Research knowledge among parents of children participating in a randomized clinical trial.
Research knowledge among parents of children participating in a randomized clinical trial.
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参与随机临床试验的儿童家长的研究知识。
DOI：
10.1097/00004583-200502000-00006
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发表时间：
2005
影响因子：
13.3
通讯作者：
Arnold,LEugene
中科院分区：
文献类型：
--
作者：
Vitiello,Benedetto;Aman,MichaelG;Scahill,Lawrence;McCracken,JamesT;McDougle,ChristopherJ;Tierney,Elaine;Davies,Mark;Arnold,LEugene
目的儿童研究需要父母的许可，但父母对研究目的和程序的理解还没有得到很好的记录。方法对101例5~17岁自闭症儿童的父母在研究结束时进行问卷调查。结果在完成调查问卷的95名父母中，99%的人知道可能的安慰剂分配，调查人员的主要目的是测试药物疗效；96%~98%的人知道研究涉及风险和潜在的好处，确定研究的药物，并知道他们有权随时停药；90%~95%的人知道药物的主要副作用；87%的人报告被告知了参与研究的可能替代方案；72%的人知道治疗是随机分配的(而27%的人报告说，治疗是根据个人需求选择的，以确保最佳护理)。有大学学历的父母更有可能认识到治疗分配的随机性。结论总的来说，父母对主要研究组成部分有很高的了解。然而，大约四分之一的人似乎没有意识到治疗是随机决定的，而不是个性化的，这表明治疗的误解可能会影响到一些原本知情的父母。
OBJECTIVEParental permission is required for child research, but parents' understanding of research aims and procedures has not been well documented. Parental research knowledge was assessed during a clinical trial in autism.METHODParents of 101 children (age 5-17 years) with autism participating in a placebo-controlled trial of risperidone were given a questionnaire at the end of the study.RESULTSOf the 95 parents completing the questionnaire, 99% knew of possible placebo assignment and that testing the medication efficacy was the main purpose of the investigators; 96% to 98% knew that research involved both risks and potential benefits, identified the study medication, and knew of their right to withdraw at any time; 90% to 95% knew of the medication's main side effects; 87% reported having been informed of possible alternatives to research participation; and 72% were aware that treatment was randomly assigned (whereas 27% reported that treatment was chosen based on individual needs to ensure best care). Parents with a college degree were more likely to recognize the random nature of treatment assignment.CONCLUSIONSOverall, parents were highly knowledgeable of the main research components. About one fourth, however, seemed unaware that treatment was randomly determined and not personalized, suggesting that therapeutic misconception may affect some otherwise well-informed parents.