Sequels generally disappoint. Jason couldn’t match the fear he generated in the original Friday the 13th. The sequel to the Parachute, a satirical piece canvassing PubMed for randomized controlled trials (RCTs) comparing parachutes to placebo, matched its brilliance, and even exceeded it, though the margin can’t be confirmed with statistical significance. The Parachute, published in BMJ’s Christmas edition, will go down in history with Jonathan Swift’s Modest Proposal and Frederic Bastiat’s Candlemakers’ Petition as timeless satire in which pedagogy punched above, indeed depended on, their absurdity.
In the Parachute, researchers concluded, deadpan, that since no RCT has tested the efficacy of parachutes when jumping off a plane, there is insufficient evidence to recommend them. At first glance, the joke was on RCTs and those who have an unmoored zeal for them. But that’d be a satirical conclusion. Sure, some want RCTs for everything, for whom absence of evidence means no evidence. But that’s because of a bigger problem which is that we refuse to acknowledge that causality has degrees, shades of gray, yet causality can sometimes be black and white. Somethings are self-evident.
In medicine, causation, even when it’s not correlation, is often probabilistic. Even the dreaded cerebral malaria doesn’t kill everyone. If you jump from a plane at 10, 000 feet without a parachute death isn’t probabilistic, it is certain. And we know this despite the absence of rigorous empiricism. It’s common sense. We need sound science to tease apart probabilities, and grayer the causality the sounder the empiricism must be to accord the treatment its correct quantitative benefit, the apotheosis of this sound science being an RCT. When empiricism ventures into certainties, it’s no longer sound science. It is parody.
Historically, the Centers for Medicare & Medicaid Services’ (CMS) stance on the influence that social determinants of health (SDOH) have on health outcomes has been equal parts signal and noise. In April 2016, the agency announced it would begin adjusting the Medicare Advantage star ratings for dual-eligibility and other social factors. This was amid calls for increased equity in the performance determinations from the managed care industry. At the same time, CMS continued to refuse risk-adjustment for SDOH in the Hospital Readmissions Reduction Program (HRRP) despite the research supporting the influence of these factors on the HRRP.
It wasn’t until Congress interceded with the 21st Century Cures Act that CMS conceded to adjusting for dual-eligibility under the new stratified approach to determining HRRP penalties beginning in fiscal year 2019. The new methodology compares hospital readmission performance to peers within the same quintile of dual-eligible payer mix. The debate surrounding the adjustment of incentive-based performance metrics for SDOH likely is to continue, as many feel stratification is a step in the right direction, albeit a small one. And importantly, the Cures Act includes the option of direct risk-adjustment for SDOH, as deemed necessary by the Secretary of Health and Humans Services.
SDOH are defined as “the conditions in which people are born, grow, live, work and age.” The multidimensional nature of SDOH reach far beyond poverty, requiring a systemic approach to effectively moderate their effects on health outcomes. The criteria used to identify SDOH include factors that have a defined association with health, exist before the delivery of care, are not determined by the quality of care received and are not readily modifiable by health care providers.
The question of modifiability is central to the debate. In the absence of reimbursement for treating SDOH, providers lack the resources to modify health outcomes attributable to social complexities. Therefore, statistical adjustments are needed to account for differences in these complexities to ensure risk-adjusted performance comparisons of hospitals are accurate.
There was a very sobering piece in NEJM by the FDA last month in which the authors try to explore what went wrong with the Keynote-183, Keynote-185 and checkmate 602 trials testing PD-1 inhibitors combinations with pomalidomide or lenalidomide and dexamethasone in multiple myeloma. Interim analysis of Keynote 183 and 185 revealed detrimental effects on overall survival (OS) with hazard ratios of 1.61 and 2.06, not explained by differences in toxicities alone. The checkmate 602 trial was also halted in light of these findings and also showed higher mortality in the nivolumab combination arm.
