My Slate Article on the Importance of Replicating Science

I have a long article in Slate (with Chris Chabris) on the importance of replicating science. We use a recent (and especially bitter) dispute over the failure to replicate a social psychology experiment as an occasion for discussing several things of much broader import, including:

  • The facts that replication, despite being a cornerstone of the scientific method, is rarely practiced (and even less frequently published) not only in psychology but across science, and that when such studies are conducted, they frequently fail to replicate the original findings (let this be a warning to those of you who, like me, cite empirical literature in your scholarship);
  • Why replications are so rarely conducted and published, relative to their importance (tl;dr: it’s the incentives, stupid);
  • Why it’s critical that this aspect of the academic research culture change (because academic science doesn’t only affect academic scientists; the rest of us have a stake in science, too, including those who fund it, those who help researchers produce it (i.e., human subjects), those who consume and build on it (other scholars and policy-makers), and all of us who are subject to myriad laws and policies informed by it); and
  • Some better and worse ways of facilitating that cultural change (among other things, we disagree with Daniel Kahneman’s most recent proposal for conducting replications).

Serious Risks from New Prescription Drugs

by Donald W. Light

Based on http://www.ethics.harvard.edu/lab/blog/436-new-prescription-drugs-a-major-health-risk

Few people know that new prescription drugs have a 1 in 5 chance of causing serious reactions after they have been approved. That is why expert physicians recommend not taking new drugs for at least five years unless patients have first tried better-established options and need to. Faster reviews advocated by the industry-funded public regulators increase the risk of serious harm to 1 in 3. Yet most drugs they approve are found to have few offsetting clinical advantages over existing ones.

Systematic reviews of hospital charts by expert teams have found that even properly prescribed drugs (aside from misprescribing, overdosing, or self-prescribing) cause about 1.9 million hospitalizations a year. Another 840,000 hospitalized patients given drugs have serious adverse reactions for a total of 2.74 million. Further, the expert teams attributed as many deaths to the drugs as people who die from stroke. A policy review done at the Edmond J. Safra Center for Ethics at Harvard University concluded that prescription drugs are tied with stroke as the 4th leading cause of death in the United States. The European Commission estimates that adverse reactions from prescription drugs cause 200,000 deaths; so together, about 328,000 patients in the US and Europe die from prescription drugs each year. The FDA does not acknowledge these facts and instead gathers a small fraction of the cases.

Perhaps this is “the price of progress”? For example, about 170 million Americans take prescription drugs, and many benefit from them. For some, drugs keep them alive. If we suppose they all benefit, then 2.7 million people have a severe reactions, it’s only about 1.5 percent – the price of progress?

However, independent reviews over the past 35 years have found that only 11-15 percent of newly approved drugs have significant clinical advantages over existing, better-known drugs. While these contribute to the large medicine chest of effective drugs developed over the decades, the 85-89 percent with little or no clinical advantage flood the market. Of the additional $70 billion spent on drugs since 2000 in the U.S. (and another $70 billion abroad), about four-fifths has been spent on purchasing these minor new variations rather than on the really innovative drugs.

In a recent decade, independent reviewers concluded that only 8 percent of 946 new products were clinically superior, down from 11-15 percent in previous decades. (See Figure) Only 2 were breakthroughs and another 13 represented a real therapeutic advance.

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Call for Submissions: Journal of Law and the Biosciences

JLB coverCall for Submissions: Journal of Law and the Biosciences

Deadline: Rolling.

The Journal of Law and the Biosciences (JLB) is actively soliciting original manuscripts, responses, essays, and book reviews devoted to the examination of issues related to the intersection of law and biosciences, including bioethics, neuroethics, genetics, reproductive technologies, stem cells, enhancement, patent law, and food and drug regulation. JLB welcomes submissions of varying length, with a theoretical, empirical, practical, or policy oriented focus.

JLB is the first fully open access peer-reviewed legal journal focused on the advances at the intersection of law and the biosciences. A co-venture between Duke University, Harvard Law School, and Stanford University, and published by Oxford University Press, this open access, online, and interdisciplinary academic journal publishes cutting-edge scholarship in this important new field. JLB is published as one volume with three issues per year with new articles posted online on an ongoing basis.

