Tales from the EMR: Does a 21st-Century Data Warehouse Facilitate Clinical Research for Pancreatic Cancer?

Background: The importance of an electronic medical record has been highlighted for both clinical care and research. In the current era, data warehouses and repositories have been established to serve the dual function of patient care and investigation. Purpose: The aim of this study was to compare a newly developed institutional clinical data warehouse, linked with the hospital information system (HIS), to a prospectively-maintained departmental database. Methods: A novel HIS-linked institutional clinical data warehouse was queried for 9 primary and secondary ICD-9-CM discharge diagnosis codes for pancreatic cancer. The database captured inpatient and outpatient clinical and billing information from a pool of over 2 million patients evaluated at an academic medical institution and its affiliates since 1995. A cohort was identified; following Institutional Review Board approval, demographic and clinical data was obtained. This data was compared to a manually-entered and prospectively-maintained surgical oncology database of the same institution, tracking 394 patients since 1999. Duplicated patients, and those unique to either dataset, were flagged. Patients with diagnosis dates prior to 1999 were excluded to allow comparison over the same time period. For validation purposes, a 10% random sample of remaining patients unique to each dataset underwent manual review of medical records including clinic notes, admission/discharge notes, diagnostic imaging, and pathology reports. Results: 1107 patients were identified from the HIS-linked dataset with pancreatic neoplasm-associated diagnosis codes dating from 1999 to 2009. Of these, 254 (22.9%) were captured in both datasets, while 853 (77.1%) were only in the HIS-linked dataset. Manual review of the 10% subset of the HIS-only group demonstrated that 55.6% of patients were without identifiable pancreatic pathology, suggesting miscoding, while 31.7% had diagnoses consistent with pancreatic neoplasm, and 12.7% had pseudocyst or pancreatitis. Of the 394 patients tracked by surgical oncology, 254 (64.5%) were captured in both datasets, while 140 (35.5%) had not been captured in the HIS-linked dataset. Manual review of the 10% subset of the non-captured patients demonstrated 93.3% with pancreatic neoplasm and 6.7% with pseudocyst or pancreatitis. Lastly, a review of the 10% subset of the 254 patient overlap demonstrated that 87.5% of patients were with pancreatic neoplasm, 8.3% with pseudocyst or pancreatitis, and 4.2% without pancreatic pathology. Conclusions: While technological advances provide a powerful means to automate institutional-level cohort identification and data collection, a high degree of misclassification may be present if queries are based solely on ICD-9-CM discharge codes. For that reason, careful validation and data cleaning are critical steps prior to research use. These results also suggest cautious interpretation of national-level administrative data utilizing ICD-9-CM diagnosis codes. Our findings suggest that the current state-of-the-art data warehouses continue to require clinical correlation and validation through traditional retrospective mechanisms

Endemic Gallbladder Cancer: Is There a Role for Prophylactic Cholecystectomy?

Background: Gallbladder cancer (GBC) is an often lethal malignancy with variable distribution. Incidence in the United States is low. However, in areas of Central/South America, Central Europe, Japan, and the Indian subcontinent, GBC is a major cause of cancer death. Cholecystectomy is safe and commonly performed worldwide. Thus, prophylactic cholecystectomy (PCCY) has been proposed in regions with endemic GBC. We developed a simple decision model to assist caregivers in determining the optimal strategy for managing GBC based on local incidence and technological capabilities. Methods: Rates of disease and outcomes were derived from a review of the literature. Using TreeAge-Pro software, a decision model was created to simulate expected health outcomes for populations with high GBC incidence, following 3 treatment strategies: no early intervention, one-time screening ultrasound (US), or PCCY. Lifetime cancer-specific survival was the outcome of interest. Sensitivity analyses were performed to determine threshold values. Results: Based on our model, populations where lifetime risk of GBC exceeds 0.4% may benefit from early intervention by US or PCCY. Two-way sensitivity analysis shows that over a relatively narrow range of disease incidence, US may be favored if sensitivity exceeds 50%. In many cases where lifetime risk exceeds 1%, PCCY may improve survival. Conclusions: GBC varies in incidence, but affects many individuals in some populations in the Americas. The lethality of GBC may justify aggressive public health intervention including screening or prophylactic cholecystectomy. Decision analysis models using best-available evidence may help determine the optimal treatment of individuals at risk for GBC

