News, and Thoughts, on Comparative Effectiveness Research

Last week the U.S. Government Accountability Office (GAO) appointed several new members to the board of the Patient-Centered Outcomes Research Institute (PCORI). This group will oversee the application of comparative effectiveness research in health care reform. The panel’s composition was the subject of two posts today by Merrill Goozner, a long-standing observer of health care economics and journalist.

The group may play a key role in forming health care policy in the years ahead. According to the Patient Protection and Affordable Care Act, signed into law in March of this year, the PCORI is slated as a private, non-profit agency. The Institute’s purpose is:

to assist patients, clinicians, purchasers, and policy-makers in making informed health decisions by advancing the quality and relevance of evidence concerning the manner in which diseases, disorders, and other health conditions can effectively and appropriately be prevented, diagnosed, treated, monitored, and managed through research and evidence synthesis that considers variations in patient subpopulations, and the dissemination of research findings with respect to the relative health outcomes, clinical effectiveness, and appropriateness of the medical treatments, services, …”

This is no small task, to say the least.

What is comparative effectiveness research and why does it matter? The idea, basically, is to inform medical decisions with relevant data derived from well-designed clinical trials. This sort of research will provide the foundation for evidence-based medicine (EBM).

Some casual readers of this blog may not appreciate the extent to which I support these endeavors. I do, 100 percent. I say this for several reasons:

First, as a patient: We need to obtain as much information as possible on the best way to treat common and rare medical conditions that arise in humans. Knowing which treatments work, and don’t, ultimately will promote care that’s effective and diminish use of procedures, devices and medications that are ineffective and/or harmful.

Second, as a citizen: We don’t have a surplus of health-care resources to throw around, so to speak, in vain efforts to treat things that can’t be fixed.

As an oncologist, I was not one to give treatments that I didn’t believe would help a patient to feel better and, ideally, get well. Rather, I think the value of chemotherapy and other treatments needs be demonstrated in clinical trials prior to their routine administration, or that their worth be measured otherwise – such as by careful testing of how a drug might work in a subset of patients or even in a particular patient who has a condition like breast cancer and, upon careful monitoring, it is apparent that nothing helps except Avastin in her case.

Third, as a doctor: I would never want to cause avoidable harm to a patient. If a drug, device or procedure is ineffective or damaging, we shouldn’t often prescribe that, if ever. The best way to help patients get well, and harm them less, is by knowing what works and what doesn’t in most cases and by knowing the limitations of aggregated, statistically-valid data applied to individual patients.

Cost analyses are needed, too, but that’s a somewhat separate issue.

I wish the panel good luck in their important work ahead.

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No More Clipboards

“This kind of aid to decisions, spread across tens of thousands of decisions every day, leads to much, much lower costs with no intrusion on clinical autonomy”

– David Blumenthal, M.D., M.P.P., National Coordinator for Health Information Technology, U.S. Department of Health & Human Services, speaking at Weill-Cornell Medical College, Sept. 15, 2010

Last week I had the opportunity to hear Dr. David Blumenthal, head honcho for national health IT development, give a presentation on electronic health records (EHR), the future of health information technology (IT) and meaningful use. He spoke at a health policy colloquium at Weill-Cornell Medical College.

The points he made were clear – to begin, that health IT encompasses three areas of value:

1. Electronic Health Records (EHR)

2. Health Information Exchange (HIE)

3. Clinical Decision support (CDS)

Notes on Electronic Health Records:

“What do patients think if you ask them what’s the value of an EHR?” he half-asked the audience, a group of 250 or so, mainly physicians. He answered: “No more clipboards.”

The problem is that doctors are reluctant to take on electronic systems. Prior to the Health Information Technology for Economic and Clinical Health Act (or HITECH Act) of 2009, only 6 percent of physicians used fully-functional EHRs; only 20 percent used any EHR in their practices. Hospitals weren’t doing any better, he said. We’re running far behind our European counterparts in this arena.

“What’s the barrier?” he asked, and answered: “Money is numbers one through eight. Then logistics, technical problems and fear.”

Physicians, and hospitals, are concerned about buying into systems that will become obsolete. “And it’s a psychological issue,” he added. “That comes in whenever you’re asking people to change.”

The benefit of EHRs will be more efficient care and better health outcomes. As things stand, the quality of a nurse or doctor’s care is limited by the information they have about the patient in front of them. If providers have access to a patient’s compete record – say a cardiologist who’s evaluating a patient with notes provided by the primary care provider (PCP) – that’ll save both parties (patient and doctor) time, reduce duplication of tests and facilitate the coordination of care.

