{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T03:19:28Z","timestamp":1790047168440,"version":"4.0.1"},"reference-count":20,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2022,8,29]],"date-time":"2022-08-29T00:00:00Z","timestamp":1661731200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"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":"NIH","doi-asserted-by":"publisher","award":["UM1AI104681"],"award-info":[{"award-number":["UM1AI104681"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000060","name":"NIAID","doi-asserted-by":"publisher","award":["UM1AI104681"],"award-info":[{"award-number":["UM1AI104681"]}],"id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100006229","name":"Oak Ridge Institute for Science and Education","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006229","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000015","name":"US Department of Energy","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000015","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000038","name":"FDA","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000038","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,2,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Traditional end points used in registrational randomized, controlled trials (RCTs) often do not allow for complete interpretation of the full range of potential clinical outcomes. Desirability of outcome ranking (DOOR) is an approach to the design and analysis of clinical trials that incorporates benefits and risks of novel treatment strategies and provides a global assessment of patient experience.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Through a multidisciplinary committee of experts in infectious diseases, clinical trial design, drug regulation, and patient experience, we developed a DOOR end point for infectious disease syndromes and demonstrated how this could be applied to 3 registrational drug trials (ZEUS, APEKS-cUTI, and DORI-05) for complicated urinary tract infections (cUTIs). ZEUS compared fosfomycin to piperacillin\/tazobactam, APEKS-cUTI compared cefiderocol to imipenem, and DORI-05 compared doripenem to levofloxacin. Using DOOR, we estimated the probability of a more desirable outcome with each investigational antibacterial drug.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In each RCT, the DOOR distribution was similar and the probability that a patient in the investigational arm would have a more desirable outcome than a patient in the control arm had a 95% confidence interval containing 50%, indicating no significant difference between treatment arms. DOOR facilitated improved understanding of potential trade-offs between clinical efficacy and safety. Partial credit and subgroup analyses also highlight unique attributes of DOOR.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>DOOR can effectively be used in registrational cUTI trials. The DOOR end point presented here can be adapted for other infectious disease syndromes and prospectively incorporated into future clinical trials.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/cid\/ciac692","type":"journal-article","created":{"date-parts":[[2022,8,28]],"date-time":"2022-08-28T21:48:20Z","timestamp":1661723300000},"page":"e1157-e1165","source":"Crossref","is-referenced-by-count":42,"title":["Improving Traditional Registrational Trial End Points: Development and Application of a Desirability of Outcome Ranking End Point for Complicated Urinary Tract Infection Clinical Trials"],"prefix":"10.1093","volume":"76","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9924-0458","authenticated-orcid":false,"given":"Jessica","family":"Howard-Anderson","sequence":"first","affiliation":[{"name":"Department of Medicine, Division of Infectious Diseases, Emory University School of Medicine , Atlanta, Georgia , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshimitsu","family":"Hamasaki","sequence":"additional","affiliation":[{"name":"Biostatistics Center and Department of Biostatics and Bioinformatics, Milken Institute School of Public Health, George Washington University , Washington, DC , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Weixiao","family":"Dai","sequence":"additional","affiliation":[{"name":"Biostatistics Center and Department of Biostatics and Bioinformatics, Milken Institute School of Public Health, George Washington University , Washington, DC , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deborah","family":"Collyar","sequence":"additional","affiliation":[{"name":"Patient Advocates in Research , Danville, California , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Rubin","sequence":"additional","affiliation":[{"name":"Center for Drug Evaluation and Research, US Food and Drug Administration , Silver Spring, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sumathi","family":"Nambiar","sequence":"additional","affiliation":[{"name":"Johnson & Johnson , Raritan, New Jersey , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tori","family":"Kinamon","sequence":"additional","affiliation":[{"name":"Center for Drug Evaluation and Research, US Food and Drug Administration , Silver Spring, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carol","family":"Hill","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute , Durham, North Carolina , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven P","family":"Gelone","sequence":"additional","affiliation":[{"name":"Nabriva Therapeutics US, Inc , Fort Washington, Pennsylvania , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Mariano","sequence":"additional","affiliation":[{"name":"Nabriva Therapeutics US, Inc , Fort Washington, Pennsylvania , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takamichi","family":"Baba","sequence":"additional","affiliation":[{"name":"Biostatistics Center, Shionogi & Co, Ltd , Osaka , Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas L","family":"Holland","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute , Durham, North Carolina , USA"},{"name":"Department of Medicine, Duke University Medical Center , Durham, North Carolina , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah B","family":"Doernberg","sequence":"additional","affiliation":[{"name":"Department of Medicine, Division of Infectious Diseases, University of California , San Francisco, California , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Henry F","family":"Chambers","sequence":"additional","affiliation":[{"name":"Department of Medicine, Division of Infectious Diseases, University of California , San Francisco, California , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"Jr","given":"Vance G","family":"Fowler","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute , Durham, North Carolina , USA"},{"name":"Department of Medicine, Duke University Medical Center , Durham, North Carolina , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott R","family":"Evans","sequence":"additional","affiliation":[{"name":"Biostatistics Center and Department of Biostatics and Bioinformatics, Milken Institute School of Public Health, George Washington University , Washington, DC , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helen W","family":"Boucher","sequence":"additional","affiliation":[{"name":"Tufts University School of Medicine and Division of Geographic Medicine and Infectious Diseases, Tufts Medical Center , Boston, Massachusetts , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2022,8,29]]},"reference":[{"key":"2023082904320304200_ciac692-B1","doi-asserted-by":"crossref","first-page":"e420","DOI":"10.1093\/cid\/ciaa092","article-title":"Antibiotic development incentives that reflect societal value of antibiotics","volume":"72","author":"Boucher","year":"2021","journal-title":"Clin Infect Dis"},{"key":"2023082904320304200_ciac692-B2","doi-asserted-by":"crossref","first-page":"267","DOI":"10.1038\/s41579-019-0293-3","article-title":"Antibiotic development","volume":"18","author":"\u00c5rdal","year":"2020","journal-title":"Nat Rev 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