How Often Do Screening Colonoscopies Result in a Complication?

Harlan Krumholz, MD is the director of the Yale Center for Outcomes Research and Evaluation (CORE). His team at Yale is being paid extraordinarily well to determine what works and what doesn’t in Medicare. Their data will theoretically allow Medicare to issue payment for services based on success rates of care without complications. His group is part of a national program promoted by the Center for Medicare Services (CMS) to spend less for more effective high quality care. This in my humble opinion is “voodoo” health care policy.

One of their areas of interest is trips to the emergency room or hospital within 7 – 14 days of a colonoscopy. They developed a formula to look at this problem and applied it to Medicare claims data in the year 2010 in NY, Nebraska, Florida and California. They found 1.6% of healthy individuals going for screening colonoscopy ended up at the hospital within seven days. They found wide variations in this rate coming from different facilities and different doctors. When the data is extrapolated to the 1.7 million Medicare beneficiaries undergoing screening colonoscopy annually it indicates there will be at least 27,000 unplanned hospital visits within seven days of the procedure.

Determining what causes complications of a screening procedure so we can determine a root cause and then prevent it is a good thing. However; the research needs to be done by independent groups not receiving funds from CMS which has a clear and strong conflict of interest!

We need to be looking at complications related to the choice of preparation, choice of colonoscopy, choice of anesthesia and whether polyps were removed and or biopsies taken. We additionally need to assess the definition of “low risk patient.”

Within the recommended age group for screening colonoscopies of 50-75 years old, very few patients are not taking prescription medications as well as supplements. The research needs to look at procedures such as CT Scan virtual colonoscopy and fecal immunochemical human occult blood testing as well for efficacy and complication rate.

There are currently DNA analysis tests of columnar epithelium colon cells sloughed during a normal bowel movement. Pre-cancerous polyps and colon cancer have distinctive DNA patterns that can be detected by looking at fecal material. There is no prep but the cost of $500 makes determining if it works and under what circumstances important. If it works then shouldn’t it be the screening test to determine who needs to have a colonoscopy? Yes, the research must be done but it must be done by agencies not affiliated with CMS with their stated goal of spending less for better service and better quality.

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Does Not Testing the PSA Lead to More Advanced Prostate Cancer?

Mortality from prostate cancer has diminished by almost 40% since the introduction of the PSA test in the late 1980’s. Much of this is due to the use of the PSA blood test for screening purposes. In 2011 The US Preventive Screening Task Force strongly condemned the use of PSA screening. They felt that we were finding too many inconsequential early malignancies that would not lead to death and were being over treated. In their eyes, prostate cancer treatment with surgery and or radiation carried a high price tag with multiple long term complications and the benefit of screening was not worth the risk. Prior to the USPSTF”s 2011 recommendation against screening for prostate cancer with a PSA there were 9000 – 12,000 new cases of prostate cancer diagnosed per month. In the month following the USPSTF recommendation not to screen with PSA the number of new cases dropped by almost 1400 a month or over 12%. Over the next year the decline in prostate cancer diagnosis was 37.9 % for low-risk prostate cancer, 28.1% for intermediate risk, 23.1 5 for high risk and 1.1% for non-localized cancer. Clearly if you do not look for a disease you will not find it.

In the December issue of the Journal of Urology, Daniel Barocas, MD, of Vanderbilt University and colleagues discussed the PSA testing controversy. They too noted that the consequences of not screening for intermediate and high risk prostate cancer by performing the PSA test may lead to individuals presenting with far more advanced disease that is more difficult to treat, has more complications and ultimately leads to disease related deaths. His position was debated by two major urologists in the editorial section of the journal with no firm conclusion being reached.

In an unrelated article, the Center for Medicare Services or CMS announced that it is considering penalizing physicians who test the PSA for screening in Medicare patients beginning in 2018 as part of their paying for value and quality. They said that physicians need to present their patients with an ABN (advanced beneficiary notice) stating that Medicare will not pay for this test, before the blood is drawn or face fines and penalties.

Men in their forties and older have been put in an uncomfortable and inappropriate position by health policy leaders. The truth is we are currently unsure how and when to test for prostate cancer in men with a normal digital rectal exam (DRE). The consequences of not paying for screening will not be known or understood for easily ten to fifteen years. It is clear that early stage disease has the option to be observed for progression with minimal consequences in the short term. Not enough time has elapsed for anyone to know the long term effects of this policy change. Unfortunately, men in this age group are all guinea pigs in the public health policy laboratory while the data to reach a firm scientific conclusion is assembled. The predominant policy today is spending less and doing less. With this in mind, it is best for men to see their doctor, have an annual digital rectal exam, discuss their family history of prostate disease and reach an individual decision on PSA screening appropriate for their unique situation rather than one based on large population policy.

