DC Medical Malpractice & Patient Safety Blog

A recent study published in Health Affairs either proves the superiority of U.S. medical care for cancer, or illustrates again how ignorance of basic statistical principles can lead to wrong conclusions.

The study found that U.S. cancer patients who were diagnosed between 1995 and 1999 lived, on average, 11.1 years after their diagnosis. Similar patients from 10 European countries lived an average 9.3 years. By 1999 (the last year the researchers analyzed), the average U.S. expenditure per cancer case was $70,000. That was nearly 50 percent higher than the cost in 1983. The cost in Europe was $44,000—16 percent higher for the same interval. Using standard figures for each extra year of life, the researchers concluded that the value of the U.S. survival gains outweighed the cost by an average $61,000 per case. They pronounced the additional spending on cancer care in the United States "worth it."

But a Reuters story analyzing the research begged to differ. "This study is pure folly," Dr. Don Berry, a biostatistician at MD Anderson Cancer Center in Houston, told Reuters. "It's completely misguided and it's dangerous. Not only are the authors' analyses flawed but their conclusions are also wrong."

Reuters also found the credentials of the study’s lead author, Tomas Philipson of the University of Chicago, wanting. He’s a health economist who served in the administration of President George W. Bush and advised the McCain presidential campaign on health-care issues. The point? The research might not be as unbiased as science demands.

Thirteen common cancers were examined in the study. Researchers analyzed survival—how long a patient lived after being diagnosed—in the period from 1983-1999. They looked at survival gains, or how long patients diagnosed in later years lived compared with those diagnosed earlier in the period. Those gains, they said, demonstrate the progress countries made in treating cancer.

Sounds reasonable. But survival data are tricky; they’re not cold, irrefutable numbers that can quantify success, thanks to something called lead-time bias.

Take two hypothetical people who both get the same kind of cancer on the same day. One of them gets an immediate diagnosis and lives another two years. The other is diagnosed eighteen months after the first, and lives only six months. Patient No. 1 had a "better" survival rate -- two years compared to the six months of Patient No. 2, but she didn't live any longer. She just knew she was sick earlier. Both patients lived two years. That's "lead-time bias" at work.

That’s why, as the Reuters analysis says, “Crediting medical care with ‘improving survival’ is therefore misleading, cancer experts have long argued. Lead-time bias makes it seem patients live longer, but the only thing that is longer is the number of years they know they have cancer…”

But Philipson’s team based its conclusions on survival data, arguing that because U.S. cancer mortality rates declined faster than those of Europe, they’re evidence of survival gains.

Berry articulated a related point with which readers of this blog will be familiar: that overdiagnosis is a problem. Cancer screening, particularly for breast and prostate cancers, is more common in the U.S. than in Europe, and the more testing, the more cancer will be found. But as Berry noted for Reuters, "These are cancers that tend to be slowly growing and many would never kill anyone."

Link here and here to read our posts about the misguided use of screenings for breast and prostate cancers, respectively.

If, in a diagnostic procedure, you find what you’re looking for, does that denote a successful test? Not if it makes a healthy person a cancer patient if the tumor otherwise is not life-threatening. Including such cases, whose numbers are higher in the U.S. than in Europe, makes survival data bogus.

The Health Affairs study showed survival gains in the U.S. versus Europe were greatest for prostate cancer; breast cancer claimed the second-best U.S. survival data--the two cancers where lead-time bias figures most prominently in overdiagnosis.

It’s interesting that Europe had the survival edge in data for melanoma and colorectal and uterine cancer survival gains.

According to Reuters, U.S. cancer mortality places the U.S. in the middle of countries reporting to the Organization for Economic Co-operation and Development.

If that’s not enough to prompt questions about the “Spend More! Live Longer!” theory of cancer survival, consider this: Even the study’s researchers concede that it’s impossible to state that improved survival is a direct result of spending money on cancer care. It might result from improved screenings that detect the “pseudo-disease,” or nonaggressive, nonthreatening tumors that artificially enhance survival data.

And Philpson said, “In the last decade, spending in the U.S. has increased more than in Europe. I would be extremely surprised if the survival gains haven't continued. But it is a much more open question whether that additional spending has been accompanied by an increase in longevity."

