Philipson S J, Doyle M A, Gabram S G, Nightingale C, Philipson E H
Reading and Language Arts Center, University of Connecticut, USA.
J Investig Med. 1995 Oct;43(5):459-67.
Ninety million Americans are reported to have low literacy skills, and the problems associated with illiteracy permeate all areas of our society, including medical research. The purpose of this study was to determine the readability and comprehensibility of human research informed consent forms using established reading comprehension processes. Further, if comprehension problems were present in the forms, the study sought to identify the exact nature of these difficulties and identify specific areas where the forms could be rewritten to increase readability and understanding.
All human research informed consents approved by Hartford Hospital in 1993 were evaluated by a Readability and Processability Form (RPF) based on reading research, including the Fry Scale which yields an approximate grade reading level. The RPF assigned points to each of the 20 areas of analysis according to strict scoring criteria, and target scores were established by the authors in consultation with the hospital.
Seventy-six informed consent forms were evaluated, and neither the Fry score or the RPF score was in the target range. Ninety-six percent of the forms were found to have readability levels higher than the target level (8th grade). The mean readability and processability score was 46, resulting in the classification, Minimally Adequate/Needs Improvement. (The target range was Good, 61-100.) A question by question analysis of each of the 20 checklist items on the RPF identified important aspects of text writing style that were scored as Unacceptable or Poor.
The descriptive data indicates that there were problems with the readability of the informed consent documents studied. The prescriptive portion of this study provides researchers with information on specific areas where their forms need to be studied and rewritten. The comprehension problems found in this study may alert others to similar problems and may provide the basis for other institutional review boards (IRBs) to study their consent forms in order to ensure that the interests of both the patient and the researcher are protected and that the obtained consent is truly informed.
据报道，9000万美国人识字能力较低，与文盲相关的问题渗透到我们社会的各个领域，包括医学研究。本研究的目的是使用既定的阅读理解流程来确定人体研究知情同意书的可读性和可理解性。此外，如果同意书中存在理解问题，该研究旨在确定这些困难的确切性质，并确定可以重写同意书以提高可读性和理解性的具体领域。
1993年由哈特福德医院批准的所有人体研究知情同意书均通过基于阅读研究的可读性和可处理性表格（RPF）进行评估，包括得出近似年级阅读水平的弗莱阅读分级法。RPF根据严格的评分标准为20个分析领域中的每一个领域打分，作者与医院协商确定了目标分数。
对76份知情同意书进行了评估，弗莱分数和RPF分数均未在目标范围内。发现96%的同意书的可读性水平高于目标水平（八年级）。平均可读性和可处理性分数为46，结果分类为勉强合格/需要改进。（目标范围是良好，61 - 100。）对RPF上20个清单项目逐一进行问题分析，确定了文本写作风格中被评为不可接受或较差的重要方面。
描述性数据表明，所研究的知情同意文件存在可读性问题。本研究的规范性部分为研究人员提供了有关其同意书需要研究和重写的具体领域的信息。本研究中发现的理解问题可能会提醒其他人注意类似问题，并可能为其他机构审查委员会（IRB）研究其同意书提供依据，以确保患者和研究人员的利益都得到保护，并且所获得的同意是真正知情的。
