… more or less
RYAN P RADECKI MD MS FACEP
@emlitofnote
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Probably Random Association Between Coffee and Health
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Kids Precisely Correctly, and We Should Do Better
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RYAN P RADECKI MD MS FACEP
@emlitofnote

OHSU Chair's Conference March 2017

Editor's Notes

  • #3 So, 2017 has been shaping up to be a great year! And what better way to celebrate international women’s day than to flash back to Hillary Clinton’s inauguration. It’s great to have a strong leader in this country who is so universally respected around the globe.
  • #4 And, of course, along with that Democratic landslide, we also see the gavel returned to Nancy Pelosi as speaker of the house, as you can see here being sworn back in.
  • #5 And look how happy Chuck Schumer is! The new Senate Majority Leader. Ready to get to work with Hillary and Nancy and continue many of the great works initiated by President Obama – most importantly, continuing to evolve and improve the Affordable Care Act.
  • #6 Because, we have a lot of work to do. Healthcare spending as % of GDP and on a per capita basis is, of course, totally out of sorts here in the U.S. Lots of countries are struggling with aging populations, increases in the costs of specialty drugs, but we seem to have it worse than most.
  • #7 Despite our initial attempts at healthcare reform, it is still quite the popular whipping boy of both health care policy pundits, and even mainstream physician authors like Atul Gawande. yes! American’ healthcare: OVERKILL
  • #8 So, perhaps, with our unified democratic government working together in perfect harmony, we can do something great – you know, like one of those scandanvian countries you’re always reading about – the perfect people with the perfect lives, wholesome blue-eyed children, playing with Legos, riding bicycles, and taking public transportation – and, of course, nationalized, high-quality healthcare. Single-payer, government run, devoid of the conflicts of interest with profit by insurance companies and the duplicative overhead.
  • #9 Or, something like the Swiss healthcare market, which is a sort of hybrid with insurance companies and a mandatory insurance purchase, but 90% of premiums go to services and the companies are not for profit.
  • #10 But, regardless, the unifying feature of these programs – the vast majority of single-payer or various community-solidarity programs – is their pursuit of high-value care – like the NICE offering guidelines in the United Kingdom.
  • #11 It’s going to take a lot of cultural transformation to continue to evolve our current system into something more resembling those higher-functioning systems, and to control our costs, but I’m sure our newly elected government is up to the task. So, I’m going to talk to you today about my experience in a value-based healthcare system – and someday… we can all go to the promised land together.
  • #12 YAY. Good times.
  • #13 Or, maybe, this what’s in store. It’s a little hard to tell exactly where this Republican ACA repeal/replace draft is going to end up, but it’s probably not a step forward towards the semi-idyllic future for which we were all hoping.
  • #14 Looking forward to a responsible, socially conscious system with – you’ve probably heard this term – is a lot more “individual responsibility”. You know, because that’s exactly what someone born into the NICU needs – more “skin in the game” as they say. But, dramatization aside, what is definitely the case – rather than everyone sort of contributing a fair portion to preserve our nation’s overall health – is our individuals patients will probably be responsible for paying for a greater percentage of their own care.
  • #15 There have been a few unambiguously true things Trump has said – ever. And, surprisingly enough, some have been about healthcare in America. It is “unbelievably complex”. Who would have thunked. But he also said, even after paying your premiums, you end up with such high deductibles, you effectively can’t use it.
  • #16 What do you think the average deductible is for a individual bronze plan on the marketplace? Over $6,000. For a marketplace family plan like this – over $13,000. People don’t have much in their savings – half of America has a “rainy day fund”, and the average dollar amount of that fund – $400.
  • #17 The point I’m trying to make – it isn’t just a nationalized healthcare system, or a Kaiser Permanente, or another innovative cost-sharing/risk-sharing setup that cares about controlling costs or value in healthcare. Our patients could in theory, increasingly be asking us about the care we give them with regard to cost.
  • #18 So who here has heard of Choosing Wisely? Cool. So this is put together by the American Board of Internal Medicine, and it essentially claims “to promote conversations between clinicians and patients by helping patients choose care that is: Supported by evidence, Not duplicative of other tests or procedures already received, Free from harm, Truly necessary” So this is for patients – and clinicians – to discuss things.
