Department of Medical Psychology and Psychotherapy, Erasmus MC Rotterdam, The Netherlands.
Patient Educ Couns. 2012 Jun;87(3):268-76. doi: 10.1016/j.pec.2011.09.006. Epub 2011 Oct 22.
To systematically review the state of knowledge regarding the understanding and experience of psychological burden and risk of children and adolescents who participate in medical research. Further to provide recommendations to maximize understanding and minimize the burden and risk.
Studies were selected that focus on children and adolescents as source of information via PubMed and PsycINFO; search terms were medical research or trial or experiment, child or adolescent, non-therapeutic, therapeutic, psychology, consent or understanding, risk, burden or stress.
Of 413 abstracts identified, ten studies on understanding and eight on the experience of burden and risk met our selection criteria. Overall, understanding of the study purpose was reasonable, but low for the procedure. Understanding increased with age and appeared to be overestimated by the young participants. Research on experience of burden was scarce, but identified invasive procedures and procedures related to sexual development as the most burdensome. Only one study assessed psychological risks.
Systematic evidence should be collected on the various aspects of medical procedures related to the experienced burden and risk. This will be useful in informing children and adolescents, parents and medical ethical committees.
系统回顾关于参与医学研究的儿童和青少年对心理负担和风险的理解和体验的知识状况。并提供建议，以最大程度地提高理解程度，减轻负担和风险。
通过 PubMed 和 PsycINFO 选择了以儿童和青少年为信息源的研究；检索词为医学研究或试验或实验、儿童或青少年、非治疗性、治疗性、心理学、同意或理解、风险、负担或压力。
在 413 篇摘要中，有 10 项关于理解的研究和 8 项关于负担和风险的经验的研究符合我们的选择标准。总的来说，对研究目的的理解是合理的，但对程序的理解较低。理解随着年龄的增长而增加，而且年轻参与者的理解似乎被高估了。关于负担的经验研究很少，但确定了侵入性程序和与性发育有关的程序是最具负担性的。只有一项研究评估了心理风险。
应系统地收集与所经历的负担和风险相关的各种医学程序方面的证据。这将有助于告知儿童和青少年、家长和医学伦理委员会。
