Hidden Fault Lines in the Bedrock: A Critical Examination of Surrogate Decision-Making Standards in Ethics Consultation.

AbstractClinical ethicists are routinely consulted in cases that involve conflicts and uncertainties related to surrogate decision-making for incapacitated patients. To navigate these cases, we invoke a canonical ethical-legal hierarchy of decision-making standards: the patient's known wishes, substituted judgment, and best interest. Despite the routine application of this hierarchy, however, critical scholarly literature alleges that these standards fail to capture patients' preferences and surrogates' behaviors. Moreover, the extent to which these critiques are incorporated into consultant practices is unclear. In this article I thus explore whether, and how, existing critiques of the hierarchy affect the application of these standards during ethics consults. After discussing four critiques of the hierarchy, I examine how two prominent published ethics consultation methodologies-bioethics mediation and CASES-incorporate these critiques differently. I then argue that while both methodologies explicitly endorse the same hierarchy, the varying degrees to which these four criticisms are incorporated into the prescribed consultation process could produce different applications of the same standard. I demonstrate with a case study how an ethics consultant following either methodology might produce two substantively different recommendations despite using the same substituted judgment standard. I conclude that while this heterogeneity of application should not dismantle the hierarchy's status as field-wide canon, it complicates projects of professional ethics consultation consensus building.

Should Providers Ask Family Members What They Want When Establishing Surrogate Decision-Making?

AbstractIn this piece I discuss optimal approaches that providers may take when pursuing surrogate decision-making. A potential critical problem here is some providers' approach differing from that of others. To the extent that this occurs, the results may be arbitrary, and the harm from this may be profound since this may affect, of course, even whether some of these patients will live or die. One factor possibly resulting in these differences is the moral weight providers place on what family members want when these outcomes differ from what they think patients would want. Providers now most commonly place greatest moral weight on following what patients would want to maximally respect their autonomy, but this view may clash with the view of others who see autonomy as more relational and thus based on prior and present social relations with others. Giving family members' wants more moral weight is a radical departure from what providers do now and may increase these differences. I discuss here the rationales for and against these competing choices.

The Effects of 15 Golden Key Points to Increase the Family Consent Rate in Iran.

OBJECTIVES: In nations where organ donation is governed by the opt-in policy, the most crucial stage in the organ procurement process is the family approach and gaining the approval of families of decedents with brain death. In times of grief and sorrow, the ability of health care workers to communicate and have donation conversations is vital to the decision-making process of families and the subsequent consent rate. In this study, we investigated the effects of teaching important points to coordinators in the family approach and gaining consent of families for organ donation. MATERIALS AND METHODS: A new training program for Iranian coordinators was designed to increase the skills and knowledge of interviewers and increase the self-confidence of the coordinators. In the training program, 15 golden key points to have when meeting with families of brain dead decedents regarding organ donation consent were presented and discussed with participants. Three coordinating groups participated in this training program. The satisfaction rate of the families was assessed at comparable intervals (12 months for group 1, 6 months for group 2, and 3 months for group 3) before and after the training session to assess the continuity of the training impact. We used the Wilcoxon signed rank test for comparisons. RESULTS: The family consent rate was significantly different for all participants, before and after the 15 golden key points were presented, increasing from 50% to 62.5% (P = .037). In addition, participant sex (P = .051), previous training (P = .090), education (P = .068), and cooperation time (P = .008) had significant effects on family consent rate. CONCLUSIONS: Our training approach can increase the performance of coordinators in achieving family satisfaction.

Barriers and Facilitators of Surrogates Providing Consent for Critically Ill Patients in Clinical Trials: A Qualitative Study.

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: We conducted semistructured 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: 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 systematic review and narrative synthesis of the research provisions under the Mental Capacity Act (2005) in England and Wales: Recruitment of adults with capacity and communication difficulties.

BACKGROUND: The Mental Capacity Act (MCA, 2005) and its accompanying Code of Practice (2007), govern research participation for adults with capacity and communication difficulties in England and Wales. We conducted a systematic review and narrative synthesis to investigate the application of these provisions from 2007 to 2019. METHODS AND FINDINGS: We included studies with mental capacity in their criteria, involving participants aged 16 years and above, with capacity-affecting conditions and conducted in England and Wales after the implementation of the MCA. Clinical trials of medicines were excluded. We searched seven databases: Academic Search Complete, ASSIA, MEDLINE, CINAHL, PsycArticles, PsycINFO and Science Direct. We used narrative synthesis to report our results. Our review follows Preferred Reporting Items for Systematic Reviews and is registered on PROSPERO, CRD42020195652. 28 studies of various research designs met our eligibility criteria: 14 (50.0%) were quantitative, 12 (42.9%) qualitative and 2 (7.1%) mixed methods. Included participants were adults with intellectual disabilities (n = 12), dementia (n = 9), mental health disorders (n = 2), autism (n = 3) and aphasia after stroke (n = 2). We found no studies involving adults with acquired brain injury. Diverse strategies were used in the recruitment of adults with capacity and communication difficulties with seven studies excluding individuals deemed to lack capacity. CONCLUSIONS: We found relatively few studies including adults with capacity and communication difficulties with existing regulations interpreted variably. Limited use of consultees and exclusions on the basis of capacity and communication difficulties indicate that this group continue to be under-represented in research. If health and social interventions are to be effective for this population, they need to be included in primary research. The use of strategic adaptations and accommodations during the recruitment process, may serve to support their inclusion.

