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Tuesday, May 25, 2004

Misguided Advocacy 

The American Medical News, May 24/31, 2004 says: 'Network for men' sends patients to the doctor.

My thoughts are in [italics]. They say:
Spike TV, a men's cable television network, will urge viewers to "check up or check out," as part of a campaign to improve men's health by urging them to go to the doctor annually.

An annual checkup ... is the easiest preventive step for all diseases...[Hmmm, apparently the annual visit can find every condition known to man.]

"Prostate. It isn't as bad as it sounds -- just a quick check of the tailpipe and a PSA blood test and you're set for a year," is one example of the card's message. [Never mind that this has unproven benefit and small but known risk.]

And even if every man does not need an annual exam, anything that encourages the idea is a good thing. [Ahhh, the classic advocacy position: All benefit and no risk.]
I think this information is meant to support the position but it strikes me as bad logic:
7,000,000 men have not visited a doctor in 10 years. [I suspect most of them are under 50 years of age and the screening benefits are therefore minimal. Instead, I think the current health care system is clearly not meeting their needs. Having this group come in every year would be unsatisfying for both of us.]

90% of testicular cancer is curable if caught early. [Are they saying annual visits will reduce testicle cancer mortality?]

Life expectancy for men is 74.7 years compared with 79.9 years for women. [So, if all men just went to the doctor more then they would live as long as women?]
Patients want good information. We have an obligation to give it to them. Consider this: JAMA -- Abstracts: Schwartz et al. 291 (1): 71, "Enthusiasm for Cancer Screening in the United States". The survey tells me too many patients would choose dubious interventions. The issue is not that some would but that most would. As long as medical information is so poorly presented we deserve the current system of misinformation.

Thursday, May 20, 2004

Yet Another Women's Health Issue 

The statin companies must be struggling with this from JAMA.

Their comment section says it all:

Our systematic review found that pharmacological lipid-lowering therapy, primarily with statin drugs, reduced the risk of CHD events for women with cardiovascular disease. In women without cardiovascular disease, the effect of lipid-lowering therapy was not clear because of the relatively small number of events in the primary prevention trials. For the trials reporting total mortality, lipid lowering did not appear to have a beneficial effect for women with or without previous cardiovascular disease over the 2.8- to 6-year study period in the available trials, although a longer length of follow-up may be necessary to find a reduction in mortality. In addition, the women in these studies were all relatively young, which might also limit the ability to find an effect on total mortality.
I don't know which is harder to believe, the lack of benefit or the limited number of high quality trials available.

I did not see any headlines that said primary prevention does not work in women.

Tuesday, May 18, 2004

Crestor Update 

Back in October I had concerns about using a new drug when we already had options with known benefits (including outcomes) and long term safety.

These stories (Yahoo! News - Public Citizen Seeks Cholesterol Drug Ban and Yahoo! News - AstraZeneca Cautions Doctors on High Dose Crestor) just remind me why it is better to be conservative with new interventions and why I hold me too products to a higher standard.

Monday, May 17, 2004

Family History and Cardiovascular Risk 

I recently calculated the 5 year cardiovascular risk for a middle aged male using the conventional risk factors (sex, age, diabetes, smoking, BP and total chol/HDL). He had some questions about the contribution of weight, exercise and family history. I told him those were already accounted for in the initial risk factors.

Besides, I've not have much luck finding any consistent age cut off for whatever "positive family history for heart disease" is.

This week, he sends me USATODAY.com - Parents' history major factor in heart disease. The highlights include:
A parent's history of early heart disease poses a major risk of heart disease and stroke, independent of cholesterol, blood pressure, diabetes and smoking, a new study shows.

A child is twice as likely to develop a serious heart or circulatory disease by middle age if one or both parents developed heart disease early in life, the study found.

