Djupesland P G, Reitsma S, Hopkins C, Sedaghat A R, Peters A, Fokkens W J
Optinose AS, Oslo Science Park, Oslo, Norway.
Department of Otorhinolaryngology, Amsterdam University Medical Centres, location AMC, Amsterdam, The Netherlands.
Rhinology. 2022 Jun 1;60(3):169-176. doi: 10.4193/Rhin21.401.
Endoscopic grading of nasal polyps (NP) is typically a coprimary endpoint in clinical trials evaluating treatments for chronic rhinosinusitis with nasal polyps (CRSwNP). However, a consensus on the most effective way to grade nasal polyps has not been reached. Different scales have been used, hampering the interpretation of data across trials. This review compares the characteristics of NP grading systems used in registration trials for approved NP treatments. These fundamental differences in grading systems make quantitative comparison of outcomes between trials inaccurate and potentially misleading. In lieu of a universal grading system, reporting the baseline distribution of polyp grades (unilateral and/or summed/total grades), as well as changes from baseline over time by baseline grade may help improve interpretability of outcomes and reduce inaccuracy when attempting cross-trial comparisons and making therapeutic decisions.
鼻息肉(NP)的内镜分级通常是评估鼻息肉慢性鼻窦炎(CRSwNP)治疗方法的临床试验中的共同主要终点。然而,尚未就鼻息肉最有效的分级方法达成共识。已使用了不同的量表,这妨碍了对各试验数据的解读。本综述比较了已批准的NP治疗注册试验中使用的NP分级系统的特征。分级系统中的这些根本差异使得试验间结果的定量比较不准确且可能产生误导。由于缺乏通用的分级系统,报告息肉分级的基线分布(单侧和/或总和/总分级)以及随时间推移各基线分级相对于基线的变化,可能有助于提高结果的可解释性,并在尝试进行跨试验比较和做出治疗决策时减少不准确之处。