For more information about JLB, click here. To submit a manuscript, click here.

How an IRB Could Have Legitimately Approved the Facebook Experiment—and Why that May Be a Good Thing

Image courtest Flickr

Image courtesy Flickr

By now, most of you have probably heard—perhaps via your Facebook feed itself—that for one week in January of 2012, Facebook altered the algorithms it uses to determine which status updates appeared in the News Feed of 689,003 randomly-selected users (about 1 of every 2500 Facebook users). The results of this study—conducted by Adam Kramer of Facebook, Jamie Guillory of the University of California, San Francisco, and Jeffrey Hancock of Cornell—were just published in the Proceedings of the National Academy of Sciences (PNAS).

Although some have defended the study, most have criticized it as unethical, primarily because the closest that these 689,003 users came to giving voluntary, informed consent to participate was when they—and the rest of us—created a Facebook account and thereby agreed to Facebook’s Data Use Policy, which in its current iteration warns users that Facebook “may use the information we receive about you . . . for internal operations, including troubleshooting, data analysis, testing, research and service improvement.”

Some of the discussion has reflected quite a bit of misunderstanding about the applicability of federal research regulations and IRB review to various kinds of actors, about when informed consent is and isn’t required under those regulations, and about what the study itself entailed. In this post, after going over the details of the study, I explain (more or less in order):

  • How the federal regulations define “human subjects research” (HSR)
  • Why HSR conducted and funded solely by an entity like Facebook is not subject to the federal regulations
  • Why HSR conducted by academics at some institutions (like Cornell and UCSF) may be subject to IRB review, even when that research is not federally funded
  • Why involvement in the Facebook study by two academics nevertheless probably did not trigger Cornell’s and UCSF’s requirements of IRB review
  • Why an IRB—had one reviewed the study—might plausibly have approved the study with reduced (though not waived) informed consent requirements
  • And why we should think twice before holding academics to a higher standard than corporations

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High Noon for Population-Wide Mammography Screening?

By Prof. Dr. med. Dr. phil. Nikola Biller-Andorno

Director, Institute of Biomedical Ethics, University of Zurich, Switzerland

Safra Network Fellow, Harvard University (13-14)

Visiting Professor, Div. Medical Ethics, Harvard Medical School (12-14)

It is amazing how much heat a report can draw that simply states what has been all over town for some time now: We do not know if mammography screening does more good than harm, we do not even know for sure if it does any good at all.

The Swiss Medical Board, an independent health technology assessment initiative that was started in 2008, stated that based on the empirical data availability the introduction of mammography screening all over Switzerland could not be recommended.

As could be expected the report drew fire. Curiously, one of the chief complaints was that it was “unethical” to upset women who might no longer know if screening was good for them or not.

This sounds just a little bit paternalistic – particularly given that we know that most women seriously overestimate the benefits of screening when making their decision, a point that my colleague Peter Juni and myself illustrate in a Perspective piece published on May 22, 2014 in the New England Journal of Medicine.

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The U.S. Supreme Court vs. the American Psychological Association

by Dov Fox

The U.S. Supreme Court has not in recent years held the views of the American Psychological Association (APA) in so high regard as it did this week.

In 2012, the Court set aside the APA’s arguments for why due process requires the exclusion of eyewitness testimony obtained under suggestive circumstances that rendered it especially likely to be unreliable.

And in 2011, when the Court struck down on free speech grounds a state regulation on violent video games, it gave short shrift to the APA’s warnings about those games’ connection to violent behavior in young boys.

