The MACRO Trial, part of the MACRO Programme (defining best Management for Adults with Chronic RhinOsinusitis), has been funded by the National Institute of Health Research to compare longer-term antibiotics, matched placebo and sinus surgery in 600 adult CRS patients across 16 hospitals, with the SNOT-22 as the main outcome measure. The study reported here aimed to evaluate current subjective and objective outcome assessments for nasal syndromes and identify any assessments that are redundant. The study also aimed to work with patient representatives and include their perspectives on the outcomes work undertaken during their experience of a ‘MACRO trial visit’ to determine acceptability and final choice of the chosen assessments for the trial.
Adults diagnosed with CRS and meeting the provisional eligibility criteria for the MACRO trial were recruited to take part in this mixed-method study from 2 tertiary centre ENT clinics to undergo all of the proposed objective outcome measures and the SNOT-22 questionnaire. Correlations between objective tests and SNOT-22 item scores were evaluated. Purposively selected participants were also invited to take part in a semi-structured telephone interview to explore their experiences and views of undergoing the proposed outcome measures in a simulated trial visit.
A total of 70 patients were recruited, 36 had CRS without nasal polyps, 34 had CRS with nasal polyps and 37% of patients were male. There was a weak inverse correlation between the SNOT-22 “Blockage” ratings and Peak Nasal Inspiratory Flow (PNIF) readings. There was a moderate inverse correlation between the SNOT-22 “Smell” ratings and Sniffin’ Sticks scores. There was no significant correlation between the SNOT-22 item ratings (runny, post nasal drip, thick nasal discharge) and Saccharin test results. The participants’ experience of the trial visit was generally positive and the duration of the simulated trial visit of <1.5 hours was deemed acceptable. The majority of the proposed outcome measures were valued by the participants by providing a way of quantifying their symptoms, with the exception of the Saccharin test.
The Sniffin’ Sticks test and PNIF correlate with their respective component SNOT-22 scores but are considered important by patients and PNIF remains a simple cheap test to perform. The Saccharin test will be removed as participants did not value it and was not highly rated in parallel work on a core outcome set for CRS. To our knowledge, our study is the first to assess acceptibility of proposed objective outcome measures for a CRS trial using a combined approach of considering both statistical analysis of outcome data and participants’ perspectives. Whilst this study was designed specifically for the MACRO trial, it demonstrated a good mixed methods research model to select the most appropriate objective tools for a large Randomised Control Trial (RCT). We propose that future studies in CRS should adopt the same methodology to assess their outcome measures to reduce patient and research burden.
|Number of pages||9|
|Publication status||Published - 2019|