According to Reuters, in 2004 (the last year for which figures were available), the U.S. spent $72 billion on cancer care. It also noted that Philipson’s research was supported in part by Bristol-Myers Squibb Co. That company makes a melanoma drug, Yervoy, that costs $120,000 for a full course of treatment.

Certainly the cost of cancer drugs have increased. Dendreon Corp. makes Provenge for prostate cancer at $93,000 per treatment. Bristol and Eli Lilly and Co. make Erbitux at $100,000 per year. The researchers said their analysis "does not imply that all treatments are cost-effective."

Remember, Philipson is an economist. His scholarship concerns how much an additional year of life is worth. His researchers assumed the value to be $150,000 to $360,000.

No wonder economics is referred to as “the dismal science.”

Footnote: Here is a good explanation from "the Incidental Economist" blog of the "lead-time bias" problem in medical statistics and why the correct number to focus on is death rates, not survival rates. However, important caveat from the same blog: Survival rates are very important to any individual patient, because they can tell you how long YOU might live with a particular cancer at a particular stage. The importance of death rates is on the macro level: Does early screening bend the death curve down, or not?

Created by the health reform legislation of 2010, the Patient-Centered Outcomes Research Institute (PCORI) is charged with helping to determine the most effective treatments using objective, science-based standards. We introduced this agency to our readers last year.

Last week, as reported by Kaiser Health News, the PCORI issued its draft priorities and research agenda. What it didn’t do was enumerate specific diseases, treatments or procedures warranting further study.

The agency, which is composed of health care professionals and is not a governmental body, will oversee billions of dollars in research funding. In declining to cite in the draft specific areas of inquiry, it defines “a set of questions and topics” under five broad categories. They are:
1. comparing medical options;
2. improving the health-care system;
3. improving communication of research findings to patients and clinicians;
4. addressing health disparities; and
5. improving research methods.

We’ve written before about “comparative effectiveness research,” a concept that is the currency of PCORI. It’s about comparing different treatments for a given illness and compiling a body of knowledge from which doctors and patients can choose the best option for a given case.

Unfortunately, comparative effectiveness research is wearing a “kick me” sign for Republican lawmakers, who say it will be used to ration care. By failing to be disease-specific, as Kaiser Health News points out, the PCORI draft “sidesteps controversy that might arise from selecting certain diseases or treatments, but not others.” So instead of setting priorities for which diseases to study, researchers will submit questions they want answered in funding applications.

“If they get 1,000 grants submitted on 400 different topics, who is going to make the decision on, say, whether they should fund a project on low back pain, but not one on multiple sclerosis?” Robert Dubois, chief science officer for the National Pharmaceutical Council, told Kaiser Health News. His organization is a policy research group funded by the drug industry.
Dubois said the PCORI approach lends itself to one of the institute’s goals of creating a self-sustaining and robust research community, but he’s not alone in wanting funding to be directed as well toward “actual, unanswered clinical questions.”

Arnold Epstein, chairman of the Department of Health Policy and Management at Harvard University School of Public Health is a board member of PCORI. He said that the agency’s priorities are to get patients involved from the beginning and to fund research that incorporates solid scientific methods to illuminate the gaps in knowledge. The point is to enable patients and doctors to make informed decisions.

PCORI has $3 billion over the next decade to dole out for comparative effectiveness research. If you want to weigh in on how those funds should be spend, review the draft agenda here. Public comment is open through March 15, then a final version will be adopted. PCORI is staging a series of focus groups and sponsoring a national forum on Feb. 27 in Washington, D.C.

A recently introduced bill in the House of Representatives seeks to update legislation for “orphan” diseases and drugs. “Orphan” status denotes disorders that are extremely rare—generally afflicting 6,000 or fewer patients.

Pharmaceutical companies have no financial incentive to develop drugs and treatments for them because there aren’t enough users to pay the costs and sustain the consumer market. In order to encourage the development of drugs and other treatments for orphan diseases, the government provides incentives it doesn’t grant to more common disorders, such as easier and faster FDA approval, and extended periods for developing companies to market the drugs exclusively.

