[Capacity to consent of people with dementia : Insights into the S2k AWMF guidelines 108-001]

[Capacity to consent of people with dementia : Insights into the S2k AWMF guidelines 108-001]
J Haberstroh, VA Tesky, J Pantel
Journal of Gerontology and Geriatrics, 7 December 2020
People with dementia often require medical and nursing care and are regularly confronted with the need to make decisions in this respect; however, in practice uncertainty often exists as to whether a person with dementia is capable of providing consent, what procedures should be used to obtain informed consent, how to provide the necessary information and how capacity to consent can be assured. By providing structured practical recommendations, the S2k guidelines “Consent of persons with dementia to medical treatment” (coordinated by the Association of the Scientific Medical Societies of Germany, AWMF, registration number 108-001) provide a first attempt to summarize and update the relevant medical, legal, ethical and psychological requirements that should be satisfied in this respect. This article enables insights into the guidelines and an overview of the most important recommendations.

Editor’s note: This is a German Language Publication

Ethics of Informed Consent, Coercive and Preventive Medication

Ethics of Informed Consent, Coercive and Preventive Medication
Hanfried Helmchen
NeuroPsychopharmacotherapy, 5 December 2020; pp 1-16
Acknowledgement of human rights and its translation into psychiatric action is an increasingly extensive achievement of the past decades. Orientation towards the individual patient means to recognize both his/her right and capacity of self-determination as well as to consider his/her preferences. This is particularly valid in the use of psychotropic medication in problematic situations such as in coercive and in preventive medication. In view of coercive medication in life-threatening psychiatric emergencies, psychiatrists must convert a seemingly antagonism between respecting the autonomy of the mentally ill and their obligation to care into an ethically acceptable complementary solution. Medication for primary prevention confronts the psychiatrist with difficulties of informing an (almost) healthy individual in view of uncertainties of conversion rates in schizophrenia as well as of lacking drugs with satisfying efficacy in dementia. The application of psychotropic drugs in such cases is often only the last choice due to their questionable or low efficiency, unwanted effects, and other preferences of the comprehensively informed patient.

When patients behave badly: Consent, breach of the duty of care and the law

When patients behave badly: Consent, breach of the duty of care and the law
Anne‐Maree Kelly, Tina Cockburn, Bill Madden
Emergency Medicine Australasia, 2 December 2020
Patients who are abusive or aggressive in ED raise special clinical and legal challenges. These include what steps clinicians should take to exclude serious illness/injury as the cause of the behaviour and when investigations or treatments can be imposed on these patients without their consent. Using a case illustration, this paper discusses legal issues which arise in this context, including how the standard of care owed by clinicians is determined and what may constitute a breach of duty; such patients’ right to consent to (or decline) tests and treatment; and when clinicians may lawfully act without consent and/or control the patient’s behaviour.

Informed Consent in Right-to Try – A Dubious Assumption

Informed Consent in Right-to Try – A Dubious Assumption
Rebecca Dresser
Wake Forest Journal of Law & Policy, 2020; 11(1)
Open Access
In the debate over right-to-try, everyone agrees that the patient’s informed consent is essential. If individual autonomy is the justification for giving patients access to experimental interventions, then adequate understanding must be part of the process. To make autonomous choices, patients must compare the potential harms and benefits of investigational drugs to their other medical options.
Is it possible for patients to make informed decisions in the right-to-try context? Will patients make autonomous decisions about trying investigational drugs when expert oversight is absent? Much of the critical commentary on right-to-try laws focuses on the damage the laws could do to other patients in need of safe and effective treatments.1 But these laws also present dangers to the patients who are their purported beneficiaries.2 Right-to-try supporters claim that patient autonomy underlies their crusade, but they have done little to ensure that patients actually understand the choices these laws allow them to make.
This article examines the deficiencies in right-to-try requirements for informed consent. Part I reviews right-to-try statutes, focusing on the federal right-to-try law that was adopted in 2018. This part also compares the informed consent provisions in right-to-try laws with informed consent provisions in two other laws authorizing patient access to experimental interventions: federal law governing participation in human subject research and the Food and Drug Administration’s (“FDA”) Expanded Access Program…

Clinicians’ consent law knowledge: The case for education

Clinicians’ consent law knowledge: The case for education
Denise Patricia Craig, Fintan Thompson
Focus on Health Professional Education, 2020; 21(3)
The short-term objectives of this study were to investigate clinicians’ confidence with, and knowledge of, consent laws, their behaviour regarding familiarisation with patients’ advance care plans and the potential benefit of brief education. Education covered patients’ rights to refuse treatment, including via advance directive, and the legislated hierarchy of decision-making authority.
Throughout 2018, all clinicians at one Queensland Hospital and Health Service were invited to attend a 1-hour legal education session. The study used a crosssectional survey to measure clinicians’ knowledge before and after education. Responses from 316 pre- and 319 post-education questionnaires were analysed.
A 1-hour legal education session improved clinicians’ understanding of legislated consent hierarchy and patients’ rights. Pre education, 4.1% of participants correctly identified the lawful consent hierarchy, rising to 65.5% after education. Accuracy increased significantly after education; however, substantial errors persisted.
The potential benefit of education to increase multidisciplinary clinicians’ legal knowledge was supported. Education can ensure that clinicians are made aware of patients’ rights and the potential complexity of lawful substitute decision making.       

