Feasibility, Acceptability, and Outcomes of a Mobile Health Tool for Radical Cystectomy Recovery.

PURPOSE: Postoperative education and symptom tracking are essential following cystectomy to reduce readmission rates and information overload. To address these issues, an internet-based tool was developed to provide education, alerts, and symptom tracking. We aimed to evaluate the tool's feasibility, acceptability, and impact on complication and readmission rates. MATERIALS AND METHODS: Thirty-three eligible patients over 18 years old scheduled for cystectomy were enrolled. Patients were asked to use the mobile health (mHealth) tool daily for the first 2 weeks, then less frequently up to 90 days after discharge. Descriptive statistics were used to summarize study variables. Feasibility was defined as at least 50% of patients using the tool once a week, and acceptability as patient satisfaction of > 75%. RESULTS: Use of the mHealth tool was feasible, with 90% of patients using it 1 week after discharge, but engagement declined over time to 50%, with technological difficulties being the main reason for nonengagement. Patient and provider acceptability was high, with satisfaction > 90%. Within 90 days, 36% experienced complications after discharge and 30% were readmitted. Engagement with the mHealth application varied but was not statistically associated with readmission (P = .21). CONCLUSIONS: The study showed that the electronic mobile health intervention for patients undergoing cystectomy was feasible, acceptable, and provided valuable educational content and symptom management. Future larger studies are needed to determine the tool's effectiveness in improving patient outcomes and its potential implementation into routine clinical care.

Urbanization extends flight phenology and leads to local adaptation of seasonal plasticity in Lepidoptera.

Urbanization is gaining force globally, which challenges biodiversity, and it has recently also emerged as an agent of evolutionary change. Seasonal phenology and life cycle regulation are essential processes that urbanization is likely to alter through both the urban heat island effect (UHI) and artificial light at night (ALAN). However, how UHI and ALAN affect the evolution of seasonal adaptations has received little attention. Here, we test for the urban evolution of seasonal life-history plasticity, specifically changes in the photoperiodic induction of diapause in two lepidopterans, Pieris napi (Pieridae) and Chiasmia clathrata (Geometridae). We used long-term data from standardized monitoring and citizen science observation schemes to compare yearly phenological flight curves in six cities in Finland and Sweden to those of adjacent rural populations. This analysis showed for both species that flight seasons are longer and end later in most cities, suggesting a difference in the timing of diapause induction. Then, we used common garden experiments to test whether the evolution of the photoperiodic reaction norm for diapause could explain these phenological changes for a subset of these cities. These experiments demonstrated a genetic shift for both species in urban areas toward a lower daylength threshold for direct development, consistent with predictions based on the UHI but not ALAN. The correspondence of this genetic change to the results of our larger-scale observational analysis of in situ flight phenology indicates that it may be widespread. These findings suggest that seasonal life cycle regulation evolves in urban ectotherms and may contribute to ecoevolutionary dynamics in cities.

Evolution of butterfly seasonal plasticity driven by climate change varies across life stages.

Photoperiod is a common cue for seasonal plasticity and phenology, but climate change can create cue-environment mismatches for organisms that rely on it. Evolution could potentially correct these mismatches, but phenology often depends on multiple plastic decisions made during different life stages and seasons that may evolve separately. For example, Pararge aegeria (Speckled wood butterfly) has photoperiod-cued seasonal life history plasticity in two different life stages: larval development time and pupal diapause. We tested for climate change-associated evolution of this plasticity by replicating common garden experiments conducted on two Swedish populations 30 years ago. We found evidence for evolutionary change in the contemporary larval reaction norm-although these changes differed between populations-but no evidence for evolution of the pupal reaction norm. This variation in evolution across life stages demonstrates the need to consider how climate change affects the whole life cycle to understand its impacts on phenology.

How do I reduce variation in red blood cell transfusion practices in a large integrated health care system?

