Department of Anesthesiology, University of Michigan, Ann Arbor, MI 48109, USA.
JAMA Pediatr. 2013 Jul;167(7):640-6. doi: 10.1001/jamapediatrics.2013.1385.
Research information should be presented in a manner that promotes understanding. However, many parents and research subjects have difficulty understanding and making informed decisions.
To examine the effect of different communication strategies on parental understanding of research information.
Observational study from January 2010 to June 2012 using a fractional factorial design.
Large tertiary care children's hospital.
Six hundred forty parents of children scheduled for elective surgery.
Parents were randomized to receive information about a hypothetical pain trial presented in 1 of 16 consent documents containing different combinations of 5 selected communication strategies (ie, length, readability, processability [formatting], graphical display, and supplemental verbal disclosure).
Parents were interviewed to determine their understanding of the study elements (eg, protocol and alternatives) and their gist (main point) and verbatim (actual) understanding of the risks and benefits.
Main effects for understanding were found for processability, readability, message length, use of graphics, and verbal discussion. Consent documents with high processability, eighth-grade reading level, and graphics resulted in significantly greater gist and verbatim understanding compared with forms without these attributes (mean difference, 0.57; 95% CI, 0.26-0.88, number of correct responses of 7 and mean difference, 0.54; 95% CI,0.20-0.88, number of correct responses of 4 for gist and verbatim, respectively).
Results identified several communication strategy combinations that improved parents' understanding of research information. Adoption of these active strategies by investigators, clinicians, institutional review boards, and study sponsors represents a simple, practical, and inexpensive means to optimize the consent message and enhance parental, participant, and patient understanding.
研究信息的呈现方式应该有助于理解。然而，许多家长和研究对象在理解和做出明智决策方面存在困难。
研究不同沟通策略对家长理解研究信息的影响。
2010 年 1 月至 2012 年 6 月采用分阶实验设计的观察性研究。
大型三级儿童保健医院。
640 名计划接受择期手术的儿童的家长。
家长随机接受 16 份包含 5 种选定沟通策略（即长度、可读性、可处理性[格式]、图形显示和补充口头披露）不同组合的假设性疼痛试验知情同意书。
对家长进行访谈，以确定他们对研究要素（例如方案和替代方案）以及对风险和益处的主旨（要点）和逐字（实际）理解的理解程度。
处理能力、可读性、信息长度、使用图形和口头讨论对理解有主要影响。具有较高处理能力、八年级阅读水平和图形的知情同意书与不具有这些属性的表格相比，主旨和逐字理解明显提高（差异均值为 0.57；95%置信区间为 0.26-0.88，正确答案分别为 7 和 4）。
结果确定了几种可提高家长对研究信息理解的沟通策略组合。研究人员、临床医生、机构审查委员会和研究赞助商采用这些积极的策略，代表了优化同意书信息、增强家长、参与者和患者理解的一种简单、实用和经济的方法。