Is pancreatic cancer palliatable? A national study

Background: Pancreatic cancer is frequently diagnosed at advanced stages where potentially curative resection is no longer possible. Palliative procedures can be performed; however, results on a national level are unknown. This study examines pancreatic cancer patients who underwent potentially palliative procedures including gastric bypass, biliary bypass surgery, celiac block, biliary stent, gastrostomy or jejunostomy, and examines post-intervention complications and 30-day mortality. Methods: SEER-Medicare 1991-2005 was used to identify patients with Stage 3-4 pancreatic cancer. Complication rates were calculated including post-op infection, myocardial infarction, aspiration pneumonia, DVT/PE, pulmonary compromise, gastric bleed, acute renal failure, and reoperation. Kaplan-Meier survival analysis was performed. Finally, Cox proportional hazards modeling was used to control for the effects of age, sex, race, stage, and resection. Results: Of 22,314 pancreatic cancer patients, 858 (3.9%) patients were Stage 3, and 11,149 (50.0%) stage 4. Post-procedure median survival for all patients is approximately two months, with longest survival for biliary bypass patients (3.2mo, 95% CI(2.9-3.7), and lowest survival for jejunostomy 1.3 mo (1.2-1.5) and gastrostomy 1.5 mo (1.4-1.8). Post-procedure 30-day mortality was highest for gastrostomy patients at 41.5%; followed by jejunostomy (39.1%), celiac plexus block (30.0%), gastric bypass (23.8%), biliary bypass (17.8%), and biliary stent (21.2%). The rate of complications averaged 40%, with highest rate for gastrostomy (47.4%) and gastric bypass (45.3%) and lowest for celiac plexus block (29.3%). Stage 4 disease was an independent predictor of death for patients undergoing five out of six procedures. Conclusion: We found that morbidity and mortality of palliative procedures in unresectable pancreatic cancer is high, especially in stage 4 patients. Further studies need to be conducted to identify patients who will have sufficient expected post-procedure survival to benefit from these palliative interventions

Improving patient notification of solid abdominal viscera incidental findings with a standardized protocol

BACKGROUND: The increasing use of computed tomography (CT) scans in the evaluation of trauma patients has led to increased detection of incidental radiologic findings. Incidental findings (IFs) of the abdominal viscera are among the most commonly discovered lesions and can carry a risk of malignancy. Despite this, patient notification regarding these findings is often inadequate. METHODS: We identified patients who underwent abdominopelvic CTs as part of their trauma evaluation during a recent 1-year period (9/2011-8/2012). Patients with IFs of the kidneys, liver, adrenal glands, pancreas and/or ovaries had their charts reviewed for documentation of the lesion in their discharge paperwork or follow-up. A quality improvement project was initiated where patients with abdominal IFs were verbally informed of the finding, it was noted on their discharge summary and/or were referred to specialists for evaluation. Nine months after the implementation of the IF protocol, a second chart review was performed to determine if the rate of patient notification improved. RESULTS: Of 1,117 trauma patients undergoing abdominopelvic CT scans during the 21 month study period, 239 patients (21.4%) had 292 incidental abdominal findings. Renal lesions were the most common (146 patients, 13% of all patients) followed by hepatic (95/8.4%) and adrenal (38/3.4%) lesions. Pancreatic (10/0.9%) and ovarian lesions (3/0.3%) were uncommon. Post-IF protocol implementation patient notification regarding IFs improved by over 80% (32.4% vs. 17.7% pre-protocol, p = 0.02). CONCLUSION: IFs of the solid abdominal organs are common in trauma patients undergoing abdominopelvic CT scan. Patient notification regarding these lesions is often inadequate. A systematic approach to the documentation and evaluation of incidental radiologic findings can significantly improve the rate of patient notification

Progress for resectable pancreatic [corrected] cancer?: a population-based assessment of US practices

BACKGROUND: : Pancreatic adenocarcinoma is a deadly disease; however, recent studies have suggested improved outcomes in patients with locoregional cancer. Progress was evaluated at a national level in resected patients, as measured by the proportion who received guideline-directed treatment and trends in survival. METHODS: : The linked Surveillance, Epidemiology, and End Results and Medicare databases were queried to identify resections for pancreatic adenocarcinoma performed between 1991 and 2002. Receipt and timing of chemotherapy and radiation with respect to time-trend were assessed. Using logistic regression, factors associated with adjuvant combination chemoradiotherapy were identified. Kaplan-Meier curves stratified by year and treatment were used to assess survival. RESULTS: : Of the 1910 patients, 47.9% (n = 915) received some form of adjuvant therapy within the first 6 months postoperatively; 34.4% (n = 658) received combination chemoradiotherapy (chemoRT). ChemoRT demonstrated a significant increase, from 29.2% to 37.5% (P \u3c .0001). Neoadjuvant therapy was used in 5.7% (n = 108) of patients; no trend was observed during the study (P = .1275). The in-hospital mortality rate was 8.0% (n = 153 patients); no significant trend was noted (P = .3116). Kaplan-Meier survival, stratified by year group of diagnosis, did not change significantly over time (log-rank test, P = .4381), even with comparisons of the first 3 years with the last 3 years of the study (log-rank test, P = .3579). CONCLUSIONS: : Adherence to guideline-directed care isimproving in the United States; however, the pace is slow, and overall survival has yet to be impacted significantly. Both increased use of adjuvant therapy and the development of more promising systemic treatments are necessary to improve survival for patients with resectable pancreatic cancer. Cancer 2010. (c) 2010 American Cancer Society