But the real value in EHR, he suggests, is in the system’s potential output of information: “Cutting down the rate of dissemination of conventional information from 17 years down to months to weeks.” What he means, as I understand it, is that by having current findings – published data and recommendations – linked to a patient’s electronic chart and diagnostic codes, the doctors will see and (hopefully) read new materials having to do with their patients’ medical conditions.

Notes on Health Information Exchange:

This component of health IT relies on having a common language. “If physicians don’t speak the same language, their computers won’t either.” He emphasized the need for standard terms using this example: there are many ways to say “high blood pressure” in English; for a health information exchange to be functional, we need to agree on one term and use it.

“Information exchange is a team sport,” he considered further. “It’s a challenge, and we’re not always good at voluntary collaboration.”

Next, he listed some HIE essentials:

– a vocabulary and statistics (I’m not sure why these were paired as he spoke);

– a way of packaging information that it can travel on the Internet;

– electronic directories, so information goes where it should;

– protocols for delivery;

– security in transit.

What will it take to get physicians on board with this kind of plan? “We need economic incentives, trust, and requirements,” he indicated. Mandates might, in the future, involve licensing boards and other accrediting agencies that would test physicians’ competency in HIT. In his view, managing electronic information is an essential skill for doctors to provide effective medical care.

Notes on Clinical Decision Support:

First, he listed the four elements – algorithms, statistics, guidelines and institutional policy – that can be incorporated into CDS to promote evidence-based practice.

Second, CDS allows for Computerized Provider Order Entry (CPOE). This is a huge benefit at several levels, but the surprise for some in the audience is that the process becomes an opportunity for continuing medical education (CME).

(The idea for doctors’ learning as they enter orders, which I think important, is this, and  I’ll provide my own example here: if you’re a physician about to order a drug, like a new antibiotic for a patient who’s got liver failure, the computerized system might have a pop-up message that says “are you sure you want to order that? Antibiotic X is metabolized by the liver…” And so you’d learn that the new antibiotic X is metabolized by the liver, and you might then look over a readily-accessible table of alternative antibiotics.)

“This caught my interest because it doesn’t diminish physicians’ autonomy,” he said. It just enables them to make decisions for their patients in the context of additional, current information. “The end goal is not to adopt technology, but to improve care.”

Notes on Meaningful Use:

He listed “five pillars of meaningful use”:

1. patient and family enlightenment

2. coordinated care

3. quality, safety and efficiency

4. privacy and security

5. improved public and population health

Then the discussion turned to some big money questions – including a critical issue having to do with companies competing to develop better EHR systems and physicians’ incentives. If you’d like to read more details about meaningful use, I recommend a recent perspective in the New England Journal of Medicine and a brief in the August issue of Health Affairs, to which Blumenthal referred during his informative talk.

As for me, I’m tired of clipboards. I look forward to expanded health IT and EHRs. In the future, patients will be more informed in their decisions, and doctors will be in theirs. Maybe, sometime…

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Eye Care

On Friday I had a slightly, subtly dehumanizing experience at the eye doctor. It’s no big deal, really, almost not worth mentioning –

It was an entirely ordinary set of events that triggered this near-rant from this determinately positive blogger. But maybe the commonality of it – the blandness of what happened when I visited the doctor the other day – typifies what’s as a tragedy in modern health care: the loss of caring.

eyeglasses on a table (Wikimedia Commons)

How it went was like this:

That morning I raced (or, rather, walked quickly – but dangerously quickly for a woman with poor balance and limited gait) to catch the bus to take the train to reach the optometrist’s office on time. And I did.

The office was crowded but not full. A receptionist sat behind a partly glass-enclosed counter with desks, fax machines and filing cabinets and other workers.

“Name, please” she asked me.

I told the woman my name.

She nodded. “Take a seat, someone will be right with you.”

I waited just over half an hour, during which time I had the opportunity to look around and listen.  A man, who said he’d undergone Lasik surgery the day prior was “seeing great” as he chatted enthusiastically with a couple to my left, one half of which was contemplating the procedure.

“It’s a miracle,” he said. “I’m having each done separately, one at a time.”

After a while I returned to the receptionist’s window and noticed a sign having to do with Botox injections and information on a doctor who might provide those.

