From bioethics to medical anthropology to humanities and back: A year in review

I thought I would take this opportunity to reflect on the past year, where I will be in the future, and how the student fellowship has impacted me. I still hope to contribute to the Bill of Health blog going forward, but as my last official post as a Petrie-Flom Student Fellow, I would be remiss if I did not express my sincere gratitude to everyone at the Petrie-Flom Center, the faculty and staff, the other student fellows, and especially my mentors: Professors I. Glenn Cohen, Carmel Shachar, and Intisar A. Rabb.

My own project took a few different turns this year. My original proposal was to explore the ways in which bioethics and biomedical issues will play a significant role in reviving the dialectic between secular scholars and religious authority. Ayman Shabana rightly argues that respect for Islamic religious norms is essential for the legitimacy of bioethical standards in the Muslim context, wherein he attributes the legitimating power of these norms—as well as their religious and spiritual underpinnings—to their moral, legal, and communal dimensions. Building off of Shabana’s work, my initial argument held that the relationship between the secular and religious worlds is important because the discourse between the two, although often presumed to be dichotomous, is not necessarily antithetical nor is it impassable. This led me back to the arguments of the venerable philosophers Alasdair MacIntyre and Charles Taylor whereby, in critiquing the concept of secularism itself along with its historical contexts, furthered my argument and helped me to clarify the significant role that religion plays vis-à-vis categorical issues such as fundamental beliefs and metaphysics. I still maintain this, and it is something I continue to work on, although I decided to take my project in another direction.

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Mass embryo destruction, reproductive never events, and the not-quite-Wild West

By Dov Fox

Information found in this new post by Dov Fox is also available in Slate’s March 19th article In Vitro Injuries: How should courts compensate would-be parents when assisted reproductive technology goes terribly wrong?

More than 1 in 10 Americans seek fertility treatment. IVF and similar technologies result in 64,000 babies—1.6% annually—of all those born in the U.S. each year. For people willing to move heaven and earth to form a family, this is the medicine of miracles. But reproductive mishaps turn these dreams into nightmares. Some result in unplanned pregnancies. Others, lost chances for parenthood. I’ve considered the legal complexities elsewhere at law review length. (A reply to critics Robert Rabin, Carol Sanger, and Gregory Keating is out shortly with Columbia.) But it’s the facts that have made headlines of late.

The Today Show and Nightly News interviewed me in the wake of recent storage tank malfunctions at two major fertility clinics—one in San Francisco, the other outside Cleveland—that destroyed more than 4,000 cryopreserved eggs and embryos. The Cleveland facility said that “alerts that should have been sent to staff were never sent.” These incidents have left over a thousand affected couples mourning future children who would never be; practitioners wondering how something like this could have happened; and prospective parents around the country worrying that tragedy could strike again.

It’s not the first time. NBC News uncovered a history of freezer malfunctions. Over a decade ago in Florida over 60 cancer survivors lost their stored sperm “when a tank made by the same manufacturer failed.” Exact figures for such breakdowns are hard to come by, however. Elsewhere in health care delivery, most states mandate reporting of “never events,” such as surgery on the wrong body part or patient. But the United State has no public or private system for tracking what I’ve referred to as “reproductive” never events, let alone less serious errors. So it’s impossible to know with any reliability or precision the incidence of professional mistakes in matters of procreation.

Available data points are bracing. A 2008 survey of nearly half of all U.S. fertility clinics found that more than one in five misdiagnosed, mislabeled, or mishandled reproductive materials. A 2014 study revealed that popular methods of prenatal screening for fetal abnormality sound “a false alarm half of the time.” And in 2016, a national ratings website found that 18-24% of fertility patients reported damaged or destroyed samples among a host of other errors.

None among regulators, agencies, insurers, medical boards, or professional societies require safeguards that might prevent mistakes like these from happening in the first place. The U.S. stands out among developed countries for its failure to rein in wrongdoing that forces parenthood on people who don’t want it or that denies it to those who do. In the United Kingdom, by contrast, a national agency requires that all facilities comply with a standard of professional conduct that covers “all details of the clinical and embryological practice associated with assisted reproductive technology.”

