https://caltcm.memberclicks.net/assets/documents/acc_aha_chf_2013_guidelines.pdf

2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines

Objectives. —To improve end-of-life decision making and reduce the frequency of a mechanically supported, painful, and prolonged process of dying. Design. —A 2-year prospective observational study (phase I) with 4301 patients followed by a 2-year controlled clinical trial (phase II) with 4804 patients and their physicians randomized by specialty group to the intervention group (n=2652) or control group (n=2152). Setting. —Five teaching hospitals in the United States. Patients. —A total of 9105 adults hospitalized with one or more of nine life-threatening diagnoses; an overall 6-month mortality rate of 47%. Intervention. —Physicians in the intervention group received estimates of the likelihood of 6-month survival for every day up to 6 months, outcomes of cardiopulmonary resuscitation (CPR), and functional disability at 2 months. A specially trained nurse had multiple contacts with the patient, family, physician, and hospital staff to elicit preferences, improve understanding of outcomes, encourage attention to pain control, and facilitate advance care planning and patient-physician communication. Results. —The phase I observation documented shortcomings in communication, frequency of aggressive treatment, and the characteristics of hospital death: only 47% of physicians knew when their patients preferred to avoid CPR; 46% of do-not-resuscitate (DNR) orders were written within 2 days of death; 38% of patients who died spent at least 10 days in an intensive care unit (ICU); and for 50% of conscious patients who died in the hospital, family members reported moderate to severe pain at least half the time. During the phase II intervention, patients experienced no improvement in patient-physician communication (eg, 37% of control patients and 40% of intervention patients discussed CPR preferences) or in the five targeted outcomes, ie, incidence or timing of written DNR orders (adjusted ratio, 1.02; 95% confidence interval [Cl], 0.90 to 1.15), physicians' knowledge of their patients'preferences not to be resuscitated (adjusted ratio, 1.22; 95% Cl, 0.99 to 1.49), number of days spent in an ICU, receiving mechanical ventilation, or comatose before death (adjusted ratio, 0.97; 95% Cl, 0.87 to 1.07), or level of reported pain (adjusted ratio, 1.15; 95% Cl, 1.00 to 1.33). The intervention also did not reduce use of hospital resources (adjusted ratio, 1.05; 95% Cl, 0.99 to 1.12). Conclusions. —The phase I observation of SUPPORT confirmed substantial shortcomings in care for seriously ill hospitalized adults. The phase II intervention failed to improve care or patient outcomes. Enhancing opportunities for more patient-physician communication, although advocated as the major method for improving patient outcomes, may be inadequate to change established practices. To improve the experience of seriously ill and dying patients, greater individual and societal commitment and more proactive and forceful measures may be needed. (JAMA. 1995;274:1591-1598)

https://jamanetwork.com/HttpHandlers/ArticlePdfHandler.ashx?journal=JAMA&articleId=391724&pdfFileName=jama_274_20_032.pdf

A controlled trial to improve care for seriously ill hospitalized patients: The study to understand prognoses and preferences for outcomes and risks of treatments (SUPPORT)

ACC
: American College of Cardiology
ACE
: angiotensin-converting enzyme
ACS
: acute coronary syndrome
AF
: atrial fibrillation
AGNES
: Arrhythmia Genetics in the Netherlands
AHA
: American Heart Association
AMIOVIRT
: AMIOdarone Versus Implantable cardioverter-defibrillator:

/pdf/2015-esc-guidelines-for-the-management-of-patients-with-3hzn8vw0c4.pdf

2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: The Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC). Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC)

Many believe that informed consent makes clinical research ethical. However, informed consent is neither necessary nor sufficient for ethical clinical research. Drawing on the basic philosophies underlying major codes, declarations, and other documents relevant to research with human subjects, we propose 7 requirements that systematically elucidate a coherent framework for evaluating the ethics of clinical research studies: (1) value-enhancements of health or knowledge must be derived from the research; (2) scientific validity-the research must be methodologically rigorous; (3) fair subject selection-scientific objectives, not vulnerability or privilege, and the potential for and distribution of risks and benefits, should determine communities selected as study sites and the inclusion criteria for individual subjects; (4) favorable risk-benefit ratio-within the context of standard clinical practice and the research protocol, risks must be minimized, potential benefits enhanced, and the potential benefits to individuals and knowledge gained for society must outweigh the risks; (5) independent review-unaffiliated individuals must review the research and approve, amend, or terminate it; (6) informed consent-individuals should be informed about the research and provide their voluntary consent; and (7) respect for enrolled subjects-subjects should have their privacy protected, the opportunity to withdraw, and their well-being monitored. Fulfilling all 7 requirements is necessary and sufficient to make clinical research ethical. These requirements are universal, although they must be adapted to the health, economic, cultural, and technological conditions in which clinical research is conducted. JAMA. 2000;283:2701-2711.

