目的:本研究旨在开发基于共识的核心结果集(COS),用于评估口干干预措施的临床试验。
方法:通过2篇系统文献综述和对口干患者的访谈,我们确定了口干评估的相关结局域.Delphi调查已提交给参加在孟菲斯举行的美国口腔医学学会年会的医疗保健提供者,田纳西州,美国,2022年5月(n=104)和科克大学牙科学校和医院的10名口干患者,爱尔兰共和国。随后在第二个共识过程中讨论了未达成共识的结果领域,该过程由来自世界口腔医学VIII口干工作组的11名口腔医学专家组成的虚拟特殊利益集团领导。
结果:在2步共识过程之后,对12个口干结果域达成共识(即,唾液腺流,唾液分泌不足的迹象,粘膜湿度/湿度,口干症的严重程度,口干症的持续时间,口干症的总体影响,对身体功能的影响,唾液分泌不足对一般健康的影响,对社会活动的影响,生活质量,口干的经济影响,患者满意度)纳入最终COS。
结论:我们提出了一种基于共识的COS来评估临床试验中的口干干预措施。该COS包括所有评估口干治疗的临床试验应评估的最小但强制性的一组领域。
This study aimed to develop a consensus-based core outcome set (COS) to be used in clinical trials assessing dry mouth interventions.
Through 2 systematic literature reviews and interviews with dry mouth patients, we identified relevant outcome domains for dry mouth assessment. A Delphi survey was presented to health care providers attending the American Academy of Oral Medicine annual meeting in Memphis, Tennessee, USA, on May 2022 (n = 104) and 10 dry mouth patients at Cork University Dental School and Hospital, Republic of Ireland. The outcome domains for which no
consensus was reached were subsequently discussed in a second
consensus process led by a virtual Special Interest Group of 11 oral medicine experts from the World Workshop on Oral Medicine VIII dry mouth working group.
After the 2-step
consensus process, a
consensus was reached for 12 dry mouth outcome domains (i.e., salivary gland flow, signs of hyposalivation, mucosal moisture/wetness, the severity of
xerostomia, duration of
xerostomia, the overall impact of
xerostomia, impact on physical functioning, impact of hyposalivation on general health, impact on social activities, quality of life, the economic impact of dry mouth, patient satisfaction) to be included in the final COS.
We propose a
consensus-based COS to assess dry mouth interventions in clinical trials. This COS includes the minimum but mandatory set of domains that all clinical trials evaluating dry mouth treatments should assess.