{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T03:19:38Z","timestamp":1790047178915,"version":"4.0.1"},"reference-count":27,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2026,6,22]],"date-time":"2026-06-22T00:00:00Z","timestamp":1782086400000},"content-version":"vor","delay-in-days":21,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["UM1AI104681"],"award-info":[{"award-number":["UM1AI104681"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,6,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Desirability of outcome ranking (DOOR), a paradigm for the design, analysis, and interpretation of clinical trials based on patient-centered benefit-risk evaluation, could help inform drug development for acute bacterial skin and skin structure infections (ABSSSIs).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Method<\/jats:title>\n                    <jats:p>A multidisciplinary committee created an infectious diseases DOOR endpoint, incorporating clinical response, infectious complications, serious adverse events, and mortality, and adapted this for ABSSSI. We retrospectively applied DOOR to 2 previous ABSSSI randomized controlled registrational trials (OASIS-1 and OASIS-2), both comparing omadacycline with linezolid. We evaluated the DOOR distribution and estimated the probability of having a more desirable outcome with omadacycline compared with linezolid. For OASIS-2, we used the 36-Item Short Form Health Survey Version 2 (SF-36v2) scores as a \u201ctiebreaker\u201d for participants who would otherwise have the same DOOR outcome. We performed DOOR component, partial credit, and subgroup analyses.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The ABSSSI DOOR demonstrated similar overall clinical outcomes between treatment arms for OASIS-1 and OASIS-2. The probability of a more desirable outcome for a participant treated with omadacycline, compared with linezolid, was 50.6% (95% confidence interval [CI], 47.4%\u201353.7%) and 52.1% (95% CI, 49.2%\u201355.0%) in OASIS-1 and OASIS-2, respectively. In OASIS-2, applying a health-related quality-of-life score as a tiebreaker did not significantly change the DOOR probability. Partial credit and subgroup analyses demonstrated similar overall results.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>DOOR may provide additional perspective on benefit versus risk in individual patients in ABSSSI trials. Future trials using DOOR prospectively will continue inform how to incorporate patient-centered outcomes in ABSSSI trials.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ofid\/ofag320","type":"journal-article","created":{"date-parts":[[2026,5,30]],"date-time":"2026-05-30T11:41:17Z","timestamp":1780141277000},"source":"Crossref","is-referenced-by-count":2,"title":["Development and Application of a Desirability of Outcome Ranking (DOOR) Endpoint for Acute Bacterial Skin and Skin Structure Infections"],"prefix":"10.1093","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9924-0458","authenticated-orcid":false,"given":"Jessica","family":"Howard-Anderson","sequence":"first","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine , Atlanta, Georgia 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,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9458-4331","authenticated-orcid":false,"given":"Sara E","family":"Cosgrove","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine , Baltimore, Maryland ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah B","family":"Doernberg","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, University of California School of Medicine , SanFrancisco, California ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Holly","family":"Geres","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute, Duke University School of Medicine , Durham, North Carolina ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ramya","family":"Gopinath","sequence":"additional","affiliation":[{"name":"Center for Drug Evaluation and Research, United States Food and Drug Administration , Washington, D.C. ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas L","family":"Holland","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute, Duke University School of Medicine , Durham, North Carolina ,","place":["USA"]},{"name":"Division of Infectious Diseases, Department of Medicine, Duke University School of Medicine , Durham, North Carolina ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heather A","family":"King","sequence":"additional","affiliation":[{"name":"Division of Internal Medicine, Department of Medicine, Duke University School of Medicine , Durham, North Carolina ,","place":["USA"]},{"name":"Department of Population Health Sciences, Duke University School of Medicine , Durham, North Carolina ,","place":["USA"]},{"name":"Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham Veterans Affairs Health Care System , Durham, North Carolina ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sumathi","family":"Nambiar","sequence":"additional","affiliation":[{"name":"Johnson & Johnson , Raritan, New Jersey ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Rubin","sequence":"additional","affiliation":[{"name":"Center for Drug Evaluation and Research, United States Food and Drug Administration , Washington, D.C. ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5317-4491","authenticated-orcid":false,"given":"Henry F","family":"Chambers","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, University of California School of Medicine , SanFrancisco, California ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vance G","family":"Fowler","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute, Duke University School of Medicine , Durham, North Carolina ,","place":["USA"]},{"name":"Division of Infectious Diseases, Department of Medicine, Duke University School of Medicine , Durham, North Carolina ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3186-172X","authenticated-orcid":false,"given":"Scott R","family":"Evans","sequence":"additional","affiliation":[{"name":"The Biostatistics Center and Department of Biostatics and Bioinformatics, Milken Institute School of Public Health, George Washington University , Washington, D.C. ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helen 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