Vol. 219 October 1, 2019 Vitamin D Supplement; Take It or Leave It?

October 1, 2019

Ever since the French sailors, weakened by scurvy, lost control of the seas to the British navy which was scurvy-free by vitamin C in the lime juice added to their daily ration of grog (hence the name “Limeys”), vitamins have been a subject of great interest and, even now, a lot of mystery. Everyone agrees that a little bit of them is essential for good health, but even two-time Nobel Prize winner Linus Pauling couldn’t convince all of us that a lot of vitamin C  could cure a cold. (1)

Vitamin D is currently the most popular vitamin to study because of some past research suggesting that vitamin D protects us from heart disease, particularly the elderly. A 2012 survey reported that about 20% of respondents were taking vitamin D supplements (multivitamin supplements were not included).  Supplemental vitamin D AND supplemental calcium have long been touted for preventing loss of bone density, or osteoporosis, especially in post-menopausal women. 

It is clear that Vitamin D deficiency can cause growth retardation and bone disease, particularly in the first years of life. It is a bit unclear as to how much of vitamin D we need. The American Academy of Pediatrics recommends vitamin D supplements of 400 units a day for breast-fed babies. Recommendations for minimum doses in other than infants range from 400 units to 2000 units a day. It is said to be almost impossible to be “vitamin deficient” on a normal diet nowadays, but certain very restricted vegan diets can cause some problems in rare cases.  Also, studies of Northern urban  children (less sun exposure) revealed “low” Vitamin D blood levels which stirred up a lot of discussion about its significance and about “what level was normal”. Too much of most vitamins can’t really hurt you too much. Most “excess” of vitamins ingested ( the amount over the minimum required to prevent a deficiency disease)  just ends up in the toilet via your urine.

A recent systematic review of a large number of peer-reviewed research studies on the use of supplemental Vitamin D to reduce the risk of cardiovascular disease was recently published. (2) This meta-analysis (our trade name for such huge reviews) of 21 randomized clinical trials with over 83,000 participants (mean age, 65) followed for 1 to 12 years showed that using a variety of Vitamin D supplements did NOT lower the risk for myocardial infarction, stroke, cardiovascular-related deaths, or all-cause deaths. This is “the best evidence to date that fails to support use of vitamin D supplementation for lowering cardiovascular risk.” (3)

Of course, the results of that meta analysis was muddied just a bit by another meta analysis of 52 clinical trials with over 75,000 participants (mean age, 74) with 1 year follow-up which showed that Vitamin D supplements was associated with 4 per 1000 persons fewer deaths from cancer in a small sub-group of participants. (4)  To further confuse the issue, it was noted that this small but significant difference occurred in only those people taking the D³ form of oral Vitamin D, not those taking the D² form. But, this review also revealed no cardiovascular benefits.

What about effects of vitamin D supplements on bone-density? If the recommended daily dose of vitamin D is from 400 to 2000 units, what if we took twice that? About 3% of U.S. adults take over 4000 units of vitamin D daily. A Canadian randomized study of 311 adults with pre-study normal vitamin D blood levels took either 400, 4000, or 10,000 units per day of supplemental vitamin D for three years.  Bone density actually DECREASED in those taking the higher doses. Also, the vitamin D blood levels in those taking the 400 units (recommended minimum) did not increase above normal. “The findings point to no benefit for bone integrity—and even harm—with high dose vitamin D supplementation in patients with adequate vitamin D blood levels.” (5) 

In today’s blog I offer evidence-based skepticism about the benefits of both vitamin C and vitamin D supplements. In my last blog I cautioned against vitamin E . . .at least the inhaled form. Is there a vitamin F supplement to continue my progression? Yes, there is! Vitamin F is an outdated term for omega-3 and omega-6 fatty acids,  but I think I’ll let that subject “sleep with the fishes” for the moment.

References
1. “Vitamin C and The Common Cold”, Linus Pauling, 1970 and 1976.
2. JAMA Cardiology 2019 Aug; 4:765
3. NEJM Journal Watch cardiology,vol.39, Oct. 2019)
4. NEJM 2019;380:33
5. JAMA 2019Aug27;322:736

 

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Vol. 218 September 15, 2019 Vaping and Fatal Pneumonia

September 15, 2019

“The rise in vaping-associated illness is a frightening public health phenomenon.”

