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.

Why are the courts having so much trouble deciding what should be done with Phillip Becker? Two years ago this column discussed the first series of cases involving Phillip. At that time the California courts decided that his parents had the right to refuse recommended heart surgery for this twelve-year-old Down syndrome child, even though this would result in a slow and painful death for Phillip t "Denying the Rights of the Retarded: The Phillip Becker Case," Hastings Center Report, December 1979, pp. 1820). That decision was arbitrary, unprincipled emotional and paced parental autonomy ahead of the right to life of a mentally retarded child.

'A wonderful case and an irrational tragedy': The Phillip Becker case continues.

A Poor Read On Rights, Rationing, And Racism

i t is commendable and appropriate for members of the American College of Obstetricians and Gynecologists (ACOG) to be concerned about issues of informed consent in clinical practice. However, despite obvious good intentions, the Committee on Ethics has taken a relatively straightforward legal doctrine and created more confusion than enlightenment by attempting to transform it into a "ethical concept." Because of inconsistencies and inaccuracies, we believe that the "Ethical Dimensions of Informed Consent" statement should be reconsidered. This recommendation is made even though the continued existence of the statement may cause little harm and it is unlikely to be read by many ACOG members or to provide meaningful guidance because of its abstract nature and overall length. There is one major and three somewhat more minor problems that led us to these characterizations and recommendation. The major problem is that informed consent is primarily a legal doctrine, articulated not only by the American judges sitting at Nuremberg, but also by judges in almost all of the 50 states, by more than half of the state legislatures, and by federal research regulations.~ It also has constitutional dimensions and has been the basis for portions of United States Supreme Court opinions on both abortion and the right to refuse treatment. 2 It is true that the president's Bioethics Commission said that, "Although the informed consent doctrine has substantial foundations in law, it is essentially an ethical imperative." But it is very unclear what the commission meant by this, as its own report (Making Health Care Decisions) is almost exclusively informed by the principles set forth in judicial opinions regarding informed consent. Making Health Care Decisions is based on the premise that informed © 1993 by The Jacobs Institute of Women's Health 1049-3867/93/$6.00

Confusing law and ethics: Why the committee's report on informed consent should be reconsidered

Hospitals are not isolated islands, and physicians are not foreign diplomats with legal immunity Medicine must be practiced within the framework of the law of the United States and of the state in which the patient, physician, and hospital are located All health care facilities are bound by state regulations, by the standards of the Joint Commission on Accreditation of Healthcare Organizations (JCAH) if they are so accredited, and by their own internal bylaws and policies Public facilities, in addition, must assure that those human rights guaranteed by the United States Constitution are afforded to all patients Perhaps the most important thing for patients and their advocates to realize is that few doctors and nurses have a sophisticated understanding of what the law is, and often when they think they know the law, they have it wrong Readers of this book will almost certainly know more about the law than anyone a patient is likely to encounter in a health care facility, HMO, or doctor’s office

Rules Hospitals Must Follow

The major medical/scientific research project of the past two decades consists of the human genome project and its clinical applications. The project can usefully be framed as a quest to cure disease, especially cancer, and even to defy mortality. The hero of this quest is the project leader, who currently is trying, almost desperately, to “translate” the science of the genome into public health practice and the practice of medicine, termed ‘personalised medicine.’ In America’s dysfunctional and patchwork healthcare system, adding another layer of extremely expensive and (to date) marginally effective screening procedures is a hard sell. Nonetheless, using metaphor to frame the human genome project as a mythical ‘quest for life’ can make it seem altogether normal, even natural, and can help rally the public to its support. A second, parallel quest is the political quest for a system that guarantees universal access to healthcare for Americans. The ultimate success of this quest will depend not on any scientific or medical breakthrough, but on political will. An alternative literary device: the deployment of narratives of real Americans whose lives have been made much more miserable by the lack of access to decent healthcare, is more likely to create and sustain political support for universal healthcare. Literary devices—quest myths, metaphor, and narrative—used in relation to new technology and political change—can be employed for both ethical and unethical outcomes.

George J. Annas

Papers

'A wonderful case and an irrational tragedy': The Phillip Becker case continues.

A Poor Read On Rights, Rationing, And Racism

Confusing law and ethics: Why the committee's report on informed consent should be reconsidered

Rules Hospitals Must Follow

The Songs of Spring: Quest Myths, Metaphors, and Medical Progress