The new study confirms what doctors have long believed — that genes contribute markedly to a person's risk of heart disease.
Just because a bunch of doctors believe something doesn't make it so. Here is the JAMA abstract and my thoughts from reading the whole article:
1. The design is prospective and overcomes previous cohort study limitations about self reporting.
2. They define premature parental cardiovascular disease as an event (coronary death, MI, coronary insufficiency, angina, CVA, claudication or cardiovascular death) before age 55 in a father or age 65 years in a mother. The USA Today article did not make this clear. I was pleased to see they also included a source for the age cut offs. Unfortunately, the definition mirrors the NCEP and JNC 7. The NCEP language is recommendation (category C = observational and strength 1 = very strong) but the evidence calls for the language of option. Observational studies should not guide therapy.
3. They say: "After multivariable adjustment for offspring age and all other risk factors, parental occurrence of CVD remained a significant predictor of offspring events in men. In women, the multivariable association was of borderline statistical significance. In age-adjusted and multivariable-adjusted analyses, the ORs for offspring CVD were higher for premature (Table 2) than for nonpremature parental CVD (Table 3)." I say: The risk doubles for men with family history of premature cardiovascular disease in one or both parents (OR 2.0, 95% CI 1.2-3.1) but it is almost entirely due to paternal risk. For offspring women, neither paternal (CI 0.7-3.9) or maternal (CI 0.8-3.4) family history reached statistical significance. I don't think "borderline" applies.
4. The article also states: "At very low and very high predicted risk, the increase in event rates associated with the presence of premature parental CVD was modest: offspring with favorable risk factor profiles were not at substantially increased risk despite parental CVD, and offspring with very unfavorable risk factor profiles remained at high risk even in the absence of parental CVD. In the intermediate quintiles, premature parental CVD was associated with significantly higher cardiovascular event rates (Figure 1)." I guess this is supposed to influence a shared decision making moment.
5. It was a pleasant surprise to see some ROC curve information. However, the addition of family history doesn't seem to make enough difference to me when they say: "Inclusion of premature parental CVD as a covariate altered the c statistic (area under the receiver operating characteristic curve) for our multivariable model predicting offspring CVD from 0.80 to 0.81 for men and from 0.81 to 0.82 for women. When men and women were combined, inclusion of premature parental CVD in the multivariable model altered the c statistic from 0.82 to 0.83."
6. At least in the Clinical Implications section they reveal: "Recent studies confirm that these traditional risk factors are present in almost all patients who develop CVD, and that they account for the majority of risk."
7. Since it is Framingham data, it is mostly a white cohort.
8. How big is the effect of "doubling" the risk for offspring men with a paternal family history? Of the 1128 offspring men, 164 had events which is 14.5%. This seems high enough to me to change a future exam room conversation. I don't mind spending the extra time with this group. I do question the time I spend trying to unlearn the misleading information in the other groups.

Friday, May 14, 2004

Drug Rep Tales #3 

The Adderall XR folks were in to see me.
The idea was to switch everybody over to XR.
The studies were either poor quality (unblinded) or RCT's about something irrelevant.

The company data relies on the "CGI-P: Conner's Global Index - Parent Version" which is ten questions. I wanted to know about validity. For example, what is the gold standard for ADHD?

This month's (May 2004) print version of The Journal of Family Practice (online is only up to April at this time) has a clinical inquiry: Does a short symptom checklist accurately diagnosis ADHD?

The Evidence-based answer is a "B" based on cohort studies and consensus opinion.

There is a nice table that does not include the same Conner's scale.

The recommendations from other organizations say:
The American Academy of Pediatrics states that the use of ADHD-specific checklists is a clinical option when evaluating children for ADHD. They caution that the ADHD scales may function less well in clinicians' offices than suggested by reported effect size and, in addition, rating scales are subject to bias and may convey a false sense of validity. They also state that it is not known if these scales provide additional information beyond a careful clinical assessment.

The Institute for Clinical Systems Improvement recommends use of at least 1 ADHD-specific rating scale to be administered to parents and teachers. This information should be used as part of the overall historical database for the child and should not be used as the sole criteria for diagnosis of ADHD.

Many sources agree that ADHD-specific rating scales allow a rapid and consistent collection of information from multiple sources. However, the information they provide is necessary, but not sufficient, to make a definitive diagnosis of ADHD. In addition to assisting in diagnosis, checklists can be helpful in monitoring treatment changes once a diagnosis has been established.
It is nice to try and be as objective as possible when making a diagnosis and monitoring the illness. However, the rating scales aren't valid enough to influence therapy.

