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Guideline Summary
Guideline Title
NIH State-of-the-Science Conference Statement on enhancing use and quality of colorectal cancer screening.
Bibliographic Source(s)
Steinwachs D, Allen JD, Barlow WE, Duncan RP, Egede LE, Friedman LS, Kim P, Lave JR, Laveist TA, Ness RB, Optican RJ, Virnig BA. NIH State-of-the-Science Conference Statement on enhancing use and quality of colorectal cancer screening. NIH Consens State Sci Statements. 2010 Feb 4;27(1):1-31. PubMed External Web Site Policy
Guideline Status

This is the current release of the guideline.

Scope

Disease/Condition(s)

Colorectal cancer

Guideline Category
Prevention
Screening
Clinical Specialty
Family Practice
Gastroenterology
Geriatrics
Internal Medicine
Preventive Medicine
Intended Users
Health Care Providers
Patients
Physicians
Public Health Departments
Guideline Objective(s)

To provide healthcare providers, patients, and the general public with a responsible assessment of currently available data on enhancing use and quality of colorectal cancer screening

Target Population

U. S. population over age 50 at average risk of colorectal cancer

Interventions and Practices Considered

Colorectal cancer screening

Major Outcomes Considered
  • Colorectal cancer (CRC) screening rates
  • Patient factors influencing CRC screening
  • Effectiveness of provider interventions
  • Capacities and resources needed for CRC screening

Methodology

Methods Used to Collect/Select the Evidence
Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

Note from the National Guideline Clearinghouse (NGC): A systematic review of the literature was prepared by the RTI International–University of North Carolina Evidence-based Practice Center (EPC) for the Agency for Healthcare Research and Quality (AHRQ) for use by the National Institutes of Health (NIH) (see the "Availability of Companion Documents" field).

Literature Search

To identify articles relevant to each key question (KQ) EPC staff searched three electronic databases—MEDLINE®, the Cochrane Library, and the Cochrane Central Trials Registry—for articles published from January 1998 through September 2009. They used either Medical Subject Headings (MeSH or MH) as search terms when available or key words when appropriate. MeSH terms for the searches included colorectal neoplasms, colonoscopy, sigmoidoscopes; major headings included mass screening; and key terms included stool test, FOBT, and DNA stool. The full search strategy of exact search strings is presented in Appendix A of the Evidence Report (see the "Availability of Companion Documents" field).

The initial searches of electronic databases produced 3,029 unduplicated records. The electronic searches were supplemented by manually searching reference lists of included studies, pertinent review articles, and editorials. Additional included studies were identified from recommendations of members of the technical expert panel (TEP) and by peer reviewers. All citations were imported into an electronic database (EndNote X.3).

Inclusion and Exclusion Criteria

EPC staff developed detailed eligibility criteria with respect to population, interventions, outcomes, time period, and study design. Eligible studies were limited to those conducted in the United States so that the data would reflect domestic health care concerns, practices, and guidelines. The searches were restricted to studies published in 1998 or later to ensure that results had relevance to current trends and practice for colorectal cancer (CRC) screening. EPC staff excluded studies that (1) were published in languages other than English, (2) did not report information pertinent to the KQs, (3) had fewer than 30 subjects for randomized or nonrandomized controlled trials or fewer than 100 subjects for observational studies, (4) were not original research, or (5) evaluated interventions that were conducted in academic settings that would not be applicable to most practice settings. See Table 1 of the Evidence Report for details.

Abstracts of all articles were examined to determine whether studies met the eligibility criteria. Two members of the research team reviewed each abstract independently for inclusion or exclusion, using an Abstract Review Form (see Appendix B of the Evidence Report). If one reviewer concluded on the basis of the abstract that the article should be considered in the review, the full text was obtained. Two members of the research team then independently reviewed each full-text article for inclusion or exclusion using a Full Text Review Form (Appendix B). The two relevant reviewers discussed disagreements; when they could not reach consensus, the team met and discussed the article to determine as a group whether the study met eligibility criteria. Articles that did not meet criteria for inclusion are listed in Appendix D of the Evidence Report along with reasons for exclusion.

Number of Source Documents

Articles included in this review: n = 116

Key Question (KQ) 2 = 74

KQ 3 = 22

KQ 4 = 12

KQ 5 = 8

Methods Used to Assess the Quality and Strength of the Evidence
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence

Strength of Evidence Grades and Definitions

High - High confidence that the evidence reflects the true effect. Further research is very unlikely to change the confidence in the estimate of effect.

Moderate - Moderate confidence that the evidence reflects the true effect. Further research may change the confidence in the estimate of effect and may change the estimate.

Low - Low confidence that the evidence reflects the true effect. Further research is likely to change the confidence in the estimate of effect and is likely to change the estimate.

