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.

"It is what I tell her that she will do": a mixed methods study of married men's knowledge and attitude towards supporting their wives' cervical cancer screening in rural South-East Nigeria.

INTRODUCTION: cervical cancer is a leading cause of death among Nigerian women. Women often require spousal support before attending cervical cancer screening services. This study assessed married men´s knowledge and attitude towards male involvement in cervical cancer screening of their wives. METHODS: a cross-sectional study using a mixed methods approach was conducted among 245 married men in Izzi, Local Government Area of Ebonyi State, South-East Nigeria. Quantitative data collected using structured, interviewer-administered questionnaires and qualitative data from focus group discussions were triangulated. Data analysis was done using IBM SPSS version 20. Qualitative findings were analysed using thematic analysis. RESULTS: the mean knowledge of cervical cancer was 2.06±0.55. Only 2.9% of the respondents had adequate knowledge of risk factors for cervical cancer. Up to 89.8% were willing to approve screening for their spouses. Majority (76.3%) considered screening important in cervical cancer prevention, while 91.4% were willing to pay for the screening test. Most of them exhibited patriarchal tendencies and insisted that their wives must obtain their consent before screening as depicted by the statement "It is what I tell her that she will do". Previous spousal screening was a predictor of good knowledge (OR = 10.94, 95% CI = 2.44-48.93; P=0.002). CONCLUSION: married men in this study had poor knowledge of cervical cancer. However, they were willing to support cervical cancer screening conditional on their pre-information and consent. Awareness creation activities on cervical cancer screening should incorporate active engagement of husbands in order to promote screening uptake by their wives.

Recall of consent information by day care prostate biopsy patients: An assessment of the role of a third-party check.

BACKGROUND: To evaluate the extent of recall of consent information by daycare prostate biopsy patients in our low-literacy setting. And to evaluate the role of a 3rd party check on patient's recall of consent information. SUBJECTS AND METHODS: As part of our standard of care, a formal informed consent session for day care prostate biopsy takes place 3 days prior to the procedure. For this study, before leaving the outpatient clinic the same day, the patient acknowledged before a third-party that his concerns were or were not satisfactorily addressed. The extent of recall of consent information was assessed on the morning of the procedure using a researcher-administered questionnaire. Consecutive patients participated in this cross-sectional study for day care prostate biopsy at a tertiary hospital in southeast Nigeria from February to November 2015 after obtaining due consent. RESULTS: The recall of the risks associated with the planned procedure was poorer than the recall of the nature of the disease condition or the nature of the planned procedure. However, it was observed that aggregate recall was significantly poorer among patients who negatively attested to a satisfying consent session (OR 0.125; P < 0.0005). CONCLUSION: The use of a third-party in determining patient satisfaction after a consent session may be a better indicator of patient comprehension and subsequent recall of consent information, especially in low-literacy settings. Using a third-party, in this manner, may assist in checking paternalism inherent in the patient-doctor relationship.

Safety of Major Abdominal Operations in the Elderly: A Study of Geriatric-Specific Determinants of Health.

BACKGROUND: Preoperative assessment of geriatric-specific determinants of health may enhance perioperative risk stratification among elderly patients. This study examines effects of geriatric-specific variables on postoperative outcomes in patients undergoing elective major abdominal operations. METHODS: Patients included in the ACS NSQIP pilot Geriatric Surgery Research File program who underwent elective pancreatic, liver, and colorectal operations between 2014 and 2016 were examined. Multivariable analyses were performed to evaluate associations between patient-specific geriatric variables and risk of death, morbidity, readmission, and discharge destination. RESULTS: A total of 4165 patients were included. Patients ≥85 years were more likely to die, experience postoperative morbidity, and be discharged to a facility (all p ≤ 0.039) than younger patients. Preoperatively, patients ≥85 years were more likely to use a mobility aid, have a prior fall, have consent signed by a surrogate, and to live alone at home prior to operation (all p < 0.001). After adjustment for ACS NSQIP-estimated probabilities of morbidity or mortality, no geriatric-specific preoperative risk factors were significantly associated with increased risk of death or complications in any age group (all p > 0.055). Patients 75-84 and ≥85 years were more likely to be discharged to facility (OR 2.33 and 4.75, respectively, both p < 0.001) compared to patients 65-74 years. All geriatric-specific variables: use of mobility aid, living alone, consent signed by a surrogate, and fall history, were significantly associated with discharge to a facility (all p ≤ 0.001). CONCLUSIONS: After adjusting for comorbid conditions, geriatric-specific variables are not associated with postoperative mortality and morbidity among elderly patients; however, geriatric-specific variables are significantly associated with discharge to a facility.