BACKGROUND: Reducing variation in transfusion practices can prevent unwarranted transfusions, an outcome that improves quality of care and patient safety, while lowering costs and eliminating waste of blood. We developed and assessed a system-wide initiative to reduce variation in red blood cell (RBC) transfusion in terms of both transfusion utilization and the number of units transfused. INTERVENTION DESIGN AND METHODS: Our initiative combined a single-unit default order for RBC transfusion in hemodynamically stable, non-bleeding patients with a "Why Give 2 When 1 Will Do?" Choosing Wisely campaign, while also promoting a restrictive hemoglobin threshold (Hb <7 g/dl). This multimodal intervention was implemented across an academic medical center (AMC) with over 950 beds and 10 community hospitals. RESULTS: Between our baseline (CY 2020) and intervention period (CY 2021), single-unit orders increased from 57% to 70% of all RBC transfusion orders (p < .001). The greatest change in ordering practices was at community hospitals, where single-unit orders increased from 46% to 65% (p < .001). Over the same time period, the system-wide mean (SD) Hb result prior to transfusion fell from 7.3 (0.05) to 7.2 g/dl (0.04) (p < .05). We estimate this effort saved over 4000 units of blood and over $4 million in direct and indirect costs in its first year. DISCUSSION: By combining a single-unit default setting in the RBC order with a restrictive hemoglobin threshold, we significantly reduced variation in ordering practices. This effort demonstrates the value of single-unit policies and "nudges" in system-wide patient blood management initiatives.

Reducing Opioid Prescribing after Cesarean Delivery by Utilizing a Tailored Opioid Prescribing Algorithm.

OBJECTIVE: There are increasing efforts among health care systems to promote safe opioid prescribing; however, best practice for minimizing overprescription is not established. Our study aimed to evaluate the effect of a tailored opioid prescribing algorithm on opioid prescription quantities. STUDY DESIGN: A tailored opioid prescribing algorithm was developed to provide a recommended prescription quantity based on inpatient opioid use. A retrospective analysis of opioid prescribing 3 months before and after implementation was performed. Our primary outcome was the number of oxycodone 5-mg tablets prescribed. Subgroup analysis by oxycodone consumption in the 24 hour prior to discharge was performed. Patient satisfaction and unused opioid tablets were assessed by text message survey 2 weeks' postpartum. RESULTS: We included 627 (n = 313 preimplementation; n = 314 postimplementation) patients who underwent cesarean delivery. Clinical characteristics were similar between groups. The median number of oxycodone 5-mg tablets prescribed in the baseline group was 20 (interquartile range [IQR]: 20-30), compared with 5 (IQR: 0-10) in the tailored prescribing group (p < 0.0001). For patients with no opioid use in the 24 hours prior to discharge, the median number of tablets prescribed decreased from 20 (IQR: 10-20) to 0 (IQR: 0-5) following the intervention (p < 0.0001). The proportion of patients discharged without an opioid prescription increased from 7% (23/313) in the baseline group to 35% (111/314) in the tailored prescribing group (odds ratio: 6.9, 95% confidence interval [4.3, 11.1]). CONCLUSION: Tailored opioid prescribing reduced the number of opioid tablets prescribed and increased the proportion of patients who were discharged without an opioid prescription. KEY POINTS: · Opioid prescribing should be tailored by inpatient use.. · Tailored prescribing reduced opioid prescription amounts.. · Many patients do not require an opioid prescription..

Relationships among uncertainty, post-traumatic stress disorder symptoms, and quality of life in non-muscle-invasive bladder cancer survivors.

PURPOSE: The aim of this study was to examine relationships among uncertainty, PTSD symptoms (PTSS), and quality of life (QOL) in non-muscle-invasive bladder cancer (NMIBC) survivors. METHODS: Eligible NMIBC survivors were identified through the North Carolina Central Cancer Registry, and 398 survivors participated in a mailed survey that measured survivor's outcomes (uncertainty, PTSS, and QOL). Structural equation modeling was used to examine the mediating effect of uncertainty and PTSS on the association between personal characteristics and QOL in NMIBC survivors. RESULTS: NMIBC survivors experienced cancer-related uncertainty; higher uncertainty was associated with male, lower income, lack of cure, and lower cognition-ability. Uncertainty was significantly and negatively associated with QOL. In addition, PTSS completely mediated the effect of uncertainty on QOL, and higher PTSS had a strong association with poorer QOL. Additionally, comorbidities, cognition-general concerns, uncertainty, and PTSS had strong negative effects on QOL. CONCLUSION: This study has identified modifiable psychosocial factors which affect QOL in NMIBC survivors. The study findings can be used in the development of interventions to improve QOL for NMIBC survivors.

