How to deal with the consent of adults with cognitive impairment involved in European geriatric living labs?
Guillaume Sacco, Frédéric Noublanche, Frédéric Blazek, Catherine Hue, Loïc Carballido, Marine Asfar, Philippe Allain, Cédric Annweiler
Philosophy, Ethics, and Humanities in Medicine, 16 June 2021; 16(3)
Living labs are realistic environments designed to create links between technology developers and end-users (i.e. mostly older adults). Research in LLH (Living labs in health) covers a wide range of studies from non-interventional studies to CT (clinical trials) and should involve patients with neurocognitive disorders. However, the ethical issues raised by the design, development, and implementation of research and development projects in LLH have been the subject of only little interest thus far.
Our aim was to determine a pragmatic, ethical and regulatory correct approach to seek the informed consent of patients with neurocognitive disorders according to the different types of studies carried out in European LLH, with a focus on the French context.
A narrative review of regulatory texts and clinical articles was conducted, and a pragmatic procedure to determine the decision-making capacity of older adults in LLH was proposed.
Individuals must be adequately informed and freely agree to participate in CT. The capacity to consent should be assessed in CT including cognitively impaired older adults. We propose the following steps: first to assess for delirium using the 4 ‘A’s Test (4AT) or the 3-min Diagnostic interview for Confusion Assessment Method (3D-CAM), second to search for medical history of major neurocognitive disorder, and third to assess the decision capacity using the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC).
Including individuals with neurocognitive disorders in research implies using an efficient and pragmatic strategy to inform participants and obtain their consent. The tool we offer here may be useful in the routine operation of LLH but can also be extended to all CT with this population.
The Convention on the Rights of Persons with Disabilities and the challenge to treatment without consent of individuals with psychosocial disabilities [BOOK CHAPTER]
Bernadette McSherry, Lisa Waddington
Routledge, Human Rights Education for Psychologists, 2020
This chapter explores the developing emphasis on human rights in mental health care and treatment and what it means in particular for the compulsory treatment of individuals with psychosocial disabilities. Informed consent to treatment is generally presumed to be central to the provision of good-quality health care. However, many countries have mental health laws that enable the detention and treatment without consent of individuals with “psychosocial disabilities”. Awareness of the need to support people with psychosocial disabilities to make their own decisions is an obvious starting point for promoting human rights in this area. Psychologists and professional associations may have a role in ensuring that mental health care and treatment are provided on a voluntary basis as much as possible. The chapter provides an overview of the conceptual aspects of human rights and compulsory mental health treatment and analyse what the Convention on the Rights of Persons with Disabilities may mean for the practice of human rights-based treatment.
Assessment of capacity to give informed consent for medical assistance in dying: a qualitative study of clinicians’ experience
Ellen Wiebe, Michaela Kelly, Thomas McMorrow, Sabrina Tremblay-Huet, Mirna Hennawy Abstract
Canadian Medical Association Journal, 13 April 2021;9(2) pp E358-E363
Under the Canadian Criminal Code, medical assistance in dying (MAiD) requires that patients give informed consent and that their ability to consent is assessed by 2 clinicians. In this study, we intended to understand how Canadian clinicians assessed capacity in people requesting MAiD.
This qualitative study used interviews conducted between August 2019 and February 2020, by phone, video and email, to explore how clinicians assessed capacity in people requesting MAiD, what challenges they had encountered and what tools they used. The participants were recruited from provider mailing listserves of the Canadian Association of MAiD Assessors and Providers and Aide médicale à mourir. Interviews were audio-recorded and transcribed verbatim. The research team met to review transcripts and explore themes as they emerged in an iterative manner. We used abductive reasoning for thematic analysis and coding, and continued to discuss until we reached consensus.
The 20 participants worked in 5 of 10 provinces across Canada, represented different specialties and had experience assessing a total of 2410 patients requesting MAiD. The main theme was that, for most assessments, the participants used the conversation about how the patient had come to choose MAiD to get the information they needed. When the participants used formal capacity assessment tools, this was mostly for meticulous documentation, and they rarely asked for psychiatric consults. The participants described how they approached assessing cases of nonverbal patients and other challenging cases, using techniques such as ensuring a quiet environment and adequate hearing aids, and using questions requiring only “yes” or “no” as an answer.
The participants were comfortable doing MAiD assessments and used their clinical judgment and experience to assess capacity in ways similar to other clinical practices. The findings of this study suggest that experienced MAiD assessors do not routinely require formal capacity assessments or tools to assess capacity in patients requesting MAiD.
Impact of Age on Consent in a Geriatric Orthopaedic Trauma Patient Population
Madeline M. McGovern, Michael F. McTague, Erin Stevens, Juan Carlos Nunez Medina, Esteban Franco-Garcia, Marilyn Heng
Geriatric Orthopedic Surgery & Rehabilitation, 30 March 2021
Persistent misconceptions of frailty and dementia in geriatric patients impact physician-patient communication and leave patients vulnerable to disempowerment. Physicians may inappropriately focus the discussion of treatment options to health care proxies instead of patients. Our study explores the consenting process in a decision-making capable orthogeriatric trauma patient population to determine if there is a relationship between increased patient age and surgical consent by health care proxy.
