Global considerations for informed consent with shared decision-making in the digital age
Education
Edward Robert St John, Connor James Stewart Moore, Raghu Ram Pillarisetti, Erica Sarah Spatz
BMJ Evidence-Based Medicine, 20 September 2024
Background
Shared decision-making (SDM) is increasingly recognised as fundamental to patient-centred care and enabling patients to make voluntary, informed decisions about their health. SDM is the process whereby patients and clinicians come together to share their expertise. The patient acts as an expert of themselves, understanding their own preferences and their attitudes to risk. The clinician is an expert on the medical knowledge and scientific evidence. Together, treatment options should be explored, arriving at a treatment decision that is right for the patient and supported by the clinician. When dealing with invasive or high-risk procedures (eg, operations, chemotherapy, radiotherapy, immunotherapy), once the treatment decision has been made, the conversation turns to informed consent. This is the process of communicating and agreeing to the potential risks and benefits of the procedure, while acknowledging that there are alternative treatment options that have not been chosen. Though informed consent should be the culmination of SDM, alone it does not encapsulate the entire process. There is a distinction between decision-making and consent and this should ideally be accompanied by a period for reflection. Despite advances in SDM, the subsequent informed consent process has remained stagnant, often failing to meet ethical or legal standards of supporting meaningful patient autonomy.
Year: 2024
Multidisciplinary Team Discussions and the Inclusion of Individualized Patient Factors May Improve Informed Consent in Sports Medicine
Multidisciplinary Team Discussions and the Inclusion of Individualized Patient Factors May Improve Informed Consent in Sports Medicine
John Grossi, Lexi Garber, Brandon Klein, Luke Bartlett, Adam Bitterman, Randy Cohn, Nicholas Sgaglione
Arthroscopy, Sports Medicine, and Rehabilitation, 20 September 2024
Open Access
Abstract
Informed consent allows for the maintenance of patient autonomy and is essential in establishing trusting relationships between physicians and their patients. This process involves thorough discussion of the risks and alternatives, as well as the short- and long-term outcomes, of proposed treatment options. Inadequacies with informed consent can lead to inferior patient outcomes and may be subject to severe legal consequences. Individualized discussions are warranted to address the questions of these patients, whether it be the high-level athlete or the weekend warrior. This review highlights factors, identifies barriers, and proposes potential solutions to improve informed consent within orthopaedic sports medicine.
Developing a computer based standardised consent form for laparoscopic cholecystectomy
Developing a computer based standardised consent form for laparoscopic cholecystectomy
Charles Carey, Stuart James, Gemma Richardson, Shameen Jaunoo
British Journal of Surgery, 9 September 2024
Abstract
Aims
Laparoscopic cholecystectomy is a common general surgical procedure with approximately 65,000 procedures performed per year. The consent process is imperative as serious life changing and life-threatening risks must be discussed with the patient before surgery. At our trust [East Sussex Healthcare NHS Trust], this is currently performed with a generic consent proforma which is filled in during each consent process. We aimed to streamline this process for clinicians and ensure all risks were discussed. Further, we aimed to ensure the process was more medico-legally sound with increased legibility by removing the handwritten aspect and ensure concordance with GMC and RCS informed consent guidance.
Methods
We produced a standard computerised consent form for laparoscopic cholecystectomy. This included a diagram to aid patient explanation and sections where all the key risks of the procedure could be checked off once discussed.
Results
The consent form has proven popular with clinicians and has streamlined the consent process. It has ensured legibility of the consent form for all involved and is therefore preferable from a medico-legal perspective. It also ensures consistency for all patients undergoing the same consent process.
Conclusions
Standardising the consent process using this procedure specific form has helped clinicians cover all the necessary areas with patients before surgery and should be considered for other common operations. Producing the consent form has also been an excellent educational opportunity for trainees, who can now consider all risks associated with laparoscopic cholecystectomy using a single document.
