ACP结直肠癌筛查指南2012

Screening for Colorectal Cancer: A Guidance Statement From the American College of Physicians Amir Qaseem, MD, PhD, MHA; Thomas D. Denberg, MD, PhD; Robert H. Hopkins Jr., MD; Linda L. Humphrey, MD, MPH; Joel Levine, MD; Donna E. Sweet, MD; and Paul Shekelle, MD, PhD, for the Clinical Guidelines Committee of the American College of Physicians* Description: Colorectal cancer is the second leading cause of cancer-related deaths for men and women in the United States. The American College of Physicians (ACP) developed this guidance statement for clinicians by assessing the current guidelines devel- oped by other organizations on screening for colorectal cancer. When multiple guidelines are available on a topic or when existing guidelines conflict, ACP believes that it is more valuable to provide clinicians with a rigorous review of the available guidelines rather than develop a new guideline on the same topic. Methods: The authors searched the National Guideline Clearing- house to identify guidelines developed in the United States. Four guidelines met the inclusion criteria: a joint guideline developed by the American Cancer Society, the U.S. Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology and individual guidelines developed by the Institute for Clinical Systems Improvement, the U.S. Preventive Services Task Force, and the American College of Radiology. Guidance Statement 1: ACP recommends that clinicians perform individualized assessment of risk for colorectal cancer in all adults. Guidance Statement 2: ACP recommends that clinicians screen for colorectal cancer in average-risk adults starting at the age of 50 years and in high-risk adults starting at the age of 40 years or 10 years younger than the age at which the youngest affected relative was diagnosed with colorectal cancer. Guidance Statement 3: ACP recommends using a stool-based test, flexible sigmoidoscopy, or optical colonoscopy as a screening test in patients who are at average risk. ACP recommends using optical colonoscopy as a screening test in patients who are at high risk. Clinicians should select the test based on the benefits and harms of the screening test, availability of the screening test, and patient preferences. Guidance Statement 4: ACP recommends that clinicians stop screening for colorectal cancer in adults over the age of 75 years or in adults with a life expectancy of less than 10 years. Ann Intern Med. 2012;156:378-386. www.annals.org For author affiliations, see end of text. Colorectal cancer is the second leading cause of cancer-related deaths among both men and women in the United States (1). The incidence of colorectal cancer was 102 900 people in 2010, and prevalence was 1 110 077 people in 2008, including 542 127 men and 567 950 women (2, 3). Americans have a 5% lifetime risk for colo- rectal cancer (2), and approximately 51 370 Americans die of the disease each year (3). However, the incidence of colorectal cancer has been declining in the United States by 2% to 3% per year over the past 15 years (4). Colorectal cancer is rare before age 40 years in both men and women, with 90% of cases occurring after age 50 years (2). The usual pathogenesis of colorectal cancer is an ad- enomatous polyp that slowly increases in size, followed by dysplasia and finally cancer. Screening for colorectal cancer is valuable because early detection and removal of pre- malignant adenomas or localized cancer can prevent cancer or cancer-related deaths. Good evidence shows that screen- ing reduces mortality from colorectal cancer (5). Several methods are currently available for colorectal cancer screening. They fall under 2 categories: stool-based tests, including guaiac-based fecal occult blood test (gFOBT), immunochemical-based fecal occult blood test (iFOBT), and stool DNA panel (sDNA); and endoscopic and radio- logic tests, including flexible sigmoidoscopy, optical colonoscopy, double-contrast barium enema (DCBE), and computed tomography colonography (CTC) (virtual colonoscopy). Of these screening methods, only gFOBT and flexible sigmoidoscopy have been evaluated in ran- domized, controlled trials that showed that they are asso- ciated with decreased colorectal cancer–related mortality. The purpose of this guidance statement is to critically review available guidelines to help internists and other cli- * This paper, written by Amir Qaseem, MD, PhD, MHA; Thomas D. Denberg, MD, PhD; Robert H. Hopkins Jr., MD; Linda L. Humphrey, MD, MPH; Joel Levine, MD; Donna E. Sweet, MD; and Paul Shekelle, MD, PhD, was developed for the Clinical Guidelines Committee of the American College of Physicians: Paul Shekelle, MD, PhD (Chair); Roger Chou, MD; Paul Dallas, MD; Thomas D. Denberg, MD, PhD; Nick Fitterman, MD; Mary Ann Forciea, MD; Robert H. Hopkins Jr., MD; Linda L. Humphrey, MD, MPH; Tanveer P. Mir, MD; Holger J. Schu¨nemann, MD, PhD; Donna E. Sweet, MD; and David S. Weinberg, MD, MSc. Approved