{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,12]],"date-time":"2026-09-12T04:06:43Z","timestamp":1789186003772,"version":"build-2803163510"},"reference-count":46,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T00:00:00Z","timestamp":1777420800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T00:00:00Z","timestamp":1777420800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Laryngoscope"],"published-print":{"date-parts":[[2026,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To assess the statistical fragility of randomized controlled trials (RCTs) evaluating high\u2010volume saline nasal irrigation (SNI) for rhinosinusitis using fragility analysis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data Sources<\/jats:title>\n                    <jats:p>PubMed, MEDLINE, and Embase were searched for RCTs published between May 1976 and January 2026.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Review Methods<\/jats:title>\n                    <jats:p>This study was reported as per PRISMA guidelines. RCTs that compared high\u2010volume SNI to non\u2010irrigation standard care for acute, recurrent, or chronic rhinosinusitis, and reported \u2265\u20091 dichotomous outcome, were included. Fragility index (FI), the minimum number of event reversals needed to alter statistical significance, and fragility quotient (FQ), FI normalized to sample size, were calculated for statistically significant dichotomous outcomes. Reverse FI (rFI) and reverse FQ (rFQ) were calculated for non\u2010significant outcomes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Eight RCTs were included, yielding 38 dichotomous outcomes. Eight outcomes (21.1%) were statistically significant. The overall combined median FI was 5 (FQ 0.062), with similar FI values between significant and non\u2010significant outcomes. In over one\u2010fifth of outcomes, loss to follow\u2010up exceeded FI. Analysis of principal dichotomous outcomes from studies demonstrated a median FI of 6 (FQ 0.092), with five of eight (62.5%) outcomes non\u2010significant.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>RCTs evaluating SNI for rhinosinusitis exhibit moderate\u2010to\u2010high statistical fragility, with small outcome changes capable of reversing study conclusions. Because fragility analysis was limited to dichotomous outcomes while many primary endpoints were continuous, our findings should be interpreted as complementary rather than comprehensive appraisals of RCTs. Future RCTs with larger sample sizes, reduced bias, and pre\u2010specified fragility considerations are needed to better define the clinical role of SNI.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/lary.70601","type":"journal-article","created":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T11:55:57Z","timestamp":1777463757000},"page":"4117-4129","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["The Statistical Fragility of Saline Nasal Irrigation for Rhinosinusitis: A Systematic Review"],"prefix":"10.1002","volume":"136","author":[{"given":"Ronit","family":"Sethi","sequence":"first","affiliation":[{"name":"Department of Otolaryngology\u2010Head and Neck Surgery Icahn School of Medicine at Mount Sinai  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kaan","family":"Oral","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology\u2010Head 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