Patients aged 65 and older who underwent operative orthopaedic fracture fixation between 1 of 2 Level 1 Trauma Centers were retrospectively reviewed. Decision-making capable status was defined as an absence of patient history of cognitive impairment and a negative patient pre-surgical Confusion Assessment Method (CAM) and Mini-Cog Assessment screen. Provider of surgical consent was the main outcome and was determined by signature on the consent form.
510 patients were included, and 276 (54.1%) patients were deemed capable of consent. In 27 (9.8%) of 276 decision-capable patients, physicians obtained consent from health care proxies. 20 of these 27 patients (74.1%) were 80 years of age or older. However, in patients aged 70 to 79, only 7 health care proxies provided consent. (p = 0.07). For every unit increase in age, the log odds of proxy consent increased by .0008 (p < 0.001). Age (p < 0.001), income level (p = 0.03), and physical presence of proxy at consult (p < 0.001) were factors associated with significantly increased utilization of health care proxy provided consent. Language other than English was a significant predictor of proxy-provided consent (p = 0.035). 48 (22%) decision-making incapable patients provided their own surgical consent.
The positive linear association between age and health care proxy provided consent in cognitively intact geriatric orthopaedic patients indicates that increased patient age impacts the consenting process. Increased physician vigilance and adoption of institutional consenting guidelines can reinforce appropriate respect of geriatric patients’ consenting capacity.
Competence and informed consent
Adam Doležal, Tomáš Doležal
Vnitr̆ní lékar̆ství, Winter 2021; 67(1) pp 49-55
The issue of a patient´s competence is often solved in practice without a major theoretical concept. Such an approach, focused only on the basis of intuitions and experiences of physicians, however, may lead in some cases to an inadequate assessment of competence of a particular patient. Ultimately, it can happen that the decision of an incompetent person will be respected or that the decision of the competent person will be disrespected. Both possibilities can have ethical as well as legal consequences. This article addresses both theoretical and practical issues of competence in adult patients.
Editor’s note: Internal Medicine is the official journal of the Czech Internal Medicine Society.
Psychological, ethical and legal aspects of neurosurgical procedures in conscious patients with judgment consent
Zygmunt Siedlecki, Agnieszka Gutkowska, Karol Nowak, Sheeba Shaik, Maciej Śniegocki
Psychology and Education, 2021; 58(2) pp 7179-7183
Neurosurgical procedures are often performed on patients with brain diseases, making them mentally dysfunctional. These patients may be unconscious, and the surgery is emergency and life-saving then. Its execution from a legal point of view is performed with implied consent. Another problem, both ethically and legally, are the conscious patients who, however, has mental limitations and disturbed criticism, are fully conscious and who do not agree to pronounced treatment. Judgment approval is necessary in these cases. A certain dilemma is the implementation of treatment during the consistently emphasized refusal of treatment. It is difficult for physician, especially since he has contact with this patient every day. We present our own experience in the treatment of such patients. We share our comments and observations. We describe cases of patients treated for brain tumors, hydrocephalus and chronic subdural hematomas. We present the daily ethical, legal and organizational aspects of treating such patients. We suggest that empathy and conversation with such patients is of key importance.
Consent, Informed: Rethinking Informed Consent & Competency for Patients with Schizophrenia & Anosognosia
Boston College Law Review, 24 February 2021; 62(2)
Anosognosia is a common symptom of schizophrenia and schizoaffective disorder that renders individuals unable to understand that they are living with a disease. This symptom often leads people to refuse anti-psychotic medication, and may increase an individual’s likelihood of becoming homeless or incarcerated. When courts find individuals to be a danger to others or themselves, states can impose involuntary commitment. When a state grants involuntary commitment, however, a court may find the individual remains competent to refuse medication. This Note argues that documented anosognosia requires a finding of incompetency, whether people are a danger to themselves or not. Science suggests that a person with severe anosognosia lacks the insight to refuse treatment. This Note proposes a novel statutory definition of competency, encompassing the specific needs of people with anosognosia, and grapples with the significant interests at stake in taking away an individual’s right to choose or refuse treatment, including antipsychotic medication.
Informed Consent or Assent Strategies for Research with Individuals with Deafblindness or Dual Sensory Impairment: A Scoping Review
Archives of Rehabilitation Research and Clinical Translation, 22 February 2021
Abinethaa Paramasivam, Atul Jaiswal, Renu Minhas, Walter Wittich, Roxanna Spruyt-Rocks
To synthesize evidence on existing informed consent/assent strategies and processes that enable the participation of individuals with deafblindness or dual sensory impairment in research.
Five scientific databases (PubMed, MEDLINE, CINAHL, Web of Science, and PsycINFO) and other sources such as Google Scholar, the Journal of Visual Impairment and Blindness, and the British Journal of Visual Impairment were hand-searched from January 2015 until July 2020.