  • #19 Generally speaking, it’s a bit of a challenge to translate these into patient care. I certainly have never had a patient come in – and stop me if this sounds too fantastic – and say “oh, I hurt my back, it’s not getting better, but _definitely don’t do any imaging_”, or a parent say “can you try some oral hydration before putting in an IV?” or “can we not delay hospice involvement?” Where I’ve been able to use these, on the few occasions they’ve been relevant, is actually
  • #24 So they’ve checked – this an article in press talking about the original five recommendations … this is a survey they ran at ACEP Scientific Assembly, and they could tell from the survey instrument and the little clinical vignettes they gave which cases were part of the Choosing Wisely recommendations. And it seems like about reported it gave them some sort of backup regarding the use of these guidelines.
  • #25 Of course, self-reported attitudes and practices with regard to choosing wisely are one thing …. this looked at actual outcomes in an Anthem insurance database. They looked at 7 recommendations across several different specialties, both diagnostic testing and unnecessary treatment
  • #26 and …. flat. There are tiny absolute differences, but I don’t think there is any noticeable trend – and, even if there were, I’m not sure you could claim it weren’t confounded. This is just one cross-section of practice patterns, and it’s hard to generalize. But, people do _like_ Choosing Wisely.
  • #27 And it’s become trendy to critique healthcare resource utilization. Archives of Internal Medicine – now JAMA Internal Medicine – started a series led by Rita Redberg and one of her co-faculty down at UCSF to have recurrent publications in the realm of low-value care, over use, and overdiagnosis.
  • #28 One of the reasons why this has come out of UCSF – it’s sort of made an academic niche out of this topic. This comes out of JAMA from last week, it’s an QA for too much testing! Not a QA with patient harms or failing in some important therapeutic or diagnostic step, but because the house staff did too many lab tests. This is about a patient admitted to the medicine for sepsis, who ultimately where they ultimately did imaging and found cholecystitis and consulted surgery – but then the overnight house staff did a big autoimmune and serology workup on the elevated LFTs and consulted hepatology … and whole other big rabbit’s hole of other consults outside the scope of the current problem
  • #29 But, it’s not just UCSF … The BMJ has a series of articles called “Too Much Medicine” to go along with their partnering with a “preventing overdiagnosis” conference.
  • #30 And, like the Preventing Overdiagnosis conference, there’s another foundation called the Lown Institute that also addresses the same issues – their catchphrase being “RightCare”, again, trying to reduce the amount of harm done by testing and treatment compared with the absolute benefits.
  • #32 kaiser Wilhelm the first, king of prussia 1861, first german emperor 1871
  • #33 keyzer soze
  • #35 made his fortune paving roads in Cuba, bizarrely
  • #36 grand coolee dam
  • #37 sidney garfield’s little hospital - 5 cents a day
  • #38 and then, once the liberty ships ramped up, it was mega kaiser time … immediate membership of 20,000 patients, with first-aid stations, a local clinic, and a critical care hospital in oakland
  • #39 9.6 million members, $54.6 billion in revenue with a net income of $3.1 billion, with 177,445 employees - plus 17,791 physicians and that makes it the oldest, and largest HMO other prominent HMOs are Intermountain Healthcare in Utah and Idaho, geisinger health system
  • #40 but why is this the future of medicine? cost-certainty.
  • #41 fee for service is the traditional model hospital payments are sort of a hybrid – with diagnosis related group payments, you get the same payment for specific diagnoses, regardless of how much it takes provide that care … and HMO’s take that to the next level for maximum premium cost control so very little financial risk to you, but you get the ultimate in narrow networks so the organization can completely control every aspect of care. And that means doing more with less – optimizing the benefit to resource utilization ratio.
  • #43 But … where I really like to spend my time … both in my professional roles, in practice, and on the internet … is tearing apart bad science. Because, if you think about it, when we adopt practices that are inadequately tested, or inappropriately tested, where there is no benefit and only costs and harms … that’s the ultimate in low value care.
