Initiation of adjuvant therapy following surgical resection of pancreatic ductal adenocarcinoma (PDAC): Are patients from rural, remote areas disadvantaged?

BACKGROUND AND OBJECTIVES: Although race and socioeconomic status have been shown to affect outcomes in pancreatic ductal adenocarcinoma (PDAC), the impact of rural residence on the delivery of adjuvant therapy (AT) has not been studied. METHODS: Patients with resected PDAC were identified using the National Cancer Database (NCDB). Individuals were classified as living in a metro area, urban/rural adjacent to a metro area (URA), and urban/rural remote (URR) area. Multivariate logistic regression was used to assess geographic inhabitance as a predictor of receiving AT. RESULTS: A total of 32 521 individuals who underwent pancreatectomy for PDAC were identified. Univariate analysis demonstrated individuals in URR areas were less likely to receive adjuvant chemotherapy (ACT) than those living in URA or metro areas (55.3% vs 55.6% vs 58.8%, P = 0.011). However on multivariate analysis URR inhabitance was no longer a predictor of ACT (OR = 0.911 P = 0.125) or ART (OR = 0.953 P = 0.462). Cox proportional hazard modeling demonstrated URR inhabitance remained independently associated with poor OS (HR 1.076; 95% CI [1.008, 1.149], P < 0.029). CONCLUSIONS: URR inhabitance does not impact access to AT, however it is independently associated with a decreased OS. Attention must be focused on optimizing oncologic care to patients with disparate access to healthcare.

Prostate Needle Biopsy Outcomes in the Era of the U.S. Preventive Services Task Force Recommendation against Prostate Specific Antigen Based Screening.

PURPOSE: We determined whether the characteristics of patients undergoing prostate needle biopsies and prostate needle biopsy results changed after the U.S. Preventive Services Task Force recommendation in 2012 against prostate specific antigen based screening for prostate cancer for men of any age. MATERIALS AND METHODS: A prospective database of patients undergoing prostate needle biopsies at Virginia Mason from 2004 to 2014 was reviewed. Welch's t-test and chi-square tests were used to compare patients seen before to those seen after the USPSTF recommendation. Relative risks and corresponding confidence intervals were estimated by general linear regression. RESULTS: Patients in the post-USPSTF group (310) had a higher prostate specific antigen (p <0.001), were more likely to be diagnosed with higher clinical stage (2b, p=0.003; 2c-3a, p=0.027) and D'Amico high risk prostate cancer (p=0.036), with an adjusted relative risk for high risk prostate cancer of 1.25 (95% CI 1.02-1.52) compared to those in the pre-USPSTF group (1,416). Limiting the pre-USPSTF group to the 30 months before the draft guidelines (448 patients) yielded similar results. The absolute number of biopsies performed decreased by 31%, with the majority of the decrease occurring in the detection of intermediate risk tumors. CONCLUSIONS: In the 2 and a half years after the USPSTF recommendation against prostate specific antigen based screening, patients undergoing prostate needle biopsies were significantly more likely to be diagnosed with high risk disease. However, a reduction in the number of prostate needle biopsies performed occurred concomitantly with a decrease in the detection of intermediate risk, potentially curable prostate cancer. Future focus on informed application of screening techniques may prevent the reversal of decades of improvement in the prostate cancer mortality rate.

Beyond Data Capture: A Single Institutional Experience with Establishing a Pelvic Floor Surgery Web Based Database.

INTRODUCTION: The American Urological Association has highlighted the need for complete and long-term data collection in female pelvic medicine and reconstructive surgery. We describe our institution's experience with transitioning our pelvic floor surgery database to a secure web based platform. In this article we share this experience and its challenges to help facilitate the process for other institutions. METHODS: In 1999 our institution implemented electronic data capture of pelvic floor cases using a stand-alone spreadsheet. By 2001 it was apparent that this modality could no longer sustain growth while maintaining data integrity. We converted to a relational database system but limitations involving multiuser data entry and efficient querying became apparent. After consultation with outcomes research experts across the country we evaluated database alternatives for capacity, ease of use and security. REDCap® (Research Electronic Data Capture), a low cost, server based database software, provided all 3. RESULTS: In 2011 the transition of our electronic outcomes database to REDCap commenced. The transition required approximately 100 person-hours for data dictionary creation and 200 person-hours for the transfer of existing data into REDCap. A database administrator was hired to maintain data integrity, automate the process of generating questionnaires for long-term followup and facilitate data queries. CONCLUSIONS: We describe the transition of our institution's outcomes database to REDCap providing the means for secure and streamlined data capture and quality assurance. This platform also facilitates effective multi-institutional collaboration with the goals of developing quality data to advance research and improve care for our patients.

Analysis of the Completely Dry Rate Over Time After Mid-urethral Sling in a Real-world Clinical Setting.

