‘Hobson’s choice’: a qualitative study of consent in acute surgery
Anthony Howard, Jonathan Webster, Naomi Quinton, Peter V Giannoudis
BMJ Open, 25 August 2020; 10
Open Access
Abstract
Objectives
The study aimed to understand through qualitative research what patients considered material in their decision to consent to an acute surgical intervention.
Participants, setting and intervention
The patients selected aged between 18 and 90, having been admitted to a major trauma centre to undergo an acute surgical intervention within 14 days of injury, where English was their first language. Data saturation point was reached after 21 patients had been recruited. Data collection and analysis were conducted simultaneously, through interviews undertaken immediately prior to surgery. The data were coded using NVIVO V.12 software.
Results
The key theme that originated from the data analysis was patients were unable to identify any individual risk that would modify their decision-making process around giving consent. The patient’s previous experience and the experience of others around them were a further theme. Patients sensed that there were no nonoperative options for their injuries.
Conclusion
This is the first study investigating what patient considered a material risk in the consent process. Patients in this study did attribute significance to past experiences of friends and family as material, prompting us to suggest that the surgeon asks about these experiences as part of the consent process. Concern about functional recovery was important to patients but insufficient to stop them from consenting to surgery, thus could not be classified as material risk.
What Do you Mean by “Informed Consent”? Ethics in Economic Development Research
What Do you Mean by “Informed Consent”? Ethics in Economic Development Research
Featured Article
Anna Josephson, Melinda Smale
Applied Economic Perspectives and Policy, 27 October 2020
Open Access
Abstract
The ethical conduct of research requires the informed consent and voluntary participation of research participants. Institutional Review Boards (IRBs) work to ensure that these ethical standards are met. However, incongruities in perspective and practice exist across regions. In this article, we focus on informed consent as practiced by agricultural and applied economists, with emphasis on research conducted in low income and/or developing countries. IRB regulations are clear but heterogeneous, emphasizing process rather than outcome. The lack of IRBs and institutional reviews in some contexts and the particulars of the principles employed in others may fail to adequately protect research participants.
Philosophical and Cognitive Elements of Risk Communication in Informed Consent [BOOK CHAPTER]
Philosophical and Cognitive Elements of Risk Communication in Informed Consent [BOOK CHAPTER]
Daniele Chiffi
Clinical Reasoning: Knowledge, Uncertainty, and Values in Health Care, 2 October 2020; pp 145-157
Abstract
There is growing scientific interest in studying the multidisciplinary aspects of risk. Still, no universally accepted definition of risk has been agreed upon. When dealing with the sector of health-related risk, there should be an essential interplay between risk perception and risk communication. The present chapter argues that the effectiveness of risk communication in the health domain can be considerably improved by taking into consideration the cognitive and emotional biases along with all the factors affecting risk perception. I contend that risk communication is effective when based on the negotiation of meanings and therapeutic options in the clinical encounter, which is essential in the context of informed consent and in a person-centred and humanistic perspective in health care.
Informed Consent: A Monthly Review
___________________________
October 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
PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_October 2020
Consent in the time of COVID-19
Consent in the time of COVID-19
Helen Lynne Turnham, Michael Dunn, Elaine Hill, Guy T Thornburn, Dominic Wilkinson
BMJ Medical Ethics, 26 August 2020; 46(9) pp 565-568
Open Access
Abstract
The COVID-19 pandemic crisis has necessitated widespread adaptation of revised treatment regimens for both urgent and routine medical problems in patients with and without COVID-19. Some of these alternative treatments maybe second-best. Treatments that are known to be superior might not be appropriate to deliver during a pandemic when consideration must be given to distributive justice and protection of patients and their medical teams as well the importance given to individual benefit and autonomy. What is required of the doctor discussing these alternative, potentially inferior treatments and seeking consent to proceed? Should doctors share information about unavailable but standard treatment alternatives when seeking consent? There are arguments in defence of non-disclosure; information about unavailable treatments may not aid a patient to weigh up options that are available to them. There might be justified concern about distress for patients who are informed that they are receiving second-best therapies. However, we argue that doctors should tailor information according to the needs of the individual patient. For most patients that will include a nuanced discussion about treatments that would be considered in other times but currently unavailable. That will sometimes be a difficult conversation, and require clinicians to be frank about limited resources and necessary rationing. However, transparency and honesty will usually be the best policy.
The ethics of deferred consent in times of pandemics
The ethics of deferred consent in times of pandemics
Rieke van der Graaf, Marie-Astrid Hoogerwerf, Martine C. de Vries
Nature Medicine, 10 July 2020; 26 pp 1328–1330
Open Access
Excerpt
In the current COVID-19 pandemic, many researchers are applying to research ethics committees for deferred-consent procedures for protocols that aim either to test treatments or to obtain tissue or samples from research participants. However, the deferred-consent procedure has not been developed for pandemics. In this Comment, we interpret existing guidance documents and argue when and under which conditions deferred consent can be considered ethically acceptable in a pandemic…
The Use of Electronic Consent for COVID‐19 Clinical Trials: Lessons for Emergency Care research During a Pandemic and Beyond
The Use of Electronic Consent for COVID‐19 Clinical Trials: Lessons for Emergency Care research During a Pandemic and Beyond
Eric Jaton, Jamie Stang, Michelle Biros, Abbey Staugaitis, Julie Scherber, Florian Merkle, Nicholas M. Mohr, Christopher Streib, Lauren Klein, Michael A. Puskarich
Academic Emergency Medicine, 24 September 2020
Open Access
Abstract
The novel SARS‐CoV‐2 coronavirus poses many unique challenges to the implementation of clinical research, particularly as it relates to the processes of informed consent. Traditional methods of in‐person informed consent were no longer plausible, as face‐to‐face discussions may expose researchers and patients to increased risk of contracting and spreading the virus. In many circumstances the research personnel obtaining consent were considered non‐essential workers, and thus did not have priority for personal protective equipment in light of national shortages.
