In healthcare today, a colonoscopy is considered by many to be the “gold standard” for diagnosing colorectal cancer. A colonoscopy is an invasive procedure that involves inserting a flexible, narrow tube into the rectum. It is used to look for benign or malignant polyps in the colon and rectum. Currently, a colonoscopy is believed to be the most accurate one-time use diagnostic test. However, while this is perhaps true, calling it a “gold standard” may be a bit of a stretch. It’s not only invasive, but also requires specific expertise, costs thousands of dollars, and carries risks. In fact, 3-5 patients in 1000 experience harmful effects of colonoscopies, such as a perforated colon or ulcer. In totality, it’s an uncomfortable, expensive, and sometimes dangerous test that requires a burdensome preparation process.
Other popular diagnostic and screening tests carry risks and also have flaws. A sigmoidoscopy, another popular invasive test, only examines the left side of the colon (rectum and sigmoid colon). Although the preparation is less tedious and the test is more comfortable, a sigmoidoscopy is only a partial exam. Therefore, cancer in the unexamined regions may not be detected. A virtual colonoscopy, a less invasive procedure relative to a colonoscopy, costs about $2,400 on average without health insurance. Some insurance companies will pay for the test, but they will only cover adults over 50 or with clear symptoms of colon cancer. Unfortunately, this means most young adults aren’t covered. Another less invasive test, called a Double Contrast Barium Enema (DCBE), carries a small risk of a perforated colon. Similar to a virtual colonoscopy, it also exposes the patient to a small amount of radiation.
Guaiac-based fecal occult blood tests (gFOBT) look for blood from hemoglobin based on a nonspecific peroxidase reaction. Because guaiac-based tests do not find most polyps and cancers, and have a high false-positive rate if dietary preparation is not thorough enough, they are no longer recommended. Cologuard, a fairly new screening test, looks for DNA mutations and blood in the stool. While some studies indicate promising results, other studies report inaccuracies in the test. Regardless, the current cost of Cologuard is $649, which is expensive compared to other at-home stool tests.
Due to the need for a more convenient and less expensive screening test, patients started using FIT or Fecal Immunochemical Test. FIT is currently the most popular blood test and is commonly used as the “first-line of defense” screening method. It tests for hidden blood in the stool, which is one of the earliest (if not the earliest) sign of colon cancer. When food waste brushes against the polyps, the polyps may bleed and the blood may become mixed with the stool. Unlike a colonoscopy, FIT is noninvasive, convenient, inexpensive, and has no risks. There are few if any dietary, drug, or dental procedure restrictions involved.
So, should we continue to consider a colonoscopy as the “gold standard?” It seems that it is only a gold standard for those who have health insurance and those who walk out of the gastroenterologist’s office risk-free. What happens to the 25% of Hispanics in the U.S. living in poverty? How do we screen the 12% of African Americans without health insurance? A $1,200 test is clearly not affordable for this population. Moreover, the current goal for colon cancer screening is 80% by 2018. Knowing there are at least 80,494,283 Americans ages 50 to 75 living in the US based on consensus data from 2010, and 0.5% of people will experience harmful effects of colonoscopies, that means more than 400,000 are expected to walk out of the hospital with a perforated colon, internal bleeding, or not walk out at all. We need solutions – not radical ones that completely eradicate colonoscopies, but instead alternatives that direct patients to colonoscopies only when necessary, and makes the entire process more efficient.
One solution that would lower the number of colonoscopies annually is the coupling of FIT and colonoscopy, so that a patient uses their FIT result to determine whether they need a colonoscopy. Using a massive pool of subjects, researchers in a study published last year had 513,283 Taiwanese adults participate in FIT screening between 1994 and 2007, and progressively analyzed the data for the next decade. In the study, the researchers found that integrating FIT screening was more effective than simply undergoing a colonoscopy without FIT screening first. Take the age group of 50 to 74 years. With just a colonoscopy, the NNS was 100. With the use of FIT first, the NNS dropped significantly to 12. This means that it only took 12 colonoscopies to find one colorectal cancer case when using FIT first. Taking a step further, the researchers made visible data showing a patient’s average risk for colorectal cancer and cancer latency (the time it would take to develop the cancer) simply based on FIT result and age. By using this solution and this new data, patients could avoid a colonoscopy if their FIT result showed little or no risk of cancer.
Some may disregard this idea due to doubts about FIT. However, more and more research continues to validate the accuracy of FIT, especially with successive use. For example, in the study using the Taiwanese population, FIT had a sensitivity performance of 93%, meaning only 7% of FIT results were false negatives. This number decreases significantly with continuous use of FIT. To elaborate, in a 2012 study called “Colonoscopy versus fecal immunochemical testing in colorectal-cancer screening,” 26,703 adults between the ages of 50 to 69 who underwent one colonoscopy were compared to 26,599 adults of the same age who had taken a FIT test every two years. At the end of ten years, the researchers found that the same percent of subjects had been diagnosed with colorectal cancer in both groups. Therefore, FIT is very accurate and perhaps, as some studies have suggested, as accurate as our current “gold standard” with successive use.
Like I have said before, colonoscopies should be done only when necessary. While using FIT as a screening process before any expensive diagnostic test is very effective, it isn’t a solution for those who actually need a colonoscopy – those showing clear symptoms of colon cancer or have a family history of cancer. In that case, there is solution number two. This solution requires more thought because it tackles an issue at the core of modern healthcare, which is our use of technology in a cost-effective manner.
The solution is to make colonoscopies more efficacious. To do so, we need to develop ways to achieve scale within the procedure. As we know, one inherent problem in the practice of providing colonoscopies is how to achieve optimal productivity in a practice that does not regularly have a full schedule of patients every day. The result is higher cost and higher price for the procedure.
What if we were to develop centers (ASC, Hospital, other sites) that had the ability (and willingness) to promote “screening days” (Bottoms Up Day) whereby large numbers of patients would be screened? The assumption is that this assembly line fashion and related protocol could significantly decrease the cost of a single colonoscopy and perhaps change the economic rationale as to what age is most appropriate to begin (and end) screening. It just seems that a wider use of FIT and more effective use of colonoscopy might get us on the track to finally see some remarkable advances in the total number of Americans screened and similar decreases in the incidence of the disease and adverse effects resulting from colonoscopies.