How many facts make an “informed patient”? Practical challenges for junior doctors in acquiring surgical informed consent
Josephine de Costa, Alan De Costa, Mandy Shircore
ANZ Journal of Surgery, 6 February 2020; 89 (S1) pp 106-1063
Abstract
Purpose
In addition to technical surgical skills, the complete surgeon requires skills in communication and consenting patients. This protects patients, hospitals, and doctors themselves, but also promotes best practice. However, surgical informed consent (SIC) is commonly acquired by junior doctors (defined as PGY1 until completion of specialist training). Little is known about the quality of SIC that doctors at this level may acquire. This study aimed to synthesize known evidence on challenges faced by junior doctors on this issue.
Methodology
The authors conducted a systematic review of all English-language studies published from 1 January 2007 looking at junior doctors (considered to be from PGY1 to the end of specialist training) and any issues that arose around acquiring SIC. A qualitative synthesis was then conducted.
Results
Junior doctors understanding of the legal standards of consent, including both capacity/competence and the concepts of material risk, varied considerably across studies. Documentation and discussion of possible complications in surgery was found to be highly variable within both trainees and consultants consenting practices. Few junior doctors discussed alternative treatment options, including the possibility of having no treatment; evidence on discussion of benefits and recovery were conflicting. Overall documentation of the SIC process was poor.
Conclusions
While junior doctors are commonly responsible for acquiring SIC, this study shows that there are significant practical deficiencies in how they discharge this duty. As a result, SIC acquired by junior doctors may not always comply with required legal standards, which may open up this cohort, and their hospitals, to legal action.
Year: 2020
Montgomery in, Bolam out: are trainee surgeons ‘material risks’ when taking consent for cataract surgery?
Montgomery in, Bolam out: are trainee surgeons ‘material risks’ when taking consent for cataract surgery?
Review Article
Omar Qadir, Yusuf Abdallah, Helen Mulholland, Imran Masood, Stephen A. Vernon, Simon N. Madge
Eye, 4 February 2020
Abstract
Trainee involvement in cataract surgery is vital to allow proper training of the next generation of ophthalmic surgeons. However, recent changes in the UK Law, coupled with open publication of National Cataract Dataset results, lead us to conclude that the status of being a trainee is itself a material risk that now needs to be divulged to patients during the consent process. The opinions of current trainee surgeons in the UK were sampled via questionnaire and clinical negligence counsel was involved in the authorship of the paper in order to analyse the legal issues at stake. Attitudes towards consent regarding trainee involvement in UK cataract surgery need to change.
Informed consent for invasive procedures in the emergency department
Informed consent for invasive procedures in the emergency department
Max M. Feinstein, Janet Adegboye, Joshua D. Niforatos, Richard M. Pescatore
The American Journal of Emergency Medicine, 28 January 2020
Abstract
Background
Informed consent for procedures in the emergency department (ED) challenges practitioners to navigate complex ethical and medical ambiguities. A patient’s altered mental status or emergent medical problem does not negate the importance of his or her participation in the decision-making process but, rather, necessitates a nuanced assessment of the situation to determine the appropriate level of participation. Given the complexities involved with informed consent for procedures in the ED, it is important to understand the experience of key stakeholders involved.
Methods
For this review, we searched Medline, the Cochrane database, and Clinicaltrials.gov for studies involving informed consent in the ED. Inclusion and exclusion criteria were designed to select for studies that included issues related to informed consent as primary outcomes. The following data was extracted from included studies: Title, authors, date of publication, study type, participant type (i.e. adult patient, pediatric patient, parent of pediatric patient, patient’s family, or healthcare provider), number of participants, and primary outcomes measured.
Results
Fifteen articles were included for final review. Commonly addressed themes included medical education (7 of 15 studies), surrogate decision-making (5 of 15 studies), and patient understanding (4 of 15 studies). The least common theme addressed in the literature was community notification (1 of 15 studies).