Thursday, May 13, 2004

Transparency and The Rules 

My initial exposure to the term came from rule #7 from Crossing the Quality Chasm in the context of the The Institute for Healthcare Improvement's "Formulating New Rules to Redesign and Improve Care".

I have all ten rules posted in my exam rooms. They are, What Patients Should Expect from Their Health Care:
1. Beyond patient visits: You will have the care you need when you need it… whenever you need it. You will find help in many forms, not just in face-to-face visits. You will find help on the Internet, on the telephone, from many sources, by many routes, in the form you want it.

2. Individualization: You will be known and respected as an individual. Your choices and preferences will be sought and honored. The usual system of care will meet most of your needs. When your needs are special, the care will adapt to meet you on your own terms.

3. Control: The care system will take control only if and when you freely give permission.

4. Information: You can know what you wish to know, when you wish to know it. Your medical record is yours to keep, to read, and to understand. The rule is: “Nothing about you without you.”

5. Science: You will have care based on the best available scientific knowledge. The system promises you excellence as its standard. Your care will not vary illogically from doctor to doctor or from place to place. The system will promise you all the care that can help you, and will help you avoid care that cannot help you.

6. Safety: Errors in care will not harm you. You will be safe in the care system.

7. Transparency: Your care will be confidential, but the care system will not keep secrets from you. You can know whatever you wish to know about the care that affects you and your loved ones.

8. Anticipation: Your care will anticipate your needs and will help you find the help you need. You will experience proactive help, not just reactions, to help you restore and maintain your health.

9. Value: Your care will not waste your time or money. You will benefit from constant innovations, which will increase the value of care to you.

10. Cooperation: Those who provide care will cooperate and coordinate their work fully with each other and with you. The walls between professions and institutions will crumble, so that your experiences will become seamless. You will never feel lost.
Now consider this from the BMJ. I particularly like:
1. What isn't transparent is assumed to be biased, incompetent, or corrupt until proved otherwise.
2. ... increasing the degree of transparency in health care is inevitable, but ... transparency can never completely replace trust.
The rules remind me of the old joke:
It was Mickey's first night in the penitentiary. All of the inmates were in their cells and he was trying to become a bit more comfortable with his meager surroundings. As he leaned against the bars at the front of his cell, Mickey heard a voice call out "44" and the whole cell block erupted into laughter!

Another voice called "16" and again there was laughter.

A third voice called "62" which was followed by laughter throughout the block.

Mickey didn't know what was going on so he rapped on his cell wall.

"Yeah, whaddaya want?" came the gruff reply from next door. "What's going on, here?" asked Mickey.

"Well," said the other inmate, "down in the prison library there's only one joke book. We've all read the book so many times that we don't waste time telling the joke, we just call out it's number."

So the next day Mickey went down to the library and, sure enough, found the yellowed, dog-eared joke book and read it from cover to cover.

That night, wanting to be part of the group, Mickey confidently called out "44" and everyone laughed! He tried calling "16" and "62" and again there were peals of laughter. Then he called 57, and the halls rang with laughter.

After several minutes, one prisoner was still rolling on the floor laughing. More minutes - still laughing.

Mickey rapped on the cell wall.

"Yeah, waddaya want?" asked the other inmate.

"I don't understand it," asked Mickey, "Why is Tommy STILL laughing?"

"Well," said the gruff inmate, "He'd never heard that one before!"
I like an alternate punchline better when the new prisoner calls out a number and no one laughs because: "Some guys can tell a joke and some guys can't".

Whenever my patients have an unpleasant experience with the health care experience we go to the list. I recently had a patient with an unsatisfying experience with a specialist. Turns out she had a "4, 5 and 10".

Thursday, May 06, 2004

Obesity Surgery 

A recent New York Times - Operation for Obesity Leaves Some in Misery article left me thinking there is a better strategy.

