Informed Consent: How much information is enough? In a Obstetrics and Gynaecology Department in Tertiary Care Hospital – An Interventional Study
Indian Journal of Forensic Medicine & Toxicology, 17(2), April-June 2023
Open Access
Abstract
Permission granted in full knowledge of the possible consequences, typically that which is given by a patient to a doctor for treatment with knowledge of the possible risks and benefits. A process in which patients are given important information, including possible risks and benefits, about a medical procedure or treatment, genetic testing, or a clinical trial. This paper was an interventional study it was conducted in the Department of Forensic Medicine and Toxicology, Sri Manakula Vinayaga Medical College and Hospital, Madagadipet, Puducherry to audit and to improve it was conducted in the Department of Obstetrics and Gynaecology. The deficiencies were identified and it was analysed. The results of both pre-interventional and post-interventional were recorded, which showed the significant improvement in the consent form of the major and minor procedures. It is essential that this information be discussed in simple terminology that can be easily readily understood and help the patient to give proper consent for the procedures.

Traditional Health Care Practitioners’ Perspectives on Applying Informed Consent During African Traditional Medical Practice in Akwa Ibom State, Nigeria: A Cross-Sectional Qualitative Study
Francis Akpa-Inyang, Sylvester C. Chima
Journal of Integrative and Complementary Medicine, 17 April 2023
Abstract
Introduction
This study explored the perspectives of traditional health care practitioners (THPs) practicing in the areas of herbalism, bone setting, and traditional birth attendance, from Akwa Ibom state, Nigeria, on the possibility and implications of applying informed consent (IC) during African traditional medicine (ATM) practice.
Methods
Semistructured interviews were conducted with 11 THPs, consisting of 5 herbalists, 3 traditional bone setters (TBS), and 3 traditional birth attendants (TBAs), who represented the diverse groups that the study intended to cover. In-depth interviews were conducted using a semistructured guide and were recorded, transcribed, and analyzed using thematic analysis with the assistance of NVivo® qualitative analysis software.
Results
Participants were seven males (64%) and four females (36%), 35–67 years of age, with 5–25 years of experience as THPs. Forty-six percent of participants were herbalists (27%), TBS, and TBAs (27%). Most participants (82%) were Annang, and (18%) were Ibibio first-language speakers. Three major themes emerged from the data analysis: (i) Existing ethical framework related to IC, (ii) knowledge of consent, and (iii) application of IC during traditional medical practice. These themes and relevant subthemes were explored. All (100%) THPs agreed that it was essential to communicate risks and benefits while allowing patients to ask questions before treatment. All participants (100%) stated that risk communication is essential in ATM, whereas 36% said they communicated all therapy benefits to their patients. Respondents believed patients could make an informed choice if they had complete information disclosure. However, THPs in this study had limited knowledge of formal IC rules and regulations.
Conclusions
This study revealed that THPs in this setting disclose a diagnosis, risks, some benefits, and treatment options to patients. Consent/agreement was obtained verbally and voluntarily during ATM practice, consistent with IC doctrine. THPs had limited knowledge of the critical elements of IC. However, they suggested that a form of IC that does not conflict with traditional African norms could be applicable in ATM. IC could facilitate documentation and help reduce risks in ATM practice.

Determination of the Readability Level of Consent Forms Used in the Gynecology and Obstetrics Clinic at Suleyman Demirel University
Cem Dağdelen, Evrim Erdemoğlu
Cureus, 5 April 2023; 15(4)
Open Access
Abstract
Background
This study aimed to evaluate the readability level of consent forms used for interventional procedures in the obstetrics and gynecology clinic and to determine the readability of the texts according to the education level of the patient.
Methodology
This study determined the readability of patient consent forms used before interventional procedures in the gynecology and obstetrics clinic at the Suleyman Demirel University Hospital, Isparta. The consent forms were divided into two main groups according to their use in obstetrics and gynecology procedures. The readability level of consent forms was assessed using two readability formulas developed by Ateşman and Bezirci-Yılmaz, which determine the readability level of Turkish texts in the literature.
Results
When the consent forms were analyzed according to Atesman’s readability formula, they were found to be readable with more than 15 years of education at the undergraduate level, while according to Bezirci-Yılmaz’s readability formula, they were found to be readable with 17 years of education at the postgraduate level.
Conclusions
Easy-to-read consent forms will ensure that patients are more informed about interventional procedures and participate more effectively in the treatment process. There is a need to develop readable consent forms suitable for the general education level.

