Adopting treatment guidelines based on studies of what actually works is downright un-American.
With concerns over health-care rationing reaching near-hysterical levels, imagine this scenario in an ER in the not-too-distant future. A 4-year-old suffers minor head trauma, perhaps from falling off a swing and hitting her head on the ground. She is dazed, and although she doesn't lose consciousness her worried parents—visions of subdural hematomas and concussion dancing in their own heads—rush her to the local emergency room, expecting that the doctors there will immediately do a CT scan.
Surprise. The ER intake nurse talks to the child, who is able to say her name and explain what happened in the playground. She did not lose consciousness, her mother (who witnessed the fall) tells the nurse. The little girl is not vomiting, the ER doctor determines that there are no signs of fracture of the base of her skull, and she does not have a severe headache. Verdict: no CT scan.
In a more innocent age, the parents might have been puzzled, but accepting. What do you want to bet that, whatever happens to health-care reform (since the nation will continue to struggle with skyrocketing medical costs), in the current climate of rationing fears, they will be suspicious, even furious, believing that their child is being denied proper medical care for some nefarious economic reason? Yet the conclusion that children with head injuries do not necessarily need a CT scan—and that such scans expose them to high levels of cancer-causing radiation for no benefit—is supported by the largest study of its kind.
For the study, described in a paper in the online edition of The Lancet, scientists led by Nathan Kuppermann of the University of California, Davis, School of Medicine, analyzed the medical records of 42,000 children with head trauma. (The U.S. Centers for Disease Control and Prevention estimates that 435,000 children under 14 visit ERs every year to be evaluated for traumatic brain injury.) Of the 15,000 who got a CT scan, 376 had serious brain injuries, and 60 underwent surgery.
Comparing the outcomes of the 27,000 children who did not receive CT scans and had no adverse consequences from that omission, and the nearly 15,000 who did but did not benefit from it, the scientists came up with criteria for when a child should receive a CT scan after a head injury. For children under 2, if there is normal mental status, no scalp swelling, no significant loss of consciousness, no palpable skull fracture, and no behavioral changes (as reported by a parent), and if the injury occurred in a nonsevere way (something other than a car crash), it is safer to skip the CT scan. For a child 2 and older, Kuppermann and his team concluded, it is safe to skip the CT scan if he did not lose consciousness, is not vomiting, has no fracture of the base of the skull, and does not have a severe headache.
After inferring these rules of thumb, the researchers applied them to 8,600 different children who had sustained a head injury. In more than 99.9 percent of the cases, the rules accurately predicted which ones did not have a serious brain injury and could therefore have skipped the CT. Said Kuppermann, "CT use can be safely reduced by eliminating its application in those children who are at very low risk of serious brain injuries." Yet based on the criteria, one in five children over the age of 2 and nearly one quarter of those under 2 who received a CT scan following head trauma did not need it, and the risk of developing cancer due to the radiation exposure outweighed the risk of serious brain injury.
Will patients, and doctors trained in defensive medicine, adopt these guidelines? I'm not holding my breath. For reasons I will leave to the sociologists to parse, Americans believe that there is no such thing as too much treatment. That, of course, ignores the fact that few treatments are without risk and that every time the medical system gets its hands on you there is another possibility of medical error (which kills as many as 98,000 Americans each year). In the case of CT scans, that risk is the radiation: a study published in August in The New England Journal of Medicine found that at least 4 million Americans under age 65 are exposed to high doses of radiation each year from medical imaging tests, mostly from CT scans. About 10 percent of those get more than the maximum annual exposure allowed for nuclear-power-plant employees or others who work with radioactive material. Radiation, of course, increases the risk of cancer, and radiation exposure to the brain of developing children is of particular concern.
If you share my hunch that American parents are unlikely to accept the idea that their child doesn't need a CT scan after a head injury—you are rationing my child's medical care!—then join me in wondering how Americans will accept what seems like a step down the road to rationing when it comes from—gasp—the government.
In a new report, the Agency for Healthcare Research and Quality (part of the Department of Health and Human Services) warns that particle-beam radiation therapy (in this link, scroll down to Question 6), which has been hyped as superior to traditional radiation for eradicating tumors, in fact poses significant safety risks without—so far—any evidence that it brings added, let alone compensating, benefits.
Particle-beam radiation therapy bombards a tumor with beams of protons or other charged subatomic particles; traditional radiation uses photons, particles of electromagnetic radiation such as X-rays or gamma rays. Particle-beam radiation therapy is more precise (less likely to hit healthy tissue) but also more expensive, with the cost typically exceeding $100,000. (Each machine costs an estimated $175 million, and the seven centers in the United States that currently offer it want to make back their capital outlay.) AHRQ's bottom line: after analyzing 243 studies of particle-beam radiation, it concludes that "no study found that [it] is significantly better than alternative treatments with respect to patient-relevant clinical outcomes."
New York Times economics writer David Leonhardt used particle-beam radiation as part of a case study of whether the nation is serious about applying effectiveness research—studies of what works and what doesn't—to medical decisions. He focused on its use in prostate cancer, making the point that Americans—patients and doctors—seem to clamor for the shiny new treatment regardless of whether there is any good evidence that it works, let alone that it is better than older treatments. Now we have the government saying, for particle-beam therapy, there is no evidence of that, despite hundreds of attempts to look for it. Just as I doubt that parents will quietly accept that their child won't benefit from a CT scan, my bet is that this study will do little to dampen the clamor for particle-beam therapy. That just isn't the American way.