Understanding the multilevel determinants of clinicians' imaging decision-making: setting the stage for de-implementation of low-value imaging.

BACKGROUND: De-implementation requires understanding and targeting multilevel determinants of low-value care. The objective of this study was to identify multilevel determinants of imaging for prostate cancer (PCa) and asymptomatic microhematuria (AMH), two common urologic conditions that have contributed substantially to the annual spending on unnecessary imaging in the US. METHODS: We used a convergent mixed-methods approach involving survey and interview data. Using a survey, we asked 33 clinicians (55% response-rate) to indicate their imaging approach to 8 clinical vignettes designed to elicit responses that would demonstrate guideline-concordant/discordant imaging practices for patients with PCa or AMH. A subset of survey respondents (N = 7) participated in semi-structured interviews guided by a combination of two frameworks that offered a comprehensive understanding of multilevel determinants. We analyzed the interviews using a directed content analysis approach and identified subthemes to better understand the differences and similarities in the imaging determinants across two clinical conditions. RESULTS: Survey results showed that the majority of clinicians chose guideline-concordant imaging behaviors for PCa; guideline-concordant imaging intentions were more varied for AMH. Interview results informed what influenced imaging decisions and provided additional context to the varying intentions for AMH. Five subthemes touching on multiple levels were identified from the interviews: National Guidelines, Supporting Evidence and Information Exchange, Organization of the Imaging Pathways, Patients' Clinical and Other Risk Factors, and Clinicians' Beliefs and Experiences Regarding Imaging. Imaging decisions for both PCa and AMH were often driven by national guidelines from major professional societies. However, when clinicians felt guidelines were inadequate, they reported that their decision-making was influenced by their knowledge of recent scientific evidence, past clinical experiences, and the anticipated benefits of imaging (or not imaging) to both the patient and the clinician. In particular, clinicians referred to patients' anxiety and uncertainty or patients' clinical factors. For AMH patients, clinicians additionally expressed concerns regarding legal liability risk. CONCLUSION: Our study identified comprehensive multilevel determinants of imaging to inform development of de-implementation interventions to reduce low-value imaging, which we found useful for identifying determinants of de-implementation. De-implementation interventions should be tailored to address the contextual determinants that are specific to each clinical condition.

Predicting risk of multiple levels of recurrence and progression after initial diagnosis of nonmuscle-invasive bladder cancer in a multisite, community-based cohort.

BACKGROUND: Nonmuscle-invasive bladder cancer (NMIBC) has heterogeneous recurrence and progression outcomes. Available risk calculators estimate recurrence and progression but do not predict the recurrence stage or grade, which may influence downstream treatment. The objective of this study was to predict risk-stratified NMIBC recurrence and progression based on recurrence tumor classification and grade. METHODS: In total, 2956 patients with NMIBC (

Fibroblast growth factor receptor 3 alterations and response to immune checkpoint inhibition in metastatic urothelial cancer: a real world experience.

BACKGROUND: FGFR3-altered urothelial cancer (UC) correlates with a non-T cell-inflamed phenotype and has therefore been postulated to be less responsive to immune checkpoint blockade (ICB). Preclinical work suggests FGFR3 signalling may suppress pathways such as interferon signalling that alter immune microenvironment composition. However, correlative studies examining clinical trials have been conflicting as to whether FGFR altered tumours have equivalent response and survival to ICB in patients with metastatic UC. These findings have yet to be validated in real world data, therefore we evaluated clinical outcomes of patients with FGFR3-altered metastatic UC treated with ICB and investigate the underlying immunogenomic mechanisms of response and resistance. METHODS: 103 patients with metastatic UC treated with ICB at a single academic medical center from 2014 to 2018 were identified. Clinical annotation for demographics and cancer outcomes, as well as somatic DNA and RNA sequencing, were performed. Objective response rate to ICB, progression-free survival, and overall survival was compared between patients with FGFR3-alterations and those without. RNA expression, including molecular subtyping and T cell receptor clonality, was also compared between FGFR3-altered and non-altered patients. RESULTS: Our findings from this dataset confirm that FGFR3-altered (n = 17) and wild type (n = 86) bladder cancers are equally responsive to ICB (12 vs 19%, p = 0.73). Moreover, we demonstrate that despite being less inflamed, FGFR3-altered tumours have equivalent T cell receptor (TCR) diversity and that the balance of a CD8 T cell gene expression signature to immune suppressive features is an important determinant of ICB response. CONCLUSIONS: Our work in a real world dataset validates prior observations from clinical trials but also extends this prior work to demonstrate that FGFR3-altered and wild type tumours have equivalent TCR diversity and that the balance of effector T cell to immune suppression signals are an important determinant of ICB response.