My mind wandered… I never knew that eye doctors do Botox. Then again, maybe they don’t…Perhaps this office maintains a reciprocal relationship with an office that provides those, where the staff posts notices about Lasik surgery. Either way, the sign is nothing more than a business strategy, which is fair enough if you believe that health care can or should be run as a money-making enterprise. (I don’t.)

Back to my optometrist, who was running late (OK, usually forgivable, human):

How I first met this capable woman was through the long-ago care of my semi-retired ophthalmologist, a medical doctor (MD) who provided start-to-finish eye examinations and might, if you ever needed it, perform eye surgery. I trusted him and always felt good about visiting his office.

Some time ago he expanded his practice, taking in some less-established doctors and optometrists. The idea, I imagine, was to have a doctor of optometry (DO) carefully perform the initial eye exams, patiently fit vision-impaired people with just the right prescriptions for their lenses and, finally, refer any questions or concerns to the ophthalmologist in the same office. In this sort of setting, he could spend more of his time helping, and doing procedures, for patients with serious eye problems like glaucoma.

I was happy with the system for most of 10 years. I genuinely liked the optometrist, and still do – she did a terrific job evaluating my vision and optimizing my lenses. Around the time I had breast cancer, bald and walking with a needed cane, she looked into my eyes with extra care. She was sympathetic and spent an unusual amount of time making sure that my glasses would be all right, if nothing else.

The problem – what I’d diagnose as a change in the practice’s character – manifest a few years ago after the group moved to a new office space where there seems to be a lot more traffic. The carpeting on the floors, once fresh-appearing, is no longer. The waiting area, formerly quiet, has a TV broadcasting CNN. But I don’t care much about the floors or media selection.

What bugs me is that the office has expanded and become so systematized that when I go there I don’t feel like I’m visiting a doctor, the kind of professional who sincerely cares about my health. Instead I feel like a commodity, which I suppose I am.

Back to the visit:

As has happened before, a technician called my name  and asked me to come with him, so I did. He was young and unfamiliar. He told me his first name and, without further explanation, indicated where I should sit while he used a machine to take pictures of each retina, the light-receiving membranous surface at the back of the eyes. Next, he asked me to follow him into a small room where he proceeded to open my chart and question me, sketchily, about my recent medical history.

I wasn’t thrilled about sharing, but went along up until a point. Then, when he began to perform my eye evaluation – the exact sort of work that the optometrist used to spend her time with me doing, I asked him what was going on. Where was she?

“She doesn’t do this part any more. It’s been like that for a while. Now please, can you read the letters in the first row…”

So now the optometrist, who had for years assisted the ophthalmologist, has an assistant who would evaluate my vision instead. This saddened me, first and selfishly because I’d spent the better part of my morning going to see her so that she could check my eyes and write another ideal prescription I could rely on, and now I couldn’t count on that small part of my health care going smoothly ever again.

What’s more – and the bigger picture – is that she no longer has time for me and my eye glasses. I see this simultaneously as good and bad:

Good – I suppose, because we don’t really need people with MDs, and probably not even with DOs, for routine examinations and procedures that could be handled by someone with less training and who is, therefore, less valuable in our limited health care system.

Bad – It happens that the particular technician who started to check my eyesight did a poor job until I stopped him at that. The machine he used to project letters into a mirror shook so much that the small blurry letters in the lowest row wobbled clearly.

More generally – it’s bad because the time I once valued with my optometrist, as previously with the ophthalmologist, is gone. I guess it wasn’t sufficiently worthwhile for them to keep the relationship going as it was. No more annual, while they’re flipping the glass circles, questions like “how are your kids?” or “how’s your summer going” or a generous, once-credible “how are you feeling?”

My visit was almost reduced to a series of standard interactions with a technician of unknown credentials who I don’t expect to ever see again. I intercepted that, this time, but this scenario will surely recur, overwhelmingly, as health care delivery becomes more checklist-based and efficiency-minded.

—–

Some definitions – for those of you who aren’t completely confident in your knowledge of the distinctions among eye care specialists:

An ophthalmologist is a medical doctor (MD) who specializes in eye diseases and might perform eye surgery.

An optometrist is a professional who’s earned a doctor of optometry (DO). Usually this requires four years of post-graduate education that covers eye diseases, pharmacology, anatomy and more. Optometrists are trained, extensively, to examine the eyes, give prescriptions and perform certain procedures.

An optician is someone, typically a licensed professional, who helps people get the eye care they need and may prescribe eye glasses or contact lenses.

