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Waiting for perfect science on antimicrobial resistance is a dangerous excuse for policy inaction

A discussion paper newly released by the National Academy of Medicine–Antibiotic Resistance in Humans and Animals–marks the 40 year anniversary of the first definitive evidence  that antibiotic usage in livestock results in the direct spread of antibiotic-resistant bacteria to humans. In releasing the report, the authors pull no punches:

Thus, we have known definitively for more than 40 years that antibiotic usage in livestock results in the direct spread of antibWhatIsDrugResistanceiotic-resistant bacteria to humans. The complete failure of our society to address this concern in the United States is profoundly disappointing and alarming to providers who increasingly struggle to care for patients infected with antibiotic-resistant bacteria. Apologists abound. Excuses are rampant. As alluded to by the British report, “more science” is the often-heard refrain. Those who espouse the need for yet further study before action can be taken typically have close links to farms that continue to use antibiotics. Yet we are past the scientific tipping point.

The issue at hand is one of policy. All policy issues are matters of choosing between pros and cons, risks and benefits. Policy makers almost never have a perfect understanding of all variables at play, nor is it necessary for them to have such precision of information to make choices. Waiting for perfect science is not possible either, because science is constantly in a state of evolution of knowledge based on changing research. Thus, we seek here to summarize the state of the problem in human terms and to inform policy makers of the risks and benefits of taking action or not.

CDCinfographicANTIBIORESISTANCEThis report joins the increasingly urgent public calls for global collective policy action to address the threats posed by antimicrobial resistance to worldwide public health. A World Health Organization (WHO) report released April 2014 called for action against the “serious threat” posed by antimicrobial resistance, a threat that is “happening right now in every region of the world and has the potential to affect anyone, of any age, in any country. Antibiotic resistance—when bacteria change so antibiotics no longer work in people who need them to treat infections—is now a major threat to public health.” 

The report is timely as well as urgent. Earlier this year, scientists discovered the first United States cases of a gene that renders infectious bacteria resistant to the “last-resort” antibiotic drug colistin, a Centers for Disease Control and Prevention (CDC) official testified last week during a congressional hearing on the danger posed by “superbugs”.  Although the NAM report focuses on livestock antimicrobial use as a top priority, antimicrobial use in humans is still an important focus, especially in light of a report last month finding that at least 30 percent of antibiotics prescribed to humans in the United States are unnecessary.

 

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AHRQ and CMS Public Reporting Measures Fail to Describe the True Safety of Hospitals

A new study from the Johns Hopkins Armstrong Institute for Patient Safety and Quality, published in the journal Medical Care, performed a systematic review and meta-analysis of two sets of safety measures used for pay-for-performance and public reporting The measures evaluated in the study are used by several public rating systems, including U.S. News and World Report’s Best Hospitals, Leapfrog’s Hospital Safety Score, and the Center for Medicare and Medicaid Services’ (CMS’) Star Ratings.

The two sets of measures evaluated are:

The investigators first performed a systematic review of all published medical research since 1990, looking for studies that addressed the validity of the HAC  and PSI measures.  They identified only 5 of these 40 safety measures with enough data in these prior studies to permit a pooled meta-analysis:

  • A. Iatrogenic Pneumothorax (PSI 6/HAC 17)
  • B. Central Line-associated Bloodstream Infections (PSI 7)
  • C. Postoperative hemorrhage/hematoma (PSI 9)
  • D. Postoperative deep vein thrombosis/pulmonary embolus (PSI 12)
  • E. Accidental Puncture/Laceration (PSI 15)

The investigators then performed a meta-analysis, pooling the results of all studies about the validity of each of these measures.  Their findings in the figure below show that in pooled studies (the diamond at the bottom of each lettered rectangle) only one measure–Measure E, PSI 15 (Accidental Puncture and Laceration)–met the investigators’ criteria for validity: a positive predictive value of at least 80% (indicating that at least 80% of the patients determined by the measure to have an accidental puncture or laceration truly had an accidental puncture or laceration.) Actual occurrence (reference standard) of each reported safety event was determined, in each individual study, by medical chart review.

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Measure D, PSI 9 (Postoperative hemorrhage or hematoma) came close to the 80% PPV threshold, with a pooled PPV of 78.6%.

Based on these findings, the investigators conclude that these measures, widely used for public reporting and pay-for-performance, should not be used for either purpose:

 CMS and others have created payment incentives based on hospitals’ performance for a variety of hospital-acquired complications, which are measured with the respective PSIs and HAC measures. Policy makers and payers have argued that the PSIs and HAC measures are good enough for reporting and pay-for-performance, whereas many providers believe they are not. Our results suggest that the PSIs and HAC measures may not be valid enough and/or have insufficient data to support their use for these purposes. This is especially true given the potential financial impact these pay-for-performance approaches may have on the narrow financial margins on which most hospitals function.