Another advantage lawmakers hope to grant to orphan drug development is the routine use of a “surrogate endpoint.” Before drugs are given FDA approval, generally they must pass rigorous clinical muster; they must be tested in studies that identify the risks and side effects as well as the benefits of the treatment using meaningful numbers of real subjects. A surrogate endpoint substitutes for a real, observable, provable clinical result—the surrogate endpoint doesn’t necessarily have a guaranteed relationship with a clinical result like actual cure or extension of life, but it has a “biomarker,” according to the National Institutes of Health, that researchers can accept as indicative of clinical benefit, harm or the lack thereof.

Surrogate markers are used if the number of subjects that might be suitable for a clinical trial is so small that it wouldn’t result in a statistically significant result. It would be impractical to conduct a clinical trial in such circumstances, but the people who suffer—the people stricken with an orphan disease—still need treatment, so the surrogate endpoint, the more relaxed standard, is critical to their well-being.

The proposed law is called the Unlocking Lifesaving Treatments for Rare-Diseases Act, or ULTRA. Specifically, according to the FDA Law Blog, it would permit the FDA to approve an application for a drug designated both as an orphan drug and as a fast-track product by allowing the surrogate endpoint standard.

Currently, the FDA is able to “fast track” approval for a product that addresses a serious or life-threatening illness, and when it provides a meaningful therapeutic benefit to patients beyond the existing treatments.

If a product meets the criteria, the FDA may grant marketing approval based on a demonstrated effect on a surrogate endpoint reasonably likely to predict clinical benefit. Also, the manufacturer must commit to completing studies after marketing approval that confirm its benefits.

Knowledge, they say, is power. It’s also a necessary tool for crafting cost-effective medical practices and protecting patient safety.

Medicare has an enormous claims database from which valuable knowledge can be mined. Finally, within about one year, employers, insurance companies and consumer groups will be able to unearth its information to produce “report cards” on doctors and hospitals.

This blog has championed this access to information, and the subject also figures mightily in “The Life You Save: Nine Steps to Finding the Best Medical Care and Avoiding the Worst,” my book about patient advocacy and medical mistakes.

As described in an Associated Press story, researching a health-care provider’s history in the Medicare database has not been possible before, thanks to a decades-old court decision. Releasing such information, the ruling read, violates the privacy of doctors. The medical establishment was vigorous and vocal in not wanting the people who pay for and receive its ministrations to know how its members rate.

Congress and the executive branch disagreed. For once, both parties were unified on this issue, and federal law has been revised to authorize access to the Medicare database.

What does this mean to the average patient? Suppose you need a knee replacement. Wouldn’t it be nice to compare potential surgeons by how many such procedures they’ve performed, if there were preventable complications and how many?

Experts who analyze Medicare’s billing records glean critical information that not only promotes quality care, it reduces cost and waste by promoting practitioners who are skilled and responsive. The delivery of health care is more efficient and outcomes improve when complications, readmissions and legal adventures are kept to a minimum.

"This is a giant step forward in making our health care system more transparent," said Marilyn Tavenner, Medicare's acting administrator of the newly accessible Medicare mother lode.

Performance reports could be available to consumers by the end of next year. Although individual doctors will be identified in the files, patient names and personal information will not.

Companies are keen to identify the economies of scale that will emerge from analyzing Medicare’s data as it applies to their insurance coverage. But some employer groups also want their workers to know how well their health-care providers are doing their jobs. An executive with the Business Roundtable, which represents CEOs of major corporations, told AP, "We want to make it understandable and usable by our employees. That has always been the goal."

The American Medical Association, which represents doctors, claimed that this data could be misleading or misunderstood by the average consumer. A surgeon with many patients who develop complications, for example, actually might be a top practitioner. He or she just might be willing to accept difficult cases others reject.

There are accommodations to the medical community—providers have the right to see their information before it is released publicly, and they will have 60 days to challenge it.

And Medicare promises to screen the analytical methods of groups requesting access to the data, which isn’t free—access to the files comes at a cost.

The price for transparency is worth it.

First published on Technorati as Finally, Accurate Report Cards on Doctors' Safety and Quality of Care.