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Follow-up on the Harlem Heart Tests

Last month I examined the serious case of the overlooked heart tests at Harlem Hospital, as told initially in the New York Times. Since then, Times journalist Anemona Hartocollis has followed-up on the disorder at the medical center.

The problem is older and wider in scope than first indicated. Another 1,000 echocardiograms, beyond the first 4,000 told, went without review by a cardiologist.  The situation dates back to 2005, rather than 2007.  An additional 2,000 exams were reviewed by doctors who didn’t complete or sign reports on those studies, taking the total number of missing reports to the range of 7,000.

Concern persists that the errors arose due to administrative decisions and a shortage of cardiologists at the hospital. According to the paper:

…After the backlog was discovered, some doctors at Harlem Hospital said they had complained of understaffing to the administration but had been ignored. At one point, they said, the hospital was down to one cardiologist, who could not possibly review all of the echocardiograms.

Last week the hospital finished an internal investigation. Approximately 200 of the patients who had echocardiograms died before their tests were analyzed. According to the Times, a hospital spokeswoman stated that 14 patients received an incorrect diagnosis because the tests were mishandled.

Upon further contemplation, I’ve upped my lessons learned from 2 to 3:

1. For hospital administrators:

When doctors complain that they’re overworked, so much so they can’t meet their clinical responsibilities, don’t dismiss their concerns. A stressed system – with fewer clerks, escort workers, nurses, phlebotomists, aides and other workers – is a setup for rushed or frankly skipped work. These kinds of errors (delayed reports) might apply to how physicians interpret other kinds of complex medical tests including CT and MRI scans, pathology reports, bone marrow findings and other specialized evaluations.

Most physicians I know work long days, weekends and nights. Many work putting out one fire and then the next; it seems unlikely that this problem is isolated to a single department in one hospital. Rather, it’s a flag.

With so much new emphasis by law on restricting resident physicians’ hours, perhaps there’s insufficient attention to the workload of senior (“attending”) physicians. Their responsibilities should be limited, too, such that they can accomplish their work in a careful manner in a reasonable number of hours per week.

2. For doctors:

If neither you nor the patient has sufficient reason or even the inclination to check a test result, don’t order it. As I’ve suggested previously, we might save a lot (billions?) of dollars, besides precious medical resources – personnel, transport workers, clerks, machines and patients’ valuable time – which are limited whether we acknowledge that or not, by thinking more carefully about the tests we order.

This is not just about heart tests. I’m thinking of urine examinations, routine chest x-rays, nerve conduction studies, pulmonary function tests, swallowing tests, etc.

3. For patients:

What happened at Harlem Hospital is, among other things, a lapse in communication between patients and their physicians. The responsibility is shared. So if you don’t understand the reason for a test, ask for a better explanation. If you need a translator, ask for one. Ask for results. Be persistent.

Aspire to be pro-active, not passive in the health care system which, otherwise, may treat you like an object. “Own” yourself!

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On People Who Receive Care From Physicians

This week’s medical blog Grand Rounds will focus on posts having to do with “customer service” in health care. A problematic concept, it seems to me.

As a physician I never considered my patients as buyers or consumers. People came to me as their doctor, or I visited them in the hospital, and I thought my job was to identify if something was wrong and, if so, to identify the exact nature of the problem and then take care of the person as best I could. I didn’t contemplate the situation with a business mind-set.

As a patient I don’t think in shopping terms when I visit my doctors or my physical therapist, although I do sometimes pay significant bills. Even for lab services, such as at Quest Diagnostics, I don’t feel as if I’m making a purchase. Sure, I’m annoyed when there’s a long wait or my results are inexplicably delayed. And I sometimes prefer one technician to another. I might mind the costs, and if there’s an error in my bill I’ll challenge that. Still, I don’t perceive myself as a health care customer.

In medical journals a patient typically is called a person, an individual, a subject in a clinical trial or (unfortunately) a case. But in some blogs and other sources I’ve been reading lately, most often having to do with health care delivery or IT, consumers pop up constantly. A good example occurs in a recent article in the journal Health Affairs, “Evidence That Consumers Are Skeptical About Evidence-Based Health Care.” This study generated a small brouhaha (in my opinion undeserved) about the public’s alleged blind faith in their personal physicians’ advice.

