Giving Consent to the Ineffable
Original Paper
Daniel Villiger
Neuroethics, 15 February 2024; 17(11)
Open access
Abstract
A psychedelic renaissance is currently taking place in mental healthcare. The number of psychedelic-assisted therapy trials is growing steadily, and some countries already grant psychiatrists special permission to use psychedelics in non-research contexts under certain conditions. These clinical advances must be accompanied by ethical inquiry. One pressing ethical question involves whether patients can even give informed consent to psychedelic-assisted therapy: the treatment’s transformative nature seems to block its assessment, suggesting that patients are unable to understand what undergoing psychedelic-assisted therapy actually means for them and whether it aligns with their values. The present paper argues that patients often have sufficient knowledge to give informed consent because they know that they want to change their negative status quo and that psychedelic-assisted therapy offers an effective way to do so. Accordingly, patients can understand what the transformative nature of psychedelic-assisted therapy means for them and a make a value-aligned choice even if they are unable to anticipate the manifestation of a psychedelic experience.
Month: March 2024
Barriers and Facilitators of Surrogates Providing Consent for Critically Ill Patients in Clinical Trials. A Qualitative Study
Barriers and Facilitators of Surrogates Providing Consent for Critically Ill Patients in Clinical Trials. A Qualitative Study
Original Research
Dustin C. Krutsinger, Shannon I. Maloney, Katherine R. Courtright, Karsten Bartels
Chest, 20 February 2024
Abstract
Background
Enrollment into critical care clinical trials is often hampered by the need to rely on surrogate decision-makers. To identify potential interventions facilitating enrollment into critical care clinical trials, a better understanding of surrogate decision-making for critical care clinical trial enrollment is needed.
Research Question
What are the barriers and facilitators of critical care trial enrollment? What are surrogate decision makers’ perspectives on proposed interventions to facilitate trial enrollment?
Study Design and Methods
The authors conducted semi-structured interviews with 20 surrogate decision-makers of critically ill patients receiving mechanical ventilation. The interviews were recorded and transcribed verbatim, and analyzed for themes using an inductive approach.
Results
Twenty surrogate decision-makers of critically ill patients participated in the semi-structured interviews. Thematic analysis confirmed previous research showing that trust in the system, assessing the risks and benefits of trial participation, the desire to help others, and building medical knowledge as important motivating factors for trial enrollment. Two previously undescribed concerns among surrogate decision makers of critically ill patients were identified, including the potential to interfere with clinical treatment decisions and negative sentiment about placebos. Surrogates viewed public recognition and charitable donations for participation as favorable potential interventions to encourage trial enrollment. However, participants viewed direct financial incentives and prioritizing research participants during medical rounds negatively.
Interpretation
This study confirms and extends previous findings that health system trust, study risks and benefits, altruism, knowledge generation, interference with clinical care and placebos are key concerns and barriers for surrogate decision-makers to enroll patients in critical care trials. Future studies are needed to evaluate if charitable giving on the patient’s behalf and public recognition are effective strategies to promote enrollment into critical care trials.
A survey on service users’ perspectives about information and shared decision‐making in psychotropic drug prescriptions in people with intellectual disabilities
A survey on service users’ perspectives about information and shared decision‐making in psychotropic drug prescriptions in people with intellectual disabilities
Original Research
Gerda de Kuijper Josien Jonker, Rory Sheehan, Angela Hassiotis
British Journal of Learning Disabilities, 1 February 2024
Open Access
Abstract
Background
In people with intellectual disabilities and mental disorders and/or challenging behaviours, rates of psychotropic drug prescription are high. In clinical treatments and evaluations, all stakeholders should be involved in a process of shared decision-making (SDM). We aimed to investigate the perspectives of clients and their carers on clients’ treatments with psychotropic drugs.
Methods
We conducted a survey among adults with intellectual disabilities in a Dutch mental healthcare centre providing community, outpatient and inpatient care. Data were collected between January and June 2022. Questions focused on experiences with the provision of information, treatment involvement and SDM and participants’ wishes in this regard.
