The SF-36 and SGRQ: validity and first look at minimum important differences in IPF.
The SF-36 and SGRQ: validity and first look at minimum important differences in IPF.
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DOI：
10.1016/j.rmed.2009.09.006
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发表时间：
2010-02
影响因子：
4.3
通讯作者：
Wambold, Frederick S.
中科院分区：
文献类型：
--
作者：
Swigris, Jeffrey J.;Brown, Kevin K.;Behr, Juergen;du Bois, Roland M.;King, Talmadge E.;Raghu, Ganesh;Wambold, Frederick S.
健康相关生活质量 (HRQL) 是药物试验的重要结果。人们对简表 36 (SF-36) 和圣乔治呼吸问卷 (SGRQ) 在特发性肺纤维化 (IPF) 中的表现知之甚少。检查 SF-36 和 SGRQ 的有效性并确定构成最小重要差异 (MID) 的分数。我们分析了最近完成的一项试验的数据，该试验招募了患有明确 IPF 的受试者，这些受试者在基线和六个月时完成了 SF-36、SGRQ 和基线/过渡性呼吸困难指数。我们根据临床锚点（FVC、DLCO 和呼吸困难）比较了疾病严重程度在六个月内发生变化的受试者组之间 HRQL 评分的平均变化。我们使用基于锚点和基于分布的方法来估计每个域的 MID。结果支持了 SF-36 和 SGRQ 在纵向研究中使用的有效性。根据锚点，临床状态改善的受试者和临床状态下降的受试者之间的领域分数的平均变化存在显着差异。 MID 对 SF-36 的评估范围为 2-4 分，对 SGRQ 的评估范围为 5-8 分。在 IPF 中，SF-36 和 SGRQ 对于区分疾病严重程度随时间变化的受试者具有合理的有效性。需要更多的研究来继续验证过程，完善 SF-36 或 SGRQ 的 MID 估计，并确定特定疾病的仪器是否会比这两种仪器表现更好。
Health-related quality of life (HRQL) is an important outcome in drug trials. Little is known about how the Short Form-36 (SF-36) and Saint George's Respiratory Questionnaire (SGRQ) perform in idiopathic pulmonary fibrosis (IPF). To examine the validity of the SF-36 and SGRQ and to determine scores from each that would constitute a minimum important difference (MID). We analyzed data from a recently completed trial that enrolled subjects with well-defined IPF who completed the SF-36, SGRQ, and Baseline/Transition Dyspnea Index at baseline and six months. We compared mean changes in HRQL scores between groups of subjects whose disease severity changed over six months according to clinical anchors (FVC, DLCO, and dyspnea). We estimated the MID for each domain by using both anchor- and distribution-based approaches. Results supported the validity of the SF-36 and SGRQ for use in longitudinal studies. Mean changes in domain scores differed significantly between subjects whose clinical status improved and those whose clinical status declined according to the anchors. MID estimates for the SF-36 ranged from 2-4 points and from 5-8 points for the SGRQ. In IPF, the SF-36 and SGRQ possess reasonable validity for differentiating subjects whose disease severity changes over time. More studies are needed to continue the validation process, to refine estimates of the MIDs for the SF-36 or SGRQ, and to determine if a disease-specific instrument will perform better than either of these.
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