In the thoughtful NEJM piece, the authors make at least three important points. First, they question why these PD-1 inhibitors were tested in combination despite their having limited single-agent activity. In fact, a couple of years ago, Vinay Prasad and I asked the same question: why are novel cancer drugs being tested in combination despite having limited activity as a single agent? We found that these drugs, even when ultimately approved, provide relatively low value and recommended that drugs with poor single agent activity not be tested in combinations unless there are specific reasons to expect synergy.
The second important point in the article is that many cancer drug approvals are lately based on durable response rates in single arm trials without a control group, a situation in which it is difficult to evaluate the safety and efficacy of drug combinations. Indeed, without an RCT, the oncology community would never have known these signals of detrimental effect. If the FDA had approved these PD-1 inhibitors in multiple myeloma on the basis of non-randomized trials, which it often does in other oncology contexts, who knows how long it would have taken to recognize the increased mortality in patients—and at what cost. This is another reason why we need RCTs more now than ever. Finally, the authors point out that these PD-1 inhibitors in multiple myeloma were directly advanced to phase 3 trials after phase 1 trials were completed, without phase 2 information. Indeed, in a recent paper, Alfredo Addeo and I showed that a substantial percentage of drugs that fail in phase 3 trials do not have supporting phase 2 data. Continue reading…
Much of the media coverage following the high-profile suicides of Kate Spade and Anthony Bourdain has followed recommended best practices to reduce risk of suicide contagion or “copycat” suicides by including warning signs a person may be at risk of suicide due to depression and contact information for the national hotline for suicide prevention. This overly simplistic approach implies that we can prevent all suicides by reaching out to loved ones in emotional distress and advertising the existence of mental health treatment.
As a psychiatrist who treats individuals hospitalized for acute suicide risk, I am concerned that much of the media coverage has belied the complexity of suicide. While we do not yet fully understand why suicide rates are rising, we do know that suicide is a complex public health problem that will require a multifaceted approach to reduce deaths. Increased awareness of depression as a treatable medical illness is an important but insufficient response to the suicide epidemic.
When it comes to health care prices, the burden piled on payers can seem almost cartoonishly heavy. News stories on the state of the industry read as though some satirist decided to exaggerate real systemic flaws into cost-prohibitive fiction. A particularly painful example hit the presses earlier this year, when a writer for Reuters revealed that the cost of a full course of oncology treatment skyrocketed from $30,447 in 2006 to $161,141 in the last few years. The change was so unbelievable as to verge on dark comedy — but there isn’t much to find funny in the situation when lives and health outcomes are on the line.
For the average employee in my home of Silicon Valley, the price crunch is challenging regardless the size of your paycheck. For local employers, however, the dilemma can be even more pointed. Today, employees of companies, large and small, expect their employer to provide comprehensive health care benefits and are largely unaware of or insensitive to the factors exacerbating market problems today. Providing these benefits, however, is easier said than done.
Employers and insurers alike face a multitude of barriers to connecting employees with affordable care. Recent research suggests that prices will increase at an average clip of 5.8% annually between now and 2024, well above the expected rate of inflation. Even worse, the increased consolidation of healthcare providers has drastically undermined the negotiating power that payers would otherwise have in more competitive markets. In Northern California, for example, major health systems, including Sutter Health, sparked outrage and protest as they have managed to amass enough of the region’s hospitals, outpatient facilities, and primary care offices to diminish regional competitors and set what many view as unacceptably high rates — all the while knowing that the lack of local competition makes it challenging for the major health insurers to push back.
Today, we are featuring Dr. Jesse Ehrenfeld from the American Medical Association (AMA) on THCB Spotlight. Matthew Holt interviews Dr. Ehrenfeld, Chair-elect of the AMA Board of Trustees and an anesthesiologist with the Vanderbilt University School of Medicine. The AMA has recently released their Digital Health Implementation Playbook, which is a guide to adopting digital health solutions. They also launched a new online platform called the Physician Innovation Network to help connect physicians with entrepreneurs and developers. Watch the interview to find out more about how the AMA is supporting health innovation, as well as why the AMA thinks the CVS-Aetna merger is not a good idea and how the AMA views the role of AI in the future of health care.