Conclusions
Studies of informed consent for procedures in the ED span many aspects of informed consent. The aim of the present narrative review is to summarize the work that has been done on informed consent for procedures in the ED.
Infringement of the right to surgical informed consent: negligent disclosure and its impact on patient trust in surgeons at public general hospitals – the voice of the patient
Infringement of the right to surgical informed consent: negligent disclosure and its impact on patient trust in surgeons at public general hospitals – the voice of the patient
Gillie Gabay, Yaarit Bokek-Cohen
BMC Medical Ethics, December 2019; 20(1)
Abstract
Background
There is little dispute that the ideal moral standard for surgical informed consent calls for surgeons to carry out a disclosure dialogue with patients before they sign the informed consent form. This narrative study is the first to link patient experiences regarding the disclosure dialogue with patient-surgeon trust, central to effective recuperation and higher adherence.
Methods
Informants were 12 Israelis (6 men and 6 women), aged 29-81, who underwent life-saving surgeries. A snowball sampling was used to locate participants in their initial recovery process upon discharge.
Results
Our empirical evidence indicates an infringement of patients’ right to receive an adequate disclosure dialogue that respects their autonomy. More than half of the participants signed the informed consent form with no disclosure dialogue, and thus felt anxious, deceived and lost their trust in surgeons. Surgeons nullified the meaning of informed consent rather than promoted participants’ moral agency and dignity.
Discussion
Similarity among jarring experiences of participants led us to contend that the conduct of nullifying surgical informed consent does not stem solely from constraints of time and resources, but may reflect an underlying paradox preserving this conduct and leading to objectification of patients and persisting in paternalism. We propose a multi-phase data-driven model for informed consent that attends to patients needs and facilitates patient trust in surgeons.
Conclusions
Patient experiences attest to the infringement of a patient’s right to respect for autonomy. In order to meet the prima facie right of respect for autonomy, moral agency and dignity, physicians ought to respect patient’s needs. It is now time to renew efforts to avoid negligent disclosure and implement a patient-centered model of informed consent.
Consent for Emergency Treatment: Emergency Department Patient Recall and Understanding
Consent for Emergency Treatment: Emergency Department Patient Recall and Understanding
Ashley LaFountain
Wright State Univseriity CORE Scholar, Scholarship in Medicine Papers, 2019
Abstract
Informed consent is an important ethical and legal requirement that underlies the concept of patient autonomy. This prospective survey study was conducted to assess patient recall and understanding of consent for treatment in adult emergency department (ED) patients at an urban level 1 trauma center with annual volume of 95,000, Miami Valley Hospital. Out of a total 293 patients, most individuals reported only receiving a verbal explanation of the consent document (45%) or not reading the document at all (36%). About half of the patients recalled consenting to treatment (N=144, 49%) and over one third of patients could not recall anything that they consented to during the consent process. These results demonstrate poor understanding of the informed consent document.
Unethical informed consent caused by overlooking poorly measured nocebo effects
Unethical informed consent caused by overlooking poorly measured nocebo effects
J. Howick
Journal of Medical Ethics, 16 February 2020
Open Access
Abstract
Unlike its friendly cousin the placebo effect, the nocebo effect (the effect of expecting a negative outcome) has been almost ignored. Epistemic and ethical confusions related to its existence have gone all but unnoticed. Contrary to what is often asserted, adverse events following from taking placebo interventions are not necessarily nocebo effects; they could have arisen due to natural history. Meanwhile, ethical informed consent (in clinical trials and clinical practice) has centred almost exclusively on the need to share intervention risks with patients to preserve their autonomy. Researchers have failed to consider the harm caused by the way in which such risk information is shared. In this paper, I argue that the magnitude of nocebo effects must be measured using control groups consisting of untreated patients. And, because the nocebo effect can produce harm, the principle of non-maleficence must be taken into account alongside the principle of autonomy when obtaining (ethical) informed consent.
