Posts Tagged ‘JAMA’

Cancer Screening Part one: Incidentalomas & PSA

Monday, August 5th, 2013

I was reading the New York Times online today and noticed an important article in the Health section. A working group from the National Cancer Institute (NCI) had just published an article in the pre-print edition of JAMA that will likely change a highly significant face of medicine for many of us.

The issue is cancer diagnosis and, in many cases, over-diagnosis. Some pre-malignant conditions, in the viewpoint of this distinguished group, now come with the word cancer attached. That may lead to extensive testing, surgery or chemotherapy (or radiation therapy) and much mental anguish (and potential physical harm) for the patient involved.

Abnormalities, potentially malignant, can be discovered while scanning or even examining for something else. Dr. Peter Libby, chief of cardiovascular medicine at Brigham and Woman's Hospital in Boston, a Harvard medical school teaching facility, wrote a June 8, 2010 piece in The New York Times titled "The 'Incidentaloma' Problem with Medical Scans." A columnist for that paper had a CT scan for other reasons; a kidney mass was detected and a three-hour operation and eventually a six-inch scar ensued, yet the mass was benign. Dr. Libby's review of the medical literature with his area of expertise in mind showed that greater than eight percent of cardiovascular imaging studies revealed incidental findings that led to further medical procedures.

His conclusion was we're doing far too many CT scans.

Another physician wrote an April, 2011 piece in US News and World Report about a woman referred to him as a followup of an ER visit for abdominal pain that turned out to be viral gastritis. She too had a CT scan which showed her liver and intestines were normal, but one of her kidneys had a tiny mass, almost certainly a benign cyst. But the radiologist, while noting this lesion had all the features of something non-cancerous, covered his or her behind by saying, "Cannot rule out malignancy. Clinical correlation required." Translation: it was almost certainly nothing serious, but there was a very small chance that it might be cancer, and now it was the surgeon's job to make sure it wasn't.

But it's not just those advanced radiologic procedures, or MRIs or other tests; It's the mentality involved and that includes physical exams.

Let me give you a personal vignette. In 1969, as a second year clinical fellow in Nephrology, I went to see the Chief of Urology because of an abnormal lab test that involved my kidney function. A few questions later, he determined it was due to a diet I was on for a research project.

"But as long as you're here, Peter," he said, "I'll check your prostate."

It wasn't quite normal, a tad bigger than it should have been. He said, "You'll have a TURP (transurtheral resection of the prostate) by the time you're sixty"

He recommended I monitor my symptoms (I had none at the time) and get repeat examinations at intervals.

Well, I'm seventy-two and haven't had that surgical procedure. But what I did have, for many years, was a yearly digital prostate exam and, after 1994, a PSA (prostate specific antigen) blood test done periodically. At some point not only was the gland enlarged, but it the urologist involved thought it was also slightly asymmetric, so I had multiple biopsies, even though my PSA had consistently been less than 1.0, e.g., way below the level of concern.

All those biopsies showed benign (non-cancerous) tissue.

Now that I'm over seventy I don't ask for a PSA test, wouldn't agree with one if it were suggested and had my last digital exam of the gland several years ago.

But if I had that cancer at age 28 or 40, I would have been in real trouble. I would have been concerned about a malignancy that would likely kill me and would have welcomed any logical treatment for the disease. The NCI webpage on prostate cancer estimates nearly 240,000 new cases will be diagnosed in the United States this year and almost 30,000 men will die from that disease.

But the natural history of the tumor in most older men (>70 years old) is such that they will most likely die from something else (e.g., heart disease).

The NCI's fact sheet on the PSA test is well worth reading. An initial statement is that the higher a man's PSA level is, the more likely he has cancer of the prostate. Then the caveats begin: there are other reasons for the PSA to be elevated (I now have one of those, BPH or benign prostatic hypertrophy, an enlarged prostate). Half of all men over the age of fifty have BPH that is symptomatic with some hesitancy in starting their urine stream and/or a smaller stream.

If I had actually had cancer of the prostate at age sixty, my PSA may have been elevated. Then I would likely have had surgery to remove the tumor if it was localized to the gland and my physicians would then have periodically repeated my PSA testing to monitor if I had a recurrence of the neoplasm (a new and abnormal growth of tissue in some part of the body, especially as a characteristic of cancer).

