Table 2 Variables, measures, and planned statistical analyses. ESS, endoscopic sinus surgery; SNOT-22, Sinonasal Outcome Test Quality of Life Questionnaire; RAND 36, Research and Development 36 Item Health Survey; MIC, minimal clinically important change; CI, confidence interval; NNT, number needed to treat
Variable/outcome | Hypothesis | Outcome measure | Method of analysis |
|---|---|---|---|
Primary outcome | ESS improves outcome from baseline to 6 months | Difference between the mean SNOT-22 change scores of ESS and control group | Analysis of covariance, estimate for difference between means with 95% CI (adjusted age (≤ 50 vs. > 50 years), sex, and allergy status (yes vs. no)) |
Distributions of different SNOT-22 domain scores reported in ESS and control group | |||
Secondary outcomes | |||
General QoL change | Improvement occurs | Difference between the mean RAND-36 change scores of ESS and control group | Analysis of covariance |
Proportion benefiting | Improvement occurs | Difference in proportions benefiting (SNOT-22 > MIC) in ESS and control group | Chi-squared test, risk ratio with 95% CI, NNT |
No. of episodes, visits, antibiotic courses, sick days | Improvement occurs | Difference in number of episodes, visits, antibiotic courses, and sick days in ESS and control group | Difference in means with 95% CI |
No. of symptomatic days | Improvement occurs | Difference in no. of days with nasal obstruction, nasal discharge, facial pain/pressure, and fever in ESS and control group | Difference in means with 95% CI |
No. of postoperative complications | Improvement occurs | Frequency of postoperative synechia formations, infections, nasal pain, bleeding, and orbital and intracranial complications | Number (%) |