Nursing Roles in the Quality of Information in Informed Consent Forms of a Spanish County Hospital

Abstract

(1) Background: Because of their direct and continuous contact with the patient, nurses play a relevant role in ensuring that informed consent forms are complete and easy to read and comprehend. The objective of this study was to analyze the legibility and formal quality of informed consent forms for non-surgical procedures in a county hospital. (2) Methods: The readability of these forms was analyzed using the INFLESZ scale and the information they provided according to the formal quality criteria established for these forms. (3) Results: Readability was difficult in 78.08% of the forms analyzed. No form fulfilled all the criteria, the most non-compliant being the non-appearance of the verification of delivery of a copy to the patient (100%), the contraindications (94.59%), and the alternatives (83.78%) of the procedure. Statistically significant differences were observed between disciplines with respect to the INFLESZ readability score and the formal quality score, but no statistically significant correlation was found between the two scores. (4) Conclusions: The informed consent forms for non-surgical procedures analyzed presented mostly difficult readability and poor formal quality, making it difficult for patients to have understandable and complete information. Nursing professionals should be actively involved in their improvement to facilitate patient decision making.

Readability and Comprehension of Anesthesia Informed Consent Forms in a Spanish County Hospital: An Observational Study

“…There is a need to improve the readability of these anesthesia informed consent forms to promote comprehension and facilitate the informed consent process. These forms should be modified so that their readability is equal to that presented by the general and sports press that is considered “normal” on the INFLESZ scale [ 10 , 29 ]. To improve the readability of these forms, they should be made shorter, use short sentences, highlight the most important information, use text boxes, and even add illustrations [ 38 , 39 ].…”

“…Based on the length of words and sentences in the text, this scale establishes five readability grades that correspond to a given educational level and to the types of publications considered to be easily read and comprehended at each educational level ( Table 1 ). A readability score of a healthcare text equal to or greater than 55 is considered “normal” because it can be read and comprehended by most patients [ 10 , 29 ].…”

“…Informed consent forms should be adequately structured to include all the information that patients may need to make a decision according to their needs and preferences [ 6 , 7 , 8 , 9 , 10 ]. Therefore, all sections of the informed consent forms considered necessary should be present and duly completed to ensure that they include all relevant and specific information that the patient may need to make an appropriate decision [ 6 , 9 ].…”

“…Therefore, all sections of the informed consent forms considered necessary should be present and duly completed to ensure that they include all relevant and specific information that the patient may need to make an appropriate decision [ 6 , 9 ]. In addition, the wording of these forms should use language that is adapted to the specific characteristics of the patients to whom it is addressed so that it is easy to read and comprehension is favored [ 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 ].…”

“…Because of their proximity to patients and their family, nursing professionals have a primary role in the entire informed consent process and particularly in the adaptation of informed consent forms to the specific characteristics of patients to favor their comprehension [ 25 , 26 ]. Nursing professionals should ensure that the information contained in informed consent forms is complete and easy to read for patients [ 6 , 10 ]. In addition, they should check that patients have adequately comprehended all the information provided by the informed consent forms and clarify their doubts to ensure that these forms satisfactorily fulfill the ethical and legal functions entrusted to them [ 25 , 27 , 28 ].…”