Surgeon clinical practice variation and patient preferences during the informed consent discussion: a mixed-methods analysis in lumbar spine surgery
Ali Zahrai, Kunal Bhanot, Xin Y. Mei, Eric Crawford, Zachary Tan, Albert Yee, Valerie Palda
Canadian Journal of Surgery, 10 October 2019; 63(3)
Open Access
Abstract
Background
Patients with lumbar disc herniation may greatly benefit from microdiscectomy. Although spine surgeons performing microdiscectomy routinely obtain informed consent, the potential adverse events they disclose often vary. Moreover, little is known about what disclosures are deemed most valuable by patients. The aim of this mixed-methods study was to determine practice variations among spine surgeons in regard to the disclosure of potential adverse events during informed consent discussions
for lumbar microdiscectomy and to determine which topics patients perceived to be valuable in the consent discussion.
Methods
A survey evaluating the frequency with which spine surgeons disclose 15 potential adverse events related to lumbar microdiscectomy during informed consent discussions was distributed among Canadian Spine Society members. Additionally, semistructured interviews were conducted with preoperative patients, postoperative patients, attending spine surgeons, spine fellows and orthopedic residents. Interview transcripts were analyzed using thematic analysis with open coding.
Results
Fifty-one Canadian Spine Society members completed the survey. The number of potential adverse events not routinely discussed was greater among orthopedic surgeons than among neurosurgeons (relative risk 1.83; 95% confidence interval 1.22–2.73; p = 0.003). Three preoperative patients, 7 postoperative patients, 6 attending spine surgeons, 3 spine fellows and 5 orthopedic residents participated in the semistructured interviews. The interviews identified gaps in information provided to patients, particularly on topics relating to postoperative care such as expected recovery time, activity restrictions and need for a caregiver.
Conclusion
There is variation in the disclosure of potential adverse events during informed consent discussions for lumbar microdiscectomy among Canadian spine surgeons. Patients desire more information regarding their postoperative care. Further research should focus on developing guidelines to reduce practice variation and optimize the effectiveness of consent discussions.
Partnering With Patients to Bridge Gaps in Consent for Acute Care Research
Partnering With Patients to Bridge Gaps in Consent for Acute Care Research
Neal W. Dickert, Amanda Michelle Bernard ,JoAnne M. Brabson, Rodney J. Hunter, Regina McLemore, Andrea R. Mitchell, Stephen Palmer, Barbara Reed, Michele Riedford, Raymond T. Simpson, Candace D. Speight, Tracie Steadman, Rebecca D. Pentz
The American Journal of Bioethics, 4 May 2020; 5 pp 7-14
Abstract
Clinical trials for acute conditions such as myocardial infarction and stroke pose challenges related to informed consent due to time limitations, stress, and severe illness. Consent processes should be sensitive to the context in which trials are conducted and to needs of patients and surrogate decision-makers. This manuscript describes a collaborative effort between ethicists, researchers, patients, and surrogates to develop patient-driven, patient-centered approaches to consent for clinical trials in acute myocardial infarction and stroke.
Our group identified important ways in which existing consent processes and forms for clinical trials fail to meet patients’ and surrogates’ needs in the acute context. We collaborated to create model forms and consent processes that are substantially shorter and, hopefully, better-matched to patients’ and surrogates’ needs and expectations from the perspective of content, structure, and tone. These changes, however, challenge some common conventions regarding consent.
What Does the Evolution From Informed Consent to Shared Decision Making Teach Us About Authority in Health Care?
What Does the Evolution From Informed Consent to Shared Decision Making Teach Us About Authority in Health Care?
History of Medicine
James F. Childress, Marcia Day Childress
AMA Journal of Ethics, May 2020
Open Access
Abstract
This article examines the legal doctrine and ethical norm of informed consent and its deficiencies, particularly its concentration on physician disclosure of information rather than on patient understanding, which led to the development of shared decision making as a way to enhance informed consent. As a vague and imprecise rubric, shared decision making encompasses several different approaches. Narrower approaches presuppose an individualistic account of autonomy, while broader approaches view autonomy as relational and hold that clinician-patient relationships grounded in good communication can assist decision making and foster autonomous choices. Shared decision making faces conceptual, normative, and practical challenges, but, with its goal of respecting, protecting, and promoting patients’ autonomous choices, it represents an important cultural change in medicine.
Informed Consent: A Monthly Review
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May 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 Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org
PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_May 2020
Communicating genetic information to family members: analysis of consent forms for diagnostic genomic sequencing
Communicating genetic information to family members: analysis of consent forms for diagnostic genomic sequencing
Article
Amicia Phillips, Emilia Niemiec, Heidi Carmen Howard, Kalliopi Kagkelari, Pascal Borry & Danya F. Vears
European Journal of Human Genetics, 27 April 2020
Abstract
Communicating results from genomic sequencing to family members can play an essential role allowing access to surveillance, prevention, treatment or prophylactic measures. Yet, many patients struggle with communication of these results and it is unclear to what extent this is discussed during the consent process. We conducted an online systematic search and used content analysis to explore how consent forms for genomic sequencing address communication of genetic information to family members. Our search yielded 68 consent forms from 11 countries. Although 57 forms alluded to the familial nature of results, forms varied in their discussion of the potential familial implications of results. Only 11 addressed communication of genetic information with family members, with differences in who would be responsible for this process. Several forms offered patients options regarding communication, even in countries where national guidelines and legislation allow for the disclosure of results in the absence of patient consent. These findings are concerning because they show how forms may potentially mislead patients and health care professionals about whether communication is permissible in cases where the patient does not consent. We suggest that providers and health care professionals reconsider how consent forms address communicating genetic information to family members.
