Wyrwich Kathleen W, Fihn Stephan D, Tierney William M, Kroenke Kurt, Babu Ajit N, Wolinsky Fredric D
Saint Louis University, Department of Research Methodology, School of Public Health, St Louis, Mo 63103, USA.
J Gen Intern Med. 2003 Mar;18(3):196-202. doi: 10.1046/j.1525-1497.2003.20203.x.
Without clinical input on what constitutes a significant change, health-related quality of life (HRQoL) measures are less likely to be adopted by clinicians for use in daily practice. Although standards can be determined empirically by within-person change studies based on patient self-reports, these anchor-based methods incorporate only the patients' perspectives of important HRQoL change, and do not reflect an informed clinical evaluation. The objective of this study was to establish clinically important difference standards from the physician's perspective for use of 2 HRQoL measures among patients with chronic obstructive pulmonary disease (COPD).
We assembled a 9-person expert panel of North American physicians familiar with the use of the Chronic Respiratory Questionnaire (CRQ), a disease-specific HRQoL measure, or the generic Medical Outcomes Study Short-Form 36-Item Health Survey (SF-36, Version 2.0) among patients with COPD.
Using 2 rounds of the Delphi process, 1 in-person meeting, and an iterative improvement process for circulating and correcting the final report, the expert panel established small, moderate, and large clinically important change levels for the CRQ and SF-36.
For this expert physician panel, levels for detecting clinically important differences on the CRQ were equal to or slightly higher than previous studies based on patient-reported differences. Clinically important differences on the SF-36, Version 2.0, were noticeably larger than previous estimates based on cross-sectional differences between clinically defined patient groups.
由于缺乏关于何为显著变化的临床意见,临床医生在日常实践中采用健康相关生活质量(HRQoL)测量指标的可能性较低。尽管可以通过基于患者自我报告的个体内变化研究凭经验确定标准,但这些基于锚定的方法仅纳入了患者对重要HRQoL变化的看法,并未反映出明智的临床评估。本研究的目的是从医生的角度为慢性阻塞性肺疾病(COPD)患者使用两种HRQoL测量指标建立临床重要差异标准。
我们组建了一个由9名北美医生组成的专家小组,他们熟悉在COPD患者中使用特定疾病的HRQoL测量指标慢性呼吸问卷(CRQ)或通用的医学结局研究简明健康调查(SF-36,第2.0版)。
通过两轮德尔菲法、一次面对面会议以及一个用于分发和修正最终报告的迭代改进过程,专家小组为CRQ和SF-36确定了小、中、大三个临床重要变化水平。
对于这个专家医生小组而言,CRQ上检测临床重要差异的水平等于或略高于以往基于患者报告差异的研究。SF-36第2.0版上的临床重要差异明显大于以往基于临床定义患者组之间横断面差异的估计值。