To my knowledge the available literature is largely case series and observational in nature. Here is some of the article:
In the last year, Dr. Jensen said, he has seen a "tremendous surge" in patients like Ms. Culpepper who have complications from the surgery or have not been taught how to change their eating habits to adjust to the drastic changes in their digestive systems. Most of the patients had surgery at smaller hospitals that were not equipped for the problems, he said, adding that he sees as many as one such case a week.

A recent study suggests that the overall death rate is twice the figure of 0.5 to 1 percent that is usually cited, and higher still if a surgeon lacks experience.

Dr. Philip Schauer, director of bariatric surgery, the technical name for weight-loss surgery, at Magee-Womens Hospital of the University of Pittsburgh, which has one of the largest programs in the United States, said: "There are a lot of surgeons who are new to this field and frankly haven't had much training. It's the biggest problem we're having right now in this field."

In an interview last month, Dr. Schauer said, "I've got three patients now that were treated by other surgeons, with major complications."

To master a weight-loss operation, he added, a surgeon needs to perform it 100 times.

The National Institutes of Health has also begun a study of the surgery. And the professional group for doctors who perform weight-loss surgery, the American Society for Bariatric Surgery, has begun a program to identify "centers of excellence" for the operations, collect information on their results and use it to help others adopt the best surgical techniques.

At the Tufts New England Medical Center in Boston, Dr. Scott Shikora, an obesity surgeon, said he had seen one or two dozen patients with complications in the past few years, referred from other centers, usually smaller hospitals. "If you ask any major medical center, you'll hear the same story," Dr. Shikora said. "They are receiving patients who were mismanaged."

According to the National Institutes of Health, 10 to 20 percent of patients need additional surgery for such complications, and nearly 30 percent develop nutritional deficiencies that lead to conditions like anemia and bone loss.

Researchers at the University of Washington looked at the records of more than 66,000 obese people, including 3,328 who had bariatric surgery at various hospitals from 1987 to 2001. Within 30 days of the surgery, the death rate was 1.9 percent. Patients were 4.7 times as likely to die during a surgeon's first 19 procedures than after the surgeon had gained more experience.

Dr. David R. Flum, a gastrointestinal surgeon who led the study, said the real death rate might be higher than 2 percent, because the study did not include patients older than 65, and their risks appear higher. In addition, Dr. Flum said, the results published in medical journals often come from the best, most experienced surgeons.

"And usually, the best results have very little to do with what's going on in the community at large," he added. "It is particularly important that we acknowledge that the risk of death is higher than previously reported. Nobody's looking at new centers out there and their mortality rates."

Patients who survive the surgery do live longer than very obese who do not have the surgery, Dr. Flum's study found. After 15 years, patients who had the bypass were more likely to be alive than those who did not, 88.2 percent versus 83.7 percent.
My commentary:
1. The large/academic institutions seem to think they are better in the absence data.
2. I was unable to locate the U of Wash study by Dr. Flum in PubMed. The article implies the research was retrospective/observational. I figure it may help to understand the natural history of the disease and may quantify some safety issues. On the other hand, it isn't going to guide treatment decisions.
3. We need a prospective study to "see if it works".
4. In some ways, this situation reminds me of the recent moratorium on breast implants. What should have happened is the high quality research before the surgery became popular.
5. The NYT article experts claim there is a threshold number of surgeries to acquire competence. Yet, the number has to come from a wild guess and it varies between 19 and 100?
6. The solution is a randomized controlled trial (RCT) that measures the risks and benefits. Long term safety data would be nice. This situation exists because no one insisted on conclusive research before the surgery became popular.

Wednesday, May 05, 2004

Ovary Cancer Screening Hype 

A recent issue of the Family Practice News, April 1 2004 had several articles about ovary cancer screening.

First the conservative view:
1. The USPSTF says don't screen the general population and there is insufficient evidence in the high risk population. However, the last update was 1996.
2. The National Cancer Institute (NCI) also says there is insufficient evidence and they go on to say the benefits are unclear and there are known risks.

