Medical Error -Overestimated as Cause of Death

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A recent NY Times article provides some context to previous studies claiming that medical error could cause 100,000-250,000 deaths per year: Aaron Carroll Death by Medical Error

Here’s some excerpts:

When I started out as a doctor in 1999, the Institute of Medicine published a blockbuster report that declared that up to 98,000 people were dying in United States hospitals each year as a result of preventable medical errors. Just a few months ago, a study in the BMJ declared that number has now risen to more than 250,000, making preventable medical errors in hospitals the third-largest cause of death in the country in 2013…

There are about 2.5 million deaths each year in the United States, about 700,000 of which are hospitalized patients. This means that medical errors — in hospitals — would have to account for up to 10 percent of all deaths, or up to more than a third of hospitalized patients. That’s hard to fathom….

It’s somewhat sensationalistic to keep coming up with increasing numbers. I’m not sure it’s doing much good. After the publication of the initial report, defenders of the 98,000 number argued that even if the numbers were wrong, bringing attention to this problem would be good in itself.

Unfortunately, research doesn’t necessarily back that up. A 2010 study in The New England Journal of Medicine followed 10 North Carolina hospitals in the 10 years after the Institute of Medicine report. They found that the overall rate of harms, and the rate of preventable harms, did not significantly improve over that period.

My take: The article, in full, makes some compelling arguments that medical errors are overly-attributed as causes of death. At the same time, the article does not dismiss the importance of medical errors.  Many of the harms from medical errors do not result in death.

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Obeticholic Acid in Primary Biliary Cholangitis

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While Primary Biliary Cholangitis (PBC) (previously called primary biliary cirrhosis) is seen mainly in adult hepatology practices, a new treatment may be emerging and this same medication is likely to be considered for several liver conditions.

Reference: F Nevens et al. NEJM 2016; 375: 631-43.

This 12 month, double-blind, placebo-controlled phase 3 “POISE” trial with 217 patients examined the use of obeticholic acid with or without ursodeoxycholic acid.  Surrogate markers of PBC were followed & the treatment groups improved compared to placebo.  However, adverse effects, particularly itching, were more common in the obeticholic acid groups; serious adverse effects were 11-16% in the treatment groups compared with 4% in the placebo group.

Results below:

PBC Rx

My take: It will be nice when important clinical endpoints can be assessed for this therapy like progression to cirrhosis.  For now, the cost of this treatment is ~$70,000 yearly.

Related blog post:

Breakthrough for Fatty Liver Disease? | gutsandgrowth

More advice on Proton Pump Inhibitors

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L Laine, A Nagar. Am J Gastroenterol 2016; 111: 913-15.

This reference explains how these clinicians discuss the long-term use of proton-pump inhibitors with their adult patients.  Thanks to Ben Gold for this reference.  Here are a couple pointers:

  • “The recent studies about CKD (chronic kidney disease) and dementia, similar to many prior studies assessing PPI risk, are retrospective observational studies…This results in differences between PPI users and non-users in factors that may impact study outcomes and confound results.”
  • Gastroesophageal reflux disease: The authors suggest that PPIs for GERD can be stopped >2 weeks after symptoms resolve.  For infrequent symptoms, H2RAs, lifestyle modifications and intermittent PPIs often suffice.
  • Barrett’s esophagus: “observational sutdies suggest that PPIs may decrease progression to neoplastic Barrett’s esophagus”

WHAT WE TELL PATIENTS: “Because of inherent risk of bias and low effect sizes we cannot conclude that associations of PPIs and adverse outcomes such as dementia and CKD in recent observational studies are vailid…Nevertheless, we cannot conclude that risks do not exist…we need to ensure that benefits outweigh potential risk.  If PPIs are indicated, using the lowest effective dose and, if possible, intermittent rather than daily therapy..should decrease the risk of potential side effects.”

