Fostering research in pediatric interventional radiology: needs assessment and suggestions for support.

BACKGROUND: Due to the rarity of pediatric diseases, collaborative research is the key to maximizing the impact of research studies. A research needs assessment survey was created to support initiatives to foster pediatric interventional radiology research. OBJECTIVE: To assess the status of pediatric interventional radiology research, identify perceived barriers, obtain community input on areas of research/education/support, and create metrics for evaluating changes/responses to programmatic initiatives. MATERIALS AND METHODS: A survey link was sent to approximately 275 members of the Society for Pediatric Interventional Radiology (SPIR) between May and October 2020. Data was collected using a web-based interface. Data collected included practice setting, clinical role, research experience, research barriers, and suggestions for future initiatives. RESULTS: Fifty-nine surveys were analyzed with a staff physician survey response rate of 28% (56/198). A wide range of practice sizes from 15 countries were represented. Respondents were predominantly staff physicians (95%; 56/59) with an average of 11 years (range: 1-25 years) of clinical experience working at academic or freestanding children's hospitals. A total of 100% (59/59) had research experience, and 70% (41/58) had published research with a mean of 30 peer-reviewed publications (range: 1-200). For job security, 56% (33/59) of respondents were expected or required to publish, but only 19% (11/58) had research support staff, and 42% (25/59) had protected research time, but of those, 36% (9/25) got the time "sometimes or never." Lack of support staff, established collaborative processes, and education were identified as top barriers to performing research. CONCLUSIONS: The needs assessment survey demonstrated active research output despite several identified barriers. There is a widespread interest within the pediatric interventional radiology community for collaborative research.

Phase I Study of Acalabrutinib Plus Danvatirsen (AZD9150) in Relapsed/Refractory Diffuse Large B-Cell Lymphoma Including Circulating Tumor DNA Biomarker Assessment.

PURPOSE: Novel targeted and immunotherapies have improved outcomes in relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL), but toxicities limit widespread use. The selective Bruton tyrosine kinase (BTK) inhibitor acalabrutinib has activity in patients with R/R DLBCL but durable responses are uncommon. STAT3 inhibition has demonstrated clinical activity in DLBCL. PATIENTS AND METHODS: Final results of the phase I study of acalabrutinib plus STAT3 inhibitor (danvatirsen; AZD9150) in patients with R/R DLBCL are reported. Danvatirsen 200 mg intravenous infusion [Days 1, 3, 5 (Cycle 1); weekly infusions starting Day 8, Cycle 1] was administered in combination with oral acalabrutinib 100 mg twice daily until progressive disease (PD) or unacceptable toxicity. Primary endpoints were safety and tolerability. Secondary endpoints included efficacy, pharmacokinetics, and immunogenicity. RESULTS: Seventeen patients received combination treatment. One dose-limiting toxicity (Grade 3 liver transaminase) occurred in 1 patient. The most common reason for treatment discontinuation was PD (65%). In evaluable patients (n = 17), objective response rate was 24%; median duration of response was 1.9 months. All responders with available DLBCL cell-of-origin data were either activated B-cell or nongerminal center B-cell like subtype. Genetic subtype did not correlate with response. Baseline and longitudinal plasma cell-free DNA (cfDNA) concentrations were mostly higher in nonresponding patients. cfDNA changes were generally concordant with imaging. Pretreatment circulating B-cell levels were higher in responders versus nonresponders. CONCLUSIONS: Targeting both STAT3 and BTK in combination is safe and tolerable but efficacy is limited in R/R DLBCL. Results support evaluation of circulating tumor DNA as a biomarker for clinical response.

Outcomes and Costs Following Mini-percutaneous Nephrolithotomy or Flexible Ureteroscopic Lithotripsy for 1-2-cm Renal Stones: Data From a Prospective, Randomized Clinical Trial.

