{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T14:38:29Z","timestamp":1786977509997,"version":"build-2736575974"},"reference-count":17,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2023,1,23]],"date-time":"2023-01-23T00:00:00Z","timestamp":1674432000000},"content-version":"vor","delay-in-days":22,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100009995","name":"Treuman Katz Center for Pediatric Bioethics","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009995","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009633","name":"Eunice Kennedy Shriver National Institute of Child Health and Human Development","doi-asserted-by":"publisher","award":["K23HD103872"],"award-info":[{"award-number":["K23HD103872"]}],"id":[{"id":"10.13039\/100009633","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Ethics &amp; Human Research"],"published-print":{"date-parts":[[2023,1]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>Inconsistent enrollment among hospitals for neonatal clinical trials may lead to study populations that are not representative of the patient population in the neonatal intensive care unit. The High\u2010Dose Erythropoietin for Asphyxia and Encephalopathy (HEAL) trial was a multisite randomized clinical trial investigating erythropoietin as a neuroprotective treatment for term infants (those born between 37 and 42 complete weeks) with hypoxic ischemic encephalopathy. Substantial variability was noted in enrollment rate by hospital. We developed survey questions across five conceptual domains to understand systems\u2010level issues that might contribute to variation in enrollment rate by hospital. Our study found that hospitals varied in their responses across these five domains. We propose three potential reasons that we found a lack of identifiable hospital\u2010level factors that correlated with enrollment rates: sample\u2010size limitations, methodological concerns, and confounding factors. Future studies with a larger sample size should be considered to evaluate contributors to hospital\u2010level variability. This will lead to more robust recruitment strategies, improved enrollment, and decreases in the waste of research resources.<\/jats:p>","DOI":"10.1002\/eahr.500154","type":"journal-article","created":{"date-parts":[[2023,1,24]],"date-time":"2023-01-24T01:53:11Z","timestamp":1674525191000},"page":"29-38","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Factors That Impact Hospital\u2010Specific Enrollment Rates for a Neonatal Clinical Trial: An Analysis of the HEAL Study"],"prefix":"10.1002","volume":"45","author":[{"given":"Katherine F.","family":"Guttmann","sequence":"first","affiliation":[{"name":"Assistant professor in the Department of Pediatrics at the Icahn School of Medicine at Mount Sinai"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sijia","family":"Li","sequence":"additional","affiliation":[{"name":"Doctoral student in the Department of Biostatistics at the University of Washington School of Public Health"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yvonne W.","family":"Wu","sequence":"additional","affiliation":[{"name":"Professor of neurology and pediatrics in the Departments of Neurology and Pediatrics at the University of California San Francisco School of Medicine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandra E.","family":"Juul","sequence":"additional","affiliation":[{"name":"Professor in the Department of Pediatrics at the University of Washington School of Medicine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benjamin S.","family":"Wilfond","sequence":"additional","affiliation":[{"name":"Professor in the Department of Pediatrics at the University of Washington School of Medicine and Treuman Katz Center for Pediatric Bioethics at the Seattle Children's Research Institute"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elliott Mark","family":"Weiss","sequence":"additional","affiliation":[{"name":"Associate professor at the University of Washington School of Medicine and Treuman Katz Center for Pediatric Bioethics at the Seattle Children's Research Institute"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"HEAL Recruitment Collaborative","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,1,23]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jstrokecerebrovasdis.2010.05.014"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2020.32106"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2009-3353"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1186\/1745-6215-10-52"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1177\/1740774514543539"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2393-8-36"},{"key":"e_1_2_8_8_1","unstructured":"Peckhamet al. \u201cSuccessful Recruitment to Trials: Findings from the SCIMITAR+ Trial.\u201d"},{"issue":"1","key":"e_1_2_8_9_1","first-page":"2019","article-title":"Estimating Site Performance (ESP): Can Trial Managers Predict Recruitment Success at Trial Sites? An Exploratory Study,","volume":"20","author":"Tooher Middleton","year":"2019","journal-title":"Trials"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1159\/000486820"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/mgg3.453"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1097\/ACM.0b013e3182306440"},{"issue":"2","key":"e_1_2_8_13_1","first-page":"2014","article-title":"Successful Recruitment to Trials\u201d; Bhatnagar, S., et al., \u201cDevelopment and Impact of an Intervention to Boost Recruitment in a Multi\u2010Center Pediatric Randomized Clinical Trial,","volume":"53","author":"Peckham","year":"2014","journal-title":"Clinical Pediatrics"},{"key":"e_1_2_8_14_1","unstructured":"Weisset al. \u201cParental Factors Associated with the Decision to Participate in a Neonatal Clinical Trial\u201d; Weiss et al. \u201cParental Enrollment Decision\u2010Making for a Neonatal Clinical Trial.\u201d"},{"issue":"23","key":"e_1_2_8_15_1","first-page":"2015","article-title":"Short\u2010Term Outcomes of Infants Enrolled in Randomized Clinical Trials vs Those Eligible but Not Enrolled,","volume":"313","author":"Foglia E. E.","year":"2015","journal-title":"Journal of the American Medical Association"},{"key":"e_1_2_8_16_1","unstructured":"Weisset al. \u201cParental Factors Associated with the Decision to Participate in a Neonatal Clinical Trial\u201d; Weiss et al. \u201cParental Enrollment Decision\u2010Making for a Neonatal Clinical Trial.\u201d"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2016-2822"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cct.2012.08.011"}],"container-title":["Ethics &amp; Human Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/eahr.500154","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/eahr.500154","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/eahr.500154","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,20]],"date-time":"2023-08-20T16:08:12Z","timestamp":1692547692000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/eahr.500154"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,1]]},"references-count":17,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2023,1]]}},"alternative-id":["10.1002\/eahr.500154"],"URL":"https:\/\/doi.org\/10.1002\/eahr.500154","archive":["Portico"],"relation":{},"ISSN":["2578-2355","2578-2363"],"issn-type":[{"value":"2578-2355","type":"print"},{"value":"2578-2363","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,1]]},"assertion":[{"value":"2023-01-23","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}