Cost-Effectiveness Analysis of the Clear Cell Likelihood Score against Renal Mass Biopsy for Evaluating Small Renal Masses.

OBJECTIVE: To examine the cost-effectiveness of the clear cell likelihood score compared to renal mass biopsy alone. METHODS: The clear cell likelihood score, a new grading system based on multiparametric magnetic resonance imaging, has been proposed as a possible alternative to percutaneous renal mass biopsy for identifying clear cell renal carcinoma in small renal masses and expediting treatment of high-risk patients. A decision analysis model was developed to compare a renal mass biopsy strategy where all patients undergo biopsy and a clear cell likelihood score strategy where only patients that received an indeterminant score of 3 undergo biopsy. Effectiveness was assigned 1 for correct diagnoses and 0 for incorrect or indeterminant diagnoses. Costs were obtained from institutional fees and Medicare reimbursement rates. Probabilities were derived from literature estimates from radiologists trained in the clear cell likelihood score. RESULTS: In the base case model, the clear cell likelihood score was both more effective (0.77 vs. 0.70) and less expensive than renal mass biopsy ($1629 vs. $1966). Sensitivity analysis found that the nondiagnostic rate of renal mass biopsy and the sensitivity of the clear cell likelihood score had the greatest impact on the model. In threshold analyses, the clear cell likelihood score was the preferred strategy when its sensitivity was greater than 62.7% and when an MRI cost less than $5332. CONCLUSIONS: The clear cell likelihood score is a more cost-effective option than renal mass biopsy alone for evaluating small renal masses for clear cell renal carcinoma.

A sampling strategy for longitudinal and cross-sectional analyses using a large national claims database.

Importance: The United States (US) Medicare claims files are valuable sources of national healthcare utilization data with over 45 million beneficiaries each year. Due to their massive sizes and costs involved in obtaining the data, a method of randomly drawing a representative sample for retrospective cohort studies with multi-year follow-up is not well-documented. Objective: To present a method to construct longitudinal patient samples from Medicare claims files that are representative of Medicare populations each year. Design: Retrospective cohort and cross-sectional designs. Participants: US Medicare beneficiaries with diabetes over a 10-year period. Methods: Medicare Master Beneficiary Summary Files were used to identify eligible patients for each year in over a 10-year period. We targeted a sample of ~900,000 patients per year. The first year's sample is stratified by county and race/ethnicity (white vs. minority), and targeted at least 250 patients in each stratum with the remaining sample allocated proportional to county population size with oversampling of minorities. Patients who were alive, did not move between counties, and stayed enrolled in Medicare fee-for-service (FFS) were retained in the sample for subsequent years. Non-retained patients (those who died or were dropped from Medicare) were replaced with a sample of patients in their first year of Medicare FFS eligibility or patients who moved into a sampled county during the previous year. Results: The resulting sample contains an average of 899,266 ± 408 patients each year over the 10-year study period and closely matches population demographics and chronic conditions. For all years in the sample, the weighted average sample age and the population average age differ by <0.01 years; the proportion white is within 0.01%; and the proportion female is within 0.08%. Rates of 21 comorbidities estimated from the samples for all 10 years were within 0.12% of the population rates. Longitudinal cohorts based on samples also closely resembled the cohorts based on populations remaining after 5- and 10-year follow-up. Conclusions and relevance: This sampling strategy can be easily adapted to other projects that require random samples of Medicare beneficiaries or other national claims files for longitudinal follow-up with possible oversampling of sub-populations.

Central Sleep Apnea in Patients With Coronary Heart Disease Taking P2Y12 Inhibitors.