Editor’s note: Suleyman Demirel University is located in the Karasay region of Kazakhstan.

Cardiac Transplant in Southeast Asia: Challenges and Opportunities
Sulague, N. Cruz, R. Ricardo, P. Alfonso, D. Vervoort
The Journal of Heart and Lung Transplantation, April 2023; 42(4)
Abstract
Purpose
Among the 18.6 million cardiovascular deaths worldwide, 33.5% occurred in Southeast Asia, where cardiovascular diseases constitute 40.2% of all causes of mortality and injury. There is higher prevalence of symptomatic heart failure in Southeast Asian countries compared with the rest of the world. While advances improved cardiac transplantation, challenges remain to make it widely available. The study aims to discuss its challenges and opportunities in Southeast Asia.
Methods
A review of related literature was conducted on PubMed using combinations of variations of key terms such as cardiac transplant, heart transplant, Southeast Asia, and countries within the region. Ministries of health websites in the region were reviewed for cardiac transplant-related policies. The global burden of disease of heart failure-associated conditions from 2000 to 2019 in disability-adjusted life-years were assessed in the Southeast Asian region and other select geographical region using the Institute for Health Metrics and Evaluation Global Burden of Disease Results Tool.
Results
Southeast Asia’s burden of disease is comparable to Western Europe but does not have the same high volume of cardiac centers, health workforce, and robust network of organ donors. Substantial financial risk protection remains limited for most of the countries. Main barriers to organ donation include knowledge gaps, sociocultural and religious restrictions, and lack of infrastructure. At present, all countries follow an opting-in system based on informed consent, except Singapore which follows an opting-out system based on presumed consent. Association of Southeast Asian Nations may be optimized to promote cooperation, physician mobility, improved training, and policymaking.
Conclusion
Southeast Asian countries may benefit from considering opting-out scheme for donation, implementing a national system for organ donation, forming a centralized body directing all transplant activities, and improving public health education on transplantation.

Understanding of informed consent by patients at the Faculty of Dentistry of the University of Costa Rica
José Manuel Fernández Chaves
Medicina Legal de Costa Rica, March 2023
Abstract
Introduction
Informed consent is the result of the evolution of the relationship between health professionals and their patients or users where the principle of autonomy is above anything else. There are many articles on informed consent but none of the studies found assessed whether patients really understand it. The objective of this research was to determine the level of understanding of informed consent by the patients of the Clinic of Oral Surgery of the Faculty of Dentistry of the University of Costa Rica, in the period August to September 2022, by means of a questionnaire that would allow correlating the understanding with the level of schooling.
Materials and methods
A questionnaire was administered to 100 people divided into two parts, one on sociodemographic data and the other to establish the understanding of informed consent and to determine whether the level of schooling was related to the understanding of the same.
Results
The group between 20 and 30 years of age was the largest, of these 51% had university studies, and although the majority (98%) referred to knowing the concept of informed consent, only 33% obtained the correct answers to the clinical questions asked.
Conclusions
Even though patients refer to knowing what informed consent is the results suggest an unclear understanding of important concepts such as complications or immediate or late adverse reactions produced by the effect of dental treatments or surgical procedures.

Informed Consent in Dental Practice: A Qualitative Analysis of Awareness and Apprehensions Among Practitioners in South India
Dr Baiju R M, Dr Elbe Peter, Dr Vivek Narayan, Dr Roshna E K, Dr Abhilash Babu, Dr Nandimath Omprakash V
International Journal of Social Science And Human Research, 2 February 2023; 6(2)
Open Access
Abstract
Context
The push for autonomy and liberalization has transformed the practice of medicine and dentistry from paternalism to a patient cantered model. Patient’s choice to accept or reject the proposed treatment is central to this new paradigm of health care. Informed consent is an essential tool for an ethical dental practice.
Aim
The objective of the present study was to explore the knowledge, attitudes, perceptions and prevailing practices among dentists regarding the informed consent process.
Materials and methods
A phenomenological approach was undertaken. A semi structured telephonic interview was conducted based on a flexible topic guide and continued until data saturation.
Statistical analysis
The data was transcribed verbatim. Coding and categorisation done. Anonymity was ensured in all steps. The data was subjected to a thematic analysis.
Results
Participants were apprehensive about the influence of social media on the new paradigm of doctor patient relationship and the increasing utility of specialists as a protection from litigation. Lack of clarity regarding the consent method has prevented its routine application.
Conclusions
It can be concluded that a comprehensive understanding regarding informed consent process was lacking among the participants.