Impairment and Longitudinal Recovery of Older Adults Treated with Radical Cystectomy for Muscle Invasive Bladder Cancer.

PURPOSE: Treatment for muscle invasive bladder cancer includes radical cystectomy, a major surgery that can be associated with significant toxicity. Limited data exist related to changes in patient global health status and recovery following radical cystectomy. We used geriatric assessment to longitudinally compare health related impairments in older and younger patients with muscle invasive bladder cancer who undergo radical cystectomy. MATERIALS AND METHODS: Older and younger patients (70 or older and younger than 70 years) with muscle invasive bladder cancer undergoing radical cystectomy at an academic institution were enrolled between 2012 and 2019. Patients completed the geriatric assessment before radical cystectomy, and 1, 3 and 12 months after radical cystectomy. For each geriatric assessment measure the Wilcoxon rank sum test was used to compare score distribution between age groups at each time point. The Wilcoxon signed rank test was used to compare distributions between time points within each age group. RESULTS: A total of 80 patients (42 younger and 38 older) were enrolled. Before radical cystectomy 78% of patients were impaired on at least 1 geriatric assessment measure. Both age groups had worsening physical function and nutrition at 1 month after radical cystectomy, with older patients having a greater decline in function than younger patients. Both groups recovered to baseline at 3 months after radical cystectomy and maintained this status at 1 year. CONCLUSIONS: High rates of impairments were found across age groups in the short term after radical cystectomy, followed by recovery to baseline.

Patient Reported vs Claims Based Measures of Health for Modeling Life Expectancy in Men with Prostate Cancer.

PURPOSE: Life expectancy has become a core consideration in prostate cancer care. While multiple prediction tools exist to support decision making, their discriminative ability remains modest, which hampers usage and utility. We examined whether combining patient reported and claims based health measures into prediction models improves performance. MATERIALS AND METHODS: Using SEER (Surveillance, Epidemiology, and End Results)-CAHPS (Consumer Assessment of Healthcare Providers and Systems) we identified men 65 years old or older diagnosed with prostate cancer from 2004 to 2013 and extracted 4 types of data, including demographics, cancer information, claims based health measures and patient reported health measures. Next, we compared the performance of 5 nested competing risk regression models for other cause mortality. Additionally, we assessed whether adding new health measures to established prediction models improved discriminative ability. RESULTS: Among 3,240 cases 246 (7.6%) died of prostate cancer while 631 (19.5%) died of other causes. The National Cancer Institute Comorbidity Index score was associated but weakly correlated with patient reported overall health (p <0.001, r=0.21). For predicting other cause mortality the 10-year area under the receiver operating characteristic curve improved from 0.721 (demographics only) to 0.755 with cancer information and to 0.777 and 0.812 when adding claims based and patient reported health measures, respectively. The full model generated the highest value of 0.820. Models based on existing tools also improved in their performance with the incorporation of new data types as predictor variables (p <0.001). CONCLUSIONS: Prediction models for life expectancy that combine patient reported and claims based health measures outperform models that incorporate these measures separately. However, given the modest degree of improvement, the implementation of life expectancy tools should balance model performance with data availability and fidelity.

The IDENTIFY study: the investigation and detection of urological neoplasia in patients referred with suspected urinary tract cancer - a multicentre observational study.

