Informed consent in assisted reproductive technology: Implications for pediatric clinicians
Mary E Graham, Shannon Blee, Rebecca D Pentz, Emily Roebuck, Alexander H Hoon Jr, Mara Black
Developmental Medicine & Child Neurology, 17 November 2024
Abstract
After conceiving through assisted reproductive technologies (ART), parents may present to their pediatrician with concerns related to their child’s neurodevelopment, including whether their child’s health may be related to their use of ART. Pediatricians may be unfamiliar with the ART process and what the families endured up to this point, resulting in difficulty counseling parents through these discussions. Before presentation to the pediatrician, parents have undergone extensive evaluation with reproductive endocrinologists. During counseling, the reproductive endocrinologist provides information on maternal and childhood risks associated with ART. However, in this rapidly evolving field, providing comprehensive, patient-centered, informed consent is increasingly complex and counseling patients properly can be challenging. When parents have gone through the proper informed consent process, and when the pediatrician has an understanding of what this process entails, care of the child can be optimized. In this review, we discuss the complexities of the prenatal informed consent process that parents navigate before presenting to pediatricians. We emphasize the importance of these discussions and highlight ethical principles, as well as emotional, medical, legal, and financial stressors that parents face during ART, with the belief that this understanding will improve the care that pediatricians subsequently provide.

Consent to advanced imaging in antenatal pulmonary embolism diagnostics: Prevalence, outcomes of nonconsent and opportunities to mitigate delayed diagnosis risk
David R Vinson, Madeline J Somers, Edward Qiao, Aidan R Campbell, Grace V Heringer, Cole J Florio, Lara Zekar, Cydney E Middleton, Sara T Woldemariam, Nachiketa Gupta, Luke S Poth, Mary E Reed, Nareg H Roubinian, Ali S Raja, Jeffrey D Sperling
Academic Emergency Medicine, 17 November 2024
Abstract
Background
Nonconsent to pulmonary vascular (or advanced) imaging for suspected pulmonary embolism (PE) in pregnancy can delay diagnosis and treatment, increasing risk of adverse outcomes. We sought to understand factors associated with consent and understand outcomes after nonconsent.
Methods
This retrospective cohort study was undertaken across 21 community hospitals from October 1, 2021, through March 31, 2023. We included gravid patients undergoing diagnostics for suspected PE who were recommended advanced imaging. The primary outcome was verbal consent to advanced imaging. Diagnostic settings were non-obstetric (99% emergency departments [EDs]) and obstetrics (labor and delivery and outpatient clinics). Using quasi-Poisson regression, we calculated adjusted relative risks (aRRs) of consenting with 95% confidence intervals (CIs). We also reported symptom resolution and delayed imaging at follow-up and 90-day PE outcomes.
Results
Imaging was recommended for 405 outpatients: median age was 30.5 years; 50% were in the third trimester. Evaluation was more common in non-obstetric (83%) than obstetric settings (17%). Overall, 314 (78%) agreed to imaging and 91 (22%) declined imaging. Consenting was more prevalent in obstetric settings compared with non-obstetric settings: 99% versus 73% (p < 0.001). When adjusted for demographic and clinical variables, including pretest probability, only obstetric setting was independently associated with consenting: aRR 1.26 (95% CI 1.09-1.44). Seventy-nine (87%) patients declining imaging had 30-day follow-up. Eight of 12 who reported persistent or worsening symptoms on follow-up were again recommended advanced imaging and consented. Imaging was negative. None who initially declined imaging were diagnosed with PE or died within 90 days.
Conclusions
One in five gravid patients suspected of PE declined advanced imaging, more commonly in non-obstetric (principally ED) settings than obstetric settings. Patients symptomatic on follow-up responded favorably to subsequent imaging recommendations without 90-day outcomes. Improving the communication and documentation of informed consent and securing close follow-up for non-consenters may mitigate risks of missed and delayed PE diagnosis.

Editor’s note: Academic Emergency Medicine is the official journal of the Society for Academic Emergency Medicine.

