Readability of Informed Consent Documents (1987–2007) for Clinical Trials: A Linguistic Analysis

Abstract

We investigated the readability of informed consent documents linguistically and compared old and new ICDs. Twenty ICDs (ten from 1987-1992 and ten from 2006-2007) were included. The Evaluative Linguistic Framework (ELF) was used to analyze the texts. The ELF evaluates the following items: main themes, order of themes, rhetorical functions, the relationship between reader and writer, metadiscourse, headings, expert terminology, and visual aspects. An ICD is considered readable if it achieves the goal of inviting the reader to participate and explaining the implication of participation. The new ICDs were more readable than the old ones, as they were more oriented towards research, contained instructions about how to consent, and provided clear contact information. Aspects that reduced the readability of the new ICDs were the large number of topics, details, and actors presented. The readability of the old ICDs was enhanced by fewer topics, a clear presentation of the involved actors, and brevity. However, their readability was reduced by the inclusion of a vast amount of information about the reader's diagnosis and treatment.

Are the Judicial Reports Prepared in Emergency Services Consistent with Those Prepared in Forensic Medicine Department of a University Hospital?

“…Considering the increasing number of law suits filed against physicians, especially in recent years, the importance of expert opinion in addition to accurate and ontime patient intervention means that physicians need specific training for preparing accurate judicial reports (15). Even though both clinical and judicial reports require good writing skills and extensive experience (16)(17)(18), judicial reports have a different purpose, which is reflected in their impact, quality and style (19,20). When conducting a clinical evaluation, the patient is likely the person being tested.…”

Is it Necessary to Develop a Series of Rational Standards for Informed Consent?

“…1987-1992 ile 2006-2007 yılları arasındaki bilgilendirilmiş rıza formlarını okunabilirlik açısından inceleyen Sand ve ark., yeni üretilen bilgilendirilmiş rıza formlarının eskilere oranla daha okunaklı olduğunu ve net bilgiler sağladığını ifade etmişlerdir. 18 Okunabilirlik, 19. yüzyılın başlarında Amerika Birleşik Devletleri (ABD)'nde geliştirilen dile özgü bir kavramdır. Kısaca okunabilirlik; ilgili dildeki hecelerin, sözcüklerin ve cümlelerin özellikleriyle ilgili bilgi verirken, metinlerle ilgili bazı niceliksel veriler getirerek bir okuyucu tarafından kolayca anlaşılabilir olup olmadığı hakkında bilgi vermektedir.…”

Do the Patients Read the Informed Consent?

“…The suggestions for this are about the typefont, the rhetoric used and the general statement. For example, some of the suggestions include making the font size 12 or larger, using either Times New Roman or Bookman Old Style, not making all of the letters capital and bold-faced, using short sentences (less than 20 words) and limiting paragraphs to no longer than 10 lines (22).…”