Prevalence of the Inability to Give Informed Consent in the Elderly Orthopaedic Trauma Population [DISSERTATION]
David G. Clossey
Harvard Medical School Doctoral Dissertation, 2020
Abstract
Purpose
Despite the fact that fractures are a leading cause of morbidity in the elderly, a study of the prevalence of the inability to give informed consent in the elderly orthopaedic trauma population has, to the best of our knowledge, not been performed. In addition, the condition of mild cognitive impairment (MCI) has become increasingly recognized since the introduction of the Montreal Cognitive Assessment (MoCA). By simultaneously determining capacity for consent (by clinician gestalt – the gold standard) and degree of cognitive impairment (by utilizing the MoCA), we hope to better understand the relationship between the ability to consent and MCI as well as the specific components of cognition that may allow for decision-making capacity (DMC).
Methods
This prospective study was carried out at Brigham and Women’s Hospital (BWH). English and Spanish speaking patients older than 65 who were admitted for orthopaedic injury requiring surgical management were included in the study. Those who had previously known dementia and delirium were excluded from the study, as well as those who were unable to communicate. (NB: A recent IRB amendment has now allowed us going forward to approach certain patients with known dementia and delirium). Attending physicians determined whether or not a patient had DMC. Independently, a research staff member administered the confusion assessment method (CAM) short form to screen for delirium and the MoCA to screen for cognitive impairment. Various other background data were obtained retrospectively.
Results
While the prevalence of the inability to give informed consent cannot be determined since the project is still actively recruiting patients, we hypothesize that this prevalence is at least 15.6%. While patients with DMC had various demographic data characteristic of the elderly orthopaedic trauma population, 81.8% had an abnormal total MoCA score. Participants generally scored worse on tasks assessing for certain cognitive domains, such as visuospatial/executive function tasks (mean score: 46.7%) and the delayed recall task (mean score: 40%). The vast majority of participants (90.5%) who struggled with the delayed recall task were, however, able to remember additional words with category and/or multiple choice clues. None of the participants had a positive screen for delirium.
Conclusions
Mild cognitive impairment at the time of consent appears not to preclude a patient from having DMC. Although the relationship between cognitive ability and DMC remains not well understood, further conclusions regarding early cases of dementia should be studied going forward. Deficits in certain domains of cognitive thinking may be correlated with an inability to give informed consent, although a comparison of testing results between patients with versus without DMC will be required to further understand this idea.
Year: 2020
Consent to Trainee Involvement in Pediatric Care
Consent to Trainee Involvement in Pediatric Care
Emily A. Largent
New England Journal of Medicine, 17 September 2020
Audio Interview
Interview with Dr. Michael Greene on considerations regarding the consent process for procedures performed by medical students and residents. [09:09]
Excerpt
…Consent to the involvement of students, interns, and residents in the care of children has received scant attention as compared with consent for either care or research. But there are compelling reasons for routinely obtaining children’s assent to trainee involvement…
Enrolment of children in clinical research: Understanding Ghanaian caregivers’ perspectives on consent/assent procedures, and their attitudes towards storage of biological samples for future use
Enrolment of children in clinical research: Understanding Ghanaian caregivers’ perspectives on consent/assent procedures, and their attitudes towards storage of biological samples for future use
Research Article
George O Adjei, Amos Laar, Jorgen AL Kurtzhals, Bamenla Q Goka
Clinical Ethics, 13 September 2020
Abstract
Child assent is recommended in addition to parental consent when enrolling children in clinical research; however, appreciation and relevance ascribed to these concepts vary in different contexts, and information on attitudes towards storage of biological samples for future research is limited, especially in developing countries. We assessed caregivers’ understanding and appreciation of consent and assent procedures, and their attitudes towards use of stored blood samples for future research prior to enrolling a child in clinical research. A total of 17 in-depth interviews were conducted with primary caregivers of children (fathers [n = 3], mothers [n = 12], and grandmothers [n = 2]) at enrolment or on the immediate follow-up date. All caregivers recalled significant amount information from the study information sheet and were able to appropriately link such information to the consent process. While all participants confirmed information received prior to blood sampling as adequate, a few noted that the purpose was not sufficiently well communicated. Caregivers felt children were cognitively vulnerable, and prone to decisions that were not necessarily in their best interest. Nearly all caregivers felt it was their right and responsibility to overrule objections from their ward’s regarding enrolment into specific study or receipt of a therapeutic procedure. There were no objections or concerns regarding use of stored biological samples for future research purposes. There is thus, a need to improve understanding of caregivers on the information provided during the informed consent process. Context-specific studies on the age of assent in specific populations are needed.
