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
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
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.

The Paradox of Consent for Capacity Assessments
Research Article
Peter Koch
The Journal of Law, Medicine and Ethics, 19 January 2020
Abstract
The use of decision-making capacity assessments (DMCA) in clinical medicine is an underdeveloped yet quickly growing practice. Despite the ethical and clinical importance of these assessments as a means of protecting patient autonomy, clinicians, philosophers, and ethicists have identified a number of practical and theoretical hurdles which remain unresolved.2 One ethically important yet largely unaddressed issue is whether, and to what extent physicians ought to inform and obtain consent from patients prior to initiating a capacity assessment. In what follows, I address the following question: Must, or should, physicians obtain consent for capacity assessments? I argue that physicians have an ethical obligation to obtain express patient consent for capacity assessments, and in doing so, I challenge the predominant view which requires physicians to merely inform patients without obtaining consent. I then identify an underlying philosophical paradox that complicates the clinician’s duty to obtain consent: in short, consent is needed for an assessment of one’s ability to consent. Finally, I recommend a practical solution to this paradox of consent for capacity assessments by proposing a model of double consent from both the patient and health care representative.

Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: An Updated Systematic Review
Review Article
Johanna Glaser, Sarah Nouri, Alicia Fernandez, Rebecca L. Sudore, Dean Schillinger, Michele Klein-Fedyshin, Yael Schenker
Medical Decision Making, 16 January 2020
Abstract
Background
Patient comprehension is fundamental to valid informed consent. Current practices often result in inadequate patient comprehension.
Purpose
An updated review to evaluate the characteristics and outcomes of interventions to improve patient comprehension in clinical informed consent.
Data Sources
Systematic searches of MEDLINE and EMBASE (2008–2018).
Study Selection
We included randomized and nonrandomized controlled trials evaluating interventions to improve patient comprehension in clinical informed consent.
Data Extraction
Reviewers independently abstracted data using a standardized form, comparing all results and resolving disagreements by consensus.
Data Synthesis
Fifty-two studies of 60 interventions met inclusion criteria. Compared with standard informed consent, a statistically significant improvement in patient comprehension was seen with 43% (6/14) of written interventions, 56% (15/27) of audiovisual interventions, 67% (2/3) of multicomponent interventions, 85% (11/13) of interactive digital interventions, and 100% (3/3) of verbal discussion with test/feedback or teach-back interventions. Eighty-five percent of studies (44/52) evaluated patients’ understanding of risks, 69% (41/52) general knowledge about the procedure, 35% (18/52) understanding of benefits, and 31% (16/52) understanding of alternatives. Participants’ education level was reported heterogeneously, and only 8% (4/52) of studies examined effects according to health literacy. Most studies (79%, 41/52) did not specify participants’ race/ethnicity.
Limitations
Variation in interventions and outcome measures precluded conduct of a meta-analysis or calculation of mean effect size. Control group processes were variable and inconsistently characterized. Nearly half of studies (44%, 23/52) had a high risk of bias for the patient comprehension outcome.
Conclusions
Interventions to improve patient comprehension in informed consent are heterogeneous. Interactive interventions, particularly with test/feedback or teach-back components, appear superior. Future research should emphasize all key elements of informed consent and explore effects among vulnerable populations.

Treatment Decisions for a Future Self: Ethical Obligations to Guide Truly Informed Choices
Viewpoint
Claire J. Creutzfeldt, Robert G. Holloway
JAMA, 2 January 2020; 323(2) pp 115-116
Excerpt
It is estimated that every 3 minutes in the United States, a person dies after sustaining a severe acute brain injury, such as an ischemic stroke, intracranial hemorrhage, traumatic brain injury, or cardiac arrest.1 Almost half of deaths after severe acute brain injury, 100 000 per year, occur during the acute hospitalization, and approximately 90% of patients die after a decision to limit the intensity of treatment rather than from the direct effects of the brain injury.1,2

The decision to continue or withdraw life-sustaining treatment usually involves asking a surrogate decision maker to balance the uncertain possibility that a patient will return to some minimally acceptable quality of life against the burden of a prolonged hospital and rehabilitation course, which are options that are difficult to predict and difficult to fathom…

