Long term understanding of study information in research participants with Parkinson's disease
Long term understanding of study information in research participants with Parkinson's disease
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DOI：
10.1016/j.parkreldis.2009.05.007
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发表时间：
2010-01-01
影响因子：
4.1
通讯作者：
Kim, Scott Y. H.
中科院分区：
文献类型：
--
作者：
Ravina, Bernard;Swearingen, Christopher;Kim, Scott Y. H.
背景：在临床研究过程中，研究参与者对同意信息的理解以及这些信息与参与者行为的关系知之甚少。方法：我们在帕金森病临床试验结束时对患者进行了理解和满意度问卷调查。主要结果：在涵盖知情同意关键要素的30项问卷中，9项理解得分。结果：78%的符合条件的试验参与者完成了这个子研究。超过90%的受访者对研究目的、治疗分配方法、药物的实验性质、自愿参与以及试验对其PD的预期效果有很好的理解。然而，42.3%的受试者错误地认为参加这项研究是他们PD的“常规治疗”的一部分。我们发现理解、依从性和满意度与自己的神经科医生是否是研究医生没有关系。受教育年限和基线认知功能与学习信息的理解相关。结论：参与试验12个月后，对同意书中提供的关键研究信息的总体理解程度较高，尽管在反应方面存在不一致，需要进一步研究。2009爱思唯尔有限公司版权所有。
Context: Little is known about research participants' understanding of consent information over the course of a clinical study and the relationship of this information with participant behavior.Methods: We conducted a cross sectional patient completed questionnaire of comprehension and satisfaction administered at the end of a Parkinson's disease clinical trial.Main outcome: Scores on 9 comprehension items in a 30 item questionnaire covering the key elements of informed consent.Results: 78% of eligible trial participants completed this substudy. Greater than 90% of respondents showed good comprehension of the study purpose, method of treatment assignment, experimental nature of drugs, voluntary participation, and expected effect of the trial on their PD. However, 42.3% of Subjects incorrectly endorsed that participating in the study was part of the "usual treatment" for their PD. We found no relationship between comprehension, compliance, and satisfaction with whether or not one's own neurologist was also the study doctor. Years of education and cognitive function at baseline were correlated with comprehension of study information.Conclusions: Overall comprehension of key study information presented in the consent was high after 12 months of trial participation, although there were inconsistencies in responses that need further study. (C) 2009 Elsevier Ltd. All rights reserved.