Palliative care research raises a host of ethical concerns. Obtaining informed consent from seriously ill patients and their families is often perceived as an additional burden. Alternative approaches to traditional written informed consent reflects the changing nature of modern trial design, embracing real-world effectiveness and pragmatic clinical trials with those who are seriously ill. Ethicists, clinical investigators, and regulatory bodies have acknowledged the challenges to rigorous, meaningful, and generalizable research across diverse patient populations in real-world settings. The purpose of this paper is to describe how these clinical trial designs have driven innovation in methods for achieving informed consent, with a focus on palliative care research. In this paper, we describe, and provide examples of consent waivers and three types of alternative approaches to consent, including broadcast notification, and integrated and targeted consent. We also present our experiences in an ongoing palliative care clinical trial, specifically using broadcast notification. Working with participants and regulatory oversight organizations, investigators can address the limits of traditional written informed consent and adopt innovative consent models to advance the science of palliative care. Research is now needed to determine the impact of these differing consent models on clinical trial recruitment, enrollment, and retention, as well as participants' informed understanding of their research participation using such models.
BACKGROUND: Clinical cancer research trials may offer little or no direct clinical benefit to participants where a cure is no longer possible. As such, the decision-making and consent process for patient participation is often challenging.
AIM: To gain understanding of how patients make decisions regarding clinical trial participation, from the perspective of both the patient and healthcare professionals involved.
METHODS: In-depth, face to face interviews using a grounded theory approach. This study was conducted in a regional Cancer Centre in the United Kingdom. Of the 36 interviews, 16 were conducted with patients with cancer that had non-curative intent and 18 with healthcare professionals involved in the consent process.
RESULTS: 'Nothing to lose' was identified as the core category that underpinned all other data within the study. This highlighted the desperation articulated by participants, who asserted trial participation was the 'only hope in the room'. The decision regarding participation was taken within a 'trusting relationship' that was important to both patients and professionals. Both were united in their 'fight against cancer'. These two categories are critical in understanding the decision-making/consent process and are supported by other themes presented in the theoretical model.
CONCLUSION: This study presents an important insight into the complex and ethically contentious situation of consent in clinical trials that have non-curative intent. It confirms that patients with limited options trust their doctor and frequently hold unrealistic hopes for personal benefit. It highlights a need for further research to develop a more robust and context appropriate consent process.
Background: Involving adults lacking capacity (ALC) in research on end of life care (EoLC) or serious illness is important, but often omitted. We aimed to develop evidence-based guidance on how best to include individuals with impaired capacity nearing the end of life in research, by identifying the challenges and solutions for processes of consent across the capacity spectrum.
Methods: Methods Of Researching End of Life Care_Capacity (MORECare_C) furthers the MORECare statement on research evaluating EoLC. We used simultaneous methods of systematic review and transparent expert consultation (TEC). The systematic review involved four electronic databases searches. The eligibility criteria identified studies involving adults with serious illness and impaired capacity, and methods for recruitment in research, implementing the research methods, and exploring public attitudes. The TEC involved stakeholder consultation to discuss and generate recommendations, and a Delphi survey and an expert ‘think-tank’ to explore consensus. We narratively synthesised the literature mapping processes of consent with recruitment outcomes, solutions, and challenges. We explored recommendation consensus using descriptive statistics. Synthesis of all the findings informed the guidance statement.
Results: Of the 5539 articles identified, 91 met eligibility. The studies encompassed people with dementia (27%) and in palliative care (18%). Seventy-five percent used observational designs. Studies on research methods (37 studies) focused on processes of proxy decision-making, advance consent, and deferred consent. Studies implementing research methods (30 studies) demonstrated the role of family members as both proxy decision-makers and supporting decision-making for the person with impaired capacity. The TEC involved 43 participants who generated 29 recommendations, with consensus that indicated. Key areas were the timeliness of the consent process and maximising an individual’s decisional capacity. The think-tank (n = 19) refined equivocal recommendations including supporting proxy decision-makers, training practitioners, and incorporating legislative frameworks.
