{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T10:10:09Z","timestamp":1777543809362,"version":"3.51.4"},"reference-count":20,"publisher":"SAGE Publications","issue":"5","license":[{"start":{"date-parts":[[2012,7,25]],"date-time":"2012-07-25T00:00:00Z","timestamp":1343174400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Clinical Trials"],"published-print":{"date-parts":[[2012,10]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Low participation rates in randomised controlled trials involving children are almost a universal problem, leading to high cost and low statistical power. Trial, parent\/family, child, and physician factors have been reported to influence parental willingness to consent for paediatric trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>To identify modifiable and unmodifiable factors associated with parental consent.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Demographic and clinical characteristics of children and their families and physician characteristics associated with parental consent were evaluated in a recent randomised placebo-controlled trial of prophylactic antibiotics to prevent recurrent urinary tract infection.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Of 1109 eligible children identified (mean age, 2.0 years), 412 parents (37.2%) consented. On a multivariate analysis, the only modifiable factor associated with consent was request for consent by a member of the research study team rather than by a member of the clinical team (risk ratio (RR) = 1.9, 95% confidence interval (CI): 1.2\u20132.9). The unmodifiable factors significantly associated with consent were age of the child (\u22654 years) (RR = 1.2, 95% CI: 1.1\u20131.4), presence of vesicoureteric reflux (RR = 1.5, 95% CI: 1.3\u20131.8), inpatient management of the index infection (RR = 0.8, 95% CI: 0.7\u20130.9), and multiple (\u22654) symptoms at presentation (RR = 1.3, 95% CI: 1.1\u20131.5).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Limitations<\/jats:title>\n                    <jats:p>We have reported data from only one of the four participating centres in this trial. Data on non-consenters in other participating centres were not completely collected. Data on characteristics of the recruiting physician were limited. These findings are applicable for those considering a single randomised controlled trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Parent, child, and physician factors are associated with consent for trial participation, with most not being modifiable. Having a member of the research study team approach the parent for consent appears to be the only feasible strategy for increasing recruitment to randomised trials in this setting.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/1740774512453219","type":"journal-article","created":{"date-parts":[[2012,7,25]],"date-time":"2012-07-25T23:24:36Z","timestamp":1343258676000},"page":"645-651","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":11,"title":["Parental consent to participation in a randomised trial in children: Associated child, family, and physician factors"],"prefix":"10.1177","volume":"9","author":[{"given":"Premala","family":"Sureshkumar","sequence":"first","affiliation":[{"name":"Centre for Kidney Research, NHMRC Centre for Clinical Research Excellence, The Children\u2019s Hospital at Westmead, Westmead, Sydney, NSW, Australia"},{"name":"Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Patrina","family":"Caldwell","sequence":"additional","affiliation":[{"name":"Centre for Kidney Research, NHMRC Centre for Clinical Research Excellence, The Children\u2019s Hospital at Westmead, Westmead, Sydney, NSW, Australia"},{"name":"Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alison","family":"Lowe","sequence":"additional","affiliation":[{"name":"Centre for Kidney Research, NHMRC Centre for Clinical Research Excellence, The Children\u2019s Hospital at Westmead, Westmead, Sydney, NSW, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Judy M","family":"Simpson","sequence":"additional","affiliation":[{"name":"Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gabrielle","family":"Williams","sequence":"additional","affiliation":[{"name":"Centre for Kidney Research, NHMRC Centre for Clinical Research Excellence, The Children\u2019s Hospital at Westmead, Westmead, Sydney, NSW, Australia"},{"name":"Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jonathan C","family":"Craig","sequence":"additional","affiliation":[{"name":"Centre for Kidney Research, NHMRC Centre for Clinical Research Excellence, The Children\u2019s Hospital at Westmead, Westmead, Sydney, NSW, Australia"},{"name":"Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2012,7,25]]},"reference":[{"key":"bibr1-1740774512453219","unstructured":"National Institutes of Health. 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