Findings
Respondents (57 clients and 21 carers) were largely satisfied with the overall care from their clinicians, and with how information on the pharmacological treatment was provided verbally, but written information was insufficient or not provided. Seventy per cent of clients and 60% of carers reported being involved in medication decision-making. However, over 75% of participants desired greater involvement in SDM and over 60% in medication reviews.
Conclusions
Service users and representatives were satisfied about the treatment and verbal information on their psychotropic drug use. The provision of written information, the SDM process and ongoing evaluation of psychotropic medication use could be improved.
Effect of enhanced informed consent on veteran hesitancy to disclose suicidal ideation and related risk factors
Effect of enhanced informed consent on veteran hesitancy to disclose suicidal ideation and related risk factors
Original Article
Brock C. Tucker, Vivian M. Gonzalez
Suicide and Life-Threatening Behavior, 12 February 2024
Abstract
Introduction
The concealment of suicidal ideation (SI) constitutes a significant barrier to reducing veteran deaths by suicide and is associated with fear of negative consequences (e.g., involuntary hospitalization). This study examined whether augmenting informed consent with psychoeducation aimed to help patients achieve a more realistic risk appraisal of consequences associated with disclosure of SI, decreased hesitancy to disclose SI, and related risk behaviors among U.S. veterans.
Method
Participants (N = 133) were recruited from combat veteran social media groups and were randomly assigned to a video simulated treatment-as-usual informed consent (control) or to one of two psychoeducation-enhanced informed consent conditions (psychoed, psychoed + trust).
Results
Compared with the control group, participants in both psychoeducation and enhanced informed consent conditions reported lower hesitancy to disclose SI, firearm access, and problems with drugs/thoughts of harming others, as well as greater trust and respect for the simulated clinician.
Conclusions
These findings suggest that brief psychoeducation regarding common factors that affect hesitancy to disclose SI may be beneficial for increasing trust in providers during the informed consent process and decreasing concealment of SI and firearm access among veterans.
P50: Looking for the best: Video vs written informed consent in coronary angiography procedures
P50: Looking for the best: Video vs written informed consent in coronary angiography procedures
Ines Testoni, Francesca Lampis, Erika Iacona, Roberto Valle, Gabriele Boscolo, Diego De Leo
Cambridge University Press, 2 February 2024
Abstract
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Background
Informed consent practices in healthcare are a fundamental element of patient-centred care; however, the traditional written description of the medical procedure for obtaining informed consent seems to have several limitations.
Aim
This research aimed to evaluate the effects of an alternative method of obtaining informed consent, based on a short informative video for patients waiting to undergo a coronary angiography procedure in Italy.
Methods
The study involved 40 participants, 28 males and 12 females (mean age: 68.55, SD = 13.03), equally divided into two groups, one that received video informed consent and the other the traditional written one. Each group was asked to fill out two questionnaires, one created ad hoc by the authors to measure the level of understanding of the information provided and the perception of usefulness of informed consent, and the other the DASS-21 scale, able to assess anxiety, depression and stress levels.
Results
Comparing the results of the two groups showed that informed consent via video enabled participants to better understand the information provided, as well as feel more confident in their subjective understanding of it, while perceiving informed consent via video as more useful than the traditional one. Video informed consent did not lead to higher levels of anxiety, depression, or stress among participants.
Conclusion
It can be hypothesized that video formats could represent a more useful and understandable alternative to traditional informed consent in the coronary angiography procedure sector.
Informed consent-patients’ understanding of risk
Informed consent-patients’ understanding of risk
Wijohn TR, Newcombe RM, Reynolds J, El-Jack S, Armstrong GP
The New Zealand Medical Journal, 23 February 2024; 137(1590) pp 14-21
Abstract
Aims
The central concept of informed consent is communication of the chance of a successful outcome. The risks and benefits are probabilistic concepts derived from populations; they do not map with any certainty to the individual. We tested patients’ comprehension of basic probability concepts that are needed for informed consent.
Methods
Patients (n=478) completed five questions designed to test risk estimates that are relevant to informed consent. The questions posed non-medical scenarios to avoid patients associating them with their clinical care. The questionnaire was in English and was only offered to patients whose nurse felt that they had sufficient English literacy to understand the questions.