by the ACP Board of Regents on 19 November 2011. See also: Print Summary for Patients. . . . . . . . . . . . . . . . . . . . . . . I-30 Web-Only CME quiz (preview on page I-20) Conversion of graphics into slides Guidance Statements Clinical Guideline 378 © 2012 American College of Physicians nicians in making decisions about screening for colorectal cancer. The target patient population for this guideline is all men and women. This statement is derived from an evaluation of current guidelines in the United States on screening for colorectal cancer. METHODS The Clinical Guidelines Committee of the American College of Physicians (ACP) developed this guidance state- ment for clinicians, according to methods published previ- ously (6), by assessing current guidelines from other organiza- tions on screening for colorectal cancer. When multiple guidelines are available on a topic or when existing guidelines conflict, ACP believes that providing clinicians with a rigorous review of the available guidelines is more useful than develop- ing a new guideline on the same topic. We searched the National Guideline Clearinghouse (NGC) to identify all discrete guidelines on screening for colorectal cancer developed in the United States. After review- ing the titles and abstracts of each identified document, we excluded articles that simply restated guidelines from other organizations. The NGC included 4 U.S. guidelines on screening for colorectal cancer: the joint guideline developed by the American Cancer Society (ACS), the U.S. Multi- Society Task Force on Colorectal Cancer (USMSTF), and the American College of Radiology (ACR) (7) and individual guidelines developed by the Institute for Clinical Systems Im- provement (ICSI) (8), the U.S. Preventive Services Task Force (USPSTF) (9), and the ACR (10). The 7 co-authors reviewed these guidelines independently by using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) ap- praisal instrument (11), which asks 23 questions in 6 do- mains: scope and purpose, stakeholder involvement, rigor of development, clarity and presentation, applicability, and edi- torial independence. We selected 1 guideline to calibrate our scores on the 6 domains of the AGREE II instrument, scored each guideline independently, and then compared the scores. Although total quantitative scores varied somewhat, the qual- itative assessment of guideline quality was consistent among the 7 reviewers; indeed, the overall rankings of the quality of the guidelines were similar (Table 1). Of note, the American College of Gastroenterology (ACG) published a 2008 update to its colorectal cancer screening guideline (12), but this guideline is not currently included in the NGC database. Because many clinicians involved in decision making about colorectal cancer screen- ing consult the ACG guidelines, we chose to summarize this guideline despite its absence from the NGC. However, we did not formally evaluate it by using the AGREE II instrument because our predefined methods were to rate guidelines available in the NGC. In addition, the ACG was a contributor to the joint ACS/USMSTF/ACR guideline. SUMMARY AND EVALUATION OF REVIEWED GUIDELINES ACS/USMSTF/ACR (2008) ACS/USMSTF/ACR recommends screening average-risk adults starting at age 50 years. ACS/USMSTF/ACR recommends that individuals should have an opportunity to make an informed deci- sion when choosing one the following screening tests: flexible sigmoidoscopy every 5 years, colonoscopy every 10 years, double-contrast barium enema every 5 years, CT colonography every 5 years, annual gFOBT with high test sensitivity for cancer or annual fecal immuno- chemical testing with high test sensitivity for cancer, and/or fecal sDNA with high test sensitivity for cancer at an unspecified interval. ACS/USMSTF/ACR recommends that tests that are designed to detect both early cancer and adenomatous polyps should be encouraged if resources are available and patients are willing to undergo an invasive test. Comments The stated purpose of the ACS/USMSTF/ACR guide- line is to assess the data and comparative evidence for var- ious screening tests for colorectal cancer and to assess when to screen adults who are at average risk for colorectal can- cer. The guideline divides screening methods into tests that can detect adenomatous polyps and cancer and can there- fore be considered preventive (flexible sigmoidoscopy, colonoscopy, DCBE, and CTC) and tests that primarily detect cancer (gFOBT, fecal immunochemical test [FIT], and sDNA). The ACS/USMSTF/ACR encourages using, when possible, the structural methods that are considered pre- ventive techniques. The guideline presents a very clear ratio- nale for the starting age of screening and acknowledges that none of the currently available screening tests is perfect for detecting cancer or adenomas. The guideline acknowledges the limitations of evidence related to sensitivity and specificity of various screening