ABSTRACT: Central sleep apnea (CSA) is common in patients with heart failure. Recent studies link ticagrelor use with CSA. We aimed to evaluate CSA prevalence in patients with coronary heart disease (CHD) and whether ticagrelor use is associated with CSA. We reviewed consecutive patients with CHD who underwent a polysomnography (PSG) test over a 5-year period from 3 sleep centers. We sampled patients who were on ticagrelor or clopidogrel during a PSG test at a 1:4 ticagrelor:clopidogrel ratio. Patients with an active opioid prescription during PSG test were excluded. Age, left ventricle (LV) dysfunction, and P2Y12 inhibitor use were included in a multivariate logistic regression. A total of 135 patients were included with 26 on ticagrelor and 109 on clopidogrel (age 64.1 ± 11.4, 32% male). High CSA burden (12%) and strict CSA (4.4%) were more common in patients on ticagrelor than in those on clopidogrel (27% vs. 8.3% and 10.0% vs. 1.8%). Ticagrelor use (vs. clopidogrel) was associated with high CSA burden (OR 3.53, 95% CI 1.04-12.9, P = 0.039) and trended toward significance for strict CSA (OR 6.32, 95% CI 1.03-51.4, P = 0.052) when adjusting for age and LV dysfunction. In an additional analysis also adjusting for history of atrial fibrillation, ticagrelor use and strict CSA became significantly associated (OR 10.0, 95% CI 1.32-117, P = 0.035). CSA was uncommon in patients with CHD undergoing sleep studies. Ticagrelor use (vs. clopidogrel) was associated with high CSA burden and trended toward significance for strict CSA.

Characterization of sleep efficiency transitions in family caregivers.

Family caregivers are at high risk of psychological distress and low sleep efficiency resulting from their caregiving responsibilities. Although psychological symptoms are associated with sleep efficiency, there is limited knowledge about the association of psychological distress with variations in sleep efficiency. We aimed to characterize the short- and long-term patterns of caregivers' sleep efficiency using Markov chain models and compare these patterns between groups with high and low psychological symptoms (i.e., depression, anxiety, and caregiving stress). Based on 7-day actigraphy data from 33 caregivers, we categorized sleep efficiency into three states, < 75% (S1), 75-84% (S2), and ≥ 85% (S3), and developed Markov chain models. Caregivers were likely to maintain a consistent sleep efficiency state from one night to the next without returning efficiently to a normal state. On average, it took 3.6-5.1 days to return to a night of normal sleep efficiency (S3) from lower states, and the long-term probability of achieving normal sleep was 42%. We observed lower probabilities of transitioning to or remaining in a normal sleep efficiency state (S3) in the high depression and anxiety groups compared to the low symptom groups. The differences in the time required to return to a normal state were inconsistent by symptom levels. The long-term probability of achieving normal sleep efficiency was significantly lower for caregivers with high depression and anxiety compared to the low symptom groups. Caregivers' sleep efficiency appears to remain relatively consistent over time and does not show rapid recovery. Caregivers with higher levels of depression and anxiety may be more vulnerable to sustained suboptimal sleep efficiency.

Comparison of microwave ablation and partial nephrectomy for T1a small renal masses.

OBJECTIVE: To compare the oncological and renal function outcomes of microwave ablation (MWA) compared to partial nephrectomy (PN) in two small renal mass (SRM) tumor size cohorts, <3 cm and 3-4 cm. MATERIALS AND METHODS: This study included retrospective data from 2009 to 2015 and prospective data since 2015 from a single-institution database. Patient demographics, renal mass characteristics, and treatment outcomes were collected. Survival curves and hazard analysis were used to assess oncological outcomes. Changes in eGFR and CKD stage following surgery were used to assess renal function outcomes. RESULTS: A total of 80 PN and 126 MWA patients were analyzed. Median age and Charlson Comorbidity Index (CCI) of MWA patients were greater than PN for each tumor size cohort. Cumulative progression free survival at 36-months was 91% for MWA and 90% for PN. Preoperative renal function was significantly lower in patients undergoing MWA for both tumor sizes, however there was no significant difference in the postoperative change in renal function between MWA and PN for tumors up to 4 cm. CONCLUSIONS: Oncological outcomes and renal preservation were comparable between MWA and PN cohorts for SRMs <3cm and 3-4cm despite the MWA cohort being older and having more comorbidities. Our findings suggest that MWA can be used as a safe and effective alternative to PN for T1a renal tumors up to 4 cm.

Microwave ablation of the T1a small renal mass: expanding beyond 3 cm.