PURPOSE: We evaluate the outcomes of ureteroscopy vs prone mini-percutaneous nephrolithotomy for 1-2-cm renal stones using a 2-group parallel randomized control trial. MATERIALS AND METHODS: Adult patients presenting with renal stones between 1 and 2 cm were randomized. Exclusion criteria included solitary kidney, multiple stones, and comorbidities precluding prone positioning. Block randomization was performed and was opened to the surgeon the morning of the procedure. Stone-free rate was evaluated by computed tomography 1-30 days postoperatively. Complications, re-treatment rates, and costs were evaluated. RESULTS: A total of 51 mini-percutaneous nephrolithotomy and 50 ureteroscopy patients were included. Baseline demographics were similar. Using a 2-mm cutoff, stone-free rate was higher in the mini-percutaneous nephrolithotomy group (76 vs 46%, P = .0023). The residual stone burden was significantly higher in the ureteroscopy group than the mini-percutaneous nephrolithotomy group (3.6 vs 1.4 mm, P = .0026). Fluoroscopy time was significantly higher in the mini-percutaneous nephrolithotomy group (273 vs 49 seconds, P < .0001). There were no differences in postoperative complications within 30 days, the necessity of a secondary procedure within 30 days, and pre- to postoperative creatinine change (P > .05). Surgical time did not vary significantly (P = .1788). Average length of stay was higher in the mini-percutaneous nephrolithotomy group (P < .0001). Both net revenue and direct costs were higher in mini-percutaneous nephrolithotomy procedures (P < .05), though they offset each other with a nonsignificant operating margin (P = .2541). CONCLUSIONS: In a prospective, randomized, controlled clinical trial using a 2-mm residual stone burden cutoff, mini-percutaneous nephrolithotomy was more likely to render patients stone-free than flexible ureteroscopy. Complications, surgical times, and operating margins did not vary between the approaches.

Medical and economic burden of delirium on hospitalization outcomes of acute respiratory failure: A retrospective national cohort.

Although delirium in patients with acute respiratory failure (ARF) may evolve in any hospital setting, previous studies on the impact of delirium on ARF were restricted to those in the intensive care unit (ICU). The data about the impact of delirium on ARF hospitalizations outside of the ICU is limited. Therefore, we conducted the first national study to examine the effect-magnitude of delirium on ARF in all hospital settings, that is, in the ICU as well as on the general medical floor. We searched the 2016 and 2017 National Inpatient Sample databases for ARF hospitalizations and created "Delirium" and "No delirium" groups. The outcomes of interest were mortality, endotracheal intubation, length of stay (LOS), and hospitalization costs. We also aimed to explore any potential demographic, racial, or healthcare disparities that may be associated with the diagnosis of delirium among ARF patients. Multivariable logistic regression was used to control for demographics and comorbidities. Delirium was present in 12.7% of the sample. Racial disparities among African Americans were also significant. Delirious patients had more comorbidities, higher mortality, and intubation rates (17.5% and 9.2% vs 10.6% and 6.1% in the "No delirium" group [P < .001], respectively). Delirious patients had a longer LOS and higher hospitalization costs (5.9 days and $15,395 USD vs 3.7 days and $9393 USD in "No delirium" [P < .001], respectively). Delirium was associated with worse mortality (adjusted odds ratio 1.49, confidence interval [CI] = 1.41, 1.57), higher intubation rates (adjusted odds ratio 1.46, CI = 1.36, 1.56), prolonged LOS (adjusted mean ratio 1.40, CI = 1.37, 1.42), and increased hospitalization costs (adjusted mean ratio 1.49, CI = 1.46, 1.52). A racial disparity in the diagnosis of delirium among African Americans hospitalized with ARF was noted in our sample. Patients in small, non-teaching hospitals were diagnosed with delirium less frequently compared to large, urban, teaching centers. Delirium predicts worse mortality and morbidity for ARF patients, regardless of bed placement and severity of the respiratory failure.

Brief Report: Financial Burden of Toxoplasmosis Encephalitis Treatment at a Safety Net Hospital.