OBJECTIVE: To evaluate the contemporary prevalence of urinary tract cancer (bladder cancer, upper tract urothelial cancer [UTUC] and renal cancer) in patients referred to secondary care with haematuria, adjusted for established patient risk markers and geographical variation. PATIENTS AND METHODS: This was an international multicentre prospective observational study. We included patients aged ≥16 years, referred to secondary care with suspected urinary tract cancer. Patients with a known or previous urological malignancy were excluded. We estimated the prevalence of bladder cancer, UTUC, renal cancer and prostate cancer; stratified by age, type of haematuria, sex, and smoking. We used a multivariable mixed-effects logistic regression to adjust cancer prevalence for age, type of haematuria, sex, smoking, hospitals, and countries. RESULTS: Of the 11 059 patients assessed for eligibility, 10 896 were included from 110 hospitals across 26 countries. The overall adjusted cancer prevalence (n = 2257) was 28.2% (95% confidence interval [CI] 22.3-34.1), bladder cancer (n = 1951) 24.7% (95% CI 19.1-30.2), UTUC (n = 128) 1.14% (95% CI 0.77-1.52), renal cancer (n = 107) 1.05% (95% CI 0.80-1.29), and prostate cancer (n = 124) 1.75% (95% CI 1.32-2.18). The odds ratios for patient risk markers in the model for all cancers were: age 1.04 (95% CI 1.03-1.05; P < 0.001), visible haematuria 3.47 (95% CI 2.90-4.15; P < 0.001), male sex 1.30 (95% CI 1.14-1.50; P < 0.001), and smoking 2.70 (95% CI 2.30-3.18; P < 0.001). CONCLUSIONS: A better understanding of cancer prevalence across an international population is required to inform clinical guidelines. We are the first to report urinary tract cancer prevalence across an international population in patients referred to secondary care, adjusted for patient risk markers and geographical variation. Bladder cancer was the most prevalent disease. Visible haematuria was the strongest predictor for urinary tract cancer.

Compensating for climate change-induced cue-environment mismatches: evidence for contemporary evolution of a photoperiodic reaction norm in Colias butterflies.

Anthropogenic climate change alters seasonal conditions without altering photoperiod and can thus create a cue-environment mismatch for organisms that use photoperiod as a cue for seasonal plasticity. We investigated whether evolution of the photoperiodic reaction norm has compensated for this mismatch in Colias eurytheme. This butterfly's wing melanization has a thermoregulatory function and changes seasonally. In 1971, Hoffmann quantified how larval photoperiod determines adult wing melanization. We recreated his experiment 47 years later using a contemporary population. Comparing our results to his, we found decreased melanization at short photoperiods but no change in melanization at long photoperiods, which is consistent with the greater increase in spring than summer temperatures recorded for this region. Our study shows that evolution can help correct cue-environment mismatches but not in the same way under all conditions. Studies of contemporary evolution may miss important changes if they focus on only a limited range of conditions.

Microhematuria: AUA/SUFU Guideline.

PURPOSE: Patients presenting with microhematuria represent a heterogeneous population with a broad spectrum of risk for genitourinary malignancy. Recognizing that patient-specific characteristics modify the risk of underlying malignant etiologies, this guideline sought to provide a personalized diagnostic testing strategy. MATERIALS AND METHODS: The systematic review incorporated evidence published from January 2010 through February 2019, with an updated literature search to include studies published up to December 2019. Evidence-based statements were developed by the expert Panel, with statement type linked to evidence strength, level of certainty, and the Panel's judgment regarding the balance between benefits and risks/burdens. RESULTS: Microhematuria should be defined as ≥ 3 red blood cells per high power field on microscopic evaluation of a single specimen. In patients diagnosed with gynecologic or non-malignant genitourinary sources of microhematuria, clinicians should repeat urinalysis following resolution of the gynecologic or non-malignant genitourinary cause. The Panel created a risk classification system for patients with microhematuria, stratified as low-, intermediate-, or high-risk for genitourinary malignancy. Risk groups were based on factors including age, sex, smoking and other urothelial cancer risk factors, degree and persistence of microhematuria, as well as prior gross hematuria. Diagnostic evaluation with cystoscopy and upper tract imaging was recommended according to patient risk and involving shared decision-making. Statements also inform follow-up after a negative microhematuria evaluation. CONCLUSIONS: Patients with microhematuria should be classified based on their risk of genitourinary malignancy and evaluated with a risk-based strategy. Future high-quality studies are required to improve the care of these patients.

