Are Patients Willing to Be Informed on the Risks and Complications Associated with the Proposed Therapy? A Survey on Informed Consent
Aigli Dafni, Panagoula Oikonomou, Konstantinos Anagnostopoulos, Christos Tsalikidis, Nigyar Dzhafer, Alexandra K. Tsaroucha, Mickael S. Pitiakoudis
Folia Medica, 31 August 2021; 63(4) pp 569-575
Abstract
Introduction
Informed consent is essential to the patient-physician relationship. The paternalistic old-time approach used by physicians to achieve the optimal management is changing today; detailed medical information must be disclosed to the patients regarding their health problem.
Aim
The aim of this study was to highlight the value of informed consent in the context of medical practice as well as to emphasize its importance through the prism of human rights.
Materials and methods
A patient survey was conducted in two public and one private hospitals in Greece. Eighty-three inpatients from the Surgical Departments of Democritus University Hospital of Alexandroupolis (DUHA), Laikon University Hospital of Athens (LUHA) and a private hospital were included in the study. A questionnaire regarding patients’ attitude towards informed consent was distributed to patients prior to surgery.
Results
The majority of the patients (63.86% in DUHA, 59.38% in LUHA, and 78.95% in the private hospital) opted for full disclosure regarding the course and development of their condition.
Conclusion
Patients want to be informed about their treatment options and possible complications so that they can make decisions about their treatment after a comprehensive and understandable discussion.

Informed consent and birth preparedness/complication readiness: A qualitative study at two tertiary maternity units
Original Article
Sally Ely, Susanne Langer, Hans Peter Dietz
The Australian and New Zealand Journal of Obstetrics and Gynaecology, 29 August 2021
Abstract
Background
Informed consent in obstetrics should involve full disclosure of risks, benefits and alternative interventions. However, we have found no evidence of a formal informed consent process before an attempt at vaginal delivery in published policy or practice. The idea of informed consent in vaginal birth has attracted controversy and has been the subject of some debate.
Aim
To explore the perspectives and experiences of informed consent and birth preparedness/complication readiness for birthing women in a high resource setting.
Materials and methods
Qualitative study using semi-structured interviews to examine experiences and perspectives of women following birth.
Results
Forty telephone interviews were concluded. Eight statement categories were identified: (i) no issues of consent, (ii) absent/inadequate informed consent, (iii) adequate birth preparedness/complication readiness, (iv) inadequate birth preparedness/complication readiness, (v) desire to forfeit decision making to a trusted and accountable health professional, (vi) belief that informed consent is not realistic in birth under some circumstances, (vii) negative feelings related to birth and (viii) poor postnatal follow-up.
Conclusions
When complications arose during birth, 20% of participants felt that informed consent was absent/inadequate, 25% of participants suggested policy change in favour of a formal informed consent process and 55% of participants suggested policy change in favour of increased birth preparedness/complication readiness. Our study suggests that informed consent for vaginal birth and formal birth preparedness/complication readiness should form part of routine antenatal care. Women’s preferences for decision-making and informed consent should be established before birth.

Ethical evaluation of informed consent forms used in cardiology clinics and the importance of institutional standardized approach
Original Article
Aksüyek Savaş Çelebi, Perihan Elif Ekmekçi, Müberra Devrim Güner
Turkish Society of Cardiology, 9 February 2021; 49(6) pp 477-487
Open Access
Abstract
Objective
This study aimed to evaluate the content of informed consent forms (ICFs) used during cardiology interventions by the university, research and training (R&T), and private hospitals with regard to ethical standards and compare them with the Turkish Society of Cardiology (TSC) templates and among various institutions.
Methods
A total of 185 forms from the university, R&T, and private hospitals and 19 TSC templates were selected and analyzed for 26 criteria. Compliance with TSC templates was also evaluated. Data were presented as the percentage of ICFs satisfying the criteria and compared using the Fisher exact test, and 95% confidence intervals were calculated.
Results
TSC templates were more compatible and included more information to comply with ethical standards than ICFs of all 3 types of healthcare institutions. The areas of improvement for these templates were prospects of treatment and alternative treatments, quality of life, explanation for third-party consent, duration of hospitalization, and time to return to normal life. Among the 3 types of hospitals, R&T-ICFs were more compatible with templates. Private hospital ICFs had the poorest compliance with TSC templates. Separate anesthesia ICFs and detailed information about exposure to radioactivity were lacking.
Conclusion
The current ICFs for cardiology interventions have major ethical deficiencies and need urgent improvement. Professional societies such as TSC are essential institutions to develop and provide guidance and templates for ICFs to meet the ethical standards during the informed consent process and standardization of the process among various institutions.

