Pain Management Consent Considerations
Book Chapter
Elizabeth Wilson, Kristopher Schroeder
Perioperative Pain Management, 16 October 2024 [Springer]
Abstract
Healthcare professionals must consider patients as collaborators in the process of healthcare decision making. In matters of perioperative pain management, it is important to consider and include patients in decisions that may be impacted by their personal history of pain management/analgesic administration, value system/thought process regarding pain management, and the relative impact of potential complications related to analgesic procedures and opioid analgesics. To make these decisions, healthcare professionals must consider the ability of patients to make decisions in the setting of pain and polypharmacy and if the use of adjunct/surrogate decision makers may be appropriate/beneficial. In addition, it is important to consider how information is conveyed and the degree of detail that is required to ensure that patients are equipped to make a decision that best aligns with their belief system and values. Finally, patient decisions must be respected, and they must know that they possess the autonomy to be ultimately responsible for the decisions that will impact their healthcare delivery.
Role of procedure-specific consent forms in clinical practice: a systematic review
Role of procedure-specific consent forms in clinical practice: a systematic review
Research Article
J Norvill, C Bent, JA Mawhinney, N Johnson
The Annals of The Royal College of Surgeons of England, 3 October 2024
Open access
Abstract
Introduction
Consent forms play an active role in the consent process with generic, handwritten consent forms (GCF) often the standard across the National Health Service. Increasingly, procedure-specific consent forms (PSCF) are being used as an alternative. However, concerns remain about whether they meet the standard for consent. We therefore conducted a systematic review with the objectives of investigating evidence for PSCF, study methodology and medicolegal criteria.
Methods
This systematic review was prospectively registered on PROSPERO (CRD42023392693) and conducted from 1 January 1990 to 17 March 2023 using the MEDLINE, Embase, CINAHL, CENTRAL and Emcare databases. A grey literature search was also performed. All studies evaluating PSCF in medical and surgical settings were included. Risk-of-bias analysis was performed using ‘RoB 2’ and ‘ROBINS-I’. Meta-analysis was not possible because of the results’ heterogeneity.
Findings
We identified 21 studies investigating PSCF with no systematic reviews and meta-analyses reported. Most studies were quality improvement projects (n = 10) followed by randomised studies (n = 5). No definitive legal guidance for PSCFs and no studies assessing their role in litigation post-procedural complications were identified. PSCFs were associated with improved documentation (70%–100%; n = 11) and legibility (100%; n = 2) compared with GCF. Randomised studies (n = 4) investigating patient understanding and recall for PSCF were inconclusive compared with GCF.
Conclusions
The heterogeneous evidence available merely demonstrates superior documentation of PSCF compared with GCF. Studies do not adequately investigate the impact on informed consent and fail to address the associated legal concerns. Further randomised studies with patient-centric outcomes and consideration for medicolegal criteria are needed.
A tool for optimising shared decision making and informed consent for surgical innovation: development and implementation of a core information set
A tool for optimising shared decision making and informed consent for surgical innovation: development and implementation of a core information set
Christin Hoffmann, Daisy Elliott, Cynthia Ochieng, Samuel Lawday, Abigail Vallance, Leila Rooshenas, Barry Main, Jane Blazeby, Pete Wheatstone, Angus McNair
BMJ Surgery, Interventions, & Health Technologies, 27 September 2024
Abstract
Introduction
There are significant challenges in achieving high-quality shared decision making (SDM) and informed consent for surgical innovation. Evidence shows that patients’ information needs are insufficiently addressed. We co-developed a core information set (CIS) to provide baseline information for consultation discussions between clinicians and patients offered novel surgical procedures/devices.
Methods
This study adhered to guidance for CIS and core outcome set development (COS-STAD) to (i) generate a provisional CIS from data sources (44 stakeholder interviews, 34 consultations, 213 studies, 58 policies) applying thematic content analysis, (ii) refine/agree CIS with stakeholders (patients, surgeons, anaesthetists, lawyers, ethicists, medical directors, SDM experts, regulators) using nominal group technique, (iii) conduct UK public consultation, (iv) implement the CIS nationally.