Conclusions: The MORECare_C statement details 20 solutions to recruit ALC nearing the EoL in research. The statement provides much needed guidance to enrol individuals with serious illness in research. Key is involving family members early and designing study procedures to accommodate variable and changeable levels of capacity. The statement demonstrates the ethical imperative and processes of recruiting adults across the capacity spectrum in varying populations and settings.
Background: To characterize patients dying in a community hospital with or without attempting cardiopulmonary resuscitation (CPR) and to describe patient involvement in, documentation of, and compliance with decisions on resuscitation (Do-not-attempt-to-resuscitate orders; DNAR).
Methods: ll patients who died in Kalmar County Hospital during January 1, 2016 until December 31, 2016 were included. All information from the patients’ electronic chart was analysed.
Results: Of 660 patients (mean age 77.7 ± 12.1 years; range 21–101; median 79; 321 (48.6%) female), 30 (4.5%) were pronounced dead in the emergency department after out-of-hospital CPR. Of the remaining 630 patients a DNAR order had been documented in 558 patients (88.6%). Seventy had no DNAR order and 2 an explicit order to do CPR. In 43 of these 70 patients CPR was unsuccessfully attempted while the remaining 27 patients died without attempting CPR. In 2 of 558 (0.36%) patients CPR was attempted despite a DNAR order in place. In 412 patients (73.8%) the DNAR order had not been discussed with neither patient nor family/friends. Moreover, in 75 cases (13.4%) neither patient nor family/friends were even informed about the decision on code status.
Conclusions: In general, a large percentage of patients in our study had a DNAR order in place (88.6%). However, 27 patients (4.3%) died without CPR attempt or DNAR order. DNAR orders had not been discussed with the patient/surrogate in almost three fourths of the patients. Further work has to be done to elucidate the barriers to discussions of CPR decisions with the patient.
BACKGROUND: Facing the relentless worsening of their condition, ALS patients are required to make decisions on treatments and end-of-life care. A cognitive impairment showed to be a negative prognostic factor in ALS patients, perhaps affecting the ability to make informed decisions. Notwithstanding its crucial role, the capacity to consent to treatment (CCT) has never been evaluated in these patients.
OBJECTIVES: To assess the CCT in an ALS cohort in comparison to a control group, and to study the effects of demographic and clinical variables on this high-level cognitive function.
METHODS: 102 ALS patients and 106 healthy controls (HC) were enrolled. CCT was assessed using the MacArthur Competence Assessment Tool for Treatment (MAC-CAT-T) and the performance was classified into the three CCT outcomes (full credit, partial credit, no credit). Cognitive and psychological variables were assessed by MMSE, phonemic fluencies, Frontal System Behavioural Scale (FrSBe), and ALS Depression Inventory (ADI). Clinical and demographic variables were analyzed as possible predictors of the MAC-CAT-T outcomes. After a 1-year follow-up, CCT and neuropsychological assessments were repeated.
RESULTS: Most ALS patients (i.e., from 75 to 83% according to the different sub-items) retain full CCT. However, a subpopulation of the ALS patients showed a reduced CCT with respect to the HC. Age, education, phonemic fluency, and depression appeared related to the CCT outcomes. After 1 year, only the reasoning items worsened.
CONCLUSIONS: This is a preliminary report suggesting that the large majority of ALS patients can retain full ability to choose between treatment options. However, demographic and neuropsychological variables may affect CCT, pointing to the need for special attention to the consent disclosure in this disease.
BACKGROUND: South Africa (SA) has very low and unchanging organ donation rates. A key point in the pathway of organ donation is obtaining informed consent from the family, which is necessary before organ donation can proceed. There is no published SA research on the consent rate and factors that influence this.
OBJECTIVES: To describe the number of requests for consent and factors influencing this process in the SA context.
METHODS: A prospective descriptive study was performed of all requests to families for organ donation in Western Cape Province, SA, by Groote Schuur Hospital (state sector), Red Cross War Memorial Children's Hospital (state sector) and Netcare (private sector) transplant co-ordinators from 1 May 2017 to 1 May 2018 to describe factors influencing consent rates.