Clinical staff attitudes towards opt-out consent for blood-borne virus screening in emergency departments in England
Esther G Blakey, Cassandra E L Fairhead, Alison J Rodger, Fiona M Burns, Lucie Ralph, David R Chadwick
HIV Medicine, 13 November 2024
Abstract
Objective
Opt-out screening for blood-borne viruses (BBVs) in emergency departments (EDs) has been established in areas with a high prevalence of HIV diagnoses in England. This multi-site study explored the attitudes of healthcare workers (HCWs) towards BBV screening in EDs post-implementation.
Design
This was a cross-sectional electronic survey of HCWs.
Methods
Between November 2023 and February 2024, HCWs across 33 EDs in England participating in opt-out BBV screening were invited to complete a survey about the feasibility and acceptability of screening, including the opt-out consent process. Factors independently associated with acceptability of opt-out screening were identified using multivariable logistic regression. Free-text responses were analysed thematically.
Results
Responses from 610 HCWs in 19 EDs were provided: 50.4% were nurses, 43.1% doctors, and 6.5% other healthcare professionals. Acceptability of the screening programme and opt-out consent was high (90.3% and 77.7%, respectively), with some variation between EDs. Acceptability of opt-out consent was greater among doctors than among other HCWs, and among HCWs who proactively discussed screening further with patients who opted out. However, 50.8% of HCWs felt that patients should be verbally reminded at blood draw, and 44.3% of HCWs wanted more training in discussing opt-out screening with patients. Free-text answers suggested changes to test-ordering systems, including simple integration of tick boxes to document whether patients opted out and to block repeated testing.
Conclusions
There was substantial support from ED HCWs for routine opt-out ED BBV screening, including opt-out consent. Key areas suggested for improvement included changes to test-ordering systems and additional training for HCWs. Frequent preference for verbal reminders at the point of blood draw suggests continued HIV testing exceptionalism.

Improving the Consent Process for Superficial Abscesses Through Pre-printed Consent Forms
Sima Patel, Ceri Gillett
Cureus, 11 November 2024; 16(11)
Abstract
Introduction
Informed consent is essential to ensure that patients are appropriately educated about proposed procedures, including associated risks and potential benefits, to make a valid decision. Incision and drainage of an abscess is a common procedure performed by various healthcare professionals. Inconsistent practices in the consent process can lead to misunderstandings among the patient and have financial and legal complications for both the clinician and the hospital. This study aims to improve the consent process for the incision and drainage of a superficial abscess via the implementation of pre-printed consent forms.
Method
We conducted a retrospective, single-centre study to evaluate existing consent forms, found in patients’ notes, for the incision and drainage of superficial abscesses. The goal was to assess these forms for standardisation, ultimately developing a pre-printed consent form suitable for use by a diverse range of healthcare professionals.
Results
This study revealed significant inconsistencies in consent documentation. While 20 out of 22 (91%) consent forms included infection as a documented risk, only 11 out of 22 (50%) mentioned COVID-19 as a potential risk. The study found that 22 of our 22 (100%) consent forms were documented in black ink. Providing patients with copies of the consent forms can enhance their understanding by allowing them to review the information at home. Eight out of 22 (36%) patients were offered a copy, and 13 out of 22 consent forms (59%) were noted to have abbreviations, both of which may limit understanding and comprehension of the procedure. After implementing a pre-printed consent form, 14 clinicians surveyed (100%) reported that the forms were effective, with 12 out of 14 (86%) indicating they would use these pre-printed forms in their future practice.
Conclusion
The identified variations and inconsistencies in the consent process prompted the creation of a standardised pre-printed consent form. Feedback on this form has been positive, indicating its potential to transform the consent process. The sample size was small, so early results are positive; however, further ongoing work would be required to draw a more definitive conclusion.

Interventions and strategies for enhancing the consent process in neurosurgery. A systematic review of the literature
Review Article
Ashraf Elmahdi, David Smith
British Journal of Neurosurgery, 3 November 2024
Abstract
Background
The informed consent process in neurosurgery aims to support patient autonomy and provide comprehensive information for decision-making. However, gaps in communication and understanding between patients and surgeons persist, that need to be addressed. This systematic review examined the interventions and strategies which to enhance the process of consent in neurosurgery.
Methods
A comprehensive search of databases and relevant sources to identify relevant studies for inclusion. Systematic review of prospective and retrospective studies that assess the effect of interventions which improve the consent process. Data collection and analysis involved independent reviewers assessing eligibility, study quality, and risk of bias. Findings from the included studies were used to write the review.
Main results
The reviewed identified seven studies notably revealed an educational and interactive consent process involving strategies like booklets, videos, multiple interviews, and interactive websites showed improvements in patient knowledge. Recall of risks decreased over time, and factors like age, education, and timing of consent influenced recall.
Authors’ conclusions
To maximise informed consent, neurosurgeons should consider various strategies. Tailoring communication-based on patient’s health literacy and treatment knowledge, involving their support system, and using a bullet-point consent form is essential. Utilising multiple modalities like verbal, static, and dynamic visuals improve information retention. Creative and memorable visual aids enhance comprehension. Allowing time for questions and team approach is superior.