Informed Consent Practices for Publication of Patient Images in Dermatology Journals
Informed Consent Practices for Publication of Patient Images in Dermatology Journals
Toluwani Taiwo, Bianca Obiakor, Sarah McClung, Kanade Shinkai
Journal of the American Academy of Dermatology, September 2024
Abstract
Clinical images play a crucial role in dermatology for patient care and education. The lack of standardized informed consent for publishing images in dermatology journals creates ambiguity for both patients and authors. This cross-sectional study examined informed consent practices in the top 50 dermatology journals based on the 2022 Clarivate Journal Impact Factor ranking. We reviewed journal websites and patient consent forms during June 28 to July 24, 2023 using an author-created checklist compiled from available best practices for image publication. Approximately 90% of journals specified image consent requirements, though there was notable variability in criteria related to image modification, safeguards for anonymity (e.g., eyebars, cropping, blurring), and the definition of identifiable features. Examples of identifiable features (e.g., tattoos, birthmarks, jewelry) were provided in 14% of journals. Despite the prevalence of social media presence among journals (70%), only 6% acknowledged potential risks associated with image dissemination on these platforms. While around 52% of journals presented journal or publisher-specific consent forms, inclusion of essential components, guided by International Committee of Medical Journal Editors guidelines, varied. Notably, 77% of these forms explicitly addressed how images could be disseminated beyond print publication, with 39% detailing patients’ ability to revoke consent, and 19% considering the possibility of patients benefiting financially from publication. Our assessment revealed inconsistencies in image consent practices across journals and their associated consent forms for patients. These findings highlight important opportunities for improvement, including uniform consent guidelines and standardized definitions of identifiable features to protect patient privacy in medical image publication.
Surgical Options for Breast Cancer and Consent Guidelines for Indigenous Women
Surgical Options for Breast Cancer and Consent Guidelines for Indigenous Women
Book Chapter
Jennifer Erdrich, Felina Cordova-Marks, Amanda Bruegl
Indigenous and Tribal Peoples and Cancer, 31 August 2024 [Springer]
Open Access
Key Points
- Women diagnosed with breast cancer and preparing for surgery can choose between breast-conserving therapy (BCT) and mastectomy. Breast cancer survival for BCT and mastectomy are equivalent.
- Surgical patterns show that American Indian/Alaska Native (AI/AN) women in the United States have more mastectomy and less breast-conserving therapy for early-stage breast cancer compared to non-Hispanic White (NHW) women.
- For all women, regardless of race, informed consent for lumpectomy vs. mastectomy is a complex, time-intensive process entailing comprehensive counseling. Additional historical and cultural considerations must inform consent guidelines for Indigenous women preparing for breast cancer surgery.
- We propose innovative solutions to overcome the challenges that limit Indigenous women’s access to their preferred surgical choice.
Abstract
Breast-conserving therapy (BCT) consists of lumpectomy followed by radiation. A lumpectomy removes the tumor and surrounding rim of normal breast tissue, leaving most of the breast volume and shape intact. A mastectomy removes the entirety of the breast tissue. Randomized trials with long-term follow-up demonstrate that, regardless of the stage of disease, survival is equivalent for both treatment options. While the risk of recurrence with lumpectomy alone is higher, modern multidisciplinary care combining lumpectomy with radiation and various forms of systemic therapy achieves a similar low risk of recurrence, allowing clinicians to offer BCT or mastectomy as equally safe standard care options. This establishes a surgical choice that is highly personal and should be individualized to consider multiple unique factors, including age, family history, hereditary gene mutations, size of the tumor relative to total breast volume, ability to complete multimodality breast care and surveillance, future plans regarding fertility and lactation, and overall best outcome for the individual’s body-image, lifestyle, and peace of mind.
