Capacity to consent to treatment in psychiatry inpatients – a systematic review
Aoife Curley, Carol Watson, Brendan D. Kelly
International Journal of Psychiatry in Clinical Practice, 23 December 2021
Mental capacity for treatment decisions in psychiatry inpatients is an important ethical and legal concern, especially in light of changes in mental capacity legislation in many jurisdictions.
To conduct a systematic review of literature examining the prevalence of mental capacity for treatment decisions among voluntary and involuntary psychiatry inpatients, and to assess any correlations between research tools used to measure mental capacity and binary judgements using criteria such as those in capacity legislation.
We searched PsycINFO, Ovid MEDLINE and EMBASE for studies assessing mental capacity for treatment decisions in people admitted voluntarily and involuntarily to psychiatric hospitals.
Forty-five papers emanating from 33 studies were identified. There was huge variability in study methods and often selective populations, but the prevalence of decision-making capacity varied between 5% and 83.7%. These figures resulted from studies using cut-off scores or categorical criteria only. The prevalence of decision-making capacity among involuntary patients ranged from 7.7% to 42%, and among voluntary patients ranged from 29% to 97.9%. Two papers showed positive correlations between clinicians’ judgement of decision-making capacity and scores on the MacArthur Competence Assessment Tool for Treatment; two papers showed no such correlation.
Not all voluntary psychiatry inpatients possess mental capacity and many involuntary patients do. This paradox needs to be clarified and resolved in mental health legislation; supported decision-making can help with this task.
Doing research with intellectually disabled participants: reflections on the challenges of capacity and consent in socio-legal research
Journal of Law and Society, 16 December 2021
In this article, I reflect on the praxis of doing qualitative interview research involving intellectually disabled people as participants. I explore the ways in which ethical and legal norms work together to shape what is possible in research with intellectually disabled participants. I use stories from the field to explore issues of recruitment and sampling, working with ‘gatekeeper’ organizations, accessible information and informed consent, and data sharing and open access. As these reflections demonstrate, undertaking fieldwork involving intellectually disabled participants presents multiple challenges for socio-legal researchers. They also show that many of the challenges are surmountable, offering concerns, considerations, and solutions that can, and perhaps should, be considered by all socio-legal researchers who wish to ensure that all of the voices of society are included and reflected in their research.
Doctors’ knowledge regarding decision-making capacity: A survey of anesthesiologists|
Alastair Moodley, Ames Dhai
Clinical Ethics, 6 December 2021
Informed consent for anesthesia is an ethical and legal requirement. A patient must have adequate decision-making capacity (DMC) as a prerequisite to informed consent. In determining whether a patient has sufficient DMC, anesthesiologists must draw on their knowledge of DMC. Knowledge gaps regarding DMC may result in incorrect assessments of patients’ capacity. This could translate to an informed consent process that is ethically and legally unsound. This study examined the DMC-related knowledge of anesthesiologists in a group of four university-affiliated hospitals. The findings suggest that anesthesiologists have several areas of knowledge deficiency regarding DMC and DMC assessment. These findings could inform the development of undergraduate and postgraduate curricula.
Supported Decision-Making in Persons With Dementia: Development of an Enhanced Consent Procedure for Lumbar Puncture
Theresa S. Wied, Julia Haberstroh, Jakov Gather, Tarik Karakaya, Frank Oswald, Mishal Qubad, Matthé Scholten, Jochen Vollmann, Johannes Pantel, the ENSURE Consortium
Frontiers in Psychiatry, 16 November 2021
The right to make autonomous decisions is enshrined in law. However, the question how persons with cognitive deficits can be enabled to make autonomous decisions has not been satisfactorily addressed. In particular, the concept of supported decision-making and its implementation into practice has been poorly explored for persons with dementia (PwD).This article describes the empirical development and implementation of support tools to enhance informed consent processes (so called enhanced consent procedures/ECP) for PwD on whether to undergo lumbar puncture. In the end of the process of pilot testing and further development of the tools, the following tools were defined: (1) Standardized Interview Structure, (2) Elaborated Plain Language, (3) Ambience and Room Design, (4) Keyword Lists, (5) Priority Cards, (6) Visualization, and (7) Simplified Written Informed Consent (Patient Information), as well as the general attitude (8) Person-Centered Attitude of the facilitator. As the development, implementation and evaluation of ECP tools is one objective of the transnational ENSURE project, we also include an overview of future empirical procedures. So far, our findings can serve as a selection of possibilities to support PwD in decision-making and help practitioners achieve an appropriate balance between the autonomy and protection of PwD in complex decision-making situation. Future studies should address the question if the proposed set of tools is effective to enhance informed consent processes in PwD.