BACKGROUND: Although the price increase of pyrimethamine in 2015 received heavy media coverage, there are little data regarding specific implications to hospitals and the total costs of treating inpatients with toxoplasmosis encephalitis (TE). METHODS: Using average drug wholesale costs, we estimated the inpatient drug costs of TE drugs 3 years prepyrimethamine and postpyrimethamine price increase in August 2015. The drug regimens and total doses were determined through retrospective chart review of patients living with HIV who received treatment for TE while inpatient during this period. RESULTS: The 3-year pre-increase TE drug costs for 66 admissions were estimated at $50,310 compared with a total drug cost of $1,026,006 for 61 admissions postincrease. Pyrimethamine made up 98% of the drug costs postincrease, compared with 57% pre-increase. Pyrimethamine-based regimens were the most frequently used throughout the study period. CONCLUSIONS: The price increase of pyrimethamine in 2015 led to a substantial and unnecessary financial burden to hospitals. This required health care systems to shift valuable resources to continue to provide medications to a vulnerable patient population. There has been more focus on providing high-value care in recent years. Our study highlights the need for further examination of pharmaceutical companies' arbitrary determination of medication costs and how they contribute to patient care.

Lessons Learned: Social Determinants of Health Screening Pilot in 2 Urology Clinics.

INTRODUCTION: Unmet social needs lead to adverse health outcomes and contribute to health inequities. Efforts to screen for social determinants of health (SDOH) have occurred primarily within primary care. Here, we describe the feasibility of implementing a workflow for SDOH screening within 2 urology clinics in Charlotte, North Carolina. METHODS: Our pilot was adapted from the WE CARE Model, which integrates a referral to community resources for patients identified with social needs and an optional followup with a navigator for additional assistance. Patients were screened with the validated Healthy Opportunities SDOH tool to assess food, housing, utilities, transportation and physical safety needs; 40 patients were screened at 2 urology clinics, totaling 80 patients. Surveys were sent to 16 clinicians and staff who participated in the pilot to assess feasibility of implementation. RESULTS: In all, 24/80 patients (30%) were screened for 1 or more social needs, with food and housing being the most frequent; 20/24 patients with social need (83%) successfully received a community resource guide, and 13 of those patients also requested a referral. All survey respondents either agreed or strongly agreed that screening was valuable and allowed them to better understand the needs of their patients. They also felt that understanding SDOH aligns with departmental goals and mission. CONCLUSIONS: Our results suggest that SDOH screening within a urological setting is feasible, and dedicated support staff should be available to ensure adequate followup for patients with unmet needs. Future work is needed to expand resources for patients and optimize workflow for clinicians.

Differentiating severe and non-severe lower respiratory tract illness in patients hospitalized with influenza: Development of the Influenza Disease Evaluation and Assessment of Severity (IDEAS) scale.

BACKGROUND: Experimental studies have shown that vaccination can reduce viral replication to attenuate progression of influenza-associated lower respiratory tract illness (LRTI). However, clinical studies are conflicting, possibly due to use of non-specific outcomes reflecting a mix of large and small airway LRTI lacking specificity for acute lung or organ injury. METHODS: We developed a global ordinal scale to differentiate large and small airway LRTI in hospitalized adults with influenza using physiologic features and interventions (PFIs): vital signs, laboratory and radiographic findings, and clinical interventions. We reviewed the literature to identify common PFIs across 9 existing scales of pneumonia and sepsis severity. To characterize patients using this scale, we applied the scale to an antiviral clinical trial dataset where these PFIs were measured through routine clinical care in adults hospitalized with influenza-associated LRTI during the 2010-2013 seasons. RESULTS: We evaluated 12 clinical parameters among 1020 adults; 210 (21%) had laboratory-confirmed influenza, with a median severity score of 4.5 (interquartile range, 2-8). Among influenza cases, median age was 63 years, 20% were hospitalized in the prior 90 days, 50% had chronic obstructive pulmonary disease, and 22% had congestive heart failure. Primary influencers of higher score included pulmonary infiltrates on imaging (48.1%), heart rate ≥110 beats/minute (41.4%), oxygen saturation <93% (47.6%) and respiratory rate >24 breaths/minute (21.0%). Key PFIs distinguishing patients with severity < or ≥8 (upper quartile) included infiltrates (27.1% vs 90.0%), temperature ≥ 39.1°C or <36.0°C (7.1% vs 27.1%), respiratory rate >24 breaths/minute (7.9% vs 47.1%), heart rate ≥110 beats/minute (29.3% vs 65.7%), oxygen saturation <90% (14.3% vs 31.4%), white blood cell count >15,000 (5.0% vs 27.2%), and need for invasive or non-invasive mechanical ventilation (2.1% vs 15.7%). CONCLUSION: We developed a scale in adults hospitalized with influenza-associated LRTI demonstrating a broad distribution of physiologic severity which may be useful for future studies evaluating the disease attenuating effects of influenza vaccination or other therapeutics.