Malignant Intraductal Papillary Mucinous Neoplasm: Are We Doing the Right Thing

BACKGROUND: Because of the malignant potential, resection has been recommended for some intraductal papillary mucinous neoplasms (IPMN). We hypothesize that a large cancer database could be used to evaluate national resection rates and survival for malignant IPMN. MATERIALS AND METHODS: Using the Surveillance Epidemiology and End Results (SEER) database, 1988-2003, cases of malignant IPMN were identified using histology codes. Age-adjusted incidence rates were calculated; Cochran-Armitage tests evaluated trends over time. Predictors of resection were evaluated using chi(2) and logistic regression. Kaplan-Meier curves and Cox models were constructed to evaluate survival. RESULTS: Of 1834 patients, 209 (11.4%) underwent resection. Annual age-adjusted incidence decreased over the study time-course (P\u3c0.05), while annual proportion of patients presenting with localized lesions and the proportion being resected increased (P\u3c0.05). Predictors of resection on multivariate analysis included localized stage [versus distant, adjusted odds ratio (OR) 31; 95% confidence interval (CI) 17-56], and more recent diagnosis [referent 1988-1991; 2000-2003, OR 3.0 (95%CI 1.7-5.3)]. Median survival for resected patients was 16 mo versus 3 mo without resection (P\u3c0.0001). After adjusting for age, gender, stage, year, and tumor location, surgical resection remained a significant predictor of survival [hazard ratio 0.44 (95% CI 0.36-0.54), P\u3c0.0001]. CONCLUSIONS: In this population-based cohort, detection of malignant IPMNs is decreasing, with an increasing proportion of patients diagnosed at local stages and undergoing resection. Increased awareness of IPMN may be contributing to earlier detection, which might include benign/premalignant lesions, and greater utilization of resection for appropriate candidates; thus, we may be improving survival for this most treatable form of pancreatic cancer

A Neoadjuvant Strategy for Pancreatic Adenocarcinoma Helps Patients Receive All Components of Care: Lessons from a Single-Institution Database

Objective: To evaluate factors predictive of pancreatic adenocarcinoma patients receiving both surgical resection and adjuvant therapy

A Neoadjuvant Strategy for Pancreatic Adenocarcinoma Helps Patients Receive All Components of Care: Lessons from a Single-Institution Database

Objective: To evaluate factors predictive of pancreatic adenocarcinoma patients receiving both surgical resection and adjuvant therapy

Potential benefit of resection for stage IV gastric cancer: a national survey

INTRODUCTION: Controversy exists as to whether patients with stage IV gastric cancer should undergo surgical resection. We examined the association of gastrectomy with survival in this population. METHODS: Stage IV gastric cancer diagnoses were identified using the SEER database (1988-2005). Analyses examined three subgroups divided on the basis of whether cancer-directed surgery was recommended and performed. Univariate analyses included chi-square and Kaplan-Meier survival analyses. Cox proportional hazards modeling was performed to assess independent determinants of survival. RESULTS: Of 66,751 identified gastric cancer patients, 23,830 had stage IV disease. Resected patients had a significant survival advantage; survival outcomes of patients who had been recommended for, but had not undergone, surgery were identical to that of patients who had not been recommended (3 months vs. 9 months for resected, p \u3c 0.0001). Furthermore, resection status was the most significant independent predictor of increased risk of death (hazard ratios 2.0 for non-cancer-directed surgery groups). CONCLUSIONS: Patients with stage IV gastric cancer who undergo resection, a highly selected population, have significantly greater survival than unresected patients, including those who were recommended for, but did not receive, resection. Stage IV gastric cancer patients who are reasonable operative candidates should be offered resection