PDF(Pubmed)
Abstract：
BACKGROUND: Chronic rhinosinusitis with nasal polyposis (CRSwNP) often coexists with lower airway disease. With the overlap between upper and lower airway disease, optimal management of the upper airways is undertaken in conjunction with that of the lower airways. Biologic therapy with targeted activity within the Type 2 inflammatory pathway can improve the clinical signs and symptoms of both upper and lower airway diseases. Knowledge gaps nevertheless exist in how best to approach patient care as a whole. There have been sixteen randomized, double-blind, placebo-controlled trails performed for CRSwNP targeted components of the Type 2 inflammatory pathway, notably interleukin (IL)-4, IL-5 and IL-13, IL- 5R, IL-33, and immunoglobulin (Ig)E. This white paper considers the perspectives of experts in various disciplines such as rhinology, allergy, and respirology across Canada, all of whom have unique and valuable insights to contribute on how to best approach patients with upper airway disease from a multidisciplinary perspective.
METHODS: A Delphi Method process was utilized involving three rounds of questionnaires in which the first two were completed individually online and the third was discussed on a virtual platform with all the panelists. A national multidisciplinary expert panel of 34 certified specialists was created, composed of 16 rhinologists, 7 allergists, and 11 respirologists who evaluated the 20 original statements on a scale of 1-9 and provided comments. All ratings were quantitively reviewed by mean, median, mode, range, standard deviation and inter-rater reliability. Consensus was defined by relative interrater reliability measures-kappa coefficient ([Formula: see text]) value > 0.61.
RESULTS: After three rounds, a total of 22 statements achieved consensus. This white paper only contains the final agreed upon statements and clear rationale and support for the statements regarding the use of biologics in patients with upper airway disease.
CONCLUSIONS: This white paper provides guidance to Canadian physicians on the use of biologic therapy for the management of upper airway disease from a multidisciplinary perspective, but the medical and surgical regimen should ultimately be individualized to the patient. As more biologics become available and additional trials are published we will provide updated versions of this white paper every few years.
METHODS: A Delphi Method process was utilized involving three rounds of questionnaires in which the first two were completed individually online and the third was discussed on a virtual platform with all the panelists. A national multidisciplinary expert panel of 34 certified specialists was created, composed of 16 rhinologists, 7 allergists, and 11 respirologists who evaluated the 20 original statements on a scale of 1-9 and provided comments. All ratings were quantitively reviewed by mean, median, mode, range, standard deviation and inter-rater reliability. Consensus was defined by relative interrater reliability measures-kappa coefficient ([Formula: see text]) value > 0.61.
RESULTS: After three rounds, a total of 22 statements achieved consensus. This white paper only contains the final agreed upon statements and clear rationale and support for the statements regarding the use of biologics in patients with upper airway disease.
CONCLUSIONS: This white paper provides guidance to Canadian physicians on the use of biologic therapy for the management of upper airway disease from a multidisciplinary perspective, but the medical and surgical regimen should ultimately be individualized to the patient. As more biologics become available and additional trials are published we will provide updated versions of this white paper every few years.
摘要：
背景：慢性鼻-鼻窦炎伴鼻息肉病（CRSwNP）常与下气道疾病并存。由于上呼吸道和下呼吸道疾病的重叠，上呼吸道的优化管理与下呼吸道的优化管理相结合。在2型炎症途径内具有靶向活性的生物治疗可以改善上呼吸道和下呼吸道疾病的临床体征和症状。然而，在如何从整体上最好地对待患者护理方面存在知识差距。已经有16个随机化，双盲,对2型炎症途径的CRSwNP靶向成分进行安慰剂对照试验，特别是白细胞介素（IL）-4，IL-5和IL-13，IL-5R，IL-33和免疫球蛋白(Ig)E.本白皮书考虑了各个学科的专家的观点，例如鼻学，过敏,和整个加拿大的呼吸科，所有这些人都有独特而有价值的见解，可以从多学科的角度为如何最好地治疗上呼吸道疾病患者做出贡献。
方法：采用德尔菲法过程，涉及三轮问卷，其中前两轮分别在线完成，第三轮在虚拟平台上与所有小组成员讨论。成立了一个由34名认证专家组成的国家多学科专家小组，由16位鼻学家组成，7名过敏症患者,和11名呼吸科医生，他们以1-9的比例评估了20份原始声明并提供了评论。所有评级均按平均值进行了定量审查，中位数，mode,范围,标准偏差和评估者间可靠性。共识由相对评分者间可靠性度量-卡帕系数([公式：见正文])值>0.61定义。
结果：经过三轮，共有22项声明达成共识。本白皮书仅包含最终商定的声明，以及关于在上呼吸道疾病患者中使用生物制剂的声明的明确理由和支持。
结论：本白皮书从多学科的角度为加拿大医生使用生物疗法治疗上呼吸道疾病提供了指导。但药物和手术方案最终应针对患者进行个体化治疗。随着越来越多的生物制剂可用和更多试验的发布，我们将每隔几年提供本白皮书的更新版本。
方法：采用德尔菲法过程，涉及三轮问卷，其中前两轮分别在线完成，第三轮在虚拟平台上与所有小组成员讨论。成立了一个由34名认证专家组成的国家多学科专家小组，由16位鼻学家组成，7名过敏症患者,和11名呼吸科医生，他们以1-9的比例评估了20份原始声明并提供了评论。所有评级均按平均值进行了定量审查，中位数，mode,范围,标准偏差和评估者间可靠性。共识由相对评分者间可靠性度量-卡帕系数([公式：见正文])值>0.61定义。
结果：经过三轮，共有22项声明达成共识。本白皮书仅包含最终商定的声明，以及关于在上呼吸道疾病患者中使用生物制剂的声明的明确理由和支持。
结论：本白皮书从多学科的角度为加拿大医生使用生物疗法治疗上呼吸道疾病提供了指导。但药物和手术方案最终应针对患者进行个体化治疗。随着越来越多的生物制剂可用和更多试验的发布，我们将每隔几年提供本白皮书的更新版本。