RESULTS: The 6 co-ordinators (3 state sector and 3 private sector) recorded data of 83 consecutive families approached in 16 hospitals over the 1-year period. Consent to organ donation was granted for 23 family requests (n=18 (state sector); n=5 (private sector)). The number of families approached was greater in the state sector (n=74) than in the private sector (n=9). The overall consent rate was 27.7% (24.3% (state sector); 55.5% (private sector)). The majority of referrals came from trauma and emergency units (n=55; 66.3%) and very few from intensive care units (n=25; 30.1%). Immediate fluid resuscitation was required in 56 (67.5%) potential donors. The majority of families (n=74; 89.2%) were receptive to the organ donation request, independent of their ultimate decision regarding donation. The main reason given for refusing to consent was that it was against their religion (n=21) or culture (n=18).
CONCLUSIONS: This study showed that the number of families approached for consent to organ donation were low in the Western Cape (lower in the private sector), with a low consent rate (lower in the state sector). Donor management by clinical teams needs to be ongoing and active during the consent process. Consent discussions (and public awareness initiatives) need to be sensitive to and deal with religious and cultural reservations about organ donation.
La pratique de prélèvement d’organe selon la procédure dite Maastricht III (MIII) est l’objet de discussions et de controverses éthiques. Au premier plan de ces craintes, est celle de la dérive utilitariste privilégiant une éthique sociétale à une éthique individuelle. On peut proposer néanmoins un certain nombre de garde-fous éthiques discutés dans cet article et dont les principaux sont les suivants : le MIII ne doit pas être la solution unique face à la pénurie de greffons. Les décisions de limitation et arrêt thérapeutique doivent être strictement appliquées dans le cadre de la loi Claeys Leonetti sans interférence avec l’équipe de prélèvement ; un consentement explicite est la garantie du respect de la volonté du donneur ; les procédures de sédation accompagnant l’arrêt des traitements de support vitaux doivent être identiques qu’il y ait ou non de prélèvement MIII.
Peu d’analyses des premiers résultats ont été publiées sur la procédure de don d’organes dite Maastricht 3 (M3), mise en place en 2014 en France. Pourtant, cette procédure est soumise à un conflit d’intérêt intérieur pour le médecin qui devra éclaircir son désir d’être utile aux autres par le biais de la promotion du don d’organes sans que cela n’influence sa décision d’arrêt des traitements de l’éventuel patient donneur. Ceci, alors même que les moyens d’établir un pronostic sont souvent limités. Toute modification des pratiques liées à la fin de vie au cours de l’instauration de la procédure M3 – telles la politique d’admission des patients en réanimation, l’administration de la sédation ou encore la procédure de séparation du ventilateur – peut témoigner d’une volonté de maximisation de l’utilité à court terme de cette procédure. Le consentement des proches peut lui aussi se retrouver biaisé par une forte désirabilité sociale ou par un sentiment de culpabilité, et une évaluation sereine ne sera pas réalisée du fait de la rapidité de la procédure. L’éclairage des tensions philosophiques entre les pensées conséquentialistes et déontologiques, l’importance d’un débat dans chaque structure, une indication très restrictive aux patients anoxiques les plus graves, un contrôle a posteriori indépendant, font partie des solutions proposées dans cet article pour réduire ces problèmes. Alors que la « pénurie » actuelle liée au don d’organes pourrait être résolue par un meilleur taux d’acceptabilité de prélèvements de patients en état de mort encéphalique, se pose finalement la question d’un dépassement irrémédiable des limites éthiques qui garantissent le sens premier de l’engagement des professionnels auprès de leurs patients.
Introduction: Advance directives are legal documents which individuals draw up to declare their treatment preferences and to appoint well-informed proxies to safeguard patient autonomy in critical situations when that individual is temporarily or no longer able to communicate these preferences. On December 22, 2017, the Italian Parliament approved the first law on end of life (“Provisions for informed consent and advance directives” L.219/2017), after a heated public and political debate lasting almost twenty years.