On the same topic, Paul Moayyedi (in Gastroenterology and Endoscopy News, August 2016): “Every study has shown that sicker patients tend to be prescribed PPIs…Sick patients tend to develop other illnesses so PPIs will be associated with about any disease you can imagine in a database.”  As such, he asserts that weak associations (OR <2) are usually due to cofounding factors.  “The only benefit [these studies]..have is that it is another opportunity to discuss with the patients about stopping their PPI therapy, as there are a significant proportion…on these drugs unnecessarily.”

purple flowers

Optimistic Results for Hepatitis C plus Hepatology Update

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The August issue of Hepatology had several articles on Hepatitis C confirming the efficacy of newer agents:

  • LI Backus et al Hepatology 2016; 64: 405-14.  This “real-world” observational study from the VA Clinical registry with 4,365 genotype 1 treatment-naive patients who received ledipasvir/sofosbuvir showed SVR rates of 91.3% (w/o ribavirin) and 92% (w ribavirin).
  • P Kwo et al. Hepatology 2016; 64: 370-80 (OPTIMIST-1) This study showed that 12 weeks of simeprevir+sofusbuvir for 12 weeks was highly effective (97% SVR) and that 8 weeks of this therapy was inferior (83% SVR).  N=310 with genotype 1 (w/o cirrhosis).  No patients stopped therapy due to adverse effects.
  • E Lawitz et al. Hepatology 2016; 64: 360-69 (OPTIMIST-2) This study showed that simeprevir+sofusbuvir for 12 weeks was effective in genotype 1 patients (n=103) with cirrhosis.  For treatment-naive, the SVR was 88% and for treatment-experienced patients, the SVR was 79%.

Also in Hepatology:

  • S Heibani et al Hepatology 2016; 64: 549-55. This study looked at 1-week versus 2-week intervals for endoscopic ligation.  While 1-week ligation eradicated varices more quickly, neither approach was associated with differences in number of endoscopies, complications (including rebleeding) or other clinical outcomes.
From earlier study of "real-world" treatment of Genotype 1. Gastroenterol 2016; 150: 419-29.

From earlier study of “real-world” treatment of Genotype 1. Gastroenterol 2016; 150: 419-29. (Full text link)

 

NPR: Children Missing Out on Hepatitis C Treatment

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From NPR: Children Missing Out on Hepatitis C Treatment

An excerpt:

A study by the Philadelphia Department of Health points to what Wen and others in the medical profession see as a worrisome trend: Children with hepatitis C may be unaware of their diagnosis and the potential need for treatments down the road in order to prevent long-term liver damage.

Using city surveillance data, the study found that as many as 8 in 10 children at high risk for hepatitis C exposure in Philadelphia were never screened for the condition. More specifically, of the approximately 500 moms-to-be who were registered as having hepatitis C between 2011 and 2013, only 84 of their newborns, or about 16 percent, were tested for the virus by 20 months of age.

My take: As the article discusses, with the advent of better treatments, which will be available for children (?next 1-2 years), identifying Hepatitis C acquired prenatally is becoming important.

Related blog posts:

Rising HCV mortality

How Watching TV Food Commercials Affects Children’s Brains

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A recent study of 23 children (8-14 yrs) correlated functional MRI results with watching commercials.

Full text: The Influence of Televised Food Commercials on Children’s Food Choices

Key finding: The ventromedial prefrontal cortex, a reward valuation brain region, showed increased activity during food choices after watching food commercials compared with after watching nonfood commercials.

Author’s conclusion: Overall, our results suggest watching food commercials before making food choices may bias children’s decisions based solely on taste, and that food marketing may systematically alter the psychological and neurobiologic mechanisms of children’s food decisions.

My take: When is the last time you saw a commercial for broccoli?  While food companies may not fully understand how their marketing affects kids’ brains, I’m certain they understand how it affects their bottom line.

Lake McDonald, Glacier Natl Park

Lake McDonald, Glacier Natl Park

 

Biologic Exposure Prenatally and Perinatally

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The widespread use of anti-TNF therapy for inflammatory bowel disease has improved clinical outcomes including fewer surgeries, hospitalizations, and complications.  One consequence of this usage has been the exposure of infants to biologics due to their usage by their mothers during pregnancy.  A recent study (M Julsgaard et al. Gastroenterol 2016; 151: 110-19) explores this topic further.

