In today's Study of the Week, Vinay and I offer commentary on one of the most important trials of the year--the NordICC trial of screening colonoscopy.
I'd like to see a follow up on this discussion (now about year and a half later.)
I'm not sure risks associated with colonoscopy under anesthesia v colonoscopy without anesthesia fully factored.
Under anesthesia has 2 risks: the anesthesia itself (of course low but not zero and increasing with age) but also perforations. Without anesthesia patients aren't letting MD perforate because they tell MD: stop you're hurting me.
Key point about NORDICC is that standard of care in Europe is no anesthesia! A decade ago for first and only colonoscopy (so far was in 50s), I asked MD if I could do it without anesthesia - refused I'd have to reschedule with someone else! I balked.
I think complaints about prep overblown. (Gen X are babies.) But what if the prep itself is the benefit. Would really like RCT: prep plus sham v prep plus scope v prep plus flex sig v flex sig v prep plus cologuard (eg) v annual cologuard.
Great analysis. Even in the best case scenario and ARR (absolute risk reduction) is 0.3%, this would put NNT (number needed to treat) at 333 colonoscopies per year to save 1 patient from dying at the end of 10 years. If colonoscopy cost is $3000, this would equates to spending $1,000,000 (=333 x $3000) to save 1 person from dying from colon cancer every 10 years. If we interpolate, this means spending $10,000,000 to save 1 person from dying from colon cancer each year through widespread colonoscopy screening. So does colonoscopy screening save lives? YES, but at what cost!!! Colonoscopy is NOT a screening test, it's a diagnostic test. Screening test should be cheap, easy, and ideally with a decent sensitivity (can accept lower specificity). For example, d-dimer is a good screening test for PE/ DVT, while chest CTA and Doppler US are good diagnostic tests. Bottom line: colonoscopy is not a realistic screening test. Agree that we need a good RCT on FIT which is setup as a much better screening test (cheaper and easier to do).
I'd love to see the medical establishment look at population health in re: to colonoscopy. As pointed out by Dr Prasad, flexible sigmoidoscopy is also an excellent endoscopic screening test. It is less expensive, more widely available (or used to be/could easily be), and also does a good job screening for colon polyps. In addition to real data, I'd like to have our country's medical establishment look at the bigger picture here. Right now, we have diverted the bulk of GI specialists into the endoscopy suite to scope all day long. In the office, we are left with APPs evaluating everything else. The loss of GI specialist input/oversight - the work force - should be considered as well. This cannot be good for the overall health of the US population. If we expand the pool of endoscopists (for flex sig - used to be done in primary care offices - easily; could now train APPs to do them in GI office) - we could get the GI specialist back to the bedside. And get their diagnostic skills and clinical oversight back to where they are needed. That should really play some role in the cost/benefit analysis.
In addition, the cost differential should be fully considered - flex sig vs colonoscopy. Would likely be a better cost balance.
Doctors make a mistake when they downplay the stress, anxiety and discomfort caused by colonoscopy. It absolutely IS a big deal for many people. So much so that I know numerous people in their 60's who after having their first colonoscopy have sworn off ever having another one. If you gave people a choice between colonoscopy and sigmoidoscopy where choosing a sigmoidoscopy means a slightly higher risk of developing and/or dying of colon cancer many people would find that increased risk an acceptable trade off. Also GI doctors have a skewed perspective of this issue because they are desensitized to the downsides of colonoscopies to a degree.
I had 2 colonoscopies before age 40 and I'd be willing to accept a 5% higher risk of developing colon cancer and/or dying of colon cancer if it meant never having to have another colonoscopy. I would guess that many others feel the same way.
Don't know about others, but my screening kept finding polyps, none of significance. DNA tests didn't find a reason. All sort of diets over the years, still finding more than one or two. Many years (~15) of a yearly routine snipping and then one day in the yearly check, the doc found a mass, an aggressive mass - so much for slow growth. Out comes the colon with some lymph node involvement. Lucky to get laparoscopic surgery for sub-total removal. Had done so many, I chose minimal sedation so I could watch the work. Now 10 years out with no evident spread. Your mileage may vary.
Who knows if some other diagnostic technique would have discovered a cancer any earlier. I suspect I am atypical given many get screened and find a few or no polyps. Do we fully understand the creation of polyps which may become cancerous? Most people I know get their initial screening at age 50 and are told to check back at 55.
As a practicing oncologist, relatively simple guidelines are ignored by many ,possibly a majority of my peers. This includes inappropriate use of pet scans and eternal blood tests for surveillance of early stage breast cancer. If we can’t even get physicians to stop ordering a useless blood test, no way we’ll get a procedure like screening colonoscopy that makes millions for hospitals and physicians to go the way of menopausal HRT. Not going to happen unless payers stop paying.