Informed Consent in Dentistry – When, Why and How
Jelena Roganović
Studia Universitatis Babes-Bolyai Bioethica, 2021; 65 pp 147
Abstract
For dentists, as well as for other health care practitioners, it is mandatory to obtain informed consent from their patients, implying that a dialog has taken place and that patients understand the risks, benefits and alternatives to rendered treatments. Having in mind that majority of dental procedures are surgical in nature, leading to irreversible change to orofacial tissues and with the risk of unwanted side effects, well-documented informed consent process needs to be a basic norm in the dental practice. Clinical experience suggests that verbal discussion along with providing informed consent forms may not be enough and that patients response and understanding may improve by adding adjunctive materials like brochures or videos related to planned procedures. Many companies for implants and dental materials supply dental offices with the brochures and pamphlets, mostly for marketing purposes. Therefore, the use of these materials must be used with caution while objectively discussing other reasonable options. With the increasingly growing phenomenon of dental tourism, an important dentist-patient relationship ethical issues arise. Namely, issues regarding patient autonomy over practitioner choice, patient safety, and optimal care are under constant reconsideration while informed consent has to specify circumstances underlying treatment plan and posttreatment care. Currently, there is a paucity of information regarding informed consent in dentistry, and vital ethical issues associated with recent developments in dental practice need to be addressed in the near future.

Practice variation in the informed consent procedure for thrombolysis in acute ischemic stroke: a survey among neurologists and neurology residents
Research
Valentijn J. Zonjee, Jos P. L. Slenders, Frank de Beer, Marieke C. Visser, Bastiaan C. ter Meulen, Renske M. Van den Berg-Vos, Sander M. van Schaik
BMC Medical Ethics, 25 August 2021; 22(114)
Open Access
Abstract
Background
Obtaining informed consent for intravenous thrombolysis in acute ischemic stroke can be challenging, and little is known about if and how the informed consent procedure is performed by neurologists in clinical practice. This study examines the procedure of informed consent for intravenous thrombolysis in acute ischemic stroke in high-volume stroke centers in the Netherlands.
Methods
In four high volume stroke centers, neurology residents and attending neurologists received an online questionnaire concerning informed consent for thrombolysis with tissue-type plasminogen activator (tPA). The respondents were asked to report their usual informed consent practice for tPA treatment and their considerations on whether informed consent should be obtained.
Results
From the 203 invited clinicians, 50% (n = 101) completed the questionnaire. One-third of the neurology residents (n = 21) and 21% of the neurologists (n = 8) reported that they always obtain informed consent for tPA treatment. If a patient is not capable of providing informed consent, 30% of the residents (n = 19) reported that they start tPA treatment without informed consent. In these circumstances, 53% of the neurologists (n = 20) reported that the resident under their supervision would start tPA treatment without informed consent. Most neurologists (n = 21; 55%) and neurology residents (n = 45; 72%) obtained informed consent within one minute. None of the respondents used more than five minutes for informed consent. Important themes regarding obtaining informed consent for treatment were patients’ capacity, and medical, ethical and legal considerations.
Conclusion
The current practice of informed consent for thrombolysis in acute ischemic stroke varies among neurologists and neurology residents. If informed consent is obtained, most clinicians stated to obtain informed consent within one minute. In the future, a shortened information provision process may be applied, making a shift from informed consent to informed refusal, while still considering the patient’s capacity, stroke severity, and possible treatment delays.

