Meeting report from the joint IARC-NCI international cancer seminar series: a focus on colorectal cancer.

Despite significant progress in our understanding of the etiology, biology and genetics of colorectal cancer, as well as important clinical advances, it remains the third most frequently diagnosed cancer worldwide and is the second leading cause of cancer death. Based on demographic projections, the global burden of colorectal cancer would be expected to rise by 72% from 1.8 million new cases in 2018 to over 3 million in 2040 with substantial increases anticipated in low- and middle-income countries. In this meeting report, we summarize the content of a joint workshop led by the National Cancer Institute and the International Agency for Research on Cancer, which was held to summarize the important achievements that have been made in our understanding of colorectal cancer etiology, genetics, early detection and treatment and to identify key research questions that remain to be addressed.

Achieving quality in flexible sigmoidoscopy screening for colorectal cancer.

BACKGROUND: Sigmoidoscopy screening, which can dramatically reduce colorectal cancer mortality, is supported increasingly by physicians and payers, and is likely to be performed more frequently in the future. As more physicians and nonphysician medical personnel learn how to perform this procedure, and with attention to quality standards, the overall impact of sigmoidoscopy screening may improve. This review describes elements that characterize high-quality examinations and identifies resources for in-depth information on performing flexible sigmoidoscopy. METHODS: The domains of quality were identified from textbooks, articles, and the professional opinions of gastroenterologists and primary care physicians. Information was obtained from MEDLINE, bibliographies in recent articles, medical professional organizations, equipment manufacturers' representatives, and focus groups of primary care physicians. RESULTS: Nine domains of quality are identified and discussed: training, logistical start-up, patient interaction, bowel preparation, examination technique, lesion recognition, complications, reporting, and processing (equipment cleaning and disinfection). CONCLUSIONS: Persons learning how to perform and to implement flexible sigmoidoscopy may use this information to help ensure the quality of screening examinations.

The practices and attitudes of primary care nurse practitioners and physician assistants with respect to colorectal cancer screening.

OBJECTIVES: Although nurse practitioners and physician assistants form a large and growing portion of the primary care workforce, little is known about their colorectal cancer screening practices. The aim of this study was to assess the colorectal cancer screening practices, training, and attitudes of nurse practitioners and physician assistants practicing primary care medicine. METHODS: All nurse practitioners (827) and physician assistants (1178) licensed by the Medical Board of the State of North Carolina were surveyed by mail. Both groups were further divided into primary care versus non-primary care by self-described roles. Self-reported practices, training, and attitudes with respect to colorectal cancer screening were elicited. RESULTS: Response rates were 71.4% and 61.2%, for nurse practitioners and physician assistants respectively. A total of 51.3% of nurse practitioners and 50.3% of physician assistants described themselves as adult primary care providers. No primary care nurse practitioners and only 3.8% of primary care physician assistants performed screening flexible sigmoidoscopy. However, 76% of primary care physician assistants and 69% of primary care nurse practitioners reported recommending screening flexible sigmoidoscopy. A total of 95% primary care physician assistants and 92% of primary care nurse practitioners reported performing fecal occult blood testing. Only 9.4% of physician assistants and 2.8% of nurse practitioners received any formal instruction in flexible sigmoidoscopy while in their training. Additionally, 41.4% of primary care physician assistants and 27.7% of primary care nurse practitioners reported that they would be interested in obtaining formal training in flexible sigmoidoscopy. CONCLUSIONS: Physician assistants and nurse practitioners are motivated, willing and underutilized groups with respect to CRC screening. Efforts to increase education and training of these professionals may improve the availability of CRC screening modalities.

Effectiveness and economic impact of screening for colorectal cancer by mass fecal occult blood testing.

OBJECTIVES: Fecal occult blood testing has been shown to reduce mortality from colorectal cancer in large randomized, controlled trials conducted in the United States, Denmark, and the United Kingdom, and mathematical simulation modeling found it to be cost-effective relative to other health care services. Before making a concerted effort to implement mass fecal occult blood testing based on this evidence alone, however, we considered it prudent to critically re-evaluate the effectiveness and economic impact of screening in the US population as a whole. METHODS: To assess the effectiveness of screening, we projected published outcomes from each of the three large randomized controlled trials of fecal occult blood testing to the US population, as if each clinical trial had been done in the population as a whole. We then determined the resource costs of detection and treatment that would be associated with the outcomes predicted from each trial. RESULTS: More than 1 million colorectal cancers could be expected to arise over 10 yr in the cohort of US residents eligible to enter a screening program in 1997, and trial outcomes indicate that > or = 60% of these cancers would be fatal. If the 60-67% compliance rate of the population-based randomized controlled trials were achieved, a fecal occult blood testing program would detect 30% of known colorectal cancers and save 100,000 lives over 10 yr. Screening would incur total costs of $3-4 billion over 10 yr, or $2,500 per life-year saved. CONCLUSIONS: Mass fecal occult blood testing is cost-effective, and, although not inexpensive, many would consider the total cost acceptable. Even with a concerted effort to achieve compliance, however, the effectiveness of fecal occult blood testing would be limited to saving the lives of < or = 15% of those who otherwise would die from their cancer in the first 10 yr after beginning mass screening. The limitations of fecal occult blood testing suggest the need to further evaluate the role of endoscopy in screening, and to develop more effective, noninvasive screening tools.