Objective: The aim of this study was to investigate the awareness, knowledge, opinions and attitudes regarding Italian Law 219/2017 and advance directives among the Italian population 15 months after its entry into force.
Methods: A nationwide population-based survey was conducted by a certified public opinion survey company. A sample size of 2000 interviews was planned. A structured questionnaire was developed to investigate awareness, opinions and attitudes concerning the law by a multiprofessional research team. The agreed-on version was pretested on a sample of 70 selected participants.
Results: The sample included 2000 valid interviews; 70.1% of respondents declared they had heard about the law on informed consent and advance directives. Respondents were asked to express their overall opinion on the law’s utility and importance: 88% declared that the law was quite or very important and 76% had a positive attitude towards making/registering advance directives.
Conclusion: The principles of Italian Law 219/2017 are aligned with the ethical sentiment of the vast majority of the Italian population. It is crucial to stimulate discussion to increase knowledge and awareness in order to increase the number of advance directives.
In the half-century history of clinical practice of diagnosing brain death, informed consent has seldom been considered until very recently. Like many other medical diagnoses and ordinary death pronouncements, it has been taken for granted for decades that brain death is diagnosed and death is declared without consideration of the patient’s advance directives or family’s wishes. This essay examines the pros and cons of using informed consent before the diagnosis of brain death from an ethical point of view. As shared decision-making in clinical practice became increasingly indispensable, respect for the patients’ autonomous wishes regarding how to end their lives has a significant role in deciding how death is diagnosed. Brain death, as a fully technologically controlled death, may require a different ethical framework from the old one for traditional cardiac death. With emerging and proliferating options in end-of-life care for those who suffer from catastrophic brain injury, the traditional reasoning that ‘death gives no choice, hence no consent’ requires another examination. Patients facing imminent brain death now have options other than undergoing the diagnostic workup for brain death, such as donation after circulatory death and withdrawal of life-sustaining treatment with maximum comfort measures for death with dignity. Nevertheless, just as in the debate over opt-in versus opt-out organ donation policies, informed consent before the diagnosis of brain death faces fierce opposition from consequentialists urging the expansion of the donor pool. This essay examines these objections and provides constructive replies along with a proposal to accommodate this morally required consent.
Le mot "éthique", lorsqu’il est appliqué aux sciences et à la médecine du vivant, semble recouvrir indifféremment l’"éthique médicale" proprement dite, c’est-à-dire l’exigence d’un certain comportement de la médecine au service du malade, et la bioéthique, qui est la mise en forme, à partir d’une recherche pluridisciplinaire, d’un questionnement sur les conflits de valeurs suscités par le développement techno-scientifique dans le domaine du vivant. Ces deux termes ont, du reste, des champs d’application voisins ou croisés lorsqu’il s’agit du don d’organe ou de l’assistance à la procréation.
Didier Sicard clarifie les enjeux respectifs et communs de l’éthique médicale et de la bioéthique. Il met ainsi en perspective les notions de consentement, de préservation du secret ou encore de non-discrimination, essentielles à cette éthique appliquée.
Face au refus de soins, l’infirmier doit s’interroger. En effet, le consentement du patient est essentiel et doit être recherché. Dans le cas contraire, quelle est la responsabilité de l’infirmier ? Tout dépend des situations qui sont envisagées par la loi.
Limited research is available on parental decision-making regarding their children's participation in pediatric phase I oncology trials compared with the adult population. The objectives of this review were to describe: (1) the process of parental decision-making in this situation; (2) the optimal communication features physicians need when proposing inclusion in such trials; and (3) the place of the child/adolescent in the assent process. Thirty relevant studies meeting inclusion criteria were identified by searching five computerized databases (PubMed, Web of Science, Cairn, Psychinfo, EM Premium). Parental decision-making is a complex process based on hopeful expectations, multiple family considerations and the child's previous cancer experience. It is highly impacted by the quality of physicians' communication. A therapeutic alliance along with an empathetic attitude and a timely delivery of accurate information is essential. Due weight should be given to the voice of children or adolescents and their optimal level of involvement may be discussed depending on their age and maturity. They should be given age-adapted information in order to empower them to be rightfully and meaningfully involved in early-phase research. This review highlights the main gaps and necessary remedial actions to support an optimal patient care management in this situation. Physicians' training in communication, structured interdisciplinary teamwork and early integration of palliative care are three key challenges which need to be implemented to actively engage in optimization strategies which would improve patient care and family support when offering enrollment in a phase I trial.