Health-related quality of life among non-muscle-invasive bladder cancer survivors: a population-based study.

OBJECTIVE: To examine the effect of non-muscle-invasive bladder cancer (NMIBC) diagnosis and treatment on survivors' quality of life (QoL). PATIENTS AND METHODS: Of the 5979 patients with NMIBC diagnosed between 2010 and 2014 in North Carolina, 2000 patients were randomly selected to be invited to enroll in this cross-sectional study. Data were collected by postal mail survey. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core (QLQ-C30) and the NMIBC-specific module were included in the survey to measure QoL. Descriptive statistics, t-tests, anova, and Pearson's correlation were used to describe demographics and to assess how QoL varied by sex, cancer stage, time since diagnosis, and treatment. RESULTS: A total of 398 survivors returned questionnaires (response rate: 23.6%). The mean QoL score for QLQ-C30 (range 0-100, higher = better QoL in all domains but symptoms) for global health status was 73.6, function domain scores ranged from 83.9 to 86.5, and scores for the top five symptoms (insomnia, fatigue, dyspnoea, pain, and financial difficulties) ranged from 14.1 to 24.3. The lowest NMIBC-specific QoL domain was sexual issues including sexual function, enjoyment, problems, and intimacy. Women had worse bowel problems, sexual function, and sexual enjoyment than men but better sexual intimacy and fewer concerns about contaminating their partner. Stage Ta had the highest global health status, followed by T1 and Tis. QoL did not vary by time since diagnosis except for sexual function. The cystectomy group (n = 21) had worse QoL in sexual function, discomfort with sexual intimacy, sexual enjoyment, and male sexual problems than the non-cystectomy group (n = 336). CONCLUSION: Survivors of NMIBC face a unique burden associated with their diagnosis and the often-lifelong surveillance and treatment regimens. The finding has important implications for the design of tailored supportive care interventions to improve QoL for NMIBC survivors.

Using qualitative research to reduce readmissions and optimize perioperative cystectomy care.

BACKGROUND: Preventable complications and readmissions after cystectomy may be detectable via postoperative monitoring of patient-reported outcomes (PROs). However, no study has defined meaningful PROs or the use of mobile communication devices (mobile health [mHealth]) to capture them. The objectives of this study were to determine which high-priority PROs influence patients' perioperative experience, what processes influence these outcomes, how patients and caregivers differ in their experiences, and how mHealth might be used to improve outcomes. METHODS: Forty-five semistructured, in-depth interviews were conducted with readmitted cystectomy patients, caregivers, and providers with an interview guide that addressed perioperative education, symptoms, function, and the potential for mHealth interventions. Among 15 patients, 10 had an interviewed partner. A thematic analysis of interviews conducted with readmitted patients, caregivers, and providers was performed to examine processes that affected perioperative care and readmission and to determine how mHealth interventions might be implemented. RESULTS: Readmitted patients and caregivers ranged in age from 33 to 78 years and were diverse in race and stage. The providers included a diverse representation of physicians, nurses, and other specialists. Cystectomy preoperative education was overwhelming and lacked personalization, and this contributed to a fundamental lack of knowledge regarding normal and abnormal symptoms after surgery. Three connecting themes were identified: 1) cystectomy education overload, 2) a need to define normal symptoms, and 3) education with incremental learning through mHealth. CONCLUSIONS: A personalized mHealth intervention addressing themes of education overload, the definition of normality, and incremental learning could be realized through mHealth technology and provide the right information for the right patient at the right time.

Cost-effectiveness of surveillance schedules in older adults with non-muscle-invasive bladder cancer.

