡量药物治疗满意度的多维通用问卷。该问卷旨在供患有任何疾病并正在接受药物治疗的慢性病患者使用。

方法

在经过文献综述以及与一个由六名成员组成的专家小组和四个焦点小组中的21名慢性病患者进行认知反馈过程后,开发了一份初步问卷,其中包含36个项目,分为六个维度。在整个过程中纳入了三个患者样本:1)12名患者以评估项目的可行性和相关性;2)150名患者用于项目精简;3)455名患者用于评估该问卷的心理测量学特性。后两个样本按性别、年龄和主要疾病(2型糖尿病、高血压、骨关节炎、良性前列腺增生、慢性阻塞性肺疾病/哮喘、抑郁症和偏头痛)进行分层。还收集了其他用于概念效度的指标:临床和治疗信息、患者和临床医生对治疗耐受性和有效性的评估、治疗满意度(药物治疗满意度问卷[TSQM])以及治疗依从性(Morisky-Green)。评估了可行性、信度和效度(内容效度、区分效度、结构效度和同时效度)。

结果

通过因子分析进行项目精简后,得到了一份包含17个项目、六个维度的问卷:治疗效果、使用便利性、对日常活动的影响、医疗护理、总体满意度和不良副作用。单维度量表(Cronbach's α系数范围为0.813 - 0.912)具有相关性,并可计算出一个综合汇总得分(α = 0.890)。SATMED-Q量表的维度与TSQM量表的维度显示出中等但显著的相关性(0.577 - 0.680)。根据维度以及信息提供者是临床医生还是患者,在耐受性和有效性组之间发现了差异。治疗依从性组在一些治疗满意度维度上存在差异。

结论

SATMED-Q是一种可靠且有效的治疗满意度测量工具,分为六个维度并有一个综合汇总得分。需要进一步开展工作来评估其对变化情况的敏感性。

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