Effect of Postoperative Additive Systemic Steroids in CRSwNP

Lund-Kennedy-Score (LKS)

Lund-Kennedy-Scores range from 0-12. Scoring includes the assessment of polyps (0=no polyps, 1=middle meatus, 2= beyond middle meatus), discharge (0=no discharge, 1=thin discharge, 2=edema/scarring/crusting (0=absent, 1=mild, 2=severe)

Time frame: first visit until 24 months, change is measured between baseline and each follow-up time point up to 24 months (follow-up time points are as follows: 3 weeks, 3 months, 6 months, 9 months, 12 months, 18 months)

Smell Scores

Sniffing Sticks Screening-16 test ("forced choice"), graded from 0-16 with a higher score indicating a better sense of smell, anosmia is defined as a score ≤7

Time frame: first visit until 24 months, change is measured between baseline and each follow-up time point up to 24 months (follow-up time points are as follows: 3 weeks, 3 months, 6 months, 9 months, 12 months, 18 months)

Recurrence rates

Increase of NPS per side ≥ 2 within 2 year follow-up

Time frame: first visit until 24 months, change is measured between baseline and each follow-up time point up to 24 months (follow-up time points are as follows: 3 weeks, 3 months, 6 months, 9 months, 12 months, 18 months)

Sinonasal Symptom Score

nasal congestion, anterior rhinorrhea, posterior rhinorrhea, sneezing, pruritus in the nose, tearing, ear pressure, throat pain, facial pain or pressure, headache, numbness in cheek/lips/teeth. All graded from 0-3 (0=no problems, 1=mild problems, 2= moderate problems, 3= severe problems)

Time frame: first visit until 24 months, change is measured between baseline and each follow-up time point up to 24 months (follow-up time points are as follows: 3 weeks, 3 months, 6 months, 9 months, 12 months, 18 months)

Mucus and serum biomarker levels

Pappalysin-1, Cystatin-SN, Periostin, SerpinE1, SerpinF2 (measured in pg/ml)

Time frame: first visit until 24 months, change is measured between baseline and each follow-up time point up to 24 months (follow-up time points are as follows: 3 weeks, 3 months, 6 months, 9 months, 12 months, 18 months)

RSDI (Rhinosinusitis Disability Index)

validated 30-item Likert scale instrument containing three subscales that assess the impact of sinusitis on physical, functional, and emotional domains. The Score ranges from 0-120. Higher total and subscale RSDI scores represent a worse impact of sinus disease.

Time frame: first visit until 24 months, change is measured between baseline and each follow-up time point up to 24 months (follow-up time points are as follows: 3 weeks, 3 months, 6 months, 9 months, 12 months, 18 months)

SF-36 (Short Form-36)

There is no single overall score for the SF-36, instead, it generates 8 subscales and two summary scores. The subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role-limitations due to emotional problems, mental health. The scoring ranges from 0-100. Higher total and subscale scores represent a better health situation.

Time frame: first visit until 24 months, change is measured between baseline and each follow-up time point up to 24 months (follow-up time points are as follows: 3 weeks, 3 months, 6 months, 9 months, 12 months, 18 months)