Consent In Forefoot Surgery; What Does It Mean To The Patient?
Leo D. Baxendale-Smith, Scott D. Middleton, John C. McKinley, Colin E. Thomson
The Foot, 25 September 2020
Abstract
Aims
This study aimed to assess patient risk recall and find risk thresholds for patients undergoing elective forefoot procedures.
Methods
Patients were interviewed in the pre-assessment clinic (PAC) or on day of surgery (DOS); some in both settings. A standardised questionnaire was used for all interviews, regardless of setting. Patients were tested on which risks they recalled from their consent process, asked for thresholds for five pre-chosen risks and asked about a sham risk.
Results
Across all interviews, risk recall on DOS (2.34 risks/patient interview) was significantly lower (p = .05) than in PAC (2.95 risks/patient interview) – this was repeated when comparing results from patients interviewed in both settings only with PAC mean recall of 2.93 risks/patient interview and DOS mean recall of 2.57 risks/patient interview. The mean reported risk thresholds greatly exceeded X’s observed complication rates for forefoot procedures. The five risks tested for thresholds produced the same order in each interview setting, suggesting a patient-perceived severity ranking. Patients answering the sham risk question incorrectly tended to recall fewer risks across all interviews.
Conclusions
This study shows that patient risk recall is poor, as previous literature outlines, reinforcing that consent process improvements could be made. It also illustrates the value of PAC visits in patient education, as shown by higher levels of recall when compared to DOS.
Unplanned Cesarean Birth: Can the Quality of Consent Affect Birth Experiences?
Unplanned Cesarean Birth: Can the Quality of Consent Affect Birth Experiences?
Paul Burcher,Shazneen Hushmendy, Meredith Chan-Mahon, Megha Dasani, Jazmine Gabriel, Erin Crosby
AJOB Empirical Bioethics, 18 September 2020
Abstract
Background: Unplanned cesarean birth is associated with high levels of patient dissatisfaction and negative birth experiences, which in turn can negatively impact birth outcomes. Previous research has demonstrated that issues of physician-patient communication, mistrust, fear of the operating room (OR), and loss of control contribute to patient dissatisfaction with unplanned cesarean birth. We hypothesized that altering the nature and structure of the informed consent prior to the surgery might improve patient satisfaction and birth experience. Specifically, we explored whether educating resident physicians in counseling skills could shift the focus of informed consent from a checklist merely informing the patient of the risks, benefits, and alternatives to a discussion that informs the physician of the patient’s concerns and fears. By approaching consent in this manner, the goal of informed consent expands beyond autonomy rights to include beneficence as well. Methods: Residents received education to discuss issues of communication, fear, mistrust, and loss of control when seeking consent for an unplanned cesarean birth. Patients were randomized to receive either additional counseling that encouraged a discussion or a standard informed consent for cesarean birth. Participants were interviewed two weeks later and scored their satisfaction using a Likert scale on the four themes: communication, mistrust, fear of OR, and loss of control. Results: Both groups had very high patient satisfaction scores; there was no statistical difference between them. Conclusions: Both groups exhibited significantly higher levels of birth satisfaction than present in prior research. Training residents to discuss these issues while seeking consent for an unplanned cesarean birth may have improved patient satisfaction for all participants in this study. This suggests that educating residents to engage patients in a dialogue during informed consent counseling is more important than a specific script.
Informed consent: a shared decision-making process that creates a new professional obligation for care
Informed consent: a shared decision-making process that creates a new professional obligation for care
Guidelines
Arthur Rawlings, Lelan Sillin, Phillip Shadduck, Marian McDonald, Peter Crookes, Bruce MacFadyen Jr, John Mellinger, SAGES Ethics Committee
Surgical Endoscopy, 15 September 2020
Abstract
This statement on informed consent, developed by the SAGES Ethics Committee, has been reviewed and approved by the Board of Governors of SAGES. This statement is provided to offer guidance about the purpose and process of obtaining informed consent, and it is intended for practicing surgeons as well as patients seeking surgical intervention. It is an expression of well-established principles and extensive literature. Excluded from this document are discussions of informed consent for research and informed consent for introduction of new technology, as that has been addressed in previous publications (Strong in Surg Endosc 28:2272, 2014; Stefanidis in Surg Endosc 28:2257, 2014; as reported by Sillin (in: Stain (ed) The SAGES Manual Ethics of Surgical Innovation, Springer, Switzerland, 2016)).
