Twenty-five years ago this month, the New England Journal of Medicine published a special report on something that’s become medical gospel:
That’s right. Not as in “take two and call me in the morning,” but in the realm of the randomized double-blinded placebo-controlled trial. Or what we generally consider the gold standard of evidence in medical research.
If you’ve often heard that bit of jargon but always wondered why it’s so exalted, break it down:
- randomized: the assignment of the treatment (aspirin) or placebo (‘inert’ sugar pill) is not given in any planned sequence.
- double-blinded: neither the researchers nor the subjects know who is taking what (everything is coded so that analysts can find out at the end).
- placebo-controlled: the study compares the treatment against placebo to see if it’s helpful or harmful.
Even though acetylsalicylic acid’s properties as a pain reliever and fever reducer had been known in the time of Hippocrates, it was in 1899 that Bayer first patented and marketed what came to be known as aspirin worldwide.
A mere 89 years later, researchers from the “Physicians Health Study” did something unusual. Citing aspirin’s “extreme beneficial effects on non-fatal and fatal myocardial infarction”–doctor speak for heart attacks–the study’s Data Monitoring Board recommended terminating the aspirin portion of the study early (the study also was looking at the effects of beta-carotene). In other words, the benefit in preventing heart attacks was so clear at 5 years instead of the planned 12 years of study that it was deemed unethical to continue blinding participants or using placebo.
Continue reading “What the Story of a Famous Little White Pill Says About How Medical Research Works”
Filed Under: THCB, The Insider's Guide To Health Care
Tagged: aspirin, aspiversary, Bayer, gold standard of evidence, John H. Schumann, medical research, NEJM, randomized double-blinded placebo controlled trial, randomized trials
Jan 20, 2013
She was 94 years old with advanced Alzheimer’s. She thought it was 1954 and asked if I wanted tea. Not a bad memory for someone in a hospital bed with a broken left hip.
She’d fallen at her assisted living facility. It was the second time in as many months. She’d broken her collarbone on the previous occasion.
Over the past year, she’d lost thirty pounds. This is natural in the progression of Alzheimer’s. But it’s upsetting to families all the same.
My patient was lucky. She’d lived to 94, and had supportive children who were involved in her care. Her son had long ago been designated as power-of-attorney for her health care. This meant officially that his decisions regarding her care were binding. She was not capable of making sound decisions, medical or otherwise.
The patient had been under the care of a geriatrician. His office chart told me that the option of hospice and palliative care had been discussed with the family. They were interested in learning more; the son had agreed that “Do Not Resuscitate” status was appropriate for his mother. Doing chest compressions on a frail 94 year-old is something none of us want to do.
The morning after her hospital admission for the broken hip, the medical intern called me with an ethical dilemma: “She’s DNR,” the intern explained. “She’s having intermittent VTach on the monitor, and I fear she won’t be stable enough to have the hip repaired. The family is open to the idea of hospice, but I don’t know whether to treat the arrhythmia or not.”
Elaine (not her real name) is one of our brightest interns. She’s thinking about going into geriatrics. Situations like this are in many ways the most meaningful for doctors. Too often we stress about minutiae at the expense of the big picture; helping guide a family and patient through a period of critical illness is of true service.
Continue reading “Building a Better Health Care System: End of Life Care – A Case Study”
Filed Under: THCB
Tagged: DNR, End of Life Care, Hip Replacement, Hospice, John H. Schumann, Palliative Care
Jan 1, 2013
In some ways, the Insititute of Medicine is like the famed “Academy” of Motion Picture Arts & Sciences. Having membership conferred is the ultimate accolade in a field full of brains, competition, money, and ego. A major difference is that the IOM doesn’t give out annual awards for best studies or best theories–the whole institute is comprised of lifetime achievement award winners.
That’s why when the IOM issues a report, it garners a lot of attention.
Their most recent, “Best Care at Lower Cost: The Path to Continuously Learning Health Care in America” attracted the usual spate of headlines:
I’ve looked over the report–it’s been released in ‘pre-publication’ form on their website, and you can read the whole thing. It’s a worth a click over, because even if you can’t slog through 350+ pages, they’ve made several executive summary features (including a top ten list) andgraphics that do a great job of conveying the authors’ findings and recommendations. A few things jumped out at me:
- $750 billion of our collective annual $2.3 trillion health care outlay does not improve health
- we still have far too many errors in hospitals
- too many patients discharged from hospitals are readmitted in less than a month (20%!)
- which points to the lousy job we do ‘transitioning’ people from hospital to home
- communication amongst medical personnel is abysmal
The report uses analogies from many industries. There’s the requisite comparison to aviation, since the safety record of commercial airlines is enviable. But there are also comparisons to hotels, manufacturing, general contractors, engineers, and even ‘mission control’ at NASA. [Health care does not compare favorably to NASA. Doctors should, but are not working for a common purpose like getting people to the moon.]
Continue reading “Waste Not”
Filed Under: Hospitals
Tagged: Costs, Health Reform, IOM, John H. Schumann, NIH, Patient Safety, Quality
Sep 21, 2012
Despite its complexities and its politics, I support the Affordable Care Act (aka “Obamacare”). As I’ve written elsewhere, I think it would be both morally and economically wrong for Governor Fallin and the Oklahoma legislature to opt out of the ACA’s vast Medicaid expansion – a position shared by Oklahoma Policy Institute. So if Oklahoma does the right thing and opts to expand Medicaid for adults with incomes at or below 133 percent of the federal poverty level, what will happen?
Oklahoma faces a serious shortage of primary care access. The Oklahoma Health Care Authority, the agency in charge of administering Medicaid, recently compiled county-by-county maps, color-coded to classify areas of severe physician shortage based on presumptive levels of Medicaid expansion. At a glance, these maps reveal something we already know: rural areas are hurting for physicians and populous counties seem to have more capacity. In my opinion, however, the maps don’t paint a full picture of the eventual shortfall. Continue reading “‘Help Wanted’ For Medicaid Expansion”
Filed Under: Uncategorized
Tagged: Affordable Care Act, Health Reform, John H. Schumann, Medicaid Expansion, OK Policy, primary care
Jul 31, 2012