Results
Out of a possible total of five correct answers, Asian patients scored lowest, and significantly less than Pākehā/Europeans (average total score 2.6±1.7 vs 3.6±1.4, p<0.001, 95% confidence interval 0.5 to 1.38). The total score for Māori/Pasifika was intermediate (3.2±1.4), yet they had the lowest deprivation index. This discordant finding may be due to poorer English literacy among Asian participants. On multiple linear regression, Asian ethnicity and advancing age were the independent predictors of a low score. Socio-economic deprivation decile and sex were not.
Conclusions
When answering questions constructed according to best practice, many (but not all) patients have reasonable risk comprehension. Further improvement could target older patients, those of Asian ethnicity and probably all patients where English is a second language. Liberal use of interpreters is suggested.
Macro and micro ethics in fetal and embryological collections: Exploring the paradigms of informed consent among Australian education-focused stakeholders
Macro and micro ethics in fetal and embryological collections: Exploring the paradigms of informed consent among Australian education-focused stakeholders
Joyce El-Haddad, Nalini Pather
Anatomical Sciences Education, 12 February 2024
Abstract
The management of human fetal and embryological collections presents an ethical challenge that can be explored from different perspectives, particularly when considering informed consent. The “micro ethics” level focuses on parties engaged in giving and receiving human tissue while the “macro ethics” level focusses on the collective responsibility of the discipline and society. Additionally, adopting a framework, where ways of working are designed with relevant communities, requires understanding the perspectives of individuals, communities, and organizations. The aim of this study therefore was to assess the perceptions of education-focused Australian stakeholders. A survey collected the perspectives of 198 participants. The majority of participants (61.6%; n = 122/198) indicated that human fetal and embryological remains obtained prior to era of informed consent should be retained for use in education/research. It is likely that their perspective is based on the notion that if human fetal and embryological collections are used for good, then disposing of them would deny this benefit. Women (p < 0.001) indicated a preference for obtaining fetuses and embryos with informed consent for education and research (38.4%; n = 76/198). Majority were in favor of recording both maternal (MI) (59.6%; n = 118/198) and paternal information (PI) (58.1%; n = 115/198) with each donation. Majority (56.1%; n = 111/198) expressed that donations should be accepted from both parental sources. Consideration of stakeholder perspectives is important in developing guidelines regarding these collections. The results from this study demonstrate a level of discomfort with respect to collections without informed consent, which should be considered at the macro ethical and micro ethical level.
Consented maternal care and associated factors among mothers who gave birth at public health institutions in South Wollo Zone, Amhara region, Ethiopia 2022
Consented maternal care and associated factors among mothers who gave birth at public health institutions in South Wollo Zone, Amhara region, Ethiopia 2022
Research Article
SAGE Open Medicine, 12 February 2024
Open Access
Wassie Yazie Ferede, Besfat Berihun Erega, Fillorenes Ayalew Sisay, Abeba Belay Ayalew, Yismaw Yimam Belachew, Tigist Seid Yimer
Abstract
Introduction
Informed consent in healthcare services is a legal, ethical, and professional requirement on the part of all treating health providers and providing person-centered care. The methods of requesting consent during childbirth have not been extensively studied. In Ethiopia, there is not at all a single study done.
Objective
The purpose of this study is to determine associated factors among mothers who gave birth at health institutions in the South Wollo Zone, Amhara region, Ethiopia in 2022.
Methods
Mothers who gave birth at South Wollo Zone public health institutions, from 01 March to 30 April 2022 participated in a multi-center institutional-based cross-sectional study design. Systematic random sampling was used to select 423 study participants. A validated questionnaire was used for data collection, and the data were collected through face-to-face interviews. Data were entered into Epi-Data version 4.6 and exported to SPSS version 23 for analysis. A multivariable logistic regression analysis was performed to identify factors associated with the outcome variable. The level of significance was determined using an adjusted odds ratio with a 95% confidence interval.
Result
The study had 416 participants in total, with a response rate of 98.3%. Out of the 416 respondents interviewed, 67.1% of the women received consented care. The age group of 30–34, complications during childbirth, intended pregnancy, merchant, and primary and referral hospital were significantly associated with consented care.
