KEYSTONE, COLO. – Research-minded otolaryngologists have gotten serious about conducting high-quality, patient-centered outcomes studies of endoscopic sinus surgery for chronic rhinosinusitis, which more than 250,000 Americans undergo each year. And the results are eye opening.
Mounting evidence documents that endoscopic sinus surgery (ESS) in properly selected patients with chronic rhinosinusitis (CRS) results in markedly improved quality of life, functional status, and reduced use of medications, compared with medical management, Dr. Todd T. Kingdom said at a meeting on allergy and respiratory diseases sponsored by National Jewish Health.
These studies utilize validated measures of patient-centered quality of life and symptoms. They are nothing like the lightweight, less-than-persuasive ESS research published in the 1990s, which reported glowing ‘success’ rates of 80%-97% in single-institution retrospective studies using variable inclusion criteria and often-sketchy definitions of success.
Dr. Todd Kingdom
"Those data are not acceptable, but that’s what we had. This was before evidence-based medicine with an emphasis on rigorously designed studies took hold," explained Dr. Kingdom, professor and vice chairman of the department of otolaryngology – head and neck surgery, at the University of Colorado, Denver, and immediate past president of the American Rhinologic Society.
Current research emphasizes the use of modern, validated patient-centered quality of life tools and symptom scores because CRS is a symptom-based diagnosis and it is symptom severity that drives patients to seek treatment. Also, objective measures, such as the Lund-Mackay CT staging system, fail to capture the full experience of disease burden. Nor do objective measures necessarily correlate with patient symptoms, according to the otolaryngologist.
A low point in the field of sinus surgery, in Dr. Kingdom’s view, was the 2006 Cochrane systematic review which concluded ESS "has not been demonstrated to confer additional benefit to that obtained by medical therapy" (Cochrane Database Syst. Rev. 2006:CD004458).
"This review was a disservice," he asserted.
The review was based entirely on three older randomized trials, which not only did not use current treatment paradigms but also did not study the key research question, which Dr. Kingdom believes is this: What’s the comparative effectiveness of ESS vs. continued medical therapy in patients who’ve failed initial medical therapy?
He offered as an example of the contemporary approach to comparative outcomes research in the field of ESS a recent multicenter prospective study led by otolaryngologists at Oregon Health and Science University, Portland. It involved 1 year of prospective follow-up of patients with CRS who had failed initial medical therapy, at which point they elected to undergo ESS or further medical management.
The 65 patients who opted for ESS and the 50 whose chose more medical management were comparable in terms of baseline CRS severity and comorbidities. Both groups showed durable improvement at 12 months, compared with baseline. But ESS was the clear winner, with a mean 71% improvement in the validated Chronic Sinusitis Survey total score, compared with a 46% improvement in the medically managed group. Moreover, during the year of follow-up 17 patients switched over from medical management to ESS and they, too, showed significantly greater improvement than those who remained on medical management (Int. Forum Allergy Rhinol. 2013;3:236-41).
An earlier interim report featuring 6 months of followup showed the surgical group experienced roughly twofold greater improvement, compared with the medical cohort in endpoints including number of days on oral antibiotics or oral corticosteroids and missed days of work or school (Int. Forum Allergy Rhinol. 2011;1:235-41).
Cost-effectiveness studies by various research groups are in the pipeline. The early indication is that the data will show an economic advantage for ESS over medical therapy in patients with recalcitrant disease, according to Dr. Kingdom.
The next research frontier in surgical outcomes in CRS is identification of cellular and molecular markers of disease activity and their genetic underpinnings, which it’s hoped can be used to select the best candidates for ESS, he added.
Dr. Kingdom reported having no financial conflicts of interest.