Center for Health Outcomes Research, United BioSource Corporation, Bethesda, Maryland 20814, USA.
Am J Rhinol Allergy. 2011 May-Jun;25(3):99-106. doi: 10.2500/ajra.2011.25.3575.
Evaluation of acute rhinosinusitis treatment effectiveness is based on patient-reported relief of symptoms. This study was designed to develop a multiattribute utility scoring algorithm for the Major Symptom Score (MSS) and secondarily to evaluate the psychometric characteristics (i.e., validity and responsiveness) of the MSS Utility Index (MSSUI).
Adult patients with acute rhinosinusitis were recruited for this longitudinal observational study through primary care and specialist physician offices. One hundred ninety patients participated in a preference elicitation exercise for MSS health states. Resulting preference data were used to generate a utility scoring algorithm for the MSS. Participants completed the MSS and 20-Question Sino-Nasal Outcome Test (SNOT-20) at baseline and completed the MSS twice daily for 15 days via daily diary. On days 7 and 15, participants completed the MSS, SNOT-20, and Overall Treatment Effect scale and were evaluated by physicians via the Physician Global Improvement Scale (PGIS).
At baseline, the mean ± SD. MSSUI score was 0.51 ± 0.17 and was negatively correlated with SNOT-20 scores (r = -0.58; p < 0.001). Days 2-8 average MSSUI scores were negatively correlated with day 7 SNOT-20 (r = -0.46; p < 0.001) and PGIS (r = -0.22; p < 0.001) scores; whereas days 9-15 average MSSUI scores were inversely related to day 15 SNOT-20 (r = -0.40; p < 0.001) and PGIS (r = -0.32, p < 0.001) scores. Mean MSSUI scores improved from baseline with effect sizes at days 7 and 15 of 0.82 and 1.20, respectively.
The MSSUI represents an acceptable and psychometrically sound patient-reported end point for clinical trials comparing treatments for acute rhinosinusitis.
急性鼻窦炎治疗效果的评估基于患者症状缓解的报告。本研究旨在开发主要症状评分(MSS)的多属性效用评分算法,并次要评估 MSS 效用指数(MSSUI)的心理测量特性(即有效性和反应性)。
通过初级保健和专科医生办公室招募患有急性鼻窦炎的成年患者参加这项纵向观察研究。190 名患者参与了 MSS 健康状况的偏好 elicitation 练习。由此产生的偏好数据用于生成 MSS 的效用评分算法。参与者在基线时完成 MSS 和 20-Question 鼻-鼻窦炎结局测试(SNOT-20),并通过每日日记在 15 天内每天两次完成 MSS。在第 7 天和第 15 天,参与者完成 MSS、SNOT-20 和总体治疗效果量表,并由医生通过医生总体改善量表(PGIS)进行评估。
在基线时,MSSUI 评分的平均值 ± SD 为 0.51 ± 0.17,与 SNOT-20 评分呈负相关(r = -0.58;p < 0.001)。第 2-8 天平均 MSSUI 评分与第 7 天 SNOT-20(r = -0.46;p < 0.001)和 PGIS(r = -0.22;p < 0.001)评分呈负相关;而第 9-15 天平均 MSSUI 评分与第 15 天 SNOT-20(r = -0.40;p < 0.001)和 PGIS(r = -0.32,p < 0.001)评分呈反比。MSSUI 评分从基线开始改善,第 7 天和第 15 天的效应量分别为 0.82 和 1.20。
MSSUI 代表了一种可接受且具有心理测量学意义的患者报告终点,可用于比较急性鼻窦炎治疗的临床试验。