Fact: About 1 in 20 patients contracts an infection related to his or her hospital care.

Fact: An average of 1 in 7 Medicare beneficiaries is harmed in the course of his or her care, costing the government an estimated $4.4 billion every year.

Fact: Nearly 1 in 5 Medicare patients discharged from the hospital is readmitted within 30 days. That’s approximately 2.6 million seniors at a cost of over $26 billion annually.

In April, Health and Human Services Secretary Kathleen Sebelius introduced a new program in which a coalition of health-care interests – hospitals, professional medical provider organizations, patient advocates, insurers, pharmaceutical companies – define and establish standards to turns these facts into old news.

Called the national Partnership for Patients (NPP), the program aims to address problems such as medication errors and lack of infection control that, Sebelius said, can happen “when hospitals do one thing, health plans do another and Medicare goes in a third direction.”

To see the generic pledge NPP members make, link here.

Sebelius said the administration’s Affordable Care Act would earmark as much as $1 billion in funding and considerable human resources to reach two primary goals for the next three years:

• Keep patients from getting injured or sicker. Reduce preventable hospital injuries by 40 percent, which will prevent 1.8 million injuries and save 60,000 lives; and


• Help patients heal without complication. Cut preventable hospital readmissions by 20 percent, which will save more than 1.6 million patients from complications prompting a return to the hospital.

That’s a ton of public money and staff time for a program to which only half of all U.S. hospitals have signed on, and only 22 assorted health-care organizations have made specific commitments to improve patient safety.

The effort is doomed to fail if it’s not embraced industry-wide with something more than lip service. It’s easy for a single establishment or organization to express support, and considerably more difficult for it to enumerate exactly how it intends to effect positive change.

Clearly, with so much energy and funding being directed to the NPP, the government must demand accountability. Sebelius’ promise that hospital Medicare and Medicaid payments would reward those delivering the best care nods toward that obligation, but patients and anybody who cares about hospital safety have a right to expect to be told the whole story as it unfolds. What have members promised to do? How is their progress being tracked and measured? What are the consequences of failure?

Who runs a hospital better, a physician or a businessperson? And which is better for patient safety and healthy outcomes?

As reported in the New York Times, the conventional wisdom that doctors should focus on patient care and managers should run the infrastructure was challenged by a study in the journal Social Science & Medicine.

Of the nearly 6,500 hospitals in the U.S., only 235 are run by physician administrators.

In a review of 300 top-ranked U.S. hospitals specializing in a variety of disorders, "overall hospital quality scores were about 25% higher when doctors ran the hospital, compared with other hospitals," The Times said. "For cancer care, doctor-run hospitals posted scores 33% higher.

Study author Dr. Amanda Goodall said the finding was consistent with corollary research showing that research universities perform better when led by outstanding scholars and that basketball teams perform better when led by former top players.

Goodall said the results may reflect the fact that doctors truly understand “the core business of health. ... M.D. CEOs are more likely to prioritize patients because patient care is at the heart of their education and working life as a physician. When it comes to making hard budgetary decisions or rationing choices, M.D. CEOs may be able to make more informed decisions.”

The study results, Goodall pointed out, show only an association between high hospital scores and doctor CEOs; they do not prove that doctors make better leaders. Maybe top hospitals are more likely to seek out doctor leaders; maybe top doctor managers seek out the best hospitals.

Bottom line: The best hospitals seem to choose physician executives, and lower-ranked hospitals usually have managers with a business or administrative background.

That's something for patients to consider if they have a choice of hospital facilities.

The cost of treating multiple sclerosis (MS) with a certain class of drugs is significantly higher than the cost of addressing the symptoms of MS with other therapies, according to a study in the journal Neurology.

Analyzing data from 844 individuals with early-stage MS and projecting health-care costs, including the cost of the drugs and lost productivity over a 10-year period, the study found that MS patients using disease-modifying drugs experienced modest health gains. But the cost associated with using such drugs is more than eight times higher than what is considered “reasonable” from a cost-effectiveness perspective.