A Critical Appraisal of Variability in Informed Consent for Vascular Access Procedures
Research Article
Blake Hotchkiss, Judy Thompson
Journal of the Association for Vascular Access, 18 August 2021
Abstract
Background
Vascular access device insertion is one of the most performed procedures in healthcare today. With different device types available to provide infusion therapy, there are many different variables to consider, including the process of obtaining informed consent from patients. This literature review aims to discuss common themes present in current evidence-based practice and point out critical areas of variability that exist.
Methods
A literature review was conducted searching Cochrane Library, Joanna Briggs Institute for Evidence-Based Practice, Cumulative Index to Nursing and Allied Health Literature, PubMed, and Google Scholar databases for recently published articles in the English language and those written in English. Articles were screened to include those that describe informed consent within the context of vascular access or other invasive procedures. There were 35 articles and 5 systematic reviews identified that met criteria for inclusion in this literature review.
Discussion
The topics of ethics, legal responsibility, who provided consent, and how education about procedures was performed demonstrated clear insight into how to improve the consent process. Some areas in current evidence lack clear direction and create variability in the informed consent procedure. These included who should obtain consent from the patient and which vascular access devices required a written consent. Who obtains consent was found to be more related to current legal precedence and not the clinician inserting the device like that found when a nonphysician clinician performed the procedure. Vascular access device related variability in requiring written versus verbal consent was found to be rooted in the degree of complexity of the procedure, need for specialized training, and the inherent risk to the patient.
Conclusion
These two areas of variability described in current clinical practice require more research and consensus agreement to standardize the practice of obtaining informed consent in vascular access device insertion.

Does radiology require informed consent for radiation risk?
Commentary
Elizabeth M Davies, Andrew J Bridges, Emma ML Chung
The British Institute of Radiology, 6 August 2021
Abstract
Recent trends in medical decision-making have moved from paternalistic doctor-patient relations to shared decision-making. Informed consent is fundamental to this process and to ensuring patients’ ongoing trust in the health-care profession. It cannot be assumed that patients consent to the risk associated with medical exposures, unless they have been provided with the information to make that decision. This position is supported by both the legal and ethical framework around Radiation Protection detailed in this commentary.

Are patients truly informed? A retrospective chart review of the documentation of informed consent in laparoscopic cholecystectomy
Erin Williams, Raj Selvam, Wilma Hopman, Sulaiman Nanji
Canadian Journal of Surgery, 29 July 2021; 64(4)
Abstract
Background
Research on informed consent (IC) has traditionally focused on the documentation of the discussion with patients of potential complications. We sought to examine the completeness of documentation for all elements of IC for laparoscopic cholecystectomy (LC): potential complications, alternatives to LC and details of the procedure. Differences in the documentation of IC for elective and emergent LC were examined.
Methods
A retrospective chart review of patients undergoing LC at our institution between 2015 and 2017 was performed. Completeness of documentation was defined as documentation of all 3 elements of IC in the clinic note, the operating room note or the consent form itself. Data were analyzed descriptively. We compared documention for emergent and elective cases as well as documentation by residents and attending physicians using t tests.
Results
A total of 270 patients were included in the analysis. Only 5 (2%) had complete documentation of all elements of IC. Documentation of potential complications was noted in 232 cases (86%), of which 58 (25%) were elective and 174 (75%) were emergent. Details were noted in 28 (10%) cases, of which 21 (75%) were elective and 7 (25%) were emergent. Alternatives were documented the least frequently: they were documented in 23 cases (9%), of which 20 (87%) were elective and 3 (13%) were emergent. Residents performed better than attending physicians in documenting IC discussions in clinic notes and on consent forms, but not in operating room notes.
Conclusion
Documentation of the elements of IC for LC was poor. Potential complications were the most frequently documented element of IC; alternatives and details were often omitted. Future studies comparing audiotaped IC conversations with the documentation of IC are warranted. The use of procedure-specific consent forms for LC may facilitate documentation.

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, 26 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.

An Evaluation of the Comprehensibility Levels of Ophthalmology Surgical Consent Forms
Original Article
Ibrahim Ethem Ay, Mustafa Doğan
Cureus, 26 July 2021
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.