But in its recent death penalty decision, Florida v. Hall, the Court relied heavily on important APA insights in declaring it unconstitutional for states to set an IQ cutoff to determine whether a prisoner is eligible to receive capital punishment. Continue reading

Wait Times in the News in Canada

At the same time that wait times at VA hospitals have been in the news here in the U.S., a recent report has put healthcare queues in the news in Canada.  Specifically, a recent report from the Fraser Institute (a research institute that I’ve seen described as “conservative” and “pro-free market“) concluded that 44,723 women in Canada died between 1993 and 2009 due to increased wait times–or 2.5% of all female deaths during that period.  One week of delay was equated with 3 extra deaths per 100,000.  That surprising result led to a good bit of coverage, which is how it came across my desk (thanks to a google news search).  (See here, here, and here.)  But I have to admit I am a little bit skeptical.

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TUESDAY, 5/20 conference: “Biostatistics & FDA Regulation: The Convergence of Science & Law”

Biostatistics and FDA Regulation: The Convergence of Science and Law

Tuesday, May 20, 2014, 8:00am – 5:00pm

Wasserstein Hall, Milstein West AB, Harvard Law School, 1585 Massachusetts Ave.

Symposium Presented by the Drug Information Association (DIA), the Food and Drug Law Institute (FDLI), and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, in collaboration with the Harvard School of Public Health Department of Biostatistics and Harvard Catalyst | The Harvard Clinical and Translational Science Center.

Biostatistics is the application of statistics — the study of the collection, organization, analysis, interpretation and presentation of data — to a wide range of topics in life sciences.  Biostatistics informs the Food and Drug Administration’s regulatory decision-making processes for premarket review of investigational drugs and devices and post-market surveillance of medical products, including decisions to require safety labeling changes and withdraw approval.   Recent developments, such as Congress’s creation of a new federal infrastructure for the dissemination of comparative effectiveness information, point to the need for a fresh look at the way in which biostatistical principles inform federal health care policy, particularly at the FDA.  This one-day symposium will give attendees the foundational knowledge they need to understand how biostatistics applies in FDA regulation, and will also address closely related issues residing at the intersection of statistical analysis and life sciences litigation. The full conference agenda is available on the website.

Registration is required in order to attend this event. Please register here.

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5/20 conference: “Biostatistics & FDA Regulation: The Convergence of Science & Law”

Biostatistics and FDA Regulation: The Convergence of Science and Law

Tuesday, May 20, 2014, 8:00am – 5:00pm

Wasserstein Hall, Milstein West AB, Harvard Law School, 1585 Massachusetts Ave.

Symposium Presented by the Drug Information Association (DIA), the Food and Drug Law Institute (FDLI), and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, in collaboration with the Harvard School of Public Health Department of Biostatistics and Harvard Catalyst | The Harvard Clinical and Translational Science Center.

Biostatistics is the application of statistics — the study of the collection, organization, analysis, interpretation and presentation of data — to a wide range of topics in life sciences.  Biostatistics informs the Food and Drug Administration’s regulatory decision-making processes for premarket review of investigational drugs and devices and post-market surveillance of medical products, including decisions to require safety labeling changes and withdraw approval.   Recent developments, such as Congress’s creation of a new federal infrastructure for the dissemination of comparative effectiveness information, point to the need for a fresh look at the way in which biostatistical principles inform federal health care policy, particularly at the FDA.  This one-day symposium will give attendees the foundational knowledge they need to understand how biostatistics applies in FDA regulation, and will also address closely related issues residing at the intersection of statistical analysis and life sciences litigation. The full conference agenda is available on the website.

Registration is required in order to attend this event. Please register here.

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#BELHP2014 Panel 3, Behavioral Economics and Health Care Costs

[Ed. Note: On Friday, May 2 and Saturday, May 3, 2014, the Petrie-Flom Center hosted its 2014 annual conference: "Behavioral Economics, Law, and Health Policy."  This is an installment in our series of live blog posts from the event; video will be available later in the summer on our website.]