 

E.coli bacteria. Coloured scanning electron micrograph of the rod-shaped, Gram-negative bacteria, Escherichia coli, commonly known as E. coli. These bacteria are normal inhabitants of the human intestine (also animal intestines) and are usually harmless. Under certain conditions E. coli may increase in number and cause infection. Serotypes of E. coli are responsible for gastro- enteritis in children, particularly in tropical countries. In adults it is the cause of "traveller's diarrhoea"; and of 80% of all urinary tract infections. It is also the organism most used in genetic studies. Magnification: x3,000 at 6x7cm, x1,500 at 35mm size. x10,000 at 8x10"

Medical ecology: tending the microbiome

Today, the Obama administration announces the new National Microbiome Initiative, intended to create scientific tools, discoveries and training techniques related to the human microbiome, the 100 trillion microbes that live in the human body. Tending the human microbiome may help in the treatment of infections, as well as disorders that would seem unrelated to microbes, including obesity and diabetes.

The microbiome represents the only organ that can be replaced without surgery,” said Jo Handelsman, a microbiologist at the White House. “Just by eating differently, taking drugs, exercising and other things, you can have fairly immediate effects on your microbiome and your health, if we only knew how.”

Microbiome research also has important public health implications. New research, for instance, suggests that much of the world’s childhood malnutrition arises not from a lack of food, but from problems with children’s intestinal microbiomes caused by poor sanitation.India-Sanitation-web-Artboard_1

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Pay for performance penalties fail again

The Incidental Economist astutely deconstructs the assumptions leading to the failure of the nationwide Hospital-Based Purchasing Program’s pay-for-performance penalties to reduce 30-day mortality.  These assumptions include:

  • 30-day mortality is the right outcome measure because it is feasible to measure
  • 30-day mortality is a valid proxy for the quality of inpatient care delivered.

As shown with readmissions based penalties and with other pay for performance penalties, many of the determinants of outcomes such as mortality and readmissions lie outside of the control of the hospital, including factors such as the patient’s educational attainment, income and access to care.

Until we apply more evidence-based science to selection of our pay-for-performance metrics, they will continue to fail to achieve their intended goals, and will, instead, penalize hospitals for the patient populations they serve.f2-large

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The Minimum Wage and the Social Determinants of Mental Health

A new study in Health Economics shows a temporal association between Britain’s minimum wage law and substantially improved mental health of the low wage workers benefitting from the policy.

Source: The Minimum Wage and the Social Determinants of Mental Health

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Should Doctors Undergo Opioid Prescribing Risk Training?

Earlier this week, an advisory panel recommended that the Food and Drug Administration require doctors who prescribe painkillers s to undergo training aimed at reducing misuse and abuse of the medications. The New York Times notes:

It is the second time since 2010 that an F.D.A. panel has recommended expanding safety measures for painkillers. But the training plans instituted about four years ago are voluntary, and data shows that under half of the doctors targeted by the effort have completed the training.

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Despite the rising opioid-related death rate since the initial FDA panel’s initial recommendation in 2010, the panel strongly recommended training physicians. Given the amount of training we all underwent in preparation for US cases during the most recent Ebola epidemic, the physician training for this pandemic, far more deadly on our shores, seems both feasible and urgent.

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What are the priority Emergency Department (ED) presenting conditions for which ED-based Shared Decision-Making should be most urgently developed?

An article in this week’s Wall Street Journal focused on the development and use of shared decision-making (SDM) tools in the emergency department (ED).  Decision tools can help engage patients in making decisions about their care, including decisions about which tests and treatments to pursue.  In the ED, relevant decisions are (1) decisions involving two similarly reasonable options (“preference-sensitive health care decisions”) and (2) decisions that patients or their families can take some time to consider. The examples mentioned in the WSJ article are

  1. children with uncomplicated acute appendicitis: IV antibiotics versus surgery
  2. adults with chest pain and normal initial test results: watchful waiting (not doing any tests) versus extensive testing (you can try out this tool here)
  3. mild traumatic injury: watchful waiting versus head CT scan

Other scenarios for which SDM tools have been studied include

  • testing for bacterial infections among children with fever-without-an-obvious-source
  • choice of anesthesia and sedation for the repair of small lacerations in children
  • choice of hydration methods (IV or oral) for children with dehydration from a vomiting/diarrhea illness.
  • management of acute musculoskeletal pain in adults

shared-decision-making-were-in-this-together-3-728Selection of SDM is the focus for the 2016 Academic Emergency Medicine consensus conference, “Shared Decision-making in the Emergency Department: Development of a Policy-relevant Patient-centered Research Agenda”. I pose here one of the many questions to be addressed at that conference: What are the priority ED presenting conditions for which ED-based SDM should be most urgently developed?