Table 1 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) schedule patient enrolment, interventions and assessments

Timepoints

<10 wks

<6 wks

3 months

6 months

12 months

18 months

24 months

ENT-surgeons asks patient to participate

x

Informed Consent

x

Demographic Data

x

Medical History including earlier sinus surgery

x

Inclusion Criteria

x

Exclusion criteria

x

Randomisation

x

ESS or intensify medical treatment based on randomisation

x

Vital Signs and bodyweight

x

Symptoms

x

x

x

x

x

x

Disease specific HRQOL and symptoms (SNOT-22)

x

x

x

x

x

x

Generic HRQOL (EQ-5D-5L)

x

x

x

x

x

x

Endoscopic assessment of the nose

x

x

x

x

x

Olfactory function (Sniffin’ Sticks)

x

x

x

x

x

Nasal obstruction (PNIF)

x

x

x

x

x

Daily records cards (DRC)

x

x

x

x

x

x

CRS disease control

x

x

x

x

x

Asthma control

x

x

x

x

x

x

Healthcare resource use

x

x

x

x

x

Adverse effects

x

x

x

x

x

CT scan (Lund-Mackay score)

x

Surgical report

x

Laboratory tests, pregnancy test

x

Skin Prick test (if done in the last year, results are recorded)

x