Reliable, low-cost, fully integrated hydration sensors for monitoring and diagnosis of inflammatory skin diseases in any environment.

Present-day dermatological diagnostic tools are expensive, time-consuming, require substantial operational expertise, and typically probe only the superficial layers of skin (~15 µm). We introduce a soft, battery-free, noninvasive, reusable skin hydration sensor (SHS) adherable to most of the body surface. The platform measures volumetric water content (up to ~1 mm in depth) and wirelessly transmits data to any near-field communication-compatible smartphone. The SHS is readily manufacturable, comprises unique powering and encapsulation strategies, and achieves high measurement precision (±5% volumetric water content) and resolution (±0.015°C skin surface temperature). Validation on n = 16 healthy/normal human participants reveals an average skin water content of ~63% across multiple body locations. Pilot studies on patients with atopic dermatitis (AD), psoriasis, urticaria, xerosis cutis, and rosacea highlight the diagnostic capability of the SHS (P AD = 0.0034) and its ability to study impact of topical treatments on skin diseases.

Daily Pad Usage Versus the International Consultation on Incontinence Questionnaire Short Form for Continence Assessment Following Radical Prostatectomy.

PURPOSE: Continence assessment is an essential component of follow-up after radical prostatectomy (RP). Several methods exist to assess the severity of urinary incontinence (UI). Our study examined the relationship and degree of agreement between International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) scores and the number of pads used in a 24-hour period in the assessment of UI following RP. METHODS: Continence was prospectively assessed in 746 men from a Spanish urology clinic 12 months after RP using the ICIQ-SF and pad usage. The relationship between ICIQ-SF scores and pad usage was assessed using Spearman rank correlation coefficients. The Jonckheere-Terpstra trend test was used to determine whether the ICIQ-SF score and the component question scores increased with increasing pad usage. The Bonferroni-corrected pairwise Wilcoxon rank-sum test was used to determine which pairs of pad usage levels differed. The weighted kappa was used to evaluate the agreement between pad usage levels and ICIQ-SF questions. RESULTS: The continence rate was 82% using the "no pad usage" definition of continence versus 78% using the definition of an ICIQ-SF score of 0 (P<0.001). Strong positive correlations were observed between the number of pads and the ICIQ-SF total and component question scores (rs>0.85, P<0.001). The ICIQ-SF total and component question scores increased significantly with increasing pad usage (P<0.001). The ICIQ-SF scores (P<0.018) for all pairs of pad usage levels (0, 1, 2, or 3 or more) differed significantly. The agreement between the ICIQ-SF leakage amount question and pad usage was very good (rs=0.861, P<0.001). CONCLUSION: At 12 months post-RP, 24-hour pad usage was closely correlated with ICIQ-SF, although the continence rate differed depending on the definition used. Higher levels of pad usage were associated with higher questionnaire scores, more leakage, and poor quality of life (interference with everyday life).

Teaching medical students digital rectal examination: a randomized study of simulated model vs rectal examination volunteers.

