Do patients actually understand? An evaluation of the informed consent process for endoscopic procedures in rural Uganda
Abhishek R. Mogili, Daniel Mukisa, Peter Campbell, Angellica Giibwa, Moses Binoga, Arthur Emoru, Anna T. Kalumuna, Joseph O. Damoi, Chelsia Melendez, Jerome Waye, Michael L. Marin, Linda P. Zhang
Surgical Endoscopy, 14 June 2024
Abstract
Introduction
Improving surgical access in low- and middle-income countries is vital for the 5 billion people who lack safe surgical care. Tailoring a culturally sensitive approach to consent is essential for patient comprehension and comfort, thereby alleviating the effects of resource constraints and advancing equitable care. This study examines the consenting process for endoscopy at Kyabirwa Surgical Center in Kyabirwa, Jinja, Uganda, to assess patients’ knowledge and attitudes as a potential barrier to participating in endoscopic procedures.
Methods
All adult upper endoscopy (EGD) and colonoscopy patients were recruited to participate in a survey of their demographics, knowledge, and attitudes toward their procedure. All patients received a standard consultation explaining the procedure and its risks and benefits.
Results
75 patients were included; median age was 54 years and 56% (n = 42) were women. 92% (n = 69) of patients had never had an endoscopy before and 73% (n = 55) of patients were scheduled for an EGD while the remaining 27% (n = 20) were scheduled for a colonoscopy. Most patients 80% (n = 60) had a basic understanding of what an endoscopy is and 87% (n = 65) its diagnostic purpose. Few patients 15% (n = 11) knew of the most common side effects or if they would have a surgical scar 27% (n = 20). Overall, 46.7% (n = 35) of patients were moderately or severely fearful of getting an endoscopy. Additionally, 45.3% (n = 34) of patients were moderately or severely fearful of receiving anesthesia during their endoscopic procedure. Despite this fear, most patients 85.3% (n = 64) stated that they understood the benefits of the procedure either very well or extremely well.
Conclusions
Most patients understood the role that an endoscopic procedure plays in their care and its potential benefits. Despite this, many patients continued to have high levels of fear associated with both the endoscopic procedure and with receiving anesthesia during their procedure. Future patient education should focus on addressing patients’ fears and the risks of undergoing an endoscopy, which may improve the utilization of surgical services.
Month: June 2024
Consent and Educational Sensitive Exams on Anesthetized Patients: Experiences of Medical Students Across Canada
Consent and Educational Sensitive Exams on Anesthetized Patients: Experiences of Medical Students Across Canada
Phoebe Friesen, Wan-Li Sun, Sarah Towle
Journal of Obstetrics and Gynaecology Canada, 13 June 2024
Abstract
Objective
This study investigates experiences of medical students across Canada related to consent for educational sensitive (i.e., pelvic, rectal) exams under anesthesia (EUAs).
Methods
A bilingual online questionnaire was developed and distributed to medical students across Canada.
Results
Of 134 respondents, 63% had performed a pelvic EUA, 35% a rectal EUA, and 11% another sensitive EUA during their training. For those who had performed pelvic EUA, 28% were unsure if consent had taken place, 26% reported no specific consent, 20% reported specific consent, and 25% had mixed experiences of consent. For rectal EUAs, 48% reported no specific consent, 37% were unsure if consent had taken place, 13% reported that there had been specific consent, and 2% reported mixed experiences. Most respondents were uncomfortable (36%) or not sure if they were comfortable (32%) with how the consent process was handled for student pelvic EUAs; 31% were comfortable. In open-ended responses, respondents described a variety of experiences related to variability, discomfort, and authority.
Conclusion
Non-consensual educational sensitive EUAs continue to take place in medical training across Canada, although practices of consent are highly variable. The majority of respondents reported being uncomfortable or unsure if they are comfortable with how consent for educational sensitive EUAs was practiced during their training, and some respondents struggled to express their discomfort given the power dynamics at play.
Navigating the Ethical Terrain towards a Responsible Adoption of Health Information Systems: Recommended Ethical Pathways
Navigating the Ethical Terrain towards a Responsible Adoption of Health Information Systems: Recommended Ethical Pathways
Namgay Rinchen, Sonam Yoezer
Bhutan Health Journal, 28 May 2024
Abstract
Health Information System (HIS) improves healthcare data accuracy, care coordination, resource allocation, and informed decision-making. However, ethical concerns arise with data security, privacy, informed consent, and patient autonomy. This paper discusses the benefits and drawbacks of HIS and offers recommendations to address the ethical issues, crucial for countries like Bhutan undergoing healthcare digital transformation with Electronic Patient Information System (e-PIS) adoption. The main recommendations are: educating system personnel, establishing regulatory and ethical frameworks, implementing strong security standards, obtaining informed consent from patients, and enabling patients to access their own records. An integrated approach that balances technology and ethics is needed to successfully adopt HIS.