“While it is clear that disease-modifying drugs are beneficial to some MS patients, those gains come at a tremendous economic cost,” said Katia Noyes, Ph.D., M.P.H., associate professor in the Department of Community and Preventive Medicine at the University of Rochester Medical Center and lead author of the study. “These results point to the need to continually evaluate the cost-effectiveness of new treatments in the interest of controlling health care costs.”

MS, a disease of the central nervous system, is the most common cause of neurological disability in young adults, causing muscle weakness, numbness or tingling in arms and legs, difficulty with coordination, balance and walking, blurred vision and slurred speech. The disease first manifests in cycles of acute symptoms followed by periods of remission and recovery. Eventually, the symptoms generally become debilitating.

Several new drugs introduced in the 1990s modified the course of the disease; traditional therapies primarily treat the symptoms of the disease. The drugs have been shown in large clinical studies to slow the progression of the disease and reduce relapses, but are associated with side effects and are very expensive -- as much as $30,000 per year.

The researchers employed a method called quality-adjusted life years (QALY) to evaluate the health effects of the drugs. QALY is a standard tool for evaluating disease burden by estimating the improved quality of life gained over time from a particular medication or course of therapy. Health policy experts generally accept that for an intervention to be judged “cost-effective” it should cost $100,000 or less to produce an extra QALY. According to the study, disease-modifying drugs for MS cost more than $800,000 per QALY.

And that came with only a modest improvement in health, according to the study. For example, MS patients taking one of the drugs gained about two quality-adjusted months over 10 years compared with patients who did not take disease-modifying drugs. They had an average of six out of 10 free of relapses compared with five years for patients not taking the drugs. The authors also found that the benefit to patients was greater if they began taking the drugs early during the onset of the disease.

U.S. News & World Report recently issued its ranking of Best Hospitals in the United States as well as a host of interpretive articles to help people refine their understanding of what constitutes "best" and how to locate the "best" hospital in your area.

The article "When a Hospital is Bad for You" explains that a facility offering excellent treatment for someone seeking treatment for, say, a broken leg can be less than the best place for someone who needs her aortic valve replaced.

Because the U.S. is a developed nation with regulatory oversight, few hospitals offer truly abysmal care. Such incompetence is rewarded with the withdrawal of credentials and a shuttered physical plant.

But there are important differences, and when it comes to your health, you can't be too careful about separating the merely good from the superior. As the magazine says, "Rates of postsurgical complications such as bleeding, infection, and sudden kidney failure vary surprisingly little, according to a recent study of nearly 200 hospitals across the country. What does differ are deaths from such complications," said John Birkmeyer, M.D., and the study's co-author.

Here, according U.S. News, are five signs that should prompt you to continue shopping for a hospital that meets your medical needs:

• 1. Low volume. This falls under the "practice makes perfect" category. A hospital should be able to provide figures for the most recent year, along with death and complication rates, and you should ask for them. If it doesn't have much experience with the procedure you need, go elsewhere. According to the Leapfrog Group, a business-sponsored organization that evaluates hospital performance, these are acceptable numbers, per year, for some common procedures:
  bypass surgery-- 450;
  coronary angioplasty and stenting--400;
  weight-loss surgery--125;
  aortic valve replacement--120;
  repair of abdominal aortic aneurism--50;
  removal of cancerous portions of esophagus and pancreas, respectively--13 and 11.

  If these numbers are low, ask your doctor about options.



• 2. Low surgeon volume. A hospital can register high-volume numbers for procedures, but individual surgeons might be low-volume practitioners. Some operations, such as aortic valve replacement, require lots of practice to maintain sharp skills. Your surgeon should be willing to supply the latest yearly total as well as rates of death and complications for your procedure. If not, or if he or she seems indignant at the request, seek alternatives.


• 3. No intensivist. Hospitals that employ specialists to care for patients in intensive care, versus the traditional practice of surgeons or other physicians taking charge of their intensive care patients show a decrease of deaths of 25% or more. Specializing in critical care, intensivists work primarily inside the ICU; surgeons, in contrast, spend most of their time in the OR. Hospitals with more than 250 beds should be able to summon an intensivist to the ICU within five minutes of being paged.