– Andrew Cuomo, NewYork Governor

 

Severe pneumonia in over 400 people, including 10 deaths, in 36 states have been associated with vaping certain products. The CDC is investigating the phenomenon as a mysterious, previously unrecognized epidemic. Patients from 18 to 88 years of age have been arriving at Emergency Rooms with severe shortness of breath, cough, little or no fever, and a chest Xray with markedly abnormal diffuse infiltrates. Blood cultures show no bacteria, and the response to the usual antibiotics is sluggish or absent. Some patients require intubation and artificial ventilation in order to maintain oxygenation of their blood. A few die. All have a history of vaping, most often using flavored vaping solutions purchased “on the street” or over the internet, i.e. not from licensed vape shops.

The speculation at this point is that flavored vaping solutions have additives that are causing this illness.  The current focus is on Vitamin E oil, added to flavored vaping solutions as a thickening agent. Vitamin E is well recognized as a beneficial skin emollient and an oral nutrient supplement, so it sounds harmless and enjoys a “good-health” reputation. It is inexpensive and readily available, so is a “logical” additive for cheaper, unlicensed vaping solutions sold on the black market (“street-made”) and the internet. The street vendors use the cheaper additives to cut the expensive THC oil and make more profit per vaping cartridge.

In an e-cigarette the Vitamin E oil is heated up and vaporized by a battery-fed hot wire, and the vapor is inhaled. As the temperature of the Vitamin E oil vapor lowers to the normal body temperature of 98.6 degrees Fahrenheit the Vitamin E vapor in the lungs reverts to its liquid form, oil. Any form of oil is extremely toxic to lung tissue. Just ask any physician who has dealt with a patient with oil-aspiration pneumonia, sometimes called “lipoid pneumonia“. The first case report of lipoid pneumonia after vaping was actually reported in 2015 in the journal Chest  as a unique, interesting, never-before seen case of a 31 yo. West Virginian woman who required intubation in the ICU after presenting to the ER in severe respiratory distress after vaping.

There are so many additives in vaping solutions that it is not absolutely certain that Vitamin E oil is the culprit, but some of the counterfeit vaping solutions used by recent respiratory-distress patients contained more than 50% Vitamin E oil!  A 2015 Harvard study that tested 51 of 7,000 vaping solutions found Vitamin E oil in all the flavored ones, and it commented on the potential dangers of inhaling flavored vaping solutions. None of the vaping solutions containing “only” nicotine  or marijuana (THC) contained Vitamin E oil. By the way, the FDA and the various state cannabis commissions have NO idea of the ingredients and additives in vaping solutions. There are currently NO regulations requiring the listing of vaping solution ingredients, even those sold in licensed vape shops. “The cannabis commission does not regulate the ingredients in licensed marijuana stores’ vape cartridges. . . Licensed producers can source their ingredients from anywhere.”

As an aside, this reminds me of a story told by my cousin, a biochemical Ph.D candidate in the 1960’s researching how chlorophyll (the green substance) carried on photosynthesis. In his chromatographic analysis of all sorts of substances, including tobacco, he determined that Marlboro cigarettes had no tobacco in them. They appeared to be made of cabbage leaves infused with nicotine. Incensed (he was a smoker), he wrote an emphatic letter to the company documenting his findings and scolding them for false advertising.. The company’s response was a polite letter pointing out that at no time did they claim in their ads that their cigarettes had any tobacco in them, that they merely promised a smooth taste  . . .and “good luck on your quest to synthesize an artificial chlorophyll.”

The CDC is foraging ahead aggressively with detailed investigations, state legislatures are composing all sorts of ingredient disclosure laws for vaping manufacturers, and, I am sure, many personal injury lawyers are trolling for potentially lucrative suits. In the meantime, I think it would be the better part of valor if everyone stopped vaping until the dust . . . er . . . the vapor settles. Who would guess that we would ever say, “It appears to be much safer to just smoke a joint!”


