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.
Month: November 2024
Interventions and strategies for enhancing the consent process in neurosurgery. A systematic review of the literature
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
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
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
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.
Informed Consent: A Monthly Review
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November 2024 :: Issue 71
In preparing this digest, we monitor a broad range of academic journals and utilize Google Scholar to search articles referencing informed consent or assent. After careful consideration, a selection of these results appear in the digest. We also monitor other research, analysis, guidance and commentary beyond the academic literature globally, including calls for public consultation and symposia/conferences which address consent/assent in whole or in part. We recognize that some of the arguments presented in this edition may be controversial and may warrant closer scrutiny. We have elected to be generous in our inclusion with the goal of presentating of a wholistic landscape of informed consent literature as it is being published. We acknowledge that this scope yields an indicative and not an exhaustive digest product.
Informed Consent: A Monthly Review is a service of the Center for Informed Consent Integrity, a program of the GE2P2 Global Foundation. The Foundation is solely responsible for its content. Comments and suggestions should be directed to:
Editor
Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org
PDF Version: Center for Informed Consent Integrity – A Monthly Review_November 2024
Spotlight – Revised Declaration of Helsinki adopted by the global medical community, strengthening ethical standards in clinical research involving humans
SPOTLIGHT
This month we have chosen to spotlight the recently revised Declaration of Helsinki and have provided the World Medical Association press release which positions the revision and how it was achieved below. We invite readers to review the full declaration as consent related issues are interwoven throughout, and we make special note of paragraphs 25-32 which deal with free and informed consent.
Revised Declaration of Helsinki adopted by the global medical community, strengthening ethical standards in clinical research involving humans
Press Release
World Medical Association, 21 October 2024
The World Medical Association (WMA) has announced the adoption the 2024 Revision of the Declaration of Helsinki (DoH), the global reference for medical research involving human participants, at its General Assembly in Helsinki, Finland.
Newly inaugurated President of the WMA, Dr Ashok Philip said, “This landmark revision of the Declaration of Helsinki highlights the World Medical Association’s commitment to reinforcing the ethical principles that guide medical research involving human participants, to safeguard patient rights and to ensure the integrity of scientific studies.
“This was a mammoth revision process spanning 30 months, and the World Medical Association extends its heartfelt thanks to everyone who participated,” continued Dr Ashok Philip, President of the World Medical Association.
Under the leadership of Dr. Jack Resneck Jr., Chair of the WMA Declaration of Helsinki revision workgroup, the revision team concluded that some areas of the document had to be updated to ensure the Declaration’s continued relevance. The 2024 revision of the Declaration of Helsinki provides for increased protection for vulnerable populations, improved transparency in clinical trials, and stronger commitments to fairness and equity in research.
“Previously, the Declaration of Helsinki addressed WMA members and constituents. The new version of the Declaration says that as physicians, it’s part of our moral obligation to ensure that our patients and the participants in research are respected and treated with dignity,” said Dr Jack Resneck Jr.
“The revised Declaration of Helsinki calls on everybody involved in the research enterprise now to uphold those principles, whether they are individuals or teams or organizations across the medical research activity,” he continued.
Dr Resneck Jr. highlighted some new language in the sixth paragraph of the Declaration as important, saying, “To really address the theme of distributive and global justice, this change means that the Declaration of Helsinki calls on researchers to carefully consider how the benefits, the risks, the burdens of research are distributed.”
The substantive changes to the Declaration of Helsinki can be categorised in two areas:
- Participant-centered inclusion, respect and protection, including recognition of participant vulnerability, calls for community engagement, pursuit of global justice, obtaining informed consent, and use of participant-centered language.
- Research beneficence and value, including the pursuit of “individual and public health”, upholding scientific rigor and integrity, and considered distribution of benefits, risks and burdens.
More information
- See the Declaration of Helsinki 2024 full text here.
- See JAMA Viewpoint Revisions to the Declaration of Helsinki on Its 60th AnniversaryA Modernized Set of Ethical Principles to Promote and Ensure Respect for Participants in a Rapidly Innovating Medical Research Ecosystem, by Dr Jack Resneck Jr.
- Listen to JAMA Author Interview with Dr Jack Resneck Jr. Declaration of Helsinki Addresses New Ethical Challenges.
- Jama published a number of relevant papers on the date the revision was approved, these papers are available here.
- See WMA Declaration of Helsinki 2024 interview with Dr Jack Resneck Jr.
- Read Background information on the Declaration of Helsinki here.
