Christopher Paul P, Foti Mary Ellen, Roy-Bujnowski Kristen, Appelbaum Paul S
Department of Psychiatry, Brown Medical School, Butler Hospital, 345 Blackstone Blvd., Providence, RI 02906, USA.
Psychiatr Serv. 2007 Feb;58(2):227-32. doi: 10.1176/ps.2007.58.2.227.
Poor readability of informed consent forms has been a persistent problem in clinical research. The low educational attainments of many patients with mental illness might suggest a still greater problem in mental health settings. To explore this potential disparity, this study sought to determine whether the informed consent forms used in research approved by the Massachusetts Department of Mental Health were written at a grade level that was higher than that achieved by potential study participants.
The readability (grade level necessary to read text) of informed consent forms for 154 studies was calculated with several standard formulas. Readability scores were stratified on the basis of the risk level of the study from which the consent form was taken. These data were then compared with data on the maximum attained grade level of potential participants aged 19 years or older.
The overall mean readability scores for the informed consent forms, as determined by the four methods, ranged from grade levels 12 to 14.5. Furthermore, the mean readability scores increased with higher risk levels of the studies. Approximately 35% of potential participants had not graduated from high school, 37% had graduated from high school or obtained a GED, and 28% had some education beyond the 12th grade.
These data demonstrate poor readability of informed consent forms used in research approved by the Massachusetts Department of Mental Health and highlight a mismatch between consent form readability and the educational level of potential study participants. The findings suggest that methods of reducing the complexity of forms, as part of improving the overall consent process, are much needed.
知情同意书可读性差一直是临床研究中的一个长期问题。许多精神疾病患者教育程度较低，这可能意味着在心理健康领域存在更严重的问题。为了探究这一潜在差异，本研究试图确定马萨诸塞州心理健康部批准的研究中使用的知情同意书的编写年级水平是否高于潜在研究参与者所达到的年级水平。
使用几种标准公式计算了154项研究的知情同意书的可读性（阅读文本所需的年级水平）。根据同意书所来自研究的风险水平对可读性得分进行分层。然后将这些数据与19岁及以上潜在参与者所达到的最高年级水平的数据进行比较。
通过四种方法确定的知情同意书的总体平均可读性得分在12年级至14.5年级之间。此外，平均可读性得分随着研究风险水平的提高而增加。约35%的潜在参与者未高中毕业，37%的人高中毕业或获得同等学历，28%的人接受过12年级以上的教育。
这些数据表明马萨诸塞州心理健康部批准的研究中使用的知情同意书可读性差，并突出了同意书可读性与潜在研究参与者教育水平之间的不匹配。研究结果表明，作为改进整体同意过程的一部分，非常需要降低表格复杂性的方法。
