{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T03:19:41Z","timestamp":1790047181221,"version":"4.0.1"},"reference-count":19,"publisher":"Oxford University Press (OUP)","issue":"1","funder":[{"DOI":"10.13039\/100000038","name":"FDA","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000038","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000060","name":"NIAID","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","id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Antibacterial Resistance Leadership Group"},{"name":"ARLG)"},{"DOI":"10.13039\/501100009930","name":"Basilea Pharmaceutica","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100009930","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,7,19]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Desirability of outcome ranking (DOOR) is an innovative approach to clinical trial design and analysis that uses an ordinal ranking system to incorporate the overall risks and benefits of a therapeutic intervention into a single measurement. Here we derived and evaluated a disease-specific DOOR endpoint for registrational trials for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP\/VABP).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Through comprehensive examination of data from nearly 4000 participants enrolled in six registrational trials for HABP\/VABP submitted to the Food and Drug Administration (FDA) between 2005 and 2022, we derived and applied a HABP\/VABP specific endpoint. We estimated the probability that a participant assigned to the study treatment arm would have a more favorable overall DOOR or component outcome than a participant assigned to comparator.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>DOOR distributions between treatment arms were similar in all trials. DOOR probability estimates ranged from 48.3% to 52.9% and were not statistically different. There were no significant differences between treatment arms in the component analyses. Although infectious complications and serious adverse events occurred more frequently in ventilated participants compared to non-ventilated participants, the types of events were similar.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Through a data-driven approach, we constructed and applied a potential DOOR endpoint for HABP\/VABP trials. The inclusion of syndrome-specific events may help to better delineate and evaluate participant experiences and outcomes in future HABP\/VABP trials and could help inform data collection and trial design.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/cid\/ciae163","type":"journal-article","created":{"date-parts":[[2024,3,25]],"date-time":"2024-03-25T02:54:57Z","timestamp":1711335297000},"page":"60-69","source":"Crossref","is-referenced-by-count":6,"title":["Exploration of a Potential DOOR Endpoint for Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Using Six Registrational Trials for Antibacterial Drugs"],"prefix":"10.1093","volume":"79","author":[{"given":"Tori","family":"Kinamon","sequence":"first","affiliation":[{"name":"Center for Drug Evaluation and Research, US Food and Drug Administration , Silver Spring, Maryland , USA"},{"name":"Department of Medicine, Duke University Medical Center , Durham, North Carolina , USA"},{"name":"Oak Ridge Institute for Science and Education, United States Department of Energy , Oak Ridge, Tennessee , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4517-6790","authenticated-orcid":false,"given":"Ursula","family":"Waack","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":"Mark","family":"Needles","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":"Daniel","family":"Rubin","sequence":"additional","affiliation":[{"name":"Center for Drug Evaluation and Research, US Food and Drug Administration , Silver Spring, Maryland , 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Durham, North Carolina , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshimitsu","family":"Hamasaki","sequence":"additional","affiliation":[{"name":"Biostatistics Center and Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, George Washington University , Washington D.C. , USA"},{"name":"Antibacterial Resistance Leadership Group , Durham, North Carolina , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas L","family":"Holland","sequence":"additional","affiliation":[{"name":"Department of Medicine, Duke University Medical Center , Durham, North Carolina , USA"},{"name":"Duke Clinical Research Institute , Durham, North Carolina , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessica","family":"Howard-Anderson","sequence":"additional","affiliation":[{"name":"Antibacterial Resistance Leadership Group , Durham, North Carolina , USA"},{"name":"Department of Medicine, Division of Infectious Diseases, Emory University School of Medicine , Atlanta, Georgia , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Henry","family":"Chambers","sequence":"additional","affiliation":[{"name":"Department of Medicine, Division of Infectious Diseases, University of California San Francisco , San Francisco, California , USA"},{"name":"Antibacterial Resistance Leadership Group , Durham, North Carolina , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"Jr.","given":"Vance G","family":"Fowler","sequence":"additional","affiliation":[{"name":"Department of Medicine, Duke University Medical Center , Durham, North Carolina , USA"},{"name":"Antibacterial Resistance Leadership Group , Durham, North Carolina , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sumati","family":"Nambiar","sequence":"additional","affiliation":[{"name":"Antibacterial Resistance Leadership Group , Durham, North Carolina , USA"},{"name":"Johnson and 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