Advance Consent for Participation in Acute Stroke Trials: A Focus Group Study with People with Lived Experience of Stroke
Advance Consent for Participation in Acute Stroke Trials: A Focus Group Study with People with Lived Experience of Stroke
Brief Communication
Ubong Udoh, Rena Seeger, Emma Cummings, Brian Dewar, Stuart Nicholls, Mark Fedyk, Sophia Gocan, Victoria Shepherd, Dar Dowlatshahi, Michel Shamy
The Canadian Journal of Neurological Sciences, 15 October 2024
Abstract
Advance consent could address many of the limitations traditional consenting methods pose to participation in acute stroke trials. We conducted a series of five focus groups with people with lived experience of stroke. Using an inductive thematic approach, two themes were developed: factors in favour of, and against, advance consent. Participants supported the idea of advance consent and highlighted trust, transparent communication and sufficient time as major factors that would positively affect their decision to provide advance consent. The results will be used to finalise a model of advance consent suitable for testing the feasibility in stroke prevention clinics.
Advance Consent for participation in Acute Stroke Trials (ACTION): protocol for a feasibility study
Advance Consent for participation in Acute Stroke Trials (ACTION): protocol for a feasibility study
Ubong Udoh, Rena Seeger, Brian Dewar, Emma Cummings, Sophia Gocan, Stuart Nicholls, Mark Fedyk, Victoria Shepherd, Jeff Perry, Robert Fahed, Tim Ramsay, Jamie Brehaut, Michael D Hill, Alexandre Y Poppe, Bijoy K Menon, Richard H Swartz, Dar Dowlatshahi, Michel Shamy
Stroke and Vascular Neurology, 2 October 2024
Abstract
Introduction
Obtaining informed consent for research from patients in medical emergencies remains a challenge, particularly in acute stroke care as treatment must be administered quickly and patients often arrive in the hospital in a state of incapacitation. Adaptations to standard consenting approaches-such as the use of surrogate consent or deferral of consent-have significant limitations. This feasibility study aims to test a new consenting approach in acute stroke care that we call advance consent. Advance consent has the potential to render emergency trial enrolment faster, fairer and more transparent, leading to more generalisable results.
Methods and design
We will conduct a five-part study at The Ottawa Hospital, a quaternary care stroke centre: (1) administering questionnaires in the Ottawa Hospital Stroke Prevention Clinic that will examine patients’ perspectives on research participation and advance consent; (2) inviting participants to consent in advance to any or both currently enrolling acute stroke trials; (3) tracking patient enrolment into these trials over 1 year; (4) administering a follow up questionnaire to participants at 1 year and (5) administering a questionnaire to participating hospital staff in order to interrogate their experiences with advance consent. Outcomes include but are not limited to eligibility rate, recruitment rate, withdrawal rate and the proportion of patients whose advance consent results in trial enrolment.
Conclusion
This study will test the feasibility of enrolling patients at risk of stroke into acute stroke trials using advance consent.
Comparing ChatGPT vs. Surgeon-Generated Informed Consent Documentation for Plastic Surgery Procedures
Comparing ChatGPT vs. Surgeon-Generated Informed Consent Documentation for Plastic Surgery Procedures
Ishan Patel, Anjali Om, Daniel Cuzzone, Gabriela Garcia Nores
Aesthetic Surgery Journal, 22 October 2024
Abstract
Background
Informed consent is a crucial requirement of a patient’s surgical care but can be a burdensome task. Artificial intelligence (AI) and machine learning language models may provide an alternative approach to writing detailed, readable consent forms in an efficient manner. No studies have assessed the accuracy and completeness of AI-generated consents for aesthetic plastic surgeries.
Objectives
This study aims to compare the length, reading level, accuracy, and completeness of informed consent forms that are AI chatbot (ChatGPT-4, OpenAI, San Francisco, CA)-generated versus plastic surgeon-generated for the most commonly performed aesthetic plastic surgeries.
Methods
This study is a cross-sectional design comparing informed consent forms created by the American Association of Plastic Surgeons (ASPS) with informed consent forms generated by ChatGPT-4 for the five most commonly performed plastic surgery procedures: liposuction, breast augmentation, abdominoplasty, breast lift, and blepharoplasty.
Results
The average word count of ChatGPT forms was lower than for the ASPS generated forms (1023 vs 2901, p=0.01). Average reading level for ChatGPT forms was also lower than ASPS forms (11.2 vs 12.5, p=0.02). There was no difference between accuracy and completeness scores for general descriptions of the surgery, risks, benefits, or alternatives. The mean overall impression score for ChatGPT consents was 2.33, whereas it was 2.23 for ASPS consent forms (p=0.18).
Conclusions
Our study demonstrates that informed consent forms generated by ChatGPT were significantly shorter and more readable than ASPS forms with no significant difference in completeness and accuracy.