OBJECTIVE: To estimate the cost-effectiveness of surveillance schedules for non-muscle-invasive bladder cancer (NMIBC) amongst older adults. PATIENTS AND METHODS: We developed a MIcrosimulation SCreening ANalysis (MISCAN) microsimulation model to compare the cost-effectiveness of various surveillance schedules (every 3 months to every 24 months, for 2, 5 or 10 years or lifetime) for older adults (aged 65-85 years) with NMIBC. For each surveillance schedule we calculated total costs per patient and the number of quality adjusted life-years (QALYs) gained. Incremental cost-effectiveness ratios (ICERs), as incremental costs per QALY gained, were calculated using a 3% discount. RESULTS: As age increased, the number of QALYs gained per patient decreased substantially. Surveillance of patients aged 65 years resulted in 2-7 QALYs gained, whereas surveillance at age 85 years led to <1 QALY gained. The total costs of the surveillance schedules also decreased as age increased. The ICER of 6-monthly surveillance at age 65 years for lifetime was $4999 (American dollars)/QALY gained. Amongst patients aged >75 years, the incremental yield of QALY gains for any increase in surveillance frequency and/or duration was quite modest (<2 QALYs gained). CONCLUSION: With increasing age, surveillance for recurrences leads to substantially fewer QALYs gained. These data support age-specific surveillance recommendations for patients treated for NMIBC.

A Systematic Review of Clinical Decision Support Systems for Clinical Oncology Practice.

BACKGROUND: Electronic health records are central to cancer care delivery. Electronic clinical decision support (CDS) systems can potentially improve cancer care quality and safety. However, little is known regarding the use of CDS systems in clinical oncology and their impact on patient outcomes. METHODS: A systematic review of peer-reviewed studies was performed to evaluate clinically relevant outcomes related to the use of CDS tools for the diagnosis, treatment, and supportive care of patients with cancer. Peer-reviewed studies published from 1995 through 2016 were included if they assessed clinical outcomes, patient-reported outcomes (PROs), costs, or care delivery process measures. RESULTS: Electronic database searches yielded 2,439 potentially eligible papers, with 24 studies included after final review. Most studies used an uncontrolled, pre-post intervention design. A total of 23 studies reported improvement in key study outcomes with use of oncology CDS systems, and 12 studies assessing the systems for computerized chemotherapy order entry demonstrated reductions in prescribing error rates, medication-related safety events, and workflow interruptions. The remaining studies examined oncology clinical pathways, guideline adherence, systems for collection and communication of PROs, and prescriber alerts. CONCLUSIONS: There is a paucity of data evaluating clinically relevant outcomes of CDS system implementation in oncology care. Currently available data suggest that these systems can have a positive impact on the quality of cancer care delivery. However, there is a critical need to rigorously evaluate CDS systems in oncology to better understand how they can be implemented to improve patient outcomes.

Study design choices for evaluating the comparative safety of diabetes medications: An evaluation of pioglitazone use and risk of bladder cancer in older US adults with type-2 diabetes.

AIM: The aim of the study was to empirically demonstrate the effect of varying study designs when evaluating the safety of pioglitazone in treating bladder cancer. METHODS: We identified Medicare beneficiaries above 65 years of age with diabetes between 2008 and 2015 and with classified exposure (at least two claims within 180 days) to glucose-lowering drugs (GLD), pioglitazone or another drug. The effects of varying the following study design parameters on bladder cancer risk were assessed: use of a new vs existing drug, choice of referent (all non-users and users of GLDs, non-insulin GLDs and DPP-4s) and whether or not censoring accounted for treatment change. We used the Cox proportional hazards model to obtain adjusted HRs and 95% CIs. RESULTS: We included 1,510,212 patients classified as pioglitazone users (N = 135,188) or non-users (N = 1,375,024). Users had more diabetic complications than non-users, but fewer than insulin users. The HR ranged from 1.10 (1.01-1.20) to 1.13 (0.99-1.29) when censoring ignored treatment change, suggesting a weak association or none between pioglitazone and bladder cancer, probably under-estimating risk. However, the HR was 1.20 (1.01-1.42) when cohorts were restricted to new users, censored upon treatment change, and when DPP-4 was used as the referent, suggesting an increased risk of bladder cancer associated with pioglitazone. CONCLUSIONS: The continued demand for new GLDs indicates the need for more robust observational methods to improve the value of generating real-world evidence in equipping clinicians to make informed prescribing decisions. Although there is no one-size-fits-all approach, we recommend active comparator new user study designs that compare therapeutically equivalent drugs and account for treatment changes during follow-up to present the least biased comparative safety estimates.