BACKGROUND Among surgically treated patients with colon cancer, lower long-term mortality has been demonstrated in those with 12 or more lymph nodes evaluated. We examined whether patients receiving adequate lymph node evaluation were also more likely to receive comprehensive postsurgical care, leading to lower mortality. STUDY DESIGN We used the 1992 to 2007 Surveillance, Epidemiology, and End Results (SEER)-Medicare data to identify surgically treated American Joint Committee on Cancer (AJCC) stage III colon cancer patients. We used chi-square analyses and logistic regression to evaluate the association between adequate (≥12) lymph node evaluation and receipt of postsurgical care (adjuvant chemotherapy, surveillance colonoscopy, CT scans, and CEA testing) and Cox proportional hazards regression to evaluate 10-year all-cause mortality, adjusting for postsurgical care. RESULTS Among 17,906 surgically treated stage III colon cancer patients, adequate (≥12) lymph node evaluation was not associated with receiving comprehensive postsurgical care after adjustment for patient and tumor characteristics (p > 0.05 for all). Initially, adequate lymph node evaluation was associated with lower all-cause mortality (hazard ratio [HR] 0.88; 95% CI [0.85 to 0.91]), but among 3-year survivors, the impact of adequate lymph node evaluation on lower mortality was diminished (HR 0.94; 95% CI [0.88 to 1.01]). However, receiving comprehensive postsurgical care was associated with continued lower mortality in 3-year survivors. CONCLUSIONS Adequate lymph node evaluation for colon cancer was associated with lower mortality among all patients. However, among 3-year survivors, the association between lymph node evaluation and lower hazard of death was no longer significant, while postsurgical care remained strongly associated with lower long-term mortality, indicating that postsurgical care may partially explain the relationship between lymph node evaluation and mortality.

Models—mathematical frameworks that facilitate estimation of the consequences of health care decisions—have become essential tools for health technology assessment. Evolution of the methods since the first ISPOR modeling task force reported in 2003 has led to a new task force, jointly convened with the Society for Medical Decision Making, and this series of seven papers presents the updated recommendations for best practices in conceptualizing models; implementing state–transition approaches, discrete event simulations, or dynamic transmission models; dealing with uncertainty; and validating and reporting models transparently. This overview introduces the work of the task force, provides all the recommendations, and discusses some quandaries that require further elucidation. The audience for these papers includes those who build models, stakeholders who utilize their results, and, indeed, anyone concerned with the use of models to support decision making.

BACKGROUND: Considerable disparities exist in colorectal cancer (CRC) incidence and mortality rates between blacks and whites in the United States. We estimated how much of these disparities could be explained by differences in CRC screening and stage-specific relative CRC survival. METHODS: We used the MISCAN-Colon microsimulation model to estimate CRC incidence and mortality rates in blacks, aged 50 years and older, from 1975 to 2007 assuming they had: (i) the same trends in screening rates as whites instead of observed screening rates (incidence and mortality); (ii) the same trends in stage-specific relative CRC survival rates as whites instead of observed (mortality only); and (iii) a combination of both. The racial disparities in CRC incidence and mortality rates attributable to differences in screening and/or stage-specific relative CRC survival were then calculated by comparing rates from these scenarios to the observed black rates. RESULTS: Differences in screening accounted for 42% of disparity in CRC incidence and 19% of disparity in CRC mortality between blacks and whites. Thirty-six percent of the disparity in CRC mortality could be attributed to differences in stage-specific relative CRC survival. Together screening and survival explained a little more than 50% of the disparity in CRC mortality between blacks and whites. CONCLUSION: Differences in screening and relative CRC survival are responsible for a considerable proportion of the observed disparities in CRC incidence and mortality rates between blacks and whites. IMPACT: Enabling blacks to achieve equal access to care as whites could substantially reduce the racial disparities in CRC burden.

