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IV Methods IV.A Topic Development

a standardized table format and the quality of each study was evaluated to receive a level based on the Oxford levels of evidence (from level 1 to 5, Table IV-1). 139 Adjustments were made to the level of evidence due to the quality of each study based on accepted standards and changes were made transparent in the text of the section and/or the evi dence summary table. 140 At the completion of the system atic review and research quality evaluation for each clin ical topic, an aggregate grade of evidence was produced for the topic based on the guidelines from the American Academy of Pediatrics (AAP) Steering Committee on Qual ity Improvement and Management (Table IV-2). 141 For topics with more limited evidence, the EBR process was completed with the evidence table. For those topics with sufficient evidence to produce a recommendation (ie, an EBRR), a recommendation using the AAP guidelines was produced. It is important to note that each evidence based recommendation took into account the aggregate grade of evidence along with the balance of benefit, harm, andcosts (Table IV-3). Determination of LOE for an individual publication is not always straightforward. In certain cases, individual studies do not fit neatly into one of the Oxford LOE cat egories. Oxford LOE grading has also changed over time, which adds complexity to evidence grading. This issue is more complicated for certain documents that employ advanced evidence searches and systematic literature eval uation to create recommendations, practice parameters, and guidelines (eg, Clinical Practice Guidelines, ICAR, EPOS, etc). For such publications, even methodological experts may disagree on evidence levels – some seeing these documents as systematic reviews with higher evi dence levels, and others seeing them as consensus state ments/expert opinion or guidelines and assign lower evi dence levels. Moreover, these large reviews assess difer ent levels of evidence for different subsections. As a result, when these large reviews are cited for particular sub jects, they may be graded as different LOEs. In ICAR-RS 2021, we have honored the author/reviewer LOE grading for each individual topic in order to remain true to the ICAR methodology. Therefore, the reader may notice some fluctuation in LOE for certain frequently-cited documents throughout the ICAR text, depending on the individual topic area. Following the development of the initial topic LR, EBR, or EBRR, the manuscript underwent a 2-stage online itera tive review process using 2 blinded independent reviewers. The purpose of these steps was to evaluate the complete ness of the identified literature and ensure any recommen dations were appropriate. Following the first review, the reviewer was unblinded and any necessary changes were agreed upon by both reviewer and initial authors. The topic

The methodology for this consensus statement largely fol lowed that of the ICAR-RS-2016 document. The ICAR doc uments are developed and written so as to have the maxi mal reliance on published evidence and minimal impact from expert opinion and other biases. To this end the method of writing an evidence-based review with recom mendations which was described by Rudmik and Smith in 2011 has been adapted. 4 The subject of RS was initially divided into over 180 topics, more than 40 more topics than ICAR-RS-2016, reflecting the growth of evidence in the field of RS. Each topic was then assigned to a senior author who is a recognized expert in the field of rhinology, and specifically in RS. Some topics had significant evidence but did not lend themselves to providing a recommenda tion, such as those addressing diagnosis and pathogenesis, and these were assigned as evidence-based reviews (EBRs) without recommendations. Other topics had sufficient evi dence for not only a systematic review but also for the creation of recommendations based on the evidence and were assigned as EBRs with recommendations (EBRRs). A few of the topics had little significant evidence and were assigned as literature reviews. For topics included in ICAR RS-2016, authors were asked to update the content and rec ommendations based on evidence published since ICAR RS-2016. To provide the content for each topic, a system atic review of the literature for each topic using Ovid MEDLINE R (1947-July 2019), EMBASE (1974- July 2019) and Cochrane Review databases was performed using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) standardized guidelines. 138 The search began by identifying any previously published sys tematic reviews or guidelines pertaining to the assigned topic. Since clinical recommendations are best supported by randomized controlled trials (RCTs), the search focused on identifying these studies to provide the strongest level of evidence (LOE). Reference lists of all identified stud ies were examined to ensure all relevant studies were cap tured. If the authors felt as though a non-English study should be included in the review, the article was appro priately translated to minimize the risk of missing impor tant data during the development of recommendations. 138 In some more rapidly evolving topics, additional studies were included after the July 2019 searches where they sig nificantly affected the understanding on the topic and/or impacted recommendations. To ensure complete transparency of the evidence in EBR and EBRR sections, all included studies were presented in