PURPOSE: To compare the oncological and renal function outcomes for patients receiving microwave ablation (MWA) in tumors < 3 and 3-4 cm. METHODS: Retrospective analysis of a prospectively maintained database identified patients with < 3 or 3-4 cm renal cancers undergoing MWA. Radiographic follow-up occurred at approximately 6 months post-procedure and annually thereafter. Serum creatinine and estimated glomerular filtration rate (eGFR) were calculated before and 6-months post-MWA. Local recurrence-free survival (LRFS) was estimated using the Kaplan-Meier method. Tumor size was evaluated as a prognostic factor using Cox proportional-hazards regression. Predictors for change in eGFR and chronic kidney disease (CKD) stage were modeled using linear and ordinal logistic regression. RESULTS: A total of 126 patients fit the inclusion criteria. Overall recurrences were 2/62 (3.2%) and 6/64 (9.4%) for < 3 versus 3-4 cm. Both recurrences in the < 3 cm group were local, 4/6 in the 3-4 cm group were local and 2/6 were metastatic without local progression. For < 3 versus 3-4 cm, cumulative LRFS at 36 months was 94.6% versus 91.4%. Tumor size was not a significant prognostic factor for LRFS. Renal function did not change significantly after MWA. Patient comorbidities and RENAL nephrometry score significantly affected change in CKD. CONCLUSION: With comparable oncological outcomes, complication rates, and renal function preservation, MWA is a promising management strategy for renal masses of 3-4 cm in select patients. Our findings suggest that current AUA guidelines, which recommend thermal ablation for tumors < 3 cm, may need review to include T1a tumors for MWA, regardless of size.

Association of disrupted sleep with 24-hour blood pressure variability in caregivers.

BACKGROUND: A growing body of research highlights the negative impact of caregiving on cardiovascular disease (CVD) risk. OBJECTIVES: This study aimed to examine associations of psychological symptoms and sleep quality with 24-hour blood pressure variability (BPV), which is an independent predictor of CVD, among family caregivers of community-dwelling individuals with chronic illness. METHODS: For this cross-sectional study, we assessed caregiving burden and depressive symptoms using questionnaires and 7-day sleep quality (i.e., number of awakenings, wake after sleep onset, sleep efficiency) using an actigraph. The participants carried out a 24-hour ambulatory BP monitoring for systolic and diastolic BPV over 24 h and during awake/sleep times. We performed Pearson's correlations and multiple linear regression. RESULTS: The analytic sample consisted of 30 caregivers (25 female; mean age 62 years). The number of awakenings during sleep was positively correlated with systolic BPV-awake (r = 0.426, p = 0.019) and diastolic BPV-awake (r = 0.422, p = 0.020). Sleep efficiency was negatively correlated with diastolic BPV-awake (r = -0.368, p = 0.045). Caregiving burden and depressive symptoms were not correlated with BPV. After controlling for age and mean arterial pressure, the number of awakenings was significantly associated with increased systolic BPV-24 h (ß = 0.194, p = 0.018) and systolic BPV-awake (ß = 0.280, p = 0.002), respectively. CONCLUSIONS: Caregivers' disrupted sleep may play a role in increased CVD risk. While these findings should be confirmed in large clinical studies, improving sleep quality would need to be considered in CVD prevention for caregivers.

Decision Analytic Modeling for Global Clinical Trial Planning: A Case for HIV-Positive Patients at High Risk for Mycobacterium tuberculosis Sepsis in Uganda.

Sepsis is a significant cause of mortality among people living with human immunodeficiency virus (HIV) in sub-Saharan Africa. In the planning period prior to the start of a large multi-country clinical trial studying the efficacy of the immediate empiric addition of anti-tuberculosis therapy to standard-of-care antibiotics for sepsis in people living with HIV, we used decision analysis to assess the costs and potential health outcome impacts of the clinical trial design based on preliminary data and epidemiological parameter estimates. The purpose of this analysis was to highlight this approach as a case example where decision analysis can estimate the cost effectiveness of a proposed clinical trial design. In this case, we estimated the impact of immediate empiric anti-tuberculosis (TB) therapy versus the diagnosis-dependent standard of care using three different TB diagnostics: urine TB-LAM, sputum Xpert-MTB/RIF, and the combination of LAM/Xpert. We constructed decision analytic models comparing the two treatment strategies for each of the three diagnostic approaches. Immediate empiric-therapy demonstrated favorable cost-effectiveness compared with all three diagnosis-dependent standard of care models. In our methodological case exemplar, the proposed randomized clinical trial intervention demonstrated the most favorable outcome within this decision simulation framework. Applying the principles of decision analysis and economic evaluation can have significant impacts on study design and clinical trial planning.