Tangential question: hypothetically, if the the study had met the secondary endpoint for all-cause mortality, how would your interpretation of the results change?
Generally, positive secondary endpoints are hypothesis generating, and not practice changing.
Would the same generality have applied to this study if the secondary endpoint of all-cause mortality had been met?
You're not responsible for the widespread misuse and misunderstanding of trial designs and conclusions, Doctor, but mark my words; NordICC will be used to deny care in the same fashion as ISCHEMIA has been.
I'd go so far as to assert that articles such as this one, may reduce harmful misrepresentations, but history doesn't provide fertile soil within which to plant the seeds of optimism.
The control group has zero chance of colonoscopies' (screening and follow-up) adverse events. Those are relatively small but rise with age.
So, to be fair, add in the AE rate across the cohort and see if the 100% exposure to a smallish risk of perforation, etc. (plus what all the smarties add in other comments) doesn't balance out or obliterate any benefit from colonoscopy in toto. (Except, of course, for supporting the proctology cohort in their vehicle payments and kids' college tuition . . .):
<< 4.7 serious adverse events per 1,000 screening colonoscopies and 6.8 per 1,000 follow-up colonoscopies. Polypectomy increased the rate of serious adverse events (relative rate [RR], 2.64; 95% confidence interval [CI], 1.97-3.56). Older age was associated with increased risk of serious adverse events, after adjusting for polypectomy, gender, and indication. Compared to individuals aged 50-64 years, risk was elevated for those aged 65-74 (RR, 1.93; 95% CI, 1.40-2.65) and 75-85 (RR, 3.21; 95% CI 2.14-4.86). We observed similar age effects in individuals with and without significant comorbid conditions. >>
There is another component here that should also be recognized. Virtually all colonoscopies can be done in a properly arranged doctor's office. But hospitals go out of their way to have them done there, costing (for just the one payor for whom I consulted) an extra $5B/year, because hospitals charge more using something called HOPD (hospital outpatient department) rates.
This borders on fraud in every way and is solely a way to extract more money for the same services, delivered the same way. This is not unusual, but colonoscopy is one of the biggest offenders. So perhaps decreasing the "everyone must have a colonoscopy" mantra will also help save disproportionate dollars by disproportionately decreasing these procedures in hospitals.
Thank you for an excellent article. When one reads studies and analytics (especially for anyone not trained in this), and I suspect for almost everyone, there is a personal and emotional component, and a question left unanswered, because we all know someone who died of colorectal cancer or who at least was diagnosed and treated for same. One of my best friends, my stepdaughter's father, died of colon cancer about 3 years ago. His daughter blamed him (briefly) for not having done the standard colonoscopy in his 60's. I have no position that he would or would not have died if he did.
And of course, all studies like this give us no grip on the causes of said cancers, and for that I have long had many questions and find very little research of value.
Of particular interest to me is that there seems to be little interest in studying the effects of lifestyle components that really do affect health, primarily diet, exercise, and toxic exposure to various environments or occupations with specific toxic exposures. At the very least, I'm sure that digging through insurance data, for instance, would readily tell us what occupations are hazardous. But beyond that, there's one helluva lot of studying, slicing and dicing of data to do, to round out a better way to conceive of and deliver health care.
Another thing to think about. From this article "Consider 10,000 people who have a colonoscopy: 9,985 incur all the burden and costs and get no benefit." From another article "A study published by the Yale Center for Outcomes Research and Evaluation in 2010 showed that colonoscopy side effects serious enough to require a visit to a hospital occur in otherwise healthy people for an average 1.6% of procedures." And finally, a quick search of "Colonoscopy Death" on the internet indicates that the procedure, at least to my mind, is not worth the risk.,
I understand your positive expectation as regards the two trials currently being conducted in the US, as you generally trust and believe in the western medical system. However, seeing as how many in the field of research now believe that trials are mainly for the purpose of justifying pharmaceutical interventions, I doubt that any meaningful information will be found. And with the recent revelations regarding the circles of “arranged peer reviews” in medical literature, it seems that the actual trials don’t matter-only the “results”
I have consistently refused screening colonoscopy as there is zero history of cancer of any kind in my family for many generations. I eat well and exercise. Admittedly there are changes in available foods now than in the past. I did follow through with the fecal DNA testing (negative) when it became available for what it’s worth. This article is supportive for me. Thanks.
I'd like to see a follow up on this discussion (now about year and a half later.)
