Modifications to consent documentation with adults with communication disorders following brain injury: An exploratory study
Original Article
Jennifer Watermeyer, Chiara Aylward
Developing World Bioethics, 14 July 2024
Open Access
Abstract
Consent documentation for research studies is often inaccessible to people with neurogenic communication disorders following brain injury and there is limited literature on specific modifications for informed consent. This exploratory study aimed to identify effective strategies and modifications to consent processes for adults with brain injury. Using a fictitious research study, we developed a set of Participant Information Sheets (PISs) varying in complexity, presentation format, and communication modality. Evaluations were conducted with eight participants. Findings indicated diverse participant preferences for PIS modifications, suggesting simplified vocabulary, reduced text, carefully selected images, and an interactive presentation modality as helpful strategies. Building on previous literature, we present refined guidelines for consent modifications for adults with neurogenic communication disorder after brain injury. These guidelines can promote more appropriate inclusion of communicatively impaired populations in research and assist ethics committees and researchers in preparing modified consent documents.
Measuring Cognition in Clinical Trials in Parkinson’s Disease, Dementia with Lewy Bodies, and Related Disorders
Measuring Cognition in Clinical Trials in Parkinson’s Disease, Dementia with Lewy Bodies, and Related Disorders
Roundtable Proceedings and Roadmap for Research
Shannon D. Donofry, Claire E. O’Hanlon
Rand, 8 July 2024
Excerpt
Emerging research suggests that Parkinson’s disease (PD) and dementia with Lewy bodies (DLB) share underlying pathology and may represent a single, biologically defined disease spectrum. Cognitive changes are among the most worrisome symptoms for patients with PD, and are the core feature of DLB. While the cognitive changes experienced by individuals with PD and mild cognitive impairment share some clinical characteristics with patients who have undiagnosed or prodromal DLB, these changes are distinct from other types of dementias, such as Alzheimer’s disease.
To spur the adaptation of existing cognition-focused measures and the development of new ones to underlie clinical trial endpoints in PD and DLB, the PD/DLB Cognition Roundtable was held on January 10 and 11, 2024, in Washington, D.C. The roundtable brought together representatives from academia and industry, as well as with representatives of regulatory agencies, community partners, patient advocates, and research funders, to build consensus and collaborate on the outcome assessment and trial design methods that will support the development of new treatments for early or mild cognitive changes in disorders on the PD/DLB spectrum.
The authors of this document summarize the roundtable, discussing the state of the field for clinical trial design and cognition measures in PD and DLB, promising avenues of research, and perspectives of regulatory agencies…
Important legal principles of consent and mental capacity
Important legal principles of consent and mental capacity
Iwan Dowie
British Journal of Community Nursing, 4 July 2024
Abstract
Consent is an essential part of healthcare practice, allowing patients to make autonomous decisions. However, this changes when a patient has mental incapacity or is unable to make decisions for themselves for a duration of time. This month’s Policy column looks at some of the key principles of the Mental Capacity Act 2005, and how this can be applied in community nursing practice.
Informed Consent and Surrogate Interference at the Initiation of Community-Based Palliative Care Services
Informed Consent and Surrogate Interference at the Initiation of Community-Based Palliative Care Services
John C. Stys
Palliative Medicine Reports, 22 April 2024
Open Access
Abstract
Community-based palliative care (CBPC) clinicians sometimes contend with an ethically charged scenario when they encounter patients for the first time: The patient’s spouse, or other loved one or caregiver, revokes the patient’s valid informed consent to initiate care. While surrogates are usually motivated by protective instincts, there are other situations where surrogates act out of self-interest. This article considers whether it is ever ethically justified for an adult to revoke another adult’s valid informed consent to initiate palliative care services. The article examines this scenario from three perspectives: the patient’s capacity to give or relinquish informed consent, the surrogate’s intent and use of substituted judgment or best interest, and the clinician’s duty to provide clinical care. This ethical analysis argues that CBPC clinicians have an ethical responsibility to provide palliative care services for patients who have given valid informed consent for those services even when a surrogate acts as an interfering or oppositional force.