That agency—the Human Fertilisation and Embryology Authority—maintains rigorous laboratory inspections, often without notice. And even under its careful oversight, the agency reports that 1 out of every 100 fertility procedures—over 500 each year—involve reproductive materials that’s lost, damaged or destroyed. It stands to reason that these errors are at least as common in the United States, where fertility clinics, sperm banks, and surrogacy agencies aren’t monitored or supervised in any meaningful way. My own research uncovered hundreds of American cases in which procreation was negligently imposed, deprived, or confounded.

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Learning the lessons from patient safety errors of the past

By John Tingle

A common theme found in patient safety reports in England going back as far as the year 2000 is that the NHS (National Health Service) is poor at learning lessons from previous adverse health incident reports and of changing practice. The seminal report on patient safety in England, Organisation with a memory in 2000  stated:

“There is no single focal point for NHS information on adverse events, and at present it is spread across nearly 1,000 different organisations. The NHS record in implementing the recommendations that emerge from these various systems is patchy. Too often lessons are identified but true ‘active’ learning does not take place because the necessary changes are not properly embedded in practice.” (x-xi).

In late 2003 our NRLS (National Reporting and Learning System) was established.This is our central database of patient safety incident reporting. Can we say today that the NHS is actively learning from the adverse patient safety incidents of the past and changing practice? That the NRLS has been a great success? Or is the jury still out on these questions? Unfortunately the jury is still out. Sadly, there is no shortage of contemporary reports saying that the NHS still needs to improve its lesson learning capacity from adverse events.

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Save the Date, April 12-13, 2018! Diseases of Despair: The Role of Policy and Law

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Anne Case and Angus Deaton shocked the world with their 2015 report that noted an increase in all-cause mortality among middle-aged white non-Hispanic men and women in the United States. This pattern is not occurring in other groups within the United States and Europe. Their report, and others since then, have linked this trend to so-called deaths of despair (death from suicide, chronic substance use, and overdoses) and their linkage to other determinants of health (education, labor markets, marital patterns). A recent update to the report makes it clear that this trend is no longer limited to any particular geographic region within the United States.

This year’s NUSL Center for Health Policy and Law annual conference and associated scholarship will bring together experts, policymakers, and academics to discuss the causes behind such trends, and to explore potential political, policy, and legal responses for addressing broader determinants that affect the physical and mental health of Americans dying from these diseases of despair. Deeper examination into similar patterns among diverse populations, as well as analysis of continuing racial, ethnic, and socioeconomic disparities, will be central to the discourse.

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The Opioid Crisis Requires Evidence-Based Solutions, Part I: How the President’s Commission on Combating Drug Addiction Misinterpreted Scientific Studies

By Mason Marks

The opioid crisis kills at least 91 Americans each day and has far-reaching social and economic consequences for us all. As lawmakers explore solutions to the problem, they should ensure that new regulations are based on scientific evidence and reason rather than emotion or political ideology. Though emotions should motivate the creation of policies and legislation, solutions to the opioid epidemic should be grounded in empirical observation rather than feelings of anger, fear, or disgust. Legislators must be unafraid to explore bold solutions to the crisis, and some measured risks should be taken. In this three-part series on evidence-backed solutions to the opioid crisis, I discuss proposals under consideration by the Trump Administration including recent recommendations of the President’s Commission on Combating Drug Addiction and the Opioid Crisis. Though the Commission made some justifiable proposals, it misinterpreted the conclusions of scientific studies and failed to consider evidence-based solutions used in other countries. This first part of the series focuses on the misinterpretation of scientific data.