Caregiver knowledge, opinion, and willingness to consent to trainee involvement in pediatric surgical care.

PURPOSE: Surgical training is shifting toward competency-based models that promote earlier supervised autonomy. We assessed caregiver knowledge, willingness to consent, and opinions regarding trainee autonomy in their child's operation. METHODS: At two academic children's hospitals, 100 caregivers of children aged 0-17 years completed an electronic survey in the pediatric surgery clinic (1/2018-4/2018). Knowledge, willingness to consent, and opinions of trainee involvement in their child's operation in standard and competency-based training models were assessed. McNemar's test compared willingness to consent with standard and competency-based training (p < 0.05). RESULTS: Caregivers were 75% female, 41% age 30-39 years old, and 78% white. All provider roles were correctly identified by 14% of caregivers. For routine procedures, caregivers would consent to a fellow assisting (95%) or independently operating with the attending present (78%). They would less likely consent if the attending was not in the operating room (39%) or the hospital (25%). Competency-based training improved willingness to consent, but was significant only for independence with the attending present. Most caregivers wanted to know about (81%) and be asked permission for (82%) trainee involvement in their child's operation. CONCLUSIONS: This study suggests that surgeons in academic settings must balance transparency with trainee autonomy when obtaining caregiver consent. LEVEL OF EVIDENCE: Level III.

Factors associated with organ donation by trauma patients in Nova Scotia.

BACKGROUND: Trauma patients represent a significant pool of potential organ donors (PODs), and previous research suggests that this population is underutilized for organ donation (OD). Our objective was to assess factors associated with OD in the trauma population. METHODS: We retrospectively analyzed OD in Nova Scotia over a 7-year period (2009-2016) using data from the Nova Scotia Trauma Registry and Nova Scotia Legacy of Life Donor Registry. All trauma patients who died in the hospital were included. Multiple logistic regression was used to assess factors associated with donation. We also evaluated characteristics, donation types, and reasons for nondonation among trauma PODs. RESULTS: There were 689 trauma-related deaths in all hospitals in NS during the study period, of which 39.8% (274 of 689) met the Nova Scotia Trauma Registry definition of a POD. Data on OD were available for 108 of these patients who were referred to the Legacy of Life Program. The conversion rate was 84%. Compared with nondonors, organ donors were significantly younger, had a higher Abbreviated Injury Scale head score and a lower scene Glasgow Coma Scale score, were more likely to suffer ischemia from drowning or asphyxia and to require air transport, and were less likely to have comorbidities. Regression analysis showed that donation was associated with younger age (odds ratio [OR], 0.97; 95% confidence interval [CI], 0.95-0.99) and lower Glasgow Coma Scale score at the scene (OR, 0.76; 95% CI, 0.66-0.88). Odds of donation were increased with air transport compared with land ambulance (OR, 8.27; 95% CI, 2.07-33.08) and injury within Halifax Regional Municipality compared with injury outside Halifax Regional Municipality (OR, 4.64; 95% CI, 1.42-15.10). Among the 60 referred PODs who did not donate, family refusal of consent was the most common reason (28 [46.7%] of 60). CONCLUSION: Younger age, greater severity of injury, and shorter time to tertiary care were associated with OD in trauma patients. LEVEL OF EVIDENCE: Prognostic and Epidemiological, Level III.

Speaking for Our Father.