A PSA level under 4.0 (nanograms/mililiter) was considered to be normal (my last PSA, done three years ago, was 0.7 ng/mL). In the past, if a man had a PSA level above 4.0 his physician  would have likely suggested biopsy to see if he had prostate cancer. But there are men who have that malignancy and yet have a PSA under 4.0 and, as I mentioned above, other, benign conditions can elevate the PSAwhile some medications used for BPH can lead to a lower PSA level. Only a quarter of those guys who have a prostate biopsy because of a PSA that's elevated actually have cancer of the gland.

But now there's considerable question whether PSA testing should be a routine, even though medicare and many private medical insurance plans cover a yearly screening using this test. The consensus seems to be that men should hear the pros and cons of the test before giving consent for it to be performed.

If 1,000 men in the 55 to 69 age range get screened with this test every one to four years, 100-200 will have false-positive results (no cancer, but an elevated PSA) and may have a biopsy recommended and, of course, worry about what's going on with their prostate.

One hundred ten, according to the website, will be diagnosed as having prostate cancer and nearly half of those will have treatment complications (The National Cancer Institute website mentions sexual dysfunction, bowel or bladder control issues and infections.)

Four to five will actually die from prostate cancer, but five of every 1,000 who don't have the screening will die from that cancer.

So the net is 1,000 have been screened to save 0-1 life.

And to further complicate things, the research done to determine what the normal upper limit of PSA is has largely been done in white men only.

So where do we go from here? There are studies being done to look at precursors of PSA, rate of change of PSA. free versus bound PSA etc.

We need  a better method to tell us if a man has a cancer or a benign prostate condition and to determine which prostate cancers are highly malignant fromt hose that are slow growing.

And all that's just one cancer-screening tool.


team-based home blood pressure control

Wednesday, July 10th, 2013

I was reading the July 3, 2013 edition of JAMA and came across an article and an editorial on better ways to manage elevated blood pressure (BP). The basic concept stems from data reviewed by the CDC in a 2012 online publication: high BP, AKA hypertension, is a major risk factor for both stroke and cardiovascular disease which jointly are the number one causes of preventable death in the United States.

Check your blood pressure and let your healthcare team know the reading

Check your blood pressure and let your healthcare team know the reading

Do you know what your BP is? Let's start from scratch with the kind of numbers you might hear about when you see your doctor or have your BP checked in other settings (e.g., the grocery store we usually shop at has a free automated system for BP measurement).

My BP usually runs about 116/ 68, but, similar to yours and everyone else's, my BP varies from those numbers from minute to minute. The top number, called my systolic pressure is always higher than the lower (diastolic pressure) It measures pressure in my arteries when my heart contracts (beats) while the bottom number measures it between heart beats when that muscular organ is resting and refilling with blood about to be pumped out to the rest of my body. The American Heart Association has a nice webpage explaining BP.

I'd like to see BPs under 120/80 and that seems to be a reasonable consensus figure in articles I read. Hypertension (HTN) is conventionally defined as a BP higher than 140/90 and the National Heart, Lung and Blood Institute's website calls any BP between 120/80 and 140/90 prehypertension. That's new to me, as the designation used to be applied to those with BPs between 130 and 139 for the upper number and 85 to 90 for the lower one. But I retired in 1998 and the BP goals changed in 2003.

My 2006 copy of Kaplan's Clinical Hypertension, the ninth edition of this amazing, mostly one-person work by a senior professor in Dallas (I just ordered a used copy of the 2010 tenth edition), mentions that 120-129/80-84 used to be considered normal  and 130-139/85-89 was thought to be borderline. But the 2003 report of the Seventh Joint National Committee  put BPs anywhere over 120/80 into the new category saying it wasn't a disease, but a designation to identify those at high risk of developing hypertension.

So what if one of your numbers is in this range, but not the other? The Harvard Medical School's Family Health Guide article on prehypertension notes that BPs vary from time to time and from arm to arm. If you have BP numbers over 120/80, the classification will depend on your average/usual readings, not the extremes. They suggest you always use the systolic or diastolic number that puts you in a higher category (normal, prehypertension, hypertension).  So, for example, if your average is 124/76 or 118/83, you're in the prehypertensive group

The CDC paper and others say the overall prevalence (i.e., the proportion of a population having a disease) of HTN in America is ~30%, but that increases with age with many estimates stating it's 70% in those of us 65 and older. That group is more prone to systolic HTN with only the upper number being elevated. That's still high BP and dangerous.

