{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,9,6]],"date-time":"2024-09-06T17:46:24Z","timestamp":1725644784920},"reference-count":13,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2015,1,19]],"date-time":"2015-01-19T00:00:00Z","timestamp":1421625600000},"content-version":"vor","delay-in-days":18,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Hastings Center Report"],"published-print":{"date-parts":[[2015,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p><jats:italic>The debate about the ethics of the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) often focuses on the assumptions made by the different parties involved, failing to note the lack of a necessary connection between those assumptions and the main criticism of the study\u2014that the parents appear to have been poorly informed. The fact that the target ranges of oxygen saturation (SpO2) used in SUPPORT were within the range recommended as an appropriate \u201cstandard of care\u201d does not mean that the infants randomized to one of two restricted SpO2 ranges received the same treatment they would have received outside of the trial. The corresponding observation that randomization altered the potential harms to which an individual infant was exposed does not mean that the risks of being in SUPPORT were greater than or in addition to the risks associated with usual care. The argument that parents should have been better informed about these potential harms does not entail the (incorrect) assumption that neonatal clinicians make individualized treatment decisions rather than follow a standardized protocol when adjusting the level of oxygen a preterm infant receives. The fact that parents are unaware of the trade\u2010off clinicians make between these potential harms when establishing such a protocol does not justify the failure to adequately inform parents about the purpose of SUPPORT and the risks and harms that were involved<\/jats:italic>.<\/jats:p>","DOI":"10.1002\/hast.415","type":"journal-article","created":{"date-parts":[[2015,1,20]],"date-time":"2015-01-20T14:12:58Z","timestamp":1421763178000},"page":"40-42","update-policy":"http:\/\/dx.doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["SUPPORT: <i>Risks, Harms, and Equipoise<\/i>"],"prefix":"10.1002","volume":"45","author":[{"given":"Robert M.","family":"Nelson","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2015,1,19]]},"reference":[{"key":"e_1_2_3_1_1","doi-asserted-by":"crossref","unstructured":"J. D. Lantos and C. Feudtner \u201cSUPPORT and the Ethics of Study Implementation: Lessons for Comparative Effectiveness Research from the Trial of Oxygen Therapy for Premature Babies \u201dHastings Center Report45 no. 1 (2015): 30\u201340.","DOI":"10.1002\/hast.407"},{"key":"e_1_2_3_2_1","unstructured":"National Institute of Child Health and Human Development Neonatal Research Network \u201cThe Surfactant Positive Airway Pressure and Pulse Oximetry Trial in Extremely Low Birth Weight Infants: The SUPPORT Trial \u201d August 28 2004 last modified March 28 2005 accessed November 29 2014 http:\/\/www.nih.gov\/icd\/od\/foia\/library\/Protocol.pdf; see especially p. 9."},{"key":"e_1_2_3_3_1","doi-asserted-by":"crossref","unstructured":"C. H. Cole et\u00a0al. \u201cResolving Our Uncertainty about Oxygen Therapy \u201dPediatrics112 no. 6 part 1 (2003): 1415\u201319.","DOI":"10.1542\/peds.112.6.1415"},{"key":"e_1_2_3_4_1","unstructured":"National Institute of Child Health and Human Development Neonatal Research Network \u201cThe Surfactant Positive Airway Pressure and Pulse Oximetry Trial in Extremely Low Birth Weight Infants.\u201d"},{"key":"#cr-split#-e_1_2_3_5_1.1","doi-asserted-by":"crossref","unstructured":"I. Chalmers et\u00a0al. \"Data Sharing among Data Monitoring Committees and Responsibilities to Patients and Science \"Trials14 no. 102 (2013) doi 10.1186\/1745-6215-14-102","DOI":"10.1186\/1745-6215-14-102"},{"key":"#cr-split#-e_1_2_3_5_1.2","doi-asserted-by":"crossref","unstructured":"L. M. Askie et\u00a0al. \"NeOProM: Neonatal Oxygenation Prospective Meta\u2010analysis Collaboration Study Protocol \"BMC Pediatrics11 no. 6 (2011): doi 10.1186\/1471-2431-11-6.","DOI":"10.1186\/1471-2431-11-6"},{"key":"e_1_2_3_6_1","doi-asserted-by":"crossref","unstructured":"L. M. Askie D. J. Henderson\u2010Smart and H. Ko \u201cRestricted versus Liberal Oxygen Exposure for Preventing Morbidity and Mortality in Preterm or Low Birth Weight Infants \u201dCochrane Database of Systematic Reviews1 (2009): CD001077.","DOI":"10.1002\/14651858.CD001077.pub2"},{"key":"e_1_2_3_7_1","unstructured":"Cole et\u00a0al. \u201cResolving Our Uncertainty about Oxygen Therapy.\u201d"},{"key":"e_1_2_3_8_1","doi-asserted-by":"crossref","unstructured":"H. J. Silverman and D. Dreyfuss \u201cWere There \u2018Additional Foreseeable Risks\u2019 in the SUPPORT Study? Lessons Not Learned from the ARDSnet Clinical Trials \u201dHastings Center Report45 no. 1 (2015): 21\u201329.","DOI":"10.1002\/hast.403"},{"key":"e_1_2_3_9_1","doi-asserted-by":"crossref","unstructured":"B. J. Stenson et\u00a0al. \u201cOxygen Saturation and Outcomes in Preterm Infants \u201dNew England Journal of Medicine368 (2013): 2094\u20132104.","DOI":"10.1056\/NEJMoa1302298"},{"key":"e_1_2_3_10_1","doi-asserted-by":"crossref","unstructured":"B. Schmidt et\u00a0al. \u201cEffects of Targeting Higher vs Lower Arterial Oxygen Saturations on Death or Disability in Extremely Pre\u2010term Infants: A Randomized Clinical Trial \u201dJournal of the American Medical Association309 (2013): 2111\u201320.","DOI":"10.1001\/jama.2013.5555"},{"key":"e_1_2_3_11_1","unstructured":"M. S. Carome S. Wolfe and R. Macklin \u201cAnalysis of the Complete Protocol and Consent Form for the SUPPORT Study: Lack of Informed Consent and a Failure to Ensure That Risks Were Minimized \u201d May 8 2013 http:\/\/www.citizen.org\/docu\u2010ments\/2124.pdf; see p. 11 for a discussion of the factorial protocol design."},{"key":"e_1_2_3_12_1","doi-asserted-by":"crossref","unstructured":"A. M. Capron \u201cThe Real Problem Is Consent for Treatment Not Consent for Research \u201dAmerican Journal of Bioethics13 no. 12 (2013): p. 27\u201329.","DOI":"10.1080\/15265161.2013.856150"}],"container-title":["Hastings Center Report"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fhast.415","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fhast.415","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/hast.415","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,25]],"date-time":"2023-09-25T03:03:55Z","timestamp":1695611035000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/hast.415"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2015,1]]},"references-count":13,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2015,1]]}},"alternative-id":["10.1002\/hast.415"],"URL":"https:\/\/doi.org\/10.1002\/hast.415","archive":["Portico"],"relation":{},"ISSN":["0093-0334","1552-146X"],"issn-type":[{"value":"0093-0334","type":"print"},{"value":"1552-146X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2015,1]]},"assertion":[{"value":"2015-01-19","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}