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Original Article
November 2003

Methodologic Assessment of Studies on Endoscopic Sinus Surgery

Author Affiliations

From the Department of Otolaryngology–Head and Neck Surgery, Washington University School of Medicine, St Louis, Mo. The authors have no relevant financial interest in this article.

Arch Otolaryngol Head Neck Surg. 2003;129(11):1230-1235. doi:10.1001/archotol.129.11.1230

Background  Functional endoscopic sinus surgery (ESS) has become the procedure of choice for surgical treatment of chronic rhinosinusitis. Does the published literature support the claims of greater efficacy than medical treatment alone or older sinus procedures?

Objective  To analyze the methodology of the published literature regarding the efficacy of ESS.

Data Sources  MEDLINE search for primary studies published in 1987 through 2001, written in the English language, reporting results on more than 100 patients, using the MeSH (medical subject headings) terms sinusitis [subheadings surgery or therapy] and endoscopy.

Study Selection  Of 512 studies initially identified, 29 studies met the inclusion and exclusion criteria for further assessment of methodologic criteria. An additional 6 studies were found when the reference lists of reviews or included studies were searched.

Data Extraction  Articles were evaluated for 4 core (inclusion/exclusion criteria, control group, intervention, and clear outcome measure) methodologic criteria essential to the determination of efficacy of ESS. Eight additional methodologic criteria were also used to rate the articles.

Data Synthesis  Three studies met all 4 core methodologic criteria. Only 4 of 35 studies used a control group to evaluate efficacy of ESS to treat chronic sinusitis. Mean number of criteria met was 7.2, with a range of 2 to 11.

Conclusions  Absence of a control group is the most important reason that studies are unable to scientifically assess the comparative efficacy of ESS to medical therapy or other sinus procedures. The methodologic criteria described here can be used to evaluate studies of interventions for other disorders.