Surgical Consent in the Pediatric Age Group: Parental Perceptions Toward Legal Aspects of Informed Consent
Original Article
Madani Essa
Saudi Journal of Medicine & Medical Sciences, October–December 2023; 11(4) pp 326-331
Abstract
Background
The perceptions of parents/legal guardians may drive their decisions on providing informed consent for minors. Currently, no study from Saudi Arabia has assessed the perceptions of parents/legal guardians toward informed consent for pediatric surgical procedures.
Objective
To determine parents’ perception and understanding of pediatric informed consent for surgeries from Saudi Arabia and determining their level of participation in the decision-making process of the treatment modality.
Methods
This observational cross-sectional study was conducted among parents from the Jazan region of Saudi Arabia with at least one child aged ≤ 12 years. Three aspects of surgical informed consent were evaluated: parents’ awareness, attitude, and understanding of informed consent and its legal issues; the knowledge they sought during informed consent discussions; and parents’ opinions about their respective roles in the decision-making process for the treatment.
Results
A total of 366 responses were included in this study. More than 95% of the participants agreed that informed consent was necessary; however, 94.7% felt that regardless of their beliefs, they had to sign the form. Surprisingly, the majority (61%) believed that any relative can sign the consent form on behalf of the parents/legal guardian. Most respondents believe that pre-operative procedures (80.8%), the cost (93.9%), and the reason for the procedure and its alternatives (87.2%) should be discussed when informed consent is being sought. About 76.5% of the participants wanted to know all the information regarding the procedure; of these, 48.3% responded that they would play a role in deciding the eventual treatment modality.
Conclusion
The findings of this study indicate the need to increase knowledge regarding surgical informed consent among parents in the Jazan region of Saudi Arabia.
Month: November 2023
Family-based consent and motivation for familial organ donation in Bangladesh: An empirical exploration
Family-based consent and motivation for familial organ donation in Bangladesh: An empirical exploration
Original Article
Sanwar Siraj
Developing World Bioethics, 19 October 2023
Abstract
The government of Bangladesh approved the human organ transplantation law in 1999 and updated it in 2018. This legislation approved both living-related donor and posthumous organ transplantation. The law only allows family members to legally donate organs to their relatives. The main focus of this study was to explore how Bangladeshis make donation decisions on familial organs for transplantation. My ethnographic fieldwork with forty participants (physicians and nurses, a healthcare administrator, organ donors, recipients, and their relatives) disclosed that the organ donation decision was family-based. An assessment of the relationship between religion, culture, and biomedicine leads to the conclusion that deciding on donating organs to relatives is primarily family-based and is perceived to be steeped in Islamic ethical principles and religious cultural tradition. The family-based consent and motivation for donor-recipient pair organ transplantation strengthen an altruistic environment for the family and act as the moral and legal authority that ensures ethical healthcare outcomes for Bangladeshis.
Examining the adequacy of preoperative informed consent in a developing country: Challenges in the era of surgical specialisation
Examining the adequacy of preoperative informed consent in a developing country: Challenges in the era of surgical specialisation
Ede O, Obadaseraye OR, Anichi I, Mbaeze C, Udemezue CO, Basil-Nwachuku C, Madu KA, Iyidobi EC, Anyaehie UE, Nwadinigwe CU, Ngwangwa C, Adetula UE
Developing World Bioethics, 9 October 2023
Abstract
Preoperative informed consent is a legal and ethical requirement that ensures patients understand a procedure, its associated risks and benefits, alternative treatment options, and potential complications to make an informed decision about their care. This cross-sectional study evaluated the informed consent process for major orthopaedic surgeries at a tertiary hospital in Nigeria. A self-administered questionnaire was used to collect data from 120 adult participants. Results showed that many patients do not read the consent form before signing it, and surgeons do not adequately explain the alternatives to surgery, potential risks, and available anaesthetic options. Higher-educated patients are more likely to read the consent form. Surgeons performed well in explaining the nature of the condition and prognosis, the procedure’s potential benefits, and answering patients’ questions. The study emphasises the need to improve the informed consent process to ensure patients understand and can make rational decisions about their healthcare.
Effects of the Informed Health Choices secondary school intervention: A prospective meta-analysis
Effects of the Informed Health Choices secondary school intervention: A prospective meta-analysis
Faith Chesire, Michael Mugisha, Ronald Ssenyonga, Christopher J. Rose, Allen Nsangi, Margaret Kaseje, Nelson K. Sewankambo, Matt Oxman, Sarah E. Rosenbaum, Jenny Moberg, Astrid Dahlgren, Simon Lewin, Andrew D. Oxman
Journal of Evidence-Based Medicine, 21 September 2023
Abstract
Aim
The aim of this prospective meta-analysis was to synthesize the results of three cluster-randomized trials of an intervention designed to teach lower-secondary school students (age 14–16) to think critically about health choices.
