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

Utilization and Outcomes of Patients with Colorectal Cancer Liver Metastases in the Medicare Population

Aggressive treatment of colorectal liver metastases (CRLM) after colectomy is increasing in the last two decades with reports of improved survival. Multiple treatment options are available for CRLM but their use and utility remains unknown. Methods: Using SEER-Medicare linked database (1991-2005), we identified 7131 patients who had undergone colectomy with CRLM. Demographic, clinical and tumor factors were examined as determinants of therapy. Treatment options consisted of surgery (resection, ablation) or chemotherapy. Univariate and multivariate analyses were performed to determine predictors of overall survival after colectomy. Results:635 patients (8.9%) underwent liver directed surgery defined as either a liver resection (n=495), ablation (n=216) or both (n=76) for CRLM. 322 patients (51%) were female and 313 (49%) were male. 147 patients (23%) were SES 1, 230 patients (36%) were SES 2, and 258 (41%) were SES 3. There was a survival advantage to receiving liver surgery or chemotherapy in selected patients with CRLM (p Conclusion: In the Medicare population, patients with CRLM who receive potentially curative therapy such as resection, ablation or chemotherapy experience a substantial survival advantage; despite this only 8.9% of patients received directed therapy for their metastasis. Barriers to treatment and its underutilization must be identified to improve survival in patients diagnosed with CRLM after colectomy

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

Pathological Margin Clearance and Survival After Pancreaticoduodenectomy in a US and European Pancreatic Center

Background: The optimal definition of a margin-negative resection and its exact prognostic significance on survival in resected pancreatic adenocarcinoma remains unknown. This study was designed to assess the relationship between pathological margin clearance, margin type, and survival. Methods: Patients who underwent pancreaticoduodenectomy with curative intent at two academic institutions, in Amsterdam, the Netherlands, and Boston, Massachusetts, between 2000 and 2014 were retrospectively evaluated. Overall survival, recurrence rates, and progression-free survival (PFS) were assessed by Kaplan–Meier estimates and multivariate Cox proportional hazards analysis, according to pathological margin clearance and type of margin involved. Results: Of 531 patients identified, the median PFS was 12.9, 15.4, and 24.1 months, and the median overall survival was 17.4, 22.9, and 27.7 months for margin clearances of 0, < 1, and ≥1 mm, respectively (all log-rank p < 0.001). On multivariate analysis, patients with a margin clearance of ≥1 mm demonstrated a survival advantage relative to those with 0 mm clearance [hazard ratio (HR) 0.71, p < 0.01], whereas survival was comparable for patients with a margin clearance of < 1 mm versus 0 mm (HR: 0.93, p = 0.60). Patients with involvement (0 or < 1 mm margin clearance) of the SMV/PV margin demonstrated prolonged median overall survival (25.7 months) relative to those with SMA involvement (17.5 months). Conclusions: In patients undergoing pancreaticoduodenectomy for pancreatic adenocarcinoma, a margin clearance of ≥1 mm correlates with improved survival relative to < 1 mm clearance and may be a more accurate predictor of a complete margin-negative resection in pancreatic cancer. The type of margin involved also appears to impact survival. Electronic supplementary material The online version of this article (10.1245/s10434-018-6467-9) contains supplementary material, which is available to authorized users

Robust estimation of bacterial cell count from optical density

Optical density (OD) is widely used to estimate the density of cells in liquid culture, but cannot be compared between instruments without a standardized calibration protocol and is challenging to relate to actual cell count. We address this with an interlaboratory study comparing three simple, low-cost, and highly accessible OD calibration protocols across 244 laboratories, applied to eight strains of constitutive GFP-expressing E. coli. Based on our results, we recommend calibrating OD to estimated cell count using serial dilution of silica microspheres, which produces highly precise calibration (95.5% of residuals &lt;1.2-fold), is easily assessed for quality control, also assesses instrument effective linear range, and can be combined with fluorescence calibration to obtain units of Molecules of Equivalent Fluorescein (MEFL) per cell, allowing direct comparison and data fusion with flow cytometry measurements: in our study, fluorescence per cell measurements showed only a 1.07-fold mean difference between plate reader and flow cytometry data