Vol. 217 September 1, 2019 Understanding Medical News of Famous People

September 2, 2019

David Andrews, veteran center for the New England Patriots, and Ruth Bader Ginsburg, veteran Supreme Court Justice, have both been in recent newspaper headlines (in different sections of the paper, of course) due to their new medical diagnoses, “clots in the lung” for Andrews and “pancreatic cancer” for RBG. Most articles devote significant space to speculation about their prognoses, i.e. when can Andrews return to play in the NFL and will Ginsburg outlast Trump’s presidency? Why do the answers seem so elusive, and almost always end up with “it depends”?

 

“Clots in the lung” are pieces of blood clots that travel through the blood steam after breaking off from blood clots in the legs (deep vein thrombosis or DVT). In the lungs the clots can clog or drastically slow down the flow of blood through lung vessels and is called pulmonary embolism (PE). PE may often produce no symptoms or cause chest pain, cough, difficulty breathing, and sudden death.

PE is treated with so-called “blood thinners” aiming to reduce the risk of more emboli traveling to the lungs. Neither of the two classes of anti-coagulation drugs actually thin the blood. Both interfere with the multiple steps of coagulation needed to form a clot, thus reducing the chance of more pieces of clot breaking off and traveling to the lungs.

How long is drug treatment necessary? It depends. The shortest duration of 3-6 months is recommended for “provoked” PE, an embolism from a leg or pelvic clot provoked by an injury, surgery, infection, cancer, or other recognizable event. An “unprovoked” PE, one without a recognizable event, is usually treated for longer periods.

It is probable that Andrews’ PE was related to a football injury, a “provoked” PE, so that anti-coagulation treatment will last for at least 3-6 months. Hence he is out for the season, since it would be dangerous for him to play football with an intentionally defective blood clotting mechanism. If his PE was not the result of an injury, then it was “unprovoked” and treatment duration may be even longer.

RBG just completed treatment for her third bout of cancer. She was treated for colon cancer in 1999, “early” pancreatic cancer in 2009, and a cancer in her lung was surgically removed in December of 2018.  This recent treatment consisted of 3 weeks of highly focussed radiation to a small malignant mass in the part of the pancreas (the “head”) that surrounds the bile duct that goes from the liver to the small intestine. A stent was placed in the bile duct presumably because even this highly focussed radiation could cause the duct to swell and obstruct resulting in her becoming jaundiced. Her doctors did not identify the mass as colon, lung, or pancreatic cancer, but reported that it was localized with “no evidence of cancer elsewhere”.

That last bit of news is significant since the prognosis of pancreatic cancer depends on the stage of disease, from 1 to 4. Stage 1, local disease, has a 5 year survival rate of 12-14% while Stage 4, widespread disease, has a 5 year survival rate of 1%. Survival rates are statistics based on the outcomes of hundreds of patients and can not be reliably applied to an individual patient. RBG has especially proved that herself. In a recent interview RBG remarked that “a certain Senator who predicted my early demise after my 2009 diagnosis of pancreatic cancer is now dead himself while I’m still alive.”

Because of the fallacy of applying the mortality statistics of hundreds of patients to an individual, the honest doctor realizes that a prognosis often can not be given accurately. That knowledge is also colored with the emotion of difficulty breaking bad news. One study showed that only about 37% of oncologists were able to give an “honest” prognosis to a cancer patient under treatment. When the doctor did give a prognosis, it was often overly optimistic. 

So, what is the prognosis for Andrews and Ginsburg? It is relatively save to say that Andrews will not play NFL football this season and that Ginsburg, a champion statistic outlier for 86 years, will probably be sitting on the bench when the Supreme Court resumes in October. After that, who knows what will happen. The doctors may guess, but they don’t know either.


Vol. 216 August 1, 2019 Parenting Choices and Other “Conventional Wisdoms”

August 1, 2019

 

The evidence supporting some of our most popular opinions is often not so compelling.

 

In 2015 31% of first time mothers were over 30 years old. In 1980 it was 8.6%, and it is safe to assume that those 2015 first time mothers got more of their parenting advice from the internet rather than from an experienced grandmother. One of those first time mothers, an economics professor at Brown, has written a book examining the presence, or absence, of real data on the conventional wisdom surrounding breast feeding, sleep training, and working mothers.