Insufficient - Evidence either is unavailable or does not permit estimation of an effect.

Methods Used to Analyze the Evidence
Systematic Review with Evidence Tables
Description of the Methods Used to Analyze the Evidence

Note from the National Guideline Clearinghouse (NGC): A systematic review of the literature was prepared by the RTI International–University of North Carolina Evidence-based Practice Center (EPC) for the Agency for Healthcare Research and Quality (AHRQ) for use by the National Institutes of Health (NIH) (see the "Availability of Companion Documents" field).

Literature Synthesis

Data Abstraction

EPC staff designed and used a structured data abstraction form. Trained reviewers abstracted data from each study and assigned an initial quality rating. A second reviewer read each abstracted article, evaluated the accuracy, completeness, and consistency of the data abstraction, and confirmed the quality rating. If differences in quality ratings could not be resolved by discussion, a third senior reviewer was involved. The full research team met regularly during the article abstraction period to discuss global issues related to the data abstraction process.

The final evidence tables are presented in their entirety in Appendix C of the Evidence Report (see the "Availability of Companion Documents" field). Studies are presented in the evidence tables alphabetically by the last name of the first author. A list of abbreviations and acronyms used in the tables appears at the beginning of Appendix C.

Rating Quality of Individual Studies

To assess the quality (internal validity or risk of bias) of studies, EPC staff used predefined criteria based on those described in the AHRQ Methods Guide for Comparative Effectiveness Reviews (ratings: good, fair, poor).

Elements of quality assessment for trials included, among others, the methods used for randomization, allocation concealment, and blinding; the similarity of compared groups at baseline; maintenance of comparable groups; overall and differential loss to follow-up; and the use of intention-to-treat analysis. Observational studies were assessed based on the potential for selection bias (methods of selection of subjects and loss to follow-up), potential for measurement bias (equality, validity, and reliability of ascertainment of outcomes), adjustment for potential confounders, and statistical analysis.

In general terms, a "good" study has the least bias and results are considered to be valid. A "fair" study is susceptible to some bias but probably not sufficient to invalidate its results. The fair-quality category is likely to be broad, so studies with this rating will vary in their strengths and weaknesses. A "poor" rating indicates significant bias (stemming from, e.g., serious errors in design, analysis reporting large amounts of missing information, or discrepancies in reporting) that may invalidate the study's results.

Studies that met all criteria were rated good quality. The majority of studies received a quality rating of fair. This category includes studies that presumably fulfilled all quality criteria but did not report their methods to an extent that answered all our questions. Thus, the fair-quality category includes studies with quite different strengths and weaknesses. Studies that had a fatal flaw (defined as a methodological shortcoming that leads to a very high probability of bias) in one or more categories were rated poor quality and excluded from the analyses. Poor-quality studies and reasons for that rating are presented in Appendix F of the Evidence Report (see the "Availability of Companion Documents" field).

Grading Strength of Evidence

EPC staff evaluated the overall strength of evidence for the questions addressing the main outcomes of the review (key questions [KQs] 3, 4, and 5) based on an approach devised for AHRQ's Method Guide. Developed to grade the overall strength of a body of evidence, this approach incorporates four key domains: risk of bias, consistency, directness, and precision. It also considers other optional domains that may be relevant for some scenarios, such as a dose-response association, plausible confounding that would decrease the observed effect, strength of association (magnitude of effect), and publication bias. The evaluation of risk of bias includes assessment of study design and aggregate quality of studies.

Evidence was graded as consistent when effect sizes across studies were in the same direction and had a narrow range. When the evidence linked the interventions directly to the outcomes of interest, the evidence was graded as being direct. Evidence was graded as being precise when results had a low degree of uncertainty. At least two members of the research team evaluated the overall strength of evidence for each outcome based on a qualitative assessment of strength of evidence for each domain and reconciled all disagreements.

See the "Rating Scheme for the Strength of the Evidence" field for the strength of evidence grades and definitions.

Applicability

EPC staff evaluated the applicability of the evidence based on a qualitative assessment of the population, intensity or quality of treatment, choice of the comparator, outcomes, and timing of follow-up. The parameters for evaluation were based on guidance provided by AHRQ's Methods Guide. Specifically, it was considered whether enrolled populations differ from target populations, whether studied interventions are comparable with those in routine use, whether comparators reflect best alternatives, whether measured outcomes are known to reflect the most important clinical outcomes, and whether follow-up was sufficient.

