Enhancement of the informed consent documents: suggestions about legibility, readability and text coherence

Abstract

Dear Editor, The initial step in the informed consent (IC) process is the disclosure of information to the patient. The information can be disclosed by means of personal communication, multimedia interventions, or through the use of a written material. From the perspective of law, it is necessary that the content of the patient-physician communication should be documented and signed by both parties. Therefore, information disclosure through a written document is the preferred method of conduct in most healthcare institutions. However, although this approach provides official recording, it bears other difficulties: The text presented to the patients should be legible, readable and coherent in itself. In patients with presbyopia or other difficulties in sight, the problems about legibility can be overcome by following the American Printing House guidelines for print document design . 1 Text coherence may require modifications with reference to 1. logical/semantic associations and; 2. grammatic associations between successive sentences; 3. proper use of the conjunctions; 4. contextual relations between parts of the text; and 5. establishment of the overall thematic integrity. 2 Finally, enhancement of the readability requires assessment formulas which are specific to that language. In case of Turkish language, to our knowledge, there is only one formula that fulfills the requirements of a scientific approach: Çetinkaya-Uzun Readability Formula. 3 The readability score in this formula is defined as Readability Score=118.8-25.9xAWL-0.9xASL where AWL is the Average Word Length, and ASL is the Average Sentence Length. Based on multiple regression analysis, the formula also provides years of schooling that correspond three categories of readability levels: Readability scores ≥51 correspond to 5-7 years; scores 35–50 correspond to 8-9 years; and scores 0-34 correspond to 10 or more years of schooling, which is the category of independent reading. Regardless of the language, any readability formula which provides such a categorical approach in schooling gives an additional insight about the IC practice: Patients below the category of independent reading (e.g. Turkish patients with schooling level of 9 years or less according to Çetinkaya-Uzun Readability Formula), are prone to misconduct in IC process, therefore increasing the liability of physicians. This group of patients can be easily discriminated by asking his/her last year in schooling. In conclusion, the above mentioned suggestions may help the researchers who are interested in enhancement of the IC documents with regard to legibility, readability and text coherence. In addition to its function as an assessment tool, any reading formula which provides a categorical approach for independent reading also serves to identify the patients at risk for IC misconduct.