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Consumer-Generated Clinical Trials? Research Minus Science = Gossip

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The internet, in democratizing knowledge, has led a lot of people to believe that it is also possible to democratize expertise.

- Commenter at Science Based Medicine

Regular readers of this blog know how passionate I am about protecting the public from misleading health information. I have witnessed first-hand many well-meaning attempts to “empower consumers” with Web 2.0 tools. Unfortunately, they were designed without a clear understanding of the scientific method, basic statistics, or in some cases, common sense.

Let me first say that I desperately want my patients to be knowledgeable about their disease or condition. The quality of their self-care depends on that, and I regularly point each of my patients to trusted sources of health information so that they can be fully informed about all aspects of their health. Informed decisions are founded upon good information. But when the foundation is corrupt – consumer empowerment collapses like a house of cards.

In a recent lecture on Health 2.0, it was suggested that websites that enable patients to “conduct their own clinical trials” are the bold new frontier of research. This assertion betrays a lack of understanding of basic scientific principles. In healthcare we often say, “the plural of anecdote is not data” and I would translate that to “research minus science equals gossip.” Let me give you some examples of Health 2.0 gone wild:

1. A rating tool was created to “empower” patients to score their medications (and user-generated treatment options) based on their perceived efficacy for their disease/condition. The treatments with the highest average scores would surely reflect the best option for a given disease/condition, right? Wrong. Every single pain syndrome (from headache to low back pain) suggested a narcotic was the most popular (and therefore “best”) treatment. If patients followed this system for determining their treatment options, we’d be swatting flies with cannon balls – not to mention being at risk for drug dependency and even abuse. Treatments must be carefully customized to the individual – genetic differences, allergy profiles, comorbid conditions, and psychosocial and financial considerations all play an important role in choosing the best treatment. Removing those subtleties from the decision-making process is a backwards step for healthcare.

2. An online tracker tool was created without the input of a clinician. The tool purported to “empower women” to manage menopause more effectively online. What on earth would a woman want to do to manage her menopause online, you might ask? Well apparently these young software developers strongly believed that a “hot flash tracker” would be just what women were looking for. The tool provided a graphical representation of the frequency and duration of hot flashes, so that the user could present this to her doctor. One small problem: hot flash management is a binary decision. Hot flashes either are so personally bothersome that a woman would decide to receive hormone therapy to reduce their effects, or the hot flashes are not bothersome enough to warrant treatment. It doesn’t matter how frequently they occur or how long they last. Another ill-conceived Health 2.0 tool.

When it comes to interpreting data, Barker Bausell does an admirable job of reviewing the most common reasons why people are misled to believe that there is a cause and effect relationship between a given intervention and outcome. In fact, the deck is stacked in favor of a perceived effect in any trial, so it’s important to be aware of these potential biases when interpreting results. Health 2.0 enthusiasts would do well to consider the following factors that create the potential for “false positives”in any clinical trial:

1. Natural History: most medical conditions have fluctuating symptoms and many improve on their own over time. Therefore, for many conditions, one would expect improvement during the course of study, regardless of treatment.

2. Regression to the Mean: people are more likely to join a research study when their illness/problem is at its worst during its natural history. Therefore, it is more likely that the symptoms will improve during the study than if they joined at times when symptoms were not as troublesome. Therefore, in any given study – there is a tendency for participants in particular to improve after joining.

3.  The Hawthorne Effect: people behave differently and experience treatment differently when they’re being studied. So for example, if people know they’re being observed regarding their work productivity, they’re likely to work harder during the research study. The enhanced results therefore, do not reflect typical behavior.

4. Limitations of Memory: studies have shown that people ascribe greater improvement of symptoms in retrospect. Research that relies on patient recall is in danger of increased false positive rates.

5. Experimenter Bias: it is difficult for researchers to treat all study subjects in an identical manner if they know which patient is receiving an experimental treatment versus a placebo. Their gestures and the way that they question the subjects may set up expectations of benefit. Also, scientists are eager to demonstrate positive results for publication purposes.

6. Experimental Attrition: people generally join research studies because they expect that they may benefit from the treatment they receive. If they suspect that they are in the placebo group, they are more likely to drop out of the study. This can influence the study results so that the sicker patients who are not finding benefit with the placebo drop out, leaving the milder cases to try to tease out their response to the intervention.

7. The Placebo Effect: I saved the most important artifact for last. The natural tendency for study subjects is to perceive that a treatment is effective. Previous research has shown that about 33% of study subjects will report that the placebo has a positive therapeutic effect of some sort.

