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评估精神分裂症患者停药和继续用药原因的 2 种测量工具的结构效度:来自临床试验中患者和临床医生的视角。

Construct validity of 2 measures to assess reasons for antipsychotic discontinuation and continuation from patients' and clinicians' perspectives in a clinical trial.

机构信息

Eli Lilly and Company, Lilly Corporate Center, DC 5024, Indianapolis, IN 46285, USA.

出版信息

BMC Med Res Methodol. 2012 Sep 13;12:142. doi: 10.1186/1471-2288-12-142.

Abstract

BACKGROUND

Little is known about the specific reasons for antipsychotic discontinuation or continuation from patients' or clinicians' perspectives. This study aimed to assess the construct validity of 2 new measures of the Reasons for Antipsychotic Discontinuation/Continuation (RAD): RAD-I (a structured interview assessing the patient's perspective) and RAD-Q (a questionnaire assessing the clinician's perspective).

METHODS

Data were used from a 12-week antipsychotic trial of schizophrenia patients in which the RAD was administered at study entry and at study completion (or discontinuation). Construct validity was assessed through comparisons of RAD responses, clinicians' responses to a standard patient disposition form identifying reasons for patient's study discontinuation, and several standard psychiatric measures. Percent agreement quantified the correspondence between patient and clinician scores.

RESULTS

Patients indicating lack of improvement/worsening of positive symptoms as a 'somewhat' to 'primary' reason for medication discontinuation had statistically significantly less improvement in Positive and Negative Syndrome Scale positive score than patients not reporting these as a reason (concurrent validity). Similar results were observed for the RAD negative symptom, functional, social support, and adherence items, whereas the mood and cognitive items were not significantly associated with change scores on standard psychiatric measures. Responses to the RAD were also weakly associated with variables that theoretically should not be related to them (divergent validity). Level of agreement between the clinician- and patient-rated RAD scores was high (60%-100%).

CONCLUSIONS

Initial validation of the RAD suggests that the instruments are valid tools for gathering detailed information regarding reasons for antipsychotic discontinuation and continuation from patients' and clinicians' perspectives.

摘要

背景

对于精神分裂症患者停止或继续使用抗精神病药物的具体原因,患者和临床医生的观点鲜为人知。本研究旨在评估两种新的抗精神病药物停药/继续治疗原因量表(RAD)的结构效度:RAD-I(一种评估患者观点的结构化访谈)和 RAD-Q(一种评估临床医生观点的问卷)。

方法

本研究的数据来自一项为期 12 周的精神分裂症患者抗精神病药物试验,在研究开始和结束时(或停药时)进行 RAD 评估。通过 RAD 反应、临床医生对标准患者处置表中识别患者研究停药原因的反应以及几项标准精神科措施的比较来评估结构效度。百分比一致性量化了患者和临床医生评分之间的一致性。

结果

患者将阳性症状无改善/恶化作为停止药物治疗的“有些”到“主要”原因,与未报告这些原因的患者相比,阳性和阴性综合征量表阳性评分的改善程度统计学上显著较低(同时效度)。RAD 阴性症状、功能、社会支持和依从性项目也观察到类似的结果,而情绪和认知项目与标准精神科措施的变化评分无显著相关性。RAD 的反应也与理论上不应与之相关的变量有微弱的相关性(区分效度)。临床医生和患者评定的 RAD 评分之间的一致性水平很高(60%-100%)。

结论

RAD 的初步验证表明,这些工具是从患者和临床医生的角度收集有关抗精神病药物停药和继续治疗原因的详细信息的有效工具。

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