Treatment of HTN with diet, weight control and meds is associated with considerable decreases in the dire consequences of uncontrolled HTN: strokes, heart attacks and congestive heart failure (a condition where your heart can't pump out enough blood to keep up with the needs of your body).

All of us should be screened for HTN, even if our BP is less than 120/80. Screening intervals should be at least every two years for those with normal BP and every year for people with prehypertension. Your physician will also consider your other risk factors (weight, age, gender, your blood lipid levels {e.g., total cholesterol, HDL and LDL levels} presence or absence of diabetes, heart disease or chronic kidney disease, exercise patterns) and may, in some case recommend drug therapy even if your BP is <140/80. That's especially likely for those with any of the three chronic diseases I just mentioned.

So do we all need to be on medications if our BP is >140/80 (no, your physician may start with non-pharmacologic modalities such as cutting our salt intake) and if we do start on BP meds how often do we need to see our doc? After all, they're really busy these days and we may not be able to get an appointment for several months.

Let me start with my own experience (in the "Dark Ages") and then come up to the present.

When I was in my first Air Force assignment at Langley AFB, VA from 1970 to 1972, I set up a HTN clinic run by a public health nurse, an RN with extras training who didn't want to be a ward nurse. My immediate boss was a cardiologist and, after I set up protocols (e.g., which meds to start with, appropriate followup intervals for various levels of BP, when to call for help), our nurse felt quite comfortable running the BP clinic.

She didn't see other kinds of patients, got very savvy about HTN, read a lot of the current medical literature on the subject, was entirely at ease with calling either of her two consultants whenever she had a question and our HTN patient population could easily get appointments in her clinic.

Fast forward ~forty years.

In 2011 a Veterans Administration group from Durham (coincidentally a place I worked when I was a resident and nephrology fellow at Duke) published an article in the Archives of Internal Medicine (now called JAMA Internal Medicine). Its title was "Home Blood Pressure Management and Improved Blood Pressure Control: Results From A Randomized Controlled Trial."

In brief they followed nearly 600 HTN patients who were randomized into one of four groups. The first had usual care, i.e., being seen in a primary care clinic at intervals. The other three groups involved nurses who administered behavioral management concepts, worked with docs on medication management or did both. The patients had their BPs monitored at home with data transmitted to the researchers. Incidentally 48% of the patients involved were African American.

Overall the research group felt the intervention effects were moderate, but those patients who started with the worst BP control had much better resultant effects.

there are a number of options for HTN meds

there are a number of options for HTN meds

Now there's the new JAMA article, "Effect of Home Blood pressure Telemonitoring and Pharmacist Management on Blood pressure Control: A Cluster Randomized Clinical Trial." Researchers associated with an integrated health system in Minnesota using electronic medical records, noting that typically only half of HTN patients have adequately controlled BPs, followed 450 patients, roughly half of whom got usual care. The other half got home BP telemonitoring and had PhD pharmacologists following their data and making changes in their BP meds by a protocol worked out with physicians.

BP control was better in the latter group at 6 and 12 months and was even better 6 months after the year-long study ended.

Lesson one: other healthcare professionals can manage HTN. Lesson: doing this via home BP measurements may be the path of the future.

The very high-priced spread

Saturday, February 4th, 2012

This obese teenager could be headed for trouble

I've been concerned about our burgeoning problem of excessive weight, so when the Journal of the American Medical Association for February 1, 2012 arrived, I was intrigued by the variety of articles touching on the subject. Let me start with a disclaimer: I have no clear-cut special competence, no magic bullet for preventing or treating obesity in our children. I do think it's a major threat to the upcoming generations here and elsewhere in the world. I am also very aware that its opposite numbers, hunger and even starvation, threaten whole populations around the globe.

But my own background, both as a physician and as someone who has successfully fought weight issues (I weighed 218 in 1969 and 148 this morning), has made me concentrate on the American epidemic of eating to excess as a major area of my interest.

The first article dealt with kids and adolescents. A group of CDC researchers reported an update on obesity in American kids, giving data from 199 to 2010. The newest statistics show nearly ten percent of our infants and toddlers are obese and close to 17% of our kids ages two to nineteen. As the kids got older, more boys than girls were obese in this survey with over 4,000 participants.