The Quality of Obtaining Surgical Informed Consent for Cesarean Section in Public Hospitals of Iran

The Quality of Obtaining Surgical Informed Consent for Cesarean Section in Public Hospitals of Iran
Shadi Sabetghadam, Sedighe Rezaie Chamani, Zahra Amirkhanzadeh Barandouzi, Sedigheh Sedigh Mobarakabadi, Yalda Donyaei Mobarrez
Journal of Holistic Nursing and Midwifery, 2021; 31(1) pp 1-7
Nowadays, about 50-65% of births in Iran occur by Cesarean Section (CS). Informed consent (IC) is one of the most important ethical, legal and professional requirements of a surgical procedure.
This study aims to assess the quality of obtaining surgical IC from women underwent CS in public hospitals of Iran.
Materials and Methods
In this analytical study with cross-sectional design, 300 postpartum women who had CS referred to two public hospitals in Rasht, Iran were participated through stratified random sampling method in 2016. Data were collected using a two-part researcher-made questionnaire. Collected data were analyzed by using descriptive statistics, Kruskal-Wallis test, Mann-Whitney U test, and Spearman’s correlation test.
The mean age of participants was 29.84 ± 5.9 years. The majority of them (45.3%) had education lower than high school. The overall mean score for the quality of obtained IC was 62.23±23.38, out of 150 points. Regarding its dimensions, quality of acquiring IC form (20.21±7.12, out of 40 points), provision of CS-related information (15.67±11.10, out of 45 points), voluntariness (7.53±6.95, out of 25), and the physician–patient relationship (18.81±8.87, out of 40 points) were perceived poor. Women’s educational level had a significant correlation with the IC quality dimensions of voluntariness (P=0.0001) and physician–patient relationship (P=0.043). The number of deliveries (P=0.008), live births (P=0.031), and stillbirth (P=0.0001) had a significant correlation with acquiring the IC form. The voluntariness was significantly associated with the number of live births (P=0.023) and stillbirth (P=0.001). The physician-patient relationship dimension was significantly associated with the number of pregnancies (P=0.023) and abortions (P=0.0001). The overall quality of obtained IC was significantly correlated with the women’ age (r= 0.162, P= 0.005).
Most of women in Iran are not informed enough about the CS and its consequences. Health care providers should pay more attention to the women’s characteristics when obtaining IC for the CS.  We recommend essential changes in the process of obtaining surgical IC for the CS in public hospitals of Iran. Obtaining IC during pregnancy may reduce unnecessary CSs.

Power-Laden (Mis)Understandings Surrounding Written Voluntary Informed Consent Procedures in Postcolonial Southern Africa

Power-Laden (Mis)Understandings Surrounding Written Voluntary Informed Consent Procedures in Postcolonial Southern Africa
Michelle R. Brear
The Qualitative Report, 4 December 2020; 25(13) pp 71-89
Written voluntary informed consent (VIC) procedures are the standard approach for operationalising the ethical principle of respect for persons’ autonomy in qualitative research. However, achieving fully informed and truly voluntary consent is challenging, particularly in qualitative research and/or postcolonial contexts. Evidence about (mis)understandings (i.e., unintended meanings) surrounding VIC comes primarily from participants in quantitative, biomedical research. I aim to advance knowledge about qualitative research participants’ (mis)understandings of VIC. I used ethnographic methods to document the evolving (mis)understandings participants attached to written VIC procedures in two postcolonial settings, Eswatini and South Africa. All participants provided me consent to document their interactions as co-researchers in participatory research, in which they learned about, designed and implemented VIC procedures. I analysed the data interpretively and abductively, informed by Bourdieu’s theory of practice. Participants valued the opportunity to decide and sign consent to participate but held (mis)understandings of study information and signing, which evolved as they participated. Many (mis)understandings were shaped by what the unfamiliar act of signing symbolised to them (i.e., binding, contractual agreements that protected the researcher/university and through which they relinquished their rights), from their positions of marginalisation amidst economic/material, cultural and social power inequalities. In postcolonial settings, requiring qualitative research participants to sign consent forms likely undermines the ethical principle of respect that VIC is intended to operationalise. Based on these findings I recommend alternative non-written procedures are used to operationalise the principle of respect in postcolonial qualitative research settings.

Surgical Residents’ Perspective on Informed Consent—How Does It Compare With Attending Surgeons?