A Consent Support Resource with Benefits and Harms of Vaccination Does Not Increase Hesitancy in Parents—An Acceptability Study
A Consent Support Resource with Benefits and Harms of Vaccination Does Not Increase Hesitancy in Parents—An Acceptability Study
Ciara McDonald, Julie Leask, Nina Chad, Margie Danchin, Judith Fethney, Lyndal Trevena
Vaccines, 2 September 2020; 8(500)
Open Access
Abstract
It is unclear whether information given about the benefits and risks of routine childhood vaccination during consent may cue parental vaccine hesitancy. Parents were surveyed before and after reading vaccine consent information at a public expo event in Sydney, Australia. We measured vaccine hesitancy with Parent Attitudes about Childhood Vaccine Short Scale (PACV-SS), informed decision-making with Informed Subscale of the Decisional Conflict Scale (DCS-IS), items from Stage of Decision Making, Positive Attitude Assessment, Vaccine Safety and Side Effect Concern, and Vaccine Communication Framework (VCF) tools. Overall, 416 parents showed no change in vaccine hesitancy (mean PACV-SS score pre = 1.97, post = 1.94; diff = −0.02 95% CI −0.10 to 0.15) but were more informed (mean DCS-IS score pre = 29.05, post = 7.41; diff = −21.63 95% CI −24.17 to −18.56), were more positive towards vaccination (pre = 43.8% post = 50.4%; diff = 6.5% 95% CI 3.0% to 10.0%), less concerned about vaccine safety (pre = 28.5%, post = 23.0%, diff = −5.6% 95% CI −2.3% to −8.8%) and side effects (pre = 37.0%, post = 29.0%, diff = −8.0% 95% CI −4.0% to −12.0%) with no change in stage of decision-making or intention to vaccinate. Providing information about the benefits and risks of routine childhood vaccination increases parents’ informed decision-making without increasing vaccine hesitancy.
Article 5: The Role of Parents in the Proxy Informed Consent Process in Medical Research involving Children
Article 5: The Role of Parents in the Proxy Informed Consent Process in Medical Research involving Children
Research Article
Sheila Varadan
The International Journal of Children’s Rights 24 August 2020; 28(3) pp 521-546
Open Access
Abstract
Medical research involving child subjects has led to advances in medicine that have dramatically improved the lives, health and well-being of children. Yet, determining when and under what conditions a child should be enrolled in medical research remains an ethically vexing question in research ethics. At the crux of the issue is the free and informed consent of the child participant. A child, who is presumed legally incompetent, or lacks sufficient understanding to exercise autonomous decision-making, will not be able to express free and informed consent in the research setting. Rather than exclude all such children from medical research, a parent (or legal guardian) is designated as a proxy to consent on the child’s behalf. However, the concept of proxy informed consent and the framework for its implementation present practical and ethical challenges for researchers, particularly in navigating the relationship between proxy decision-makers and child subjects in the medical research setting. Article 5 of the uncrc may offer guidance on this point: (1) it places boundaries around how parental authority should be exercised; (2) it offers a model for parent-child decision-making that is participatory, collaborative and linked to the child’s enjoyment of rights under the uncrc; (3) it respects and supports the autonomy of child participants by recognising their evolving capacities to give informed consent. This paper concludes that greater consideration should be given to Article 5 as a complementary framework for researchers engaged in medical research involving children.
Assessing Children’s Capacity: Reconceptualising our Understanding through the UN Convention on the Rights of the Child
Assessing Children’s Capacity: Reconceptualising our Understanding through the UN Convention on the Rights of the Child
Research Article
Aoife Daly
The International Journal of Children’s Rights, 24 August 2020; 28(3) pp 471-499
Open Access
Abstract
This article seeks to reconceptualise approaches to assessing children’s capacity, particularly in light of Article 5 of the crc, which enshrines the principle of the evolving capacities of the child. Professionals regularly assess children’s capacity, for example when doctors treat children, or when lawyers represent child clients. They usually do this assessment intuitively however, as there is little guidance on how assessment should work in practice. Medical law in England and Wales serves as a case study to examine law and practice as well as challenges in the area. It is concluded that it may not necessarily be possible objectively to measure children’s capacity, and it may need to be done intuitively. Yet it should be done via a process which is rights-based. An approach to children’s capacity is proposed through four concepts based on the UN Convention on the Rights of the Child: Autonomy, Evidence, Support and Protection.
