Use of a simplified consent form to facilitate patient understanding of informed consent for laparoscopic cholecystectomy

Abstract

<jats:title>Abstract</jats:title><jats:sec id="j_med-2016-0092_s_333_w2aab3b8c87b1b7b1aab1c14b1Aa"><jats:title>Background</jats:title><jats:p>Surgical informed consent forms can be complicated for patients to read and understand. We created a consent form with key information presented in bulleted texts and diagrams combined in a graphical format to facilitate the understanding of information during the verbal consent discussion.</jats:p></jats:sec><jats:sec id="j_med-2016-0092_s_334_w2aab3b8c87b1b7b1aab1c14b2Aa"><jats:title>Methods</jats:title><jats:p>This prospective, randomized study involved 70 adult patients awaiting cholecystectomy for gallstones. Consent was obtained after standard verbal explanation using either a graphically formatted (study group, n=33) or a standard text document (control group, n=37). Comprehension was evaluated with a 9-item multiple-choice questionnaire administered before surgery and factors affecting comprehension were analyzed.</jats:p></jats:sec><jats:sec id="j_med-2016-0092_s_335_w2aab3b8c87b1b7b1aab1c14b3Aa"><jats:title>Results</jats:title><jats:p>Comparison of questionnaire scores showed no effect of age, sex, time between consent and surgery, or document format on understanding of informed consent. Educational level was the only predictor of comprehension.</jats:p></jats:sec><jats:sec id="j_med-2016-0092_s_336_w2aab3b8c87b1b7b1aab1c14b4Aa"><jats:title>Conclusions</jats:title><jats:p>Simplified surgical consent documents meet the goals of health literacy and informed consent. Educational level appears to be a strong predictor of understanding.</jats:p></jats:sec>

The evaluation of the readability of informed consent forms used for urology: Is there a difference between open, endoscopic and laparoscopic surgery?

“…Borello et al (1) prepared ICFs that were made easier to comprehend with marked texts and diagrams for laparoscopic cholecystectomy and reported that these forms are easier to understand and remember. Shukla et al (25) reported that the cataract surgery ICFs at the second-grade reading level and video support are easier to understand.…”

“…Informed consent means the authorization given to the health professional for the diagnosis or treatment interventions planned with the patient's consent. Informed consent forms (ICF), being an inseparable constituent of the consent phase, are used to help the patients during the treatment phase by explaining the indications, advantages, and possible risks of medical applications (1). It was also shown that these texts may be effective in solving problems in the treatment phase with advantages such as providing the patient-doctor communication and making the agreement of the patient to treatment easier (2,3).…”

Piercing and tattoos in adolescents: legal and medico-legal implications

“…Another essential requirement is the consent of the person concerned, subject to adequate information regarding the conditions of the operation, the possible risks associated with such practices, the precautions to be taken after receiving a tattoo or piercing and the eventual subsequent removal of the same. Consent of the person concerned is essential for the operator to intervene on his/her body [ 9 ]. However, this consent may never be valid to authorise an activity contrary to Art.…”

Evaluation of the Readability of Informed Consent Forms Used for Emergency Procedures

“…In previous studies, it was reported that these forms were made easier with marked texts and diagrams so that ICFs could be understood and remembered more easily and these video supported forms were more understandable and easier to remember [3,20].…”