Does written informed consent adequately inform surgical patients? A cross sectional study

Abstract

BackgroundInformed consent (IC) is an essential step in helping patients be aware of consequences of their treatment decisions. With surgery, it is vitally important for patients to understand the risks and benefits of the procedure and decide accordingly. We explored whether a written IC form was provided to patients; whether they read and signed it; whether they communicated orally with the physician; whether these communications influenced patient decisions.MethodsAdult postsurgical patients in nine general hospitals of Italy’s Campania Region were interviewed via a structured questionnaire between the second and seventh day after the surgery at the end of the first surgical follow up visit. Physicians who were independent from the surgical team administered the questionnaire.ResultsThe written IC form was given to 84.5% of those interviewed. All recipients of the form signed it, either personally or through a delegate; however, 13.9% did not know/remember having done so; 51.8% said that they read it thoroughly. Of those who reported to have read it, 90.9% judged it to be clear. Of those receiving the written consent form, 52.0% had gotten it the day before the surgery at the earliest 41.1% received it some hours or immediately before the procedure. The written IC form was explained to 65.6% of the patients, and 93.9% of them received further oral information that deemed understandable. Most attention was given to the diagnosis and the type of surgical procedure, which was communicated respectively to 92.8 and 88.2% of the patients. Almost one in two patients believed that the information provided some emotional relief, while 23.2% experienced increased anxiety. Younger patients (age ≤ 60) and patients with higher levels of education were more likely to read the written IC form.ConclusionsThe written IC form is not sufficient in assuring patients and making them fully aware of choices they made for their health; pre-operative information that was delivered orally better served the patients’ needs. To improve the quality of communication we suggest enhancing physicians’ communication skills and for them to use structured conversation to ensure that individuals are completely informed before undergoing their procedures.Electronic supplementary materialThe online version of this article (10.1186/s12910-018-0340-z) contains supplementary material, which is available to authorized users.

Exploring the hospital patient journey: What does the patient experience?

“…In this sense, the use of shadowing helps to understand the experience in a real time context. Moreover, it is always useful to evaluate whether the tools and information methods used for giving information to patients are effective, and which is the best moment for each patient to receive all the information they need, by considering their ability to absorb the information in a stressful situation [46–48].…”

Trends in Shared Decision-Making Studies From 2009 to 2018: A Bibliometric Analysis

“…Therefore, five phrases with higher burst were selected for in-depth analysis: "Informed consent, " "Surgery, " "Depression, " "Older adult, " and "Patient-centered care." "Informed consent" is a dynamic process used to build mutual trust, in which the clinicians communicate with the patients to ensure that the patients know his or her own treatment decisions, and it usually includes oral communication and text material (22). A cross sectional study showed that age and level of education may influence the adequacy of written informed consent for surgical patients (22).…”

“…"Informed consent" is a dynamic process used to build mutual trust, in which the clinicians communicate with the patients to ensure that the patients know his or her own treatment decisions, and it usually includes oral communication and text material (22). A cross sectional study showed that age and level of education may influence the adequacy of written informed consent for surgical patients (22). Especially, a recent article (23) highlighted that the concept of traditional "Informed Consent" is evolving to match the requirements of the relatively new era of SDM.…”

Role of the consent form in UK veterinary practice

“…However, it is the form’s role as a record of the consent conversation that is perhaps under-researched. Few authors have examined this area, although some have included the consent conversation as an adjunct to research focused on the form itself, 9 while others have examined the respective roles of the form and the conversation with a view to improving the consent process. 10 …”