OBJECTIVES: To determine if using a digital rectal examination (DRE) human volunteer improves medical students' confidence in performing DRE in comparison to using a simulated model alone. PARTICIPANTS AND METHODS: Medical students underwent randomization into one of two groups: a control group who underwent standard teaching and an intervention group who underwent standard teaching plus further tuition involving a DRE volunteer. Standard teaching involved a 30-min lecture and a practice DRE on a simulation model. The intervention group additionally observed a tutor demonstrating DRE on a volunteer, then conducted a DRE themselves under supervision. Before and after teaching, both groups completed a survey comprised of three questions. The primary endpoint was confidence in performing a DRE, which was assessed according to the sum of the scores from the three questions. RESULTS: In total, 48 students were randomized, 22 to the control group and 26 to the intervention group. The groups were well matched prior to teaching DRE (P = 0.76) After the DRE tutorial, students in the intervention group were more confident in knowing the indications for DRE (P = 0.001), more confident in their technique for performing DRE (P < 0.001) and more confident in their ability to assess findings accurately at DRE (P < 0.001). The primary outcome measure, overall confidence (sum of the scores from all three questions) in performing DRE, was significantly better in the intervention group (score 10/15 vs 14/15; P < 0.001). CONCLUSION: This study showed that teaching DRE with the assistance of volunteer patients improves inexperienced students' confidence in performing DRE, and the incorporation of such training should be considered in the DRE education programme.

Patterns of prostate-specific antigen testing by remoteness of residence and socio-economic status: An Australian population-based study.

OBJECTIVE: Describes the variation in prostate cancer testing by the remoteness of residence and socio-economic status groups in Australia. DESIGN: A national population-based descriptive study using Medicare data extracted by the Department of Health (formerly the Department of Health and Ageing). SETTING: Australia. PARTICIPANTS: All men, with a Medicare-reimbursed prostate-specific antigen test conducted in Australia between 2002 and 2017, were included. We focused on "screening and case finding" tests (Medicare Benefits Schedule item number 66655) from 1 April 2005 to 31 December 2009, to describe testing differences in subgroups. Groups were categorised into State and Territory, socio-economic status and region of residence. A negative binomial regression model was fitted to measure the incidence rate ratios of those who had a screening prostate-specific antigen test by group. MAIN OUTCOME MEASURES: Age-standardised testing rates and incidence rate ratios. RESULTS: Between 2002 and 2017, 11 588 775 screening prostate-specific antigen tests were reimbursed by the Department of Human Services. During 2005-2009, 52% of all Australian men, aged 40 years and over, had a screening test. The incidence rate ratios differed by State and Territory. Men aged 40 years and over, living in very remote areas, were 43% less likely to have had a screening test than residents of major cities. Prostate-specific antigen testing rates fell in all age groups between 2007 and 2009 and 2017. CONCLUSIONS: The prostate-specific antigen testing behaviour differs between community groups in Australia. Men were less likely to have had a screening prostate-specific antigen test the farther they lived from the major cities. This highlights the need for a more targeted approach to achieve an equitable and evidence-based prostate cancer care across all sectors of the community.

Molecular Assessment of Anaplasma marginale in Bovine and Rhipicephalus (Boophilus) microplus Tick of Endemic Tribal Belt of Coastal South Gujarat, India.