Last year more than 64,000 Americans died of drug overdose, which is “now the leading cause of death” in people under 50. Opioids are responsible for most of these deaths. By comparison, the National Safety Council estimates about 40,000 Americans died in auto crashes last year, and the Centers for Disease Control reports that 38,000 people were killed by firearms. Unlike deaths due to cars and firearms, which have remained relatively stable over the past few years, opioid deaths have spiked abruptly. Between 2002 and 2015, U.S. opioid-related deaths nearly tripled (from about 12,000 deaths in 2002 to over 33,000 in 2015). Last year, synthetic opioids such as fentanyl contributed to over 20,000 deaths and accounted for the sharpest increase in opioid fatalities (See blue line in Fig. 1 below). Continue reading

An Analysis of Five Years of Cerebral Palsy Claims in the UK

By John Tingle

NHS Resolution, an arm’s length body of the Department of Health that manages clinical negligence and other claims brought against the NHS in England, have just published a report on cerebral palsy legal claims. These claims are complex and result in large awards of compensation. In 2016-17, whilst the obstetrics specialty accounted for only 10% of the 10,686 claims received, they represented 50% of the £4,370 Million value of claims received.

Once case may cost £20 Million or more for one child. The report shows that the same errors are often being repeated and that key patient safety lessons go unlearned. The report analyses the data held by NHS Resolution on its claims management system on compensation claims for cerebral palsy that occurred between 2012-2016.There were 50 claims between this period that were suitable for review with a potential financial liability greater than £390 Million. This figure excludes the costs of defending the claim and the wider cost impact on the NHS as a whole. The results of the report are split into two parts. Part one looks at the quality of the serious incident (SI) investigation reports and part two looks at arising clinical themes. Continue reading

Democratized Diagnostics: Why Medical Artificial Intelligence Needs Vetting

Pancreatic cancer is one of the deadliest illnesses out there.  The five-year survival rate of patients with the disease is only about 7%.  This is, in part, because few observable symptoms appear early enough for effective treatment.  As a result, by the time many patients are diagnosed the prognosis is poor.  There is an app, however, that is attempting to change that.  BiliScreen was developed by researchers at the University of Washington, and it is designed to help users identify pancreatic cancer early with an algorithm that analyzes selfies.  Users take photos of themselves, and the app’s artificially intelligent algorithm detects slight discolorations in the skin and eyes associated with early pancreatic cancer.

Diagnostic apps like BiliScreen represent a huge step forward for preventive health care.  Imagine a world in which the vast majority of chronic diseases are caught early because each of us has the power to screen ourselves on a regular basis.  One of the big challenges for the modern primary care physician is convincing patients to get screened regularly for diseases that have relatively good prognoses when caught early.

I’ve written before about the possible impacts of artificial intelligence and algorithmic medicine, arguing that both medicine and law will have to adapt as machine-learning algorithms surpass physicians in their ability to diagnose and treat disease.  These pieces, however, primarily consider artificially intelligent algorithms licensed to and used by medical professionals in hospital or outpatient settings.  They are about the relationship between a doctor and the sophisticated tools in her diagnostic toolbox — and about how relying on algorithms could decrease the pressure physicians feel to order unnecessary tests and procedures to avoid malpractice liability.  There was an underlying assumption that these algorithms had already been evaluated and approved for use by the physician’s institution, and that the physician had experience using them.  BiliScreen does not fit this mold — the algorithm is not a piece of medical equipment used by hospitals, but rather part of an app that could be downloaded and used by anyone with a smartphone.  Accordingly, apps like BiliScreen fall into a category of “democratized” diagnostic algorithms. While this democratization has the potential to drastically improve preventive care, it also has the potential to undermine the financial sustainability of the U.S. health care system.

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The Problematic Patchwork of State Medical Marijuana Laws – New Research

By Abraham Gutman

The legal status of medical marijuana in the United States is unique. On one hand, the Controlled Substance Act of 1970 classifies marijuana as a Schedule I drug with no acceptable medical use and high potential for abuse. On the other hand, as of February 1, 2017, 27 states and the District of Columbia have passed laws authorizing the use of medical marijuana. This discrepancy between federal and state regulation has led to a wide variation in the ways that medical marijuana is regulated on the state level.

