Amir Qaseem, MD, PhD, MHA; Carolyn J. Crandall, MD, MS; Reem A. Mustafa, MD, MPH, PhD; Lauri A. Hicks, DO; Timothy J. Wilt, MD, MPH *; for the Clinical Guidelines Committee of the American College of Physicians *
Note: Guidance statements are “guides” only and may not apply to all patients and all clinical situations. Thus, they are not intended to override clinicians' judgment. All ACP guidance statements are considered automatically withdrawn or invalid 5 years after publication, or once an update has been issued.
Disclaimer: The authors of this article are responsible for its contents, including any clinical or treatment recommendations. The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.
Acknowledgment: The CGC thanks the following members of the ACP CGC Public Panel for their review and comments on the paper from a nonclinician, public perspective: Cynthia Appley, Larry Curley, Ray Haeme, Billy Oglesby, James Pantelas, Missy Carson Smith, and Lelis Vernon.
Financial Support: Financial support for the development of this guidance statement comes exclusively from the ACP operating budget.
Disclosures: Authors have disclosed no conflicts of interest. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M19-0642. All financial and intellectual disclosures of interest were declared, and potential conflicts were discussed and managed according to CGC policy (28). Two committee members were recused from voting on recommendations because of moderate-level conflicts of interest: Dr. Lin (authored USPSTF systematic review) and Dr. Vijan (authored recent relevant publications). A record of disclosures of interest and management of conflicts of interest is kept for each CGC meeting and conference call and can be viewed at www.acponline.org/clinical_information/guidelines/guidelines/conflicts_cgc.htm.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that her spouse has stock options/holdings with Targeted Diagnostics and Therapeutics. Darren B. Taichman, MD, PhD, Executive Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Catharine B. Stack, PhD, MS, Deputy Editor, Statistics, reports that she has stock holdings in Pfizer, Johnson & Johnson, and Colgate-Palmolive. Christina C. Wee, MD, MPH, Deputy Editor, reports employment with Beth Israel Deaconess Medical Center. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Yu-Xiao Yang, MD, MSCE, Deputy Editor, reports that he has no financial relationships or interest to disclose.
Corresponding Author: Amir Qaseem, MD, PhD, MHA, American College of Physicians, 190 N. Independence Mall West, Philadelphia, PA 19106; e-mail, firstname.lastname@example.org.
Current Author Addresses: Dr. Qaseem: 190 N. Independence Mall West, Philadelphia, PA 19106.
Dr. Wilt: VA Medical Center 111-0, Minneapolis, MN 55417.
Dr. Crandall: 911 Broxton Avenue, 1st Floor, Los Angeles, CA 90024.
Dr. Hicks: 1600 Clifton Road, MS H16-3, Atlanta, GA 30329.
Dr. Mustafa: 3901 Rainbow Boulevard, MS 3002, Kansas City, KS 66160.
Author Contributions: Conception and design: A. Qaseem, C.J. Crandall, R.A. Mustafa, T.J. Wilt.
Analysis and interpretation of the data: A. Qaseem, C.J. Crandall, R.A. Mustafa, L.A. Hicks, T.J. Wilt.
Drafting of the article: A. Qaseem, C.J. Crandall, R.A. Mustafa, L.A. Hicks, T.J. Wilt.
Critical revision of the article for important intellectual content: A. Qaseem, C.J. Crandall, R.A. Mustafa, L.A. Hicks, T.J. Wilt.
Final approval of the article: A. Qaseem, C.J. Crandall, R.A. Mustafa, L.A. Hicks, T.J. Wilt.
Statistical expertise: A. Qaseem, T.J. Wilt.
Administrative, technical, or logistic support: A. Qaseem.
Collection and assembly of data: A. Qaseem, R.A. Mustafa.
The purpose of this guidance statement is to guide clinicians on colorectal cancer screening in average-risk adults.
This guidance statement is derived from a critical appraisal of guidelines on screening for colorectal cancer in average-risk adults and the evidence presented in these guidelines. National guidelines published in English between 1 June 2014 and 28 May 2018 in the National Guideline Clearinghouse or Guidelines International Network library were included. The authors also included 3 guidelines commonly used in clinical practice. Web sites were searched for guideline updates in December 2018. The AGREE II (Appraisal of Guidelines for Research and Evaluation II) instrument was used to evaluate the quality of guidelines.
The target audience is all clinicians, and the target patient population is adults at average risk for colorectal cancer.