A Blood Test for Irritable Bowel Syndrome?

Researchers presented a paper at the annual Digestive Disease Week meeting which introduced a commercial blood test which can help distinguish irritable bowel syndrome (IBS) from Cohn’s Disease or Ulcerative Colitis (Inflammatory Bowel Diseases) and Celiac Disease ( Gluten Sensitive Enteropathy). The test was especially effective in identifying the diarrhea predominant form of Irritable bowel syndrome. The issue was discussed today on line in the periodical MedPage Today.

Patients with Irritable Bowel Syndrome get sudden abdominal bloating, cramping and progressively watery loose bowel movements. The symptoms often occur after a meal and leave the patient frightened and exhausted. Symptoms can be prolonged and emotionally and physically incapacitate an individual. Until now physicians were forced to schedule barium enemas, small bowel x ray series and fiber optic examinations (sigmoidoscopies, colonoscopies, upper endoscopies) to distinguish irritable bowel syndrome from the more ominous inflammatory bowel diseases. Very often we needed to collect stool specimens to look for white blood cells, red blood cells, bacteria, parasites and chemical constituents. The cost, radiation exposure and risks of invasive procedures causing complications made the experience expensive and unpleasant but necessary.

The current blood tests, used in a trial of 2700 patients, detect antibodies to cytolethal distending toxin B and vinculin. Mark Pimental, MD of Cedars-Sinai Medic al Center in Los Angeles said to the tests were successful in distinguishing IBS from the other entities with specificity well above 90% and a positive predictive value of 98.6% allowing clinicians to rule out Crohn’s Disease or Ulcerative Colitis.

This is a step in the right direction but it remains to be seen when the test will be available locally through commercial labs and if it really will allow us to eliminate the many tests we now do to distinguish these problems from one another.

Real Food for Colonoscopy Preparation

Colonoscopies save lives. It is recommended that adults start having them at age 50 to detect pre malignant colon abnormalities and early colon cancer. For the physician performing the test, the colon must be clean of digested food and stool to observe the lining cells of the colon. The presence of fecal material blocks the view of the colonic mucosa. Those of us who have taken screening colonoscopies are well aware that the preparation for the test is far worse than the actual procedure (which you are usually sedated for in some manner.) Most colonoscopy preps involve starting a laxative the afternoon before the procedure and staying on clear liquids the whole day until the procedure is complete. Some preps ask you to drink large volumes of soapy flavored liquids. Others use smaller quantities of chemicals but the end result is frequent loose and watery stools until the stool looks the same on the way out as it does on the way in. At best the preparation is a necessary but unpleasant experience.

Corey Siegel, MD MS and Dough Knuth, RD along with Joshua Korzenik, MD, of Harvard Medical School have produced real food laced with PEG-3350 as a colonoscopy prep. They are so confident of this preps efficacy that they formed a company to produce it called Colonary Concepts Inc. Foods such as pasta, pretzels with dipping sauce, smoothies and nonalcoholic Pina coladas have been mixed with laxatives to produce a colonoscopy prep. They reported on their study results at Digestive Disease Week and in MedPage Today. According to the endocscopists who performed the studies on these patients, the colon was good to excellent in preparation for viewing. The patients had no problems with the prep and said they would gladly choose the real food prep again for future colonoscopies. Based on the favorable review of this prep a larger Phase II study is now in progress. This is a step forward for a necessary but uncomfortable screening procedure.

March Is Colon Cancer Awareness Month

Colon CancerColon Cancer is still the second leading cause of death from cancer in the United States despite numerous advances in screening and early detection. It is a disease that is found more commonly in black Americans with 46.7 cases per 100,000 individuals as compared to 38.9 cases per 100,000 individuals for Caucasian Americans. Death from colorectal cancer occurs in every 21.1 cases for African Americans and only 14.6 cases for white Americans.

Even with these dismal figures the cancer death rate from this disease has decreased by 22 percent over the last decade. We attribute this to increased awareness and increased screening.

All individuals should report a change in bowel habits to their doctor immediately. Blood stained stool is a cause for an immediate call to your physician. Generally at age 40 all adults should be having a digital rectal examination as part of a checkup. Stool occult blood slides or stool fecal immunoglobulin slides are used to screen for microscopic gastrointestinal tract bleeding. These tests involve placing a small smear of stool on a slide and submitting it to the lab where it is tested for microscopic blood loss. Usually a CBC or complete blood count is performed as well since gastrointestinal blood loss in small constant amounts usually produces a low blood count or anemia of the iron deficient variety.