  • #44 This is a rather infamous article from a few years ago … and Vinay Prasad, you are lucky enough to have him here over in Hemeatology/Oncology … it is great fun to follow him on twitter because there’s no shortage of things that make him angry in healthcare, and he somehow spends every waking moment tweeting at folks. But his claim to fame is this article …. NEJM, Lancet, JAMA …
  • #45 Screened 2000 articles, some of which tested established medical practices … and found … half of those that came to a useful conclusion reversed the previous findings of benefit. Some debate from various specialty societies over individual recommendations and the scope of some reversals, but … a few examples ….
  • #46 trichomonas … it used to be thought pregnant women needed to be screened and treated for this, and, asymptomatic colonization treated with metronidazole …prevent LBW and preterm birth … turns out those pregnancies did worse. oops.
  • #47 Dopamine versus norepineprine – no, dopamine is actually not better for cardiogenic shock.
  • #48 swan ganz catheters were - and sometimes are - used ubiquitously despite frequently either failing to improve outcomes or actually leading to harmful interventions. up to 40% of ICU patients had them, 1.5 million a year.
  • #49 rhythm control for afib … not adverse effects from antiarrhythmetics actually decreased quality of life
  • #50 stenting for asymptomatic stable coronary disease … no advantage! 84,000 PCI procedures each year in patients without ACS, only have of which were clearly appropriate upon limited review.
  • #51 how about our own specialty? EGDT
  • #52 steroids in spinal cord trauma … I’m not old enough to have experienced this, but they apparently faxed out a practice alert to every emergency department across the country to tell them this was the new standard of care
  • #53 of course, that’s been contested, and most guidelines either say it is inappropriate or can be undertaken as an option only recognizing the serious harms from the trials
  • #54 except the cochrane review. you know, that otherwise trusted source for systematic reviews. What do they say?
  • #55 it says go go go!
  • #56 of course … this guy might have some professional bias in his reading of the strength of the evidence. so, whenever you have some controversial results … the easiest way to get a favorable review on Yelp here is to write it yourself!
  • #57 now, everyone in academia has pressure to published … so, even if you can’t be accused of having some sort of insidious agenda, there’s still an undercurrent of bias.
  • #58 some of this bias relates to our good friend, the arbitrary and misunderstood cruel god of statistical testing, the p-value. we’re all scientists. we all want our ideas to pan out. we all want to see our studies find that magical threshold of statistical significance testing.
  • #59 and, this is a cartoon and joke off the internet … but they’ve actually done systematic reviews of the p-value and found there’s a huge spike in reported p-values right around and below 0.5 … and hardly anything _just above_ 0.5. They’ve also even done qualitative studies looking at how people explain their not-quite-significant results, and they have every linguistic calisthenic of “trend towards significance” you can think of.
  • #60 and one of my favorite creatures of all time is the half-cat. the half-cat! out for a stroll … and picked up on google street view. how can you not appreciate the glory of the half cat. but, can this possibly be real?
  • #61 and to further belabor the point, i must submit you to _another_ cartoon … this time … about the sun exploding. This device will tell you if the sun has exploded! You know, in case there was some uncertainty standing on earth. But, it rolls two dice, and if it comes up two sixes, it lies. So, when it tells you yes ….
  • #62 … operating in a vacuum, it is a highly unlikely event that the machine would be lying to you. 1/36! 0.027, way below statistical significance. therefore, you can get this published - the sun has exploded. but the bayesian statistician says … wait a minute … what’s my pretest probability of sun exploding … and let’s convert this into a likelihood ratio, which is my preferred interpretation of interpreting p-values
  • #63 this is a great example from a Nature article on the irreproducibility of research …. you can see ….
  • #64 and that simple visual plays in beautifully to John Ioannidis’ essay …. where he has mathematically proven the likelihood of research findings and true relationships is rarely true – at least isolation. I’m not going to check his math, i’m going to take it on faith, but some examples ….
  • #65 take into account the random variations you’ve accounted for with your power calculation, the chance of different sorts of systematic bias throwing off your results, and the pre-study odds … he gives these various examples of how the best evidence can be fairly predictive – but not conclusive – you know, about the odds of trump winning the election on fivethirtyeight – but as your pretest decreases by being part of a data dredge, or your bias increases due to study design flaws, or your power decreases .. it’s unbelievable.
