APPENDIX A
Sources of Cancer-Related Clinical Guidelines and Quality Indicators

The quality measures recommended in this report draw from a variety of clinical practice setting organizations, federal health agencies, provider groups, and others. This appendix describes the following organizations that were key to the IOM committee’s work (including how each organization grades levels of evidence and categorizes the strength of its clinical recommendations):

  • American Society of Clinical Oncology;

  • College of American Pathologists;

  • Commission on Cancer;

  • Healthy People 2010;

  • Institute for Clinical Systems Improvement;

  • National Comprehensive Cancer Network; and

  • U.S. Preventive Services Task Force.



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Assessing the Quality of Cancer Care: An Approach to Measurement in Georgia APPENDIX A Sources of Cancer-Related Clinical Guidelines and Quality Indicators The quality measures recommended in this report draw from a variety of clinical practice setting organizations, federal health agencies, provider groups, and others. This appendix describes the following organizations that were key to the IOM committee’s work (including how each organization grades levels of evidence and categorizes the strength of its clinical recommendations): American Society of Clinical Oncology; College of American Pathologists; Commission on Cancer; Healthy People 2010; Institute for Clinical Systems Improvement; National Comprehensive Cancer Network; and U.S. Preventive Services Task Force.

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Assessing the Quality of Cancer Care: An Approach to Measurement in Georgia American Society of Clinical Oncology Sponsor American Society of Clinical Oncology Description Professional organization of clinical oncologists, oncology nurses, and other health care professionals with a focus in oncology. Publishes guidelines and technology assessments produced by panels of experts based on the research literature. Topics are selected for clinical or economic importance, variations in patterns of or access to care, availability of data, and ethical considerations. Primary Focus Breast cancer, colorectal cancer, hematology, lung cancer, myeloma, and crosscutting topics related to cancer treatment, such as the use of antiemetics. Levels of Evidence Level I: Evidence obtained from meta-analysis of multiple, well-designed, controlled studies. Randomized trials with low false-positive and low false-negative errors (high power). Level II: Evidence obtained from at least one well-designed experimental study. Randomized trials with high false-positive and/or negative errors (low power). Level III: Evidence obtained from well-designed, quasi-experimental studies such as nonrandomized, controlled, single group, pre-post, cohort, and time or matched case-control series. Level IV: Evidence from well-designed, nonexperimental studies such as comparative and correlational descriptive and case studies. Level V: Evidence from case reports. Strength of Recommendation Grade A: There is evidence of type I or consistent findings from multiple studies of type II, III, or IV. Grade B: There is evidence of type II, III, or IV, and findings are generally consistent. Grade C: There is evidence of type II, III, or IV, but findings are inconsistent. Grade D: There is little or no systematic empirical evidence. Years Since 1993 Schedule of Updates New literature reviewed annually; guidelines updated as necessary Website www.asco.org

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Assessing the Quality of Cancer Care: An Approach to Measurement in Georgia College of American Pathologists Sponsor College of American Pathologists (CAP) Description Principal organization of board-certified pathologists concerned with the practice of pathology and laboratory medicine. Primary Focus CAP produces standardized templates, referred to as protocols or checklists, for reporting findings on cancer specimens for each organ site and type of surgical specimen. Levels of Evidence NA Strength of Recommendation NA Years Since 1998 Schedule of Updates Updated as needed Website www.cap.org NA = not applicable.

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Assessing the Quality of Cancer Care: An Approach to Measurement in Georgia Commission on Cancer Sponsor American College of Surgeons Description The Commission on Cancer (CoC) is a multi-disciplinary consortium that establishes quality standards for cancer care programs and accredits programs according to those standards. Although most CoC-accredited programs are hospital-based, freestanding treatment facilities and health care networks can also apply for CoC accreditation. Primary Focus CoC standards cover the full range of cancer center activities including clinical and pathology data and reporting, tumor registries, clinical management, research, community outreach, professional education, and quality improvement. CoC-certified pathology laboratories must comply with the College of American Pathologists’ reporting requirements for cancer-directed surgical specimens. Levels of Evidence NA Strength of Recommendation NA Years Since 1975 Schedule of Updates Updated as needed Website http://www.facs.org/cancer/coc/coc.html NA = not applicable.

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Assessing the Quality of Cancer Care: An Approach to Measurement in Georgia Healthy People 2010 Sponsor U.S. Department of Health and Human Services (DHHS) Description Healthy People 2010 is a statement of national health objectives designed to identify the most significant preventable threats to health and to establish national goals to reduce these threats. It includes specific, measurable objectives across 28 focus areas with target goals and national baseline. Primary Focus The cancer-related objectives of Healthy People 2010 relate to: Mortality (overall, lung, breast, cervical, colorectal, oropharyngeal, prostate, and melanoma) Sun exposure and skin cancer Provider counseling about cancer prevention Pap tests Colorectal cancer screening Mammograms Statewide cancer registries Survival Fruit and vegetable intake Fat intake Oral and pharyngeal cancers Tobacco use including smoking cessation and insurance coverage of tobacco cessation treatment Levels of Evidence NA Strength of Recommendation NA Years Healthy People 2000, Healthy People 2010 Schedule of Updates New objectives developed every 10 years. Each focus area is reviewed at least twice during the decade. Website www.healthypeople.gov NA = not applicable.