In reviewing that story, what most surprised me most about the paper was not so much the study’s findings (limited) or sponsorship (by the National Business Group on Health), but its language. The term “consumer” or “consumers” appears in the article’s title, no fewer than 5 times in the 125-word abstract and a noteworthy 39 times in the main paper excluding captions, tables, and references.

My point, which is really a question, is whether people who seek out or need health care should be referred to as consumers or customers. My gut feeling is that neither term is appropriate. But then again, I don’t believe that medicine can be or should be run as a business. Here’s why:

If physicians are in a position that they might be influenced by a profit motive, they’re less likely to make decisions based in evidence and are more likely to make recommendations that include income-generating procedures and treatments.

If people receive medical care from physicians who might generate greater income by recommending particular treatments, procedures or referrals, they may not receive the most appropriate care. What’s more, they are less likely to trust that their physicians are providing sound advice. The upshot is that when expensive medical care is needed – say, for the sake of this discussion, in the case of a young person with a curable leukemia – some individuals may be less trusting of physicians if they think they are motivated by money and may decline helpful and even life-saving treatments. So the profit motive, or even the appearance of a possible profit motive, has the potential to lessen the patient-doctor relationship and undermine good care.

What’s worse, though, and even more off-putting, is that in a financial transaction for medical care – in which a person with or without an illness is referred to as a “consumer” in a business called the health care industry – what’s really happening is that the illness, and maybe even the patient who has an illness, is rendered a commodity.

Ultimately this is the greatest downside of medicine as a business. No. I don’t think patients should be considered as customers or clients by any other name.

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About Those Skipped Heart Test Results

Harlem Hospital Center stands just three miles or so north of my home. I know the place from the outside glancing in, as you might upon exiting from the subway station just paces from its open doors. The structure seems like one chamber of its neighborhood’s heart; within a few long blocks’ radii you’ll find rhythms generated in the Abyssinian Baptist Church; readings at the Schomburg Center and artery-clogging cuisine at the West 135th Street IHOP.

So I was saddened to hear about the missed heart studies. Or should I say unmissed? No one noticed when nearly 4,000 cardiac tests went unchecked at the Harlem center, a public hospital managed by the city’s Health and Hospitals Corporation. The skipped beats began sometime in 2007.

According to the Times report, that’s when hospital administrators, hurting perhaps for doctors sufficiently skilled in reading echocardiograms, OK’d a process by which technicians scanning the images would alert the responsible physicians if they noticed abnormalities. Otherwise they stored the results – pictures of the heart’s contractions, wall thickness and size, valves and some large vessels – for review, later.

Usually when a person gets an echocardiogram there’s a reason. Mine, for example, was done before I received a chemotherapy drug, adriamycin that can affect the heart’s function and, another time, before I had a major operation – basically to make sure my heart was strong enough to handle the stress of surgery. Years earlier, I’d had an echo (as doctors sometimes call these tests) to evaluate shortness of breath I experienced while pregnant. I like echocardiograms, as cardiac imaging methods go, although I must admit I find the blobby representations cryptic if not frankly rorschachian. These tests rely on ultrasound, the same technology we routinely use to examine unborn fetuses by projecting and canvassing sound waves. There’s no radioisotope or x-rays. Not even a magnet’s involved.

Echocardiogram reveals 4 heart chambers - adapted from Wikimedia Commons

What generally happens is that after the procedure a doctor, usually a cardiologist, inspects the images and provides a written assessment. Ideally, the test report reflects the reason for doing the procedure. So if a teenage soccer player has an echo to evaluate an episode of fainting on the field, the physician-reviewer would focus on structural heart abnormalities associated with sudden death in some young athletes. Sometimes the studies reveal enlargement of the heart; this can occur in alcoholics, in people with chronic forms of severe anemia like sickle cell disease, and in other conditions. For patients with atrial fibrillation – a disorder in which the heart flutters irregularly – doctors might look to see if there’s clot inside the heart’s walls that might, unmitigated, migrate through the arteries to the brain. Echocardiogram can assess the heart’s condition after a heart attack or in congestive heart failure. They can visualize holes in the heart chamber walls of infants, lapsed valves and more.

The Times story indicates that doctors didn’t review images for over half of the echocardiograms performed at Harlem Hospital since 2007. The medical center, staffed by doctors from Columbia University, had six attending cardiologists and six fellows in 1999, according to the paper. Now the hospital has only three full-time cardiologists and lacks a fellowship program. The hospital runs approximately 2,500 echocardiograms each year. Among those 4,000 patients whose tests went unread, some 200 have died since the time of the procedure. Hospital officials say it’s unlikely that any deaths are attributable to the lapse.