Clinicians should screen for colorectal cancer in average-risk adults between the ages of 50 and 75 years.
Clinicians should select the colorectal cancer screening test with the patient on the basis of a discussion of benefits, harms, costs, availability, frequency, and patient preferences. Suggested screening tests and intervals are fecal immunochemical testing or high-sensitivity guaiac-based fecal occult blood testing every 2 years, colonoscopy every 10 years, or flexible sigmoidoscopy every 10 years plus fecal immunochemical testing every 2 years.
Clinicians should discontinue screening for colorectal cancer in average-risk adults older than 75 years or in adults with a life expectancy of 10 years or less.
Table 1. Scaled AGREE II Domain Scores for Each Guideline and Overall Assessment
Table 2. Summary of Included Recommendations for CRC Screening in Average-Risk Adults From Assessed Guidelines*
Table 3. Summary of Costs Associated With CRC Screening Tests in the United States
Summary of the ACP guidance statement on CRC screening in asymptomatic average-risk adults.
ACP = American College of Physicians; CRC = colorectal cancer; CT = computed tomography; FIT = fecal immunochemical test; gFOBT = guaiac-based fecal occult blood test; RCT = randomized controlled trial.
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Alain Braillon MD, PhD
University Hospital, 80000 Amiens, France
November 7, 2019
The statement from the American College of Physicians for colorectal cancer (CRC) screening deserve questions.
First, could the claim “CRC mortality has been decreasing, in large part because of improved screening”(1) be more about expectation than evidence: in the US the number of deaths is 1.45/10,000 per year, falling steadily from 2.45 in 1990, far before screening has been implemented and even more far before a putative effectiveness in the real life setting).(https://seer.cancer.gov/statfacts/html/colorect.html)
Second, why guidelines overlook quality-assurance? Screening may seem an exception but existing indicators are flawed. For fecal tests, uptake for one round is a poor surrogate to mask a shipwreck (e.g. 1/3 in France despite a national program since 2003). Early randomized controlled trials in the 90’s showed that mortality was reduced at best after 8 to 13 years of screening in two trials and not until after 15 to 18 years of screening in another two trials, conditions where compliance was optimal.(3) The Taiwanese FIT Screening Program showed no effectiveness with a 6 years follow-up when adjusting for self-selection biases.(Figure 2B in 4) For colonoscopy first, it is a bazaar.(5)
Third, why no pragmatic concerns for the implementation of shared decision making?
I crave for an updated guideline providing leaflets with common-sense pictographs using absolute numbers (with a consistent denominator, such as /1000 screened), time frames and visuals employing the same scale for information on gains and losses of the options? They change and improve decision-making.(6)
When healthcare scheme will take into account the time needed for implementing the 4 steps method? a) Trigger, indicating that all options are acceptable; b) Administer the information (see below); c) Promote active participation of the patient by the expression of his or her values; d) Analyze if the patient is comfortable with the decision by rephrasing.(6)
How to overlook that forced marketing is the common rule: editors just rejected correspondences questioning the ethic of a “mass media campaign“ for the Australian program (Journal of Medical Screening) or the delivery of Faecal Immunochemical Test to individuals coming “in community pharmacies of Switzerland” (International Journal of Clinical Pharmacy).
At least, being in France avoid to choose among tests. The national program is only about the fecal test, although most gastroenterologists have been relying on endoscopy first for themselves for long. I do not known for radiologists but in 2010 President Obama, in his first routine physical exam as commander in chief, received a CT colonography at the age of 49.(http://www.foxnews.com/projects/pdf/POTUS_EXAM.pdf?test=latestnews)
Last, as cancer risk is twice lower in woman vs man I crave for an updated guideline taking into account sex. Translational medicine and precision medicine are exciting paradigms and screening advocates must not stay backward. I must confess this is also about expectation and not evidence yet, but Michelangelo warned "The greater danger for most of us lies not in setting our aim too high and falling short; but in setting our aim too low, and achieving our mark."
1 Pignone M. Reconciling Disparate Guidelines: The American College of Physicians Colorectal Cancer Screening Guidance Statement. Ann Intern Med 2019;171:671-672.
2 Qaseem A, Crandall CJ, Mustafa RA et al. Screening for Colorectal Cancer in Asymptomatic Average-Risk Adults: A Guidance Statement From the American College of Physicians. Ann Intern Med 2019;171:643-654.