In a study published today in Addiction, our team of researchers from the Temple University Center for Public Health Law Research and the RAND Drug Policy Research Center finds that state laws mimic some aspects of federal prescription drug and controlled substances laws, and regulatory strategies used for alcohol, tobacco and traditional medicines.

In the past, studies on medical marijuana laws have focused on the spillover effect of medical marijuana to recreational use and not on whether the laws are regulating marijuana effectively as a medicine. Using policy surveillance methods to analyze the state of medical marijuana laws and their variations across states, this study lays the groundwork for future research evaluating the implementation, impacts, and efficacy of these laws.

The study focuses on three domains of medical marijuana regulation that were in effect as of February 1, 2017: patient protections and requirements, product safety, and dispensary regulation.

Here’s some of what we found:

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Making Health Care Safer: What Good Looks Like

It’s fair to say that patient safety and health quality reports in recent years have tended to focus on what is going wrong in the NHS and what needs to be done to put things right.We have had some dramatic health care systems failures which have resulted in unnecessary deaths of patients.The naming and shaming of errant health care providers has taken place and we have now through the CQC (Care Quality Commission), a much more open, stronger, intelligent and transparent way of regulating health care quality than we have ever had before.

The health care regulatory system does seem to be making a positive difference to NHS care judging from recent CQC reports with some good examples of health quality and safe care practices taking place. Other trusts can learn from these practices.

The CQC have just published a report which includes several case studies illustrating some of the qualities shown by care providers that are rated good or outstanding overall. These hospitals known as hospital trusts in the NHS have been on a journey of improvement some going from special measures to good (CQC inspection ratings). The views of some of the people involved in the care improvement initiatives are stated in the case studies revealing important insights on improvement strategies and the nature of the problems overcome. Continue reading

Fetal Consequentialism and Maternal Mortality

By Nadia N. Sawicki

It is well known that maternal mortality rates in the United States are higher than in other countries in the developed world, and that many of these deaths are preventable. But a report published by NPR last week, just a few days before Mother’s Day, drew a direct link between these poor maternal outcomes and health care providers’ focus on fetal health. The report quotes Barbara Levy, vice president for health policy and advocacy at the American Congress of Obstetricians and Gynecologists, who said, “We worry a lot about vulnerable little babies, [but] we don’t pay enough attention to those things that can be catastrophic for women.” According to the authors of the NPR report, “newborns in the slightest danger are whisked off to neonatal intensive care units … staffed by highly trained specialists prepared for the worst,” while new mothers are instead monitored by nurses and physicians “who expect things to be fine and are often unprepared when they aren’t.”

These patterns are consistent with what Prof. Jamie Abrams calls “fetal consequentialism” – the premise that the birth of a healthy child outweighs any harm to the birthing mother. The increase in U.S. maternal mortality rates highlighted in the NPR report is certainly a product of such fetal consequentialism. So is the practice of obstetric violence, described in my previous posts, where health care providers dismiss birthing mothers’ informed requests for minimal intervention during labor and delivery in an effort to reduce the risk of fetal harm, even when that risk is minimal. Fetal consequentialism is likely driven not only by providers’ judgments of the relative liability risks for harms to fetuses versus harms to mothers, but also by conservative societal trends (evidenced by increasing anti-abortion legislation) that preference fetal interests over maternal interests. Continue reading

A Quarter of the Work Force: International Medical Graduates and the Lives They Save

By Wendy S. Salkin

On Monday, May 1, 2017, International Workers’ Day, thousands took to the streets across the United States to demonstrate in support of immigrants’ rights in the United States and against immigration policies recently rolled out by President Trump.

Among the Presidential Actions taken by President Trump during his first hundred days in office has been the issuance of his “Buy American and Hire American” Executive Order, issued just two weeks ago on April 18, 2017, in which the President states that “[i]t shall be the policy of the executive branch to buy American and hire American.” What is meant by “hire American” is detailed in section 2(b) of the Executive Order:

Hire American. In order to create higher wages and employment rates for workers in the United States, and to protect their economic interests, it shall be the policy of the executive branch to rigorously enforce and administer the laws governing entry into the United States of workers from abroad, including section 212(a)(5) of the Immigration and Nationality Act (8 U.S.C. 1182(a)(5)).