National complication rates after pancreatectomy: beyond mere mortality

INTRODUCTION: National studies on in-hospital pancreatic outcomes have focused on mortality. Non-fatal morbidity affects a greater proportion of patients. METHODS: The Nationwide Inpatient Sample 1998-2006 was queried for discharges after pancreatectomy. Rates of major complications (myocardial infarction, aspiration pneumonia, pulmonary compromise, perforation, infection, deep vein thrombosis/pulmonary embolism, hemorrhage, or reopening of laparotomy) were assessed. Predictors of complication(s) were evaluated using logistic regression. Their independent effect on in-hospital mortality, length of stay, and discharge disposition was assessed. RESULTS: Of 102,417 patient discharges, 22.7% experienced a complication. Complication rates did not decline significantly over time, while mortality rates did. Independent predictors of complications included age \u3eor=75 [referent, 19-39; adjusted odds ratio (OR) 1.34, 95% confidence interval (CI) 1.2-1.5, p \u3c 0.0001], total pancreatectomy (vs proximal, OR 1.29, 95%CI 1.1-1.5, p = 0.0025), and low hospital resection volume (vs high, OR 1.61, 95%CI 1.4-1.8, p \u3c 0.0001). Complications were a significant independent predictor of death (OR 7.76, 95%CI 6.7-8.8, p \u3c 0.0001), prolonged hospital stay (OR 6.94, 95%CI 6.2-7.7, p \u3c 0.0001), and discharge to another facility (OR 0.28, 95%CI 0.26-0.3, p \u3c 0.0001). CONCLUSIONS: Despite improvements in mortality, complication rates remain substantial and largely unchanged. They predict in-hospital mortality, prolonged hospital stay, and delayed return to home. The impact on healthcare costs and quality of life deserves further study

Racial Disparities in the Care of Acute Cholecystitis: A National Study

Introduction: Racial differences in utilization and outcomes of major surgical procedures have been shown previously. We sought to investigate whether racial disparities exist in common diseases like acute cholecystitis (AC). Methods: Discharge records (Nationwide Inpatient Sample) for all adult admissions (n = 205,119) with a primary diagnosis of AC from 1998 to 2006 were examined. A cohort of only white and black patients was created. Covariates included other patient demographics, comorbidities, and hospital characteristics. Separate logistic regression models were created to identify areas of disparity in clinical care. Results: 86.0% of patients received a cholecystectomy; 89.9% were laparoscopic (LC). 22,308 (10.9%) were identified as black. Compared with white patients, black patients tended to be female (74.5% vs 58.7%), have Medicaid insurance (19.1% vs 6.2%), lower income (82.4% vs 66.8%), and have more than 1 comorbidity (69.3% vs 65.6%) (p \u3c 0.0001). After adjusting for hospital and patient factors, black patients were less likely to receive a cholecystectomy (odds ratio [OR], 0.70). For those who did, blacks were less likely to receive LC (OR, 0.70) and underwent open conversion more often (OR, 1.23). Blacks were also more likely to experience a postoperative complication (OR, 1.17), have a prolonged LOS (OR, 1.73), and more likely to die during the hospital stay when compared with white patients (OR, 1.37; 95% confidence interval, 1.17 to 1.59). Conclusions: Our findings raise concerns about the delivery of care and outcomes for black compared with white patients with common surgical diseases like AC. Future studies should investigate possible social, biologic, and economic reasons for these disparities. Presented at the 64th Annual Sessions of the Owen H Wangensteen Forum on Fundamental Surgical Problems, The American College of Surgeons 94th Annual Clinical Congress, 2009

Is the growth in laparoscopic surgery reproducible with more complex procedures

BACKGROUND: Laparoscopic (LAP) surgery has experienced significant growth since the early 1990s and is now considered the standard of care for many procedures like cholecystectomy. Increased expertise, training, and technological advancements have allowed the development of more complex LAP procedures including the removal of solid organs. Unlike LAP cholecystectomy, it is unclear whether complex LAP procedures are being performed with the same growth today. METHODS: Using the Nationwide Inpatient Sample (NIS) from 1998 to 2006, patients who underwent elective LAP or open colectomy (n = 220,839), gastrectomy (n = 17,289), splenectomy (n = 9,174), nephrectomy (n = 64,171), or adrenalectomy (n = 5,556) were identified. The Elixhauser index was used to adjust for patient comorbidities. To account for patient selection and referral bias, a matched analysis was performed using propensity scores. The main endpoints were adjusted for in-hospital mortality and prolonged length of stay (LOS). RESULTS: Complex LAP procedures account for a small percentage of total elective procedures (colectomy, 3.8%; splenectomy, 8.8%; gastrectomy, 2.4%; nephrectomy, 7.0%; and adrenalectomy, 14.2%). These procedures have been performed primarily at urban (94%) and teaching (64%) centers. Although all LAP procedures trended up, the growth was greatest in LAP colectomy and nephrectomy (P \u3c .001). In a case-controlled analysis, there was a mortality benefit only for LAP colectomy (hazard ratio [HR] = 0.53; 95% confidence interval [CI] = 0.34-0.82) when compared with their respective open procedures. All LAP procedures except gastrectomy had a lower prolonged LOS compared with their open counterparts. CONCLUSION: Despite the significant benefits of complex LAP procedures as measured by LOS and in-hospital mortality, the growth of these operations has been slow unlike the rapid acceptance of LAP cholecystectomy. Future studies to identify the possible causes of this slow growth should consider current training paradigms, technical capabilities, economic disincentive, and surgical specialization