Our third panel, moderated by PFC Academic Fellow Matthew Lawrence, addresses the use of behavioral economics techniques to control health care costs.  Speakers are Christopher T. Robertson, Brigitte Madrian, Ameet SarpatwariAnupam Jena, and Jim Hawkins.  (Many projects are co-authored, but I’m only listing the presenters here)

The first speaker is Professor Christopher T. Robertson, coming from Arizona Law but visiting Harvard and the PFC this year, speaking on Cost-Sharing as Choice Architecture.  He starts by talking about the cost side of cost sharing, which we know works in reducing consumption from empirical evidence; from the RAND study, it reduced use without reducing health.  More recent studies also confirm this.  But cost sharing presents four problems:

  1. Underinsurance relative to ability to pay
  2. Indiscriminate reductions in health care (more of an ax than a scalpel)
  3. An unfair tax on sickness (more tentative if we can solve the first two)
  4. The burden of deciding.

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5/20 conference: “Biostatistics & FDA Regulation: The Convergence of Science & Law”

Biostatistics and FDA Regulation: The Convergence of Science and Law

Tuesday, May 20, 2014, 8:00am – 5:00pm

Wasserstein Hall, Milstein West AB, Harvard Law School, 1585 Massachusetts Ave.

Symposium Presented by the Drug Information Association (DIA), the Food and Drug Law Institute (FDLI), and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, in collaboration with the Harvard School of Public Health Department of Biostatistics and Harvard Catalyst | The Harvard Clinical and Translational Science Center.

Biostatistics is the application of statistics — the study of the collection, organization, analysis, interpretation and presentation of data — to a wide range of topics in life sciences.  Biostatistics informs the Food and Drug Administration’s regulatory decision-making processes for premarket review of investigational drugs and devices and post-market surveillance of medical products, including decisions to require safety labeling changes and withdraw approval.   Recent developments, such as Congress’s creation of a new federal infrastructure for the dissemination of comparative effectiveness information, point to the need for a fresh look at the way in which biostatistical principles inform federal health care policy, particularly at the FDA.  This one-day symposium will give attendees the foundational knowledge they need to understand how biostatistics applies in FDA regulation, and will also address closely related issues residing at the intersection of statistical analysis and life sciences litigation. The full conference agenda is available on the website.

Registration is required in order to attend this event. Please register here.

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Whose Business Is It If You Want To Induce a Bee To Sting Your Penis?

Photo source: WikiMedia Commons

You might think that the answer to this question is obvious. Clearly, it’s your business, and yours alone, right? I mean, sure, maybe it would be considerate to discuss the potential ramifications of this activity with your partner. And you might want to consider the welfare of the bee. But other than that, whose business could it possibly be?

Well, as academic empiricists know, what others can do freely, they often require permission to do. Journalists, for instance, can ask potentially traumatizing questions to children without having to ask whether the risk to these children of interviewing them is justified by the expected knowledge to be gained; academics, by contrast, have to get permission from their institution’s IRB first (and often that permission never comes).

So, too, with potentially traumatizing yourself — at least if you’re an academic who’s trying to induce a bee to sting your penis in order to produce generalizable knowledge, rather than for some, um, other purpose.

Yesterday, science writer Ed Yong reported a fascinating self-experiment conducted by Michael Smith, a Cornell graduate student in the Department of Neurobiology and Behavior who studies the behavior and evolution of honeybees. As Ed explains, when, while doing his other research, a honeybee flew up Smith’s shorts and stung his testicles, Smith was surprised to find that it didn’t hurt as much as he expected. He began to wonder which body parts would really smart if they were stung by a bee and was again surprised to learn that there was a gap in the literature on this point. So he decided to conduct an experiment on himself. (In addition to writing about the science of bee stings to the human penis, Ed is also your go-to guy for bat fellatio and cunnilingus, the spiky penises of beetles and spiders, and coral orgies.)

As Ed notes, Smith explains in his recently published paper reporting the results of his experiment, Honey bee sting pain index by body location, that

Cornell University’s Human Research Protection Program does not have a policy regarding researcher self-experimentation, so this research was not subject to review from their offices. The methods do not conflict with the Helsinki Declaration of 1975, revised in 1983. The author was the only person stung, was aware of all associated risks therein, gave his consent, and is aware that these results will be made public.