Now the hype headlines (all require free registration):
1. Detecting Early Ovarian Ca: Know Your Options. The article says:
The most effective thing a physician can do to detect ovarian cancer is to perform regular rectovaginal examinations on his or her patients, according to Dr. David A. Fishman, director of the National Ovarian Cancer Early Detection Program.

Unfortunately, that's not happening today, Dr. Fishman said at a meeting of the Obstetrical and Gynecological Assembly of Southern California.

Among more than 8,000 women at high risk for ovarian cancer enrolled in a National Ovarian Cancer Early Detection Program (NOCEDP) clinical study, nearly 40% of patients reported they had never had a rectovaginal examination in their lives. Their average age was 47.

“It was a shock to me,” he said. “Please do rectovaginal exams on your patients.”

Hopes that three-dimensional ultrasound with power Doppler would improve detection of early disease were dashed with results of a huge NOCEDP trial of 5,275 women at high risk for ovarian cancer. Sequential ultrasounds every 6 months detected 11 asymptomatic gynecologic cancers, but none were stage I ovarian cancers. In fact, the only stage I cancers identified were two cases of stage Ia, grade 1 uterine cancers.
Yet the Cancer.gov - Ovarian Cancer (PDQ�): Screening page says "The sensitivity and specificity of pelvic examination for the detection of ovarian cancer is unknown. Generally, detection by this method reveals advanced disease."

So if I understand, the same group that was unable to show a benefit with serial U/S thinks a pelvic exam is better?

2. Refined Techniques Brighten Ovarian Cancer Detection Hopes. This time they say:
Researchers who reported in 2002 that they could identify ovarian cancer by viewing serum protein patterns with a mass spectrometer now say that with advanced techniques, the test is 100% accurate.

“A blood test exists today that can identify ovarian cancer with 100% sensitivity and specificity,” Dr. David A. Fishman, director of the National Ovarian Cancer Early Detection Program, said at a meeting of the Obstetrical and Gynecological Assembly of Southern California.

Using this higher resolution technology, the researchers studied blood samples from 95 unaffected subjects and 153 ovarian cancer patients. They were able to accurately identify in every case whether the sample came from a cancer patient, reported Dr. Fishman, professor of gynecologic oncology at Northwestern University, Chicago.

These results have been validated using four mathematical models, and will be published in June.

In an interview, Dr. Fishman compared the methodology used in the 2002 study to a 286 processor for one's computer. The high resolution mass spectrometer used for the latest study is more like a Pentium 4 processor, he said.

The early test compared the pattern of low molecular weight serum proteins in samples from ovarian cancer patients and subjects who did not have cancer, using artificial intelligence to analyze over 150,000 patterns simultaneously within the samples. The test correctly identified 50 out of 50 samples from patients with ovarian cancer, including 18 representing difficult-to-detect stage I disease. It was less specific, however, incorrectly flagging as cancerous three samples from a pool of 66 women who did not have cancer.

The newer version of the test examines 1,000,000 parameters from each sample and clearly distinguished results from all cancer patients and subjects who were free of the disease.
Sorry, but I will wait for the validation with special attention toward stage I disease.

Tuesday, May 04, 2004

Subclinical Hypothyroidism and the ROC Curve 

A recent patient made me rethink some notions about the diagnosis of hypothyroidism. She told me her gyn discovered a TSH of "7" on some screening (?) lab work. This resulted in her previous PCP starting levo-thyroxine. I got involved when she changed PCP's.

This young woman told me she could not tell any difference in her well being and she was still struggling with her weight (current BMI = 25).

I suggested she stop the Rx and we follow her clinically. She was not initially receptive to the idea. After we talked she did agree to try. Since the visit I've found resources for both of us:

1. Specifically, the USPSTF recently recommended against screening in the first place.
2. Also, the Treatment of Subclinical Hypothyroidism Is Seldom Necessary . Figure 1 shows the problem with a TSH between 5 and 10.
3. Then I found a patient resource from the Annals of Internal Medicine. I will e-mail the link to the patient to reinforce what we talked about.

I plan to post more on the ROC curve later but it is important to keep in mind when the issue is diagnosis rather than intervention.

There is harm in labeling.

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