{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,10,8]],"date-time":"2024-10-08T04:15:07Z","timestamp":1728360907924},"reference-count":10,"publisher":"Aerospace Medical Association","issue":"2","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["aerosp med hum perform"],"published-print":{"date-parts":[[2021,2,1]]},"abstract":"<jats:p><jats:bold>INTRODUCTION:<\/jats:bold> Noninferiority or equivalence testing are often used when comparing a novel pharmaceutical, operation, or procedure to the current standard designated as safe. Noninferiority and equivalence testing require estimates of a metric called delta: the margin of meaningful\n difference. Inappropriate delta margins can lead to invalid conclusions, thereby creating uncertainty about a studys scientific credibility. We recommend that a working group be convened with the following goals: 1) to evaluate delta values currently in use in aviation; 2) to determine if\n it is possible to develop a systematic, evidence-based, and replicable process to derive delta values based on statistical properties from population data, rather than a mixture of evidence- and opinion-based processes; and 3) based on the findings of the second goal, update the current delta\n values in use in aviation. This working group should include, at a minimum, government agencies and other key stakeholders using these values within operational settings.<jats:bold>Lamp ACM, Rempe MJ, Belenky GL. <jats:italic>Delta: the value that matters in fatigue risk management<\/jats:italic>. Aerosp Med Hum Perform.\n 2021; 92(2):127128.<\/jats:bold><\/jats:p>","DOI":"10.3357\/amhp.5768.2021","type":"journal-article","created":{"date-parts":[[2021,1,20]],"date-time":"2021-01-20T05:18:19Z","timestamp":1611119899000},"page":"127-128","source":"Crossref","is-referenced-by-count":0,"title":["Delta: The Value That Matters in Fatigue Risk Management"],"prefix":"10.3357","volume":"92","author":[{"given":"Amanda C. M.","family":"Lamp","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael J.","family":"Rempe","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gregory L.","family":"Belenky","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1911","reference":[{"issue":"10","key":"bib1","doi-asserted-by":"crossref","first-page":"915","DOI":"10.1056\/NEJMoa1810641","article-title":"Sleep and alertness in a duty-hour flexibility trial in internal medicine","volume":"380","author":"Basner","year":"2019","journal-title":"N Engl J Med."},{"issue":"5","key":"bib2","doi-asserted-by":"crossref","first-page":"433","DOI":"10.1002\/jts.20367","article-title":"Noninferiority and equivalence designs: issues and implications for mental health research","volume":"21","author":"Greene","year":"2008","journal-title":"J Trauma Stress."},{"issue":"4","key":"bib3","doi-asserted-by":"crossref","first-page":"371","DOI":"10.4103\/0253-7613.83103","article-title":"Non-inferiority clinical trials: practical issues and current regulatory perspective","volume":"43","author":"Gupta","year":"2011","journal-title":"Indian J Pharmacol."},{"key":"bib4","doi-asserted-by":"crossref","first-page":"184","DOI":"10.1016\/j.aap.2018.01.020","article-title":"Equal to or better than: the application of statistical non-inferiority to fatigue risk management","volume":"126","author":"Lamp","year":"2019","journal-title":"Accid Anal Prev."},{"issue":"3","key":"bib5","doi-asserted-by":"crossref","first-page":"678","DOI":"10.1213\/ANE.0b013e318206f872","article-title":"Equivalence and noninferiority testing in regression models and repeated-measures designs","volume":"112","author":"Mascha","year":"2011","journal-title":"Anesth Analg."},{"issue":"24","key":"bib6","doi-asserted-by":"crossref","first-page":"2594","DOI":"10.1001\/jama.2012.87802","article-title":"CONSORT Group. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement","volume":"308","author":"Piaggio","year":"2012","journal-title":"JAMA."},{"key":"bib7","article-title":"Non-inferiority clinical trials to establish effectiveness"},{"issue":"2","key":"bib8","doi-asserted-by":"crossref","first-page":"192","DOI":"10.1007\/s11606-010-1513-8","article-title":"Understanding equivalence and noninferiority testing","volume":"26","author":"Walker","year":"2011","journal-title":"J Gen Intern Med."},{"issue":"1","key":"bib9","doi-asserted-by":"crossref","first-page":"2","DOI":"10.1016\/S0197-2456(01)00196-9","article-title":"Choosing an equivalence limit for noninferiority or equivalence studies","volume":"23","author":"Wiens","year":"2002","journal-title":"Control Clin Trials."},{"issue":"4","key":"bib10","doi-asserted-by":"crossref","first-page":"383","DOI":"10.3357\/AMHP.4790.2018","article-title":"Equivalence testing as a tool for fatigue risk management in aviation","volume":"89","author":"Wu","year":"2018","journal-title":"Aerosp Med Hum Perform."}],"container-title":["Aerospace Medicine and Human Performance"],"original-title":[],"link":[{"URL":"https:\/\/asma.kglmeridian.com\/view\/journals\/amhp\/92\/2\/article-p127.xml","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/asma.kglmeridian.com\/downloadpdf\/journals\/amhp\/92\/2\/article-p127.xml","content-type":"text\/html","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/asma.kglmeridian.com\/downloadpdf\/journals\/amhp\/92\/2\/article-p127.xml","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,10,7]],"date-time":"2024-10-07T12:22:06Z","timestamp":1728303726000},"score":1,"resource":{"primary":{"URL":"https:\/\/asma.kglmeridian.com\/view\/journals\/amhp\/92\/2\/article-p127.xml"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,2,1]]},"references-count":10,"journal-issue":{"issue":"2"},"URL":"https:\/\/doi.org\/10.3357\/amhp.5768.2021","relation":{},"ISSN":["2375-6314","2375-6322"],"issn-type":[{"type":"print","value":"2375-6314"},{"type":"electronic","value":"2375-6322"}],"subject":[],"published":{"date-parts":[[2021,2,1]]}}}