BACKGROUND AND METHODS: This study described the detection, prevalence and phylogeny of Anaplasma marginale in the bovine (cattle and buffaloes) and Rhipicephalus (Boophilus) microplus tick belonged to the tribal area of coastal South Gujarat, India, by amplifying 576 bp of major surface protein (msp) 5 gene using custom designed primers in the polymerase chain reaction (PCR). RESULTS: The PCR detection limit was up to 20 parasites/µl of blood in sensitivity experiment, and observed 100% specificity against Trypanosoma evansi, Babesia bigemina and Theileria annulata. Prevalence rate of the A. marginale in the bovine (n = 211)) was 18.48% and 6.64% (p < 0.05) as per the PCR and Giemsa stained blood smear, respectively. Febrile animals (35%) observed significantly (p < 0.05) higher incidence rate than the non-febrile (14.62%). The amplified msp5 had single cut site for the EcoR1 enzyme, upon digestion yielded two fragments of 365 and 211 bp on 1.0% agarose gel. The current sequence (KC811329) showed 100% homology and 1064 total score with the published nucleotide sequences of msp5 of A. marginale in the NCBI-BLAST study. Monophyletic relationship was observed with high bootstrap proportion (> 76% in Neighbor-Joining/ Maximum Likelihood) between the current and published nucleotide sequences in the phylogeny. Twenty out of 39 A. marginale infected bovine recorded R. (B.) microplus on their body surface, out of which 18 had detected the infection. The rickettsia was in 55%, 65% and 25% of anterior half, posterior half and egg of tick, respectively. CONCLUSION: The test detected A. marginale in a carrier, pre-symptomatic and symptomatic vertebrate hosts (cattle and buffalo) and different body parts of the starved R. (B.) microplus including its egg. The current genotype could be an explanation for the frequent outbreaks of bovine anaplasmosis in the targeted areas.

Assessment of content validity for patient-reported outcome measures used in patients with non-muscle invasive bladder cancer: a systematic review.

OBJECTIVE: Non-muscle invasive bladder cancer (NMIBC) is a chronic condition requiring ongoing treatment and endoscopic examinations that are frequent and can be life-long. To ensure the comprehensive assessment of the benefits and harms of treatments for NMIBC, the impact on important and relevant patient-reported outcomes (PROs) should be determined. We systematically reviewed the NMIBC PRO literature to determine the suitability of available PRO measures (PROMs) for use in evaluating patient outcomes in NMIBC research. METHODS: We searched six electronic databases, reference lists, and key authors. Two reviewers independently applied inclusion and quality criteria and extracted findings. PROM domains, item content, and content coverage and relevance were determined for identified PROMs. Content validity was assessed against an empirically derived NMIBC-specific conceptual framework that includes 11 PRO domains and 19 sub-domains. RESULTS: Seventeen studies assessed PROs related to NMIBC and treatment impact. From these studies, 11 PROMs were identified, including three generic, three cancer-specific, and five symptom-specific. None of the PROMs cover all PRO domains important in NMIBC as assessed against our conceptual framework. The EORTC QLQ-C30 plus the NMIBC24 module was best aligned to the conceptual model, but failed to represent six outcomes important to NMIBC patients. CONCLUSIONS: Currently, some outcomes important in NMIBC are inadequately covered by generic and cancer-specific measures despite similar conceptual models. This review identified gaps in the literature regarding assessment of symptoms and other PROs considered important by NMIBC patients. Careful consideration of PROM item content is required when selecting outcome measures for use in future NMIBC clinical trials to ensure that appropriate measures are used to assess outcomes that matter to patients.

Does Advancing Technology Improve Outcomes? Comparison of the Da Vinci Standard/S/Si to the Xi Robotic Platforms During Robotic Nephroureterectomy.

INTRODUCTION: With the introduction of laparoscopy and now robotics, more patients are able to reap benefit from minimally invasive techniques during urologic surgery. With these advancing technologies, it is important to evaluate whether the outlay of hospital capital actually improves patient care. To date, there has been little literature regarding the impact of these advances on patient outcomes. In this article, we directly compare perioperative outcomes and hospital costs between the older da Vinci Standard/S/Si platform and the newer Xi robotic platform during nephroureterectomy. METHODS: A review of our robotic nephroureterectomy database between April 2009 and December 2017 identified 87 patients, 30 in group 1 (Xi) and 57 in group 2 (Standard/S/Si). Preoperative, perioperative, and postoperative parameters as well as hospital costs were evaluated. Independent t-test was performed for continuous variables, while categorical variables were evaluated using chi-square tests or Fisher's exact test. RESULTS: There were no significant differences between groups preoperatively. Operative time using the Xi was shorter, 184.4 vs 232.09 minutes (p = 0.0035). Other perioperative variables were similar. There was more lymphovascular invasion in group 2 (p = 0.0108), but there were higher stage tumors in group 1 (p < 0.0001). More patients underwent lymph node dissection in group 1 (p = 0.0186). Complications were similar between groups. Costs for anesthesia were less in group 1, which led to decreased total hospitalization costs (p < 0.001) Conclusion: Operative times were found to be less with the daVinci Xi, without any other significant difference in patient outcomes between the groups. Anesthesia and operating room cost were substantial factors in lowering the overall hospital costs. More multi-institutional studies with larger groups of patients are needed to determine if advancing technology really improves outcomes.

