One in ten UK adults suffers from chronic rhinosinusitis, yet doctors cannot agree on whether to treat it with antibiotics, steroids, or surgery. The condition—persistent inflammation of the sinuses—worsens quality of life more than angina or chronic lung disease, and drives 40,000 sinus operations and 120,000 hospital visits each year in England and Wales alone. Despite this, GPs routinely prescribe repeated antibiotics against guidelines, while surgical rates vary five-fold across the country because evidence comparing the two approaches is weak. This programme will first analyse linked NHS records to map current care pathways, then run a clinical trial with 600 patients across 16 UK centres. Patients will be randomly assigned to receive either antibiotics, a placebo, or endoscopic sinus surgery, with all groups also using nasal sprays and saline rinses. The goal is to determine definitively which treatment works best—and for whom. If successful, the results could end the current guesswork, spare patients unnecessary surgery or ineffective antibiotics, and reduce the risk of antibiotic resistance. The linked health data will also allow researchers to track long-term outcomes beyond the trial period, informing future guidelines for a condition that currently has no clear standard of care.
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Aims and Objectives: To establish best practice for Chronic Rhinosinusitis (CRS) management in adults across primary and secondary care. Background and Rationale: 11% of UK adults report CRS symptoms, with quality of life poorer than angina or chronic respiratory disease. 1% receive treatment from their GP each year, averaging 4 consultations annually. 40,000 sinus operations and 120,000 related outpatient consultations occurred in England and Wales in 2012-3. Recent European and UK guidelines emphasise limitations in current evidence. GPs often prescribe repeated antibiotic courses, contravening primary care guidelines. Evidence supporting longer-term antibiotic use in secondary care is incomplete and practice varies. Judicious use of antibiotics is essential to avoid resistance and side effects. Insufficient evidence defining the role of endoscopic sinus surgery (ESS) contributes to 5-fold variation in UK surgical rates. If surgery proves less effective than medical therapy, patients may be exposed to unnecessary risks, while if better, current delays reflect suboptimal care. Two 2014 Cochrane systematic reviews of CRS management concluded that studies are urgently needed. Research Plan: WS1: Understanding current management of patients with CRS and optimising trial design Routine data analysis: Linked national electronic health records (EHR) will identify current care pathways. Evaluation of different strategies will estimate the effectiveness of medical and surgical interventions, identify referral patterns and quantify rates of primary care consultation, hospitalisation, prescriptions (particularly antibiotic use) and surgical intervention. Health economic analysis: Cost-effectiveness analyses of treatments/pathways identified above will be conducted to inform the trial design in WS2 and identify deficiencies in anticipated data collection that could be focused upon for the trial-based health economic model. Qualitative analysis: Qualitative interviews with patients, GPs and ENT specialists will explore current attitudes towards treatment options and guidelines, including potential barriers. Interviews will explore the acceptability of 2 possible trial designs proposed for WS1, and consider recruitment, randomisation, retention, follow up and proposed outcome measures. WS1 will define current practice, estimate real world effectiveness of treatment pathways and inform trial design, including antibiotic choice and role of oral steroids. Consideration will be given to the proportion of patients with and without polyps and their natural history. Current uncertainty regarding management options necessitates pre-trial work to ensure relevance and acceptability of the trial and inform subsequent implementation programmes. WS1 will help ensure generalisability of trial outcomes and data linkage established will allow long-term outcomes to be captured, beyond the scope of the programme. WS2: Clinical trial to assess effectiveness of medical and surgical treatment Two possible designs are considered: A) 2-stage trial incorporating two linked randomised comparisons: antibiotic versus placebo for 3 months (stage 1); proceeding to randomisation to receive ESS or continued medical therapy for those without significant benefit (stage 2). B) 3-arm randomised trial patients comparing antibiotic or placebo or ESS. All patients will receive topical management with nasal corticosteroids and saline irrigation throughout in both designs. The target population is adult patients with CRS (European guidelines diagnosed). Primary outcome measure: 22-item Sinonasal Outcome Test (SNOT-22, a validated disease-specific quality of life instrument). Secondary outcome measures: endoscopic scores, SF12 and EQ-5D-5L questionnaires, adverse effects, surgical complications, costs and cost-effectiveness. 600 patients (16 UK centres) will ensure ≥80% power to detect 10 points in the SNOT-22 (0.5SD, considere
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