Tag Archives: NYT

NYT reporters tease hip replacement numbers from difficult data

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

Writing for The New York Times, Barry Meier and Janet Roberts analyzed a particularly tricky batch of federal reports detailing a variety of complaints with popular metal-on-metal hip replacements. They found that, since January, the FDA has received more complaints (5,000-plus) about the devices than it did, total, from 2007 to 2010.

kidsPhoto by Michael Simmons via Flickr

While processing the data, the paper’s staff did their best to parse duplicate reports, international filings and other inconsistencies, but the reporters make it clear that the numbers are still best viewed in general terms. Even so, they demonstrate that the surge in complaints and lawsuits involving metal-on-metal hips — and the resulting mass defection of doctors who once implanted them — signals a broad shift in hip replacement surgery, one of the most common such procedures in the country. It also signals another blow for device manufacturers and patients, and a related windfall for the legal profession.

The vast majority of filings appear to reflect patients who have had an all-metal hip removed, or will soon undergo such a procedure because a device failed after only a few years; typically, replacement hips last 15 years or more.

The mounting complaints confirm what many experts have feared — that all-metal replacement hips are on a trajectory to become the biggest and most costly medical implant problem since Medtronic recalled a widely used heart device component in 2007. About 7,700 complaints have been filed in connection with that recall.

As problems and questions grow, most surgeons are abandoning the all-metal hips, saying they are unwilling to expose new patients to potential dangers when safer alternatives — mainly replacements that combine metal and plastic components — are available. Some researchers also fear that many all-metal hips suffer from a generic flaw. Current use of all metal devices has plummeted to about 5 percent of the market, though a few of the models are performing relatively well in select patients.

Initiatives not improving patient safety; poor implementation to blame

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

A large-scale study that followed mistakes in health care delivery at 10 North Carolina hospitals from 2002 to 2007 found that, despite state efforts, there was no improvement in patient safety over the time period. According to The New York Times‘ Denise Grady, the problem lay primarily not in design, but in execution. Even when safeguards were in place, they were not followed.

The study, published in the New England Journal of Medicine, reviewed thousands of patient records and looked for any of 54 red flags that something had gone wrong.

Dr. [Christopher] Landrigan’s team focused on North Carolina because its hospitals, compared with those in most states, have been more involved in programs to improve patient safety.

But instead of improvements, the researchers found a high rate of problems. About 18 percent of patients were harmed by medical care, some more than once, and 63.1 percent of the injuries were judged to be preventable. Most of the problems were temporary and treatable, but some were serious, and a few — 2.4 percent — caused or contributed to a patient’s death, the study found.

The findings were a disappointment but not a surprise, Dr. Landrigan said. Many of the problems were caused by the hospitals’ failure to use measures that had been proved to avert mistakes and to prevent infections from devices like urinary catheters, ventilators and lines inserted into veins and arteries.

Problems cited in the study include a lack of electronic medical records, doctors and nurses regularly working long hours and poor compliance with even simple interventions such as hand washing. Proposed solutions include computerized drug ordering systems and a mandatory nationwide monitoring system.

Community-led effort sparks public health wave

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

Writing in The New York Times, Jessica Reaves writes about how a 2000-06 Chicago community survey embodies the block-by-block, community-reliant approach to public health that it helped inspire.

In the heavily Puerto Rican Humboldt Park neighborhood, researchers worked with community leaders to write study questions, then relied on community members to conduct the actual survey. From these roots, the level of community participation snowballed, and locals demonstrated an interest and investment in public health that researchers hasn’t seen before. Today, initiatives born out of that study still provide residents with access to fresh produce, free diabetes screenings, fitness classes and more.

Now, researchers are further localizing and intensifying their effort with a block-by-block approach. The Humboldt Park model has become one that others are working to replicate across the country.

The specifics of the Sinai approach (In Humboldt Park) — change-oriented and invested in the fate of a neighborhood — are distinctive, but they also reflect a sea change in the overall strategy of public health professionals, said Janine Lewis, executive director of the Illinois Maternal and Child Health Coalition, a nonprofit advocacy organization in Chicago.

“I think the field is becoming more responsive to the idea of community-based participatory research,” Ms. Lewis said. “Those of us in the field realize that community members are experts on the needs and gifts in their communities, and should be consulted” at every phase of research.

This approach, she added, not only helps investigators devise more meaningful questions, but also means residents feel a part of the process and motivated by the results.

How numbers can be used to buttress falsehoods

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

On The New York Times‘ Well blog, Tara Parker-Pope interviewed NYU journalism professor Charles Seife, author of Proofiness: The Dark Arts of Mathematical Deception. While the book’s not exclusively focused on health care, the interview does touch upon numbers and health journalism.

Once you get past all the goofy catchphrases (proofiness! randumbness!), the basic point Siefe makes in the interview, that correlation is not causation, shouldn’t surprise anyone. Nevertheless, I enjoyed his elegant, health-related illustration of the phenomenon:

We are extraordinary pattern-matchers. Anytime there is something that is happening, we try to find a cause. But sometimes in medicine, sometimes things are absolutely random. Our minds don’t accept that. We must find a cause for every effect.

A really good example is the autism issue. Whenever a parent has a child who ends up being autistic, the parent more than likely says, “What caused it? How did it happen? Is there anything I could have done differently?” This is part of the reason why people have been so down on the M.M.R. vaccine, because that seems like a proximate cause. It’s something that usually happened shortly before the autism symptoms appeared. So our minds immediately leap to the fact that the vaccine causes autism, when in fact the evidence is strong that there is no link between the M.M.R. vaccine or any other vaccines and autism.

One caveat: Covering Health is not in the book review business, and I haven’t yet read Proofiness beyond what’s been excerpted.

Assessing acute care in America

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

The New York Times‘ Kevin Sack reports on a Health Affairs study that explores “acute medical care,” particularly initial visits for the fever and cough type of stuff that would traditionally go to a primary care physician. While 42 percent of such visits were still handled by a patient’s personal physician, a full 28 percent took place in emergency rooms. According to Sack, that number includes almost all visits made outside of typical office hours, as well as most visits made by patients without insurance.acute1

More than half of acute care visits made by patients without health insurance were to emergency rooms, which are required by federal law to screen any patient who arrives there and treat those deemed in serious jeopardy. Not only does that pose a heavy workload and financial burden on hospitals, but it means that basic care is being provided in a needlessly expensive setting, often after long waits and with little access to follow-up treatment.

Reform provisions such as medical homes, accountable care organizations and more money for primary care seek to rebalance acute care delivery in the United States, but Sack reports that the study’s authors fear it won’t be enough.

The authors warn that it might not be enough. “If history is any guide, things might not go as planned,” they wrote. “If primary care lags behind rising demand, patients will seek care elsewhere.”

Remember, free access to Health Affairs is one of many perks enjoyed by AHCJ members.

Foreign trial data used in 4/5 of approved drugs

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

FairWarning’s Lea Yu and The New York Times‘ Gardiner Harris drew our attention to a report from the HHS Office of Inspector General which reviewed 2008 data and found that “Eighty percent of approved marketing applications for drugs and biologics contained data from foreign clinical trials.” Furthermore, the OIG found, “Over half of clinical trial subjects and sites were located outside the United States.”

The OIG expects the trend to grow in the future, writing that “Western Europe accounted for most foreign clinical trial subjects and sites; however, Central and South America had the highest average number of subjects per site.”

The FDA only inspected a minuscule percentage of these foreign test sites, but says it has taken the OIG’s advice and is stepping up efforts to put together agreements with its foreign counterparts and to figure out other methods to standardize and evaluate these foreign trials.