xRead - Olfactory Disorders (September 2023)

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INTERNATIONAL CONSENSUS ON OLFACTION

TABLE II.A.1 Levels of evidence

Therapy/prevention/ Etiology

Level

Diagnosis

1

Systematic review of cross-sectional studies with consistently applied reference standards and blinding Individual cross-sectional studies with consistently applied reference standards and blinding Cohort study or control arm of randomized trial a

Systematic review of randomized trials or n-of-1 trials Randomized trial or observational study with dramatic effect

2

3

Nonrandomized controlled cohort/follow-up study b

4

Case series or case-control studies, or poor-quality prognostic cohort study b

Case series or case-control studies, or historically controlled studies b

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

B Iterative Review Each topic was written with appropriate tables and poten tial recommendations by the initial author assigned. Each section then underwent an online iterative review pro cess using two independent reviewers (Figure II.A-2). Each iterative reviewer evaluated the completeness of the identi fied literature and evaluated whether EBRRs were appro priate. If any content changes were suggested by the first iterative reviewer, these were sent back to the initial author to revise the section until all changes were agreed on by the initial author and the first reviewer. The revised topic was then subsequently reviewed by a second reviewer. Both initial and first and second iterative authors of the topic agreed on all changes before each section was allowed to proceed into the final ICAR statement stage. 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, and costs (Table II.A-3). C ICAR:O Statement After the review and completion of all topic sections, the principal editor (Z.M.P.) compiled them into one ICAR:O statement. This draft document was then reviewed by all contributing authors who submitted suggestions and edits. Once consensus among all authors had been reached regarding the literature and final recommendations, the final ICAR:O article was produced.

TABLE II.A.2 Aggregate grade of evidence Grade Research quality A Well-designed RCTs B RCTs with minor limitations

Overwhelming consistent evidence from observational studies C Observational studies (case-control and cohort design) D Expert opinion Case reports Reasoning from first principles RCT = randomized controlled trial. time of the writing and editing of this document, and we felt it would do the readership a disservice if we left out pertinent information that was only realized after the liter ature search window had closed. To optimize transparency of the evidence, all included studies in EBR and EBRR topic sections are presented in a standardized table format and the quality of each study was evaluated to receive a level based on the Oxford Levels of Evidence (Level 1a to 5) (Table II.A-1). 9 At the completion of the systematic review and research quality evaluation for each clinical topic, an aggregate grade of evidence was produced for the topic based on the guidelines from the American Academy of Pediatrics (AAP) Steering Commit tee on Quality Improvement and Management (SCQIM) 10 (Table II.A-2). After providing an aggregate grade of evi dence for each EBRR topic (A to D), a recommenda tion using the AAP SCQIM guidelines was produced (Table II.A-3). The recommendation was based on the aggregate grade of evidence as well as the balance of bene fit, harm, and costs. A summary of the EBRR development process is provided in Figure II.A-1.