Informed Consent for Human Embryo Genome Editing
Informed Consent for Human Embryo Genome Editing
Erica C.Jonlin
Stem Cell Reports, 14 April 2020; 14(4) pp 530-537
Open Access
Abstract
In the event that human embryo genome editing is considered safe enough for the clinic, researchers will need to consider how to administer consent so that would-be recipients of edited embryos can make an informed decision. Informed consent will require truthfulness, sensitivity, regulatory compliance, and attention to the highest ethical standards.
Dynamic-informed consent: A potential solution for ethical dilemmas in population sequencing initiatives
Dynamic-informed consent: A potential solution for ethical dilemmas in population sequencing initiatives
Review
Fida K Dankar, Marton Gergely, Bradley Malin, Radja Badji, Samar K Dankar, Khaled Shuaib
Computational and Structural Biotechnology Journal, 2 April 2020
Open Access
Abstract
While the majority of population-level genome sequencing initiatives claim to follow the principles of informed consent, the requirements for informed consent have not been-well defined in this context. In fact, the implementation of informed consent differs greatly across these initiatives – spanning broad consent, blanket consent, and tiered consent among others. As such, this calls for an investigation into the requirements for consent to be “informed” in the context of population genomics. One particular strategy that claims to be fully informed and to continuously engage participants is called “dynamic consent”. Dynamic consent is based on a personalised communication platform that aims to facilitate the consent process. It is oriented to support continuous two-way communication between researchers and participants. In this paper, we analyze the requirements of informed consent in the context of population genomics, review various current implementations of dynamic consent, assess whether they fulfill the requirement of informed consent, and, in turn, enable participants to make autonomous and informed choices on whether or not to participate in research projects.
Patient perspectives on research use of residual biospecimens and health information: On the necessity of obtaining societal consent by creating a governance structure based on value-sharing
Patient perspectives on research use of residual biospecimens and health information: On the necessity of obtaining societal consent by creating a governance structure based on value-sharing
Original Research
Mayumi Yamanaka, Mika Suzuki, Keiko Sato
Research Ethics, April 2020
Open Access
Abstract
Very few attempts have been made to survey patient opinions, particularly regarding the use of residual biospecimens and health information in research, to clarify their values. We conducted a questionnaire survey that targeted outpatients of a university hospital to gauge their awareness levels and understand patient perspectives on research that uses these items. Few patients felt that obtaining individual consent for each research study was necessary. Most patients expressed the view that researchers should be obligated to inform them about the research use of their items and be subject to self-directed rules (including sanctions). The research community should try to obtain “societal consent regarding an opt-out system” from the public. A salient value-sharing-based governance structure is necessary for obtaining public trust.
Examining consent for interventional research in potential deceased organ donors: a narrative review
Examining consent for interventional research in potential deceased organ donors: a narrative review
Review
Cooper J, Harvey D, Gardiner D
Anaesthesia, 24 Apr 2020
Abstract
In the last decade, research in transplant medicine has focused on developing interventions in the management of the deceased organ donor to improve the quality and quantity of transplantable organs. Despite the promise of interventional donor research, there remain debates about the ethics of this research, specifically regarding gaining research consent. Here, we examine the concerns and ambiguities around consent for interventional donor research, which incorporate questions about who should consent for interventional donor research and what people are being asked to consent for. We highlight the US and UK policy responses to these concerns and argue that, whereas guidance in this area has done much to clarify these ambiguities, there is little consideration of the nature, practicalities and context around consent in this area, particularly regarding organ donors and their families. We review wider studies of consent in critical care research and social science studies of consent in medical research, to gain a broader view of consent in this area as a relational and contextual process. We contend a lack of consideration has been given to: what it might mean to consent to interventional donor research; how families, patients and health professionals might experience providing and seeking this consent; who is best placed to have these discussions; and the socio-institutional contexts affecting these processes. Further, empirical research is required to establish an ethical and sensitive model for consent in interventional donor research, ensuring the principles enshrined in research ethics are met and public trust in organ donation is maintained.
Trust trumps comprehension, visceral factors trump all: A psychological cascade constraining informed consent to clinical trials: A qualitative study with stable patients
Trust trumps comprehension, visceral factors trump all: A psychological cascade constraining informed consent to clinical trials: A qualitative study with stable patients
Original Research
Michael Rost, Rebecca Nast, Bernice S Elger, David Shaw
Research Ethics, April 2020
Open Access
Abstract
This paper addresses psychological factors that might interfere with informed consent on the part of stable patients as potential early-phase clinical trial participants. Thirty-six semistructured interviews with patients who had either diabetes or gout were conducted. We investigated stable patients’ attitudes towards participating in a fictitious first-in-human trial of a novel intervention. We focused on an in-depth analysis of those statements and explanations that indicated the existence of psychological factors impairing decision-making capacity. Three main themes emerged: insufficient comprehension of the inherent logic of clinical trials (actual comprehension), the recourse to trust over comprehension (prioritization of trust), and visceral factors that override deliberative process (visceral factors). Overall, our results indicate a limited psychological capacity on the part of stable patients to meet the requirements of informed consent as set by Declaration of Helsinki. A redesigned informed consent procedure should take account of these psychological realities.
Center for Informed Consent Integrity 