{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,5]],"date-time":"2026-09-05T22:23:28Z","timestamp":1788647008274,"version":"build-2803163510"},"reference-count":28,"publisher":"Oxford University Press (OUP)","issue":"7","license":[{"start":{"date-parts":[[2023,5,27]],"date-time":"2023-05-27T00:00:00Z","timestamp":1685145600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,10,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>It is unclear whether the reporting quality of antiretroviral (ARV) noninferiority (NI) randomized controlled trials (RCTs) has improved since the CONSORT guideline release in 2006. The primary objective of this systematic review was assessing the methodological and reporting quality of ARV NI-RCTs. We also assessed reporting quality by funding source and publication year.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>We searched Medline, Embase, and Cochrane Central from inception to 14 November 2022. We included NI-RCTs comparing \u22652 ARV regimens used for human immunodeficiency virus treatment or prophylaxis. We used the Cochrane Risk of Bias 2.0 tool to assess risk of bias. Screening and data extraction were performed blinded and in duplicate. Descriptive statistics were used to summarize data; statistical tests were 2 sided, with significance defined as P &amp;lt; .05. The systematic review was prospectively registered (PROSPERO CRD42022328586), and not funded.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>We included 160 articles reporting 171 trials. Of these articles, 101 (63.1%) did not justify the NI margin used, and 28 (17.5%) did not provide sufficient information for sample size calculation. Eighty-nine of 160 (55.6%) reported both intention-to-treat and per-protocol analyses, while 118 (73.8%) described missing data handling. Ten of 171 trials (5.9%) reported potentially misleading results. Pharmaceutical industry\u2013funded trials were more likely to be double-blinded (28.1% vs 10.3%; P = .03) and to describe missing data handling (78.5% vs 59.0%; P = .02). The overall risk of bias was low in 96 of 160 studies (60.0%).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>ARV NI-RCTs should improve NI margin justification, reporting of intention-to-treat and per-protocol analyses, and missing data handling to increase CONSORT adherence.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/cid\/ciad308","type":"journal-article","created":{"date-parts":[[2023,5,27]],"date-time":"2023-05-27T06:52:35Z","timestamp":1685170355000},"page":"1023-1031","source":"Crossref","is-referenced-by-count":6,"title":["Methodological and Reporting Quality of Noninferiority Randomized Controlled Trials Comparing Antiretroviral Therapies: A Systematic Review"],"prefix":"10.1093","volume":"77","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1620-2868","authenticated-orcid":false,"given":"Carson K L","family":"Lo","sequence":"first","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, McMaster University , Hamilton, Ontario , Canada"},{"name":"Transplant Infectious Diseases and Ajmera Transplant Centre, University Health Network, University of Toronto , Toronto, Ontario , Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2101-7701","authenticated-orcid":false,"given":"Adam S","family":"Komorowski","sequence":"additional","affiliation":[{"name":"Division of Medical Microbiology, Department of Pathology and Molecular Medicine, McMaster University , Hamilton, Ontario , Canada"},{"name":"Department of Health Research Methodology, Evidence, and Impact, Faculty of Health Sciences, McMaster University , Hamilton, Ontario , Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4623-3534","authenticated-orcid":false,"given":"Clayton 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Department of Medicine, McMaster University , Hamilton, Ontario , Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marie-\u00c8ve","family":"Benoit","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, McMaster University , Hamilton, Ontario , Canada"},{"name":"Division of Medical Microbiology, Department of Pathology and Molecular Medicine, McMaster University , Hamilton, Ontario , Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7634-6484","authenticated-orcid":false,"given":"D Brody","family":"Duncan","sequence":"additional","affiliation":[{"name":"Division of Medical Microbiology, Department of Pathology and Molecular Medicine, McMaster University , Hamilton, Ontario , Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charlotte A","family":"Fuller","sequence":"additional","affiliation":[{"name":"Division of Medical Microbiology, 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DeGroote School of Medicine, Faculty of Health Sciences, McMaster University , Hamilton, Ontario , Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fiona","family":"Smaill","sequence":"additional","affiliation":[{"name":"Division of Medical Microbiology, Department of Pathology and Molecular Medicine, McMaster University , Hamilton, Ontario , Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6078-5984","authenticated-orcid":false,"given":"Andrew K","family":"Kapoor","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, McMaster University , Hamilton, Ontario , Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1655-3761","authenticated-orcid":false,"given":"Marek","family":"Smieja","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, McMaster University , 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