This international paper, involving the foremost rhinology departments worldwide aims to provide a standardised, agreed core outcome set for chronic rhinosinusitis, which has been designed to facilitate future meta analyses of published work in systematic reviews. Stakeholders included patients, ENT surgeons, primary care physicians, allergists and researchers in CRS, and they were involved in every step of the process in defining the core outcomes. A long list of potential outcome measures was drawn up from a variety of sources. A systematic search of outcomes published in CRS using the Cochrane database was performed. Following this a project to outline the three most important factors in CRS outcomes to patients, practitioners and providers was performed. All previous patient reported outcome measures were then reviewed. Potential missing items were then reviewed by a patient focus and steering group review before a long list was compiled and mapped to simplified domains to enable a Delphi process to begin. The Delphi process enabled interested stakeholders to rate the importance of each outcome measure on the long list according to how important they thought it was: of limited importance; important or critical. A further round of scoring using a nine-point Likert scale was performed. Consensus as to whether an item should be included in the core outcome set, was that 70% of respondents indicated it was of critical importance and less than 15% indicated limited importance. The opposite was used to exclude an item.
Sixty-nine randomised controlled trials were assessed for their outcome measures from the Cochrane database. The project to find the three most important outcomes generated 653 suggestions from 235 participants. The final long list included 54 items mapped to nine different domains.
Two rounds of the delphi process were performed, unfortunately there was a significant drop out in the second round. The final core outcome set contains 15 items over four domains. The domain, patient reported symptoms and quality of life includes items such as severity, frequency and duration of symptoms, along with nasal discharge, obstruction, sense of smell and is proposed to be measured by a modified SNOT-22 score over time. Control of disease includes items such as overall control, need for surgery and endoscopic appearances measured by need for systemic medication, progression to surgery, and Lund-Kennedy score. Impact on daily activity judged by the ability to perform normal tasks would be measured again by SNOT 22. Finally, acceptability of treatment and side-effects, measured by compliance and noting of side-effects. Whilst the proposed outcome set is not expected to dictate the primary measures used for clinical trials, it is hoped that they will be included in all reporting to facilitate meta-analysis.