Qualitative Content and Discourse Analysis Comparing the Current Consent Systems for Deceased Organ Donation in Spain and England
Qualitative Content and Discourse Analysis Comparing the Current Consent Systems for Deceased Organ Donation in Spain and England
Original Research
Kate Rees, Leah Mclaughlin, David Paredes-Zapata, Cathy Miller, Nicholas Mays, Jane Noyes
Transplant International, 4 July 2024
Abstract
England switched to an opt-out system of consent in 2020 aiming to increase the number of organs available. Spain also operates an opt-out system yet has almost twice the organ donations per million population compared with England. We aimed to identify both differences and similarities in the consent policies, documents and procedures in deceased donation between the two countries using comparative qualitative content and discourse analysis. Spain had simpler, locally tailored documents, the time taken for families to review and process information may be shorter, there were more pathways leading to organ donation in Spain, and more robust legal protections for the decisions individuals made in life. The language in the Spanish documents was one of support and reassurance. Documents in England by comparison appeared confusing, since additions were designed to protect the NHS against risk and made to previous document versions to reflect the law change rather than being entirely recast. If England’s ambition is to achieve consent rates similar to Spain this analysis has highlighted opportunities that could strengthen the English system-by giving individuals’ decisions recorded on the organ donor register legal weight, alongside unifying and simplifying consent policies and procedures to support families and healthcare professionals.
Self-Rated Competence of Ugandan Healthcare Workers to Obtain Informed Consent for Autopsy
Self-Rated Competence of Ugandan Healthcare Workers to Obtain Informed Consent for Autopsy
Felix Bongomin, Winnie Kibone, Ritah Nantale, Robert Lukande, Ruth Bromley, Conrad Muzoora, Davidson H Hamer
American Journal of Tropical Medicine and Hygiene, 25 June 2024
Abstract
We examined the self-rated competence of Ugandan healthcare workers (HCWs) in obtaining informed consent for autopsies, considering the challenges of low autopsy acceptance rates globally. In September and October 2023, we conducted a nationwide cross-sectional study of HCWs, who provided informed consent to participate and completed an online, self-administered questionnaire. Participants’ self-rated competence in obtaining informed consent for autopsy was assessed through Likert scale questions. Knowledge and practices were also assessed. All scores were converted to percentages, with scores ≥80% indicating higher competence. We enrolled 216 HCWs (including 145 [67.1%] doctors), with a mean age of 31.6 ± 7.2 years. Overall, 55.6% (n = 120) had ever assisted in obtaining consent for autopsy, 43.6% (n = 100) had ever obtained consent for autopsy themselves, and 13.4% (n = 29) had ever attended training on obtaining consent for autopsy. The mean competency score was 59.8 ± 17.0% (perfect score, 100%), with 29 (13.4%) participants demonstrating high competence. Healthcare workers with adequate knowledge had higher competence scores (odds ratio [OR]: 15.0, 95% CI: 6.17-36.58, P <0.001). Compared with nurses/midwives, doctors had 73% lower odds of having a high competence score (adjusted OR: 0.27, 95% CI: 0.08-0.94, P = 0.040). Fewer than one in five Ugandan HCWs demonstrated high self-rated competence or possessed adequate knowledge regarding informed consent for autopsies, and only a few had received specialized training on how to obtain consent for an autopsy. Therefore, there is a pressing need for enhanced training and increased awareness among Ugandan HCWs in obtaining informed consent for autopsies.
Translating informed consent in Scottish maternity services: Perspectives from providers and researchers of both maternity care and translation/interpreting services
Translating informed consent in Scottish maternity services: Perspectives from providers and researchers of both maternity care and translation/interpreting services
Jenny Patterson, Sebnem Susam-Saraeva
Language and Health, 22 June 2024
Abstract / Description of output
Background
Failing to meet the communication and information needs of childbearing women leaves them unable to provide true informed consent. Lack of control or lack of involvement in decision making contribute to birth trauma. For those with Limited English Proficiency (LEP) receiving information requires use of interpreters often hindered within pressurised maternity services and urgent situations. Women with LEP are often of ethnicities at risk of poorer maternity outcomes and from cultures where maternity service practices differ from Scottish maternity services.
Question
How do maternity care professionals (MCPs) and translation & interpreting (T&I) providers experience their role around informed consent when caring for women with LEP in Scotland; what do they identify as barriers or facilitators?
Methods
Data were collected using qualitative methodology through online focus groups and interactive workshops including a mix of MCPs and T&I providers. Recruitment used a snowball approach via word of mouth and email. Focus groups were audio recorded and transcribed verbatim, workshops were audio-visually recorded and closely examined. Data were analysed using Framework analysis.
Results
Four themes emerged from the study: 1) Limited resources; 2) Inter-professional concerns; 3) Cultural heritage; and 4) Power.
Discussion
Limited resources affect women, MCPs and interpreting services. A lack of cultural awareness and power differentials create pressure for everyone within the process.
Conclusion
LEP increases complexity around informed consent. Challenges are multifaceted compounded by lack of time and resources alongside power differentials. Trust, respect and continuity are key facilitators.