Risk of advanced proximal neoplasms in asymptomatic adults according to the distal colorectal findings.

BACKGROUND AND METHODS: The clinical significance of a distal colorectal polyp is uncertain. We determined the risk of advanced proximal neoplasia, defined as a polyp with villous features, a polyp with high-grade dysplasia, or cancer, among persons with distal hyperplastic or neoplastic polyps as compared with the risk among persons with no distal polyps. We analyzed data from 1994 consecutive asymptomatic adults (age, 50 years or older) who underwent colonoscopic screening for the first time between September 1995 and December 1998 as part of a program sponsored by an employer. The location and histologic features of all polyps were recorded. Colonoscopy to the level of the cecum was completed in 97.0 percent of the patients. RESULTS: Sixty-one patients (3.1 percent) had advanced lesions in the distal colon, including 5 with cancer, and 50 (2.5 percent) had advanced proximal lesions, including 7 with cancer. Twenty-three patients with advanced proximal neoplasms (46 percent) had no distal polyps. The prevalence of advanced proximal neoplasia among patients with no distal polyps was 1.5 percent (23 cases among 1564 persons; 95 percent confidence interval, 0.9 to 2.1 percent). Among patients with distal hyperplastic polyps, those with distal tubular adenomas, and those with advanced distal polyps, the prevalence of advanced proximal neoplasia was 4.0 percent (8 cases among 201 patients), 7.1 percent (12 cases among 168 patients), and 11.5 percent (7 cases among 61 patients), respectively. The relative risk of advanced proximal neoplasia, adjusted for age and sex, was 2.6 for patients with distal hyperplastic polyps, 4.0 for those with distal tubular adenomas, and 6.7 for those with advanced distal polyps, as compared with patients who had no distal polyps. Older age and male sex were associated with an increased risk of advanced proximal neoplasia (relative risk, 1.3 for every five years of age and 3.3 for male sex). CONCLUSIONS: Asymptomatic persons 50 years of age or older who have polyps in the distal colon are more likely to have advanced proximal neoplasia than are persons without distal polyps. However, if colonoscopic screening is performed only in persons with distal polyps, about half the cases of advanced proximal neoplasia will not be detected.

Accuracy of administrative data in trauma.

BACKGROUND: Accurate data are needed to evaluate outcomes, therapeutics, and quality of care. This study assesses the accuracy of administrative databases in recording information about trauma patients. METHODS: Patients with thoracic aorta injury were identified with a state trauma registry, and the medical records were reviewed. Data collected were compared to administrative data on patients with thoracic aorta injuries, at the same hospitals in the same time period. RESULTS: Fifteen patients (16.3%) with thoracic aorta injury were not recorded in the administrative database, and 23 patients (18.7%) were misdiagnosed. Ninety-one patients were found in both data sources. The administrative database significantly (P < .05) underrecorded abdominal injuries (50 vs 35), orthopedic injuries (117 vs 75), and chest injuries (77 vs 48). The number of aortograms (78 vs 8), type of operative procedures (use of graft; 70 vs 30), use of bypass (35 vs 16), and complications (77 vs 33) were underreported (P < .05). The Injury Severity Score was underestimated by the administrative database (38.65 +/- 12.41 vs 25.66 +/- 9.53; P < .05). CONCLUSIONS: Administrative data lack accuracy in the recording of associated injury, injury severity, diagnostic, and procedural data. Whether these data should be used to evaluate treatment or quality of care in trauma is questionable.

Effectiveness and patient satisfaction with screening flexible sigmoidoscopy performed by registered nurses.

BACKGROUND: Our aim was to compare the effectiveness and patient satisfaction with flexible sigmoidoscopy performed by a registered nurse, general surgeons, and gastroenterology fellows. METHODS: Consecutive outpatients referred for sigmoidoscopy were assigned to have the procedure performed by the first available provider. Depth of insertion of the sigmoidoscope, complications, duration of the procedure, and percentage of patients with adenomas were recorded. After the procedure, patients completed a validated patient satisfaction questionnaire. RESULTS: Mean depth of insertion was less for general surgeons compared with the nurse and gastroenterology fellows (50 vs 53 vs 54 cm, respectively; p = 0.01). Mean duration of procedure was longer for the nurse compared with general surgeons and gastroenterology fellows (8.3 vs 7.6 vs 6.8 min, respectively; p = 0.0001). Percentage of patients with adenomas was similar among patients who underwent sigmoidoscopy by the endoscopists (7% vs 8% vs 9%; p = 0.81). No differences were detected between endoscopists for overall satisfaction (p = 0.60), technical skills of the endoscopist (p = 0.58), communication skills of the endoscopist (p = 0.61), or interpersonal skills of the endoscopist (p = 0.59). CONCLUSION: No clinically significant differences in effectiveness or patient satisfaction were detected with flexible sigmoidoscopy performed by a registered nurse, general surgeons, or gastroenterology fellows.