Financial Support to Eligible Countries for the Switch From Trivalent to Bivalent Oral Polio Vaccine-Lessons Learned.

The global switch from trivalent oral polio vaccine (tOPV) to bivalent oral polio vaccine (bOPV) ("the switch") presented an unprecedented challenge to countries. In order to mitigate the risks associated with country-level delays in implementing the switch, the Global Polio Eradication Initiative provided catalytic financial support to specific countries for operational costs unique to the switch. Between November 2015 and February 2016, a total of approximately US$19.4 million in financial support was provided to 67 countries. On average, country budgets allocated 20% to human resources, 23% to trainings and meetings, 8% to communications and advocacy, 9% to logistics, 15% to monitoring, and 5% to waste management. All 67 funded countries successfully switched from tOPV to bOPV during April-May 2016. This funding provided target countries with the necessary catalytic support to facilitate the execution of the switch on an accelerated timeline, and the mechanism offers a model for similar support to future global health efforts, such as the eventual global withdrawal of bOPV.

Comparison of treatment patterns and economic outcomes among metastatic pancreatic cancer patients initiated on nab-paclitaxel plus gemcitabine versus FOLFIRINOX.

BACKGROUND: The economic burden of metastatic pancreatic cancer (mPC) is substantial while treatment options are limited. Little is known about the treatment patterns and healthcare costs among mPC patients who initiated first-line gemcitabine plus nanoparticle albumin-bound paclitaxel (nab-P + G) and FOLFIRINOX. METHODS: The MarketScan® claims databases were used to identify adults with ≥2 claims for pancreatic cancer, 1 claim for a secondary malignancy, completed ≥1 cycle of nab-P + G or FOLFIRINOX during 4/1/2013 and 3/31/2015, and had continuous plan enrollment for ≥6 months pre- and 3 months after the first-line treatment. Duration of therapy, per patient per month (PPPM) costs of total healthcare, mPC-related treatment, and supportive care were measured during first-line therapy. RESULTS: 550 mPC patients met selection criteria (nab-P + G, n = 294; FOLFIRINOX, n = 256). There was no difference in duration of therapy (p = 0.60) between nab-P + G and FOLFIRINOX. Compared with FOLFIRINOX, patients with nab-P + G had higher chemotherapy drug costs but lower treatment administration costs and supportive care costs (all p < 0.01). CONCLUSIONS: Patients treated with nab-P + G (vs FOLFIRINOX) had similar treatment duration but lower costs of outpatient prescriptions, treatment administration and supportive care. Lower supportive care costs in the nab-P + G cohort were mainly driven by lower utilization of pegfilgrastim and anti-emetics.

Semi-Automatic Electronic Stent Register: a novel approach to preventing ureteric stents lost to follow up.

