Reviewing past and present consent practices in unplanned obstetric interventions: an eye towards the future
Original Research
Morganne Wilbourne, Hand, Sophie McAllister, Louise Print-Lyons, Meena Bhatia
Journal of Medical Ethics, 26 June 2024
Abstract
Many first-time mothers (primiparous) within UK National Health Service (NHS) settings require an obstetric intervention to deliver their babies safely. While the antepartum period allows time for conversations about consent for planned interventions, such as elective caesarean section, current practice is that, in emergencies, consent is addressed in the moments before the intervention takes place. This paper explores whether there are limitations on the validity of consent offered in time-pressured and emotionally charged circumstances, specifically concerning emergency obstetric interventions. Using the legal framework of the Mental Capacity Act, Montgomery v. Lanarkshire Health Board (2015) and McCulloch v Forth Valley Health Board (2023), we argue that while women have the capacity to consent during labour, their autonomy is best supported by providing more information about instrumental delivery (ID) during the antepartum period. This conclusion is supported by some national guidelines, including those developed by the Royal College of Obstetricians and Gynaecologists, but not all. Further, we examine the extent to which these principles are upheld in modern-day practice. Data suggest there is relatively little antepartum information provision regarding ID within NHS settings, and that primiparous women do not report a thorough understanding of ID before labour. Based on these results, and bearing in mind the pressures under which NHS obstetric services currently operate, we recommend further research into patient and clinician perceptions of the consent process for ID. Pending these results, we discuss possible modes of information delivery in future practice.

Antenatal reproductive screening for pregnant people including preconception: Provides the best reproductive opportunity for informed consent, quality, and safety
Douglas Wilson
Best Practice & Research Clinical Obstetrics & Gynaecology, 25 June 2024
Abstract
Introduction
This antenatal screening review will include reproductive screening evidence and approaches for pre-conception and post-conception, using first to third trimester screening opportunities.
Methods
Focused antenatal screening peer-reviewed publications were evaluated and summarized.
Results
Evidenced-based reproductive antenatal screening elements should be offered and discussed, with the pregnancy planning or pregnant person, during Preconception (genetic carrier screening for reproductive partners, personal and family (including reproductive partner) history review for increased genetic and pregnancy morbidity risks); First Trimester (fetal dating with ultrasound; fetal aneuploidy screening plus consideration for expanded fetal morbidity criteria, if appropriate; pregnant person preeclampsia screening; early fetal anatomy screening; early fetal cardiac screening); Second Trimester for standard fetal anatomy screening (18–22 weeks) including cardiac; pregnant person placental and cord pathology screening; pregnant person preterm birth screening with cervical length measurement); Third Trimester (fetal growth surveillance; continued preterm birth risk surveillance).
Conclusion
Antenatal reproductive screening has multiple elements, is complex, is time-consuming, and requires the use of pre- and post-testing counselling for most screening elements. The use of preconception and trimesters ‘one to three’ requires clear patient understanding and buy-in. Informed consent and knowledge transfer is a main goal for antenatal reproductive screening approaches.

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
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.

Transplantation and consent
Healthcare ethics and communication
John Saunders
Medicine, 29 May 2024
Abstract
This is an overview of issues relating to consent in donation and transplantation, including the types of consent currently in use in organ donation. There is a discussion of altruistic consent, opt-in, opt-out and deemed consent, and mandated choice. Donation of organs after cardiac death and after brain death is described. Reference is made to current guidance from the UK National Health Service, the Human Tissue Authority, the UK Government and the Spanish model of Organ Donation and Transplantation.

Risks and Complications Discussed in Consent for Strabismus Surgery
Research Article
Carolyn May, Evan Silverstein
Journal of Binocular Vision and Ocular Motility, 28 May 2024
Abstract
This study is a qualitative analysis of the consent process for strabismus surgery, using recordings of physicians doing a mock consent for bilateral medial rectus recession. There is considerable variation in the risks of surgery and odds of complications that are cited by pediatric ophthalmologists during the consent process. We propose a reference table with complication rates for use during the consent process.