• 4. Not enough nurses. A study in the Journal of the American Medical Association found that a patient's risk of dying was much higher where nurses on surgery floors had more than seven patients during an average shift; the ideal number is four or fewer. Also, a nursing corps that holds four-year RN degrees versus two-year RN degrees notched a lower rate of surgery-related deaths. Patients should contact a hospital's director of nursing to find out its nurse-to-patient ratio.


• 5. Too many readmissions. This is a relative figure, so you must compare several hospitals to determine which has the lowest rate. The higher the rate of readmission, the greater the likelihood that a hospital struggles to coordinate care after discharge.

For more tips and practical websites for research, check out our firm's patient safety newsletter, which devoted an issue to finding the right hospital.

Only someone who suffers from asthma can understand the panic that comes with a sudden attack that feels as though you’re suffocating. Many such victims reach for an inhaler to dispense the drug albuterol, which provides lung relief.

Now, a new study published in the New England Journal of Medicine confirms not only the drug’s benefit, but a whole lot more -- about how caring can enhance treatment.

It found that asthma patients given a placebo (inert drug, aka fake treatment) or no treatment felt better despite measurable differences in lung function improvement as compared with those receiving drug treatment.

One of the study’s authors, Ted J. Kaptchuk, associate professor of medicine at Harvard Medical School, described for WebMD the elegance of the research: "Disease is what doctors search for--the underlying physical thing they can detect with labs and imaging and can express in hard numbers," he said. "Illness is what a patient experiences. ...There is a difference between what doctors find and what patients experience."

What the asthma study demonstrates is that making patients better requires treating illness as well as treating disease. Thirty-nine asthma patients stopped taking the drugs prescribed for their condition. Then they randomly underwent four different regimens during which lung function was tested regularly. They were:

• treatment with an albuterol inhaler;


• treatment with an inhaler with no active drug (a placebo);


• treatment with bogus acupuncture (the device appeared to puncture the skin like acupuncture needles, but didn’t); and


• no treatment.

As expected, the albuterol treatment registered improved lung function by 20%. And not unexpected was that the placebo treatments improved lung function somewhat--7%. It was interesting that patients who got no treatment also improved by 7%.

But truly surprising was how patients reported their condition. Asked how much better they felt, they said 50% better with the albuterol; 46% better after fake acupuncture and 45% better after using the inert inhaler. The latter two positive reports could be attributed to the “placebo effect,” which is often seen among study subjects who don’t know that they’re not receiving the real McCoy. But even after knowingly receiving no treatment, they said they felt 21% better.

As lead study author Michael E. Wechsler, M.D. told WebMD, "with this study we saw that part of taking care of the discomfort … is being there. …There is definitely some mind-body interaction in asthma that relates to the shortness of breath that patients feel."

People who study the placebo effect draw a distinction between objective medical outcomes (in this study, lung function) and the subjective medical outcomes of patient-based feelings (in this study, less shortness of breath).

They hope to raise consciousness that, sometimes, medical research dismisses subjective results to overwhelmingly favor objective results. But the artful practice of medicine addresses the reason for the suffering as well as the suffering itself.

That said, it would be foolish to ignore the whole picture painted by the asthma study. Treatment with a proven drug clearly resulted in superior lung function. And without the availability of that treatment, people will experience preventable asthma attacks. The goal is for patients to receive medical treatment and medical care.

MarylandReporter.com reports that the state will request an exemption from a new requirement by Medicare that hospitals demonstrate their quality of care. Taking effect Oct. 1, the requirement financially rewards hospitals that meet the new standard and penalizes those that don’t.

Robert Murray, executive director of the Health Services Cost Review Commission, said the state will document for the feds that “Maryland already has those programs in our system.” The commission has tracked the quality of hospital care for three years.

“The health reform act says you can be exempt from this regulation if you show you already meet or exceed [the national requirement]," Murray said.

Maryland is the only state in the country with a waiver from the Medicare payment methodology, which was negotiated in 1977 when Medicare agreed to pay hospitals in Maryland on the basis of commission-set rates. Other states since have been granted waivers but only Maryland has maintained its waiver.

