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.

/pdf/the-right-to-die-in-america-sloganeering-from-quinlan-and-ddcp5vxaxy.pdf

The "right to die" in America: sloganeering from Quinlan and Cruzan to Quill and Kevorkian.

If you don't believe in privacy, you probably don't believe in genetic privacy. I believe in privacy, including the constitutional right of privacy. But my interest is not to persuade you to believe in privacy, but rather to expose the major issues involved in genetic privacy. What makes genetic information different from other sensitive medical information? Are we getting carried away? Are we just treating DNA based information differently because it is new? We protect certain sensitive medical information by statute: mental health information, information about alcoholism, drug treatment, and abortion.1 There is a lot of information we take very seriously and treat very, very privately. The question is whether we should treat genetic information like other especially sensitive medical information, or whether new rules are needed. They would not be constitutional rules-I would certainly agree with Judge Bork on that issue.2 If we want to protect genetic information, the protection must be statutory. I want to begin by talking about why we might see genetic information as special. Historically, we have thought of privacy in this country in at least four different ways. There is private information-- information that we do not want revealed about ourselves. There are private relationships husband-wife, priest-penitent and lawyer-client. The law also recognizes private decisions: whether or riot to use contraception, or whether or not to have an abortion. Finally, there are private places where we have an expectation of privacy: the bedroom or the phone booth, for example. Genetic information actually transects three of these four, and that is one argument for why such information is more powerfully private than other types of information. It is information about us, very private information about our likely future health. Moreover, this information is not just about us. It could also be seen relationally, because it tells us information about our parents, our siblings, and our children. If you happen to be a genetic twin-an unusual circumstance-then your genes tell exactly the same story about your twin as they tell about you. It is also information that is very important for private decision-making: who to marry, whether or not to have a child, whether or not to undergo pre-natal testing, and the future health of your child. Given that, I think it is worth looking at each of the types of privacy in a bit more detail to see if we can say that there is something unique about genetic information. First, let us examine the nature of privacy and why genetic information is private. The first thing that must be understood is that all your genetic information is contained in the nucleus of each of your cells.4 All that a geneticist needs is one cell from you to read your genetic code.5 It could be a blood cell-most genetic testing is done with blood cells.6 It could also be hair cells or even saliva.7 Once someone has a drop of your blood, or, perhaps, hair or saliva, they have your DNA from which your genetic code can be extracted. Therefore, we have to think of one drop of blood as a medical record. It is in code, it is a code that has not been broken yet, and it will require sophisticated codebreakers to break it. But the fact remains that it is a complete record of your DNA. You do not have to agree with many boosters of the Genome Project who think it is the Book of Life, that your DNA is going to tell the story of your life.8 I would not get that carried away, but it does contain an enormous amount of information about you and your probable medical future. How should you think about drops of your blood? I was struck by a column written by William Safire during the debate about Senator Packwood and whether his diaries should be made public. Safire argued that diaries are uniquely private and that we keep diaries "to inform our aging selves about our younger selves."9 I thought that was a brilliant insight, and it has its converse in genetic information. …

Genetic privacy: there ought to be a law.

Gene drives hold promise for use in controlling insect vectors of diseases, agricultural pests, and for conservation of ecosystems against invasive species At the same time, this technology comes with potential risks that include unknown downstream effects on entire ecosystems as well as the accidental or nefarious spread of organisms that carry the gene drive machinery A code of ethics can be a useful tool for all parties involved in the development and regulation of gene drives and can be used to help ensure that a balanced analysis of risks, benefits, and values is taken into consideration in the interest of society and humanity We have developed a code of ethics for gene drive research with the hope that this code will encourage the development of an international framework that includes ethical guidance of gene drive research and is incorporated into scientific practice by gaining broad agreement and adherence

A Code of Ethics for Gene Drive Research.

Conjoined twins have been the subject of scientific exhibits, medical study, human curiosity, and even entertainment, but until the year 2000, conjoined twins had never been the subject of a courtr...

/pdf/conjoined-twins-the-limits-of-law-at-the-limits-of-life-5c440aql20.pdf

Conjoined twins--the limits of law at the limits of life.

KIE: Recent judicial decisions and medical articles reflect a lack of consensus regarding who should initiate hospital "do not resuscitate" (DNR) orders and on what indications. Annas believes that the courts and physicians are failing to distinguish the two fundamentally different reasons for which DNR orders are written. When cardiopulmonary resuscitation is contraindicated because poor prognosis renders medical intervention futile, the decision should properly be made by the physician. Decisions based on the patient's quality of life, however, should remain the exclusive province of the patient or his guardian. Three legal cases are cited to illustrate these points.

George J. Annas

Papers

The "right to die" in America: sloganeering from Quinlan and Cruzan to Quill and Kevorkian.

Genetic privacy: there ought to be a law.

A Code of Ethics for Gene Drive Research.

Conjoined twins--the limits of law at the limits of life.

CPR: When the Beat Should Stop