2016 Section 5 Green Book

Cardinal symptom improvement in CRS treatment

FIGURE 4. Frequency of symptom scores for SNOT-22 item “Sense of smell/taste.”

FIGURE 5. Frequency of symptom scores for SNOT-22 item “Blockage/congestion of nose.”

value. We elected to examine the cardinal symptoms of CRS because current guidelines 1 have highlighted these as diag- nostic criteria; however, future studies illuminating other symptoms associated with treatment selection and differen- tial improvement after treatment would similarly add value to clinical decision-making. The present study has some important limitations that warrant discussion. The ability of patients to self-select on- going medical therapy or surgical intervention, with physi- cian guidance, introduces a possible source of treatment selection bias. This is inherent to the study design and ideally would be avoided through a strict randomization process. There are some important factors that preclude randomizing study participants that have been discussed elsewhere. 20 In short, after failing typical medical manage- ment many patients may be reluctant to enroll in a study

where chance alone would determine if a surgical proce- dure is performed. The differential enrollment rate (20.2% vs 79.8%) between treatment cohorts reflects this potential bias with study subjects having already failed “maximal” medical management. Despite the lack of randomization, we were able to identify and account for significant con- founders between the 2 cohorts through regression mod- eling procedures. Additionally, a subset of the originally enrolled medical cohort elected to cross over from medical therapy to surgical treatment. These subjects likely crossed over to surgical management because of a failure to achieve QOL gains; therefore, by excluding crossover subjects from analysis in the medical cohort there is an introduction of bias that favors medical therapy. Regardless, the data favor surgical management; thus we did not pursue further analy- sis of the crossover cohort. Finally, the observational nature

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