Nearly 10 years ago, the National Quality Forum (NQF) published a report, Serious Reportable Events (SREs) in Healthcare. It identified 27 really horrible mistakes occurring in hospitals deemed largely preventable and of concern to both the public and health-care providers. Thanks to their extreme nature, these "adverse events" have come to be known colloquially as "never events." They include such medical misadventures as surgery on the wrong body part, festering bedsores acquired after admission, patient falls and life-threatening medication errors.

Establishing consensus of what constitutes preventable errors among everyone vested in the satisfactory delivery of health care--consumers, providers, researchers, etc.--facilitates clear accounting and resolution of them.

The report was revised in 2006, and once again the program is updating the list of SREs.

The take-home message this time is that SREs are an equal-opportunity aspect of practicing medicine that go beyond the confines of a hospital. The mission is expanding to collect data also from:

• ambulatory and office-based surgery centers;


• long-term care settings (including skilled nursing facilities); and


• physicians' offices.

The uniform approach to measurement helps to drive national improvement in patient safety through shared learning and prevention. More than half of the states use the NQF-endorsed list of SREs in their public reporting programs.

This update adds these "never events":

• death or serious injury of a newborn associated with labor or delivery in a low-risk pregnancy;


• patient death or serious injury resulting from the irretrievable loss of an irreplaceable biological specimen;


• patient death or serious injury resulting from failure to follow up or communicate laboratory, pathology or radiology test results; and


• death or serious injury of a patient or staff associated with the introduction of a metallic object into the MRI area.

The NQF report is widely embraced as what health-care monitor Bob Wachter calls "a dominant force in the patient safety field." It has, he notes, a real and measurable impact: Medicare, for example, has stopped paying hospitals the extra costs associated with SREs. "While the money being withheld is relatively small...," Wachter says, "the policy has captured the attention of administrators and providers everywhere."

Still, Wachter sees room for improvement, noting that:

• many events on the list lack standard definitions, leaving them subject to interpretation;


• unintended consequences can occur, such as preventing a fall by tethering a patient to the bed who otherwise would benefit from walking;


• the "no pay for errors" policy might prompt private insurers to suspend all payments after a facility reports an SRE;


• the list doesn't capture some mistakes, such as diagnostic errors and errors of overuse; and


• some serious adverse events are not known to be fully preventable.

Greater accountability can only encourage sustained efforts to protect patients from sloppy, incompetent and witless medical behavior. Efforts to refine the process are good for both the providers and those of us who receive medical care.

The push to make hospitals and doctors more accountable for health care quality means more attention must be paid to the accuracy and reliability of measures used to evaluate caregivers, according to Johns Hopkins patient safety expert Peter Pronovost.

There is little consensus as to which measures are scientifically valid and accurate assessments of quality, and this risks misinforming patients who may make decisions based on metrics that poorly reflect the state of health care, Pronovost wrote in the April issue of Health Affairs.

Pronovost supports the bipartisan effort to pay for value rather than volume with health care, but says serious work needs to be done to create a “whole library of outcome measures” such efforts require. Failure to create such measures “could ultimately lead to a failure to make improvements in hospitals where quality is judged to be better than it is,” he says.

Pronovost maintains that despite the substantial, persistent shortcomings in the quality of care that causes needless patient harm and increases health care costs, fixes can’t be put in place until rigorous scientific data show exactly where systems are broken, and until hard comparative evidence points to what types of repairs work best.

In the absence of such safety and efficacy science, he says, there will remain little consensus among hospitals and physicians about the best methods to judge quality or improvement. He points to overall hospital death rates as an example of an imperfect reflection of quality of care that in many cases is the only measure used.

Pronovost notes that physicians typically support the use of outcome measures if they are valid and reliable enough to enable conclusions to be drawn about the quality of care. Unfortunately, too often they aren’t.

For example, he says, some states penalize institutions for what they deem are preventable complications contracted by patients during their hospital stays, even though the hospitals don’t know exactly what they are being judged on because those states use a proprietary algorithm (commonly referred to as a "black box") created by a private company to determine which hospitals are “successful” and which ones should be sanctioned. Clinicians and the public end up not knowing how accurate the measures are or how they were calculated.

Source: The Johns Hopkins University Gazette

You can read the abstract of the article in Health Affairs here.