Table 1 Variables, measures and planned statistical analyses
Variable/Outcome | Hypothesis | Outcome measure | Method of analysis |
|---|---|---|---|
Primary outcome | TE and TT improve TOI-14 scores at 6 months as compared to WW | Difference between the mean TOI-14 scores of combined TE+TT and WW group | Estimation of differences between log transformed means based on tobit model and adjusting for selected covariates (adjusted sex, baseline TOI-14 score, enrolling center (Oulu vs. others) and main complaint (recurrent vs. chronic tonsillitis) |
TT is non-inferior to TE in improving the TOI-14 scores | Difference between the mean TOI-14 scores of TT and TE group | ||
Secondary outcomes | |||
General QoL change | Improvement occurs | Difference between the mean RAND 36 scores at 6 months in TE+TT vs. WW groups and in TE vs. TT group | Analysis of covariance |
Proportion benefiting | Improvement occurs | Difference in proportions benefiting (TOI-14 > MIC) in TE+TT group vs. WW group and in TE vs. TT group | Estimation of risk ratio, risk difference and number needed to treat (with 95 % CI), NNT |
No. of episodes, visits, antibiotic courses, sick days | Improvement occurs | Difference in medical visits, antibiotic courses and sick days in TE+TT group vs. WW group and in TE vs. TT group | Difference in means with 95% CI |
No. of symptomatic days | Improvement occurs | Difference in no. of days with various harmful symptoms and with various analgesics taken in TE+TT group vs. WW group and in TE vs. TT group | Difference in means with 95% CI |
No. of harmful symptoms | Improvement occurs | Difference in proportions of having various harmful symptoms in TE+TT group vs. WW group and in TE vs. TT group | Chi-squared test, Risk ratio with 95% CI |
No. of postoperative complications | Improvement occurs | Frequency of postoperative pain, bleeding, infections, dental injury and anaesthetic complications | Number (%) |