BACKGROUND: Microsimulation models are important decision support tools for screening. However, their complexity makes them difficult to understand and limits realization of their full potential. Therefore, it is important to develop documentation that clarifies their structure and assumptions. The authors demonstrate this problem and explore a solution for natural history using 3 independently developed colorectal cancer screening models. METHODS: The authors first project effectiveness and cost-effectiveness of colonoscopy screening for the 3 models (CRC-SPIN, SimCRC, and MISCAN). Next, they provide a conventional presentation of each model, including information on structure and parameter values. Finally, they report the simulated reduction in clinical cancer incidence following a one-time complete removal of adenomas and preclinical cancers for each model. They call this new measure the maximum clinical incidence reduction (MCLIR). RESULTS: Projected effectiveness varies widely across models. For example, estimated mortality reduction for colonoscopy screening every 10 years from age 50 to 80 years, with surveillance in adenoma patients, ranges from 65% to 92%. Given only conventional information, it is difficult to explain these differences, largely because differences in structure make parameter values incomparable. In contrast, the MCLIR clearly shows the impact of model differences on the key feature of natural history, the dwell time of preclinical disease. Dwell times vary from 8 to 25 years across models and help explain differences in projected screening effectiveness. CONCLUSIONS: The authors propose a new measure, the MCLIR, which summarizes the implications for predicted screening effectiveness of differences in natural history assumptions. Including the MCLIR in the standard description of a screening model would improve the transparency of these models.

BACKGROUND: As the complexity of microsimulation models increases, concerns about model transparency are heightened. METHODS: The authors conducted model "experiments" to explore the impact of variations in "deep" model parameters using 3 colorectal cancer (CRC) models. All natural history models were calibrated to match observed data on adenoma prevalence and cancer incidence but varied in their underlying specification of the adenocarcinoma process. The authors projected CRC incidence among individuals with an underlying adenoma or preclinical cancer v. those without any underlying condition and examined the impact of removing adenomas. They calculated the percentage of simulated CRC cases arising from adenomas that developed within 10 or 20 years prior to cancer diagnosis and estimated dwell time-defined as the time from the development of an adenoma to symptom-detected cancer in the absence of screening among individuals with a CRC diagnosis. RESULTS: The 20-year CRC incidence among 55-year-old individuals with an adenoma or preclinical cancer was 7 to 75 times greater than in the condition-free group. The removal of all adenomas among the subgroup with an underlying adenoma or cancer resulted in a reduction of 30% to 89% in cumulative incidence. Among CRCs diagnosed at age 65 years, the proportion arising from adenomas formed within 10 years ranged between 4% and 67%. The mean dwell time varied from 10.6 to 25.8 years. CONCLUSIONS: Models that all match observed data on adenoma prevalence and cancer incidence can produce quite different dwell times and very different answers with respect to the effectiveness of interventions. When conducting applied analyses to inform policy, using multiple models provides a sensitivity analysis on key (unobserved) "deep" model parameters and can provide guidance about specific areas in need of additional research and validation.

Context Among patients surgically treated for colon cancer, better survival has been demonstrated in those with more lymph nodes evaluated. The presumed mechanism behind this association suggests that a more extensive lymph node evaluation reduces the risk of understaging, leading to improved survival. Objective To further evaluate the mechanism behind lymph node evaluation and survival by examining the association between more extensive lymph node evaluation, identification of lymph node–positive cancers, and hazard of death. Design Observational cohort study. Setting Surveillance, Epidemiology, and End Results (SEER) program data from 1988 through 2008. Patients 86 394 patients surgically treated for colon cancer. Main Outcome Measure We examined the relationship between lymph node evaluation and node positivity using Cochran-Armitage tests and multivariate logistic regression. The association between lymph node evaluation and hazard of death was evaluated using Cox proportional hazards modeling. Results The number of lymph nodes evaluated increased from 1988 to 2008 but did not result in a significant overall increase in lymph node positivity. During 1988-1990, 34.6% of patients (3875/11 200) had 12 or more lymph nodes evaluated, increasing to 73.6% (9798/13 310) during 2006-2008 (P < .001); however, the proportion of node-positive cancers did not change with time (40% in 1988-1990, 42% in 2006-2008, P = .53). Although patients with high levels of lymph node evaluation were only slightly more likely to be node positive (adjusted odds ratio for 30-39 nodes vs 1-8 nodes, 1.11; 95% CI, 1.02-1.20), these patients experienced significantly lower hazard of death compared with those with fewer nodes evaluated (adjusted hazard ratio for 30-39 nodes vs 1-8 nodes, 0.66; 95% CI, 0.62-0.71; unadjusted 5-year mortality, 35.3%). Conclusion The number of lymph nodes evaluated for colon cancer has markedly increased in the past 2 decades but was not associated with an overall shift toward higher-staged cancers, questioning the upstaging mechanism as the primary basis for improved survival in patients with more lymph nodes evaluated.

Background. Clinical trials often report intervention efficacy in terms of the reduction in all-cause