Reliability of self-report versus the capacity to consent to treatment instrument to make medical decisions in brain metastasis and other metastatic cancers
Mackenzie E. Fowler, Dario A. Marotta, Richard E. Kennedy, Adam Gerstenecker, Meredith Gammon, Kristen Triebel
Brain and Behaviour, 2 October 2021
To evaluate the ability of persons with metastatic cancer to self-assess their medical decision-making capacity (MDC). To investigate this, we compared an objective measure of MDC with self-ratings and evaluated predictors of agreement.
Data were obtained from a cross-sectional study of metastatic cancer patients at a large academic medical center. Across all standards of MDC, sensitivity, specificity, and reliability using Gwet’s AC1 statistic were calculated using the objective measure as the gold standard. Logistic regression was used to evaluate predictors of agreement between the measures across all MDC standards.
In those with brain metastases, high sensitivity (greater than 0.7), but low specificity was observed for all standards. Poor reliability was observed across all standards. Higher age resulted in higher odds of disagreement for Standard 3 (appreciation) (OR: 1.07, 95% CI: 1.00, 1.15) and Standard 4 (reasoning) (OR: 1.05, 95% CI: 1.00, 1.10). For Standard 3, chemotherapy use and brain metastases compared to other metastases resulted in higher odds of disagreement (Chemotherapy: OR: 5.62, 95% CI: 1.37, 23.09, Brain Metastases: OR: 5.93, 95% CI: 1.28, 27.55). For Standard 5 (understanding), no predictors were associated with disagreement.
For less cognitively complex standards (e.g., appreciation), self-report may be more valid and reliable than more cognitively complex standards (e.g., reasoning or understanding). However, overall, MDC self-report in the current sample is suboptimal. Thus, the need for detailed assessment of MDC, especially when patients are older or used chemotherapy, is indicated. Other studies should be conducted to assess MDC agreement longitudinally.
Awareness and Perception of Healthcare Providers about Proxy Consent in Critical Care Research
Rania Mahafzah, Karem H. Alzoubi, Omar F. Khabour, Rana Abu-Farha
Critical Care Research and Practice, 30 September 2021
Proxy consent respects patients’ autonomy when they are incapable of providing consent for research participation. Healthcare providers need to understand the ethical regulations and practices relevant to the proxy consent process. Thus, this study aimed to assess the knowledge and attitudes of healthcare providers about research proxy consent in the ICU setting.
A cross-sectional survey-based design was used in the study. Study participants were resident and specialist physicians, registered nurses, and registered pharmacists from ICU units in Jordan. Participants were asked to fill out a questionnaire developed to assess their knowledge and attitudes towards informed proxy consent for research studies conducted at the ICU.
In this study, 145 healthcare providers completed the study questionnaire. The healthcare providers agreed that the purpose of the proxy consent is to inform the participants about the potential benefits (66.9%) and risks (66.9%) related to the research to study and respect patient’s autonomy (44%), to discuss alternative options (62.1%), and to protect the researchers from any litigation (84.1%). Regarding the assessment of proxy consent, 65.5% of respondents believed that relatives are considered as an authorized legal representative for an informed consent decision on behalf of their ICU patients (65.5%) as they are knowledgeable about patients’ values and preferences and have the desire to provide the necessary help. Respondents also agreed that the informed consent process should explain research protocols and procedures (76.6%), therapeutic alternatives (84.1%), potential benefits (41.4%), and potential risks (44.1%) and that participation in the research is voluntary (66.9%). No significant differences in the responses were found among different groups of healthcare providers.
The majority of healthcare providers had inadequate awareness about the ethical aspects regarding the informed proxy consent process. Providing training regarding the informed consent process can improve the quality of the proxy consent process in clinical research studies in the ICU setting.
