Professionalism in Anesthesiology: Honesty and the Informed Consent Process
Krishnan S. Ramanujan, Saundra Curry, Stephen H. Jackson
ASA Monitor, August 2021; 85(38)
Abstract
Medical professionalism is one of the core components of the practice of medicine and an evolving concept reflecting the changes in our health care system. In 2002, the ABIM Foundation defined medical professionalism in its Physician Charter, stating that professionalism “supports physicians’ efforts to ensure that the healthcare systems and physicians working within them remain committed both to patient welfare and to the basic tenets of social justice.” (Ann Intern Med 2002;136:243-6) The Physician Charter enumerated three fundamental principles as well as 10 responsibilities by which all physicians should abide, and it soon was adopted by many professional societies, including ASA (Ann Intern Med 2003;138:839-41). Eighteen years after its publication, the Physician Charter remains as the standard for professional conduct in medicine.

An Evaluation of the Comprehensibility Levels of Ophthalmology Surgical Consent Forms
Ibrahim Ethem Ay, Mustafa Doğan
Cureus, 26 July 2021; 13(7)
Abstract
Background/Aim
This study aimed to evaluate the comprehensibility of the consent forms used for interventional procedures in the ophthalmology clinic of a university hospital and to determine which texts could be read according to patient age and education level.
Materials and methods
Forty separate consent forms used as the standard for various interventional procedures in the ophthalmology department of a university hospital were evaluated. The comprehensibility formulas used were developed for the Turkish language by Ateşman and Bezirci-Yilmaz.
Results
As a result of the evaluation of the consent forms in this study, a mean of 55.6±5.73 points was obtained according to the Ateşman comprehensibility index, and this value was found to correspond to being understood by eleventh and twelfth-grade school students. According to the Bezirci-Yilmaz comprehensibility index, the mean points of the consent forms were 10.05±2, which corresponded to a level that could be understood by 10th and 11th-grade students.
Conclusion
The comprehensibility level of the consent forms given to patients was found to be low in this study, which was similar to the findings of previous studies in the literature. When preparing informed consent forms, the education level of the country must be taken into consideration.

Patch test informed consent form: position statement by European Academy of Dermatology and Venereology Task Force on Contact Dermatitis
Position Statement
Balato, E. Scala, F. Ayala, A. Bauer, M.-N. Crépy, M. Gonçalo, J. Duus Johansen, S.M. John, T. Rustemeyer, N. Wagner, M. Wilkinson, A. Giménez-Arnau
Journal of The European Academy of Dermatology and Venereology, 19 July 2021
Abstract
Background
To our knowledge, an international consensus is lacking regarding the development of an adequate informed consent form for a patch test (PT) and the information that should be included in such document.
Objectives
The aim of the study was to reach a consensus on the specific points that need to be addressed in a PT consent form.
Methods
A Delphi survey, comprising 2 rounds and 1 final discussion, was used to gather and analyse data, which was conducted over the Internet. Each statement that reached a consensus with the respondents (9 expert dermatologists from Europe) was defined as a median consensus score (MED) of ≥7 and agreement among panelists as an interquartile range (IQR) of ≤3. All study participants were members of the EADV task force on contact dermatitis.
Results
The expert panel addressed several topics that should be included in an informed consent form for a PT: introduction, preparation for PT, testing procedure, allowed activities, adverse events and additional authorizations.
Conclusions
Our results assess recommendations regarding points to be contained in an informed consent form for a PR. Future actions towards standardization and harmonization of this specific consent form are needed.

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.

Autonomy and consent assessment for electroconvulsive therapy (ECT). A retrospective study of medical records
Jørgen Dahlberg Siri Øverstad, Vegard Dahl, Alina Coman
International Journal of Law and Psychiatry, July–August 2021; 77
Abstract
    The Norwegian Mental Health Act allows involuntary treatment for patients who lack consent capacity, however it allows only administration of pharmaceutical treatment and nutrition and not ECT. In lack of specific regulations, the legal access to ECT without valid consent has been grounded on the general rule of necessity in the Norwegian Penal code. This restriction and lack of legal regulation has implications for patients’ rights and legal security.
The study’s aim was to assess the documented consent provided by patients for electroconvulsive therapy (ECT), whether ECT was administered without valid consent or under coercion, and the documented reasons, and ultimately compare practice with the legal requirements. We analysed systematically all the relevant medical records for hospitalised patients and outpatients receiving ECT during 2011–2016. We categorized data from these two groups into seven defined categories describing the attitude and quality of the consents to the ECT (or lack thereof).
378 patients received 498 ECT series´. The noted consents varied from treatment based on request (54 treatments), consent upon recommendation (209 treatments), consent after hesitation (88 treatments), consent presumed or noted without specification (114 treatments), to no consent (21 treatments) whereof the majority with documented coercion applied (19 treatments). All cases of ECT without consent referred to a “plea of necessity”. The remaining treatments (12) lacked notifications specifying the consent (or attitude) expressed. Specific notes on the patient’s capacity to consent for the respective ECT were generally lacking.
This study indicates a large spread in patients´ acceptance and valid consent to ECT. The main reason for administering ECT without consent and/or against patients’ will was for life-saving reasons. Such treatments were justified legal under a plea of necessity in the Penal Code or lacked noted legal justification. The legal vacuum for ECT without a valid consent needs to be addressed as this kind of disputed treatment is used in some cases.