Breast Feeding
According to Emily Oster in her book Cribsheet, the current mantra is that it is best to breast feed your infant: it is easy to do, produces smarter babies with less diarrhea and ear infections, and makes “happier moms with better friendships”. In reviewing the evidence on the internet she notes that breast-fed babies in many of the observational studies of breast feeding are generally being fed by a mother with a higher IQ and in a higher educational and economically class than non-breast feeding mothers. “So which is the cause?” The difference in ear infections in one very large study was 2%. The difference in diarrhea episodes was 4%. One study of siblings, one breast fed and one not, found no difference in IQ or incidence of obesity at 6 1/2 years of age. Her conclusion: “The good news for guilt-ridden moms [who don’t breast feed their infant] is that there is very little evidence for long term effects [of not breast feeding]. Moms often feel selfish about thinking about their own wants and needs with decisions about their kids. In this case, the data gives you permission to put yourself first for once.”

Sleep Training
The internet is apparently full of stories of the extensive long-term damage to your infant if you let them “cry it out”, the code word for “sleep training”. This is apparently based on 1980s studies in orphanages in Romania. Dr. Ferber’s careful studies of sleep training and in 1986 outlined in detail how to do it. (“Ferberizing”)(1) Many studies of sleep training show sizable improvements in maternal depression, family functioning, and no negative effects on infants. But, one small study quoted all over the internet suggested that more stress was demonstrated by the infants a few weeks after sleep training even though the mothers were less stressed. Her conclusion: “Every family is different, and you may not want to let your baby cry. But if you do want to sleep train, you should not feel shame or discomfort about that decision.” ( Since it might take two or three nights to train the infant, I suggest to apartment dwellers to let the neighbors know what you are doing.)

Working Moms

In our pediatric practice we use “SAH” to describe the non-working mom as “stay-at-home”. Also for the non-working dad, but Oster restricts her discussion to the moms. She notes that there is very little data about the pros and cons of mothers working outside the house except for the evidence supporting longer maternity leave which is beneficial to mother and infant in those first months. Like other working parents I have observed, Oster finds that the switching back and forth from work mode (academic research) to child-care mode and back again can be satisfying (she uses the economic term: “marginal value”) as a change of pace that can reduce boredom and fatigue. The economic value of working outside the home is clear. Her conclusion: “Do whatever fits your family best.”

Oster relates that after she had unloaded a lengthy, multi-faceted, escalating stepwise concern to her pediatrician about what to do if her non-allergenic 2 year old child was stung by a bee on an upcoming vacation trip, she responded, “Hmm. I’d probably just try not to think about it.”

That reminds me of the old story of the 100-leg caterpillar merrily progressing along a road when a fly asked him how he coordinated all those legs. The more the caterpillar thought about it the more entangled his legs became, and he ended up curled up in a ball in the gutter.

Who Are the Real Screen Addicts?
Nielsen research found that Americans aged 35 to 49 used social media 40 minutes MORE each week than those aged 18 to 34. They were more apt to pull out their phones at dinner and spend more time on multiple devices, but they peeked at their phones while driving LESS than millennials. One researcher reported that her interviews of elementary school kids about screen times sometimes indicated that “Parents are the worst.” (2)

Stand or Sit At Work?
The 2015 studies suggesting that sitting for prolonged periods increased your risk of cardiovascular disease spawned a widespread wave of popularity for “standing desks”, but repeat analysis of the data indicated that alternating standing and sitting “may be useful for some people with low back or neck pain . . .but there is no scientific evidence for improved cardiovascular health”. (3)

References:
1.
Solve Your Child’s Sleep Patterns, Richard Ferber, MD, 1986 and revised 2006
2.
Wired, April 2018, pg. 67
3.
This Week, December 7, 2018, pg. 20


Vol. 217 July 15, 2019 NON-POLITICAL TIDBITS TO START CONVERSATIONS AT SUMMER COOKOUTS

July 15, 2019

READING TO CHILDREN: PRINT OR ELECTRONIC?