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Birth Plans as Advance Directives

By Nadia N. Sawicki

There is growing public recognition that women’s autonomy rights during labor and delivery are being routinely violated. Though such violations rarely rise to the level of egregious obstetric violence I described in an earlier blog post, women recognize that hospital births, even for the most low-risk pregnancies, often involve cascades of medical interventions that lack evidence-based support and can have negative health consequences for both mother and child. Indeed, evidence suggests that an increasing number of women are pursuing options like midwife-assisted birth, delivery in free-standing birthing centers, and even home birth in an effort to avoid interventionist hospital practices. According to the 2013 Listening to Mothers Survey, nearly six in ten women agree that birth is a process that “should not be interfered with unless medically necessary.”

One tool that women frequently use to increase the likelihood that their autonomous choices will be respected during labor and delivery is the birth plan, a document that outlines a woman’s values and preferences with respect to the birthing process, and serves as a tool for facilitating communication with care providers. However, while most women view the creation of a birth plan as empowering, there is little evidence to suggest that the use of birth plans actually improves communication, increases women’s feelings of control, or affects the process or outcome of childbirth. In fact, there appears to be some resistance within the medical community to women’s reliance on birth plans, with one article describing “the two words ‘birth plan’ strik[ing] terror in the hearts of many perinatal nurses.”  Continue reading

TOMORROW: Critical Pathways to Improved Care for Serious Illness

Close up of helpful carer hand and happy old man

Friday, March 10, 10:30am – 2:30pm

Harvard Law School, Wasserstein Hall, Milstein East BC, 1585 Massachusetts Ave.

Join leading health care executives, experts, policymakers, and other thought leaders as they embark upon a project to develop a guiding framework for providing improved care for people with serious illness. You are invited to observe the inaugural working session where distinguished panelists will discuss innovations in program design and pathways for delivering high quality care to an aging population with chronic illnesses, especially those with declining function and complex care needs.

Check out the full agenda and list of roundtable participants on the website!

Attendees are welcome to participate in Q&A sessions, and lunch will be provided. Please RSVP for lunch here.

This project is funded by the Gordon & Betty Moore Foundation, and this convening is part of the Project on Advanced Care and Health Policy, a collaboration between the Coalition to Transform Advanced Care (C-TAC) and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. 

Drained Swamps and Quackery: Some Thoughts on Efficacy

By Seán Finan

“What makes drug development long and expensive is the need to prove, beyond statistical doubt, that your damn drug works”

Michael Gilman, Biotech Entrepreneur

2017 is going to be terrific. Tremendous, even. Things are going to change, big league.

7770160314_61e7536762_kThe new President has promised fantastic reforms to the drug industry. He’s going to get the big players in the pharmaceutical industry around a table and negotiate huge price reductions. Of course, he’s not going to touch their bottom line. If anything, he’s going to improve it. Innovation is being choked by over-regulation and he’s going remove burdensome FDA hurdles. But he has Executive Orders to give and walls to build, so he’s drafting in the very best people to help. We’re still waiting for those people to be officially named. Meanwhile, the media have had a month and a half of fun and speculation. The volume and variety of names being thrown around make it feel like a food fight at a Chinese buffet. One of those names is Peter Thiel.

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March 10: Critical Pathways to Improved Care for Serious Illness

Close up of helpful carer hand and happy old man

Friday, March 10, 10:30am – 2:30pm

Harvard Law School, Wasserstein Hall, Milstein East BC, 1585 Massachusetts Ave.

Join leading health care executives, experts, policymakers, and other thought leaders as they embark upon a project to develop a guiding framework for providing improved care for people with serious illness. You are invited to observe the inaugural working session where distinguished panelists will discuss innovations in program design and pathways for delivering high quality care to an aging population with chronic illnesses, especially those with declining function and complex care needs.

