{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,25]],"date-time":"2026-07-25T21:14:05Z","timestamp":1785014045719,"version":"3.55.0"},"reference-count":13,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2004,2,6]],"date-time":"2004-02-06T00:00:00Z","timestamp":1076025600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pediatric Blood &amp; Cancer"],"published-print":{"date-parts":[[2004,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Children Cancer Group (CCG) 1991 is the first childhood acute lymphoblastic leukemia trial within CCG that allowed the utilization of a staged approach to the consent process.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>One hundred and forty subjects participated in the Project on Informed Consent which compared the primary outcome measures in the consent process of patients enrolled in CCG\u20101991 with those enrolled in other CCG leukemia studies.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The parents' trust scores were higher for the CCG\u20101991 compared with other protocols. Eighty percent of parents enrolled in CCG\u20101991 understood the distinction between the randomized clinical trial and the standard treatment arm, compared with 62.5% in the other studies, <jats:italic>P<\/jats:italic>\u2009=\u20090.05. Multiple other outcome measures suggested a positive impact from staged informed consent.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Our results suggest that a consent process with a staged approach can help investigators obtain a more truly informed consent. Future research is needed to confirm the benefits of the staged approach to the informed consent process. \u00a9 2004 Wiley\u2010Liss, Inc.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pbc.20010","type":"journal-article","created":{"date-parts":[[2004,3,24]],"date-time":"2004-03-24T08:03:35Z","timestamp":1080115415000},"page":"433-437","source":"Crossref","is-referenced-by-count":41,"title":["Staged informed consent for a randomized clinical trial in childhood leukemia: Impact on the consent process"],"prefix":"10.1002","volume":"42","author":[{"given":"A.L.","family":"Angiolillo","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C.","family":"Simon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E.","family":"Kodish","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"B.","family":"Lange","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R.B.","family":"Noll","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K.","family":"Ruccione","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Y.","family":"Matloub","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2004,2,6]]},"reference":[{"key":"e_1_2_1_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/0277-9536(91)90307-X"},{"key":"e_1_2_1_3_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-2958.1978.tb00604.x"},{"key":"e_1_2_1_4_2","unstructured":"Informed consent in research involving human participants.NIH guide vol 25 No.32 (RFA OD97001) Issued Sept. 27 1996 by National Institutes of Health Bethesda MD."},{"key":"e_1_2_1_5_2","doi-asserted-by":"publisher","DOI":"10.1067\/mpd.2003.64"},{"key":"e_1_2_1_6_2","doi-asserted-by":"publisher","DOI":"10.1097\/00043426-200001000-00002"},{"key":"e_1_2_1_7_2","doi-asserted-by":"publisher","DOI":"10.1188\/02.ONF.988-996"},{"issue":"5","key":"e_1_2_1_8_2","doi-asserted-by":"crossref","first-page":"855","DOI":"10.1542\/peds.42.5.855","article-title":"Gaps in doctor\u2013patient communication","volume":"42","author":"Korsch BM","year":"1968","journal-title":"Pediatrics"},{"key":"e_1_2_1_9_2","volume-title":"Medical men and their work","author":"Quint J","year":"1972"},{"key":"e_1_2_1_10_2","unstructured":"SvarstadB.The patient physician encounter: An observational study of communication and outcome. 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