The prevalence of electronic media has spawned a number of pediatric studies of video gaming, use of smartphones, effects of media on learning, etc. A recent small study of 37 toddlers being read to by a parent using 3 book formats (print, basic electronic, and enhanced electronic – included animation and sound effects) showed some differences in interactions between parent and toddler. Parents showed twice as much dialogue with the child while reading print books than basic electronic. Interestingly the use of the enhanced electronic books came in third. Toddler book-verbalization was slightly higher when being read print books. (1)

These study result is certainly no blockbuster, but the authors opined that reading print books slightly increased “positive interactions between child and parent” and slightly decreased negative directions (“don’t touch that button”). With electronic media parents commented less about the story line and read the text out loud less often. At least one reading specialist I know and discussed this study with plans to continue her own reading on Kindle (even though she easily loses track of the book’s title) and will continue to use electronic media in her reading recovery work with elementary school children.

AN ANTI-CANCER VACCINE THAT IS REALLY EFFECTIVE

HPV (human papilloma virus) is the leading cause of cervical cancer and is sexually transmitted. The HPV vaccine (Gardasil), if administered prior to sexual activity, can prevent the asymptomatic, silent infection by HPV that can lead to cervical cancer or genital warts later on. The vaccine has not been around long enough to show a lowering of actual cervical cancer rates, but a Canadian study showed a 83% decrease of HPV presence among girls aged 13 to 19 since 2006 when the vaccine was introduced. the authors consider this result as “a first sign that vaccination could eventually lead to the elimination of cervical cancer as a public health problem.

LESS THAN 10,000 STEPS A DAY IS OK

A  Harvard study gave fitness trackers to 16.000 women over 62 yrs. old, counted the number of their steps for 7 days, and then monitored their health for 4 years. Those walking 4,400 steps a day had a lower “premature death” rate than those walking 2,700 steps a day. Those walking more than 4,400 steps only had a moderate additionally decrease in death rate and there was no advantage for taking over 7,500 steps. Where did the 10,000 steps a day target come from?— a 1960 marketing campaign by a Japanese pedometer manufacturer that recognized that the Japanese character for 10,000 resembles a man walking! (2)

TASTE?— THERE’S AN APP FOR THAT

IBM is developing a flavor-identifying device (“e-tongue”) which when dunked into a glass of liquid will analyze the composition of the liquid using an array of electrochemical sensors. The data is then sent via the cloud to an artificial intelligence program that compares the composition to a database of known liquids. It is currently able to accurately distinguish between different brands of water, identify counterfeit wines and whiskeys. 

The speculation about the potential medical use for dealing with unsavory biological fluids reminds me of the old, old story about the medical school professor showing the class how to diagnose a diabetic by tasting the sugar in their urine. After demonstrating by dipping his finger into the cup of urine and tasting it, he instructed the class to come up one at a time and do the same, so they would learn how it worked. It was only after the entire class did so that the professor revealed that the demonstration had nothing to do with diagnosing diabetes, but was actually a lesson about careful, accurate observation. “I dipped my forefinger into the urine, but tasted the third one.”

SUVs OR SMART PHONES?

The number of pedestrians deaths was 50% higher in 2018 than the 2009 rate, even though the overall rate of traffic deaths decreased for the second year in a row in 2018. Analysts blamed the proliferation of SUVs with their greater weight, higher bumpers, and diminished visibility, but anyone who has ever driven in a city might alternatively speculate that it is the increased number of “oblivious” pedestrians crossing the street while listening to, talking on, or even texting on their smart phones.

MILLENNIALS ARE NOT THE MOST ADDICTED TO THEIR DEVICES

Research by Nielsen found that americans aged 35 to 49 used social media 40 minutes more each week than millennials. Middle aged americans were more likely to pull their phones out at the dinner table and spent more time than millennials on every type of device—phone,computer, tablet. Millennials do win the prize for the most use while driving. Obligations of work and the ease of maintaining friendships and social connections after the kids have grown up are cited as “reasons” for these findings. But, a researcher interviewing elementary school children uncovered a lot of complaints from the kids about prying their parents away from their screens. “Parents”, she sighed, “are the worst.” (3)

HOW TO SILENCE YOUR SMARTPHONE

Just send $500 to Cohda  for a Komoru ( Japanese for “ to seclude oneself”)  which is a miniature Zen garden bowl of “sand-like” nickel-coated microspheres that block electromagnetic signals from reaching the buried phone. The microspheres won’t scratch the phone nor enter into any ports. (4) It will be ready for distribution just in time for Christmas for “those who have everything else.”