BACKGROUND: Combining orders for do-not-resuscitate (DNR) for cardiac arrest with do-not-intubate (DNI) orders into a DNR/DNI code status is not evidence-based practice and may violate patient autonomy and informed consent when providers discuss intubation only in the context of CPR.
RESEARCH QUESTION: How often do providers refer to patients with a DNR order as "DNR/DNI" without documentation of refusal of intubation for non-arrest situations?
STUDY DESIGN AND METHODS: Retrospective observational study of adults (18 years or older) hospitalized in a Level 1 trauma/academic hospital between July 2017 and June 2018 inclusive with DNR orders placed during hospitalization RESULTS: Of 422 hospitalized adults with DNR orders, 261 (61.9%) had code status written in progress notes as DNR/DNI. Providers' use of the term DNR/DNI in progress notes was significantly (OR 2.21 99% CI 1.12 - 4.37) more common on medical hospital services (hospitalist, family medicine, internal medicine) than on non-medical ward services (medical/surgical intensive care units, surgery, psychiatry, neurology services).Of 261 "DNR/DNI"patients, providers did not document informed refusal of intubation for non-arrest situations for 68 (26.0%) of patients. By comparison, of 161 patients where providers documented code status in progress notes as DNR alone, 69 (42.9%) did have documentation of refusal of intubation for non-arrest events. Therefore, if a DNR/DNI code status was used in a non-arrest emergency to determine whether to intubate a patient, 68 (16.1%) of 422 patients could inappropriately be denied intubation without informed refusal (or despite their informed acceptance), and 69 (16.4%) could inappropriately be intubated despite their documented refusal of intubation.
INTERPRETATION: Conflation of DNR and DNI into DNR/DNI does not reliably distinguish patients who refuse or accept intubation for indications other than cardiac arrest, and thus may inappropriately deny desired intubation for those who would accept it, and inappropriately impose intubation on patients who would not.
CONTEXT: Few studies have examined how clinicians assess decision-making capacity for research in the last weeks of life.
OBJECTIVE: We examined the decision-making capacity for participation in a research study and its association with clinician impression and delirium among cancer patients with days to weeks of life expectancy.
METHODS: Patients admitted to our Palliative and Supportive Care Unit (PSCU) were approached for a prospective observational study. We assessed for their decision-making capacity based on clinical impression of physician and nurse, Memorial Delirium Assessment Scale (MDAS) and the MacArthur Competency Assessment Tool for Clinical Research (MacCAT-CR).
RESULTS: Among the 206 patients, 131 patients (64%) did not require MacCAT-CR assessment because they were overtly delirious or unresponsive; 37 (18%) patients were alert but did not complete the MacCAT-CR assessment for other reasons and 38 patients (18%) completed the MacCAT-CR assessment. Among these 38 patients, 5 (13%) were incapable and had normal albeit significantly higher MDAS scores compared to those who were capable (1.8 vs. 4.2, P=0.002). Compared against MacCAT-CR and MDAS, the overall agreement with capacity assessment with a clinician was 88% (95% CI 82-93%) for physicians and 90% (95% CI 82-94%) for nurses. The area-under the receiver-operating characteristics curve was 0.93 (95% CI 0.88-0.96) for physicians and 0.94 (95% CI 0.89-0.97) for nurses, suggesting high discrimination.
CONCLUSION: A majority of patients in the PSCU lacked decision-making capacity for participation in clinical research. Clinician impression had high accuracy. Few patients with normal MDAS were found to be incapable with MacCAT-CR assessment.
