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International consensus statement on rhinosinusitis

TABLE IV-1 Levels of evidence Level Diagnosis

Therapy/Prevention/Etiology

1

Systematic review of cross sectional studies with consistently applied reference standard and blinding Individual cross sectional studies with consistently applied reference standard and blinding Cohort study or control arm of randomized trial* Case-series or case control studies, or poor quality prognostic cohort study**

Systematic review of randomized trials or n -of-1 trials

2

Randomized trial or observational study with dramatic effect Non-randomized controlled cohort/follow-up study** Case-series, case-control studies, or historically controlled studies**

3 4

5 Mechanism-based reasoning *Level may be graded down on the basis of study design, inconsistency between studies, indirectness of evidence, imprecision, or because the absolute effect size is very small; level may be graded up if there is a large or very large effect size or if a significant dose-response relationship is demonstrated. **As always, a systematic review is generally better than an individual study. Not applicable

TABLE IV-2 Aggregate grade of evidence Grade

Research Quality Well-designed RCTs

A B

RCTs with minor limitations Overwhelming consistent evidence from observational studies Observational studies (case control and cohort design)

C D

Expert opinion Case reports Reasoning from first principles

V Definitions V.A Acute Rhinosinusitis (ARS)

content was then reviewed by a second blinded reviewer and changes were agreed upon by the initial authors and all reviewers.

The definition of acute rhinosinusitis (ARS) is based on expert opinion and consensus. There has been no significant change to this definition in the recent literature. 1 ARS is defined as sinonasal inflammation lasting less than 4 weeks associated with the sudden onset of symptoms. 31,88,142,143 Symptoms must include purulent nasal drainage (anterior/posterior) and nasal blockage/obstruction/congestion or facial pain/pressure or both. 31,88,142

IV.B ICAR-RS Statement Development Following the completion of all topics, the principal editors (RRO, TTK, and TLS) compiled them into one ICAR-RS statement. This draft document was then reviewed by all contributing authors. The final ICAR-RS manuscript was produced once consensus was reached among all authors regarding the literature and final recommendations.

TABLE IV-3 AAP defined strategy for recommendation development 141

Preponderance of Benefit overHarm Strong Recommendation

Preponderance of Harm over Benefit Strong Recommendation Against

Evidence Quality

Balance of Benefit and Harm

A. Well-designed RCT’s

Option

B. RCT’s with minor limitations; Overwhelmingly consistent evidence from observational studies C. Observational studies (case control and cohort design)

Recommendation

Recommendation Against

D. Expert opinion, Case reports, Reasoning from first principles

Option

No Recommendation