As Ed says, Smith’s paper is “deadpan gold.” But on this point, it’s also wrong. Continue reading

Expedited FDA Approval for Breakthrough Therapies: Promises and Pitfalls

By Michael Young

In 2012, the FDA introduced a novel pathway for expedited review of breakthrough therapies. The ‘breakthrough-drug’ designation was carved out by the Food and Drug Administration Safety and Innovation Act (FDASIA), which provided for expedited development and review of any drug “intended, alone or in combination with 1 or more other drugs, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on 1 or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.”  This pathway added to a variety of other accelerated FDA approval programs aimed at improving access to innovative, safer, or more effective therapies for serious medical conditions.

In a recent New England Journal of Medicine article, Jonathan Darrow, Jerry Avorn and Aaron Kesselheim examine the clinical consequences and ethical dimensions of the breakthrough-drug category, and raise a variety of vital questions about its implications for patients.

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Saturday, April 5th: Aid Grade! (from Harvard Effective Altruism)

A communication from Harvard Effective Altruism:

 

Hi altruists,

Saturday, April 5th is a big day for EA at Harvard: we have three different awesome events for you! Our guest for the day, flying up from DC for the occasion, will be Dr. Eva Vivalt, the founder of AidGrade. AidGrade helps figure out what works in international development by doing rigorous and engaging analyses of different interventions to find out their effects. They’re also looking for interns and full-time hires for this work, so please visit if you’re interested!

We’ll be having a talk on AidGrade’s research from 1-2pm, followed by a research-a-thon from 2-6 where we help AidGrade do some meta-analysis. The day will be topped off by a Boston-area effective altruism meetup at Clover–with another special guest, Jacob Trefethen of 80,000 Hours Cambridge UK, and many awesome local effective altruists.

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Evidence in Policy Innovation

In the last few decades, there has been a broad effort to strengthen the use of evidence-based law as a tool for the promotion of population health. There are two major fronts in the campaign, each essential, and both largely successful, though much work also remains. One aims to increase the quantity and quality of empirical research on the health effects of existing policy choices. The other focuses on how best to get such knowledge into action in the form of policy and practice. In a new PHLR Theory Practice and Evidence paper, Evan Anderson and I draw attention to a third front: the formulation of new legal interventions. Though policy experimentation is inevitable, it has been the subject of relatively little systematic study. For proponents of evidence-based public health law, policy experimentation presents a paradox: if a legal intervention is truly innovative, there will not yet be direct evidence of its impact. Yet direct evidence from policy evaluations is never the only source of research knowledge relevant to a policy decision, even under conditions of novelty and uncertainty. And few interventions are truly new in a broad sense; in most instances, similarly designed laws have been deployed before, just not for the same specific purpose.

We use the case of youth sports concussion and Washington’s Lystedt Law as a case study of how even new legal strategies dealing with new problems can be built on evidence. We show  how evidence about the problem lawmakers are addressing, combined with widely-used analytic tools like the Haddon Matrix and an understanding of the generic mechanisms through which law influences behavior and outcomes, can bring existing research knowledge into the crafting of even very innovative legal interventions for newly perceived problems.  While we don’t expect the policy sausage factory to suddenly start looking like a research lab, there’s no question that legislators typically care about getting policy right and want evidence.  The point of our paper is to get the research world to think about ways we can help even when no one has yet studied the specific law at issue.

Call for applications: Brocher Summer Academy 2014: Ethical Choices for DALYs and the Measurement of the Global Burden of Disease

Confirmed speakers: Christopher Murray (IHME)—Keynote, Matt Adler (Duke), Greg Bognar (La Trobe U), John Broome (Oxford), Dan Brock (Harvard), Richard Cookson (York U), Owen Cotton-Barratt (Oxford), David Evans (WHO), Marc Fleurbaey (Princeton U), Ned Hall (Harvard), Dan Hausman (U of Wisconsin, Madison), Elselijn Kingma (U of Eindhoven), Jeremy Lauer (WHO), Colin Mathers (WHO), Erik Nord (Norwegian Institute of Public Health, Oslo), Ole Norheim (U of Bergen), Andreas Reis (WHO), Joshua Salomon (Harvard and IHME), Abha Saxena (WHO), Erik Schokkaert (KU Leuven), Drew Schroeder (Claremont McKenna), Alex Voorhoeve (LSE), James Woodward (U of Pittsburgh).