Check out the full agenda and list of roundtable participants on the website!

Attendees are welcome to participate in Q&A sessions, and lunch will be provided. Please RSVP for lunch here.

This project is funded by the Gordon & Betty Moore Foundation, and this convening is part of the Project on Advanced Care and Health Policy, a collaboration between the Coalition to Transform Advanced Care (C-TAC) and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. 

NHS patient care and treatment errors: developing a learning culture.

By John Tingle

PACAC, the House of Commons, (Public Administration and Constitutional Affairs Committee) has just published its analysis of the PHSO’s, (Parliamentary and Health Service Ombudsman ) second report into the tragic death of Sam Morrish, a three year old child whose death from sepsis was found to have been avoidable. PACAC  is composed of MP’s (Members of Parliament) and its remit includes considering matters relating to the quality and standards of administration provided by civil service departments which includes the Department of Health. PACAC also examines the reports of the PHSO.

The PACAC report is very thorough and detailed and really gets to grips with the issues surrounding NHS (National Health Service) health adverse incident investigation. It addresses very clearly the current challenges and opportunities in this area and puts forward some major concerns which need to be fully addressed by the NHS before it can be said to have a listening and learning culture. It is clear from reading the report that the NHS has a very long way to go before it can be said to be even close to reaching its listening and learning culture attainment goal.

The PACAC report also identifies what could be regarded as some muddled thinking by the Department of Health on the concept of the ‘safe space’ in NHS investigations and identifies some important patient safety policy gaps.

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Artificial Intelligence, Medical Malpractice, and the End of Defensive Medicine

By Shailin Thomas

Artificial intelligence and machine-learning algorithms are the centerpieces of many exciting technologies currently in development. From self-driving Teslas to in-home assistants such as Amazon’s Alexa or Google Home, AI is swiftly becoming the hot new focus of the tech industry. Even those outside Silicon Valley have taken notice — Harvard’s Berkman Klein Center and the MIT Media Lab are collaborating on a $27 million fund to ensure that AI develops in an ethical, socially responsible way. One area in which machine learning and artificial intelligence are poised to make a substantial impact is health care diagnosis and decision-making. As Nicholson Price notes in his piece Black Box Medicine, Medicine “already does and increasingly will use the combination of large-scale high-quality datasets with sophisticated predictive algorithms to identify and use implicit, complex connections between multiple patient characteristics.” These connections will allow doctors to increase the precision and accuracy of their diagnoses and decisions, identifying and treating illnesses better than ever before.

As it improves, the introduction of AI to medical diagnosis and decision-making has the potential to greatly reduce the number of medical errors and misdiagnoses — and allow diagnosis based on physiological relationships we don’t even know exist. As Price notes, “a large, rich dataset and machine learning techniques enable many predictions based on complex connections between patient characteristics and expected treatment results without explicitly identifying or understanding those connections.” However, by shifting pieces of the decision-making process to an algorithm, increased reliance on artificial intelligence and machine learning could complicate potential malpractice claims when doctors pursue improper treatment as the result of an algorithm error. In it’s simplest form, the medical malpractice regime in the United States is a professional tort system that holds physicians liable when the care they provide to patients deviates from accepted standards so much as to constitute negligence or recklessness. The system has evolved around the conception of the physician as the trusted expert, and presumes for the most part that the diagnosing or treating physician is entirely responsible for her decisions — and thus responsible if the care provided is negligent or reckless. Continue reading

Maybe For-Profit Hospitals Aren’t So Bad

By Shailin Thomas

For-profit hospitals have taken their fair share of flack over the years. Much maligned by many in the medical community, they are seen as money-hungry corporate machines that pervert the medical profession by putting the bottom line before patient care. This skepticism of profit-driven hospitals feels right. Medicine has long been the purview of charitable organizations and religious institutions. It’s supposed to be a calling — a public service to which practitioners are drawn — not a check to cash at the bank.