Better Conversations for Better Informed Consent: Talking with Surgical Patients
Margaret L Schwarze, Robert M Arnold, Justin T Clapp, Jacqueline M Kruser
Hastings Center Report, May 2024; 54(3) pp 11-14
Abstract
For more than sixty years, surgeons have used bioethical strategies to promote patient self-determination, many of these now collectively described as “informed consent.” Yet the core framework-understanding, risks, benefits, and alternatives-fails to support patients in deliberation about treatment. We find that surgeons translate this framework into an overly complicated technical explanation of disease and treatment and an overly simplified narrative that surgery will “fix” the problem. They omit critical information about the goals and downsides of surgery and present untenable options as a matter of patient choice. We propose a novel framework called “better conversations.” Herein, surgeons provide context about clinical norms, establish the goals of surgery, and comprehensively delineate the downsides of surgery to generate a deliberative space for patients to consider whether surgery is right for them. This paradigm shift meets the standards for informed consent, supports deliberation, and allows patients to anticipate and prepare for the experience of treatment.

Consent and clarification: duty and right to information in dentistry
Zilda Betânia Barbosa Medeiros de Farias, Márcia Maria Fonseca da Silveira, Richardson Silva, Rebeka Thiara Nascimento dos Santos, Ana Paula Veras Sobral
Revista Bioética, 2024
Abstract
Studies on informed patient consent in the field of dentistry are scarce and present divergences, highlighting the need to deepen knowledge about definitions, dynamics, normative acts, case law and limits of responsibility in the face of diverse factors and risks inherent to the profession. From a bibliographic review that included studies indexed in the SciELO and LILACS databases, as well as textbooks, this study aimed to define what is meant by a patient’s free and informed consent, distinguish different types and highlight the so-called “informed choice,” considering that the activity of the dental surgeon is classified as a service and is regulated by the 1988 Federal Constitution of Brazil, the Consumer Defense Code, the Civil Code and special laws. The aim is to see if it is possible to improve the process of obtaining informed consent from patients, transforming it into a process of informed choice that takes into account appropriately indicated treatments whose main purpose is health.

Exploring the role of the oncologist in promoting shared decision making during treatment planning for older adults with acute myeloid leukemia
Research Letter to the Editor
Marissa LoCastro, Marielle Jensen-Battaglia, Chandrika Sanapala, Rachel Rodenbach, Jason H. Mendler, Jane Liesveld, Eric Huselton, Kah Poh Loh
Journal of Geriatric Oncology, June 2024
Introduction
Shared decision making (SDM), a process that promotes both patient autonomy and engagement, is associated with increased patient knowledge and decreased decisional regret [1]. Due to acute myeloid leukemia’s (AML) sudden onset and frequent need for rapid management decisions, achieving SDM in older patients is challenging [2]. Older adults with AML also have various vulnerabilities (e.g., functional and cognitive impairments) which further complicate decision making. This study evaluated oncologists’ current practices to promote SDM among older adults with AML using a communication tool designed to systematically elicit patient preferences regarding treatment planning.

Clear aligner therapy informed consent forms: A quality and readability evaluation
Original Article
Maurice J. Meade, Sven Jensen, Xiangqun Ju, David Hunter, Lisa Jamieson
International Orthodontics, June 2024
Open Access
Summary
Objective
The aim of the present study was to evaluate the quality and readability of content contained within clear aligner therapy (CAT) informed consent forms.
Methods
CAT informed consent forms were identified via an online search. The presence of details related to CAT-related processes, risks, benefits and alternatives in each form was recorded. A 4-point Likert type scale was used to determine the quality of content (QOC). The readability of content was evaluated with the Simple Measure of Gobbledegook (SMOG) and Flesch Reading Ease Score (FRES).
Results
A total of 42 forms satisfied selection criteria. Nineteen (45.2%) were authored by companies who provided aligners to patients via clinicians. The QOC regarding CAT-related treatment processes [median 2.0; IQR 0, 2] and benefits [median 2.0; IQR 1, 2] was adequate. The QOC scores regarding treatment alternatives, consequences of no treatment and relapse were poor. There was no difference (P = 0.59) in the median (IQR) QOC of the informed consent forms provided by direct-to-consumer (DTC) aligner providers [10 (8.25, 16.25)] and non-DTC aligner providers [12 (10, 14)]. The median (IQR) SMOG score was 12.1 (10.9, 12.7) and FRES was 39.0 (36.0, 44.25).
Conclusions
The QOC of the evaluated forms was incomplete and poor. The content was difficult to read and failed to reach recommended readability standards. Consent is unlikely to be valid if it is based solely on the content of the forms. Clinicians need to be aware of the limitations of informed consent forms for CAT particularly in relation to alternatives, prognosis, risks, and the need for long-term maintenance of results.