Citations

Abstract Objective The study sought to describe patient-entered supplemental information on symptomatic adverse events (AEs) in cancer clinical research reported via a National Cancer Institute software system and examine the feasibility of mapping these entries to established terminologies. Materials and Methods Patients in 3 multicenter trials electronically completed surveys during cancer treatment. Each survey included a prespecified subset of items from the National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Upon completion of the survey items, patients could add supplemental symptomatic AE information in a free text box. As patients typed into the box, structured dropdown terms could be selected from the PRO-CTCAE item library or Medical Dictionary for Regulatory Activities (MedDRA), or patients could type unstructured free text for submission. Results Data were pooled from 1760 participants (48% women; 78% White) who completed 8892 surveys, of which 2387 (26.8%) included supplemental symptomatic AE information. Overall, 1024 (58%) patients entered supplemental information at least once, with an average of 2.3 per patient per study. This encompassed 1474 of 8892 (16.6%) dropdowns and 913 of 8892 (10.3%) unstructured free text entries. One-third of the unstructured free text entries (32%) could be mapped post hoc to a PRO-CTCAE term and 68% to a MedDRA term. Discussion Participants frequently added supplemental information beyond study-specific survey items. Almost half selected a structured dropdown term, although many opted to submit unstructured free text entries. Most free text entries could be mapped post hoc to PRO-CTCAE or MedDRA terms, suggesting opportunities to enhance the system to perform real-time mapping for AE reporting. Conclusions Patient reporting of symptomatic AEs using a text box functionality with mapping to existing terminologies is both feasible and informative.

Background: Socioeconomic status (SES) is an important determinant of disparities in health care and may play a role in end-of-life care and decision-making. The SES is difficult to retrospectively abstract from current electronic medical records and data sets. Objective: Using a validated SES measuring tool derived from home address, the HOUsing-based SocioEconomic Status index, termed HOUSES we wanted to determine whether SES is associated with differences in end-of-life care and decision-making. Design/Setting/Participants: This cross-sectional study utilized a cohort of Olmsted County adult residents admitted to 7 intensive care units (ICUs) at Mayo Rochester between June 1, 2011, and May 31, 2014. Measurements: Multiple variables that reflect decision-making and care at end of life and during critical illness were evaluated, including presence of advance directives and discharge disposition. The SES was measured by individual housing-based SES index (HOUSES index; a composite index derived from real property as a standardized z-score) at the date of admission to the ICU which was then divided into 4 quartiles. The greater HOUSES, the higher SES, outcomes were adjusted for age, 24-hour Acute Physiology and Chronic Health Evaluation III score, sex, race/ethnicity, and insurance. Results: Among the eligible 4134 participants, the addresses of 3393 (82%) were successfully geocoded and formulated into HOUSES. The adjusted odds ratios comparing HOUSES 1 versus 2, 3, and 4 demonstrated lower likelihood of advance directives −0.77(95% CI: 0.63-0.93) and lower likelihood of discharge to home −0.60(95% CI: 1.0.5-0.72). Conclusion: Lower SES, derived from a composite index of housing attributes, was associated with lower rates of advance directives and lower likelihood of discharge to home.

Proximal interruption of the pulmonary artery (PIPA) is an uncommon developmental anomaly resulting in underdevelopment of the proximal portion of the pulmonary artery with preservation of the intrapulmonary segments. Clinical presentation ranges between an asymptomatic incidental finding to massive hemoptysis. When findings suggestive of PIPA are present radiographically, the diagnosis of PIPA can be definitively diagnosed with computed tomography or magnetic resonance pulmonary angiography. Other imaging modalities, such as nuclear perfusion scan and catheter angiography can help in the diagnosis.

Aims To perform a systematic review of studies reporting the outcomes of AMS‐800 artificial urinary sphincter (AUS) implantation in female patients with stress urinary incontinence (SUI) resulting from intrinsic sphincter deficiency (ISD). Methods A systematic literature search of the Medline and Embase databases was performed in June 2018 in accordance with the PRISMA statement. No time limit was used. The protocol was registered in PROSPERO (CRD42018099612). Study selection and data extraction were performed by two independent reviewers. Results Of 886 records screened, 17 were included. All were retrospective or prospective non‐comparative case series. One study reported on vaginal AUS implantation, 11 on open AUS implantation, two on laparoscopic AUS implantation, two on robot‐assisted AUS implantation and one compared open and robot‐assisted implantations. The vast majority of patients had undergone at least one anti‐incontinence surgical procedure prior to AUS implantation (69.1‐100%). The intraoperative bladder neck injury rates ranged from 0% to 43.8% and the intraoperative vaginal injury rates ranged from 0 to 25%. After mean follow‐up periods ranging from 5 to 204 months, the complete continence rates ranged from 61.1% to 100%. The rates of explantation, erosion and mechanical failure varied from 0% to 45.3%, 0% to 22.2% and 0% to 44.1%, respectively. Conclusions AMS‐800 AUS can provide excellent functional outcomes in female patients with SUI resulting from ISD but at the cost of a relatively high morbidity. High level of evidence studies are needed to help better define the role of AUS in the female SUI armamentarium.

