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

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.

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

International Forum of Allergy & Rhinology, Vol. 5, No. 1, January 2015