Determining Minimal Clinically Important Differences in Japanese Cedar/Cypress Pollinosis Patients
Determining Minimal Clinically Important Differences in Japanese Cedar/Cypress Pollinosis Patients
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DOI：
10.2332/allergolint.13-oa-0570
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发表时间：
2013-12-01
影响因子：
6.8
通讯作者：
Nishizaki, Kazunori
中科院分区：
文献类型：
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作者：
Higaki, Takaya;Okano, Mitsuhiro;Nishizaki, Kazunori
背景：医学干预试验的统计学显著性结果并不总是有临床意义的。我们试图估计最小临床重要差异（MCID）在日本雪松/柏树花粉症（JCCP）的季节性变化期间，对患者有意义的给定终点的最小变化。双盲，使用锚对2008年至2010年期间进行的JCCP患者的安慰剂对照试验进行了分析，的方法，其中日本鼻结膜炎生活质量问卷（JRQLQ）的面部量表被设置为锚。当面部量表评分提高或下降1分时，计算患者的平均得分变化，包括日记卡中鼻眼症状5项（T5 SS）、鼻眼症状6项（T6 SS）和JRQLQ中生活质量17项。在2009年和2010年，分别有3，698和374粒/cm（2）的花粉被分散。2009年和2010年T5 SS的MCID分别为1.426（每个项目0.285）和1.441（0.288）。2009年和2010年，T6 SS的MCID分别为4.115（0.686）和3.183（0.531）。2009年和2010年QOL的MCID分别为10.469（0.616）和6.026（0.354）。结论：JCCP患者认为日记中的T5 SS、JRQLQ中的T6 SS和QOL的单位差分别为1.5（每项0.3）、3.6（0.6）和8.2（0.5）具有临床意义。日记中记录的症状的MCID是稳定的，与分散的花粉水平无关。
Background: Statistically significant results of medical intervention trials are not always clinically meaningful. We sought to estimate the minimal clinically important difference (MCID) (the smallest change in a given end-point that is meaningful to a patient) during seasonal alteration of Japanese cedar/cypress pollinosis (JCCP).Methods: Results of a double-blinded, placebo-controlled trial of JCCP patients conducted between 2008 and 2010 were analyzed using an anchor-based method in which a face scale for Japanese rhinoconjunctivitis quality-of-life questionnaire (JRQLQ) was set as an anchor. MICDs were calculated as changes of average scores, including those for naso-ocular symptoms with 5 items in diary cards (T5SS), naso-ocular symptoms with 6 items (T6SS) and QOL with 17 items on the JRQLQ when face scale scores either improved or deteriorated by one point.Results: In 2009 and 2010, 3,698 and 374, respectively, grains/cm(2) of pollens were dispersed. The MCIDs for T5SS in 2009 and 2010 were 1.426 (0.285 per item) and 1.441 (0.288), respectively. The MCIDs for T6SS were 4.115 (0.686) and 3.183 (0.531) in 2009 and 2010, respectively. The MCIDs for QOL were 10.469 (0.616) and 6.026 (0.354) in 2009 and 2010, respectively.Conclusions: For T5SS in the diary, T6SS and QOL in JRQLQ, unit differences of 1.5 (0.3 per item), 3.6 (0.6) and 8.2 (0.5), respectively, were considered clinically meaningful by JCCP patients. The MCID for symptoms recorded in the diary was stable irrespective of the dispersed pollen level.