NHS building

First Do No Harm: The Independent Medicines and Medical Devices Safety Review

By John Tingle

A new hard-hitting report on medicines and medical device safety published in the U.K. presents controversial proposals that have the potential to improve National Health Service (NHS) patient safety.

The report, The Independent Medicines and Medical Devices Safety Review, was published on July 8th, 2020 after a two year investigation chaired by Baroness Julia Cumberlege. The review investigated two medications — Primodos and sodium valproate — and one medical device — pelvic mesh.

The reviews remit was to examine how the healthcare system in England responded to reports about harmful side effects from medicines and medical devices and how best to respond in the future.

Read More

an ambulance parked at the entrance of an emergency department

Racial Disparities Persist in Human Subjects Research

By Beatrice Brown

Human subjects research has long been plagued by racial inequality. While flagrant abuses have been curtailed, disparities have, unfortunately, persisted.

One area ripe for scrutiny is clinical trial enrollment. A 2018 study by William Feldman, Spencer Hey, and Aaron Kesselheim in Health Affairs documents racial disparities in trials that are exempt from typical requirements for informed consent from study participants.

Read More

Box of Hydroxychloroquine Tablets

Human Subjects Research in Emergencies: The Texas Nursing Home “Study” (Part II)

By Jennifer S. Bard

This post is the second in a series about conducting human subjects research in emergencies. These posts are being written in response to a rapidly evolving situation and will reflect the state of knowledge at the time of writing.

In April 2020, Dr. Robin Armstrong, medical director of the Resort, a nursing home in Texas City, Texas, reported “signs of improvement” after he gave hydroxychloroquine, a drug approved by the FDA to treat malaria, to 39 of his nursing home patients who were diagnosed with COVID-19.

At about the same time, information was emerging that now represents the current understanding that hydoxychloroquine isn’t only ineffective in treating COVID-19, but also may cause serious harm to patients. Tensions were raised even higher by the seemingly inexplicable enthusiasm for this treatment by the President and some media outlets.

Read More

Zoom in of a dashboard focusing on the "App Store" widget

Can Bedside Consent Apps Improve Informed Consent During Childbirth?

By Alexa Richardson

Informed consent in childbirth is under fire by advocates, who stress that there is a widespread absence of meaningful informed consent during birth. While informed consent in medical settings always poses challenges, informed consent in childbirth raises particular concerns. Labor unfolds in real-time, and people are heavily reliant on their provider for information during birth. Providers may not adequately seek informed consent out of a belief that they should make decisions in the fetal interest, rather than the parent. Furthermore, laboring people make choices that are more than medical: birth is a value-laden process entwined with beliefs about parenting, life-meaning, and fetal interests.  A new solution is on the table that could help improve the process of informed consent in childbirth: guided decision-making apps. This year, multiple mobile apps are in the works that would assist laboring people and clinicians in real-time decision-making during labor and birth.

Read More

Close up of a computer screen displaying code

What Google Isn’t Saying About Your Health Records

By Adrian Gropper

Google’s semi-secret deal with Ascension is testing the limits of HIPAA as society grapples with the future impact of machine learning and artificial intelligence.

I. Glenn Cohen points out that HIPAA may not be keeping up with our methods of consent by patients and society on the ways personal data is used. Is prior consent, particularly consent from vulnerable patients seeking care, a good way to regulate secret commercial deals with their caregivers? The answer to a question is strongly influenced by how you ask the questions.

Read More

Healthcare professional walking down a hospital hallway

An Urgent Need to Improve Mental Health Care in the National Health Service

Mental Health Care in the National Health Service in England has always existed in the shadow of physical care in terms of funding and NHS-government health policy priorities.

Many in the past have termed it the “Cinderella” part of the NHS. This neglect has been chronicled in numerous reports over the years pointing to many problems which include chronic under funding, poor patient safety, abuses of patient rights, poor complaint handling, unnecessary restrictive care regimes, poor patient, health carer communication, and poor patient satisfaction. Read More

Image of a surgery room with a robot whose screen has a doctor with a stethoscope

The Problem With Doctors Communicating via Robot is Attitudes About Technology, Not Poorly Communicating Doctors

By Evan Selinger and Arthur Caplan

Perhaps you’ve seen the debate? A physician used video chat technology to inform a hospitalized Ernest Quintana and his family that he would be dying sooner than they expected. After he passed away, they objected to how the news was delivered. Over at Slate, Joel Zivot an anesthesiologist and ICU physician, responded to the uproar with an essay titled, “In Defense of Telling Patients They’re Dying Via Robot.” Read More

Patient Safety, Health Quality and Learning Disability

By John Tingle

Tragic stories of mental health care failings leading to injury and in some cases death have featured strongly in the English media in recent years. The reports reveal common threads such as poor resources, inadequate staffing levels, limited service availability, poor inter-agency cooperation, poor patient engagement, poor understanding of the Mental Capacity Act 2005 and so on. This care area seems to largely remain a Cinderella health care service provision, existing in the shadows, with the focus being predominantly on physical acute care. There are however now welcome and firm Government commitments to drive improvement into mental health care supported by a raft of promising initiatives.

When patient stories of learning disability and autism care failings are read from several reference sources a picture emerges. Care for people with learning disability and autism can be seen to share many of the patient safety and health quality problems that beset patients who are classified as being mentally ill: Read More