Knowledge and Perception of Ethiopian Surgical Patients to Informed Consent Practice for Surgical Procedures
Knowledge and Perception of Ethiopian Surgical Patients to Informed Consent Practice for Surgical Procedures
Original Research
Open Access Surgery, 7 September 2020; 13 pp 65-70
Befekadu Lemmu, Abebe Megersa, Engida Abebe, Kirubel Abebe
Open Access
Abstract
Background
Surgical informed consent (SIC) is an established ethical and legal requirement for surgical treatment. Patient understanding of the process is essential for efficient surgical care. This study aimed to assess the knowledge and perception of operated patients towards surgical informed consent.
Methods
An institution-based cross-sectional study of all adult surgical patients who signed informed consent and underwent surgery at St. Paul’s Hospital Millennium Medical College (SPHHMC) from February 1st to March 30th, 2018, was performed. Data were collected postoperatively before discharge using a pretested structured questionnaire.
Results
Of 420 patients identified, 385 (91.7%, M:F=2:1) agreed and interviewed. The mean age was 40.3 years (SD± 15.1), and many of the respondents (285, 74.0%) had some level of formal education. Even if most (336, 87.3%) knew the reason why they had surgery, less knowledge and awareness was reported regarding the options of alternative treatments (153, 39.7%), identifying the operating surgeon (129, 33.5%), the type of surgery (160, 41.6%), anesthesia-related risks (96, 24.9%), complications of surgery (69, 17.9%) and postoperative care (4, 1.0%). The legal requirement of surgical informed consent was reported by 267 (69.4%) subjects; however, more than half had no information on the right to change their mind after signed surgical informed consent (223, 57.9%) and whom it protects (224, 58.2%). Only 40 (10.5%) respondents had a good level of knowledge, and it was significant in those with some level of formal education (OR=4.8; 95% CI 1.45–16.01; P=0.010) and in patients who live in an urban area (OR=4.7; 95% CI 1.81–12.35; p=0.002) than their respective groups.
Conclusion
Our patients had limited knowledge and perception regarding surgical informed consent. Hence, the current consent process seems inadequate and needs a revisit.
Universal tumor screening for lynch syndrome: perspectives of patients regarding willingness and informed consent
Universal tumor screening for lynch syndrome: perspectives of patients regarding willingness and informed consent
Research Article
Anusree Subramonian, Doug Smith, Elizabeth Dicks, Lesa Dawson, Mark Borgaonkar, Holly Etchegary
Personalized Medicine, 2 September 2020
Open Access
Abstract
Aim: Lynch Syndrome is associated with a significant risk of colorectal carcinoma (CRC) and other cancers. Universal tumor screening is a strategy to identify high-risk individuals by testing all CRC tumors for molecular features suggestive of Lynch Syndrome. Patient interest in screening and preferences for consent have been underexplored. Methods: A postal survey was administered to CRC patients in a Canadian province. Results: Most patients (81.4%) were willing to have tumors tested if universal tumor screening were available and were willing to discuss test results with family members and healthcare professionals. The majority (62.6%) preferred informed consent be obtained prior to screening. Conclusion: Patients were supportive of universal screening. They expected consent to be obtained, contrary to current practice across Canada and elsewhere.
Comparison of information delivery methods for informed consent for blood transfusions
Comparison of information delivery methods for informed consent for blood transfusions
April Jones, Krishna Badami
New Zealand Journal of Medical Laboratory Science, August 2020; 74(2) pp 149
Abstract
Objectives: Informed consent is a process in which patients are educated about their treatment options, allowing them to make autonomous decisions about whether they consent to treatment. Blood transfusions are a treatment option associated with a multitude of risks which require patient consent. There is evidence the information provided for informed consent, particularly around the risks associated with blood transfusions, is not adequately understood by patients. This project aimed to investigate whether the process of patient education can be improved by use of an information sheet. Methods: A randomised controlled trial was performed using members of the public and medical staff. Participants were randomly assigned to the control or intervention group. The control group received an audio recording replicating the current education process. The intervention group received an A4 sheet of information. Understanding and recall of the information provided was assessed using a questionnaire. The mode for each group was calculated and used to compare the survey results. Results: The results implied neither form of information was adequate in promoting understanding of the risks associated with blood transfusions. There was some evidence suggesting the intervention improved understanding and recall of the frequency of transfusion associated risks. The severity of such events appeared to be unclear irrespective of the type of information received. Conclusion: With further development of the information given, routine use of supplementary paper based information could assist understanding of the frequency and severity of transfusion associated risks through reinforcement of information given during a discussion.