Evolution of Organ Donation Consent, Retrospective Data on Potential Organ Donors
Evolution of Organ Donation Consent, Retrospective Data on Potential Organ Donors
Petru Cotraua, Marcel Negraub, Viviana Hodosana, Adriana Vladua, Cristian Marius Dainab, Dorel Dulaua, Lucia Georgeta Dainab, Carmen Pantis
Journal of Clinical Medicine, 18 June 2024; 19(2) pp 292-297
Abstract
Introduction and aim
Identifying the best practices to obtain consent for organ donation involves several strategies. This retrospective analysis of the activity in the field of organ donation identifies the most critical impediments, of which the refusal of families to donate is one of the most frequently encountered. Our main aim was to determine the factors that negatively influence the activity of organ and tissue donations from brain dead donors and to summarize the total number of potential and actual deceased donors, their yearly characteristics, and the organ and tissue donation types performed.
Materials and methods
A retrospective descriptive study, covering data from 1 January 2014 to 31 December 2023, was conducted in the intensive care unit of the Emergency Clinical County Hospital of Bihor, a recognized facility engaged in organ donation and transplantation from Romania. All potential and actual deceased donors were included in our research.
Results
During a period of 10 years, between 2014 and 2023, of the 488 potential and actual deceased donors, 355 (72.7%) were potential donors and 133 (27.3%) actual deceased donors.
Conclusions
From 2014 to 2023, a significant percentage [15.28% (133)] of the total number of actual deceased organ donors registered at the national level (870) were identified by us in the Emergency Clinical County Hospital of Bihor.
Evaluating Egg Donor Recruitment Strategies in Czech ART Clinics: A Critical Analysis of Informed Consent and Ethical Considerations
Evaluating Egg Donor Recruitment Strategies in Czech ART Clinics: A Critical Analysis of Informed Consent and Ethical Considerations
Anna De Bayas Sanchez, Jitka Fialová, Hana Konečná, Francisco Güell
Czech Sociological Review, 2024; 60(3) pp 321-346
Abstract
There is a high demand for egg donors in the Czech Republic, driven by international couples’ interest in assisted reproductive procedures due to affordable treatment, no waiting list, and an extended age limit for recipients up to 49 years. For a population of 10.5 million, the country has 48 reproductive clinics. This study aims to evaluate Czech egg donor recruitment campaigns through the lens of free, informed, and specific consent requirements. A quantitative-qualitative analysis of recruitment strategies from 29 unique clinic websites in Czechia was conducted, with 12 sites specifically designed for marketing purposes. The analysis was based on 14 criteria. Of the 29 clinic websites, only three did not indicate compensation amounts, ranging from 800 to 1400 EUR. Thirteen clinics did not provide information on risks associated with oocyte donation, with one falsely stating no risks exist. Twenty-two websites used emotionally evocative quotes and images. Thirteen clinics did not disclose time commitments, and one provided misleading information. Seventeen clinics omitted conditions for donor refusal and the number of allowable donations. Eighteen clinics did not offer post-donation referrals. Conversely, 15 clinics highlighted psychological benefits, and 23 emphasized health benefits. None fully complied with international guidelines on oocyte donation. Analysed websites lack sufficient information for responsible egg donation decisions. The emphasis on compensation, benefits, and suggestive graphics creates an image of safe, community-oriented donation, potentially leading to inadequate understanding of health risks and commodification of the female body.
A qualitative study on informed consent decision-making at two tertiary hospitals in Uganda: Experiences of patients undergoing emergency surgery and their next of kin
A qualitative study on informed consent decision-making at two tertiary hospitals in Uganda: Experiences of patients undergoing emergency surgery and their next of kin
Research Article
Olivia Kituuka, Erisa Sabakaki Mwaka, Ian Guyton Munabi, Moses Galukande, Nelson Sewankambo
SAGE Open Medicine, 22 June 2024
Open Access
Abstract
Background
In emergency situations, patients and their next of kin must make complex medical and ethical decisions in a quick and timely way.
Objectives
To describe the decision-making process during informed consent for emergency surgery among patients and the next of kin of patients who have undergone emergency surgery.
Methods
Consecutive sampling of 39 participants and in-depth semi-structured interviews were conducted at two tertiary teaching hospitals in Uganda. There were 22 patients and 17 next of kin of patients who had undergone emergency surgery within 24–72 h. Responses about decision-making were coded into themes using the social constructivist theory and phenomenological approach.
Results
There were four emergent themes; decision-makers, people consulted, documentation of the consent and factors influencing decision-making. Most patients and next of kin made decisions on their own and documented the consent for themselves. Other family members and doctors were consulted during the decision-making process. Decision-making was influenced by reassurance of good outcomes of surgery and disclosure by the doctors.
Conclusion
Decisions were made collaboratively with the patient at the center but with input of health personnel, the next of kin
and other family members. A communitarian approach combined with shared decision-making between the doctor and the patient and next of kin with adequate discussion and disclosure of information in simple language would improve decision-making for patients and their next of kin.