Licensure, use, and training of paramedical personnel to perform screening flexible sigmoidoscopy.

BACKGROUND: The purpose of this study was to assess the state board of nursing guidelines about the performance of flexible sigmoidoscopy by nurses and to determine the current use and training of paramedical personnel in flexible sigmoidoscopy at gastroenterology fellowship programs in the United States. METHODS: Separate one-page questionnaires were sent to state boards of nursing and directors of endoscopy at gastroenterology fellowship programs in the United States. RESULTS: Twenty percent (10 of 50) of state boards of nursing explicitly approve the performance of sigmoidoscopy by registered nurses, and 50% (25 of 50) explicitly approve the practice by nurse practitioners. Forty-six percent (23 of 50) of state boards of nursing have no written policy but allow nurses to use a "decision making model" to determine whether the performance of sigmoidoscopy is allowed. Fifteen percent (24 of 164) of gastroenterology fellowship programs in the United States use paramedical personnel to perform flexible sigmoidoscopy. Sixty-three percent (15 of 24) of these programs started since 1995, and 67% (16 of 24) require that the paramedical personnel perform 50 or more supervised sigmoidoscopies during their training. Forty-five percent (5 of 11) of programs with physician assistants/nurse practitioners use these personnel to perform colonoscopy or endoscopy. CONCLUSIONS: Nurses are allowed to perform flexible sigmoidoscopy in most states based on current state board of nursing guidelines. The use of paramedical personnel to perform endoscopic procedures is increasing rapidly.

What can we conclude from the randomized controlled trials of fecal occult blood test screening?

The results of three published randomized controlled trials of fecal occult blood testing (FOBT) provide unequivocal proof of the principle that screening reduces mortality from colorectal cancer (CRC). However, several interesting questions remain in interpreting and applying the results of the clinical trials, including: how well does FOBT screening work (i.e. how much can CRC mortality be reduced), how does it work, when is it worthwhile and worthwhile doing, and how can technique be optimized? The answers to these questions have important practical and clinical implications.

Lessons from the mammography screening controversy: can we improve the debate?

The debate about breast cancer screening for women in their 40s has become so contentious that effective communication and rational discussion on this topic have been compromised. This contentiousness might be defused by understanding the reasons for it. The debate is less about facts than it is about perceptions and values. There is disagreement about how to fairly describe facts about risk and how to avoid misperceptions that may distort assessment of risk. Other sources of disagreement concern the potential harms of screening, the relative roles of physicians and patients in decision making, and how to factor cost into screening decisions. The entire decision-making process has also been highly charged by single-issue advocacy groups and a kind of gender rivalry. Several approaches might help defuse the debate and improve discussion. First, those on both sides of the debate might agree on several things: 1) that the evidence from clinical trials is widely agreed-upon and thus that a main task now is to factor in the values of individual women who are making decisions; 2) that the values of women may differ substantially and that those differences should be respected; 3) that both individuals and the public should be fully and fairly informed about the pros and cons of screening; and 4) that cost-effectiveness should at least be considered during the decision-making process. Lessons from this debate may apply to other medical problems that have small degrees of risk and whose management is strongly debated.

Early detection of prostate cancer. Serendipity strikes again.

An underappreciated characteristic of prostate cancer screening is that it may detect some prostate cancers solely by serendipity or chance. Serendipity, previously described in the detection of colonic neoplasms, could affect prostate cancer detection when a screening test result is abnormal for reasons other than the presence of prostate cancer, but prostate cancer is coincidentally detected during the subsequent evaluation of the abnormal screening result. We reviewed published articles about prostate cancer screening, searching for evidence of serendipity. We defined serendipity in digital rectal examination (DRE) screening as the discovery of a prostate cancer by the random biopsy of an area of the prostate gland other than the palpable suspicious area that prompted the biopsy. We defined serendipity in prostate-specific antigen (PSA) screening as the discovery of a prostate cancer by the random biopsy of a nonpalpable (stage T1c) prostate cancer less than 1.0 cm3 in volume, since tumors less than 1.0 cm3 are generally too small to cause elevated PSA levels. We found that serendipity may be responsible for the detection of more than one quarter of apparently DRE-detected prostate cancers and up to one quarter of apparently PSA-detected cancers. Additionally, serendipity played a larger role in the detection of smaller tumors that are common but of uncertain clinical significance. We conclude that serendipity-detected prostate cancers contribute to an overestimation of the true information value of DRE and PSA screening. Whether serendipity is advantageous in prostate cancer screening depends on the as yet uncertain outcomes for men with smaller prostate cancers. However, given our estimates of the potential magnitude of the impact of serendipity, the currently popular DRE- and PSA-based screening strategy may not be optimal. If smaller prostate cancers are important, then we are not finding enough; if they are unimportant, then we are finding too many that we may feel compelled to treat aggressively.