Increasing the sampled number of lymph nodes leads to increased accuracy in node status and determination of the appropriate therapy for patients. As discussed above, increased lymph node counts are associated with significantly increased survival. Thus, the lymph node count has been Angiogenesis inhibitor touted by some to be a measure of quality by payers and policymakers. However, there are concerns regarding implementation of 12 lymph nodes as a quality indicator. First, the studies which support a minimum harvest of 12 lymph nodes are primarily observational and cannot fully explain the association

between increased lymph Inhibitors,research,lifescience,medical node count and improved survival (49). Data showing improved survival in both node-negative and node-positive patients with high

numbers of lymph nodes suggests there is a biologic association or tumor-host association that may be an independent prognostic factor. If these associations are due to confounding, using lymph node counts as a quality Inhibitors,research,lifescience,medical indicator will have little impact. Secondly, using the recommended minimum of 12 lymph nodes as a benchmark for quality assumes that lymph node numbers are relatively similar between patients. This is clearly not the case. Lymph node numbers have been shown to significantly Inhibitors,research,lifescience,medical vary by a variety of parameters. The number of lymph nodes retrieved has been directly proportional to length and width of the specimen as well as T stage/depth of invasion (32). Right-sided tumors and Inhibitors,research,lifescience,medical those with microsatellite instability are also associated with increased yield. Older patients have lower lymph node numbers, which may stem from decreasing immune function or changes in surgical technique. It also has been suggested that because of the low survival benefit or greater co-morbidity, surgeons

Inhibitors,research,lifescience,medical are less likely to perform extensive resections on elderly patients (32). Low lymph node counts have been correlated with use of neoadjuvant therapy (50). Therefore, variation in lymph node count is less likely to be an indication of quality, but rather an indication of the heterogeneity of both patients and tumors. The implementation of quality indicators may have additional unintended consequences as Simunovic and Baxter explain (51). Setting 12 lymph nodes as a quality indicator could lead pathologists to stop their search once this number is attained, thus leaving lymph nodes Astemizole behind and potentially altering prognostic indicators. Surgeons may tend to resect slightly larger specimens in order to increase the likelihood of reaching this number, possibly causing increased morbidity. There is concern over what aspect of care the quality indicator would address. Both surgeons and pathologists are responsible for factors related to the number of lymph nodes examined. Meeting a quality indicator benchmark does not guarantee that lymph nodes were not overlooked. Likewise, if an institution does not meet this benchmark, it is very difficult to determine the cause and rectify the inadequacy.