Challenges in obtaining consent for caesarean delivery in minors in South Africa
Challenges in obtaining consent for caesarean delivery in minors in South Africa
N C Ngene, T Bodiba
South African Journal of Obstetrics and Gynaecology, June 2020; 26(1)
Open Access
Abstract
A 16-year-old primigravida at term developed fetal compromise in the second stage of labour and had a delayed caesarean delivery (CD) because she declined the procedure after the medical manager had consented on her behalf following the unavailability of her parents. The baby that was delivered suffered neonatal encephalopathy. This report provides a recommendation on how to improve the process of obtaining consent for CD in minors in South Africa.
Informed consent to clinical research in India: A private law remedy
Informed consent to clinical research in India: A private law remedy
Research Article
Himani Bhakuni
Medical Law International, 23 September 2020
Abstract
There is a well-established common law doctrine for ascertaining information disclosure in informed consent claims within the treatment context that governs the doctor–patient relationship. But there is no such doctrine in clinical research governing the researcher–participant relationship in India. India, however, is not exceptional in this regard. Common law countries like the United States and Canada at most have sparse, non-systematised, criteria for such cases; arguably, a doctrine for research is at its nascent stage. But the adequacy of the existing criteria for settling informed consent claims in research has hardly ever been discussed. Furthermore, a specific discussion on the applicability of this ‘nascent doctrine’ to India is non-existent. This article discusses both. The article examines case law from India and other common law jurisdictions that hint at developments in this area. It suggests that Indian courts need to move abreast with other jurisdictions to better protect India’s patients and research participants.
Informed consent, Montgomery and the duty to discuss alternative treatments in England and Australia
Informed consent, Montgomery and the duty to discuss alternative treatments in England and Australia
Research Article
Tracey Carver
Journal of Patient Safety and Risk Management, 9 September 2020
Abstract
The UK Supreme Court in Montgomery v Lanarkshire Health Board imposes a duty on healthcare professionals in relation to information disclosure. The obligation is to take reasonable care to ensure that patients are aware, not just of material risks inherent in any recommended treatment, but of any reasonable alternative treatments. While liability for information non-provision was previously decided according to whether the profession would deem disclosure appropriate, the law now judges the sufficiency of information from a patient’s perspective. In doing so, it adopts the approach advocated for Australia in Rogers v Whitaker. However, commentators, in this journal and elsewhere, have expressed concern that the disclosure obligation is unclear. Although Montgomery defines what is ‘material’ for the purpose of identifying notifiable treatment risks, it offers less guidance as to when alternative treatments will be sufficiently ‘reasonable’ to warrant disclosure. Through an analysis of Australian and UK case law and examples, this article considers the ambit of a practitioner’s duty to discuss alternatives. It concludes that although likely subject to further litigation, the identification of reasonable treatment options requiring disclosure will be influenced by the patient’s clinical condition, their prognosis and viable options from a medical perspective, and various non-clinical matters influenced by the test of materiality.
Informed Consent for Mobile Phone Health Surveys in Colombia: A Qualitative Study
Informed Consent for Mobile Phone Health Surveys in Colombia: A Qualitative Study
Research Article
Mariana Rodriguez-Patarroyo, Angelica Torres-Quintero, Andres I. Vecino-Ortiz, Kristina Hallez, Aixa Natalia Franco-Rodriguez, Eduardo A. Rueda Barrera, Stephanie Puerto, Dustin G. Gibson, Alain Labrique, George W. Pariyo, Joseph Ali
Journal of Empirical Research on Human Research Ethics, 25 September 2020
Abstract
Public health surveys deployed through automated mobile phone calls raise a set of ethical challenges, including succinctly communicating information necessary to obtain respondent informed consent. This study aimed to capture the perspectives of key stakeholders, both experts and community members, on consent processes and preferences for participation in automated mobile phone surveys (MPS) of non-communicable disease risk factors in Colombia. We conducted semi-structured interviews with ethics and digital health experts and focus group discussions with community representatives. There was meaningful disagreement within both groups regarding the necessity of consent, when the purpose of a survey is to contribute to the formulation of public policies. Respondents who favored consent emphasized that consent communications ought to promote understanding and voluntariness, and implicitly suggested that information disclosure conform to a reasonable person standard. Given the automated and unsolicited nature of the phone calls and concerns regarding fraud, trust building was emphasized as important, especially for national MPS deployment. Community sensitization campaigns that provide relevant contextual information (such as the name of the administering institution) were thought to support trust-building. Additional ways to achieve the goals of consent while building trust in automated MPS for disease surveillance should be evaluated in order to inform ethical and effective practice.
Center for Informed Consent Integrity 