Researching consent in veterinary practice: The use of interpretive description as a multidisciplinary methodology
Researching consent in veterinary practice: The use of interpretive description as a multidisciplinary methodology
Carol A Gray
Methodological Innovations, September-December 2020
Open Access
Abstract
Informed consent in the veterinary sphere has been surprisingly under-researched, despite it being a professional ethical requirement. As consent is given by animal owners on behalf of patients who are unable to consent for themselves, its underpinning ethical basis cannot exactly mirror consent given by adult human patients with capacity. Any attempt to research consent in the veterinary context requires consideration of its legal, ethical and practical applications. This investigation of consent practices in veterinary settings in the United Kingdom was undertaken using interpretation of medicolegal cases, together with three discrete empirical studies comprising the textual analysis of consent forms, consent discussions for the elective neutering of companion animal patients, and interviews with key participants in the consent process. The chosen approach required a methodology that would facilitate triangulation between empirical data analysis and doctrinal legal research. Here, I describe the first use of interpretive description as a methodology of veterinary socio-legal studies, in the context of practice-based research. With foundations in traditional social science methodologies such as hermeneutics, grounded theory, ethnography and symbolic interactionism, interpretive description provided a multi-disciplinary methodological perspective. Its underpinning methodologies informed the methods that were used for data collection, and for subsequent analysis. I combined interpretation of legal decisions and professional ethical guidance with thematic surveys of empirical data to reach higher levels of analysis. The resulting conceptual description of consent in veterinary practice enabled the production of normative guidance appropriate for those in practice, thus fulfilling the methodological aims of interpretive description. Specifically, the key findings were that the consent form should act as a fuller record of the consent discussion, that attention should be paid to achieving an appropriate balance between client autonomy and patient ‘best interests’ and that consent should provide protection to all three parties (client, patient and veterinary professional).
More than consent for ethical open-label placebo research
More than consent for ethical open-label placebo research
Original Research
Laura Specker Sullivan
BMJ Medical Ethics, 3 September 2020
Abstract
Recent studies have explored the effectiveness of open-label placebos (OLPs) for a variety of conditions, including chronic pain, cancer-related fatigue and irritable bowel syndrome. OLPs are thought to sidestep traditional ethical worries about placebos because they do not involve deception: with an OLP, patients or subjects are told outright that they are not given an active substance. As deception is framed as the primary hurdle to ethical placebo use, the door is ostensibly opened to ethical studies of OLPs. In this article, I suggest that even though OLPs seemingly do not involve deception, there are other ethical considerations in their clinical investigation and subsequent use. Research ethics often focusses on informed consent—of which, deception and honesty are a piece—as a means to justify research practices with human subjects. Yet, it is but one of the ethical considerations that should be taken into account. With research into placebo effects in particular, I argue that the history of clinical placebo use grounds special considerations for OLP research that go beyond respect for the autonomy of individual patients through informed consent and encompass structural concerns about the type of patient for whom a placebo has historically been thought appropriate.
The Cohen problem of informed consent
The Cohen problem of informed consent
William Simkulet
BMJ Medical Ethics, 26 August 2020; 46(9) pp 617-622
Abstract
To avoid potential abuse and respect patient autonomy, physicians have a moral obligation to obtain informed consent before performing any significant medical intervention. To give informed consent, a patient must be competent, understand her condition, options and their expected risks and benefits and must freely and expressly consent to one of those options. Shlomo Cohen challenges this conception of informed consent by constructing cases based on Edmund Gettier’s classic counterexamples to traditional theories of knowledge. In this paper, I argue Cohen-style cases are not genuine threats to the concept of informed consent, however they provide an interesting challenge to theories of conscientious objection.
Informed Consent: A Monthly Review
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September 2020
This digest aggregates and distills key content adressing informed consent from a broad spectrum of peer-reviewed journals and grey literature, and from various practice domains and organization types including international agencies, INGOs, governments, academic and research institutions, consortiums and collaborations, foundations, and commercial organizations. 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
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