A living will is a document in which an individual can communicate his or her health care choices to loved ones in the event that he or she is unable to do so directly. Many surrogate decision-makers use living wills as guides; however, the existence of such documents does not entirely relieve them of their burden. Surrogate decision-makers often need to consider the impact of the personal and family burdens entailed by their decisions, and the stress accompanying these burdens regularly creates high levels of anxiety and depression. This stress can be exacerbated when two surrogate decision-makers are at loggerheads as to the best way forward. This case study illustrates the effects of stress accompanying disagreement among surrogate decision-makers-here, the patient's adult sons-and demonstrates that a process of listening can help the bioethicist identify the values that are important to the patient and, consequently, to the surrogate as well, and use these values to help address the issue.

Educating Resident and Fellow Physicians on the Ethics of Mechanical Circulatory Support.

Mechanical circulatory support (MCS) such as extracorporeal membrane oxygenation, left ventricular assist devices and total artificial hearts have altered the natural history of heart failure, and specialists in the fields of cardiology and cardiothoracic surgery are faced with more complex ethical considerations than ever before. Residency and fellowship training programs, however, do not have formal curricula in medical ethics as it applies to MCS. In response, this article proposes that ethics be integrated into graduate medical education with a focus on the following 6 constructs: patient best interest, respect for autonomy, informed consent, shared decision making, surrogate decision making, and end-of-life care. Curricula should offer learning experiences that help physicians navigate common ethical challenges encountered in practice.

How acceptable is paternalism? A survey-based study of clinician and nonclinician opinions on paternalistic decision making.

We conducted an empirical study to explore clinician and lay opinions on the acceptability of physician paternalism. Respondents read a vignette describing a patient with brain hemorrhage facing urgent surgery that would be lifesaving but would result in long-term severe disability. Cases were randomized to show either low or high surrogate distress and certain or uncertain prognosis, with respondents rating the acceptability of not offering brain surgery. Clinicians (N = 169) were more likely than nonclinicians (N = 649) to find the doctor withholding surgery acceptable (30.2% vs. 11.4%, p ≤ 0.001). Among clinicians, the doctor withholding surgery was more acceptable when prognosis was certain to be poor (odds ratio [OR] 2.04, 95% confidence interval [CI] 1.04, 4.01). There was no effect of surrogate distress on clinician ratings. Responses among lay public were more variable. Given the differences in attitudes across clinicians and lay public, there is an ongoing need to engage stakeholders in the process of end-of-life decision making.

Ethics in the Setting of Burned Patients.

This article considers multiple ethical principles in the context of patients with burns. It explores the application of these principles to burn care and the impact on medical decision making, through several clinical vignettes.

Consent to care of persons with intellectual disability in Quebec: from vulnerability to capability / Consentimiento para el cuidado de las personas con discapacidad intelectual en Quebec: desde la vulnerabilidad hasta la capacidad

Abstract: Persons with an intellectual disability (ID) who interact with the Quebec health and social services system are faced with major decisions regarding the care they are offered. As consent to care derives from the fundamental right of all persons to personal inviolability and to autonomous decision making, they therefore have the right to accept or refuse any and all health and psychosocial care proposed. However, as free and informed consent to care must be given by an able person, the situation becomes somewhat more complicated whereas persons with ID are concerned. This article presents reflections on the challenges and issues relative to these persons' consent to health and psychosocial care.

Resumen: Las personas con discapacidad intelectual (ID) que interactúan con el sistema de salud y los servicios sociales de Quebec se enfrentan a decisiones importantes sobre la atención que se les brinda. Dado que el consentimiento a la atención se deriva del derecho fundamental de todas las personas a la integridad personal y a la toma de decisiones autónomas, éstas tienen el derecho de aceptar o rechazar cualquier atención de salud y psicosocial que se les proponga. Sin embargo, como el consentimiento libre e informado a la atención debe ser dado por una persona apta, la situación se vuelve más complicada en las personas con ID. Este artículo presenta reflexiones sobre los desafíos y temas relativos al consentimiento de estas personas hacia la salud y la atención psicosocial.

Preferences about information and decision-making among older patients with and without cancer.

