Assessing the feasibility of using nasal saline irrigation for managing acute sinusitis

INTERVENTION: Participants are randomised to either: 1. Immediate antibiotics (current usual treatment in primary care) 2. Advice to do nasal irrigation for up to 3 weeks with a ‘back‐up’ or delayed antibiotic prescription (a prescription that can be used if the sinusitis does not settle) Participants will fill out a daily symptom diary to see whether irrigation makes any difference to symptom severity, or to the duration of illness, and whether antibiotics were used. Participants who are happy to have further tests will have a swab of the nose. Sample size: Feasibility estimates: to estimate follow‐up rates in each group between 65% and 80%, to be reasonably sure that the follow‐up rate is not 50% in each group (i.e.95% confidence intervals of +/‐ 15%) then 41 per group are needed. The researchers also anticipate that it should be possible for the intervention group to achieve use of antibiotics of around 65% or less. To estimate this proportion with 95% confidence intervals of +/‐ 15% (i.e. that antibiotic use is 80% or less) 41 per group is also needed. To allow for loss to follow‐up more than 100 patients are needed. Feasibility: The previous JAMA trial recruited 238 individuals/4 years with one RA (one centre), but recruitment is currently more challenging. The researchers therefore estimate that with one RA at the coordinating centre and P/T RAs in two other centres will allow them to recruit their target efficiently in 2 winter seasons. CONDITION: Sinusitis ‐ URTI ; Respiratory PRIMARY OUTCOME: ; 1. Antibiotic use measured using patient‐reported symptom diary, completed over four weeks or until symptoms resolve.; 2. Duration of moderately bad symptoms measured using a validated symptom diary; variables (using 7‐point Likert scales): nasal blockage, discharge, unpleasant taste/smell, facial pain, pain on bending, impaired activities, generally unwell, sleep disturbance. Completed over four weeks or until symptoms resolve.; SECONDARY OUTCOME: ; 1. Symptom duration until little/no problem, measured using patient‐reported symptom diary, completed over four weeks or until symptoms resolve; 2. Mean symptom score measured using patient‐reported symptom diary, completed over four weeks or until symptoms resolve; 3. Development of new/worsening symptoms measured using patient‐reported symptom diary, completed over four weeks or until symptoms resolve; 4. Health‐related quality of life measured using EQ5D, completed over four weeks or until symptoms resolve; 5. Reconsultations/resource use during the next month measured using patient note reviews conducted by staff at the surgeries; INCLUSION CRITERIA: The researchers pragmatically define acute sinusitis as having sinus discomfort and at least 2 other symptoms (2 of: patient‐reported nasal obstruction, patient‐reported purulent nasal discharge, or pus seen in the nasal cavity on inspection by the clinician). They do not propose using prior duration (e.g. the requirement for at least 7 days without improvement in the Canadian guidelines) since there is no good evidence for a particular cut‐off, and their aim is to help people who are currently being treatment with antibiotics for sinusitis, many of whom present with 7 days.