Dentists’ perspectives, practices, and factors associated with informed consent process for fixed prosthodontic treatment: a cross-sectional study of kampala metropolitan area, Uganda
Dentists’ perspectives, practices, and factors associated with informed consent process for fixed prosthodontic treatment: a cross-sectional study of kampala metropolitan area, Uganda
Research
Barbara Ndagire, John Barugahare, Sudeshni Naidoo, Joaniter Nankabirwa, Joan Nakayaga, Charles Mugisha Rwenyonyi
BMC Oral Health, 27 May 2024
Open access
Abstract
Background
Dentists have a legal and ethical obligation to obtain informed consent from patients before carrying out treatment. In Uganda, the process of obtaining informed consent in dentistry is not well documented. The aim of the present study was to determine dentists’ perspectives and practices regarding informed consent to fixed prosthodontic treatment (FPT) in Kampala Metropolitan, Uganda.
Methods
A quantitative cross-sectional study was conducted among 153 dentists from July to September 2023. Data were collected using a semi-structured self-administered questionnaire that included both closed- and open-ended questions. The questionnaire included items on participants’ sociodemographic information, perspectives, and practices about informed consent for FPT. Perspectives were rated using ten items on a five-point Likert scale. The minimum possible total score was 10, and the maximum possible score was 50. Descriptive statistics and Poisson regression were used to summarize and analyze the quantitative data, and the significance level was set at p < 0.05. Open-ended items were analyzed using content analysis.
Results
The majority (83.9%) of the participants were general dentists with working experience ranging from 1 to 38 years and a median of 8 years. The majority were familiar with the concept of informed consent and had positive perspectives regarding its use for FPT. The mean score for perspectives was 39.27 (SD, 5.42). However, there were variations in the practices of the dentists. More than three-quarters (87.6%) reported that they always obtained the patient’s informed consent before FPT. Less than a third (29.4%) obtained written consent for FPT. About half of the dentists provided information regarding the procedure, benefits, and risks of treatment during the consent process. Bivariate analysis showed that the use of written consent for FPT was significantly (p < 0.05) associated with having a work experience of more than 10 years and having had training involving informed consent after undergraduate studies.
Conclusion
The present study provides baseline data regarding perspectives and practices regarding informed consent for FPT among dentists in Uganda. It is recommended that regular training courses be developed to highlight the importance of improved informed consent practices for patient protection and to instruct dentists about obtaining valid informed consent. There is a need for future research to streamline guidelines for the informed consent process in dental care in Uganda.
Anatomical Human Body Donation In South Africa: Inconsistencies of Informed Consent
Anatomical Human Body Donation In South Africa: Inconsistencies of Informed Consent
Keegan O. Meiring, Victoria E. Gibbon, Amanda Alblas
Annals of Anatomy, 19 June 2024
Abstract
Introduction
Informed consent is critical for maintaining the ethical standards associated with the utilization of human donor bodies by tertiary education institutions. Body donation programs undertake the responsibility for procuring human donor bodies for didactic and research purposes. However, its processes require scrutiny regarding best practice guidelines and the South African National Health Act (SA-NHA) (2013). Moreover, acknowledging and addressing the current perceptions of human body donation are indispensable in bridging the gap between academia and society. This study aimed to compare informed consent documentation and procedures across South African tertiary education institutions and their affiliated human body donation programs (HBDP) in accordance with international guidelines. The findings were used to create a human body donation form template aligned to current international best practices for consideration by the South African HBDP.
Methodology
A review of information and consent forms collected from South Africa’s eight HBDP was conducted. The analyses consisted of a broad evaluation of information provided, ranging from the terms of use of bodies to the commitments made by HBDP to donors. The results were considered in conjunction with the International Federation of Associations of Anatomists and other recent publications on informed consent in HBDP.
Results
Only two of the eight HBDP provided information and consent forms in more than one language. Most allowed donors to select how their bodies will be utilized – education, training and/or research. Some (6/8) made provisions for the next-of-kin to receive the cremains. Only one tertiary educational institution mentioned the occurrence of a memorial service in its documentation. An HBDF template was created aligned to current international best practices for presentation and possible adaption by SA HBDP.
Discussion & Conclusions
Human body donation forms (HBDF) requires thorough examination for the promotion and sustainability of HBDP. Effective communication by employing standardized non-technical terminology conveyed in language that is understandable and native to potential donors facilitates the deliverance of informed consent. Inconsistencies regarding the use and management of bodies catalyze the weakening perception of human body donation. Thus, this process of securing informed consent for body donation should be conducted in conjunction with public awareness campaigns and underpinned by the necessary policy and legislative reform.