3 Braillon A. Can surrogate end points from a first-round screening be reliable for colorectal cancer screening? Gastroenterology 2012;142:e29.
4 Chiu HM, Chen SL, Yen AM, Chiu SY, Fann JC, Lee YC et al. Effectiveness of fecal immunochemical testing in reducing colorectal cancer mortality from the One Million Taiwanese Screening Program. Cancer 2015,121:3221-9.
5 Braillon A. Quality indicators for colonoscopy: Missing the wood for the trees? Gastroenterology. 2017;153:1695-1696
6 Braillon A, Bewley S. Shared Decision-Making for Cancer Screening: Visual Tools and a 4-Step Method. JAMA Intern Med 2015;175:1862.
David H. Kim
University of Wisconsin
November 8, 2019
CT colonography is an excellent screening option
To the Editor:I was disappointed to read the guidance statement put forth by the American College of Physicians regarding CT colonography (CTC) and colorectal cancer (CRC) screening (1). As an academic radiologist who has specialized in CTC research for the past 15 years and utilize it in a busy screening program at the University of Wisconsin (we have screened over 13,000 patients since 2004), I know firsthand the capabilities of this exam. The American College of Physicians (ACP) guidance statement purports to provide guidance in the face of conflicting recommendations from various national guidelines with the help of critical guideline assessment by the AGREE II methodology. Yet, it is difficult to understand the final recommendations on CT colonography. In stark contrast to the ACP document which does not recommend CTC for screening, the two highest AGREE II rated US-based guidelines (ie, USPSTF and American Cancer Society) include CT colonography as one of the acceptable options for CRC screening. All five co-authors of the ACP guideline state that they would recommend USPSTF and ACS recommendations for use (Table 1). Despite stating that the ACP methodology was not based on de novo reviews or new literature searches but rather the supporting documents and prior systemic reviews associated with these prior guidelines, the ACP Clinical Guidelines committee came to the complete opposite conclusion regarding CTC with the same underlying evidence. The written narrative supporting this position is disappointing, ignoring the wealth of literature that supports CTC screening including large observational cohorts now followed over a decade and a half (2-4). Besides detection rates for polyps and cancers, we have longitudinal data regarding negative exams which confirm that cancers and significant polyps are not missed (5). Outcomes data regarding additional clinically significant diagnoses outside the colon versus the workup rate is known (6). Instead of a nuanced, realistic assessment of the literature, the narrative simply reports that there are no assessed benefits with CTC by stating that no randomized control studies have been undertaken for confirmation. Honestly, this is akin to saying that a parachute may not be helpful when jumping out of a plane despite observational evidence because there have been no randomized trials to prove benefit (7). The benefits of CTC are so obvious when in seen in person. And in my opinion- well supported by the peer reviewed published literature. We may argue what exam is the best approach but there is no argument that screening by any of these exams including CTC is better than not screening.Given the current poor state of screening adherence for a truly preventable cancer, it is particularly disappointing that CT colonography was not added as possible option as recommended by USPSTF and ACS. At Wisconsin, the addition of CTC has allowed a combination of colonoscopy and CTC to reach an 80% threshold of screening in our serviced population where CTC accounts for 10% of that number. I truly believe that a menu of options between stool tests, CTC, and colonoscopy is the best method to move forward.Sincerely,David H. Kim MD FACR FSARProfessor of RadiologyVice Chair of EducationUniversity of Wisconsin School of Medicine and Public HealthAbdominal Imaging & InterventionReferences:1. Qaseem A, Crandall CJ, Mustafa RA, Hicks LA, Wilt TJ. Screening for Colorectal Cancer in Asymptomatic Average-Risk Adults: A Guidance Statement From the American College of Physicians. Ann Intern Med. 2019;171:643-54.2. Kim DH, Pickhardt PJ, Taylor AJ, Leung WK, Winter TC, Hinshaw JL, et al. CT colonography versus colonoscopy for the detection of advanced neoplasia. N Engl J Med. 2007;357(14):1403-12.3. Kim DH, Matkowskyj KA, Lubner MG, Hinshaw JL, Munoz Del Rio A, Pooler BD, et al. Serrated Polyps at CT Colonography: Prevalence and Characteristics of the Serrated Polyp Spectrum. Radiology. 2016;280:455-63.4. Pickhardt PJ, Kim DH, Pooler BD, Hinshaw JL, Barlow D, Jensen D, et al. Assessment of volumetric growth rates of small colorectal polyps with CT colonography: a longitudinal study of natural history. Lancet Oncol. 2013;14:711-20.5. Pickhardt PJ, Pooler BD, Mbah I, Weiss JM, Kim DH. Colorectal Findings at Repeat CT Colonography Screening after Initial CT Colonography Screening Negative for Polyps Larger than 5 mm. Radiology. 2017;282(1):139-48.6. Pooler BD, Kim DH, Pickhardt PJ. Extracolonic Findings at Screening CT Colonography: Prevalence, Benefits, Challenges, and Opportunities. Am J Roentgenol. 2017;209:94-102.7. Smith GC, Pell JP. Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials. BMJ. 2003;327:1459-61.