In my opinion, the often-missing ingredient in Health 2.0 is the medical expert. Without our critical review and educated guidance, there is a greater risk of making irrelevant tools or perhaps even doing more harm than good. Let’s all work closely together to harness the power of the Internet for our common good. While research minus science = gossip, science minus consumers = inaction.

The Wounds Of War Are Not Always Easy To See

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“My daddy’s in Iraq, but he’s not dead yet.”

– 5-year-old son of a US Marine

Photo of FDA

Roughly 1.7 million Americans have been deployed to Iraq so far. An estimated 320,000 US military have received a traumatic brain injury in the Iraq war. Another 300,000 suffer from major depression or post traumatic stress disorder. The VA is not equipped to handle the mental health needs of all returning veterans and their families. What can we do?

The Give An Hour organization has challenged mental health professionals to donate 1 hour of their time/week to serve the needs of the military. If only 1 in 10 providers joined the program, there would be enough hours to cover the unmet needs.

I met with Dr. Barbara Romberg today to discuss her plans for the program. She envisions an in-office, phone, and online platform for Give An Hour. I sure hope that I can help out with the online platform one day.

If you’re a mental health professional, please consider joining the Give An Hour initiative. Our troops risked their lives for us, and others have sustained life-long injuries – some visible, some invisible.

And there are little boys out there, wondering if this is the day their daddy will die.

Let’s consider how we can be of comfort to those who are suffering on this Veterans Day.

The Ultimate Criterion For A Hospital “Never Event”

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As many of you know, I’ve been pretty upset about the “never events” policy put forward by CMS. That’s because they took a theoretically reasonable punitive rule (Medicare will not pay hospitals for patient care related to gross medical errors, aka “never events,” like wrong-side surgery) and made it far too general (never events include delirium, falls, and any infection – even a cold). It is absolutely impossible to prevent these sorts of things 100% of the time. So how should “never events” be defined?

The Happy Hospitalist nails it:

Can the never event happen at home? If the answer is yes, it cannot be a never event. It is a natural event. Even the criminal events that nobody can foresee are considered never events. Tell me how a hospital can prevent a random crazy family member or hospital guest from going berserk and assaulting an employee or patient. It’s impossible to predict or prevent.

Who Should Determine Drug Labeling Language: Juries Or The FDA?

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Photo of FDA

Wyeth vs. Levine is an important legal case being tried before the US Supreme Court. You may have read about the lawsuit in the New York Times, NEJM, JAMA, the Wall Street Journal, or my own blog. It revolves around the tragic story of a woman (Ms. Levine) who experienced an extremely rare side effect (severe tissue damage resulting in the amputation of her right arm) because a drug was administered improperly (into an artery rather than a vein). Ms. Levine is arguing that her injury could have been avoided if the drug label had stronger warning language, and the Vermont Supreme Court ruled in her favor, awarding her $7 million. The court ruled that a jury in the state of Vermont had the right to hold Wyeth accountable for a different labeling standard than the one approved by the FDA.

The plot thickens, however, in that Wyeth’s FDA-approved label very clearly discourages injection of their drug into or near an artery, and it also describes the potential consequence (including gangrene) of such an action. The FDA approved Wyeth’s label in full knowledge of the potential risks and benefits of the drug. In fact, Wyeth asked to strengthen the language of the label before Ms. Levine was injured, and the FDA declined to make the change because label changes are based on new information about a drug’s frequency or severity of risks. Wyeth had nothing new to disclose. Read more »

My Flu Shot: A Snapshot Of US Healthcare

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Photo of Flu Shot being administered

Election anxiety has America on the edge of its seat. I anticipated long lines and a lot of drama, so I voted early to avoid the rush. That left me with nothing election-related to do today, so I decided to head over to my local pharmacy and get a flu shot instead.

Last year the flu vaccine was only 50% effective because experts did not correctly predict which viral strains would victimize Americans. This year I have my fingers crossed that the Brisbane and Florida strains included in the vaccine will do the trick. After all, Influenza is the single leading cause of vaccine-preventable disease in the U.S., with estimates between 15 million and 60 million cases in the US a year among all age groups.  Influenza leads to 200,000 hospitalizations and about 36,000 deaths a year in the U.S., mostly in infants and the elderly. I’ll never forget the touching story of how one family lost their three and-a-half year-old daughter to the flu.

So I arrived at the pharmacy only to find a disorderly group of flu-shot seekers, pacing near the entrance to the retail clinic. About 20 minutes later a young woman with a clipboard and sign up sheets came out and started asking people what kind of insurance they had. When my turn came she informed me that my insurance plan was not participating, and suggested that I leave. I asked if I could pay out-of-pocket for the shot and she said that I could and gave me a consent form. More people arrived without any movement in the line, and I overheard one person commenting that the nearby polling booth wasn’t moving as slowly. Another customer decided to leave to go vote and then come back later for the shot.