  • #66 And he demonstrates some of this in confirmatory work looking at similar things as Vinay Prasad, but also the magnitude of the change in effect size. This is what you would call regression to the mean – and he finds, of course, smaller studies with lesser power predicted greater effect sizes than their confirmatory studies, and matched control studies were more likely to have refutation when tested in well-designed studies.
  • #67 So, no, half-cat does not exist. It’s just a baffling piece of artwork that floats around on the internet.
  • #68 some of it is just outdated
  • #69 some of it is just outdated
  • #70 have you ever tried to go back and read the original literature regarding some of the things we do? obviously, we’ve asked more sophisticated questions about some things, and kayexalate is somewhat controversial, but there’s still a strong dogmatic element to it … this is a great study from the NEJM in 1961! 10 patients … 3 with sorbitol … 5 with kayexalate orally … 2 with enema. such statistical power!
  • #71 and of course there’s all sorts of extrapolation in their results … not to mention the bizarrely un-generalizable 500-700 mL of D50 or Karo syrup and ginger ale … and no medications or antibiotics would be suspected to affect gut function
  • #72 and the problem with some dogmatic things … is that if you never really test them, you never systematically identify the true balance of risk and benefits … and the incidence of, say, colonic necrosis
  • #73 Another problem is, of course, drug companies. Never forget these are for-profit companies. They are in business to return value to shareholders. Apparent charity or outreach that establishes goodwill with physicians or patients is only so we’ll cut them more slack the next time their product ends up killing us. The are out to wreck value-based healthcare as we see by testing the maximum of what the market will bear. And they are out to artificially inflate the value of their product.
  • #74 And this is something they overtly and intentionally do, and not even in the distant past.
  • #75 SSRI
  • #76 pfizer reboxetine - this is just 2010 we’re seeing this! this isn’t ancient history!
  • #77 Or how about Tamiflu. This was our largest outpatient drug spend from the Emergency Department at Kaiser a couple years back. It’s part of several nation’s strategic stockpiles in case of epidemic flu, to the order of hundreds of millions of dollars. Yet it took years of public shaming in the BMJ to get access to the clinical trial data underpinning treatment for an independent pooled analysis.
  • #78 And here’s the result! Whew, after all that, Tamiflu probably keeps people out of the hospital … or, you know, it has a trend towards working, with a 0.066 and biological plausibility. Oh, wait, that’s not the independent meta-analysis … that’s the so-called independent meta-analysis, funded by a shadow corporation involved with strategic marketing for pharma.
  • #79 There’s the analysis by the folks who demanded to see the trial data. And _their_ analysis shows no difference. Why? Because they read the original paper study reports and came up with slightly different numbers – and when there are only a handful of events one way or the other to tip the scales. Who is right? Can we ever really know for sure? Shouldn’t we know for sure before we use so much Tamiflu? Just think of all the vaccines we could buy for folks … or other critical medications that could help so many people struggling to afford healthcare ….
  • #80 This old paper doesn’t actually demonstrate anything insidious – but it’s a fantastic example of publication bias. You see, this article was published in 1993 … but actually about a trial in the 1980s. Back then, they believed if you could prevent malignant arrhythmias like vTach from occurring after a heart attack, survival would improve. They did a little trial of a class 1C drug … and it worked! At least at preventing arrythmias. They tried to publish … no one cared. So the data about 9 deaths vs 1 death stayed buried forever.
  • #81 Pradaxa…. NO REGULAR BLOOD TESTS
  • #82 of course, the company had all sorts of internal data on contributors to variability in drug levels, even down to specific alleles that decreased its anticoagulant effect … and that there really _could_ be a benefit from occasional testing. But that’s not what the marketing department wanted.
  • #83 And so they had to settle a $650 million lawsuit
  • #84 Sometimes it’s not overtly pharma This is just a review of FDA letters of concern
  • #85 death during trials, records falsified to hide … the investigator was sentenced to over 5 years in prison … but the publications regarding the trial in question make no mention of such
  • #86 36 sites in china. running trials is a big business into itself …and running them in places like china, where it can be done more cheaply, is equally a big deal, so the people running the trial have a vested interest in a happy customer. they found all sorts of irregularity
  • #87 A great source for keeping tabs on all this irregularity is retraction watch …. even got a MacArthur Grant
  • #88 It’s just about … retractions. This is a pretty common reason. Fake peer review! People would register as reviewers under different names, review their own articles, get published ….
