Neither of the two drugs used most frequently to prevent migraines in children–amitriptyline and topiramate–is more effective than a placebo, according to results of the Childhood and Adolescent Migraine Prevention (CHAMP) trial published this week in The New England Journal of Medicine. The investigators found no significant differences in reduction in headache frequency or headache-related disability in childhood and adolescent migraine with amitriptyline, topiramate, or placebo over a period of 24 weeks.
The active drugs were associated with higher rates of adverse events. One child on topiramate attempted suicide. Three taking amitriptyline had mood changes; one told his mother he wanted to hurt himself, while another wrote suicide notes at school and was hospitalized.
Migraine headaches are common in children. Up to 11 percent of 7- to 11-year-olds and 23 percent of 15-year-olds have migraines.
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.
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.
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.
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.
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.
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
- children with uncomplicated acute appendicitis: IV antibiotics versus surgery
- 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)
- 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
Selection 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?
Newly released 2014 data from the National Center for Health Statistics on life expectancy showed a worrisome decline in life expectancy for whites in the US, to 78.8 years in 2014 from 78.9 in 2013.
The good news is that, in contrast, life expectancy increased by 0.2 years for the Hispanic population (from 81.6 to 81.8 years) and by 0.1 years for the non-Hispanic black population (from 75.1 to 75.2). This continues a trend of a decreasing gap in life expectancy between black and white populations, with improving black life expectancies attributed to decreases in death rates due to heart disease, cancer, HIV disease, unintentional injuries, and perinatal conditions.
Life expectancy rates had steadily for decades, then flattened in 2010-2013. The decline in life expectancy is driven by increased death rates among young and middle-aged whites (mid 20’s to mid 50’s), especially among those with no more than a high school education. A recent study attributed the rise in mortality in this group to rising rates of suicide, liver disease and drug overdoses.
Life expectancy has dipped before–most recently in 2005, the year of a severe influenza epidemic.
This week’s NY Times science section debunks several common misconceptions. All are interesting reads: