Welcome to the Nexus of Ethics, Psychology, Morality, Philosophy and Health Care

Welcome to the nexus of ethics, psychology, morality, technology, health care, and philosophy
Showing posts with label Standard of Care. Show all posts
Showing posts with label Standard of Care. Show all posts

Friday, June 14, 2019

The Ethics of Treating Loved Ones

Christopher Cheney
www.medpagetoday.com
Originally posted May 19, 2019

When treating family members, friends, colleague, or themselves, ER physicians face ethical, professional, patient welfare, and liability concerns, a recent research article found.

Similar to situations arising in the treatment of VIP patients, ER physicians treating loved ones or close associates may vary their customary medical care from the standard treatment and inadvertently produce harm rather than benefit.

"Despite being common, this practice raises ethical concerns and concern for the welfare of both the patient and the physician," the authors of the recent article wrote in the American Journal of Emergency Medicine.

There are several liability concerns for clinicians, the lead author explained.


"Doctors would be held to the same standard of care as for other patients, and if care is violated and leads to damages, they could be liable. Intuitively, family and friends might be less likely to sue but that is not true of subordinates. In addition, as we state in the paper, for most ED physicians, practice outside of the home institution is not a covered event by the malpractice insurer," said Joel Geiderman, MD, professor and co-chairman of emergency medicine, Department of Emergency Medicine, Cedars-Sinai Medical Center, Los Angeles.

The info is here.

Wednesday, October 21, 2015

Informed Consent and Standard of Care: What Must Be Disclosed

Ruth Macklin & Lois Shepherd
The American Journal of Bioethics
Volume 13, Issue 12, 2013

Abstract

The Office for Human Research Protections (OHRP) was correct in determining that the consent forms for the National Institutes of Health (NIH)-sponsored SUPPORT study were seriously flawed. Several articles defended the consent forms and criticized the OHRP's actions. Disagreement focuses on three central issues: (1) how risks and benefits should be described in informed consent documents; (2) the meaning and application of the concept of “standard of care” in the context of research; and (3) the proper role of OHRP. Examination of the consent forms reveals that they failed to disclose the reasonably foreseeable risks of the experimental interventions in the study, as well as the potential for differences in the degree of risk between these interventions. Although the concept of “standard of care” may be helpful in determining the ethical acceptability of other aspects of research, such as clinical equipoise, it is not helpful in discussing consent requirements.

The entire article is here.

Thursday, July 24, 2014

Should We 'Fix' Intersex Children?

Standard medical practice is often to operate to "normalize" genitals, but some families are fighting back.

By Charlotte Greenfield
The Atlantic
Originally published July 8, 2014

Here is an excerpt:

M was born with genitals that were not clearly male or female. Also known as disorders of sex development (DSDs), the best guess by researchers is that intersex conditions affect one in 2,000 children.

The response by doctors is often to carry out largely unregulated and controversial surgeries that aim to make an infant’s genitals and reproductive organs more normal but can often have unintended consequences, according to intersex adults, advocates and some doctors.

A long and gut-wrenching list of damaging side effects—painful scarring, reduced sexual sensitivity, torn genital tissue, removal of natural hormones and possible sterilization—combined with the chance of assigning children a gender they don’t feel comfortable with has left many calling for the surgeries to be heavily restricted.

The entire article is here.

Monday, June 10, 2013

SUPPORT Update: OHRP’s Compliance Actions on Hold

By John B. Lantos
The Hastings Center Bioethics Forum
Originally posted June 5, 2013

In a thoughtful, nuanced letter to the University of Alabama (the home of the Principal Investigator of the SUPPORT study), the Office for Human Research Protection announced that it has “put on hold all compliance actions against UAB relating to the SUPPORT case.”  Further, OHRP promises not to initiate compliance actions “in studies involving similar designs” until it clarifies the guidelines for such studies. In doing so, it acknowledges “widespread misunderstanding about the risks that are required to be disclosed in obtaining informed consent for certain types of studies.”  (Previous posts on the SUPPORT controversy are here, here, here, and here.)

OHRP promises that the process of drafting new guidelines will be “as open as possible, with input from all interested parties.”  To achieve this, it will “engage in the usual notice and comment process with regard to draft guidance” and “will also conduct an open public meeting on this topic.” This is a welcome development.

The letter also suggests the positions that OHRP will take in these discussions. It focuses on three main points.