Percutaneous Coronary Intervention Outcomes Based on Decision-Making Capacity.

Background Long-term outcomes of percutaneous coronary intervention (PCI) based on patients' decision-making ability have not been studied. Our objective was to assess long-term outcomes after PCI in patients who provided individual versus surrogate consent. Methods and Results Data were collected retrospectively for patients who underwent PCI at Cleveland Clinic between January 1, 2015 and December 31, 2016. Inclusion criteria consisted of hospitalized patients aged ≥20 years who had PCI. Patients with outpatient PCI, or major surgery 30 days before or 90 days after PCI, were excluded. Patients who underwent PCI with surrogate consent versus individual consent were matched using the propensity analysis. Kaplan-Meier, log rank, t-statistic, and χ2 tests were used for statistical analysis. The study was approved by the Institutional Review Board at Cleveland Clinic, Ohio. Of 3136 patients who underwent PCI during the study period, 183 had surrogate consent. Propensity matching yielded 149 patients from each group. Two-year all-cause mortality was significantly higher in the surrogate consent group (38 [25.5%] versus 16 [10.7%] deaths, log-rank χ2=10.16, P<0.001). The 2-year major adverse cardiac events rate was also significantly higher in the surrogate consent group (60 versus 36 events, log-rank χ2=8.36, P=0.003). Conclusions Patients with surrogate consent had significantly higher all-cause mortality and higher major adverse cardiac events when compared with patients with individual consent. This study emphasizes the fact that patients with an inability to give consent are at high risk and may need special attention in postprocedural and postdischarge care.

In This Together: Navigating Ethical Challenges Posed by Family Clustering during the Covid-19 Pandemic.

Harrowing stories reported in the media describe Covid-19 ravaging through families. This essay reports professional experiences of this phenomenon, family clustering, as encountered during the pandemic's spread across Southern California. We identify three ethical challenges following from it: Family clustering impedes shared decision-making by reducing available surrogate decision-makers for incapacitated patients, increases the emotional burdens of surrogate decision-makers, and exacerbates health disparities for and the suffering of people of color at increased likelihood of experiencing family clustering. We propose that, in response to these challenges, efforts in advance care planning be expanded, emotional support offered to surrogates and family members be increased, more robust state guidance be issued on ethical decision-making for unrepresented patients, ethics consultation be increased in the setting of conflict following from family clustering dynamics, and health care professionals pay more attention to systemic and personal racial biases and inequities that affect patient care and the surrogate experience.

An examination of the barriers to and benefits from collaborative couple contraceptive use in Rwanda.

BACKGROUND: Supportive male involvement is strongly correlated with contraceptive use. In Rwanda, where the contraceptive prevalence rate among married women increased from 17 to 52% from 2005 to 2010, and stagnated at 53% in 2015, understanding the role of male partners in collaborative couple contraceptive use can help inform programs designed to further increase the use of contraception in Rwanda. METHODS: This study utilized qualitative methods in 2018, specifically 32 in-depth interviewers with mostly current users of modern contraceptive methods and eight focus group discussions with family planning providers-both family planning nurses and community health workers (CHWs). Respondents were from Musanze and Nyamasheke Districts, the districts with the highest and lowest modern contraceptive use, respectively, to explore the role of couple collaboration in family planning use in Rwanda. Data were analyzed using the thematic content approach in Atlas.ti (8). RESULTS: Findings demonstrate that some men are opposed to use of male methods of contraception, and some are opposed to any contraceptive use, which can lead to covert use. Women and providers prefer collaborative couple contraceptive use-as a result, providers advocate for and encourage male partner participation in contraceptive use. Women are most often burdened with seeking out information, initiating discussions, and sharing information discovered about contraceptive use with partners. Decision-making about contraceptive use, once discussed, can be collaborative and motivated by financial considerations. When couple contraceptive use is collaborative, benefits range from marital harmony to husband's support of sustained use through reminders about appointments, joint counseling, and support in managing side effects. CONCLUSION: Family planning providers at the community and clinic levels encourage collaborative contraceptive use among couples and some Rwandan couples communicate well about family planning use. Despite the positives, women are expected to source family planning information, share that information with their male partners, seek out family planning services, and use family planning. If more Rwandan male partners accepted use, used male methods of contraception, and participated even more in the work it takes to use family planning, the potential for sustained, and even enhanced, contraceptive use in Rwanda could be realized.