Obstructive sleep apnea hypopnea syndrome: Protocol for the development of a core outcome set

Abstract

Background: Obstructive sleep apnea hypopnea syndrome (OSAHS) is a common, chronic sleep disease. As the incidence of OSAHS increases, it has seriously threatened people's health. There have been an increasing number of clinical trials of OSAHS in recent years. However, the clinical trials of OSAHS have heterogeneous outcomes, surrogate outcomes, subjective outcomes, and composite outcomes, as well as the lack of endpoints or patient perspectives. The best method is to develop a core outcomes sets (COSs) for OSAHS's clinical trials. Methods: The development of COSs of OSAHS will include 5 stages: (1)set up a Steering Group, defining the scope of this COSs;(2)identifying potential core outcomes by systematic review and semi-structured interviews;(3)identifying final COSs by consensus process, includes Delphi survey and face-to-face meeting;(4)identification and evaluation of instruments used to measure the final COSs;(5)promotion and updates. Results: The results of our study will be published in a peer-reviewed journal.Discussion: The development of the COSs of OSAHS will improve the design and operation of OSAHS clinical trials to conform to international standards and ensure the credibility of the outcomes. In addition, this study will involve different stakeholder groups to help ensure that the developed COSs will be suitable and well accepted.