The Impact of the Informed Consent Process on the Anxiety Levels of Patients Undergoing Rhinoplasty
A Aysel, U Uz, B Karatan, E Aydin, E Erdoğan, F Yilmaz, T Müderris
The Journal of Craniofacial Surgery, 15 July 2021
Abstract
Septorhinoplasty is one of the most common elective surgical procedures in otolaryngology. The present study aimed to evaluate the anxiety levels of patients who underwent septorhinoplasty at different times, compare the information methods, and determine the understanding of the informed consent through recall rates of the complications explained in the informed consent process. The patients were divided into the following 2 groups: Group 1 (giving information 14 days before the surgery) and Group 2 (giving information 3 days before the surgery). For the preoperative anxiety measurement, the State anxiety scale of the State-Trait Anxiety Inventory (STAI) was used. All patients were asked to recall the complications they remembered from the consent form on the day before the surgery. Each group has consisted of 25 patients. No significant difference was found between the STAI-1 and STAI-2a anxiety scores between groups. In Group 1, the STAI-2b anxiety score was significantly lower than the STAI-1 and STAI-2a scores (P < 0.05). In Group 2, the mean score of STAI-2b was not significantly higher than the STAI-1 and STAI-2 scores (P > 0.05). When the STAI-2b scores of the two groups were compared, the scores of Group 2 were significantly higher (P < 0.05). The most commonly remembered complications were bruising and swelling in both of the groups. In conclusion, the authors believe that long-term cooperation between the surgical team and the patient will reduce the anxiety levels of the patients and increase patients’ satisfaction, resulting in a significant reduction in the amount of potential legal processes. Level of Evidence: 2.

Computer-based tutorial to enhance the informed consent process for cataract surgery in Serbian or Turkish speaking patients
Research Article
Manuel Ruiss, Oliver Findl, Ana Prinz, Guenal Kahraman, Sava Barisic, Orkun Muftuoglu, Nino Hirnschall
Ophthalmic Research, 15 July 2021
Open Access
Abstract
Introduction
This study analyses if a translated version of the CatInfo tool increases the knowledge of Serbian and Turkish speaking patients about cataract surgery.
Methods
In total, 61 cataract patients, which were literate in Serbian or Turkish, were randomly allocated into two groups. Via an interactive computer-based tool (“CatInfo”), patients either saw a detailed audio-visual presentation about cataract surgery (study group) or a “placebo” video (control group). Afterwards all participants had a face-to-face discussion with an ophthalmologist. Immediately after the interview and on the day of surgery, all patients had to fill out a questionnaire including knowledge and demographic questions. Patients in the study group were further asked about their satisfaction with the CatInfo tool and the usefulness of such a device before other interventions.
Results
Patients in the study group answered significantly more questions correctly compared to control group and this information gain remained stable over a 1-week period. There was a significant low negative correlation between educational level and the test results, whereas age and computer habits of the participants did not have an influence on correct answers. Satisfaction with the CatInfo tool was high in the Serbian and the Turkish group (96% and 84%, respectively) and 92% of Serbian patients as well as 62% of the Turkish patients rated that they could imagine to use such a device before any other surgery.
Discussion/Conclusion
The translated version of the CatInfo tool improved patients’ knowledge and this information gain remained stable until the day of the surgery.

Informed Consent in Surgical Practice in Port Harcourt: How Informed are the Patients?
Promise N. Wichendu, Rex Friday Ogoronte A. Ijah, Friday E. Aaron, Alexander A. Dimoko, Joy O. Dayi, Ebimie M. Eleke
European Journal of Clinical Medicine, 14 July 2021; 2(3)
Open Access
Abstract
Aim
The aim of this study was to ascertain the opinion of patients on counselling of the surgical patient in tertiary healthcare facilities in Port Harcourt in the months of May and June 2020.
Background
Counseling of the surgical patient is a dynamic process and its scope which is individualized should arm the patient with information on the purpose and nature of the disease and treatment, etc.
Materials and Methods
Four hundred and twenty respondents were recruited for this cross-sectional descriptive study carried out in the wards and specialist surgical out-patient clinics of Teaching Hospitals in Port Harcourt, Nigeria between the months of May and June 2020 using semi-structured questionnaires. Data obtained was analysed using the Statistical Package for the Social Sciences (SPSS) version 20.0.
Results
Two hundred and twenty-five (53.6%) respondents asserted that they had counselling sessions for the surgical operation, 108 (25.7%) respondents opined that they did not have counselling session, while 87 (20.7%) were not sure if they had or not. Forty-five (10.7%) respondents asserted that the surgeons carried out the counselling. Only, 227 (54.0%) of the respondents affirmed that they were satisfied with the counselling sessions, while 104 (24.8%) respondents asserted that there was no counselling session at all.
Conclusion
The opinion of patients on the counselling service experience is not entirely satisfactory. There is need for closer attention to be paid to issues of counselling of the surgical patient in order to ensure the full benefits of the services rendered.