BACKGROUND: Ureteric stents are indispensable tools in modern urology; however, the risk of them not being followed-up once inserted poses medical and medico-legal risks. Stent registers are a common solution to mitigate this risk; however, manual registers are logistically challenging, especially for busy units. METHODS: Western Sydney Local Health District developed a novel Semi-Automatic Electronic Stent Register (SAESR) utilizing billing information to track stent insertions. To determine the utility of this system, an audit was conducted comparing the 6 months before the introduction of the register to the first 6 months of the register. RESULTS: In the first 6 months of the register, 457 stents were inserted. At the time of writing, two of these are severely delayed for removal, representing a rate of 0.4%. In the 6 months immediately preceding the introduction of the register, 497 stents were inserted, and six were either missed completely or severely delayed in their removal, representing a rate of 1.2%. A non-inferiority analysis found this to be no worse than the results achieved before the introduction of the register. CONCLUSION: The SAESR allowed us to improve upon our better than expected rate of stents lost to follow up or severely delayed. We demonstrated non-inferiority in the rate of lost or severely delayed stents, and a number of other advantages including savings in personnel costs. The semi-automatic register represents an effective way of reducing the risk associated with a common urological procedure. We believe that this methodology could be implemented elsewhere.

A conceptual framework for patient-reported outcomes in non-muscle invasive bladder cancer.

PURPOSE: Non-muscle invasive bladder cancer (NMIBC) is a chronic condition requiring repeated treatment and endoscopic examinations that can be life-long. In this context, health-related quality of life (HRQOL) is important to patients and managing clinicians, and integral to treatment recommendations for NMIBC. The aim of this study was to develop a conceptual framework of patient-reported NMIBC symptoms, treatment side effects, and HRQOL impacts from three sources: (1) literature, (2) patients and (3) treating clinicians. METHODS: First, we undertook a scoping literature review for studies reporting patient-reported outcomes associated with NMIBC. Outcomes were extracted and grouped conceptually. Then, we conducted semi-structured interviews with patients with NMIBC and treating clinicians. Patients were asked about symptoms and HRQOL impacts experienced from their NMIBC and treatments. Clinicians were asked about commonly reported outcomes, and outcomes they felt were important to assess clinically. Interviews were audio recorded, transcribed and content analysed. RESULTS: A total of 125 symptom- and functioning-related expressions from 18 studies, 26 patients and 20 clinicians were coded into three themes and 18 sub-themes. Patients commonly reported blood in urine and frequent urination. Clinicians considered BCG sepsis and flu-like symptoms important outcomes to assess during treatment for NMIBC. CONCLUSION: Our empirically derived conceptual framework identifies patient-reported outcomes that are important to people with NMIBC, provides the basis for the development of a new NMIBC-specific symptom index, and guides the design of a comprehensive PRO assessment plan for clinical practice in NMIBC and future clinical trials of treatments for NMIBC.

Comparison of cost of care for tethered versus non-tethered ureteric stents in the management of uncomplicated upper urinary tract stones.

BACKGROUND: Many surgeons use a stent after ureteroscopic lithotripsy (URSL). For short-term stenting purposes, a surgeon has the choice of either a tethered or a non-tethered stent. Stents may be associated with complications that entail an additional cost to their use. There is a paucity of data on the direct healthcare cost of using stent type after either primary or secondary URSL. METHODS: We retrospectively reviewed medical records for patients who underwent URSL for uncomplicated urolithiasis between January 2013 and December 2013 at two tertiary referral hospitals. Costs data was sourced from the costing department with complete data available for 134 patients. The overall medical care cost was estimated by computing the cost of surgery, stent-related emergency department presentations, re-admissions and stent removal. RESULTS: A total of 113 patients had tethered stents and 21 had non-tethered stents, with similar age and gender composition between the two groups and complications rates. The mean cost of URSL and stent placement was A$3071.7 ± A$906.8 versus A$3423.8 ± A$808.4 (P = 0.049), mean cost of managing complications was A$309.4 ± A$1744.8 versus A$31.3 ± A$98.9 (P = 0.096), mean cost of out-patient clinic stent removal was A$222.5 ± A$60 versus A$1013.6 ± A$75.4 (P < 0.001) for endoscopic stent removal, overall mean cost of care was A$3603.6 ± A$1896.7 versus A$4468.1 ± A$820.8 (P = 0.042) for tethered and non-tethered stents, respectively. CONCLUSION: It is cheaper to use a tethered ureteric stent compared with non-tethered stents for short-term stenting after uncomplicated URSL, with a mean cost saving of A$864.5.