Cost-effectiveness analysis: percutaneous microwave ablation vs robotic-assisted partial nephrectomy for small renal masses.

PURPOSE: The majority of newly diagnosed renal tumors are masses < 4 cm in size with treatment options, including active surveillance, partial nephrectomy, and ablative therapies. The cost-effectiveness literature on the management of small renal masses (SRMs) does not account for recent advances in technology and improvements in technical expertise. We aim to perform a cost-effectiveness analysis for percutaneous microwave ablation (MWA) and robotic-assisted partial nephrectomy (RA-PN) for the treatment of SRMs. METHODS: We created a decision analytic Markov model depicting management of the SRM incorporating costs, health utilities, and probabilities of complications and recurrence as model inputs using TreeAge. A willingness to pay (WTP) threshold of $100,000 and a lifetime horizon were used. Probabilistic and one-way sensitivity analyses were performed. RESULTS: Percutaneous MWA was the preferred treatment modality. MWA dominated RA-PN, meaning it resulted in more quality-adjusted life years (QALYs) at a lower cost. Cost-effectiveness analysis revealed a negative Incremental Cost-Effectiveness Ratio (ICER), indicating dominance of MWA. The model revealed MWA had a mean cost of $8,507 and 12.51 QALYs. RA-PN had a mean cost of $21,521 and 12.43 QALYs. Relative preference of MWA was robust to sensitivity analysis of all other variables. Patient starting age and cost of RA-PN had the most dramatic impact on ICER. CONCLUSION: MWA is more cost-effective for the treatment of SRM when compared with RA-PN and accounting for complication and recurrence risk.

Visit-to-visit systolic blood pressure variability is associated with increased fatigue symptoms in multiple sclerosis patients.

OBJECTIVE: To evaluate the relationship between visit-to-visit systolic blood pressure variability (SBPv) and fatigue symptoms in Multiple Sclerosis (MS) patients. METHODS: This is a cross-sectional study using data for MS patients who completed the Fatigue Subscale in the Performance Scales (PS), a validated, self-reported measure of MS-related disability, between 2011 and 2015 at an academic medical center. Those who had at least 3 available SBP measures within the prior 12 months of the survey were included in the analysis. Ordinal logistic regression was used to model fatigue as a function of SBP variability, adjusting for demographic factors and mean SBP. RESULTS: Data for 91 MS subjects were analyzed. We found that, compared to those with the lowest SBP variability (Tertile 1), subjects in Tertile 2 had 2.2 times higher odds (OR = 2.19; 95% CI, 0.82-5.87; p = 0.120) and those in Tertile 3 (highest variability) 4.2 times higher odds (OR = 4.16; 95% CI, 1.56-11.13; p = 0.005) of being in a higher fatigue level group, independent of age, sex, race/ethnicity, and mean SBP. CONCLUSIONS: Our data show that MS patients with higher SBP variability had a greater degree of fatigue. Future research is needed to further explore this relationship and the potential for therapeutic opportunities to improve fatigue.

Annual wellness visits are associated with increased use of preventive services in patients with diabetes living in the Diabetes Belt.

Objective: To examine whether Annual Wellness Visits (AWVs) were associated with increased use of preventive services in Medicare patients with diabetes living in the Diabetes Belt. Methods: We used a case-control design where outcomes were utilization of preventive services recommended for patients with diabetes (foot exam, eye exam, A1c test, and microalbuminuria test) and the exposure was AWVs using data for Medicare patients with diabetes in 2014 - 2015 residing in the Diabetes Belt (N = 412,009). Results: Only 13.4% of patients in 2014 and 17.4% in 2015 used AWVs. Eye exams (61% vs 53%), foot exams (93% vs 79%), A1c tests (81% vs 71%), and microalbuminuria tests (45% vs 28%) were more common among patients who had an AWV in the preceding year compared with those who did not. These differences remained significant after adjusting for patient demographics, comorbidities, county level medical resources, and geographic factors. Conclusions: AWVs were significantly associated with increased preventive care use among patients with diabetes living in the Diabetes Belt. Low AWV utilization by patients with diabetes in and around the Diabetes Belt is concerning.