As for-profit hospitals proliferated, there was research done suggesting they had quality and cost issues stemming from their profit motives. For-profit hospitals had higher mortality rates, employed fewer trained professionals per bed, and were more expensive than their non-profit and government counterparts. Researchers speculated that this was the result of duties owned to shareholders by corporate leaders or compensation incentives for executives based on profitability rather than quality of care. These studies seemed to confirm what many thought they already knew: medicine and money don’t mix well.

More recent studies, however, suggest that for-profit hospitals may have turned over a new leaf. Since 2010, for-profit hospitals have out-performed non-profits in the “Top Performer” evaluation carried out by The Joint Commission — an organization that accredits hospitals in the US — with a higher percentage of for-profit hospitals qualifying for the honor than non-profits. A study published in JAMA from the Harvard T.H. Chan School of Public Health found that hospitals that converted from non-profit to for-profit improved their financial position by increasing their total margins and experienced no change in mortality rates.

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Missed opportunities to learn from patient deaths in the NHS

By John Tingle

The National Health Service (NHS) in England’s quality regulator, the Care Quality Commission (CQC) has recently published a highly critical report on the way patient deaths are investigated in the NHS. The investigation follows events at the Southern Health NHS Foundation Trust where a number of failings were identified in the way patient deaths were identified and investigated. Certain groups of patients including people with a learning disability and older people receiving mental health care were far less likely to have their deaths investigated by this Trust. The Secretary of State for Health called for a CQC investigation into how acute, community and mental health NHS facilities across the country investigate and learn from deaths. The findings of the report are not good and major improvements in this area are needed across the NHS.

There are failings in openness, transparency and missed opportunities to learn important patient safety lessons. Families of patients and carers told the CQC reviewers that they often have a poor experience of investigations and are not always treated with kindness, respect, honesty and sensitivity. The CQC states that across their review they were unable to identify any NHS healthcare facility that could demonstrate good practice across all aspects of identifying, reviewing and investigating deaths and ensuring that learning from the events is implemented. Continue reading

New twist in debate over resident duty hours (Part I)

By Brad Segal

Amidst a roller-coaster presidential campaign, on November 4th the Accreditation Council for Graduate Medical Education (ACGME) presented a plan to change resident duty hour limits. That the specifics have largely flown under the radar is perhaps unsurprising given the current news cycle. But the understated revision to, “Resident Duty Hours in The Learning and Working Environment” is the latest twist in a relatively contentious issue within medical education (see 2016 NEJM op-ed vs. responses). The proposal is currently undergoing requisite comment period until December 19. This week I’ll briefly lay out the history of duty hours to help explain the significance of ACGME’s proposal, and I will then go through general empirical arguments for and against such a change. My next post will examine how well these argument hold in light of the most recent data available.

Today the physicians’ training experience immediately following medical school is no longer the whir of dangerous sleep deprivation lampooned in the House of God. Amid mounting evidence that resident sleep deprivation caused medical errors, and under threat of federal legislation, in 2003 the ACGME first introduced national guidelines restricting resident work hours to 80 hours per week (averaged over 4 weeks), and capped residents to 30 hours of continuous in-house call. Then in 2009 the Institute of Medicine (IOM) released a 427-page report reviewing scientific evidence on resident work hours, sleep deprivation, and fatigue-related errors. The evidence overwhelmingly suggests that sleep deprivation significantly impairs most aspects of cognition. Hence the IOM ultimately recommended that residents not exceed 16 hours of continuous work before dedicated rest.

The ACGME subsequently modified duty hour guidelines in 2011 and limited first-year residents (‘interns’) to working 16-hour stretches. The reason ACGME’s most recent proposal is curious, though, is that it back-tracks on the 2011 intern duty-hour limits, raising their in-house cap to 28 hours. In response to this proposal a national advocacy group, Public Citizen, claimed it, “would expose residents, their patients and the general public to the risk of serious injury and death.” Continue reading