In this study, the authors prospectively followed 80 pregnant women: 36 received adalimumab & 44 infliximab. In addition, 39 received concomitant thiopurine therapy.

Key findings:

  • The time from last exposure to anti-TNF agent correlated inversely with the concentration of these drugs in the umbilical cord and in mothers at the time of birth.
  • Median ratio for infant: mother drug concentration at birth was 1.21 for adalimumab and 1.97 for infliximab.
  • Mean time for drug clearance: 4.0 months for adalimumab and 7.3 months for infliximab. Drugs were not detected after 9 months of life for adalimumab and after 12 months of life for infliximab.
  • No increased risk of adverse pregnancy outcomes were identified; preterm birth was low (n=3 or 3.8%). 48% of women experienced a disease relapse during pregnancy.
  • In this small study, the relative risk for infection was 2.7 in infants exposed to combination therapy.  Benign courses of viral infections were noted in 16 (20%) of the entire cohort and of bacterial infections in 4 (5%).

The authors recommend avoidance of live virus vaccines in biologically-exposed infants for up to 1 year unless drug clearance has been documented. Currently, this would affect only rotavirus vaccination.

My take (borrowed from editorial pgs 25-26): “For now, the sum of evidence seems to support continued use of anti-TNF therapy in pregnancy when clinically indicated and, despite measureable levels in offspring, there does not seem to be a significant clinical consequence.”

Related study: “Adverse Pregnancy Outcomes among women with inflammatory bowel disease: a population-basd study from England” Inflamm Bowel Dis 2016; 22: 1621-30. The authors identified 1969 pregnancies from a total of 364,363 singleton pregnancies.  Women with Crohn’s had increased preterm births with an Odd ratio of 1.42, babies with low birth weight (OR 1.39); women with ulcerative colitis had only a small increase risk in preterm birth (absolute risk <2.7%).

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Art at Big Creek Greenway, Alpharetta

Art at Big Creek Greenway, Alpharetta

Understanding Sodium Intake and Cardiovascular Risk

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A recent review (ME Cogswell et al. NEJM 2016; 375: 580-5) helps sort out some of the confusion regarding sodium intake and cardiovascular disease. In brief, the authors point out the excessive sodium intake is clearly linked to heart disease, stroke and death.  The importance has been questioned by some due to a few studies suggesting that low sodium intake could also increase the risk of cardiovascular disease.

The authors note that these studies have shown only weak associations & were likely a matter of reverse causation due to the low sodium group having increased numbers of participants with numerous health issues (eg diabetes, hypertension, chronic illness and cardiovascular disease).

By looking at these results based on “Hill’s Criteria” to assess whether an association is causal, the authors show that the association of low sodium intake and cardiovascular disease indicates that this association is NOT causal.

Hill’s criteria:

  • Strength -degree which the exposure is associated with the outcome
  • Consistency -is this finding observed by different persons, in different places/times
  • Specificity -is observation limited to the exposure and the outcome
  • Temporality -did observation cause the outcome or did the outcome affect changes that lead to observation
  • Biologic gradient -?dose-response noted
  • Plausibility -is there a physiologic basis
  • Coherence -does this association conflict with other known facts
  • Experiment -is the finding affected by actions to prevent the exposure
  • Analogy -does an exposure with a similar physiologic action cause the outcome

The authors note that population exposure to sodium correlates better than individual exposure, perhaps due to measurement issues. Key points:

  • “There is strong evidence of a linear, dose-response effect of sodium reduction on blood pressure.  In addition, the evidence shows that sodium reduction prevents cardiovascular disease.”
  • “Reducing the average sodium intake by just 400 mg per day could potentially avert as many as 28,000 deaths and save $7 billion in health care costs annually in the United States.”
  • “Yet sodium levels are high before food reaches the kitchen or table, and the sodium density of the U.S. diet has changed little despite consumer education encouraging individual behavior change.”

My take: If we are to take advantage of the science to reduce cardiovascular deaths, we need to convince manufacturers and restaurants to reduce sodium.

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Highline Trail, Glacier Nat'l park

Highline Trail, Glacier Nat’l park