/pdf/what-makes-clinical-research-ethical-1aaoil4fbl.pdf

What Makes Clinical Research Ethical

We describe a protocol for disclosing unfavorable information—“breaking bad news”—to cancer patients about their illness. Straightforward and practical, the protocol meets the requirements defined by published research on this topic. The protocol (SPIKES) consists of six steps. The goal is to enable the clinician to fulfill the four most important objectives of the interview disclosing bad news: gathering information from the patient, transmitting the medical information, providing support to the patient, and eliciting the patient’s collaboration in developing a strategy or treatment plan for the future. Oncologists, oncology trainees, and medical students who have been taught the protocol have reported increased confidence in their ability to disclose unfavorable medical information to patients. Directions for continuing assessment of the protocol are suggested. The Oncologist 2000;5:302-311

/pdf/spikes-a-six-step-protocol-for-delivering-bad-news-3bcah1imyb.pdf

SPIKES-A six-step protocol for delivering bad news: application to the patient with cancer.

KIE: Artificial methods of reproduction have raised profound social and ethical issues touching on the nature of family relationships and the value of the human embryo. Artificial insemination by donor has been handled by presuming the mother's husband to be the legal father of the child; now the technique of surrogate embryo transfer has further complicated the parenthood issue by making it possible to distinguish among the genetic mother, the gestational mother, and the rearing mother. Annas argues that it is in the interest of the family to codify the current legal presumption that the gestational mother is the legal mother, unless she agrees to relinquish parental rights. In the case of embryos that are not replaced in the ovum donor, he maintains that the gamete donors should have decision-making authority over whether the embryos may be frozen and for what purpose, and contends that sales of frozen embryos should be forbidden.

Redefining Parenthood and Protecting Embryos: Why We Need New Laws

Recognition of patient rights in the form of a Patient Bill of Rights is a necessary, but not sufficient, step in the protection and promotion of patient rights. Rights are not self-actualizing. We may look forward to the day when all physicians, nurses, and allied health professionals will accord patients their basic human rights as a matter of course, but this day has not yet come. Until this goal is attained, mechanisms that can help to ensure that patient rights are protected and honored will be absolute necessities. Some of these mechanisms are discussed in this chapter. I continue to favor the one Jay Healey and I proposed in 1974: the patient rights advocate. This and other approaches to protecting the rights of patients are also discussed here.

The Patient Rights Advocate

On his 10-year voyage back to Ithaca from the Trojan War, Ulysses was warned by Circe to take precautions if he wanted to hear the Sirens' transfixing song, or there would be “no sailing home for him, no wife rising to meet him, /no happy children beaming up at their father's face.”1 Ulysses accordingly ordered his men to stop their ears with beeswax and bind him firmly to the mast and instructed them that if he gestured to be set free, they should stick to the original agreement and bind him tighter still. Making an agreement that has as a . . .

Ulysses and the fate of frozen embryos--reproduction, research, or destruction?

The patient rights advocate: can nurses effectively fill the role?

KIE: Appellate courts in California and New Jersey have reached conflicting conclusions in the first legal tests of whether artificial feeding is a "medical treatment," and whether it is ever legally permissible to allow a patient to die from dehydration or starvation. In a criminal prosecution of physicians Robert Nejdl and Neil Barber, the California court ruled that there was no significant difference between a respirator and intravenous feeding, and that the two doctors had no legal duty to continue "futile" treatment of their irreversibly comatose patient. The New Jersey court rejected as purposeful killing a request to remove the nasogastric tube from elderly nursing home patient Claire Conroy, who was incompetent but not comatose. Annas considers the issue of pain or suffering to be central to decision making in such cases.

George J. Annas

Papers

Redefining Parenthood and Protecting Embryos: Why We Need New Laws

The Patient Rights Advocate

Ulysses and the fate of frozen embryos--reproduction, research, or destruction?

The patient rights advocate: can nurses effectively fill the role?

Nonfeeding: lawful killing in CA, homicide in NJ.