Since the story emerged last week, a squad of doctors has been scrambling to review the images. Heads rolled at Harlem Hospital: the clinical director was fired and the medical director has been demoted. An investigation, led by Dr. John N. Morley of the State Health Department, is underway. The press, or at least my local newspaper, is all over the matter.

So what’s to be learned from this oversight? My take’s two, so far:

1. It appears that at least some physicians working at Harlem Hospital felt it was understaffed and that they were too overworked to meet their clinical responsibilities, and that the administration did not adequately address their concerns. And while Health and Hospitals Corporation has indicated this problem is unique to that particular department – the echo lab – at one hospital, I’m not convinced.

Having worked for years in hospitals where cardiologists, gastroenterologists, hematologists and even pathologists spend much of their time putting out fires, so to speak, it’s scarily easy for me to envision how non-urgent tests could pile up without review. When hospitals operate with money as a bottom line, the difficult work doctors do doesn’t get easier. So we might blame individual physicians for not signing those reports. But I’d take the system to task, and not just at one Harlem hospital.

2. No one’s mentioned the patients’ role in all of this, which seems strange to me. These days, we expect that most patients will enter into discussions with their physicians about what tests they need done. Maybe at a medical center like Harlem Hospital, which serves a relatively poor population, the expectations differ regarding patients’ involvement in medical decisions. But if that is the case, those separate standards reflect another problem – of poor communication between physicians and their patients – equally demanding of our attention.

Lastly, as I’ve said previously here and elsewhere, we waste a lot of medical resources by ordering procedures without thinking. If a person undergoes a medical test there should be a reason for it, sufficient that either the doctor or the patient cares enough to find out the results.

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The Checklist and Future Culture of Medicine

Like many New Yorkers, I learned about the checklist in a magazine. I remember thinking, in late 2007, that maybe I’d seen something on the subject in The New England Journal. Indeed, a year earlier Dr. Peter Pronovost and colleagues reported on a simple, inexpensive strategy to save lives in a now-landmark article, “An Intervention to Decrease Catheter-Related Bloodstream Infections in the ICU.” Still, I’d missed the paper. Or at least I’d overlooked the significance.

Fortunately I had the opportunity to hear Pronovost, a still-youngish Professor at Johns Hopkins and recent MacArthur award recipient, speak at the annual meeting of the Association of Health Care Journalists in Chicago. After hearing his talk, I couldn’t wait to read more.

The checklist refers to 5 steps doctors can take to reduce the likelihood of patients getting serious infections from catheters placed in the ICU. One problem with Pronovost’s quintet is that it’s, well, unexciting. In his book Safe Patients, Smart Hospitals he reveals what a person shouldn’t forget before inserting an intravenous (IV) tube through a vein to the heart’s entryway:

1. wash hands with something like soap before the procedure;

2. set up a clean work area by covering the patient with a sterile drape and donning a gown, cap, mask and sterile gloves;

3. insert the catheter in a place other than the patient’s groin, if possible;

4. wipe down the patient’s skin with antiseptic fluid, chlorhexidine;

5. remove catheters that are no longer needed.

Pronovost, an intensive care specialist who holds an MD and a PhD in Public Health, first tested the checklist on his home turf, the surgical ICU at the Johns Hopkins Hospital in Baltimore, MD, in 2001. At the start, he distributed the list and asked ICU staff nurses to mark physicians’ compliance. It turned out the doctors skipped at least one step in over a third of central catheter placements. Next, he upped the list’s power by talking to Hopkins administrators. Nurses, they said, could call out a physician if they didn’t stick to the rules.

“This was revolutionary,” said Atul Gawande in the New Yorker.

What’s the big deal, you may wonder. It’s this – first, in the usual culture of medical practice, doctors don’t follow orders but give orders. And second, what’s implicit in the checklist is that physicians – even at one of the world’s most renowned medical facilities – are fallible to such a degree that their work can improve, and measurably so, by using something as ordinary as a checklist. It’s humbling.

“We don’t use checklists in health care because we still have his myth of perfection,” Pronovost said at the journalism conference.