References:
1.  Pediatrics.2019;143 (4)
2. JAMA Internal Medicine 2019 May 29
3. Wired magazine, April 2018
4.  http://www.cohoda.com/projects/komoru/


Vol. 216 July 1, 2019 Public Opinion About High Health Care Costs

June 30, 2019

‘TIS THE SEASON FOR POLS AND POLLS

 

As the presidential election summer season heats up with Democrat’s TV food fights and President Trump’s relentless echoes of 2016 campaign rhetoric, the frequency of public opinion polls on political issues and candidates is increasing. What do polls show about what people think about health care costs? The New England Journal of Medicine just published an analysis by three authors of 14 public opinion polls on health care costs done in 2018-2019 (1)

Two-thirds of the U.S. public thinks that reducing health care costs is a top priority for both President Trump and Congress in 2019 (second only to “strengthening the economy” at 70%).

About 90 % of respondents picked the following priorities as “extremely important”:
Reduce prescription drug prices
Reduce the overall cost of healthcare
Do not cut Medicare insurance benefits
Maintain insurance coverage for pre-existing conditions.

Half of respondents reported that health care costs had “actually affected their household a lot”.
40% were “not satisfied” with how much they had to pay for health care.

Why did respondents think that health care costs were so high?
drug companies charge too much …………. 78%
hospitals charge too much ……………………. 71%
Insurance companies charge too much ….. 71%
new drugs, treatments, and technology…….62%

The expert opinion consensus is that the over $500 Billion (yes, that’s a “B”) cost of “unnecessary services”, “inefficient delivery” , and “excessive administrative cost” is a significant cause of the high cost of our health care, but only 23% of public poll respondents thought so.

“At this level, unnecessary health care costs and waste exceed the 2009 budget for the Department of Defense by more than $100 billion (OMB, 2010). Health care waste also amounts to more than 1.5 times the nation’s total infrastructure investment in 2004, including roads, railroads, aviation, drinking water, telecommunications, and other structures. To put these estimates in the context of health care expenditures, the estimated redirected funds could provide health insurance coverage for more than 150 million workers (including both employer and employee contributions), which exceeds the 2009 civilian labor force. And the total projected amounts could pay the salaries of all of the nation’s first response personnel, including firefighters, police officers, and emergency medical technicians, for more than 12 years.” (2)

How did people think we could reduce healthcare cost?
Nearly 90% want the federal government to negotiate drug prices for Medicare
65% want the government to limit charges by hospitals and health professionals
65% want to allow 50-64 year olds to buy into Medicare
52% support “Medicare For All” with little or no private insurance.

Which government?
State 50%  (favored by 60% of Republicans)
Federal 50%  (favored by 70% of democrats)

By what mechanism?
Private insurance competition  (60% of Republicans)
Government insurance program (65% of Democrats)

A majority agreed on two unacceptable ways to reduce costs?

  1. Restrict access to treatments and prescription drugs via “expert opinion” of cost/benefit ratios.
  2. Tax incentives to individuals to buy high-deductible insurance plans.

Only 25% of the public polled were concerned that Medicare would run out of money in 10 years, i.e. little concern about the aggregate cost of health care. Most considered the cost problem as one of high prices rather than of over utilization.
Also, the public is highly skeptical that ANY approach will greatly reduce healthcare prices.

So, despite the consensus that reducing health care costs should be a high priority for President Trump and Congress, there is an obvious partisan divide about how to do it; a partisan divide that continues to make us (the U.S.) unique as the only developed nation lacking universal health care insurance for its people.

References
1. NEJM 380;26 June 27, 2019
2. Best Care At Lower Cost, National Academy of Medicine, Institute of Medicine, 2013


Vol. 215 June 15, 2019 Sometimes Even Good News is “Fake” News

June 16, 2019

A lesson in evaluation of a cost-reducing health care program:
a learned, scientific critique of a controversial Medicare reimbursement program.