I'm not sure risks associated with colonoscopy under anesthesia v colonoscopy without anesthesia fully factored.
Under anesthesia has 2 risks: the anesthesia itself (of course low but not zero and increasing with age) but also perforations. Without anesthesia patients aren't letting MD perforate because they tell MD: stop you're hurting me.
Key point about NORDICC is that standard of care in Europe is no anesthesia! A decade ago for first and only colonoscopy (so far was in 50s), I asked MD if I could do it without anesthesia - refused I'd have to reschedule with someone else! I balked.
I think complaints about prep overblown. (Gen X are babies.) But what if the prep itself is the benefit. Would really like RCT: prep plus sham v prep plus scope v prep plus flex sig v flex sig v prep plus cologuard (eg) v annual cologuard.
Let's get this as correct as we can.
Great analysis. Even in the best case scenario and ARR (absolute risk reduction) is 0.3%, this would put NNT (number needed to treat) at 333 colonoscopies per year to save 1 patient from dying at the end of 10 years. If colonoscopy cost is $3000, this would equates to spending $1,000,000 (=333 x $3000) to save 1 person from dying from colon cancer every 10 years. If we interpolate, this means spending $10,000,000 to save 1 person from dying from colon cancer each year through widespread colonoscopy screening. So does colonoscopy screening save lives? YES, but at what cost!!! Colonoscopy is NOT a screening test, it's a diagnostic test. Screening test should be cheap, easy, and ideally with a decent sensitivity (can accept lower specificity). For example, d-dimer is a good screening test for PE/ DVT, while chest CTA and Doppler US are good diagnostic tests. Bottom line: colonoscopy is not a realistic screening test. Agree that we need a good RCT on FIT which is setup as a much better screening test (cheaper and easier to do).
I'd love to see the medical establishment look at population health in re: to colonoscopy. As pointed out by Dr Prasad, flexible sigmoidoscopy is also an excellent endoscopic screening test. It is less expensive, more widely available (or used to be/could easily be), and also does a good job screening for colon polyps. In addition to real data, I'd like to have our country's medical establishment look at the bigger picture here. Right now, we have diverted the bulk of GI specialists into the endoscopy suite to scope all day long. In the office, we are left with APPs evaluating everything else. The loss of GI specialist input/oversight - the work force - should be considered as well. This cannot be good for the overall health of the US population. If we expand the pool of endoscopists (for flex sig - used to be done in primary care offices - easily; could now train APPs to do them in GI office) - we could get the GI specialist back to the bedside. And get their diagnostic skills and clinical oversight back to where they are needed. That should really play some role in the cost/benefit analysis.
In addition, the cost differential should be fully considered - flex sig vs colonoscopy. Would likely be a better cost balance.
Doctors make a mistake when they downplay the stress, anxiety and discomfort caused by colonoscopy. It absolutely IS a big deal for many people. So much so that I know numerous people in their 60's who after having their first colonoscopy have sworn off ever having another one. If you gave people a choice between colonoscopy and sigmoidoscopy where choosing a sigmoidoscopy means a slightly higher risk of developing and/or dying of colon cancer many people would find that increased risk an acceptable trade off. Also GI doctors have a skewed perspective of this issue because they are desensitized to the downsides of colonoscopies to a degree.
I had 2 colonoscopies before age 40 and I'd be willing to accept a 5% higher risk of developing colon cancer and/or dying of colon cancer if it meant never having to have another colonoscopy. I would guess that many others feel the same way.
Don't know about others, but my screening kept finding polyps, none of significance. DNA tests didn't find a reason. All sort of diets over the years, still finding more than one or two. Many years (~15) of a yearly routine snipping and then one day in the yearly check, the doc found a mass, an aggressive mass - so much for slow growth. Out comes the colon with some lymph node involvement. Lucky to get laparoscopic surgery for sub-total removal. Had done so many, I chose minimal sedation so I could watch the work. Now 10 years out with no evident spread. Your mileage may vary.
Who knows if some other diagnostic technique would have discovered a cancer any earlier. I suspect I am atypical given many get screened and find a few or no polyps. Do we fully understand the creation of polyps which may become cancerous? Most people I know get their initial screening at age 50 and are told to check back at 55.
As a practicing oncologist, relatively simple guidelines are ignored by many ,possibly a majority of my peers. This includes inappropriate use of pet scans and eternal blood tests for surveillance of early stage breast cancer. If we can’t even get physicians to stop ordering a useless blood test, no way we’ll get a procedure like screening colonoscopy that makes millions for hospitals and physicians to go the way of menopausal HRT. Not going to happen unless payers stop paying.