Forty minutes later my name was called and I entered a small room littered with papers and syringe caps. I rolled up my right sleeve and asked the technician about his injection technique. I watched him carefully draw up half a cc of vaccine from a multiple-use bottle.

He then asked me how I was going to pay. I presented my credit card and he said that he only accepted cash or check. I said that I had no idea that credit cards weren’t accepted and he seemed surprised that I wasn’t aware of the retail clinic policy. A large envelope was leaning against his chair leg, full of $30 cash deposits for the shot. Read more »

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Latest Cartoon

Richmond, VA – In an effort to simplify inpatient medical billing, one area hospitalist group has determined that “altered mental status” (ICD-9 780.97) is the most efficient code for use in any patient work up.

“When you enter a hospital, you’re bound to have some kind of mental status change,” said Dr. Fishbinder, co-partner of Area Hospitalists, PLLC. “Whether it’s confusion about where your room is located in relationship to the visitor’s parking structure, frustration with being woken up every hour or two to check your vital signs, or just plain old fatigue from being sick, you are not thinking as clearly as before you were admitted. And that’s all the justification we need to order anything from drug and toxin screens, to blood cultures, brain MRIs, tagged red blood cell nuclear scans, or cardiac Holter monitoring. There really is no limit to what we can pursue with our tests.”

Common causes of mental status changes in the elderly include medicine-induced cognitive side effects, disorientation due to disruption in daily routines, age-related memory impairment, and urinary tract infections.

“The urinalysis is not a very exciting medical test,” stated Dr. Fishbinder. “It doesn’t matter that it’s cheap, fast, and most likely to provide an explanation for strange behavior in hospitalized patients. It’s really not as elegant as the testing involved in a chronic anemia or metabolic encephalopathy work up. I keep it in my back pocket in case all other tests are negative, including brain MRIs and PET scans.”

Nursing staff at Richmond Medical Hospital report that efforts to inform hospitalists about foul smelling urine have generally fallen on deaf ears. “I have tried to tell the hospitalists about cloudy or bloody urine that I see in patients who are undergoing extensive work ups for mental status changes,” reports nurse Sandy Anderson. “But they insist that ‘all urine smells bad’ and it’s really more of a red herring.”

Another nurse reports that delay in diagnosing urinary tract infections (while patients are scheduled for brain MRIs, nuclear scans, and biopsies) can lead to worsening symptoms which accelerate and expand testing. “Some of my patients are transferred to the ICU during the altered mental status work up,” states nurse Anita Misra. “The doctors seem to be very excited about the additional technology available to them in the intensive care setting. Between the central line placement, arterial blood gasses, and vast array of IV fluid and medication options, urosepsis is really an excellent entré into a whole new level of care.”

“As far as medicine-induced mental status changes are concerned,” added Dr. Fishbinder, “We’ve never seen a single case in the past 10 years. Today’s patients are incredibly resilient and can tolerate mixes of opioids, anti-depressants, anti-histamines, and benzodiazepines without any difficulty. We know this because most patients have been prescribed these cocktails and have been taking them for years.”

Patient family members have expressed gratitude for Dr. Fishbinder’s diagnostic process, and report that they are very pleased that he is doing everything in his power to “get to the bottom” of why their loved one isn’t as sharp as they used to be.

“I thought my mom was acting strange ever since she started taking stronger pain medicine for her arthritis,” says Nelly Hurtong, the daughter of one of Dr. Fishbinder’s inpatients. “But now I see that there are deeper reasons for her ‘altered mental status’ thanks to the brain MRI that showed some mild generalized atrophy.”

Hospital administrators praise Dr. Fishbinder as one of their top physicians. “He will do whatever it takes to figure out the true cause of patients’ cognitive impairments.” Says CEO, Daniel Griffiths. “And not only is that good medicine, it is great for our Press Ganey scores and our bottom line.”

As for the nursing staff, Griffiths offered a less glowing review. “It’s unfortunate that our nurses seem preoccupied with urine testing and medication reconciliation. I think it might be time for us to mandate further training to help them appreciate more of the medical nuances inherent in quality patient care.”

Dr. Fishbinder is in the process of creating a half-day seminar on ‘altered mental status in the inpatient setting,’ offering CME credits to physicians who enroll. Richmond Medical Hospital intends to sponsor Dr. Fishbinder’s course, and franchise it to other hospitals in the state, and ultimately nationally.

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Click here for a musical take on over-testing.

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