Results
A provisional CIS contained 8 themes/28 subthemes. Some 25 stakeholders refined/agreed a final 7-theme CIS covering what is ‘new’ about the procedure, conflicts of interest, reasons for the innovation, treatment alternatives, unknowns, surgeons’ expertise, and governance. Public consultation (N=136) endorsed all themes. Industry collaboration will implement the CIS in digital consent platforms across 38 institutions.
Conclusions
An evidence-based CIS has been co-developed with key stakeholders and is the recommended standard to optimise SDM and informed consent for surgical innovation.
Exploring consent for animal-derived products in surgery
Exploring consent for animal-derived products in surgery
Tega Ebeye, Chantal R. Valiquette, Natalia Ziolkowski
The American Journal of Surgery, 24 September 2024
Abstract
Informed consent is integral to the practice of ethical and patient-centered medicine. Barring specific life and limb emergencies where there is no capable decision maker to provide consent, surgeons typically rely on informed consent to decide on provision of surgical care. However, determining what constitutes informed consent – what risks are deemed material enough, how to appropriately weigh risks, benefits, and alternatives, as well as answering procedure-related questions – is ever evolving. An emerging area of discovery, with limited literature, has focused on how to obtain informed consent when animal-derived products (ADPs) are used. Here, ADPs include both human and animal-derived products used in surgery. As surgeons and surgical trainees, we have encountered different approaches to including ADPs in informed consent – from failure to discuss ADP use in general, to the blanket statement indicating the use of potential animal-derived products in surgery, to actually discussing and listing known ADPs like “nerve glue” and “AlloDerm” on the consent form – prompting our interest in this topic as it affects surgical practice and patient autonomy. However, while it has been argued that disclosing the use of ADPs is warranted under Beauchamp and Childress’ four principles of biomedical ethics, it remains unclear how detailed our discussions need to be to meet this ethical standard without creating undue burden, and potentially substandard care, for patients.
Co-Designing Body Donation Consent Processes
Co-Designing Body Donation Consent Processes
Conference Abstract [published in special journal edition]
Georgina C. Stephens
International Federation of Associations of Anatomists Congress 2024 – Kimdaejung Convention Centre, Gwangju, Korea, South
Published: Anatomy & Cell Biology, September 2024
Abstract
It is widely accepted that body donation programs should obtain informed consent from donors during life. Despite the existence of consent guidelines, consent form content varies considerably. Furthermore, consent forms are typically developed by anatomical and legal experts, and may not include details valued by donors or students. Co-design is a form of participatory action research which engages end users to understand phenomena and inform change. Co-design may therefore be ideal to develop consent processes that better incorporate values of donors, students and educators, alongside ethical and legal considerations. As a first step to developing consent processes for a proposed body donor program at an Australian university, this study aimed to bring together participants from these groups to co-design a consent process. Study participants included 7 prospective donors, 9 anatomy students and 6 anatomy educators. Data were collected through 4 focus groups involving at least one member of each participant group. During focus groups, the facilitator worked with participants to identify priorities relating to consent processes. Thematic analysis was used to develop draft consent principles encompassing perspectives across groups. Draft principles were sent to participants, and feedback on these collected through a survey. Four principles for body donation consent processes were established: 1. Consent processes should be informative, transparent and community-focused, 2. Consent processed should include personalised and flexible options, 3. Consent processes should be developed on legal and ethical foundations, and 4. Consent processes should be future-focused. Although some principles addressed aspects within existing consent guidelines (e.g. information adequacy), participants highlighted ways consent processes typical of body donor programs in Australia could be enhanced (e.g. personalised options including naming preferences after death). Participants also expressed how co-design facilitated a deeper understanding of the value of body donation. Ongoing work will now focus on developing consent resources based on these principles.