Iranian women’s experiences of the episiotomy consent process: a qualitative study
Malihe Ghiasvand, Fatemeh Nahidi, Sedigheh Sedigh Mobarakabadi, Hamid Alavi Majd
British Journal of Midwifery, 1 February 2023; 31(2)
Abstract
Background
Knowledge of the benefits and complications of interventions related to medical procedures, such as episiotomy, enables women to make informed decisions regarding these interventions. This study investigated women’s experiences of the episiotomy consent process in Iran.
Methods
This qualitative study gathered data from 20 women through in-depth semi-structured interviews. The participants were selected from hospitals, health centers and gynecology clinics in Tehran. Content analysis was used to establish themes from the gathered data.
Results
The participants’ experiences showed that they felt that their needs were not met and that they were excluded from decision making regarding their birth.
Conclusions
Women were excluded from decision making and their unmet needs presented ethical challenges in the performance of episiotomy procedures. Neglecting women’s expectations, inducing absolute trust in obstetricians or midwives and failing to obtain informed consent paved the way for forced episiotomies. Proper education and obtaining informed and voluntary consent may facilitate women’s rights being respected.

Awareness of Post-Operative Patients Regarding Informed Consent Form in Public Tertiary Care Hospital of Peshawar Khyber Pakhtunkhwa: A Cross Sectional Survey
Original Article
Bakhtyar Ali Shah, Muhammad Anwar, Nusrat Begum, Naheed Akhtar, Amir Sultan, Muzamil Tariq, Sumaira Bibi
Pakistan Journal Of Health Sciences, 31 January 2023
Open Access
Abstract
The informed consent form is one of the components of bioethics. Written consent from the patient must be obtained prior to any medical or surgical procedure to give the patient freedom of choice. This factor has always been neglected when caring for patients in most third world countries.
Objective
To assess postoperative patient awareness of informed consent at Peshawar KP Tertiary Public Hospital (HMC).
Methods
This study was conducted from April 2021 to August 2021 at Hayatabad Medical Complex, a tertiary care public hospital in Peshawar. A total sample of 70 patients was drawn by consecutive selection. An adopted and pre-tested questionnaire was used for data collection. Questions were filled in by having the patient understand the question and receiving the answer from the patient.
Results
The majority (59%) of the patients included in this study were male, while the mean age was 35 years and the majority of the patients (44%) were illiterate. Awareness of variables (2–7) was 60%, 47%, 30%, 47%, 69%, and 53%, respectively, while awareness levels from questions 8–12 were 59%, 47%, 82%, 40%, and 60%, respectively.
Conclusions
The results of the current study indicate that the perception of informed consent among patients in tertiary care public hospitals is reasonably satisfactory, although some lack of participant knowledge of key issues has been identified and needs to be improved through education and awareness.

Consent and Complications in Health Care: The Italian Context
Review
Maricla Marrone, Enrica Macorano, Giuseppe Lippolis, Pierluigi Caricato, Gerardo Cazzato,
Antonio Oliva, Benedetta Pia De Luca
Healthcare, 27 January 2023
Open Access
Abstract
Informed consent is the manifestation of the will that a patient freely expresses toward a medical treatment. The physician is responsible for acquiring informed consent for both medical and nursing procedures. Informed consent represents a juridical–deontological tool that allows therapeutic choices to be shared with the user after having exhaustively explained the risks and benefits of the procedure itself. In fact, the physician has an obligation to provide the patient with clear and comprehensible information about the type of service, the methods of delivery, the benefits, the risks, even unforeseeable ones, and the complications. According to Italian legal guidelines, in cases of presumed health responsibility, the health professional accused of negligence will have to demonstrate that any complication that has arisen, although foreseeable, was not preventable. Through the analysis of a clinical case relating to the procedure of insertion of a bladder catheter performed by a nurse and a review of the literature, the authors explain the importance of the information that must be provided to the patient before carrying out any invasive procedure, even if not performed by the doctor. The authors describe the problem in the Italian context and propose a possible solution.