OBJECTIVE: To improve patient counseling regarding mid-urethral slings (MUS), we performed an analysis of MUS patients dry at initial follow-up to evaluate probability of remaining dry over time, and analyzed clinical factors potentially influencing the probability of remaining dry. METHODS: A retrospective review of our prospectively-collected institutional database identified patients who underwent retropubic MUS (RMUS) or transobturator MUS (TMUS) between January 2001 and March 2016 and were completely dry, defined as an answer of "not at all" to UDI-6 question 3, at first follow-up within 1.5 years of surgery. Proportion remaining dry over time was estimated by Kaplan-Meier. Associated factors were evaluated using Cox proportional hazards modeling. Proportion with urge urinary incontinence at time of sling failure was assessed. RESULTS: Of 1102 patients undergoing MUS, 38.4% returned questionnaires and 47.5% of these were completely dry at initial follow-up (139 RMUS, 62 TMUS). Probability (95% CI, n = total patients) of remaining dry after RMUS at 3, 5, and 10 years was 72% (64%-81%, n = 70), 60% (51%-70%, n = 51), and 26% (18%-43%, n = 17). Probability estimates for TMUS at 3 and 5 years were 74% (62%-88%, n = 27) and 50% (35%-70%, n = 14). Obesity (Hazard ratio 2.22, P = .003) and age (Hazard ratio 1.043, P < .001) were associated with lower probability of remaining dry after RMUS. Of patients no longer completely dry at last follow-up, 72% RMUS and 75% TMUS had urge urinary incontinence. CONCLUSION: In our real-world cohort, patients who are dry within the first 1.5 years following MUS have ≥50% chance of remaining dry for 4 more years.

Selecting an Electronic Data Capture System.

INTRODUCTION: Investigators encounter numerous challenges when initiating a research project, including selecting an appropriate electronic data capture system. Options range from simple stand-alone spreadsheets to full service, relational databases controlled by certified database administrators. We present an overview of the issues to consider when selecting an electronic data capture system and a survey of available software solutions. We also discuss how to select an electronic data capture system that best meets the data management needs of the study. METHODS: We compared software solutions based on several regulatory and budgetary issues that should be considered by investigators. Regulatory issues include HIPAA (Health Insurance Portability and Accountability Act), case report forms and adverse event reports. Technology costs, ease of use and expertise of personnel are examples of budgetary matters. RESULTS: Stand-alone spreadsheets require extra attention to regulatory matters but are intuitive to investigators. Large-scale relational database management systems can be configured for all regulatory matters but require dedicated effort from a certified database administrator, greatly increasing data management costs. Low cost, server based solutions sacrifice some of the flexibility of a relational database management system in exchange for being extremely easy to design and manage. Software as a service is a scalable third party solution. Cloud based systems are a new solution that are not widely used in institutional review board approved research. CONCLUSIONS: Due to the extensive resources required to implement an electronic data capture system it is important to carefully analyze and understand what options are available. In this way the most informed choice can be made.

Small Bowel Obstruction Is a Surgical Disease: Patients with Adhesive Small Bowel Obstruction Requiring Operation Have More Cost-Effective Care When Admitted to a Surgical Service.

BACKGROUND: Adhesive small bowel obstruction (ASBO), although a potential surgical emergency, is increasingly being managed by medical hospitalists due to the likelihood these patients will not require operation. However, the value of care delivered by medical hospitalists to patients with ASBO has not been reported. STUDY DESIGN: We hypothesized that patients admitted to the medical hospitalist service (MHS) for presumed ASBO have increased length of stay (LOS) and charges compared with patients admitted to the surgical service (SS). There were 555 consecutive admissions with presumed ASBO from 2008 to 2012; these were reviewed and grouped according to admitting service and whether an operation was performed. Group medians were compared and multivariate analysis was performed to identify variables independently associated with increased LOS, time to operation (TTO), and charges. RESULTS: Median LOS among patients whose ASBO resolved nonoperatively was similar for those on SS and MHS (2.85 days vs 2.98 days; p = 0.49). In patients without nonoperative resolution of ASBO, those admitted to MHS had longer median LOS when compared with those admitted to SS (9.57 days vs 6.99 days; p = 0.002) and higher median charges ($38,800 vs $30,100; p = 0.025). Patients admitted to MHS who had an operation, had a greater median TTO than operative patients on SS (51.72 hours vs 8.4 hours; p < 0.001). Multivariate analysis did not identify factors independently predictive of increased LOS, TTO, or charges. CONCLUSIONS: Adhesive small bowel obstruction patients are treated in a heterogeneous fashion in our hospital, causing disparate outcomes depending on admitting service when patients undergo operation. Admitting all suspected ASBO patients to SS has the potential to dramatically decrease LOS and reduce waste in those requiring operation, thereby reducing health care expenditures.