Joseph Weiss MD FACP, Nancy Cetel MD, Danielle Weiss MD FACP
University of California, San Diego, Speaking of Health
December 2, 2019
Is Age 75 Too Old for Colon Cancer Prevention & Screening?
Developing guidelines for colorectal cancer screening in asymptomatic average risk adults is challenging. The literature is inconsistent about screening technologies. The risk of screening colonoscopy increases with age and is not recommended after age 75. The incidence of colorectal cancer and polyps increases with age, and the risk of noninvasive and minimally invasive screening tests do not increase with age. To discontinue safe, rapid, painless, cost effective screening with noninvasive fecal occult blood test (FOBT), fecal immunochemistry test (FIT), or multitarget stool DNA (MTsDNA), or minimally invasive CT colonography (virtual colonoscopy) or capsule colonoscopy at age 75 is not supported by the literature. It will deny individuals the benefits of prevention and early diagnosis, and lead to increased morbidity, mortality, and expense of later diagnosis. A cancer or polyp identified by screening can be addressed with an evidence based decision considering the individual risk tolerance and desires of the patient and family.The cost of screening services, life expectancy, accuracy, and risks are factors that determine screening cost effectiveness. In Table 3 the cost of flexible sigmoidoscopy and colonoscopy are up to quadruple the next most expensive screening of CT Colonography, and over fifty times as expensive as fecal occult blood tests. The quality adjusted life year (QALY) indicator of cost effectiveness is altered by the selection of screening modality and cost. The life expectancy figures quoted are lower than the published data from the most recent social security tables (2015) of age 75 life expectancy 11.18 years for males, and 12.9 years for females. These are mean figures; half of the population will exceed these values and life expectancy may continue to rise.Striking variations in cost effectiveness are another compelling reason why the cessation of screening at age 75 should be restricted to colonoscopy. A persuasive argument is that safer cost effective screening modalities should replace colonoscopy as a screening test in all age groups. Colonoscopy has the highest risk of complications, ancillary resource utilization, work loss time intensity, challenging bowel preparation, incomplete examination with failure of cecum intubation and mucosal inspection, operator variability of adenoma detection rate, and bowel preparation failure rate.1-5 The use of colonoscopy as a screening test, and the arbitrary cessation of noninvasive screening at age 75, challenge the dictum of the Hippocratic Oath, primum non nocere, first, do no harm!Joseph B. Weiss, MD, FACPClinical Professor of Medicine University of California, San DiegoNancy S. Cetel, MDSpeaking of HealthDanielle E. Weiss, MD, FACPAssistant Clinical Professor of Medicine University of California, San Diego1. Kluge M, Williams J, Wu C, et al. Inadequate Boston Bowel Preparation Scale scores predict the risk of missed neoplasia on the next colonoscopy. Gastrointest Endosc. 2018;87(3):744-751. 2. Zhao S, Wang S, Pan P, Magnitude, Risk Factors, and Factors Associated With Adenoma Miss Rate of Tandem Colonoscopy: A Systemic Review and Meta-analysis Gastroenterology 2019;156:1661-16743. Mouchli M, Ouk L, Scheitel M, Colonoscopy surveillance for high risk polyps does not always prevent colorectal cancer World J Gastroenterol. 2018 Feb 28; 24(8): 905–916. 4. Joseph DA, Meester RGS, Zauber AG, et al Colorectal Cancer Screening: Estimated Future Colonoscopy Need and Current Volume and Capacity Cancer 2016;122(16):2479-2486. 5. Patel SS, Kilgore ML. Cost effectiveness of colorectal cancer screening strategies. Cancer Control 2015;22:248-58.
