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This article systematically addresses the concept of clinical equipoise specific to the role of HBOT in NSTI, and presents a series of considerations to be taken into account by key stakeholders at potential participating sites.<\/jats:p>","DOI":"10.28920\/dhm54.1.57-60","type":"journal-article","created":{"date-parts":[[2024,3,21]],"date-time":"2024-03-21T02:17:02Z","timestamp":1710987422000},"page":"57-60","source":"Crossref","is-referenced-by-count":1,"title":["Equipoise: an important ethical consideration when contemplating participation in a randomised controlled trial of hyperbaric oxygen treatment in necrotising soft tissue infections"],"prefix":"10.28920","volume":"54","author":[{"name":"Emergency and Trauma Centre, Alfred Health, Melbourne, Australia","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6521-418X","authenticated-orcid":false,"given":"Bridget","family":"Devaney","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"Department of Intensive Care and Hyperbaric Medicine, Alfred Health, Melbourne, Australia","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"Department of Epidemiology and Preventative Medicine, Monash University, Melbourne, Australia","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"11463","published-online":{"date-parts":[[2024,3,31]]},"reference":[{"key":"ref0","doi-asserted-by":"publisher","unstructured":"1.Devaney B, Frawley G, Frawley L, Pilcher DV. Necrotising soft tissue infections: the effect of hyperbaric oxygen on mortality. Anaesth Intensive Care. 2015;43:685-92. doi: 10.1177\/0310057X1504300604. PMID: 26603791.","DOI":"10.1177\/0310057X1504300604"},{"key":"ref1","doi-asserted-by":"publisher","unstructured":"2.Hedetoft M, Bennett MH, Hyldegaard O. Adjunctive hyperbaric oxygen treatment for necrotising soft-tissue infections: A systematic review and meta-analysis. Diving Hyperb Med. 2021;51:34-43. doi: 10.28920\/dhm51.1.34-43. PMID: 33761539. PMCID: PMC8081587.","DOI":"10.28920\/dhm51.1.34-43"},{"key":"ref2","doi-asserted-by":"publisher","unstructured":"3.Hedetoft M, Madsen MB, Madsen LB, Hyldegaard O. Incidence, comorbidity and mortality in patients with necrotising soft-tissue infections 2005-2018: a Danish nationwide register-based cohort study. BMJ Open. 2020;10(10)e041302. doi: 10.1136\/bmjopen-2020-041302. PMID: 33067303. PMCID: PMC7569942.","DOI":"10.1136\/bmjopen-2020-041302"},{"key":"ref3","doi-asserted-by":"publisher","unstructured":"4.Nardini C. The ethics of clinical trials. Ecancermedicalscience. 2014;8:387. doi: 10.3332\/ecancer.2014.387. PMID: 24482672. PMCID: PMC3894239.","DOI":"10.3332\/ecancer.2014.387"},{"key":"ref4","doi-asserted-by":"publisher","unstructured":"5.Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. 1987;317(3):141-5. doi: 10.1056\/NEJM198707163170304. PMID: 3600702.","DOI":"10.1056\/NEJM198707163170304"},{"key":"ref5","doi-asserted-by":"publisher","unstructured":"6.Edwards SJ, Lilford RJ, Braunholtz DA, Jackson JC, Hewison J, Thornton J. Ethical issues in the design and conduct of randomised controlled trials. Health Technol Assess. 1998;2(15):i-vi, 1-132. PMID: 10194615.","DOI":"10.3310\/hta2150"},{"key":"ref6","unstructured":"7.Hyperbaric Technicians and Nurses Association. Australian and New Zealand Hyperbaric Treatment Data, 1 July 2022 - 30 June 2023. HTNA 2023."},{"key":"ref7","doi-asserted-by":"publisher","unstructured":"8.Devaney B, Pilcher D, Mitra B, Watterson J. Does equipoise exist amongst experts regarding the role of hyperbaric oxygen treatment for necrotising soft tissue infection? ANZ J Surg. 2021;91:485-7. doi: 10.1111\/ans.16337. PMID: 33847053.","DOI":"10.1111\/ans.16337"},{"key":"ref8","unstructured":"9.Australian Bureau of Statistics. National, state and territory population. Reference period: March 2023. [cited 2023 Oct 3]. Available from: https:\/\/www.abs.gov.au."},{"key":"ref9","unstructured":"10.Statistics New Zealand. Tatauranga Aotearoa. National population estimates: At 30 June 2023. [cited 2023 Oct 3]. Available from: https:\/\/www.stats.govt.nz."},{"key":"ref10","unstructured":"11.NHS England. Clinical Commissioning Policy: Hyperbaric Oxygen Therapy for necrotising soft tissue infections (all ages). July 2018. [cited 2023 Oct 3]. Available from: https:\/\/www.england.nhs.uk\/wp-content\/uploads\/2018\/07\/hbot-for-necrotising-soft-tissue-infections-v2.pdf."},{"key":"ref11","doi-asserted-by":"publisher","unstructured":"12.Soh CR, Pietrobon R, Freiberger JJ, Chew ST, Rajgor D, Gandhi M, et al. Hyperbaric oxygen therapy in necrotising soft tissue infections: a study of patients in the United States Nationwide Inpatient Sample. Intensive Care Med. 2012;38:1143-51. doi: 10.1007\/s00134-012-2558-4. PMID: 22527074.","DOI":"10.1007\/s00134-012-2558-4"},{"key":"ref12","doi-asserted-by":"publisher","unstructured":"13.Stevens DL, Bisno AL, Chambers HF, Dellinger EP, Goldstein EJ, Gorbach SL, et al. Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the infectious diseases society of America. Clin Infect Dis. 2014;59:147-59. doi: 10.1093\/cid\/ciu296. PMID: 24947530.","DOI":"10.1093\/cid\/ciu296"},{"key":"ref13","doi-asserted-by":"publisher","unstructured":"14.Mathieu D, Marroni A, Kot J. Tenth European Consensus Conference on Hyperbaric Medicine: recommendations for accepted and non-accepted clinical indications and practice of hyperbaric oxygen treatment. Diving Hyperb Med. 2017;47:24-32. doi: 10.28920\/dhm47.1.24-32. PMID: 28357821. PMCID: PMC6147240.","DOI":"10.28920\/dhm47.1.24-32"},{"key":"ref14","unstructured":"15.Moon RE, editor. Undersea and Hyperbaric Medical Society. Hyperbaric oxygen therapy indications. 14th ed. North Palm Beach (FL): Best Publishing Company; 2019."},{"key":"ref15","doi-asserted-by":"publisher","unstructured":"16.Sartelli M, Coccolini F, Kluger Y, Agastra E, Abu-Zidan FM, Abbas AES, et al. WSES\/GAIS\/WSIS\/SIS-E\/AAST global clinical pathways for patients with skin and soft tissue infections. World J Emerg Surg. 2022;17:1-23. doi: 10.1186\/s13017-022-00406-2. PMID: 35033131. PMCID: PMC8761341.","DOI":"10.1186\/s13017-022-00406-2"},{"key":"ref16","doi-asserted-by":"publisher","unstructured":"17.Levett D, Bennett MH, Millar I. Adjunctive hyperbaric oxygen for necrotizing fasciitis. Cochrane Database Syst Rev. 2015;1(1):CD007937. doi: 10.1002\/14651858.CD007937.pub2. PMID: 25879088. 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