Supporting informed decision-making about vaccination: an analysis of two official websites
Original Research
Vivion, C. Hennequin, P. Verger, E. Dubé
Public Health, January 2020; 178 pp 112-119
Abstract
Objective
To analyze the content of two official French-speaking websites that are used to inform the general public about recommended vaccines in France and Quebec.
Study design
Qualitative content analysis.
Methods
All pages that inform and educate parents regarding childhood vaccination were downloaded and analyzed according to evidence-informed risk communication metrics.
Results
A total of 32 webpages, 14 videos, and two infographics were included in the analysis. The following were the most frequent risk communication approaches: ‘debunking common misconceptions about vaccination’ or ‘answering common questions about vaccines.’ Harm and benefit information focused primarily on the risks of vaccine-preventable diseases and the risks of adverse events after immunization. Most materials used qualitative terminology to describe the risk (e.g., vaccines are among the safest tools, adverse events are rare). Very few materials provided numeric likelihood of harms and benefits. When numeric information was stated, they were only presenting the risks of the diseases or number of cases in an outbreak. The approaches used to debunk misconceptions generally focused on the myth itself rather than the correct information. Few materials used visual aids (e.g., graphics, pictures, icons arrays, etc.) to convey important information.
Conclusions
It is often assumed that misinformation and rumors about vaccination found online is a leading cause of the increase in vaccine hesitancy. Existing communication materials could be improved to better align with best practices in risk communication. Given the availability of confusing and conflicting vaccine narratives, it is crucial that authoritative communication materials aim to build trust and support informed choices about vaccination.

Consent for newborn screening: screening professionals’ and parents’ views
Original Research
Ulph, N. Dharni, R. Bennett, T. Lavender
Public Health, January 2020; 178 pp 151-158
Abstract
Objectives
Expansion of newborn bloodspot screening (NBS) within England, which practices an informed consent model, justified examining acceptability and effectiveness of alternative consent models.
Study design
Qualitative focus groups.
Methods
Forty-five parents and 37 screening professionals (SPs) participated. Data were analysed using thematic analysis.
Results
Parents and SPs initially appeared to have differing views about appropriate consent models. Most parents accepted assumed consent, if adequately informed; however, once aware of bloodspot storage, informed consent was wanted. SPs valued informed consent, but acknowledged it was difficult to obtain. Both samples wanted parents to be informed but were unclear how this could be achieved. Most parents felt NBS was not presented as optional.
Conclusion
The simultaneous exploration of parents and SPs views, in real time is original. This rigour avoided the reliance on retrospective accounts which make it difficult to establish how decisions were made at the time. It is also unique in providing pre-interview consent models to drive the depth of data. It was rigorous in member checking. Findings suggested a preference for full disclosure of all information with some parents valuing this more than choice. Both samples queried whether current consent was sufficiently informed and voluntary. Results suggest differing tolerances of consent type if screening is solely for diagnostic purposes vs bloodspot storage. Results highlight the need for caution when examining consent model preferences without also checking knowledge, as opinions may be based on incomplete knowledge. Future research is needed to examine efficacy of proposed changes.

Procedural Informed Consent to Psychoanalysis: the Challenge from Transformative Experience
Christopher Poppe
Journal of Ethics in Mental Health Open, 2019; 10 pp 1-11
Abstract
Any valid informed consent to medical treatment needs the personal weighing of consequences of different treatment choices. In psychoanalysis, personal consequences are often unknown and, more importantly, cannot be reasonably weighed up before the start of analysis, as psychoanalysis constitutes a transformative experience in the sense of L.A. Paul (2014). The transformative potential hence complicates informed consent to psychoanalysis. In light of this, some authors have recommended to adopt a procedural approach to informed consent, where informed consent is repeatedly obtained throughout the process of psychoanalysis. However, this procedural informed consent, as I argue in this paper, does not constitute a valid form of informed consent due to the irreversibility of the psychoanalytic experience.

What do patients want? Surgical informed‐consent and patient‐centered care – An augmented model of information disclosure
Original Article
Gillie Gabay, Yaarit Bokek‐Cohen
Bioethics, 2 December 2019 
Abstract
The ideal moral standard for surgical informed‐consent calls upon surgeons to carry out a disclosure dialogue with patients so they have as full as possible an understanding of the procedure before they sign the informed‐consent form. This study is the first to empirically explore patient preferences regarding disclosure dialogue. Twelve Israelis who underwent life‐saving surgeries participated in a narrative study. Three themes emerged from the analysis: objectification of patients, anxiety provoking processes and information, and lack of information that was essential for patients. Findings contribute to existing debates among surgeons regarding the scope and importance of some disclosure components. Analysis led to our formulation of an augmented subjective model of information disclosure that participants prefer, which extends beyond the immediate present of the surgery to the period after discharge, and until return to routine. Surgeons should be aware of patient preferences in disclosure, and gaps between perceptions of surgeons, and preferences and needs of patients.