BCT consistently shows decreased surgical complications, decreased pain, faster recovery, more favorable cosmetics, and better-preserved sexuality and body image. This is not to say that it is the best choice for every woman. BCT is contraindicated for women with inflammatory breast cancer. For some, mastectomy is preferred for personal reasons, even with a full understanding of equivalent survival following BCT. Provided the patient is well-informed and has worked with her clinical team to ensure her decisions are safe, she should be supported in her surgical choice.
Ethical Issues and Consent in Oral and Maxillofacial Surgery
Ethical Issues and Consent in Oral and Maxillofacial Surgery
Book Chapter
Ahmad Nazari
Handbook of Oral and Maxillofacial Surgery and Implantology, 13 April 2024 [Springer]
Abstract
Oral and maxillofacial surgery, encompassing a wide range of procedures from corrective jaw surgery to facial trauma repair, sits at a complex intersection of aesthetics, functionality, and patient well-being. This specialty, therefore, faces unique ethical challenges, particularly in the realm of patient consent. Obtaining informed consent is not merely a legal formality but a fundamental ethical principle that honors patient autonomy and ensures shared decision-making. Surgeons must navigate these waters with care, ensuring patients understand the potential risks, benefits, and alternatives of proposed treatments. This chapter delves into the ethical nuances of consent in oral and maxillofacial surgery, exploring how surgeons can foster an environment of trust and transparency. It highlights the importance of clear communication, patient education, and the ethical considerations necessary to guide both routine and complex surgical decisions.
A rapid review of the benefits and challenges of dynamic consent
A rapid review of the benefits and challenges of dynamic consent
Review Article
Winnie Lay, Loretta Gasparini, William Siero, Elizabeth K Hughes
Research Ethics, 9 September 2024
Open Access
Abstract
Dynamic consent is increasingly recommended for longitudinal and biobanking research; however, the value of investing in such systems is unclear. We undertook a rapid review of the benefits and challenges of implementing dynamic consent by searching five databases (Ovid Medline, Ovid Embase, Scopus, Web of Science, Cumulative Index to Nursing and Allied Health Literature – CINAHL) for articles published up to May 2023 that report on participants’ or researchers’ experience of dynamic consent. From 1611 papers screened, 12 met inclusion criteria. Guided by thematic analysis with an inductive approach, we synthesised 31 benefits and 8 challenges. Benefits included: enhanced participant experience through improved consent management and tailoring; greater participant engagement and retention through increased autonomy, trust and communication; reduced costs and burden and increased accessibility and inclusivity. Participants and researchers also valued additional features that dynamic consent platforms facilitate such as two-way communication and return of research updates. The main challenges included the digital divide and consent fatigue. The papers gave recommendations to mitigate these challenges, for example by supplementing with other communication tools and allowing a broad consent approach, respectively. Overall, dynamic consent was described as a valuable consent approach with many benefits and some surmountable challenges. Most included literature was qualitative, so further research is needed to quantify the impact of dynamic consent on recruitment, retention, and participant experience. Further long-term investigations are necessary to explore whether participants want to and do change their consent over time, as well as the impact of dynamic consent on participant privacy.
Quantifiable Bodies: The Influence of Biometric Technologies in Patient Consent
Quantifiable Bodies: The Influence of Biometric Technologies in Patient Consent
Morgan Banville, Elena Kalodner-Martin
Surveillance & Society, 7 September 2024
Abstract
While research has been done to identify the potential implications of biometric technology on marginalized populations’ privacy and autonomy, this paper contributes to existing research by examining these technologies in healthcare settings. Drawing from insights across surveillance studies, rhetoric of health and medicine, and technical communication, we identify how one leading healthcare institution in New York City has employed rhetorics of efficiency, effectiveness, safety, and security regarding its biometric technology system. This employment of biometric technologies often contributes to patients’ marginalization and dismissal. As we explore, interrogating the language used by the healthcare institution to describe biometrics opens opportunities for us—surveillance studies scholars, patients, allies, students, and more—to ensure that innovations within the healthcare system promote equity, agency, and improved outcomes for all.