tests and relies on the judgment of the expert panel that developed the guideline. It presents informa- tion on the advantages, cost-effectiveness, limitations, and risks of each test. The strengths of this guideline include a collaborative effort; a good discussion on the benefits, harms, and limitations of various screening tests; and a discussion of the issues related to shared and informed decision making with patients. Limitations include that it did not use a system- atic literature review of evidence and, in many situations, used expert opinion. In addition, the evidence that was presented did not include evaluation of the quality. ICSI (2010) ICSI recommends routine colorectal cancer screening for all average-risk patients 50 years of age and older— age 45 and older for African Americans or American Indians. Patients with average risk for colorectal cancer Clinical GuidelineGuidance Statement on Screening for Colorectal Cancer www.annals.org 6 March 2012 Annals of Internal Medicine Volume 156 • Number 5 379 Table 1. Mean Guideline Scores and Scaled Domain Scores Across Domains of the AGREE II Instrument* AGREE II Domain ACS/USMSTF/ACR ICSI USPSTF ACR Scope and purpose 1. The overall objective(s) of the guideline is (are) specifically described. 6 5 6 4 2. The health question(s) covered by the guideline is (are) specifically described. 6 6 6 4 3. The population (patients, public, etc.) to whom the guideline is meant to apply is specifically described. 6 6 6 4 Domain score 17 17 18 12 Scaled domain score, % 79 77 84 48 Stakeholder involvement 4. The guideline development group includes individuals from all relevant professional groups. 4 4 6 3 5. The views and preferences of the target population (patients, public, etc.) have been sought. 2 2 3 1 6. The target users of the guideline are clearly defined. 4 5 4 3 Domain score 10 12 13 7 Scaled domain score, % 40 49 48 20 Rigor of development 7. Systematic methods were used to search for evidence. 4 4 6 2 8. The criteria for selecting the evidence are clearly described. 3 2 6 2 9. The strengths and limitations of the body of evidence are clearly described. 4 3 5 2 10. The methods for formulating the recommendations are clearly described. 3 3 4 2 11. The health benefits, side effects, and risks have been considered in formulating the recommendations. 5 4 6 3 12. There is an explicit link between the recommendations and the supporting evidence. 4 3 6 3 13. The guideline has been externally reviewed by experts prior to its publication. 3 4 6 2 14. A procedure for updating the guideline is provided. 2 4 3 1 Domain score 28 27 42 17 Scaled domain score, % 41 38 71 17 Clarity of presentation 15. The recommendations are specific and unambiguous. 5 5 6 5 16. The different options for management of the condition or health issue are clearly presented. 6 6 6 4 17. Key recommendations are easily identifiable. 5 6 6 5 Domain score 16 17 18 13 Scaled domain score, % 71 77 83 56 Applicability 18. The guideline describes facilitators and barriers to its application. 3 3 2 2 19. The guideline provides advice and/or tools on how the recommendations can be put into practice. 2 3 2 2 20. The potential resource implications of applying the recommendations have been considered. 3 2 2 2 21. The guideline presents monitoring and/or auditing criteria. 2 5 2 1 Domain score 11 14 8 6 Scaled domain score, % 29 40 18 10 Editorial independence 22. The views of the funding body have not influenced the content of the guideline. 4 4 5 3 23. Competing interests of guideline development group members have been recorded and addressed. 4 5 4 2 Domain score 8 9 9 5 Scaled domain score, % 49 58 61 21 Overall guideline assessment 1. Rate the overall quality of this guideline. 4 4 6 2 2. I would recommend this guideline for use (please respond: yes, yes with modifications, or no). 4 yes 2 yes with modifications 1 no 2 yes 3 yes with modifications 2 no 7 yes 7 no ACR� American College of Radiology; ACS� American Cancer Society; AGREE II� Appraisal of Guidelines for Research and Evaluation II; ICSI� Institute for Clinical Systems Improvement; USMSTF � U.S. Multi-Society Task Force on Colorectal Cancer; USPSTF � U.S. Preventive Services Task Force. * Each question was rated on a Likert scale with a maximum of 7 points. The scores were averaged for each of the 7 reviewers. The scaled domain score is calculated as follows: (obtained score minus minimum possible score)/(maximum possible score minus minimum possible score). Clinical Guideline Guidance Statement on Screening for Colorectal Cancer 380 6 March 2012 Annals of Internal Medicine Volume 156 • Number 5 www.annals.org are defined by: 50 years or older, or if African American or American Indian, 45 years or older with no personal history of polyps, colorectal cancer, or inflammatory bowel disease; no family history of colorectal cancer in: one first-degree relative diagnosed before age 60, or two first-degree