Organizers: Daniel Wikler (Harvard), Nir Eyal (Harvard), Samia Hurst (U of Geneva)

The biennial Summer Academy in the Ethics of Global Population Health is hosted by the Brocher Foundation on the shores of Lake Geneva June 9-13 2014, introducing faculty and advanced graduate students to population‐level bioethics. This fast‐developing academic field addresses ethical questions in population‐ and global health rather than ones in individual patient care.

The Global Burden of Disease (GBD) project is a systematic, scientific effort to quantify the comparative magnitude of health loss due to diseases, injuries, and risk factors. From its inception in the early 1990s, scientists and philosophers recognized that ethical and philosophical questions arise at every turn. For example, it must be decided whether each year in the lifespan is to count alike, and whether future deaths and disabilities should be given the same weight as those in the present. These choices and decisions matter: the share of disease burden due to myocardial infarction could vary as much as 400% depending on what position is adopted on two of the ethical choices described in the GBD 2010 report.  Continue reading

Harvard Effective Altruism: Josh Greene this Tuesday

Emotion, Reason and Altruism
with Professor Joshua Greene

Tuesday, March 11th, 7 PM,
Fong Auditorium, Boylston Hall
Why do people have radically different opinions as to who to help and how? How can we get along with people who seem to fundamentally disagree with us about what to want? Professor Josh Greene addresses this and more in Emotion, Reason, and Altruism.
Joshua Greene direct Harvard’s Moral Cognition Lab, which uses cutting edge cognitive neuroscience techniques to study how people actually make moral decisions, integrating thinking from philosophy, social science, and social psychology to address questions of why people disagree as much as they do, and what we can do about it.

Capsule Endoscopy Instead of Colonoscopy? The FDA Approves the PillCam COLON

By Jonathan J. Darrow

In January, the Food and Drug Administration (FDA) approved the use of the PillCam COLON 2 as a minimally-invasive means of viewing the colon, a development that is sure to be welcomed by U.S. patients who currently undergo an estimated 14 million colonoscopies each year.  While the approval represents a major step forward, the PillCam is unlikely to supplant current procedures just yet.

The colon has traditionally been examined via optical colonoscopy, a procedure perceived by many to be uncomfortable and embarrassing that involves insertion through the rectum of a 5-6 foot long flexible tube as part of an examination that can take 30 to 60 minutes. Air must be pumped in through the rectum in a process called “insufflation.” Sedatives and pain medication are generally used to help relieve discomfort. In contrast, the PillCam COLON contains a power source, light source, and two tiny cameras encapsulated in an easy-to-swallow pill that produces no pain or even sensation as it moves through the colon. Reflecting the absence of discomfort, one report from a clinical researcher noted that a few patients have insisted on X-rays to confirm that the device had passed in their stool (FDA Consumer). The pill takes about 30,000 pictures before passing naturally from the body, which usually occurs before the end of its 10-hour battery life.

The safety record of capsule endoscopy, the category to which the PillCam COLON belongs, so far appears to compare favorably with the alternatives. Capsule endoscopy may be less likely to produce accidental colonic perforations or other serious complications, which occur in less than 1% of traditional colonoscopies despite the best efforts of the treating physician. Tears of the colon wall can in turn “rapidly progress to peritonitis and sepsis, carrying significant morbidity and mortality.” (Adam J. Hanson et al., Laparoscopic Repair of Colonoscopic Perforations: Indications and Guidelines, 11 J. Gastrointest. Surg. 655, 655 (2007)). Splenic injury or other serious complications also occur rarely with optical colonoscopies. Unlike “virtual colonoscopy,” which uses computed tomography (CT) to peer into the body, capsule endoscopy does not involve bombarding the body with radiation. A leading study published in the New England Journal of Medicine reported no serious adverse events among 320 subjects given the PillCam COLON, and concluded that use of the device was “a safe method of visualizing the colonic mucosa through colon fluids without the need for sedation or insufflation.” Continue reading