 

“The Hospital Readmissions Reduction Program (HRRP) was established in 2010 by the Centers for Medicare and Medicaid Services (CMS) with a “goal of reducing ‘preventable’ re-hospitalizations by imposing financial penalties on hospitals with higher-than-expected readmission rates in the 30 days after a hospital discharge”. This was one of several new “Pay For Performance” (PFP) programs aimed at lowering federal health care costs by tying Medicare reimbursement to hospitals, physicians, and even home care agencies to the use of more appropriate (read “lower cost”) medical care delivery settings.

After implementation of the HRRP, hospital readmission rates did decrease nationwide for the targeted diagnoses of heart failure, acute myocardial infarction, and pneumonia. So, the federal government ended up reimbursing less money to those hospitals that had higher-then-expected “preventable” patient readmission rates . “Great!”, said some policy makers, “it saved us some money. Let’s expand the program to ALL conditions treated in the hospital.”

“Whoa”, said by a group of research physicians from Harvard and Washington University Medical Schools, both known as liberal academic institutions, ”let’s look at the data.”

  1. The proportion of patients that returned to the hospital within 30 days after discharge actually did NOT change.
    .        .Patients returned to the hospital within 30 days after discharge for care, BUT they weren’t “readmitted”. Instead a significant number of those returning to the hospital were treated for up to 3 days in Observation Beds/Units or overnight in an Emergency Room bed. HRRP did not measure use of Observation Units or overnight stays in the ER. No wonder the “readmission” rates went down.
  2. If a patient dies within 30 days after hospital discharge they obviously can’t be “readmitted”.
    .         .The HRRP statistics did not measure mortality rates. A hospital keeping sicker patients alive by readmitting them for appropriate care rate might have the better outcomes, i.e. a lower death rate, but it would be penalized for having a higher readmission rate. In fact, the financial penalties for higher readmission rates under HRRP are much higher than the penalties for a higher death rate under Hospital Value-Based Purchasing program (HVBP), another federal PFP program.
  3. “Risk adjustment” of patient illness severity is notoriously varied and difficult to standardize.
    .          . “Risk-adjusting” of illness severity, for example, recording the different illness severity between the heart failure patient on two drugs and slightly swollen ankles versus the patient on multiple heart drugs for decompensated heart failure, is very difficult to standardize. Some of the early enthusiasm for HRRP and its reported improvement of risk-adjusted readmission rates may have been the result of improved medical record coding of co-existing conditions. (This is well-known as “gaming the system”, legal and even ethical, sort of like taking advantage of tax code loopholes, but it does nothing to improve the quality of care.)
  4. Social risk factors like patient poverty and poor community resources like lack of public transportation and diminished access to primary care were omitted from risk-adjustment factors.
    .          .Safety-net hospitals (those in poor areas) can be penalized under HRRP as a result of such factors. “The evidence that social risk factors influence readmission rates is incontrovertible.”
  5. HRRP may even have increased the death rates for patients with heart failure.
    .          .Four independent studies showed that the death rates for patients with heart failure INCREASED significantly after implementation of HRRP. The increase was concentrated among the patients who were NOT readmitted, suggesting that the use of ER beds and Observation Units “may adversely affect patients who would benefit from higher-level care.” Two other studies found different results which suggested that HRRP was more beneficIal to patients with acute heart conditions rather than patients with chronic heart failure.The three authors urge several steps to correct what they consider a faulty, positive evaluation of HRRP before jumping into expanding the program to ALL patients admitted to a hospital. This failure to correctly evaluate HRRP “underscores the consequences of implementing national policies after [evaluation that does not include] a control group.”They also urge “policymakers to seek input from frontline clinicians and patients who understand the real-world effects of HRRP. . . . If HRRP is improved it might be transformed from a regressive penalty program to a progressive program that improves patient care.”

    Q.E.D.

    Reference:
    “The Hospital Readmissions Reduction Program—Time for a Reboot”, Drs. Wadhera, Yeh, and Maddox, NEJM 380;24 June 13, 2019.


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