A Turn Toward Caring Research: Iterative Consent, Reflexive Multilingual Methods, and Reciprocal Knowledge Production
A Turn Toward Caring Research: Iterative Consent, Reflexive Multilingual Methods, and Reciprocal Knowledge Production
Olivia Orosco
The Professional Geographer, 7 October 2024
Abstract
The discipline of geography continues to redress historically violent methods and move toward a more ethical and intentional research practice, one hopes. Derived from research with professional immigrant Latina caregivers during the first years of the COVID-19 pandemic (2021–2022), this article offers a reflective approach to the growing conversation of more intentional geographical methods. Learning from feminist and Indigenous methodologies as intertwining, this project takes reciprocity and accountability to and with the caregivers seriously. The research combines artistic portraiture and ethnographic methods to center caregivers as knowledge creators deserving of respect, attention, and artistic portrayal. Collaborative portraits, created by BIPOC artists, were part of the fifteen semistructured testimonio conversations and allowed the tangible centering of caregivers as people to be seen and heard. Learning from the caregivers themselves and through reflective work on methods, this article theorizes a process of iterative consent, multilingual methods, and reciprocal knowledge production and asks what a more ethical and accountable research partnership can and should look like.
Online cognitive assessments in elderly cohorts – the British 1946 birth cohort case study
Online cognitive assessments in elderly cohorts – the British 1946 birth cohort case study
Ziyuan Cai, Valentina Giunchiglia, Rebecca Street, Martina Del Giovane, Kirsty Lu, Maria Popham, Andrew Wong, Heidi Murray-Smith, Marcus Richards, Sebastian Crutch, Peter J. Hellyer, Jonathan M Schott, Adam Hampshire
medRxiv, 12 October 2024
This article is a preprint and has not been peer-reviewed. It reports new medical research that has yet to be evaluated and so should not be used to guide clinical practice.
Abstract
Introduction
Online assessments are scalable and cost-effective for detecting cognitive changes, especially in elderly cohorts with limited mobility and higher vulnerability to neurological conditions. However, determining the uptake, adherence, and usability of these assessments in older adults, who may have less experience with mobile devices is crucial.
Methods
1,776 members (aged 77) of the MRC National Survey of Health and Development (NSHD) [UK] were invited to complete 13 online cognitive tasks. Adherence was measured through task compliance, while uptake (consent, attempt, completion) was linked to health and sociodemographic factors. Usability was evaluated through qualitative feedback.
Results
This study’s consent (56.9%), attempt (80.5%), and completion (88.8%) rates are comparable to supervised NSHD sub-studies. Significant predictors of uptake included education, sex, handedness, cognitive scores, weight, smoking, alcohol consumption, and disease burden.
Discussion
With key recommendations followed, online cognitive assessments are feasible, with good adherence, and usability in older adults.
Patients’ Perceptions and Understanding of Pre-operative Informed Consent in a Tertiary Care Setting- Dar-es-salaam
Patients’ Perceptions and Understanding of Pre-operative Informed Consent in a Tertiary Care Setting- Dar-es-salaam
Research Article
Steven Michael, Willbroad Kyejo, Allyzain Ismail, Eric Aghan, Columba Mbekenga, Athar Ali
BMC Medical Ethics, 11 October 2024
Abstract
Background
Informed consent, grounded in the ethical principle of autonomy, represents a patient’s agreement to undergo a procedure. Given its critical role in protecting human rights and autonomy, obtaining informed consent before any surgery or procedure is now a mandatory practice. However, many studies question whether informed consent is conducted genuinely, ensuring proper understanding of the information disclosed, or merely serves as a medico-legal formality. This has led to increased malpractice, misunderstanding, anxiety, and overall postoperative dissatisfaction.
Methods
This descriptive qualitative study was conducted at Aga Khan Hospital using individual in-depth interviews. Fourteen patients who had undergone elective surgery were recruited. Baseline data were presented in tables, and inductive thematic analysis was used to interpret the qualitative data.
