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.

The Genetic Privacy Act is a proposal for federal legislation. The Act is based on the premise that genetic information is different from other types of personal information in ways that require special protection. The DNA molecule holds an extensive amount of currently indecipherable information. The major goal of the Human Genome Project is to decipher this code so that the information it contains is accessible. The privacy question is, accessible to whom? The highly personal nature of the information contained in DNA can be illustrated by thinking of DNA as containing an individual`s {open_quotes}future diary.{close_quotes} A diary is perhaps the most personal and private document a person can create. It contains a person`s innermost thoughts and perceptions, and is usually hidden and locked to assure its secrecy. Diaries describe the past. The information in one`s genetic code can be thought of as a coded probabilistic future diary because it describes an important part of a unique and personal future. This document presents an introduction to the proposal for federal legislation `the Genetic Privacy Act`; a copy of the proposed act; and comment.

/pdf/the-genetic-privacy-act-and-commentary-1zy9kd07qv.pdf

The Genetic Privacy Act and commentary

In their history of tuberculosis, The White Plague, Rene and Jean Dubos note that the first national movement to control tuberculosis in the United States came from the Medico-Legal Society of the ...

/pdf/control-of-tuberculosis-the-law-and-the-public-s-health-3z3h25x3wx.pdf

Control of tuberculosis--the law and the public's health.

Americans support both protecting the privacy of medical records and encouraging medical research. Thus, it is not surprising that a move to change practices in these two areas has generated attention and comment. The new federal regulations, promulgated under the authority of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), were adopted to protect the privacy of medical records. They were not specifically designed to facilitate or limit medical research.1 Nonetheless, the regulations have prompted strong objections from the biotechnology industry and from academic medicine. The Association of American Medical Colleges and the Biotechnology Industry Organization have argued . . .

/pdf/medical-privacy-and-medical-research-judging-the-new-federal-30vokhu7sl.pdf

Medical Privacy and Medical Research — Judging the New Federal Regulations

When Mrs. Pamela Monson was charged under a California child support statute following the death of her newborn son, she became the first woman to be criminally prosecuted for acts and omissions during pregnancy. As a result of her not having followed her doctor's advice, her son was born with massive brain damage and died a few weeks later. Annas contends that the crime of "fetal neglect" has serious implications for pregnant women who may lose their rights, suffer invasion of privacy, and even be forced to submit to unwanted medical or surgical procedures. A mother's obligations to the fetus should not be construed to allow the state to regulate her lifestyle; the state should protect fetuses by improving the welfare and opportunities of pregnant women, not by oppressing them. Language: en

Pregnant women as fetal containers.

Background: Despite the potential benefits of advance directives, few patients complete them. This study examined whether barriers to advance decision making can be overcome via a combined educational and administrative intervention targeted at physicians. Method: The subjects consisted of all the internists (n=6) at a primary care physician home care (HC) service and all the internists (n=4) at a primary care nursing home (NH) service. Physicians were given a 5-week course on the law relating to advance directives. Administrative consent was obtained to permit physicians to spend additional time with patients to discuss advance directives. Physicians were asked to discuss advance directives with newly enrolled patients and to assist interested patients to complete directives. During the first 2 months of the trial, physicians did not approach any patients. Therefore, the study design was changed to include all active patients, and physicians received additional training that involved observing and leading discussions with their own patients. Results: Physicians approached 74 of 356 competent HC patients, of whom 48 (65%) completed directives. All 42 competent NH patients were approached, and 38 (90%) completed directives. Most patients who completed a directive chose relatives as proxies. Most directed that lifesustaining treatment be withheld in the event they were permanently unconscious (HC, 81%; NH, 92%). Other common choices were to decline long-term mechanical ventilation (HC, 58%; NH, 79%), long-term artificial nutrition (HC, 44%; NH, 79%), and cardiopulmonary resuscitation (HC, 27%; NH, 66%). Conclusions: Physicians can overcome initial reluctance to integrate advance decision making into primary care provided to elderly patients. Teaching physicians about the law is not sufficient to change behavior; physicians also need practical experience discussing directives with patients. Our high patient response suggests that a physician-directed intervention is sufficient to achieve high rates of completing directives without additional, concomitant patient-directed intervention. (Arch Intern Med. 1994;154:2321-2327)

George J. Annas

Papers

The Genetic Privacy Act and commentary

Control of tuberculosis--the law and the public's health.

Medical Privacy and Medical Research — Judging the New Federal Regulations

Pregnant women as fetal containers.

Implementing advance directives in the primary care setting.