Reconsidering research exclusion for serious mental illness: Ethical principles, current status, and recommendations
Irene Harris, Devin Hanson, Jennie Leskela, John Billig, Viviana Padilla-Martinez, Jennifer Boyd, Tasha Nienow
Journal of Psychiatric Research, November 2021; 143 pp 138-143
Historically, individuals managing serious mental illness (SMI) have often been excluded from research, typically because of concern that these individuals may not be able to understand and provide truly informed consent. As treatment has improved, the assumption that individuals managing SMI may not be capable of consent needs to be re-examined. Systematic exclusion from research may limit empirically tested treatments available for people managing SMI, and may contribute to the health care disparities seen in this population.
This article examines this issue by documenting current rates of research exclusion for high disease burden conditions, based on empirical review of studies in ClinicalTrials.gov.
Current rates of exclusion from studies for psychiatric conditions were assessed through systematic review of relevant clinical trials on ClinicalTrials.gov.
Subjects in this inquiry are either articles accessed in the literature reviews, or descriptions of studies in public data on ClinicalTrials.gov.
The primary measure was a previously published coding system to document the extent and types of research exclusion related to psychiatric status.
Among studies of interventions for substance use disorders and chronic pain, individuals managing SMI were more likely to be excluded than those with other psychiatric disorders at statistically significant levels. This was not the case among studies of interventions for ischemic heart disease. In studies of substance use disorders, 9% explicitly excluded SMI and 83% could exclude people with SMI based on broader exclusion criteria. In studies of chronic pain these two categories of exclusion were 16% and 55%, and in studies of ischemic heart disease, these two categories of exclusion were 1% and 20%.
Evidence indicates that it is ethically and scientifically more appropriate to exclude based on capacity to consent than membership in the group of individuals managing SMI. The discussion outlines techniques researchers can use for more equitable and generalizable sampling.
‘Surrogate decision-making’ in India for women competent to consent and choose during childbirth
Kaveri Mayra, Zoë Matthews, Jane Sandall
Agenda: Empowering women for gender equity, 1 September 2021
In a postcolonial, deeply patriarchal culture, decisions are often made for Indian women about every aspect of their life – beginning with whether they will be allowed to be born. This is followed by every life decision, including education and marriage. A ‘surrogate decision-maker’ is a guardian who decides for an adult incapable of making their own decisions due to a mental health condition, or as a substitute based on a patient’s stated or predicted wishes. However, the majority of Indian women are ‘controlled’ and ‘allowed’ or otherwise regarding everything. No choice in women’s life is women’s own, including decisions about deeply personal experiences such as giving birth.
Our article is embedded in feminist epistemology and uses voice-centred relational analysis of interviews with four women from impoverished backgrounds in Bihar, India, to explore decision making around childbirth and throughout their lives. The surrogate decision-makers in the birth environment are: 1) healthcare and non-healthcare providers, and/or 2) family members (who play the dominant role in every other decision about women’s lives). They communicate amongst themselves about a woman’s active bodily experience. Through I-poems we present women’s varied levels of resistance and non-resistance to obstetric violence, which can be looked at as an extension of their response to violence in their routine lives. We find similarities in women’s conditioning to endure, and argue that women should be the key stakeholders of their decisions about themselves and their bodies, which includes decisions about birth.
Dental informed consent challenges and considerations for cognitively impaired patients
Ahmed Alsaleh, Anjuli Kapila, Iftee Shahriar, Yvonne L. Kapila,
Periodontology, 31 August 2021
Because the US population is living to an older age, the number of individuals with cognitive impairment and periodontitis is increasing, as both conditions/diseases increase with age. Dental informed consent best practices for dental/periodontal treatment of individuals with cognitive impairment have not been explored, yet warrant consideration, because complex dental treatments to address periodontal needs/edentulism raise challenges for informed consent in the elderly with cognitive impairment. The purpose of this review is to help practitioners better understand this topic and develop best practices in dentistry for informed consent of patients with cognitive impairment that need extensive dental treatment, including surgical and implant therapy.
Divergent Human Rights Approaches to Capacity and Consent [BOOK CHAPTER]
Mental Health, Legal Capacity, and Human Rights, 2021 [Cambridge University Press]
The institutional dialogue among the Committee on the Rights of Persons with Disabilities and other human rights tribunals has led to greater protection of rights. But not all courts and treaty bodies have accepted the Committee’s absolutist position on legal capacity. The chapter illustrates the multiple human rights-based approaches to capacity and decision-making, and describes how the Committee’s absolutism endangers many of the people living with moderate or severe dementia whom it supposedly benefits.