In the year after Pronovost’s team implemented the checklist at Hopkins, the rate of central catheter infections there dropped from eleven percent to zero. As for how much good this did – the estimate runs at 43 infections spared, 8 deaths avoided and $2 million saved in one year at that hospital alone. The work expanded, soon to cover ICUs in most hospitals in the state of Michigan. There, after a lot of fuss, administrative hurdles and number crunching of results for some 375,757 catheter-days’ worth of infection data, the incidence of central line-associated bacterial infections snapped from 2.7, on average, for every 1000 days a patient was in a Michigan ICU with at least one central line, down to 0 (zero!).

These numbers are supported by impressive stats, with p-values falling below 0.002 in the original study. Estimates for the Keystone Initiative render some 1000 lives saved and $175 million in hospital costs reduced in a single year in Michigan. What’s more, all of this was accomplished without the use of expensive technology or additional ICU staffing.

This is a win/win intervention with huge implications. Every day some 90,000 people receive care in ICUs in North America. The annual incidence of catheter-related blood infections is 80,000 per year in the U.S.; the cost of treating each line infection runs around $45,000. In the U.S., we might save over $3 billion in expenses per year.

So why aren’t more hospitals and states adopting these and other, similar measures? Gawande addresses this, to some extent, in the New Yorker piece and in his book, The Checklist Manifesto. “There are hundreds, perhaps thousands, of things doctors do that are at least as dangerous and prone to human failure as putting central lines into I.C.U. patients,” he writes. “All have steps that are worth putting on a checklist and testing in routine care. The question – still unanswered – is whether medical culture will embrace the opportunity.”

Poka-yoke, a Japanese term for rendering a repetitive process mistake-proof, may be familiar to business students and corporate executives.  This concept, that simple strategies can reduce errors in highly complex works, is not the kind of thing most doctors pick up in med school. Rather, it remains foreign.

Pronovost is unusual because he examines health care delivery, in itself, rather than attempting an innovative cure for cancer or surgical method. His work just isn’t sexy enough to sell. I suspect that’s the reason he came to the health care journalism conference in Chicago and gave such an impassioned talk about the checklist, so that a few of us might help get the word out.

Things change, after all, and sometimes they do get better.

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A Routine Visit

Yesterday I visited my internist. I had no particular complaint. My back hurt no more than usual. The numbness in my left foot was neither better nor worse than it was last month. I wasn’t suffering from vertigo or abdominal pain. I went because I had an appointment to see her, nothing more.

Until just a few years ago, I rarely visited a doctor unless I was pregnant or sick. I called when there was a problem, and my doctor would see me in whatever unusual circumstances I was in. She checked on me when I was in the hospital, reviewing my labs and x-rays and whatever else there was to take in. When I had cancer, or needed pre-operative evaluations for surgery, she would check my heart and lungs and write a note as needed. Sometimes I went to her office for a flu shot.

The idea of an adult woman seeing the doctor for regular, what some might call “well,” care might seem strange or even wasteful. Some might consider it a luxury, which I suppose it is.

But I think some of the most informative doctors’ appointments are routine. That’s because there’s value in a doctor’s getting to know a patient when she’s not particularly ill, when she’s not in pain or terrified, when she’s feeling just as usual.

I’ve had the same primary care physician since 1987. She knows my habits, my fears and my quirks. She, as much as anyone, has a sense of how I’m doing – emotionally and physically. In some years, I’ve taken better care of myself than in others, and she’s very much aware of that. She examines me carefully and makes suggestions regarding diet, physical therapy and other everyday, non-urgent matters in my life that affect my health.

The best thing about having a doctor know me so well is a matter of trust. I rely on her not to solve what’s unsolvable, which of course no one can do, but to do the best she can to take care of me. If ever I’m very sick again, in a circumstance when I can’t make decisions for myself, I know she’ll act according to my interests. She’ll be able do so because she knows me, my usual self.

Having a doctor who knows you shouldn’t be a privilege. Really I wish it for everyone. It helps.

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9 + 1 Ways to Reduce Health Care Costs

Recently in the Times‘ “Patient Money” column, Lesley Alderman shared nine physicians’ views on how we might reduce our country’s health care mega-bill.

Here, I’ll review those comments, add my two cents to each, and then offer my suggestion (#10, last but not least)  regarding how I think we might reduce health medical costs in North America without compromising the quality of care doctors might provide.

The “answers” from the Times piece*:

1. Insure Catastrophes Only

I don’t see this as a solution, first because it would reduce insurance costs without reducing routine health care costs. This sort of system would discourage people from seeking preventive or routine care. And it might effectively punish those with non-catastrophic illnesses.