Surgical Residents’ Perspective on Informed Consent—How Does It Compare With Attending Surgeons?
Sarah B. Jochum, Mandakini Venkatramani, Ethan M. Ritz, Joanne Favuzza, Dana M. Hayden, Theodore J. Saclarides, Anuradha R. Bhama
Journal of Surgical Research, April 2021, 260; pp 88-94
The informed consent discussion (ICD) is a compulsory element of clinical practice. Surgical residents are often tasked with obtaining informed consent, but formal instruction is not included in standard curricula. This study aims to examine attitudes of surgeons and residents concerning ICD.
Materials and methods
A survey regarding ICD was administered to residents and attending surgeons at an academic medical center with an Accreditation Council for Graduate Medical Education–accredited general surgery residency.
In total, 44 of 64 (68.75%) residents and 37 of 50 (72%) attending surgeons participated. Most residents felt comfortable consenting for elective (93%) and emergent (82%) cases, but attending surgeons were less comfortable with resident-led ICD (51% elective, 73% emergent). Resident comfort increased with postgraduate year (PGY) (PGY1 = 39%, PGY5 = 85%). A majority of participants (80% attending surgeons, 73% residents) believed resident ICD skills should be formally evaluated, and most residents in PGY1 (61%) requested formal instruction. High percentages of residents (86%) and attendings (100%) believed that ICD skills were best learned from direct observation of attending surgeons.
Resident comfort with ICD increases as residents advance through training. Residents acknowledge the importance of their participation in this process, and in particular, junior residents believe formal instruction is important. Attending surgeons are not universally comfortable with resident-led ICDs, particularly for elective surgeries. Efforts for improving ICD education including direct observation between attending surgeons and residents and formal evaluation may benefit the residency curriculum.

Changes in Informed Consent Policy and Treatment Delays in Stroke Thrombolysis

Changes in Informed Consent Policy and Treatment Delays in Stroke Thrombolysis
Hanzhang Xu, Deidre Anne De Silva, Fung Peng Woon, Marcus Eng Hock Ong, David B. Matchar, Janet Prvu Bettger, Daniel T. Laskowitz, Ying Xian
Journal of Stroke and Cerebrovascular Diseases, March 2021; 30(3)
The efficacy of thrombolytic therapy with tissue plasminogen activator (tPA) is highly time dependent. Although clinical guidelines do not recommend written informed consent as it may cause treatment delays, local policy can supersede and require it. From 2014 to 2017, three out of five public hospitals in Singapore changed from written to verbal consent at different time points. We aimed to examine the association of hospital policy changes regarding informed consent on door-to-needle (DTN) times.
Materials and Methods
Using data from the Singapore Stroke Registry and surveys of local practice, we analyzed data of 915 acute ischemic stroke patients treated with tPA within 3 hours in all public hospitals between July 2014 to Dec 2017. Patient-level DTN times before and after policy changes were examined while adjusting for clinical characteristics, within-hospital clustering, and trends over time.
Patient characteristics and stroke severity were similar before and after the policy changes. Overall, the median DTN times decreased from 68 to 53 minutes after the policy changes. After risk adjustment, changing from written to verbal informed consent was associated with a 5.6 minutes reduction (95% CI 1.1-10.0) in DTN times. After the policy changed, the percentage of patients with DTN ≤60 minutes and ≤45 minutes increased from 35.6% to 66.1% (adjusted OR 1.75; 95% CI 1.12-2.74) and 9.3% to 36.0% (adjusted OR 2.42; 95% CI 1.37-4.25), respectively.
Changing from written to verbal consent is associated with significant improvement in the timeliness of tPA administration in acute ischemic stroke.

Risk of withdrawal of consent for treatment with long-acting injectable versus oral antipsychotics: A meta-analysis of randomized controlled trials

Risk of withdrawal of consent for treatment with long-acting injectable versus oral antipsychotics: A meta-analysis of randomized controlled trials
Hodaka Yaegashi, Fuminari Misawa, Hokuto Noda, Yasuo Fujii, Hiroyoshi Takeuchi
Schizophrenia Research, 9 December 2020
Despite the clinical importance of antipsychotic long-acting injections (LAIs) in the treatment of schizophrenia, their use may be limited by patients’ reluctance to accept the injections. No studies to date have investigated whether patients are more likely to withdraw their consent to treatment with LAIs than to treatment with oral antipsychotics (OAPs). Therefore, we performed a meta-analysis of randomized controlled trials (RCTs) to compare the risk of withdrawal of consent between the 2 routes of administration.
PubMed, the Cochrane Library, PsycINFO, and CINAHL were systematically searched. RCTs with open-label or rater-masked design that compared LAIs with OAPs were selected. Data on study discontinuation due to withdrawal of consent and/or loss to follow-up were extracted.
A total of 16 studies (4815 patients) that met the study eligibility criteria were included in the meta-analysis. There was no significant difference between the LAI and OAP groups in the risk of cessation of treatment because of withdrawal of consent. Similarly, there was no significant difference in the risk of study discontinuation because of withdrawal of consent plus loss to follow-up.
These findings were unexpected and suggest that patients may not be more hesitant to continue LAIs than OAPs after consenting to or receiving treatment. Nevertheless, patients should be provided detailed explanations about the use of LAIs and a support system that encourages them to continue treatment.