Barber B L, Santanello N C, Epstein R S
Department of Health Economic Statistics, Merck Research Laboratories, West Point, PA, USA.
Qual Life Res. 1996 Feb;5(1):117-22. doi: 10.1007/BF00435976.
One method of defining clinically meaningful changes in quality of life domain scores is 'anchoring', that is, relating changes in domain scores to more easily understood changes on a global question. Although this methodology has been used to assess changes in domain scores in clinical trials, the choice of global question has not undergone much scrutiny. This study examines the impact of two global questions on the definition of clinically meaningful changes in an asthma specific quality of life (ASQOL) questionnaire. We tracked 343 patients with mild to moderate asthma symptoms in a placebo controlled clinical trial. The patients responded to the ASQOL questionnaire, and answered two global questions; one assessing how well their asthma is controlled, and the other assessing the change in their asthma since the start of the study. Changes in each domain of the ASQOL questionnaire were related to each global question. Since each global question led to different definitions of what constituted meaningful change, we concluded that the wording of the global question can affect the definition of meaningful change in the ASQOL domain scores. Thus, when identifying meaningful changes, it is important to state the global question so that the context of the meaningful change is correctly understood.
定义生活质量领域得分中具有临床意义的变化的一种方法是“锚定”，即把领域得分的变化与一个更易于理解的整体问题上的变化联系起来。尽管这种方法已被用于评估临床试验中领域得分的变化，但整体问题的选择并未受到太多审视。本研究考察了两个整体问题对哮喘特异性生活质量（ASQOL）问卷中具有临床意义的变化的定义的影响。我们在一项安慰剂对照临床试验中跟踪了343名有轻度至中度哮喘症状的患者。患者对ASQOL问卷做出回应，并回答了两个整体问题；一个评估他们的哮喘控制得如何，另一个评估自研究开始以来他们哮喘的变化。ASQOL问卷各领域的变化与每个整体问题相关。由于每个整体问题导致了对构成有意义变化的不同定义，我们得出结论，整体问题的措辞会影响ASQOL领域得分中有意义变化的定义。因此，在确定有意义的变化时，说明整体问题很重要，以便正确理解有意义变化的背景。