In 2015 Robert Veatch published the second edition of his Transplantation ethics, this time together with Lainie Ross. The chapters on postmortem organ procurement distinguish between 'giving' and 'taking' systems, and argue that 'taking' systems may promise a greater yield of organs for transplantation, but inevitably violate a requirement of respect for the deceased's autonomy. That argument has been very influential, and is also representative of a way of thinking that is widespread in the literature and in public debate. In this paper I contend that it is conceptually flawed in a number of important respects. These concern the understanding of both the concept of 'consent' and the requirement of respect for autonomy, the role of the relatives in any procurement system, and the factors that actually determine the extent to which a system respects autonomy, under any interpretation of that requirement.
At 35, Mr. J. was dying of an invasive pelvic sarcoma and had a tolerance to opioids. Despite his pain, he wanted to be present with his family and friends. When his physician broached the possibility of palliative sedation, he said, “We aren’t there yet.”
We do not know how much clinical physicians carrying out clinical trials in oncology and haematology struggle with ethical concerns. To our knowledge, no empirical research exists on these questions in a Nordic context. Therefore, this study aims to learn what kinds of ethical challenges physicians in Sweden, Denmark and Finland (n = 29) face when caring for patients in clinical trials; and what strategies, if any, they have developed to deal with them. The main findings were that clinical cancer trials pose ethical challenges related to autonomy issues, unreasonable hope for benefits and the therapeutic misconception. Nevertheless, some physicians expressed that struggling with such challenges was not of great concern. This conveys a culture of hope where health care professionals and patients uphold hope and mutually support belief in clinical trials. This culture being implicit, physicians need opportunities to deliberately reflect over the characteristics that should constitute this culture.
In a recent paper, Charles Foster argued that the epistemic uncertainties surrounding prolonged disorders of consciousness (PDOC) make it impossible to prove that the withdrawal of life-sustaining treatment can be in a patient's best interests and, therefore, the presumption in favour of the maintenance of life cannot be rebutted. In the present response, I argue that, from a legal perspective, Foster has reached the wrong conclusion because he is asking the wrong question. According to the reasoning in two leading cases-Bland and James-the principle of respect for autonomy creates a persuasive presumption against treatment without consent. Therefore, it is the continuation of treatment that requires justification, rather than its withdrawal. This presumption also works as the tiebreaker determining that treatment should stop if there is no persuasive evidence that its continuation is in the best interests of the patient. The presumption in favour of the maintenance of life, on the other hand, should be understood as an evidential presumption on a factual issue that is assumed to be true if unchallenged. However, the uncertainties regarding PDOC actually give reasons for displacing this evidential presumption. Consequently, decision-makers will have to weigh up the pros and cons of treatment having the presumption against treatment without consent as the tiebreaker if the evidence is inconclusive. In conclusion, when the right question is asked, Foster's argument can be turned on its head and uncertainties surrounding PDOC weigh in to justify the interruption of treatment in the absence of compelling contrary evidence.
This article discusses a recent ruling by the German Federal Court concerning medical professional liability due to potentially unlawful clinically assisted nutrition and hydration (CANH) at the end of life. This case raises important ethical and legal questions regarding a third person's right to judge the value of another person's life and the concept of 'wrongful life'. In our brief report, we discuss the concepts of the 'value of life' and wrongful life, which were evoked by the court, and how these concepts apply to the present case. We examine whether and to what extent value-of-life judgements can be avoided in medical decision-making. The wrongful-life concept is crucial to the understanding of this case. It deals with the question whether life, even when suffering is involved, could ever be worse than death. The effects of this ruling on medical and legal practice in Germany are to be seen. It seems likely that it will discourage claims for compensation following life-sustaining treatment (LST). However, it is unclear to what extent physicians' decisions will be affected, especially those concerning withdrawal of CANH. We conclude that there is a risk that LST may come to be seen as the 'safe' option for the physician, and hence, as always appropriate.