Methods Used to Formulate the Recommendations
Expert Consensus (Consensus Development Conference)
Description of Methods Used to Formulate the Recommendations

The National Cancer Institute and the Office of Medical Applications of Research of the National Institutes of Health convened a State-of-the-Science Conference on February 2–4, 2010, to assess the available scientific evidence. The key questions that the panel was asked to address were the following:

  1. What are the recent trends in the use and quality of colorectal cancer screening?
  2. What factors influence the use of colorectal cancer screening?
  3. Which strategies are effective in increasing the appropriate use of colorectal cancer screening and follow-up?
  4. What are the current and projected capacities to deliver colorectal cancer screening and surveillance at the population level?
  5. What are the effective approaches for monitoring the use and quality of colorectal cancer screening?
  6. What research is needed to make the most progress and have the greatest public health impact in promoting the appropriate use of colorectal cancer screening?

A non-Department of Health and Human Services, nonadvocate 13-member panel represented the fields of cancer surveillance, health services research, community-based research, informed decision-making, access to care, healthcare policy, health communication, health economics, health disparities, epidemiology, statistics, thoracic radiology, internal medicine, gastroenterology, public health, end-of-life care, and a public representative. In addition, 20 experts from pertinent fields presented data to the panel and conference audience.

During the first 2 days of the conference, experts presented information on each of the key questions. After weighing the scientific evidence—including the data presented by the speakers, input from attendees, and a formal evidence report commissioned through the Agency for Healthcare Research and Quality (AHRQ) and prepared by the RTI International-University of North Carolina Evidence-based Practice Center—the panel prepared and presented a draft of this State-of-the-Science Statement addressing the conference questions. The evidence report prepared for the conference is available at: http://www.ahrq.gov/clinic/tp/crcprotp.htm External Web Site Policy (see the "Availability of Companion Documents" field).

The panel drafted its statement based on scientific evidence presented in open forum and on published scientific literature. The draft statement was presented on the final day of the conference and circulated to the audience for comment. The panel released a revised statement later that day at http://consensus.nih.gov External Web Site Policy.

Rating Scheme for the Strength of the Recommendations

Not applicable

Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation
External Peer Review
Internal Peer Review
Description of Method of Guideline Validation

The draft conference statement was presented on the final day of the conference and circulated to the audience for comment. The panel released a revised statement later that day at http://consensus.nih.gov External Web Site Policy.

Recommendations

Major Recommendations

The panel finds that despite substantial progress toward higher colorectal cancer screening rates nationally, screening rates fall short of desirable levels. Targeted initiatives to improve screening rates and reduce disparities in underscreened communities and population subgroups could further reduce colorectal cancer morbidity and mortality. This could be achieved by utilizing the full range of screening options and evidence-based interventions for increasing screening rates. With additional investments in quality monitoring, Americans could be assured that all screening achieves high rates of cancer prevention and early detection. To close the gap in screening, this report identifies the following priority areas for implementation and research to enhance the use and quality of colorectal cancer screening:

  • Eliminate financial barriers to colorectal cancer screening and appropriate follow-up.
  • Widely implement interventions that have proven effective at increasing colorectal cancer screening, including patient reminder systems and one-on-one interactions with providers, educators, or navigators.
  • Conduct research to assess the effectiveness of tailoring programs to match the characteristics and preferences of target population groups to increase colorectal cancer screening.
  • Implement systems to ensure appropriate follow-up of positive colorectal cancer screening results.
  • Develop systems to ensure high quality of colorectal cancer screening programs.
  • Conduct studies to determine the comparative effectiveness of the various colorectal cancer screening methods in usual practice settings.
Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of supporting evidence is not specifically stated for each recommendation.

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Enhanced use and quality of colorectal cancer screening

Potential Harms
  • Some of the most sensitive techniques for colorectal cancer and polyp detection carry risks for adverse events. For example, colonoscopy requires sedation and carries the risk of colon perforation, which, although uncommon, is potentially serious. Computed tomography colonography carries a theoretical risk from radiation exposure.
  • Misuse of screening involves screening that is conducted in a suboptimal way such that the potential benefits are not achieved—for example, a fecal occult blood test conducted using in-office stool samples rather than the recommended home technique.

Qualifying Statements

Qualifying Statements
  • This statement is an independent report of the panel and is not a policy statement of the National Institutes of Health (NIH) or the Federal Government.
  • The statement reflects the panel's assessment of medical knowledge available at the time the statement was written. Thus, it provides a "snapshot in time" of the state of knowledge on the conference topic. When reading the statement, keep in mind that new knowledge is inevitably accumulating through medical research, and that the information provided is not a substitute for professional medical care or advice.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Implementation Tools
Resources
For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Staying Healthy
IOM Domain
Effectiveness

Identifying Information and Availability

Bibliographic Source(s)
Steinwachs D, Allen JD, Barlow WE, Duncan RP, Egede LE, Friedman LS, Kim P, Lave JR, Laveist TA, Ness RB, Optican RJ, Virnig BA. NIH State-of-the-Science Conference Statement on enhancing use and quality of colorectal cancer screening. NIH Consens State Sci Statements. 2010 Feb 4;27(1):1-31. PubMed External Web Site Policy
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2010 Feb
Guideline Developer(s)
National Institutes of Health Consensus Development Conference - Independent Expert Panel
Source(s) of Funding

