Methodologic assessment of studies on endoscopic sinus surgery.
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.


METHODS
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.


METHODS
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.


METHODS
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.


RESULTS
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.
Lieu
Judith E Cho
JE
Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine, St Louis, MO 63110, USA. lieuj@msnotes.wustl.edu
Piccirillo
Jay F
JF
D015897:Comorbidity; D004724:Endoscopy; D006801:Humans; D012107:Research Design; D012220:Rhinitis / Q000453:epidemiology / Q000601:surgery*; D012852:Sinusitis / Q000453:epidemiology / Q000601:surgery*; D016896:Treatment Outcome