Background: information of older patients with cancer is crucial to ensure optimal care. Objectives: to compare older patients with and without cancer regarding their preferences about medical information, decision-making and surrogate designation. Design: an intention-to-act questionnaire was completed by patients ≥70 y enroled in the ELderly CAncer PAtients cohort between January and June 2013 and by patients in the same age group enroled in a cross-sectional survey conducted in 2005 in acute geriatric wards. Setting: Henri-Mondor Teaching Hospital in the Paris conurbation, France. Results: the group with cancer had 133 patients [mean age, 79.6 ± 6.5 y; 54.9% women]. The main tumour sites were colorectal [24.1%], breast [23.3%] and prostate [15.8%]; 34.8% had metastases. All these patients wanted full information, 74.2% wanted to participate in decisions about their care, 87.2% would designate a family member to serve as a surrogate in life-threatening situations and 15% had already designated a surrogate. Compared to patients without cancer, those with cancer more often wanted to receive information in a life-threatening situation [93.6% versus 79.2%; P < 0.001]. Factors independently associated with patients wanting their informed consent to be obtained for all interventions were having children [adjusted odds ratio (aOR), 2.13; 95% confidence interval, 1.24; 3.66; P = 0.006], higher Mini Mental State Examination score [aORper point, 1.09; 1.02; 1.17], younger age in the group without cancer [aOR>82 y vs. ≤82 y, 0.50; 0.29-0.88] and being cancer-free [≤82 y, aOR, 0.30; 0.14-0.63; >82 y, aOR, 0.41; 0.17-0.97]. Conclusion: older patients with cancer expressed a strong preference for receiving information and participating in decisions about their care.

Ethical Barriers in Adolescent Oncofertility Counseling.

Adult survivors of pediatric cancers are at substantial risk for infertility. Oncofertility is an emerging field in medicine that has focused on the fertility preservation of these patients. As the field continues to develop, there are several areas in which our practice has improved. However, several ethical concerns still exist involving beneficence, nonmaleficence, informed consent, adolescent assent, and posthumous use of reproductive tissues. Because the field is still developing, great disparities exist in available options depending on age, ability to pay, and geographic location. Such discrepancies in access may lead to health disparities in the adolescent patient population. As the science continues to make future fertility more feasible, the ethical questions will continue to be more complex. The purpose of this article is to review some of the developments regarding oncoferility and address future directions for research and inquiry in specific areas.

[Patients' declared intentions and emergency medicine]. / Patientenwille und Akutmedizin.

Patients with complex medical problems and acute life-threatening diseases deserve a physician with the capability of rapid decision making. Despite an emergency scenario with several unknown or uncertain variables an individual therapeutic plan needs to be defined for each patient. In order to achieve this goal the physician must define medical indications for each form of treatment. Secondly, the patients declared intentions must be respected concerning the previously defined medical indications; however, very often the patients' will is not known. It is very difficult to define an individual treatment plan especially if the patient is not able to adequately communicate. In these situations a custodian is helpful to find out the patients declared intentions towards the current medical situation. If there is no advance directive, family members often have to act as surrogates to find out what therapy goal is best for the individual patient. The patients' autonomy is a very highly respected ethical priority even when the ability for the otherwise usual practice of shared decision-making between physician and patient is compromised. Therefore, in order to do justice to this demanding situation it is necessary to deal with the characteristics of the physician-patient-relatives relationship in emergency medicine.

Ethical Issues in Surgical Critical Care: The Complexity of Interpersonal Relationships in the Surgical Intensive Care Unit.

A major challenge in the era of shared medical decision making is the navigation of complex relationships between the physicians, patients, and surrogates who guide treatment plans for critically ill patients. This review of ethical issues in adult surgical critical care explores factors influencing interactions among the characters most prominently involved in health care decisions in the surgical intensive care unit: the patient, the surrogate, the surgeon, and the intensivist. Ethical tensions in the surgeon-patient relationship in the elective setting may arise from the preoperative surgical covenant and the development of surgical complications. Unlike that of the surgeon, the intensivist's relationship with the individual patient must be balanced with the need to serve other acutely ill patients. Due to their unique perspectives, surgeons and intensivists may disagree about decisions to pursue life-sustaining therapies for critically ill postoperative patients. Finally, although surrogates are asked to make decisions for patients on the basis of the substituted judgment or best interest standards, these models may underestimate the nuances of postoperative surrogate decision making. Strategies to minimize conflicts regarding treatment decisions are centered on early, honest, and consistent communication between all parties.