United States Government

Guideline Committee

National Institutes of Health (NIH) State-of-the-Science Panel

Composition of Group That Authored the Guideline

Panel Members: Donald Steinwachs, Ph.D. (Panel and Conference Chairperson), Professor and Interim Director, Johns Hopkins Institute for Policy Studies, Director, Health Services Research and Development Center, Bloomberg School of Public Health, The Johns Hopkins University, Baltimore, Maryland; Jennifer Dacey Allen, D.Sc., M.P.H., R.N., Assistant Professor, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts; William Eric Barlow, Ph.D., Senior Biostatistician, Cancer Research and Biostatistics, Research Professor, Department of Biostatistics, University of Washington Seattle, Washington; R. Paul Duncan, Ph.D., Professor and Chair, Department of Health Services Research, Management, and Policy, College of Public Health and Health Professions, University of Florida, Health Science Center, Gainesville, Florida; Leonard E. Egede, M.D., M.S., Professor of Medicine, Department of Medicine, Director, Center for Health Disparities Research, Medical University of South Carolina, Charleston, South Carolina; Lawrence S. Friedman, M.D., Professor of Medicine, Harvard Medical School and Tufts University School of Medicine, Chair, Department of Medicine, Newton-Wellesley Hospital, Newton, Massachusetts; Nancy L. Keating, M.D., M.P.H., Associate Professor of Medicine and Health Care Policy, Department of Health Care Policy, Harvard Medical School, Boston, Massachusetts; Paula Kim, Chief Executive Officer, Translating Research Across Communities, Green Cove Springs, Florida; Judith R. Lave, Ph.D., Professor of Health Economics, Director, Pennsylvania Medicaid Policy Center, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania; Thomas A. LaVeist, Ph.D., William C. and Nancy F. Richardson Professor in Health Policy, Director, Hopkins Center for Health Disparities Solutions, Bloomberg School of Public Health, The Johns Hopkins University, Baltimore, Maryland; Roberta B. Ness, M.D., M.P.H., Dean and M. David Low Chair in Public Health, The University of Texas, School of Public Health, Houston, Texas; Robert J. Optican, M.D., Director of Cardiothoracic Imaging, Baptist Memorial Hospitals, Memphis, Tennessee; Beth A. Virnig, Ph.D., M.P.H., Professor, University of Minnesota School of Public Health, Division of Health Policy and Management, Minneapolis, Minnesota

Financial Disclosures/Conflicts of Interest

All of the panelists who participated in this conference and contributed to the writing of this statement were identified as having no financial or scientific conflict of interest, and all signed forms attesting to this fact. Unlike the expert speakers who present scientific data at the conference, the individuals invited to participate on National Institutes of Health (NIH) Consensus and State-of-the-Science Panels are reviewed prior to selection to ensure that they are not proponents of an advocacy position with regard to the topic and are not identified with research that could be used to answer the conference questions. For more information about conference procedures, please see http://consensus.nih.gov/aboutcdp.htm External Web Site Policy.

Guideline Status

This is the current release of the guideline.

Guideline Availability

Electronic copies: Available from the National Institutes of Health (NIH) Consensus Development Conference Program Web site External Web Site Policy.

Print copies: Available from the NIH Consensus Development Program Information Center, PO Box 2577, Kensington, MD 20891; Toll free phone (in U.S.), 1-888-NIH-CONSENSUS (1-888-644-2667); autofax (in U.S.), 1-888-NIH-CONSENSUS (1-888-644-2667); e-mail: consensus_statements@mail.nih.gov.

Availability of Companion Documents

The following are available:

  • Enhancing the use and quality of colorectal cancer screening. Evidence report/technology assessment No. 190. RTI International–University of North Carolina Evidence-based Practice Center, Contract no. 290-2007-10056-I. Rockville (MD): Agency for Healthcare Research and Quality (US); 2010 Feb. 661 p. Electronic copies: Available in Portable Document Format (PDF) from the Agency for Healthcare Research and Quality (AHRQ) Web site External Web Site Policy.
  • About the NIH Consensus Development Program. Available from the National Institutes of Health (NIH) Consensus Development Conference Program Web site External Web Site Policy.
  • National Institutes of Health (NIH) consensus development conference on enhanced use and quality of colorectal cancer screening. Feb 2-4, 2010; Bethesda, MD. Webcast: Available from the NIH Web site External Web Site Policy.
Patient Resources

None available

NGC Status

This NGC summary was completed by ECRI Institute on May 19, 2011.

Copyright Statement

No copyright restrictions apply.

Disclaimer

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