Screening colonoscopies are recommended for all non-Black Americans at age 50. Due to the increased risk of colon cancer in Black Americans we recommend that they start screening colonoscopies at age 45. If you have a first degree relative who had colon cancer or precancerous polyps we ask that you start your screening at an age that is 10 years earlier than your relatives disease became apparent.

For those individuals unwilling to have a screening colonoscopy we can offer a CT Virtual Colonoscopy. The preparation is simpler than for a colonoscopy but the radiation dosage involved is equivalent to receiving ten years’ worth of chest x-rays all at once. If the virtual colonoscopy shows a polyp or a mass you will then need to undergo a traditional colonoscopy for biopsy and removal preceded by a traditional pre- colonoscopy bowel cleansing prep.

Cologuard is a new and attractive stool test that detects abnormal DNA associated with premalignant polyps and cancerous tumors. It is fairly new but readily available.

Numerous lifestyle choices can influence your development of colon cancer. Tobacco use is associated with an increased risk, as is drinking more than moderate alcohol. Red meat intake is associated with an increased risk of colon cancer with a 20% increase per 100 gram increase in red meat per day. Regular exercise and intake of high fiber food helps to decrease your risk of developing colon cancer.

March is colon cancer awareness month. Speak to your physician about your risk of developing this serious disease and ways to prevent it from developing. You can use the visit to establish your own personalized colon cancer screening surveillance schedule.

New Test for Colon Cancer Screening Approved

Colon Cancer RibbonThe Cologuard test is the first DNA based screening test for colorectal cancer that has received approval for use from the FDA and preliminary approval by Medicare to cover the cost of the test. The test detects hemoglobin ( a component of red blood cells) and abnormal DNA in cells picked up by stool . A positive test indicates a need for colonoscopy to identify or eliminate colon cancer as a possibility. We currently screen patients with the fecal occult blood slide test and the more sophisticated fecal immunochemical test or FIT. The new Cologuard detected 92% of colon cancers and 42% of advanced adenomatous colon polyps as compared with 74% and 24 % for FIT. While the Cologuard test was accurate in picking up more colon cancers than the FIT it had slightly more false positive tests than the traditional Fecal Occult Blood Slide.

The Center for Medicare Services ( CMS) is proposing allowing coverage of the DNA test once every three years for beneficiaries who are 50 – 85 years old, asymptomatic and have average risk of colorectal cancer. The new test adds another non-invasive means of screening for colon cancer. We will need to see the cost of the test to the individual patient and accumulate more data on its accuracy in the near future before it becomes a mainstay of colon cancer screening.

At the same time that Cologuard was approved, researchers at the University of Michigan in Ann Arbor published in the online journal Cancer Prevention Research, information showing that evaluation of the pattern of bacteria in the colon of patients improved performance and detection of colon cancer by more than 50% as compared to the Fecal Occult Blood Test alone. Researchers using DNA sequencing and polymerase chain reaction methods were able to identify distinctly different patterns of bacteria in colon cancer and pre-cancerous polyps than in patients with no colon lesions.

It is clear that as researchers apply DNA technology to cancer screening their ability to detect abnormalities and avoid invasive colorectal screening will improve. At the moment recommendations for screening colonoscopy at age 50 remain but as science moves forward that too may soon change.

American Cancer Society Issues Prostate Cancer Survivor Guidelines

Prostate CancerThe American Cancer Society issued guidelines on how prostate cancer should be followed once treatment has been provided with the bulk of the responsibility falling on primary care providers. There are 240,000 new prostate cancer diagnoses in United States each year. Most of these malignancies are localized or regional disease in older men with five year survivals approaching 100%. The guidelines are quite simple. Prostate cancer survivors should have a PSA measured every six months for the first five years after treatment. After five years an annual PSA level is considered sufficient. If the PSA is increasing a referral should be made to a specialist either a urologist skilled in treatment of prostate cancer or an oncologist. An annual digital examination should be part of the regimen of all survivors of prostate carcinoma. These new guidelines are consistent with recommendations made by the Institute of Medicine and the National Comprehensive Cancer Network.

As treatment of cancer becomes more successful we can expect to see more guidelines on how to medically screen and follow survivors. The recommendation that the responsibility fall on the shoulders of primary care physicians comes at a time when the nation faces a shortage of future primary care physicians. At the same time that recommendations call for PSA evaluation every six months for the first five years in prostate carcinoma survivors, there are no recommendations to screen healthy males for prostate cancer with PSA measurements. That is a separate and distinct controversial issue.