Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina, Charleston, SC, USA.
Otolaryngol Head Neck Surg. 2010 Nov;143(5):621-5. doi: 10.1016/j.otohns.2010.07.014.
To determine the time interval during which quality-of-life (QOL) outcomes stabilize after endoscopic sinus surgery (ESS).
Multi-institutional, longitudinal cohort.
Tertiary rhinology centers.
Adults with chronic rhinosinusitis from three medical centers were asked to provide responses to the Rhinosinusitis Disability Index (RSDI) and the Chronic Sinusitis Survey (CSS) at baseline and six months, 12 months, and 20 months after endoscopic sinus surgery. Repeated measures and post-hoc analyses were used to compare QOL scores among follow-up time points. Subgroup analyses were performed in a similar fashion for patients with and without nasal polyposis, asthma, allergies, acetylsalicylic acid intolerance, depression, and previous sinus surgery.
A total of 127 patients provided complete follow-up data for all three time points. Improvement in QOL scores was seen at six months after surgery for both the RSDI and CSS instruments. When comparing changes in mean QOL scores among all follow-up time points, there were no significant differences in either RSDI or CSS total scores (all P ≥ 0.853) or subscale scores (all P ≥ 0.251) between six, 12, and 20 months. Each individual subgroup demonstrated stable QOL scores between six and 20 months' follow-up, including patients with polyposis and those with intolerance to acetylsalicylic acid (all P ≥ 0.275).
At a cohort level, improvements in QOL after ESS do not appear to change between six and 20 months. Clinical trial designs incorporating QOL outcomes after ESS should consider the six-month time frame as an appropriate primary end point.
确定内镜鼻窦手术(ESS)后生活质量(QOL)稳定的时间间隔。
多机构、纵向队列研究。
三级鼻科中心。
来自三个医疗中心的慢性鼻-鼻窦炎成人患者被要求在 ESS 前和术后 6 个月、12 个月和 20 个月时分别使用鼻-鼻窦炎生活质量调查问卷(RSDI)和慢性鼻-鼻窦炎调查问卷(CSS)进行评估。采用重复测量和事后分析比较各随访时间点的 QOL 评分。对伴有和不伴鼻息肉、哮喘、过敏、阿司匹林不耐受、抑郁和既往鼻窦手术的患者进行类似的亚组分析。
共有 127 例患者提供了所有三个时间点的完整随访数据。术后 6 个月时,RSDI 和 CSS 两种工具的 QOL 评分均有改善。比较所有随访时间点的平均 QOL 评分变化时,RSDI 和 CSS 总分(均 P≥0.853)或各亚量表评分(均 P≥0.251)在 6、12 和 20 个月之间均无显著差异。6-20 个月的随访中,每个亚组的 QOL 评分均稳定,包括伴息肉和不耐受阿司匹林的患者(均 P≥0.275)。
在队列水平上,ESS 后 QOL 的改善似乎在 6-20 个月之间没有变化。ESS 后纳入 QOL 结局的临床试验设计应考虑 6 个月的时间框架作为合适的主要终点。