AbstractBackgroundLaparoscopic pancreaticoduodenectomy (LPD) requires sufficient laparoscopic training for optimal outcomes. Our aim is to determine the learning curve and investigate the factors influencing surgical outcomes during the learning curve.MethodsWe analyzed surgical results of 150 consecutive cases of LPD performed by three hepatopancreatobiliary surgeons during their 50 first cases. Learning curves were constructed by cumulative sum (CUSUM) analysis. Preoperative factors influencing resection time and blood loss were investigated in the introductory and stable periods.Results The learning curve could be divided into three phases: initial (1–20 cases), plateau (21–30), and stable (31–50). Resection time with lymph node dissection was significantly longer during the introductory period (initial and plateau periods) (P < 0.01) but not the stable phase (P = 0.51). Multivariate analysis revealed that patients with pancreatitis had longer resection times and massive blood loss in both the introductory and stable periods (stable phase). High visceral fat area was also significantly related to massive blood loss in the introductory period (P = 0.04).ConclusionsHepatopancreatobiliary surgeons need more than 30 cases until LPD becomes stable. Lymph node dissection and patients with high visceral fat area and concomitant pancreatitis should be avoided during the introductory period of the learning curve.

SummaryThe shift from a fee‐for‐service payment to a value‐based payment scheme, sparked by the Patient Protection and Affordable Care Act, introduced pay‐for‐performance programs such Hospital Value Based Purchasing. Previous inquiry has not considered how local community factors may affect hospital system performance. This study investigated the association between local health performance and minority population in a hospital referral region (HRR). The primary objective was to ascertain whether community diversity levels are significantly associated to local health performance guided by the ecological model. Secondary data analysis collected from the 2016 American Hospital Association, Area Health Resource File, Commonwealth Fund Scorecard on Local Health System Performance, and the Dartmouth Atlas HRR dataset was used. Our primary findings show that the more diverse a HRR is, the more likely it is to be associated with lower ranking for access and affordability prevention and treatment avoidable hospital use and cost as well as healthy lives. Total performance score was significantly related to a better health ranking on prevention and treatment, hospital use, and cost, as well as healthy lives. This research supports the assertion that communities, particularly minorities in those communities, affect local health care performance in a variety of ways.

e16003 Background: Multidisciplinary management improves complex treatment decision making in cancer care, but its impact for bladder cancer (BC) has not been documented. While radical cystectomy (RC) is currently viewed as the standard of care for muscle-invasive bladder cancer (MIBC), radiotherapy-based, bladder-sparing trimodal therapy (TMT) combining transurethral resection of bladder tumor, chemotherapy for radiation sensitization and external beam radiotherapy has emerged as a valid treatment option. In the absence of randomized studies, we compared the oncological outcomes between patients managed by RC or TMT using a propensity-score matched cohort analysis. Methods: Patients seen in our multidisciplinary bladder cancer clinic (MDBCC) from 2008 to 2013 were retrospectively reviewed. Those who received TMT for MIBC were identified and matched (for gender, cT and cN stage, ECOG status, Charlson comorbidity score, treatment date, age, CIS, hydronephrosis) using propensity scores, to patients who underwent RC. Overall survival and disease-specific survival (DSS) were assessed with Cox Proportional hazards modeling and competing risk analysis, respectively. Results: 112 patients with MIBC were included after matching, 56 treated with TMT and 56 by RC. Median age was 68.0 years and 29.5% were cT3/cT4. At a median follow up of 4.51 years, there were 20 (35.7%) deaths (13 from BC) in the RC group and 22 (39.3%) deaths (13 from BC) in the TMT group. 5 year DSS was 73.2% and 76.6%, in the RC and TMT groups, respectively (p = 0.49). Salvage cystectomy was performed in 6/56 TMT patients (10.7%). Conclusions: In the setting of a MDBCC, TMT yielded survival outcomes similar to matched RC patients. Appropriately selected MIBC patients should be offered the opportunity to discuss various treatment options including organ-sparing TMT.