Informed consent in gynecological oncology: a JAGO/NOGGO survey on real-world practices in daily clinical routine
G. Biersack, L. L. Volmer, C. Geißler, J. Fromme, S. Fröhlich, K. Pietzner, J. Sehouli, M. H. Beck
Archives of Gynecology and Obstetrics, 1 November 2024
Open Access
Abstract
Purpose
Informed consent is a quintessential element of contemporary medicine, reflecting the fundamental right of patients to participate in decision-making regarding their health. Despite its critical importance, there is a lack of data on real-world practices regarding patient informed consent in the context of modern, high-pressure medical environments.
Methods
We conducted a multinational multicentric survey from February 24, 2022, to September 14, 2022, investigating the practices and challenges surrounding informed consent in hospitals across Germany, Austria, and Switzerland with the use of a specifically developed questionnaire.
Results
Drawing on over 200 responses from gynecologists, the survey shows a critical need for structured training in conducting informed consent discussions with over 80% of participants expressing interest in courses addressing this aspect. Notably, a considerable portion of the physicians (59.9%) reported conducting discussions on procedures they had never personally witnessed. Significant disparities between types of hospitals and professional groups were observed in the frequency of informed consent discussions, with limitations arising from factors such as time constraints, language barriers, and insufficient resources for patient education. Moreover, the psychological burden experienced by physicians after informed-consent discussions underscores the need for systemic changes to alleviate concerns regarding patient safety, legal repercussions, and patient satisfaction.
Conclusion
This study serves as a call to action, emphasizing the need of enhancing resources and support for medical professionals to uphold the principles of empathic and comprehensive patient information and shared decision-making.

Bariatric Surgery: Informed Consent Resource
Rachel Stefaniuk, Sophie Lalonde-Bester, Jackie Liu, Asia Luna Patlis, Marisa Langton
Medical Students for Size Inclusivity, October 2024
Introduction
This resource was created by Medical Students for Size Inclusivity (MSSI), an international community of medical students dedicated to addressing weight bias in medicine. We have seen many patients undergo bariatric surgery aimed at promoting weight loss, and remain concerned that patients may receive misleading or insufficient information from their healthcare providers before undergoing these operations. While MSSI does not believe weight & BMI are accurate measures of health, or that weight loss improves health outcomes, we also champion patient autonomy. Weight discrimination permeates so many aspects of society, and the physical and mental harm it directly causes larger bodied people is immeasurable and far reaching. Our goal is to give patients desiring to undergo bariatric surgery to lose weight a more comprehensive understanding of bariatric surgeries, so they can make the most informed decisions about their care. Knowing what alternatives are available is part of full informed consent, so we also include evidence-based options for improving health that do not require weight loss.

Responsibility of the radiologist in the management of contrast media: Informed consent and other controversies
P. Rodríguez Carnero, C. Sebastià Cerqueda, L. Oleaga Zufiria
Radiology, October 2024
Abstract
Radiological contrast media play an essential role in radiology departments by facilitating more precise and detailed images. It is important to note that for radiologists the use of these contrast agents implies several legal responsibilities and ethical considerations towards patients. This related article will explore the main issues related to responsibility and complication management for radiologists, referring physicians and other professionals, as well as issues around informed consent, contraindications for their use and the benefit-risk balance assessed when deciding if a contrast-enhanced test should be carried out. In addition, we will address the crucial role of the radiologist in effective communication with patients and in obtaining informed consent. This research relates to Spanish legislation in the context of medical practice.