Ethical Issues of Informed Consent: Students as Participants in Faculty
Ethical Issues of Informed Consent: Students as Participants in Faculty
Research
Phatcharapon Tulyakul, Soontareeporn Meepring
Global Journal of Health Science, 15 February 2020; 12(3)
Open Access
Abstract
Educators may face an ethical dilemma when they conduct research by using their own students as participants. The dual role conflict, coercion, confidentiality, misconstruction, and unawareness of the informed consent documents have been discussed as ethical issues in such faculty research. The educators as the researchers should be aware of these ethical dilemmas and attempt to implement the informed consent effectively. Thus, this article explores the ethical considerations of informed consent for the educational setting that students are recruited in the faculty research. Furthermore, this article represented recommendations for potentially resolving the ethical dilemmas of informed consent surrounding this phenomenon which consisted of eliminating dual role conflict and coercion, guarding confidentiality, and promoting good construction and awareness of the informed consent documents.
[Consent management and workflows for cross-sectoral patient records and teleconsultations]
[Consent management and workflows for cross-sectoral patient records and teleconsultations]
Bauer J, Rohner-Rojas S, Holderried M
Der Radiologe, 14 February 2020
Abstract
Cross-enterprise electronic patient records are a key element in the design of interoperable medical care networks and process chains. However, the different requirements concerning type, performance and quality assurance of available communication services within the different healthcare sectors still require that the hospitals participate in various secure communication networks which have to be bridged for cross-sectoral communication. Cross-institutional pathways for telemedicine, however, can be mapped both within and across sectoral boundaries via automated process chains using the IHE (Integrating the Healthcare Enterprise) defined integration profile CrossEnterprise Document Sharing (XDS) and associated integration profiles. The provision of medical documents in a cross-institutional patient record outside of defined medical pathways requires differentiated authorization management. In this respect, consent documents according to the IHE APPC (Advanced Patient Privacy Consents) profile enable the documentation of the patient’s consent, including information about planned authorized people, document types, period and type of document access allowed. Providing access control to medical documentation by the patients themselves is an essential part of the required focusing of medical services on patients. New interoperability standards optimized for use on mobile devices, such as FHIR (Fast Healthcare Interoperability Resources), will enable simplified delivery of patient-centered health records and other medical services on mobile platforms in the future.
Editor’s note: This is a German language publication. Der Radiologe is an internationally recognized publication. The journal is devoted to all aspects of radiology and serves to further train radiologists who are resident and who work in the clinic.
The peculiar case of the Standards of Care: Ethical ramifications of deviating from informed consent in transgender-specific healthcare
The peculiar case of the Standards of Care: Ethical ramifications of deviating from informed consent in transgender-specific healthcare
Practices and concepts
Lipshie-Williams
Ethics, Medicine and Public Health, April – June 2020; 13
Summary
In this article, we discuss the alternate model of consent that has become dominant for the provision of transgender-specific health care within the United States, referred to here as the Standards of Care model. This model, which requires medical professionals to provide official opinions on a transgender patient’s readiness to accept and undergo care, stands in contrast to the majority model of medical consent in the US, namely individually provided informed consent. Here, we review the informed consent model, including the basic ethical components of this model and the essential elements of medical decision-making capacity. We then consider the Standards of Care model. We situate its origins in pathological understandings of gender variance and review the current requirements of the model. Consideration is given to logical inconsistencies within the current Standards of Care model, which holds that gender variance is non-pathological and affirming care is medically necessary, but that adult patients requesting such care require psychiatric diagnoses and are unable to consent to their own care. We then consider the bioethical meaning of the Standards of Care model, which others have proposed cedes some of the patient autonomy offered by informed consent for an inflated reliance on nonmaleficence. We align ourselves with this position. We continue this interpretation to suggest that the Standards of Care model ultimately fails to deliver this proffered nonmaleficence.
Informed Consent: A Monthly Review
___________________________
February 2020
This digest aggregates and distills key content around 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 Fellow
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org
Publisher
David R. Curry
President & CEO
GE2P2 Global Foundation
david.r.curry@ge2p2global.org
PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_February 2020