First, the letter acknowledges that these discussions will focus on situations where the standard of care includes known and widespread practice variation with no reliable evidence on which practices are associated with which risks or benefits. “When the SUPPORT study was initiated,” it states, “there was no clear recent evidence indicating that different oxygenation levels with the then-current standard of care (85%- 95%) would produce differences in neurological damage or survival.”

The entire blog post is here.

Sunday, June 9, 2013

Blurring the lines of ethics when doctors use social media

By Wes Fisher
Dr.KevinMD Blog
Originally posted on May 28, 2013

The position paper from the American College of Physicians and the Federation of State Medical Boards, is a humbling reminder of the challenges that today’s physicians face when entering the online space.

Their recommendations for online medical professionalism, written by ethics committees for the two organizations, “provides recommendations about the influence of social media on the patient–physician relationship, the role of these media in public perception of physician behaviors, and strategies for physician–physician communication that preserve confidentiality while best using these technologies” — no small amount of territory to summarize.

But given the tenure of their document, I should probably hang up this blog right now.  After all, why risk being vulnerable in the online world?  While well-meaning on one hand, we should appreciate that physicians have officially been put on notice on how to behave online.

To be fair, I agree with most of what they say.   All the things about patient confidentiality are appropriate.  All the things about respect for persons, better still.

But to me, the part of the document that wanders off into the “influence of social media on the patient-physician relationship” and the influence of social media on the “public perception of physician behaviors,” is more difficult to gauge in its benefit or detriment to the public discourse.

The entire article is here.

Wednesday, May 29, 2013

The SUPPORT Study and the Standard of Care Read

By Lois Shepherd
The Hastings Center Bioethics Forum
Originally posted May 17, 2013

The clinical research community and a number of prominent bioethicists have swiftly come to the defense of investigators conducting the SUPPORT study, in which approximately 1,300 premature infants were randomly assigned to be maintained at higher or lower levels of oxygen saturation. The study took place between 2005 and 2009, involved 22 sites and was reviewed by at least as many institutional review boards. In March, the Office of Human Research Protection (OHRP) concluded that investigators had violated the informed consent provisions of the federal regulations governing research by failing to inform parents of infants enrolled in the study about risks of retinopathy, neurological injury, and death. Results from the study revealed that infants assigned to receive the lower range of oxygen suffered higher rates of death than infants assigned to the upper range, while the latter suffered higher rates of retinopathy than the former.  Defenders accuse OHRP of faulting the investigators for failing to inform parents of risks they learned about only through the study.

The central point of disagreement between defenders and critics of the study appears to be whether participants in the study were receiving medical care that was different from the care they would have received outside the study and whether participation in research therefore carried any medical risks that required risk/benefit scrutiny by IRBs or disclosure to parents of the infants enrolled.  This would appear to be a factual matter about which one could obtain some clarity, but discussions of this issue have been somewhat opaque.

Part of the reason for this may be different, but unacknowledged, understandings of the concept of “standard of care,” a term used – both in the informed consent forms and the commentary about them – but rarely defined in this debate.

The entire article is here.

Friday, February 17, 2012

Most Teens Who Self-Harm Are Not Evaluated for Mental Health in ER

By Mary Elizabeth Dallas
MedicineNet.com

Most children and teens who deliberately injure themselves are discharged from emergency rooms without an evaluation of their mental health, a new study shows.

The findings are worrisome since risk for suicide is greatest right after an episode of deliberate self-harm, according to researchers at Nationwide Children's Hospital in Columbus, Ohio.

The researchers also found the majority of these kids do not receive any follow-up care with a mental health professional up to one month after their ER visit.

"Emergency department personnel can play a unique role in suicide prevention by assessing the mental health of patients after deliberate self-harm and providing potentially lifesaving referrals for outpatient mental health care," said lead study author Jeff Bridge, principal investigator at the hospital's Center for Innovation in Pediatric Practice, in a news release. "However, the coordination between emergency services for patients who deliberately harm themselves and linkage with outpatient mental health treatment is often inadequate."

The story can be found here.

The study is from Child & Adolescent Psychiatry, Volume 51, Issue 2, pages 213-222.  Here is the conclusion of the study from the abstract.
"A substantial proportion of young Medicaid beneficiaries who present to EDs with deliberate self-harm are discharged to the community and do not receive emergency mental health assessments or follow-up outpatient mental health care."