relatives diagnosed at any age; and no fam- ily history of adenomatous polyps in one first-degree relative diagnosed before age 60. ICSI recommends the following methods for colorectal cancer screening of average-risk patients based on joint decision making by patient and provider: stool testing: gFOBT annually or FIT annually; 60-cm flexible sig- moidoscopy every five years with or without stool test for occult blood annually; CT colonography every five years; or colonoscopy every 10 years. ICSI considers the following for patients at increased risk of colorectal cancer and recommends different screening for these patients: One first-degree relative with either colorectal cancer or adenomatous polyps diagnosed before age 60 years or two or more first-degree relatives diagnosed at any age: colono- scopy every five years beginning at age 40 or 10 years before the age of the youngest case in the immediate family. Inflammatory bowel disease (chronic ulcerative colitis and Crohn’s disease): colonoscopy every one to two years starting eight years after the onset of pancolitis or 12 to 15 years after the onset of left-sided colitis. Genetic diagnosis of familial adenomatous polyposis (FAP) or suspected FAP without genetic testing evi- dence: annual flexible sigmoidoscopy beginning at age 10 to 12 years, along with genetic counseling. Genetic or clinical diagnosis of hereditary nonpolyposis colorectal cancer (HNPCC): colonoscopy every one to two years beginning at age 20 to 25 years or 10 years before the age of the youngest case in the immediate family. Comments The purpose of the ICSI guideline is to address the appropriate screening method for patients at average and increased risk for colorectal cancer. The guideline provides clear recommendations, discusses the benefits and harms of various tests, and presents various implementation strate- gies. However, the details regarding the development pro- cess are not very clear in the guideline or in the available information on the ICSI Web site. Although the evidence is graded, the scoring system does not adequately differen- tiate between the high-quality and low-quality random- ized, controlled trials. The guideline does not provide an upper age limit to stop screening but recognizes that co- morbid conditions may influence the decision. USPSTF (2008 Update) USPSTF recommends screening for colorectal cancer using fecal occult blood testing, sigmoidoscopy, or colonoscopy in adults, beginning at age 50 years and continuing until age 75 years. The risks and benefits of these screening methods vary. USPSTF recommends against routine screening for colorectal cancer in adults 76 to 85 years of age. There may be considerations that support colorectal cancer screening in an individual patient. USPSTF recommends against screening for colorectal cancer in adults older than age 85 years. USPSTF concludes that the evidence is insufficient to as- sess the benefits and harms of CT colonography and fecal DNA testing as screening modalities for colorectal cancer. Comments The purpose of the USPSTF guideline is to update its 2002 guideline and present the evidence on the benefits and harms of screening technologies as well as a decision analytic model to compare the expected health outcomes and resource requirements of available screening methods. The strengths of this guideline include the use of rigorous methods, evaluation of evidence through a systematic lit- erature review, and linkages between the evidence and rec- ommendations. Recommendations have a very clear age specification for the purpose of screening. The USPSTF guideline is the only guideline we reviewed that does not recommend CTC as an option for colorectal cancer screen- ing. It does not discuss specific patient populations, such as high-risk populations, or differences based on race, such as African American. In addition, the guideline did not dis- cuss implementation-related issues, such as information on shared decision making with the patient. ACR (2010) ACR recommends CT colonography every 5 years after a negative CTC screen or X-ray colon barium enema double-contrast every 5 years after negative screen for av- erage risk patients (age�50 years) and those with moder- ate risk (personal history of adenoma or carcinoma or first- degree family history of cancer or adenoma). ACR recommends CT colonography or X-ray colon barium enema double-contrast for average risk patients following positive fecal occult blood test and for pa- tients with average, moderate or high risk after incom- plete colonoscopy. ACR recommends colonoscopy for high risk patients with ulcerative colitis or Crohn’s colitis and those with HNPCC. Clinical GuidelineGuidance Statement on Screening for Colorectal Cancer www.annals.org 6 March 2012 Annals of Internal Medicine Volume 156 • Number 5 381 Comments The ACR guideline evaluates the evidence on whom and how to screen for colorectal cancer and focuses only o