The Forgotten Element in the Resumption of Elective Bariatric Surgery During the COVID-19 Pandemic: the Patient Consent!
The Forgotten Element in the Resumption of Elective Bariatric Surgery During the COVID-19 Pandemic: the Patient Consent!
Brief Communication
Mohammed Said, Hosam Hamed
Obesity Surgery, 19 September 2020
Abstract
Safety comes first, and the sympathy with the postponed bariatric patients should not come at the expense of the proper standard of care. This study presents a survey of 266 bariatric candidates who were rescheduled for bariatric surgery after postponement during the COVID-19 pandemic. The aim was to assess their knowledge and expectations regarding bariatric surgery and the risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. A total of 233 (87.6%) candidates believed that they were prone to a higher risk of severe SARS-CoV-2 infection, and 24.4% of them believed that bariatric surgery, during the pandemic, would improve their immunity. A total of 27.8% of candidates attributed the responsibility regarding potential perioperative SARS-CoV-2 infection to the medical personnel, and 10.7% of them believed it to be the surgeon’s responsibility.
COVID-19 consent and return to elective orthopaedic surgery allowing a true patient choice?
COVID-19 consent and return to elective orthopaedic surgery allowing a true patient choice?
Timothy M. Clough, Nikhil Shah, Hiren Divecha, Sumedh Talwalkar
Bone Joint Open 2020, 14 September 2020; 1(9) pp 556–561
Abstract
Aims
The exact risk to patients undergoing surgery who develop COVID-19 is not yet fully known. This study aims to provide the current data to allow adequate consent regarding the risks of post-surgery COVID-19 infection and subsequent COVID-19-related mortality.
Methods
All orthopaedic trauma cases at the Wrightington Wigan and Leigh NHS Foundation Trust from ‘lockdown’ (23 March 2020) to date (15 June 2020) were collated and split into three groups. Adult ambulatory trauma surgeries (upper limb trauma, ankle fracture, tibial plateau fracture) and regional-specific referrals (periprosthetic hip fracture) were performed at a stand-alone elective site that accepted COVID-19-negative patients. Neck of femur fractures (NOFF) and all remaining non-NOFF (paediatric trauma, long bone injury) surgeries were performed at an acute site hospital (mixed green/blue site). Patients were swabbed for COVID-19 before surgery on both sites. Age, sex, nature of surgery, American Society of Anaesthesiologists (ASA) grade, associated comorbidity, length of stay, development of post-surgical COVID-19 infection, and post-surgical COVID-19-related deaths were collected.
Results
At the elective site, 225 patients underwent orthopaedic trauma surgery; two became COVID-19-positive (0.9%) in the immediate perioperative period, neither of which was fatal. At the acute site, 93 patients underwent non-NOFF trauma surgery, of whom six became COVID-19-positive (6.5%) and three died. A further 84 patients underwent NOFF surgery, seven becoming COVID-19 positive (8.3%) and five died.
Conclusion
At the elective site, the rate of COVID-19 infection following orthopaedic trauma surgery was low, at 0.9%. At the acute mixed site (typical district general hospital), for non-NOFF surgery there was a 6.5% incidence of post-surgical COVID-19 infection (seven-fold higher risk) with 50% COVID-19 mortality; for NOFF surgery, there was an 8.3% incidence of post-surgical COVID-19 infection, with 71% COVID-19 mortality. This is likely to have significance when planning a resumption of elective orthopaedic surgery and for consent to the patient.
Allocation of Resources and Health Professionals’ Burden During the Covid-19 Pandemic: Reflection on Advanced Directives, Informed Consent, And Social Perception in Mexico
Allocation of Resources and Health Professionals’ Burden During the Covid-19 Pandemic: Reflection on Advanced Directives, Informed Consent, And Social Perception in Mexico
Karen Herrera-Ferrá, Leonardo Souza-García, Antonio Muñoz-Torres
Online Journal of Health Ethics, 11 August 2020; 16(2)
Open Access
Abstract
One of the main problems in the COVID-19 pandemic is the insufficient availability of resources. This deficiency has resulted in emotional and moral burdens of health professionals. Decisions are having to be made as to who will live and who will die. Moreover, given the global impact of this pandemic, negative impacts are heightened in low and middle-income countries such as Mexico. Authors focus on two issues related to, but not exclusive, to the Mexican healthcare system in an attempt to partially address scarce resources and health professionals’ burden. First, is the empowerment of patients’ autonomy through the incorporation of advanced directives (i.e. nonresuscitate order, the use of intensive care unit and/or ventilator) within informed consent. And second, the socio-cultural perception of risk as relevant for public engagement on protective behavioral patterns. We argue that addressing these issues could possibly lessen the burden of healthcare professionals and bring about greater autonomy among the public.