Methods
We conducted the trials in Kenya, Rwanda, and Uganda. The intervention included a 2- to 3-day teacher training workshop, digital resources, and ten 40-min lessons. The lessons focused on nine key concepts. We did not intervene in control schools. The primary outcome was a passing score on a test (≥9 of 18 multiple-choice questions answered correctly). We performed random effects meta-analyses to estimate the overall adjusted odds ratios. Secondary outcomes included effects of the intervention on teachers.
Results
Altogether, 244 schools (11,344 students) took part in the three trials. The overall adjusted odds ratio was 5.5 (95% CI: 3.0–10.2; p < 0.0001) in favor of the intervention (high certainty evidence). This corresponds to 33% (95% CI: 25–40%) more students in the intervention schools passing the test. Overall, 3397 (58%) of 5846 students in intervention schools had a passing score. The overall adjusted odds ratio for teachers was 13.7(95% CI: 4.6–40.4; p < 0.0001), corresponding to 32% (95% CI: 6%–57%) more teachers in the intervention schools passing the test (moderate certainty evidence). Overall, 118 (97%) of 122 teachers in intervention schools had a passing score.
Conclusions
The intervention led to a large improvement in the ability of students and teachers to think critically about health choices, but 42% of students in the intervention schools did not achieve a passing score.
Informed Consent and Medicolegal Aspects
Informed Consent and Medicolegal Aspects
Book Chapter
Bernardo Hontanilla, Andrés Ros Magallón
Post-maternity Body Changes, 20 October 2023 [Springer]
Abstract
It is not seldom in our trade that one must face litigation, be it against oneself or when testifying for or against something a colleague has done in their practice. Having a working knowledge of the regulations that permeate the doctor-patient relationship is paramount to building a successful practice and reducing the risks associated with patient care.
This is especially relevant in the field of aesthetic surgery, where a patient is not seeking a treatment that is essentially curative, but one to look like a younger version of themselves or improve their appearance. Often due to the aggressive marketing performed by some surgeons or reality TV, such a patient can present with unrealistic expectations or without even knowing the risks surgery entails, which becomes even more harmful when a third party can be affected by the results of the surgery as it is the case when treating a post-maternity patient.
The aims of this chapter are to provide a basic knowledge of the different kinds of regulations that specifically affect our trade, to bring forward the possible pitfalls when treating a post-maternity patient, and to emphasize the importance of the informed consent both to reduce risk and to improve the doctor-patient relationship.
[The presumed consent legislation – A success factor or a disruptive factor for tissue donation? A qualitative study based on multidisciplinary interviews with experts]
[The presumed consent legislation – A success factor or a disruptive factor for tissue donation? A qualitative study based on multidisciplinary interviews with experts]
Kirchner K, Lauerer M, Nagel E
The Journal of Evidence and Quality in Health Care, 6 October 2023
Abstract
Introduction
Tissue transplantation can improve the quality of life of patients in a very wide range of applications. In 2021, around 900 people in Germany agreed to donate organs after death – the number of tissue donors was significantly higher. Nevertheless, there is a shortage of organs and tissues in Germany. In order to counteract this, the introduction of a presumed consent legislation has been discussed time and again. However, the debates focused on possible positive effects for organ donation, whereas potential consequences for tissue donation have so far not been considered in the political discourse or in research. Using an exploratory approach, this paper aims to contribute to closing this research gap: Multidisciplinary interviews with experts were conducted to investigate whether the presumed consent legislation is a key success factor for increasing the number of tissue donors in Germany and which other approaches might be promising.
Editor’s note: This is a German language publication.
Opt-out, mandated choice and informed consent
Opt-out, mandated choice and informed consent
Ben Saunders
Bioethics, 4 October 2023
Abstract
A number of authors criticise opt-out (or ‘deemed consent’) systems for failing to secure valid consent to organ donation. Further, several suggest that mandated choice offers a more ethical alternative. This article responds to criticisms that opt-out does not secure informed consent. If we assume current (low) levels of public awareness, then the explicit consent secured under mandated choice will not be informed either. Conversely, a mandated choice policy might be justifiable if accompanied by a significant public education campaign. However, if this entitles us to assume that members of the public are informed, then an opt-out system would also be justified in the same circumstances. The alleged advantages of mandated choice seem to rest on an unfair comparison, between mandated choice with a public education campaign and an opt-out system without one. While it may be that some countries with opt-out systems should do more to inform their publics, I see no reason to assume that this cannot be done. Indeed, advocates of mandated choice seem committed to thinking it possible to raise awareness. If opt-out systems adopt the same methods, such as writing to every individual, this should also address concerns about whether consent is informed.