Pre-Mortem Interventions for the Purpose of Organ Donation: Legal Approaches to Consent
Pre-Mortem Interventions for the Purpose of Organ Donation: Legal Approaches to Consent
Renée Taillieu, Matthew J. Weiss, Dan Harvey, Nicholas Murphy, Charles Weijer, Jennifer A Chandler
Journal of Law, Medicine & Ethics, 31 May 2024
Abstract
The administration of Pre-Mortem Interventions (PMIs) to preserve the opportunity to donate, to assess the eligibility to donate, or to optimize the outcomes of donation and transplantation are controversial as they offer no direct medical benefit and include at least the possibility of harm to the still-living patient. In this article, we describe the legal analysis surrounding consent to PMIs, drawing on existing legal commentary and identifying key legal problems. We provide an overview of the approaches in several jurisdictions that have chosen to explicitly address PMIs within codified law. We then provide, as an example, a detailed exploration of how PMIs are likely to be addressed in one jurisdiction where general medical consent law applies because there is no specific legislation addressing PMIs — the province of Ontario in Canada.
Informed consent and Montgomery implications for clinical practice
Informed consent and Montgomery implications for clinical practice
Healthcare ethics and communication
Chantal Patel
Medicine, 28 May 2024
Abstract
Consent is central to the delivery of healthcare, and all healthcare professionals must obtain consent before proceeding with any interventions. The nature of informed consent allows the patient to fully participate in any proposed healthcare interventions. Informed consent requires high-quality information to be given that enables the patient to fully understand all the benefits as well as the risks associated with proposed interventions. This approach respects the right of the patient to self-determine what happens to their body provided they have the relevant capacity to understand the nature of the proposed intervention. Although consent may be seen as a procedural ‘must’, the importance of the dialogue that takes place between the patient and the clinician is what determines the validity of the consent as advocated by the Supreme Court ruling in Montgomery v Lanarkshire Health Board (Scotland) [2015]. It is noted that the number of legal cases related to consent has risen since the Montgomery decision.
Criminal Liability For Analysing Genomic Data Without Owner’s Consent: A Comparative Study
Criminal Liability For Analysing Genomic Data Without Owner’s Consent: A Comparative Study
Research Article
Fatiha Mohammed Gourari, Mohammad Amin Alkrisheh
Access to Justice in Eastern Europe, 2024
Abstract
Background
In the rapidly evolving landscape of genomics and biotechnology, the United Arab Emirates (UAE) has launched the Emirates Genome Program to harness the potential of genomic technologies for advancing healthcare services. Central to this initiative is the informed and voluntary participation of citizens in genetic research aimed at contributing to national health objectives through genetic data utilisation. Notably, the enactment of UAE Decree-Law No. (49) of 2023 underscores the importance of safeguarding genomic privacy as a foundational element for data security and individual rights. This study addresses the challenge of striking a delicate balance between individual genetic rights and the pressing scientific and medical needs of genomic research. It aims to analyse the right to genomic privacy and examine crimes associated with the unauthorised analysis of biological samples.
Methods
This research employed an analytical legal methodology and a comparative approach to explore the crime of disclosing genomic data. By analysing Decree-Law No. (49) of 2023 and other relevant Emirati legislation, we examined the legal framework governing genomic research and data protection in the UAE. Comparative legal analysis was then conducted between Emirati and French laws to identify similarities and differences in approaches to genomic data disclosure crimes. The study also considered international standards and ethical principles to provide a comprehensive, multidisciplinary understanding of the intersection of law, ethics, and science in genomic privacy.
Results and conclusions
This study’s findings underscore the necessity of establishing a robust legal framework that safeguards individual rights and ensures the confidentiality of genetic data. Such measures are crucial for fostering public trust in genomic research and aligning the UAE’s genomic endeavours with rigorous ethical and legal standards. Ultimately, Decree-Law No. (49) of 2023 exemplifies the state’s commitment to promoting ethical and legal practices in genomic research, thereby facilitating sustainable advancements in medical science.
A Systemic Review of the “Informed Consent” Process for Aesthetic Cosmetic Surgery Procedures
A Systemic Review of the “Informed Consent” Process for Aesthetic Cosmetic Surgery Procedures
Review Article
Jacqueline Maroon, Syeda Zakia Hossain, Lynette Mackenzie
The American Journal of Cosmetic Surgery, 17 June 2024
Open Access
Abstract
Informed consent is a foundational component of ethical patient care and may be effectively provided when a competent patient is given pertinent information to make well-informed decisions on their health care. Various studies have considered patients’ experiences with surgery for aesthetic reasons, rather than plastic surgery procedures which are medically warranted for reasons such as restoring form and function. Current empirical discourse on the consenting process, and ultimately how informed patients undergoing cosmetic surgical procedures are, is scant, particularly in Australia.
