{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T16:40:26Z","timestamp":1792514426055,"version":"4.5.0"},"reference-count":21,"publisher":"SAGE Publications","issue":"5","license":[{"start":{"date-parts":[[2023,5,5]],"date-time":"2023-05-05T00:00:00Z","timestamp":1683244800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/501100000925","name":"National Health and Medical Research Council","doi-asserted-by":"publisher","award":["1049114"],"award-info":[{"award-number":["1049114"]}],"id":[{"id":"10.13039\/501100000925","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100012503","name":"Royal Hobart Hospital Research Foundation","doi-asserted-by":"publisher","award":["11-382"],"award-info":[{"award-number":["11-382"]}],"id":[{"id":"10.13039\/100012503","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Clinical Trials"],"published-print":{"date-parts":[[2023,10]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Blinding of treatment allocation from treating clinicians in neonatal randomised controlled trials can minimise performance bias, but its effectiveness is rarely assessed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>To examine the effectiveness of blinding a procedural intervention from treating clinicians in a multicentre randomised controlled trial of minimally invasive surfactant therapy versus sham treatment in preterm infants of gestation 25\u201328 weeks with respiratory distress syndrome. The intervention (minimally invasive surfactant therapy or sham) was performed behind a screen within the first 6 h of life by a \u2018study team\u2019 uninvolved in clinical care including decision-making. Procedure duration and the study team\u2019s words and actions during the sham treatment mimicked those of the minimally invasive surfactant therapy procedure. Post-intervention, three clinicians completed a questionnaire regarding perceived group allocation, with the responses matched against actual intervention and categorised as correct, incorrect, or unsure. Success of blinding was calculated using validated blinding indices applied to the data overall (James index, successful blinding defined as &gt; 0.50), or to the two treatment allocation groups (Bang index, successful blinding: \u22120.30 to 0.30). Blinding success was measured within staff role, and the associations between blinding success and procedural duration and oxygenation improvement post-procedure were estimated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>From 1345 questionnaires in relation to a procedural intervention in 485 participants, responses were categorised as correct in 441 (33%), incorrect in 142 (11%), and unsure in 762 (57%), with similar proportions for each of the response categories in the two treatment arms. The James index indicated successful blinding overall 0.67 (95% confidence interval (CI) 0.65\u20130.70). The Bang index was 0.28 (95% CI 0.23\u20130.32) in the minimally invasive surfactant therapy group and 0.17 (95% CI 0.12\u20130.21) in the sham arm. Neonatologists more frequently guessed the correct intervention (47%) than bedside nurses (36%), neonatal trainees (31%), and other nurses (24%). For the minimally invasive surfactant therapy intervention, the Bang index was linearly related to procedural duration and oxygenation improvement post-procedure. No evidence of such relationships was seen in the sham arm.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>Blinding of a procedural intervention from clinicians is both achievable and measurable in neonatal randomised controlled trials.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/17407745231171647","type":"journal-article","created":{"date-parts":[[2023,5,5]],"date-time":"2023-05-05T06:07:32Z","timestamp":1683266852000},"page":"479-485","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":9,"title":["Success of blinding a procedural intervention in a randomised controlled trial in preterm infants receiving respiratory support"],"prefix":"10.1177","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3115-6732","authenticated-orcid":false,"given":"Elizabeth","family":"Reid","sequence":"first","affiliation":[{"name":"Menzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Omar F","family":"Kamlin","sequence":"additional","affiliation":[{"name":"Newborn Research, Royal Women\u2019s Hospital, Melbourne, VIC, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesca","family":"Orsini","sequence":"additional","affiliation":[{"name":"Clinical Epidemiology & Biostatistics Unit, Murdoch Children\u2019s Research Institute, Parkville, VIC, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio G","family":"De Paoli","sequence":"additional","affiliation":[{"name":"Department of Paediatrics, Royal Hobart Hospital, Hobart, TAS, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Howard W","family":"Clark","sequence":"additional","affiliation":[{"name":"Department of Neonatal Research, University College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roger F","family":"Soll","sequence":"additional","affiliation":[{"name":"Pediatrics, The University of Vermont, Burlington, VT, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John B","family":"Carlin","sequence":"additional","affiliation":[{"name":"Clinical Epidemiology & Biostatistics Unit, Murdoch Children\u2019s Research Institute, Parkville, VIC, Australia"},{"name":"Department of Paediatrics, The University of Melbourne, Parkville, VIC, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter G","family":"Davis","sequence":"additional","affiliation":[{"name":"Newborn Research, Royal Women\u2019s Hospital, Melbourne, VIC, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter A","family":"Dargaville","sequence":"additional","affiliation":[{"name":"Menzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia"},{"name":"Department of Paediatrics, Royal Hobart Hospital, Hobart, TAS, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2023,5,5]]},"reference":[{"key":"bibr1-17407745231171647","doi-asserted-by":"publisher","DOI":"10.1093\/ije\/dym020"},{"key":"bibr2-17407745231171647","doi-asserted-by":"publisher","DOI":"10.3390\/medicina57070647"},{"key":"bibr3-17407745231171647","doi-asserted-by":"publisher","DOI":"10.3109\/10601331003777444"},{"key":"bibr4-17407745231171647","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-0528.2009.00494.x"},{"key":"bibr5-17407745231171647","doi-asserted-by":"publisher","DOI":"10.1159\/000497423"},{"key":"bibr6-17407745231171647","doi-asserted-by":"publisher","DOI":"10.1542\/peds.76.2.145"},{"key":"bibr7-17407745231171647","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2021.21892"},{"key":"bibr8-17407745231171647","volume":"5","author":"Abdel-Latif ME","year":"2021","journal-title":"Cochrane Database Syst Rev"},{"key":"bibr9-17407745231171647","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.0040061"},{"key":"bibr10-17407745231171647","doi-asserted-by":"publisher","DOI":"10.12688\/f1000research.12528.1"},{"key":"bibr11-17407745231171647","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2431-14-213"},{"key":"bibr12-17407745231171647","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-3476(05)80143-X"},{"key":"bibr13-17407745231171647","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-3476(05)81226-0"},{"key":"bibr14-17407745231171647","doi-asserted-by":"publisher","DOI":"10.1038\/sj.jp.7211381"},{"key":"bibr15-17407745231171647","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1097-0258(19960715)15:13<1421::AID-SIM266>3.0.CO;2-H"},{"key":"bibr16-17407745231171647","volume-title":"On the measurement of blinding in randomized, controlled trials","author":"Williamson CF","year":"2014"},{"key":"bibr17-17407745231171647","unstructured":"R Core Team. 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