2. Change Malpractice Law

Yes, fear of malpractice triggers some extra medical testing, driving up costs, hassle and occasional risks. But I doubt the costs of malpractice fear-inspired medical testing amount to more than two percent of our health care budget, if that much.

This point is valid but is way over-emphasized by the AMA and others.

3. Counsel Nutrition

It’s hard to argue with your mom. (Eat your fruits and vegetables.)

This falls into the category of preventive care and better public education and is obviously a good idea. But given the anticipated physician shortage, I’m not sure we can afford for many doctors to spend a lot of time on this topic. Ultimately, this agenda may be best served by nutritionists who collaborate with physicians, schools, public health programs and other agencies.

4. Rely on Evidence…

I agree. But the evidence has to be fair, current and free of bias, including academic bias.

5. But Allow for Expertise

Yes.

6. Use ‘Integrative Medicine’

I’m open to acupuncture, herbs and other “alternative” remedies if people find them to be helpful, and even more so if there’s evidence to support their use. At the same time, I’m wary – there’s a huge amount for sale in this market.

As far as reducing health care costs, I doubt that more integrative medicine would be effective. I’m not persuaded by the evidence supporting hypnosis before surgery, as is mentioned in the Times piece. (And just in case it comes up, somewhere else  – I don’t think the purchase or use of candles has anything to do with health care in the absence of an electric black-out.)

7. Pay to Treat Child Obesity

Sure, someone should intervene to help heavy kids slim down before they become heavier adults. But it’s better to reduce obesity before it happens. (Back to the garden, suggestion #3, above).

8. Stop Over-treating

This huge idea, articulated by Dr. H. Gilbert Welch, is essential to reducing health care costs.

The problem is in establishing a consensus on what’s worth screening for, what’s worth treating, and what’s best left alone.

More on this later –

9. Restore the Humanity

“…There are doctors in training now who do not want to do a physical exam; they just want the lab tests and the echo-cardiogram on a heart patient, for example. But the laying on of hands is a powerful tool in establishing trust and in healing…”

The idea here, provided by Dr. Edward Hallowell, is that doctors order tests rather than knowing and examining their patients.

I couldn’t agree more completely.

*For the names of the physicians who were quoted in the New York Times, please check that column directly. (As I’ve excerpted from their comments, that were already condensed, I don’t think it appropriate to use their names out of context here.)

So, here’s my entry – if I’d been asked by the Times columnist what I think should be done to reduce health care costs, I’d say something like this:

(10) Think More, Do Less

For a swamped, chronically-running late physician (know a few?) it’s easy to order a standard set of tests (such as blood work, an electrocardiogram, a urine analysis and sometimes even a CT scan or MRI) before meeting a patient. So a doctor working in a hospital might wait for the labs before evaluating a patient in the emergency room. In an office, a consulting doctor might “lab” a person (yes, it’s been used as a verb) before thinking about the case.

Lately, patients are speaking up a bit in this regard, partly afraid of x-rays and partly afraid of the costs of so much testing. But, especially for hospitalized patients who are sometimes quite sick and may not be able to say no, or “doctor, do I really need that test?” most rely on their physicians to weigh the costs and potential benefits of what tests they order and treatments they prescribe. (This ties in with point #8, above.)

Stabs at efficiency like admission “order sets” for hospitalized patients can be useful in busy hospitals and may, indeed, render it less likely that a needed test is left out when blood is drawn. But for patients who are hospitalized for, say, two or three weeks at a time, with multiple tubes of blood removed each day, the tests add up. (Note:  some very sick patients do indeed need lots of blood tests, sometimes as often as every few hours.)

What I’m suggesting is that doctors shouldn’t order tests by default, in a routine sort of way. Excessive, daily blood work in hospitalized patients is just one example of this phenomenon. I’m aware of other, costlier examples.

Ultimately, what I think would help patients most, and would save lots of money, are smart and well-educated doctors who have the time to know their patients (#9, above) and think really hard. The more familiar a doctor is with a person and his or her disease, the more readily she’ll pick up on a change in the patient’s condition, and the more likely she’ll prescribe therapy that meshes with the patient’s values and that works, too. When a physician stays up-to-date, she’s more likely to establish a correct diagnosis and implement appropriate, effective treatment if needed.

So I think better medical education should be added to the list, along with greater compensation for physicians’ time in terms or thinking, reading and communicating with their patients.

minor rev 4/7/10, ES

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