The key aim of this review was to synthesize qualitative and quantitative research which considers the consenting process and the factors which impact on the patient’s decision-making process to undergo invasive cosmetic procedures. Eligible studies were identified via systematic searching across the PubMed and Medline databases; and hand searches were conducted of gray literature databases including university databases and Google Scholar. Reference lists of included studies were also examined for relevant studies. Eligible studies had to meet specific participant criteria including an age requirement of 19 to 64 years and discuss factors or present discussion surrounding the “informed consent” process for invasive cosmetic procedures. The characteristics and findings of each study were extracted. The studies were analyzed and presented under question categories. The Mixed Methods Appraisal Tool was used to assess the quality of evidence. Thirty-one studies were eligible for inclusion. Most studies were quantitative (90.3%). The highest proportion of these studies were focused on the United States (51.6%), followed by the United Kingdom (12.9%). The dominant methodology utilized by these studies was questionnaires/surveys (37.5%). The literature identified was classed into one of the 5 groups based on their overall concepts and objective. These 5 categories included (1) articles focusing on the types of information which should be communicated to a patient before they undergo their procedure or provide consent; (2) legal claims and cases based on a lacking informed consent; (3) sources of information patients access to become “informed” on their procedure; (4) studies exploring the readability of online information on certain invasive cosmetic procedures; and (5) studies focusing on the most effective methods of obtaining patient consent for cosmetic surgery procedures. These categories were reformulated into research questions and addressed in the section “Results of the Findings.” Most of the studies included in this review were quantitative (90.3%). Most studies (where gender was mentioned) had a higher population of female participants or respondents. Women have a greater tendency to have cosmetic surgery opposed to men. There are few studies (particularly qualitative studies) exploring the pre-operative patient experience in Australia for those having or seeking cosmetic surgery.
A key stage in this process is obtaining and providing informed consent. A “lack of informed consent” is one of the more dominant factors identified consistently throughout these studies which focus on legal case reviews and claims. A significant source of information patients use to become informed of their procedure is through the Internet. This may be problematic as the readability of online materials is most commonly above the recommended reading level in multiple jurisdictions; and some online materials may have questionable accuracy or validity. Whether or not patients verify the information they access through external sources such as this, is of concern. There have been minimal studies identified exploring the patient experience pre-operatively including during their consultations and decision to provide consent.
Through Patients’ Eyes: Evaluating the Consent Process in Elective Orthopedic Surgery at a Tertiary Referral Center in Ireland
Through Patients’ Eyes: Evaluating the Consent Process in Elective Orthopedic Surgery at a Tertiary Referral Center in Ireland
Abobaker Younis, Mehad Elmubarak, Hussam Elkhwad
Cureus, 6 June 2024; 16(6)
Abstract
Background
Informed consent is a critical component of ethical clinical practice, particularly in elective orthopedic procedures. It ensures that patients understand the nature, benefits, and risks of the medical procedures they agree to undergo. This study aims to evaluate the informed consent process at Merlin Park University Hospital from the patient’s perspective.
Methods
This cross-sectional observational study included 140 participants undergoing elective orthopedic procedures. Data were collected via a questionnaire focusing on socio-demographic information and the informed consent process, including details on who provided the information, where and when the consent was signed, and patient understanding and satisfaction. Responses were analyzed using SPSS version 26 (IBM Corp., Armonk, NY).
Results
The majority of participants were females, with 80 (57.1%) women and 60 (42.9%) men. The average age of the participants was 60.86 years. Most participants were employed, constituting 75 (53.6%) of the sample, and 55 (39.3%) had attained university or higher education. The most common procedures were total hip replacement, with 30 (21.4%) participants, and total knee replacement, with 20 (14.3%) participants. Information during the consent process was primarily provided by consultants in 80 (57.1%) cases. High satisfaction levels were reported, with 139 (99.3%) participants expressing satisfaction. Significant correlations were found between satisfaction and the type of healthcare provider, type of operation, and educational level.
Conclusion
The informed consent process at Merlin Park University Hospital is generally effective, with high patient satisfaction and understanding. However, there is a preference for concise information delivery. Enhancing the process through personalized information delivery could further improve patient satisfaction and comprehension. These findings contribute valuable insights into patient-centered care and informed consent in elective orthopedic surgeries.
Center for Informed Consent Integrity 