Soft Tissue Filler Therapy and Informed Consent–A Canadian Review
Review Article
John P. Arlette, Andrea L. Froese, Jaspreet K. Singh
Journal of Cutaneous Medicine and Surgery, 6 July 2021
Abstract
Soft Tissue Filler (STF) Therapy for cosmetic facial rejuvenation is associated with known complications. The manifestation of these known complications can lead to patients commencing civil litigation actions or making complaints to provincial regulatory authorities and alleging that the practitioner failed to obtain the patient’s informed consent to the therapy. Data provided by the Canadian Medical Protective Association (CMPA) on medical-legal cases arising from the provision of STF therapy between 2005 and 2019 are presented. Select reported case law decisions from Canadian courts and regulatory bodies addressing the concept of informed consent are reviewed. Insights about the risk factors pertaining to the process of obtaining informed consent for STF therapy are presented to increase an understanding of the elements of communication and documentation needed to ensure patients are aware of the consequences of this treatment.

Informed consent in inflammatory bowel disease: a necessity in real-world clinical practice
Nikolaos Kyriakos, Apostolis Papaefthymiou, Marios Giakoumis, George Iatropoulos, Gerasimos Mantzaris, Christos Liatsos
Annals of Gastroenterology, 3 June 2021; 34(4) pp 466-475
Abstract
In modern medicine, any medical intervention has to be supported by a patient’s informed consent. Challenges to this process include the specificity and complexity of medical information being provided, the patient’s ability to comprehend the information, the medical uncertainty of the outcomes, and the physician’s legal concerns. Important elements of the consent process are respect for the patient’s autonomy and self-determination, appropriate disclosure and verification of their understanding, and voluntariness. In inflammatory bowel disease (IBD), pharmaceutical treatment carries significant risks, making discussion and illustration of the treatment critical for decision making. This review aims to emphasize the importance of the informed consent process in routine IBD clinical practice, and suggests an appropriate way of informing patients about the medical treatment on offer. The information that has to be comprehensively presented before consent includes: i) treatment goal; ii) basic characteristics of treatment (route and timetable of drug administration, drug efficacy, adverse events); and iii) consequences of staying untreated. The IBD physician’s main concerns must include ensuring not only that the information being provided is detailed and objective, but also that the decision-making process is shared with the patient. Ultimately, the process of obtaining informed consent in real-world clinical practice is undoubtedly of great importance, for both upholding the principles of medical ethics and avoiding legal conflicts.

Preoperative patient anxiety level before and after informed consent for general anesthesia
Ardi Pramono, Bagus Putra Raharjo
Russian Open Medical Journal, 20 April 2021; 10(2)
Open Access
Abstract
Background
Informed consent anesthesia should be administered even in pediatric patients through their parents, thereby reducing anxiety.
Objective
This study aimed to determine the difference in anxiety level of the preoperative patient before and after given informed consent about general anesthesia.
Settings and Design
This was a quasi-experimental study with one group pre-test and post-test study design.
Material and Methods
Patients who were to undergo surgery with general anesthesia in PKU Muhammadiyah Gamping Hospital were the subjects in this study. There were 41 subjects selected as study samples using consecutive sampling. Anxiety level was assessed by the HRSA scale (0.91 and 0.97). Statistical analysis used: All data were analyzed by the marginal homogeneity comparative test.
Results
A significant decrease in preoperative patient anxiety levels was observed after the patient was given general anesthesia informed consent (p<0.05), compared to levels before informed consent. Thus, giving informed consent before general anesthesia could decrease the subject’s anxiety level in preoperative patients.
Conclusion
Thus, giving informed consent prior to general anesthesia could decrease the subject’s anxiety level in preoperative patients.