Studies were selected using a priori inclusion criteria of sensory and cognitive disabilities and focused on consent/assent strategies and processes in research within this population. Articles related to the medical or sexual consent processes were excluded.
An Excel spreadsheet was used to extract data from the eligible sources. Discrepancies were resolved in discussion with team members.
A total of 2163 sources were screened, of which 16 articles were included in the review. Seven sources only examined consent strategies, whereas the remaining eight included a combination of consent/assent and dissent strategies. Using thematic analysis, three key themes emerged – consent/assent strategies, researcher capacity, and capacity to consent tools. Key identified strategies included the accessibility of the consent/assent process, building relationships with participants and caregivers, identifying behavioural cues, and communication training for researchers.
Despite the absence of literature on consent/assent strategies within the deafblind population, the review found promising strategies applied to individuals with other cognitive or sensory disabilities that researchers can adopt. Researchers are encouraged to use best practices in creating an inclusive research environment to include individuals with deafblindness.
Decisional capacity to consent to treatment and research in patients affected by Mild Cognitive Impairment. A systematic review and meta-analysis
Giovanna Parmigiani, Antonio Del Casale, Gabriele Mandarelli, Benedetta Barchielli, Georgios D. Kotzalidis, Fabrizia D’Antonio, Antonella Di Vita, Carlo de Lena, Stefano Ferracuti
International Psychogeriatrics, 15 February 2021; pp 1-14
To perform a meta-analysis of clinical studies on the differences in treatment or research decision making capacity among patients with Mild Cognitive Impairment (MCI), Alzheimer’s disease (AD), and healthy comparisons (HCs).
A systematic search was conducted on Medline/Pubmed, CINAHL, PsycINFO, Web of Science, and Scopus. Standardized mean differences and random-effects model were used in all cases.
The United States, France, Japan, and China.
Four hundred and ten patients with MCI, 149 with AD, and 368 HCs were included.
The studies we included in the analysis assessed decisional capacity to consent by the MacArthur Competence Assessment Tool for Treatment (MAcCAT-T), MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), Capacity to Consent to Treatment Instrument (CCTI), and University of California Brief Assessment of Capacity to Consent (UBACC).
We identified 109 potentially eligible studies from 1672 records, and 7 papers were included in the metaanalysis. The meta-analysis showed that there was significant impairment in a decision-making capacity in MCI patients compared to the HCs group in terms of Understanding (SMD = − 1.04, 95% CI: − 1.31 to − 0.77, P < 0.001; I 2 =52%, P= 0.07), Appreciation (SMD = − 0.51, 95% CI: − 0.66 to − 0.36, P <0.001; I 2 = 0%, P = 0.97), and Reasoning (SMD = − 0.62, 95% CI: − 0.77, −0.47, P< 0.001; I 2 =0%, P=0.46). MCI patients scored significantly higher in Understanding (SMD = 1.50, 95% CI: 0.91, 2.09, P =0.01, I 2 = 78%, P= 0.00001) compared to patients affected by AD.
Patients affected by MCI are at higher risk of impaired capacity to consent to treatment and research compared to HCs, despite being at lower risk compared to patients affected by AD. Clinicians and researchers need to carefully evaluate decisional capacity in MCI patients providing informed consent.
Surrogate Informed Consent: A Qualitative Analysis of Surrogate Decision Makers’ Perspectives
Trevor Lane , Elinor Brereton , Carolyn Nowels , Jeffrey McKeehan , Marc Moss , Daniel D Matlock
Annals of the American Thoracic Society, 2 February 2021
Clinical critical care research often hinges on surrogate informed consent as patients commonly lack decision making capacity due to their acute illness. The surrogate informed consent process has been identified as having flaws and needing improvement. A better understanding of surrogates’ perspectives is required in order to understand and address these shortcomings and thereby improve this process.
To explore the perspectives of surrogate decision makers of critically ill mechanically ventilated patients about being approached about having their loved one participate in hypothetical research studies.
We performed semi-structured qualitative interviews of surrogate decision makers of critically ill mechanically ventilated patients exploring their decisional needs surrounding participation in research. These interviews were recorded and transcribed verbatim. A thematic analysis of transcripts was performed with an iterative group framework using a mixed inductive and deductive approach.
A sample of 21 surrogate decision makers were interviewed. Thematic saturation was achieved by consensus of the investigators. We identified trust as a unifying domain for the themes that emerged through the analytic process. Embedded within the domain of trust, two central themes became apparent: knowledge-based trust and context-based trust. Knowledge-based trust includes sub-themes of logistics, accountability, and mutual respect, whereas context-based trust includes trust in the individual clinicians and trust in the hospital system.
Our findings highlight the nuanced layers of trust central to the surrogate informed consent process. To enhance the surrogate informed consent process for participation in critical care research studies it is crucial that researchers recognize the inherent importance of trust to ensure an effective informed consent process.