Results
Seven themes emerged from the data: Consent as a legal formality, autonomy and decision-making, insufficient information, time constraints and lack of opportunities for questions, use of medical jargon, patients’ desired information, and overall satisfaction with care. Despite patients’ higher levels of education and the hospital’s patient-centered care approach, many felt the information provided was insufficient, superficial, and difficult to understand.
Conclusion
The study found a significant gap between the information patients desired and what was provided. Insufficient information, coupled with the use of medical jargon and time constraints, adversely affected the informed consent process. Enhancing clarity in communication and allowing adequate time for discussions could improve patient understanding and satisfaction.
Towards Personal Data Sharing Autonomy: A Task-driven Data Capsule Sharing System
Towards Personal Data Sharing Autonomy: A Task-driven Data Capsule Sharing System
Qiuyun Lyu, Yilong Zhou, Yizhi Ren, Zheng Wang, Yunchuan Guo
arXiv, August 2024
Abstract
Personal data custodian services enable data owners to share their data with data consumers in a convenient manner, anytime and anywhere. However, with data hosted in these services being beyond the control of the data owners, it raises significant concerns about privacy in personal data sharing. Many schemes have been proposed to realize fine-grained access control and privacy protection in data sharing. However, they fail to protect the rights of data owners to their data under the law, since their designs focus on the management of system administrators rather than enhancing the data owners’ privacy. In this paper, we introduce a novel task-driven personal data sharing system based on the data capsule paradigm realizing personal data sharing autonomy. It enables data owners in our system to fully control their data, and share it autonomously. Specifically, we present a tamper-resistant data capsule encapsulation method, where the data capsule is the minimal unit for independent and secure personal data storage and sharing. Additionally, to realize selective sharing and informed-consent based authorization, we propose a task-driven data sharing mechanism that is resistant to collusion and EDoS attacks. Furthermore, by updating parts of the data capsules, the permissions granted to data consumers can be immediately revoked. Finally, we conduct a security and performance analysis, proving that our scheme is correct, sound, and secure, as well as revealing more advantageous features in practicality, compared with the state-of-the-art schemes.
Symposia/Conferences/Webinars
SYMPOSIA/CONFERENCES/WEBINARS
We will selectively include information on major symposia and conferences which address issues, evidence, analysis or debates involving consent/assent. This listing will include [1] meetings already concluded but which are posting presentations/recordings, etc.; [2] future meetings which have posted registration/logistics information, and [3] meetings which have announced calls for abstracts/panels, etc.
Patient-Centered Informed Consent in Clinical Study of FDA-Regulated Medical Products
FDA Patient Engagement Advisory Committee Meeting
Webinar: October 30, 2024
Video recording: [7:13] https://www.youtube.com/live/Th3fkIpi3vc
AGENDA:
On October 30, 2024, the Committee discussed and made recommendations on “Patient-Centered Informed Consent in Clinical Study of FDA-Regulated Medical Products.”
The individuals who volunteer to participate in clinical research play an integral role in advancing scientific knowledge and supporting the development of potentially life-saving therapies for patients in need. Informed consent is a key element in clinical studies and can be one of a patient’s first interactions with the clinical community. Too often, however, informed consent forms are lengthy and difficult for potential research participants to understand. FDA has worked to improve informed consent over the years, including several recent activities such as developing a draft guidance in identifying key information in informed consent.
The Committee will provide recommendations on the informed consent process and the areas of focus of the informed consent. The Committee will also provide recommendations on factors to consider when communicating informed consent to clinical study participants to increase the likelihood of participants understanding the key elements of research. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDA’s website at the time of the advisory committee meeting, and the background material will be posted on FDA’s website after the meeting.
Background material and the link to the online teleconference and/or video conference meeting are available at https://www.fda.gov/AdvisoryCommittee….
Briefing Documents providing further information:
Center for Informed Consent Integrity 