Conclusion
The level of non-consented care during delivery was high compared with other literature reflecting substantial mistreatment. Therefore, stakeholders should strengthen monitoring and assessment systems to prevent abuse, and further study is required to look for practical ways to make improvements. Key elements of consented care have also been included in Basic and Emergency Obstetric Care training sessions and given to health providers.
The role of self-efficacy in women’s autonomy for health and nutrition decision-making in rural Bangladesh
The role of self-efficacy in women’s autonomy for health and nutrition decision-making in rural Bangladesh
Research
Allison P. Salinger, Ellen Vermes, Jillian L. Waid, Amanda S. Wendt, Sarah J. N. Dupuis, Md Abul Kalam, Abdul Kader, Sheela S. Sinharoy
BMC Public Health, 1 February 2024
Open Access
Abstract
Background
Agency – including the sub-domains of intrinsic agency, instrumental agency, and collective agency – is a critical component of the women’s empowerment process. Self-efficacy (a component of intrinsic agency) may operate as a motivational influence for women to make choices according to their own preferences or goals, such that higher self-efficacy would be associated with more autonomous decision-making (a key component of instrumental agency).
Methods
We examine these relationships using mixed methods. We developed a series of decision-making autonomy indices, which captured alignment between the woman’s reported and preferred roles in health and nutrition decisions. Using ordinal logistic regression, we assessed the relationship between generalized self-efficacy and decision-making autonomy.
Results
There was a consistently positive association across all categories of decision-making, controlling for a number of individual and household-level covariates. In a sub-sample of joint decision-makers (i.e., women who reported making decisions with at least one other household member), we compared the association between generalized self-efficacy (i.e., one’s overall belief in their ability to succeed) and decision-making autonomy to that of domain-specific self-efficacy (i.e., one’s belief in their ability to achieve a specific goal) and decision-making autonomy. Across all decision-making categories, domain-specific self-efficacy was more strongly associated with decision-making autonomy than generalized self-efficacy. In-depth interviews provided additional context for interpretation of the regression analyses.
Conclusions
The results indicate the importance of the role of self-efficacy in the women’s empowerment process, even in the traditionally female-controlled areas of health and nutrition decision-making. The development of the decision-making autonomy index is an important contribution to the literature in that it directly recognizes and captures the role of women’s preferences regarding participation in decision-making.
Informed consent practice and associated factors among healthcare professionals in public hospitals of Southern Ethiopia, 2023: a mixed-method study
Informed consent practice and associated factors among healthcare professionals in public hospitals of Southern Ethiopia, 2023: a mixed-method study
Research
Getachew Nigussie Bolado, Bizuayehu Atnafu Ataro, Mulualem Gete Feleke, Christian Kebede Gadabo, Tamirat Ersino Kebamo, Worku Mimani Minuta
BMC Nursing volume, 30 January 2024; 23(77)
Open Access
Abstract
Background
Patients may sign a consent form before the specific treatment is offered for a variety of reasons, including during an outpatient appointment. Healthcare professionals must obtain consent from patients or other legal persons before providing any treatment or performing any procedures. But, little attention has been given to the informed consent process in Ethiopia.
Objective
To assess informed consent practice and associated factors among healthcare professionals in Wolaita Zone, Southern Ethiopia public hospitals from January, 2023.
Methods
An institutional-based cross-sectional mixed-method study was conducted among 399 healthcare professionals. Simple random sampling and purposive sampling techniques were used to select healthcare professionals for quantitative and qualitative studies respectively. Data for both studies were collected using self-administered questionnaire and key informant interview respectively. EpiDataV4.6 and the Statistical Package for the Social Science was used for entry and analysis of quantitative data. OpenCode software was used for thematic analysis for qualitative data.
Results
339 respondents were included in the study, with a response rate of 94.3%. The good practice of informed consent among the healthcare professionals is 53.1%. There was a significant association between the good practice of informed consent and being male [AOR: 0.003 (95% CI: 0.000–0.017)], working in a comprehensive specialized hospital [AOR: 4.775 (95% CI: 1.45–15.74)] and in-service training [AOR: 0.038 (95% CI: 0.013–0.114)].
Conclusion and recommendations
More than half of healthcare professionals had good practices for informed consent. However, it is critical to plan and intervene various strategies with the goal of improving knowledge and attitude toward informed consent.