Prevalence of pelvic examinations on anesthetized patients without informed consent
Rachel Cutting, Varsha Reddy, Sneha Polam, Nicole Neiman, David Manna
Journal of Osteopathic Medicine, 7 October 2024
Open Access
Abstract
Context
The pelvic examination is a fundamental tool for the evaluation and diagnosis of women’s health conditions and an important skill for all medical students to learn as future physicians for the early detection of treatable conditions such as infection or cancer. Although the American College of Obstetricians and Gynecologists (ACOG) asserts that performing pelvic examinations under anesthesia for educational purposes should only occur if the patient provides explicit and informed consent, there still have been reports of medical students performing pelvic examinations on anesthetized patients across the country, and many states are now starting to pass bills requiring informed patient consents to conduct pelvic examinations under anesthesia.
Objectives
The objectives of this study are to evaluate the prevalence of pelvic examinations performed by osteopathic medical students on anesthetized patients without consent while fulfilling their third-year OB-GYN clerkship requirements.
Methods
The survey was administered and distributed to all osteopathic medical schools in the country via the Student Osteopathic Medical Association’s (SOMA’s) chapter emails, outreach emails, and SOMA’s social media accounts to collect data. Inclusion criteria included third- or fourth-year osteopathic medical students who completed their OB-GYN clerkship rotations when taking the survey. The exclusion criteria included any osteopathic medical student who had not completed their OB-GYN clerkship rotation. We utilized descriptive analysis to summarize the final data.
Results
We received 310 responses. The final number of responses was 291 after meeting the exclusion criteria. Most osteopathic medical students (94.2 %, n=274) considered the practice of performing pelvic examinations on anesthetized patients without their explicit consent unethical. Among the participants, 40.9 % (n=119) admitted to performing pelvic examinations on patients under anesthesia while on OB-GYN rotations, but most of them (57.1 %, n=68) did so without obtaining prior consent from the patients. Notably, the number of pelvic examinations performed by medical students on patients under anesthesia ranged widely from 1 to 25 with a median number of 10. Moreover, 58.9 % (n=70) indicated that they had not been properly educated to obtain specific consent before performing pelvic examinations under anesthesia. Many participants cited efficiency of practice, lack of policy awareness and personal education by medical students, and failure to refuse to perform pelvic examinations on anesthetized patients as trainees when asked by their seniors or preceptors.
Conclusions
This study demonstrates that although most osteopathic medical students consider performing pelvic examinations on anesthetized patients unethical, many still admit to practicing pelvic examinations on patients under anesthesia, while on OB-GYN rotations for efficiency of practice, lack of policy awareness and personal education, and being in unique positions in which grades are determined by seniors and preceptors for their willingness to do what is asked even if the practice does not align with their conviction. This study highlights the importance of ongoing research and implementation of policies at institutional and state levels that will procure the value of pelvic examinations while protecting and upholding the ethics of patients’ rights and autonomy of medical students.

The Impact of Obtaining Explicit Informed Consent for Medical Student Participation in the Pelvic Exam Under Anesthesia: A Qualitative Interview Study
Research Article
Hannah C Milad, Katie Watson, Patrick F Eucalitto, Ricky Hill, Alithia Zamantakis, Marlise Jeanne Pierre Wright, Adaeze A Emeka, Susan Tsai, Susan Goldsmit, Magdy P Milad
International Journal on Obstetrics and Gynecology, 26 September 2024
Open Access
Abstract
The pelvic exam under anesthesia (EUA) is an essential step in gynecologic surgery. Attending, fellow, and/or resident physicians utilize exam findings for surgical planning. Afterwards, medical students often perform this exam for their own learning; the student exam provides no direct clinical benefit to patients. Historically, consent for trainee EUAs was embedded within the surgical consent form. At one urban academic medical center, a written consent form specifically for medical student participation in the pelvic EUA was introduced. Our study examines patient, physician, and operating room (OR) staff perceptions of this new, explicit consent process between May 2021 and May 2023. Thirty-one (31) subjects including patients, OR staff, and physicians were interviewed and Northwestern University IRB approval was obtained. Our data suggest patients appreciated being asked to explicitly consent to or refuse the student pelvic EUA and having a dedicated consent form left them with a positive feeling about the hospital and their healthcare providers. OR staff and physicians agreed that the student pelvic EUA is necessary and almost all supported an explicit consent form. Physicians did not find the additional consent form burdensome and noted only a modest decline in learning opportunities. Patients and healthcare providers agreed that requiring explicit written consent for the student pelvic EUA respected patient autonomy, improved healthcare quality, and caused minimal disruption to medical education. Our data support the use of an explicit written consent form for student participation in the pelvic exam under anesthesia as standard practice.