Tangential question: hypothetically, if the the study had met the secondary endpoint for all-cause mortality, how would your interpretation of the results change?
Generally, positive secondary endpoints are hypothesis generating, and not practice changing.
Would the same generality have applied to this study if the secondary endpoint of all-cause mortality had been met?
You're not responsible for the widespread misuse and misunderstanding of trial designs and conclusions, Doctor, but mark my words; NordICC will be used to deny care in the same fashion as ISCHEMIA has been.
I'd go so far as to assert that articles such as this one, may reduce harmful misrepresentations, but history doesn't provide fertile soil within which to plant the seeds of optimism.
The control group has zero chance of colonoscopies' (screening and follow-up) adverse events. Those are relatively small but rise with age.
So, to be fair, add in the AE rate across the cohort and see if the 100% exposure to a smallish risk of perforation, etc. (plus what all the smarties add in other comments) doesn't balance out or obliterate any benefit from colonoscopy in toto. (Except, of course, for supporting the proctology cohort in their vehicle payments and kids' college tuition . . .):
<< 4.7 serious adverse events per 1,000 screening colonoscopies and 6.8 per 1,000 follow-up colonoscopies. Polypectomy increased the rate of serious adverse events (relative rate [RR], 2.64; 95% confidence interval [CI], 1.97-3.56). Older age was associated with increased risk of serious adverse events, after adjusting for polypectomy, gender, and indication. Compared to individuals aged 50-64 years, risk was elevated for those aged 65-74 (RR, 1.93; 95% CI, 1.40-2.65) and 75-85 (RR, 3.21; 95% CI 2.14-4.86). We observed similar age effects in individuals with and without significant comorbid conditions. >>
https://pubmed.ncbi.nlm.nih.gov/22105578/
There is another component here that should also be recognized. Virtually all colonoscopies can be done in a properly arranged doctor's office. But hospitals go out of their way to have them done there, costing (for just the one payor for whom I consulted) an extra $5B/year, because hospitals charge more using something called HOPD (hospital outpatient department) rates.
This borders on fraud in every way and is solely a way to extract more money for the same services, delivered the same way. This is not unusual, but colonoscopy is one of the biggest offenders. So perhaps decreasing the "everyone must have a colonoscopy" mantra will also help save disproportionate dollars by disproportionately decreasing these procedures in hospitals.
Thank you for an excellent article. When one reads studies and analytics (especially for anyone not trained in this), and I suspect for almost everyone, there is a personal and emotional component, and a question left unanswered, because we all know someone who died of colorectal cancer or who at least was diagnosed and treated for same. One of my best friends, my stepdaughter's father, died of colon cancer about 3 years ago. His daughter blamed him (briefly) for not having done the standard colonoscopy in his 60's. I have no position that he would or would not have died if he did.
And of course, all studies like this give us no grip on the causes of said cancers, and for that I have long had many questions and find very little research of value.
Of particular interest to me is that there seems to be little interest in studying the effects of lifestyle components that really do affect health, primarily diet, exercise, and toxic exposure to various environments or occupations with specific toxic exposures. At the very least, I'm sure that digging through insurance data, for instance, would readily tell us what occupations are hazardous. But beyond that, there's one helluva lot of studying, slicing and dicing of data to do, to round out a better way to conceive of and deliver health care.
Another thing to think about. From this article "Consider 10,000 people who have a colonoscopy: 9,985 incur all the burden and costs and get no benefit." From another article "A study published by the Yale Center for Outcomes Research and Evaluation in 2010 showed that colonoscopy side effects serious enough to require a visit to a hospital occur in otherwise healthy people for an average 1.6% of procedures." And finally, a quick search of "Colonoscopy Death" on the internet indicates that the procedure, at least to my mind, is not worth the risk.,
>> Screening colonoscopy has morphed into a right of passage into middle age.
"rite" of passage
I understand your positive expectation as regards the two trials currently being conducted in the US, as you generally trust and believe in the western medical system. However, seeing as how many in the field of research now believe that trials are mainly for the purpose of justifying pharmaceutical interventions, I doubt that any meaningful information will be found. And with the recent revelations regarding the circles of “arranged peer reviews” in medical literature, it seems that the actual trials don’t matter-only the “results”
Get ready for the hellstorm that is Katie Couric on a mission.
I have consistently refused screening colonoscopy as there is zero history of cancer of any kind in my family for many generations. I eat well and exercise. Admittedly there are changes in available foods now than in the past. I did follow through with the fecal DNA testing (negative) when it became available for what it’s worth. This article is supportive for me. Thanks.