Informed Consent for Spine Procedures: Best Practice Guideline from the American Society of Pain and Neuroscience (ASPN)
Informed Consent for Spine Procedures: Best Practice Guideline from the American Society of Pain and Neuroscience (ASPN)
Timothy Deer, Ankur A Patel, Dawood Sayed, Ashley Bailey-Classen, Ashley Comer, Benjamin Gill, Kiran Patel, Alaa Abd-Elsayed, Natalie Strand, Jonathan M Hagedorn, Zohra Hussaini, Nasir Khatri, Ryan Budwany, Melissa Murphy, Dan Nguyen, Vwaire Orhurhu, Morteza Rabii, Douglas Beall, Stephen Hochschuler, Michael E Schatman, Timothy Lubenow, Richard Guyer, Ahmed M Raslan
Journal of Pain Research, 24 October 2023; pp 3559-3568
Open Access
Abstract
Introduction
The evolution of treatment options for painful spinal disorders in diverse settings has produced a variety of approaches to patient care among clinicians from multiple professional backgrounds. The American Society of Pain and Neuroscience (ASPN) Best Practice group identified a need for a multidisciplinary guideline regarding appropriate and effective informed consent processes for spine procedures.
Objective
The ASPN Informed Consent Guideline was developed to provide clinicians with a comprehensive evaluation of patient consent practices during the treatment of spine pathology.
Methods
After a needs assessment, ASPN determined that best practice regarding proper informed consent for spinal procedures was needed and a process of selecting faculty was developed based on expertise, diversity, and knowledge of the subject matter. A comprehensive literature search was conducted and when appropriate, evidence grading was performed. Recommendations were based on evidence when available, and when limited, based on consensus opinion.
Results
Following a comprehensive review and analysis of the available evidence, the ASPN Informed Consent Guideline group rated the literature to assist with specification of best practice regarding patient consent during the management of spine disorders.
Conclusion
Careful attention to informed consent is critical in achieving an optimal outcome and properly educating patients. This process involves a discussion of risks, advantages, and alternatives to treatment. As the field of interventional pain and spine continues to grow, it is imperative that clinicians effectively educate patients and obtain comprehensive informed consent for invasive procedures. This consent should be tailored to the patient’s specific needs to ensure an essential recognition of patient autonomy and reasonable expectations of treatment.
FIGO best practice guidance in surgical consent
FIGO best practice guidance in surgical consent
Special Article
Goknur Topcu, Phil McClenahan, Koketso Pule, Hajra Khattak, S. Eda Karsli, Marijo Cukelj, Akaninyene E. Ubom, Esraa Algurjia, Kubra Ozpinar, Yotin Ramon Perez, Rashid Bunu, Leopoldo S. Sanabria, Francisco J. R. Portilla, Elizabete Pumpure, Priyankur Roy, Paul Fogarty
International Journal of Gynecology & Obstetrics, 14 October 2023
Abstract
Obtaining medical consent preoperatively is one of the key steps in preparing for surgery, and is an important step in informed decision making with the patient. According to good medical practice guidelines, doctors are required to have the knowledge and skills to treat patients as well as inform them, respect their wishes, and establish trust between themselves and their patients. Valid consent includes elements of competence, disclosure, understanding, and voluntariness. Documentation of these elements is also very important. The International Federation of Gynecology and Obstetrics (FIGO) Education Communication and Advocacy Consortium (ECAC) has realized that the quality of consent varies considerably across the world and has developed simple guidelines regarding consent and procedure-specific checklists for the most common obstetric and gynecological procedures.
Knee’d To Know Basis: Informed Consent in Total Hip and Knee Arthroplasty
Knee’d To Know Basis: Informed Consent in Total Hip and Knee Arthroplasty
Commentary
Kevin C. Chang, Benjamin Hershfeld, Peter B. White, Randy M. Cohn, Michael A. Mont, Adam Bitterman
The Journal of Arthroplasty, 9 October 2023
Abstract
Informed consent is the process by which a medical provider explains the benefits, risks, and alternatives to a proposed medical intervention. It is a crucial part of maintaining patient autonomy and is particularly important in the context of elective surgical procedures, such as joint arthroplasty. The goal of this article is to review the topic of informed consent in the context of total joint arthroplasty. In this review, we discuss informed consent in general, considerations for informed consent in general arthroplasty procedures, and special twelve considerations for both hip and knee arthroplasty.
Center for Informed Consent Integrity 