Then there was an article titled "Weight Loss Stratagies for Adolescents," based on a Boston Children's Hospital Conference roughly a year ago. The MD, PhD Harvard Professor of pediatrics who discussed the issue began with the case history of a particular obese girl, a fourteen-year-old who was five foot six and weighed nearly 250 pounds (giving her a body mass index,BMI, of 40). Her adoptive parents were overweight themselves, but had to learn to "back off" in their attempts to control her diet. There is some early data that suggests that parents can help by providing health food choices in the home and facilitating enjoyable physical activity throughout the day (versus a fixed "exercise time).

I had seen an example of that with some former neighbors whose boys, in order to have their one hour of "screen time," had to be outside playing for several hours at a time. Both youngsters were lean.

One critical point to be made is avoiding focusing on obese kids only. A large Danish study, published in the New England Journal of Medicine in December, 2007,  followed over a quarter million children born in the 1930 to 1976 time period. Denmark established a national civil register of "vital statistics" in 1968 and enrolled everyone in the country, giving them a unique number, ironically termed their CPR number. Although that had nothing to do, I gather, with cardiopulmonary resuscitation, which is what I think CPR means, the study did look at risk factors for coronary heart disease.

When your heart's on fire, it may not be from love

The results are impressive and threatening: every one point increase in BMI across the spectrum was associated with an increased risk of coronary artery disease. A child didn't have to be fat to be at risk later on. One calculation estimated that a 13-year-old boy weighing 25 pounds more than the average had a one-third increase in the likelihood of having a heart attack before the age of sixty.

It's time to start helping our kids live leaner and longer, healthier lives.


Vindication? Part 1

Thursday, January 5th, 2012

One way to get lots of protein

Since the late 1990s when I invented a diet, or perhaps I should say an eating pattern, I've relied on one principal concept: Eat Less; Do More. I came upon this simple idea after listening to a group of medical professionals who were discussing which diet they should go on while they were simultaneously consuming huge portions at our hospital cafeteria.

One of them, I recalled, had tried a high-carb, low-protein diet the past year; losing nearly twenty pounds, then regained it all and more in a few months. Now she was going to attempt  to lose twenty-five pounds with a different approach, this one with an emphasis on protein. I had seen weight-loss plans come and go and didn't believe any of them were the answer, at least not for everyone. I remember coming home and saying to my wife, "Lynn, I've invented a new diet"

I explained it was simply, "Never finish anything; No snacks between (meals); Nothing after eight." I added, "Get lots of exercise."

I lost the seven pounds I had gained on a two-week vacation and didn't need my strategy again until early in 2009. Then I weighed 177 one morning, up three pounds from my normal weight since 1991. I attributed that to eating out four times in the prior week. But when I tried on a pair of good suit slacks, I realized the weight hadn't changed much, but the distribution sure had.

I went back to my eating plan, lost five pounds easily, then coasted a while before resuming the diet. Lynn bought me a digital scale and I weighed myself daily. I also started going to our gym six days a week. Eventually I shed thirty pounds and five inches off my waistline. At 147 pounds I was twenty-five under my usual high school weight. This morning, nearly two years later, I weighed 148.

I allow myself a three-pound zone of weight fluctuation, thinking that would account for fluid shifts and the occasional big splurge. Whenever I exceed 150 pounds I go back on my plan.

Then I read a Wall Street Journal article titled "New Ways Calories Can Add Up to Weight Gain: Study Challenges Idea That Varying Amounts Of Fat, Protein and Carbohydrates Are Key to Weight Loss." It quoted the Journal of the American Medical Association, AKA: JAMA. I went online and found the JAMA article and an accompanying editorial.

I read both pieces in detail, even finding a wild typo, "...their diets were returned to baseline energy levels and diet compositions (15% from protein, 35% from fat and 60% from carbohydrate)." I called the AMA and suggested they correct the numbers since they added to 110%.

Is a high-carb, low-protein diet safer?

But the basic premise of the study's data intrigued me. It's something I've believed for years, calories count, as opposed to what form those calories come in. But there's one extra facet: low-protein diets can be dangerous.

I'll analyze that in detail in my next post.