Zoya Khan is the Editor-in-Chief of THCB as well as an Associate at SMACK.health, a health-tech advisory services for early-stage startups.
I have seen the light. I now, finally, see a clear role for artificial intelligence in health care. And, no, I don’t want it to replace me. I want it to complement me.
I want AI to take over the mandated, mundane tasks of what I call Metamedicine, so I can concentrate on the healing.
In primary care visits in the U.S., doctors and clinics are buried in government mandates. We have to screen for depression and alcohol use, document weight counseling for every overweight patient (the vast majority of Americans), make sure we probe about gender at birth and current gender identification, offer screening and/or immunizations for a host of diseases, and on and on and on. All this in 15 minutes most of the time.
Never mind reconciling medications (or at least double checking the work of medical assistants without pharmacology training), connecting with the patient, taking a history, doing an examination, arriving at a diagnosis, and formulating and explaining a patient-focused treatment plan.
Today’s health care providers face the formidable challenge of delivering better, more affordable and more convenient care in the face of spiraling care costs and an epidemic of chronic disease. But the most innovative among them are making encouraging progress by “integrating”—which in this context means working across traditional boundaries between patients and clinicians, health care specialties, care sites and sectors.
The impulse to do so is shrewd, according to our innovation research in sectors from computer manufacturing to education. We’ve found that when a product isn’t yet good enough to address the needs of a particular customer segment, a company must control the entire product design and production process in order to improve it. This is necessary because in a “not-good-enough” product, unpredictable and complex interdependencies exist between components, so each component’s design depends on that of all the others.
Given this, managers responsible for the individual components must collaborate—or integrate—in order to align components’ design and assembly toward optimal performance. IBM employed an integrated strategy to improve performance of its early mainframe computers, and this enabled the firm to dominate the early computer industry when mainframes weren’t yet meeting customers’ needs.
In health care delivery, such integration is analogous to, but something more than, coordinated care. It means assembling and aligning resources and processes to deliver the right care, in the right place, at the right time. This type of integration is a core aspiration of innovative providers leading hot-spotting and aging-in-place programs, capitated primary care practices, initiatives addressing health-related social needs, and other care models that depart from America’s traditional, episodic, acute-care model. How are they tackling it? They’re leveraging very specific tools to facilitate work across boundaries. Here are six of the most common we uncovered in our research:
In this episode of Firing Line, Saurabh Jha (aka @RogueRad), has a conversation with Professor Brian Nosek, a metaresearcher and co-founder of Center for Open Science.
They discuss the implications of this study, which showed that there was a range of analytical methods when interrogating the database to answer a specific hypothesis: are soccer referees more likely to give red cards to dark skinned players? What is the significance of the variation? Does the variation in analysis explain the replication crisis?
Consumers aren’t taking their healthcare providers’ words for it anymore. They’re taking charge and leading a digital revolution where individuals have the power to make their own educated decisions about care.
According to the Healthcare Consumer Insight & Digital Engagementreport by Binary Fountain, a leading online reputation management platform, 51 percent of people who have a physician share their personal healthcare experiences via online ratings, review sites and social media.
Once shared, this information is immediately available to the entire world with just the click of a button. And people are taking full advantage of this. In fact, 80 percent of respondents in the 2018 Customer Experience Trends in Healthcare report by Doctor.com have used the internet to make a healthcare-related search in the past year. Another 81 percent said they read reviews about a referred provider.
Consumers’ accessibility to detailed, personalized experiences could make or break medical sales companies. Unfortunately, if these trends aren’t addressed appropriately, medical sales teams around the country will feel the impact.
By further empowering the general public, medical sales leaders can give their teams the tools needed to excel in the field. Here’s how:Continue reading…