Capturing Value in Advanced Medical Imaging

On December 12, a bipartisan bill entitled the Excellence in Diagnostic Imaging Utilization Act of 2013 (HR 3705) was introduced in the House of Representatives which would require clinicians to use electronic clinical decision support tools (CDS) before ordering advanced diagnostic imaging tests for Medicare patients.  Structured around appropriate use criteria  developed by professional medical societies, the tools would aim to increase the value of advanced imaging studies by informing and guiding practitioners’ decisions across a variety of clinical settings.

Such tools would provide active feedback on the appropriateness and evidence base of various imaging modalities, and would require physicians to furnish rationales for ordering tests that are inconsistent with appropriate use criteria.  The bill also envisions the creation of registries that document how diagnostic tests are used in order to facilitate research and to enable feedback to clinicians on metrics related to appropriate use criteria.  In a press release, the American College of Radiology lauded the proposed legislation, stating that it would “revolutionize the specialty of radiology.”

Mandating the use of electronic clinical decision support tools portends at least three key improvements in clinical workflows and healthcare quality more broadly.

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Sleep versus Training: The NY Times on Surgical Work Hours

Pauline Chen at the NY Times Blog has an article on cut backs on the number of hours of training for young surgeons.

According to her story:

“For the past decade, in response to increasing pressure from politicians, unions and sleep experts, the Accreditation Council for Graduate Medical Education, the organization responsible for accrediting American medical and surgical training programs, has been working to cap the hours that residents work. In 2011 the council passed the strictest limits yet. To maintain their accreditation, residency training programs had to abide by a 22-page set of scheduling rules that limited all in-hospital work including any elective “moonlighting” jobs to 80 hours per week, mandated the number of hours “free of duty” after different “duty periods” (eight hours off after 16-hour duty periods and 14 hours off after 24-hour duty periods) and even specified the timing of “strategic napping” in no uncertain terms (after 16 hours of continuous duty and between the hours of 10 p.m. and 8 a.m.).

While most residency programs chafed under the exhaustively detailed regulations, surgical training programs had particular difficulty adopting the new mandates. For nearly a century, surgical residency had been a period of both intensive experience and increasing responsibility under the guidance of more experienced surgeons. More recent research has affirmed that approach, demonstrating the strong link between a surgeon’s operative skill, the number of operations performed and patient outcomes. With limits set on their time at the hospital, young surgeons-in-training had fewer opportunities to care for patients or scrub in on operations. While previous generations of trainees had the luxury of participating in at least one operation a day, new trainees had only enough time to be involved in two or maybe three operations each week.

Calculating the number of hours “lost” by cutting back on in-hospital time, surgical leaders estimated that young surgeons-to-be were now missing out on as much as a year’s worth of experience”

She relies heavily on an new Annals of Surgery Article, wherein, as Chen reports,

“Researchers sent questionnaires to the directors of subspecialty fellowship training programs and asked them to comment on the bedside and operating skills of the young surgeons enrolling in their programs. These fellowships are a kind of high-level and often prestigious surgical “gap year” where young surgeons who have completed the basic five-year surgery residency can delay independent practice to pursue an additional year or two of training.

The results were abysmal. Fewer than half of the young surgeons could operate or make clinical decisions on their own. Nearly a third of them were incapable of performing even the most basic operations like a gallbladder removal on their own. And a quarter were unable to recognize the early signs of complications.

Even in areas of surgery where the young surgeons had had supplementary online learning modules during their residency, they performed poorly, with more than half unable to perform basic maneuvers.”

While acknowledging that “some observers have criticized the study for being self-serving – most respondents also noted that the young surgeons’ deficiencies resolved after additional training under their auspices —” Chen’s article reads largely as an attack on these new residency work hour rules.

Since I have written on the subject of these residency work hour rules with sleep specialists earlier this year in the Journal of Law, Medicine, and Ethics, it may be unsurprising that I take a somewhat different view.

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