  • #89 retractions are also reversals … this is part of the open data revolution being pushed by the BMJ Paxil
  • #90 Fabricated data, again, torpedoing a paper and a three-year clinical trial in JAMA – so it’s not just obscure journals with low standards ….
  • #91 Fake news! Medicine style … sort of. The number of articles published by predatory journals spiked from 53,000 in 2010 to around 420,000 in 2014, appearing in 8,000 active journals. By comparison, some 1.4-2 million papers are indexed in PubMed and similar vetted databases every year.
  • #94 Alltrials
  • #95 BMJ open data
  • #96 YODA
  • #97 Of course, to some – even though the great service of the trial volunteers is best celebrated by using their data to the maximum benefit and confirmation … jeff drazen, the editor in chief of the NEJM, made the poor word choice as to call people doing re-analyses “research parasites”
  • #98 Which quickly became the source of a lot of ridicule
  • #99 The problem is, a lot of the time, after something erroneous … or fraudulent … or overhyped prior to being fully tested … has been published, it gets picked up in press releases and – you know it goes viral and stuff. snapchat or vine or whatever it is tweens use.
  • #100 And newspapers love to publish sensational things … this analysis found only half of the initially published primary reports were eventually confirmed by subsequent study … and of these 34 studies that were later found to be less reliable, there were 234 articles generated the first time around, but only 4 covering the reversal ….
  • #101 so when you see things like this … how many times have we seen a study with coffee? it either kills you or it saves you. But that’s the headline you’ll click on …
  • #102 Not this one.
  • #103 Or this one, relatively recently published …
  • #104 a study that had NOTHING to do with actual overdoses or in which any children were actually harmed
  • #105 Or, every time there’s a meeting and someone presents an abstract … the breathless coverage … maybe you can find alzheimers by spitting!
  • #106 CLICKBAIT
  • #107 So, of course patients expect miracles. Think about how medicine is marketed to them in the news, the trade advertising, or on TV – the survival rate from CPR is close to 50% on television. So, of course when you systematically pool all the studies regarding patient perceptions of outcomes, they more frequently expect benefits greater than the true benefit – and fewer harms.
  • #108 But you can’t just blame or mock patients – surprisingly enough – or perhaps not so surprising after seeing how the literature and evidence are so easily warped – clinicians are almost as bad. They also consistently overstate the expected benefits from treatments, although, interestingly enough, they are almost as likely to overstate the harms as understate them.
  • #109 For example, when they do studies of risks and benefits for common treatments ….
  • #110 like preventing heart attacks with antihypertensives, preventing strokes, etc. … they almost universally overstate the benefits, and sometimes they’re way off! – although, this survey includes residents. and, again, can you really blame them? the whole system is geared towards reporting positive findings, overstating value, and throwing off the entire equation
  • #111 But, then, even after we’ve gone through the entire process of medical reversal – we still don’t stop doing things we’re not supposed to.
  • #112 This is Ionnidis again … once upon a time they thought Vitamin E conferred cardiovascular benefits – a couple very favorable epidemiological studies around 1993 …. it took seven years for the well-designed randomized controlled trials to be performed – and then, even when this paper was published in 2007, papers were still favorably citing the lower quality research rather than the high quality RCTs.
  • #113 so. well. i hope this has been the best kind of lecture – instead of clearly telling you something you can use on your next shift, i hope i’ve imparted some vague sense of dread that will haunt you forever – about how hard it is to provide value to our patients in health care because it’s so hard to actually know what’s _right_.
  • #114 we need to be better doctors. we need to be better researchers and consumers of medical evidence. we need to be better administrators of health coverage. we need the media to report more accurately – ha! and in the end it’s all about how do we serve our patients best – preventing overdiagnosis, delivering the right care at the right time, getting the most out of our finite resources.
  • #115 and now, let’s discuss!