Assessment of Factors Associated With Parental Perceptions of Voluntary Decisions About Child Participation in Leukemia Clinical Trials
| العنوان: | Assessment of Factors Associated With Parental Perceptions of Voluntary Decisions About Child Participation in Leukemia Clinical Trials |
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| المؤلفون: | Jesse Nodora, Nikhil V. Kumar, Arissa K Ma, Maria Elena Martinez, Courtney D. Thornburg, Paula Aristizabal, Bianca P. Perdomo |
| المصدر: | JAMA Network Open |
| بيانات النشر: | American Medical Association (AMA), 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Adult, Male, Parents, Adolescent, Psychological intervention, Health literacy, California, Informed consent, Surveys and Questionnaires, Humans, Medicine, Prospective Studies, Child, Socioeconomic status, Original Investigation, Ethics, Informed Consent, Leukemia, business.industry, Patient Selection, Research, Infant, Newborn, Infant, General Medicine, Voluntariness, Acculturation, Health Literacy, Clinical trial, Online Only, Cross-Sectional Studies, Socioeconomic Factors, Child, Preschool, Marital status, Female, business, Demography |
| الوصف: | Key Points Question Are health literacy, contextual factors, or sociodemographic characteristics associated with parental perception of voluntariness during informed consent for pediatric leukemia clinical trials? Findings In this cross-sectional study that included 97 parents of children with newly diagnosed leukemia, lower perception of voluntariness was significantly associated with lower health literacy. Meaning Low health literacy may have a role in parents not making complete and meaningful informed decisions for their child’s participation in cancer clinical trials. Importance Obtaining voluntary informed consent prior to enrollment in clinical trials is a fundamental ethical requirement. Objective To assess whether health literacy, contextual factors, or sociodemographic characteristics are associated with perception of voluntariness among parents who had consented for their child’s participation in a leukemia therapeutic clinical trial. Design, Setting, and Participants This cross-sectional study prospectively enrolled 97 parents of children diagnosed as having leukemia at Rady Children’s Hospital San Diego, a large tertiary academic center in California, from 2014 to 2017. Health literacy, contextual factors (acculturation, decisional regret, and satisfaction with informed consent), sociodemographic characteristics, and perception of voluntariness after consenting for a therapeutic clinical trial were measured. Univariable and multivariable regression were used to determine significant associations. The analyses for the present study were conducted from May 2019 to May 2020. Exposures Informed consent for a therapeutic leukemia clinical trial. Main Outcomes and Measures The primary outcome of interest was perception of voluntariness and its associations with health literacy and other contextual factors (acculturation, decisional regret, and satisfaction with informed consent) and sociodemographic characteristics, including age, race/ethnicity, parental language, educational level, insurance type, marital status, and socioeconomic status. Results Of 97 parents included, the majority were women (65 [67%]), married (71 [73%]), and of self-reported Hispanic ethnicity (50 [52%]). Lower perception of voluntariness was significantly associated with lower health literacy (r = 0.30; 95% CI, 0.11-0.47; P = .004), Spanish language (x̅ = −4.50, P = .05), lower acculturation if of Hispanic ethnicity (r = 0.30; 95% CI, 0.02-0.54; P = .05), greater decisional regret (r = −0.54; 95% CI, −0.67 to −0.38; P This cross-sectional study assesses whether health literacy, contextual factors, or sociodemographic characteristics are associated with perception of voluntariness among parents who consent for their child’s participation in a leukemia therapeutic clinical trial. |
| تدمد: | 2574-3805 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::96da2cbbe890246f25170003d694a8d1Test https://doi.org/10.1001/jamanetworkopen.2021.9038Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....96da2cbbe890246f25170003d694a8d1 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 25743805 |
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