Long-term Follow-Up for chronic rhinosinusitis patients in the MACRO Trial: MACRO PLUS

Research question What is the long-term evidence for effectiveness of a long course of antibiotics or sinus surgery in the management of adult chronic rhinosinusitis (CRS)? Background The NIHR PGfAR funded MACRO Programme set out to establish which treatments work best for adults with CRS and to ensure they are adopted as best practice by GPs and specialists. We have completed an RCT comparing clarithromycin (3 months), placebo (3 months) and surgery simultaneously recruiting a total sample of 514 patients with SNOT-22 (patient-rated outcome measure) as the main study outcome. In CRS, long-term follow-up over 5 years shows a clearer picture of the impacts on patients. Aims and Objectives Establish the long-term effectiveness of a prolonged course of antibiotics and endoscopic sinus surgery (ESS) in adult patients with CRS in terms of symptomatic improvement and costs to the NHS and patients. Update the decision model for the MACRO cost-effectiveness analysis comparing long course of antibiotics, sinus surgery, and appropriate medical therapy alone using 5-year follow-up data to provide more accurate results regarding the most cost-effective pathway. Consider the MACRO Programme evidence and synthesise this with evidence collected during the MACRO PLUS 5-year follow-up period, to update the ideal patient pathway for the management of patients with CRS in the NHS, across primary and secondary care, as developed through WS3 of the MACRO Programme. Methods We propose a long-term follow up of MACRO trial participants that will enable us to assess the impact of the treatment options at 5 years and allow the team to update their recommendations on the best pathway for treating people with CRS and to effectively inform patients of the recommendations. This will include refining the health economic decision analytic model comparing the three treatments used in the MACRO trial. Overall, this research will define the most effective and cost-effective treatments for CRS patients within the NHS, minimizing the impact of disease, and reducing variations in patient care and ineffective use of healthcare resources, including inappropriate use of antibiotics. Timelines for delivery The study will continue from the end of the existing MACRO Programme (finishing December 2025) and enable collection of all included participants 5-year data, the last of which is due to be returned by October 2028. Following this, the data will be analysed to determine if the 6-month findings and related recommendations have changed, and if so how. Anticipated Impact and Dissemination Due to the chronicity of the disease, 5-year data will provide a robust long-term assessment of the trial interventions and feed into international guidelines and evidence including the European Position Paper on Sinusitis and Nasal Polyps and the International Consensus Statement on Rhinology & Allergy. We will aim to publish the outcomes in a high impact journal and disseminate at international conferences. In conjunction with our PPI panel, we will set out a strategy to inform CRS patients of our findings and GPs and ENT specialists of our recommendations for the management of the condition in both settings.