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Assessing the Quality of Cancer Care: An Approach to Measurement in Georgia Institute for Clinical Systems Improvement Sponsors Six Minnesota health plans; Blue Cross and Blue Shield of Minnesota, Health Partners, Medica, PreferredOne, UCare Minnesota, and Metropolitan Health Plan Description A nonprofit collaborative that provides health care quality improvement services to its 54 member groups, including more than 7,400 physicians. Primary Focus More than 55 guidelines for the prevention or treatment of specific health conditions. Cancer-related guidelines address colorectal cancer screening, tobacco use prevention and cessation, diagnosis of breast disease, and breast cancer treatment. Levels of Evidence Primary Reports of New Data Collection Class A: Randomized, controlled trial Class B: Cohort study Class C: Nonrandomized trial with concurrent or historical controls; Case-control study; Study of sensitivity and specificity of a diagnostic tests; Population-based descriptive study Class D: Cross-sectional study; Case series; Case report Reports that Synthesize or Reflect upon Collections of Primary Reports Class M: Meta-analysis; Systematic review; Decision analysis; Cost-effectiveness analysis Class R: Consensus statement; Consensus report; Narrative review Class X: Medical opinion Strength of Recommendation Grade I: The evidence consists of results from studies of strong design for answering the question addressed. The results are both clinically important and consistent with minor exceptions at most. The results are free of any significant doubts about generalizability, bias, and flaws in research design. Studies with negative results have sufficiently large samples to have adequate statistical power. Grade II: The evidence consists of results from studies of strong design for answering the question addressed, but there is some uncertainty attached to the conclusions because of inconsistencies among the results from the studies or because of minor doubts about generalizability, bias, research design flaws, or adequacy of sample size. Alternatively, the evidence consists solely of results from weaker designs for the question addressed, but the results have been confirmed in separate studies and are consistent with minor exceptions at most.

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Assessing the Quality of Cancer Care: An Approach to Measurement in Georgia   Grade III: The evidence consists of results from studies of strong design for answering the question addressed, but there is substantial uncertainty attached to the conclusion because of inconsistencies among the results from different studies or because of serious doubts about generalizability, bias, research design flaws, or adequacy of sample size. Alternatively, the evidence consists solely of results from a limited number of studies of weak design for answering the question addressed. Years Since 1992 Schedule of Updates Reviewed every 12-18 months and updated as necessary Website www.icsi.org

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Assessing the Quality of Cancer Care: An Approach to Measurement in Georgia National Comprehensive Cancer Network Sponsor National Comprehensive Cancer Network (NCCN) Description An alliance of 19 leading cancer centers. NCCN Clinical Practice Guidelines in Oncology are the most widely used guidelines in oncology practice. Primary Focus NCCN guidelines cover treatment of more than 95 percent of all cancers and also address cancer detection; risk assessment and reduction; and supportive care for nausea and vomiting, distress management, cancer-related fatigue, and cancer pain. Levels of Evidence NA Strength of Recommendation The strength of the recommendations provided in NCCN guidelines is indicated by the Categories of Consensus, which are based on both the strength of the evidence for the recommendation and the degree of committee consensus. Category 1: There is uniform NCCN consensus, based on high-level evidence, that the recommendation is appropriate. Category 2A: There is uniform NCCN consensus, based on lower-level evidence including clinical experience, that the recommendation is appropriate. Category 2B: There is nonuniform NCCN consensus (but no major disagreement), based on lower-level evidence including clinical experience, that the recommendation is appropriate. Category 3: There is major NCCN disagreement that the recommendation is appropriate. Years Since 1995 Schedule of Updates Updated at least annually Website www.nccn.org NA = not applicable.

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Assessing the Quality of Cancer Care: An Approach to Measurement in Georgia U.S. Preventive Services Task Force (USPSTF) Sponsor U.S. Department of Health and Human Services, Agency for Healthcare Research and Quality Description An independent panel of private-sector experts appointed by the Agency for Healthcare Research and Quality. Primary Focus The appropriate use of preventive services in primary care settings, including cancer screening, counseling, chemoprevention, and immunizations. Cancer-related recommendations concern screening for 12 cancers, including breast, lung, prostate, and colorectal and counseling for gynecologic cancers, skin cancer; tobacco use, and vitamin supplementation for cancer prevention. Levels of Evidence Good: Evidence includes consistent results from well-designed, well-conducted studies in representative populations that directly assess effects on health outcomes. Fair: Evidence is sufficient to determine effects on health outcomes, but the strength of the evidence is limited by the number, quality, or consistency of the individual studies, generalizability to routine practice, or indirect nature of the evidence on health outcomes. Poor: Evidence is insufficient to assess the effects on health outcomes because of limited number or power of studies, important flaws in their design or conduct, gaps in the chain of evidence, or lack of information on important health outcomes. Strength of Recommendation A: The USPSTF strongly recommends that clinicians provide [the service] to eligible patients. The USPSTF found good evidence that [the service] improves important health outcomes and concludes that benefits substantially outweigh harms. B: The USPSTF recommends that clinicians provide [this service] to eligible patients. The USPSTF found at least fair evidence that [the service] improves important health outcomes and concludes that benefits outweigh harms. C: The USPSTF makes no recommendation for or against routine provision of [the service]. The USPSTF found at least fair evidence that [the service] can improve health outcomes but concludes that the balance of benefits and harms is too close to justify a general recommendation. D: The USPSTF recommends against routinely providing [the service] to asymptomatic patients. The USPSTF found at least fair evidence that [the service] is ineffective or that harms outweigh benefits.

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Assessing the Quality of Cancer Care: An Approach to Measurement in Georgia   I: The USPSTF concludes that the evidence is insufficient to recommend for or against routinely providing [the service]. Evidence that the [service] is effective is lacking, of poor quality, or conflicting and the balance of benefits and harms cannot be determined. Years Since 1984 Schedule of Updates Updated as needed Website www.ahrq.gov/clinic/uspstfix.htm