The research relationship: participant perspectives on consent in biobanking
The research relationship: participant perspectives on consent in biobanking
Research Article
Rachel Thompson, Kate Lyle, Gabrielle Samuel, Jo Holliday, Fenella Starkey, Susan Wallace, Anneke Lucassen
BMC Medical Ethics, 26 August 2024
Abstract
Background
This paper examines the ethical challenges associated with the governance of large-scale biobanks. As the collection and interrogation of population-scale data is increasingly positioned as the route to new understandings of health and disease, these large-scale biobanks that rely on health research governance are becoming essential elements of research infrastructure. However, their longitudinal nature presents growing challenges for governance. Typically, health research governance uses a one-off consent model where participants agree to specific activities, but evolving technologies make it difficult to anticipate future research applications at the time of consent. Using a recent case study from UK Biobank, we demonstrate how trying to reconcile new research activities with old consent forms risks overlooking critical ethical issues —particularly how the proposed activity aligns with participants’ understanding and expectation of biobank research.
Methods
We report on our qualitative research with UK Biobank participants, conducting focus groups using individual and group exercises to explore their views on consent and research applications. We conducted thematic analysis of focus group transcripts applying both an inductive and deductive approach to coding, which was done using NVIVO qualitative data analysis software.
Results
Our findings show that participants locate responsibility for research decisions with the biobank, rather than seeking control through their consent. They perceive their consent not as a one-off agreement but as the ‘opening act’ for an enduring research relationship with the biobank.
Conclusions
Prioritising the ongoing research relationship and the practices that sustain it, rather than relying solely on consent procedures, can better support ethical research over time.
The First General Consent Implementation in Swiss Traditional Chinese Medicine Practices. A Prospective One-Year Study
The First General Consent Implementation in Swiss Traditional Chinese Medicine Practices. A Prospective One-Year Study
Xiaying Wang, Xiaoying Lv, Bingjun Chen, Saroj Pradhan, Ralf Bauder, Yiming Li, Michael Furian
medRxiv, 20 August 2024
Abstract
Summary
Background
Traditional Chinese Medicine (TCM) encompasses a wide range of treatments focused on diagnosing and managing illnesses, with increasing adoption in Western countries. TCM is often applied in isolated practices, therefore, rigorous research and real-world data collection remain challenging. The implementation of the General Consent (GC) facilitates this research, therefore, the aim was to investigate the acceptance rate of the GC during the first year of its implementation in TCM practices.
Methods
This prospective cohort study was conducted from 1st January to 31st December 2023 in five TCM practices located in Bad Zurzach, Baden, Lenzburg, Wil, and Zug in Switzerland. GC, together with other registration forms, were sent to patients prior to their appointments, collected during their first visit, and recorded by clinic secretaries. Logistic regression analysis was performed to investigate demographic factors influencing GC acceptance, considering variables such as age, sex, and practice location.
Results
The study recorded 1,095 patients who sought TCM treatments in 2023, of which 73.6% returned a valid GC document. Overall, the GC acceptance rate was 611/1,095 (55.8%); of those returning the GC, the acceptance rate was 611/806 (75.8%). The median[IQR] age of patients was 52[37,64] years and female patients were twice as likely to seek TCM treatments compared to male patients. Logistic regression analysis, odds ratio (95%CI), revealed no difference in GC acceptance rate with older age: 1.015 (0.996 to 1.034), p=0.115; female sex: 1.847 (0.588 to 5.804), p=0.294 and age*female sex: 0.983 (0.962 to 1.004), p=0.119. Significant differences in GC acceptance rates were observed across the five TCM practices.
Conclusion
The GC implementation in TCM practices was feasible, and the GC was well accepted by patients, independent of sex and age. The observed practice-related differences in GC acceptance require further investigation. More TCM practices should implement the GC to enable practice-based TCM research.