Thomas F. Imperiale, Steven H. Itzkowitz, David F. Ransohoff, Philip Lavin
IU Medical Center, Mt. Sinai Medical Center, UNC at Chapel Hill, and Boston Biostatistical Research Foundation
December 4, 2019
The recent ACP Guidance Statement for Colorectal Cancer Screening
The ACP’s recent guidance statement on colorectal cancer (CRC) screening (1) is inconsistent with the guidelines of other professional organizations.(2-4) By holding to the standard of only recommending tests that have evidence from randomized clinical trials (RCTs), the authors declined to recommend multi-target stool DNA (mt-sDNA).(1) Fecal immunochemical testing (FIT), however, is recommended despite the absence of evidence from RCTs (and there are numerous FIT products available with different thresholds for hemoglobin) (5), but instead was initially included in previous medical society guidelines due to its superior diagnostic accuracy over guaiac based occult blood tests. Shouldn’t this allowance apply to mt-sDNA, which includes FIT and outperforms it? And although other risks and benefits require consideration, why not apply this same allowance to CT colonography? Every other current U.S. CRC screening guideline includes these two tests. Applying this new standard even further, the ACP guidance statement recommends colonoscopy even though it, too, has no RCT supportive evidence. The authors excuse this limitation because colonoscopy has “the best sensitivity and specificity for adenomas measuring at least 10 mm and has been widely used for CRC screening on the basis of observational and modeling data”. To be sure, RCTs with outcomes of CRC incidence and more importantly, CRC mortality, are the highest level of evidence. But we have been living without desired RCT evidence for a while and recommending tests not supported by RCTs. Further, for a cancer screening test, it would take at least 8-10 years to demonstrate efficacy, and no new test could survive that time requirement without modification or replacement by newer technology before “proven” to be effective. This limitation essentially staunches the development of any new screening test. Importantly, the ACP guidance statement’s exclusion of mt-sDNA and CT colonography as talking points for providers and patients goes against all other U.S. guidelines, making the purpose of the guidance statement unclear. As four of the academic authors of the original pivotal trial (6), we are aware that approximately 3.3 million people in the U.S. have had mt-sDNA testing, 48% of whom had no prior CRC screening. With internists on the front line of cancer screening, we hope that subsequent ACP guidance statements will apply a more thoughtful, practical, and balanced effort to weigh benefits and harms in the mission to provide guidance to its members on potentially life-saving CRC screening tests.Thomas F. Imperiale, MDIndiana University Medical Center, Indianapolis, INSteven H. Itzkowitz, MDIcahn School of Medicine at Mount Sinai, New York, NYDavid F. Ransohoff, MDUniversity of North Carolina, Chapel Hill, NCPhilip Lavin, PhDBoston Biostatistical Research Foundation, Framingham, MA REFERENCES:1. Qaseem A, Crandall CJ, Mustafa RA, Hicks LA, et al for the Clinical Guidelines committee of the American College of Physicians. Screening for colorectal cancer in asymptomatic average-risk adults: a guidance statement from the American College of Physicians. Ann Intern Med 2019; 171(9):643-654.2. U.S. Preventive Services Task Force. Screening for colorectal cancer. US Preventive Services Task Force Recommendation Statement. JAMA 2016; 315(23):2564-25753. Rex DK, Boland CR, Dominitz JA, Giardiello FM, et al. Colorectal Cancer Screening: Recommendations for Physicians and Patients from the U.S. Multi-Society Task Force on Colorectal Cancer. Am J Gastroenterol 2017; 112(7):1016-1030.4. Wolf AMD, Fontham ETH, Church TR, Flowers CR, et al. Colorectal Cancer Screening for average-risk adults: 2018 guideline update from the American Cancer Society. CA Cancer J Clin 2018; 68:250-281.5. Imperiale TF, Gruber RN, Stump TE, Emmett TW, Monahan PO. Performance characteristics of fecal immunochemical tests for colorectal cancer and advanced precancerous polyps. A systematic review and meta-analysis. Ann Intern Med 2019;170(5);319-329. 6. Imperiale TF, Ransohoff DF, Itzkowitz SI, Levin TR, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med 2014; 370(14);1287-1297.
Qaseem A, Crandall CJ, Mustafa RA, et al, for the Clinical Guidelines Committee of the American College of Physicians. Screening for Colorectal Cancer in Asymptomatic Average-Risk Adults: A Guidance Statement From the American College of Physicians. Ann Intern Med. 2019;171:643–654. doi: https://doi.org/10.7326/M19-0642
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Published: Ann Intern Med. 2019;171(9):643-654.
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