Evaluating the Costs of Nurse Burnout-Attributed Turnover: A Markov Modeling Approach.

OBJECTIVE: Burnout is a public health crisis that impacts 1 in 3 registered nurses in the United States and the safe provision of patient care. This study sought to understand the cost of nurse burnout-attributed turnover using hypothetical hospital scenarios. METHODS: A cost-consequence analysis with a Markov model structure was used to assess nurse burnout-attributed turnover costs under the following scenarios: (1) a hospital with "status quo" nurse burnout prevalence and (2) a hospital with a "burnout reduction program" and decreased nurse burnout prevalence. The model evaluated turnover costs from a hospital payer perspective and modeled a cohort of nurses who were new to a hospital. The outcome measures were defined as years in burnout among the nurse cohort and years retained/employed in the hospital. Data inputs derived from the health services literature base. RESULTS: The expected model results demonstrated that at status quo, a hospital spends an expected $16,736 per nurse per year employed on nurse burnout-attributed turnover costs. In a hospital with a burnout reduction program, such costs were $11,592 per nurse per year employed. Nurses spent more time in burnout under the status quo scenario compared with the burnout reduction scenario (1.5 versus 1.1 y of employment) as well as less time employed at the hospital (2.9 versus 3.5 y of employment). CONCLUSIONS: Given that status quo costs of burnout are higher than those in a hospital that invests in a nurse burnout reduction program, hospitals should strongly consider proactively supporting programs that reduce nurse burnout prevalence and associated costs.

A comparative study using time-driven activity-based costing in single-fraction breast high-dose rate brachytherapy: An integrated brachytherapy suite vs. decentralized workflow.

INTRODUCTION: Precision breast intraoperative radiation therapy (PB-IORT) is a novel approach to adjuvant radiation therapy for early-stage breast cancer performed as part of a phase II clinical trial at two institutions. One institution performs the entire procedure in an integrated brachytherapy suite which contains a CT-on-rails imaging unit and full anesthesia capabilities. At the other, breast conserving surgery and radiation therapy take place in two separate locations. Here, we utilize time-driven activity-based costing (TDABC) to compare these two models for the delivery of PB-IORT. METHODS: Process maps were created to describe each step required to deliver PB-IORT at each institution, including personnel, equipment, and supplies. Time investment was estimated for each step. The capacity cost rate was determined for each resource, and total costs of care were then calculated by multiplying the capacity cost rates by the time estimate for the process step and adding any additional product costs. RESULTS: PB-IORT costs less to deliver at a distributed facility, as is more commonly available, than an integrated brachytherapy suite ($3,262.22 vs. $3,996.01). The largest source of costs in both settings ($2,400) was consumable supplies, including the brachytherapy balloon applicator. The difference in costs for the two facility types was driven by personnel costs ($1,263.41 vs. $764.89). In the integrated facility, increased time required by radiation oncology nursing and the anesthesia attending translated to the greatest increases in cost. Equipment costs were also slightly higher in the integrated suite setting ($332.60 vs. $97.33). CONCLUSIONS: The overall cost of care is higher when utilizing an integrated brachytherapy suite to deliver PB-IORT. This was primarily driven by additional personnel costs from nursing and anesthesia, although the greatest cost of delivery in both settings was the disposable brachytherapy applicator. These differences in cost must be balanced against the potential impact on patient experience with these approaches.

Dynamic Transitions of Pediatric Sepsis: A Markov Chain Analysis.

Pediatric sepsis is a heterogeneous disease with varying physiological dynamics associated with recovery, disability, and mortality. Using risk scores generated from a sepsis prediction model to define illness states, we used Markov chain modeling to describe disease dynamics over time by describing how children transition among illness states. We analyzed 18,666 illness state transitions over 157 pediatric intensive care unit admissions in the 3 days following blood cultures for suspected sepsis. We used Shannon entropy to quantify the differences in transition matrices stratified by clinical characteristics. The population-based transition matrix based on the sepsis illness severity scores in the days following a sepsis diagnosis can describe a sepsis illness trajectory. Using the entropy based on Markov chain transition matrices, we found a different structure of dynamic transitions based on ventilator use but not age group. Stochastic modeling of transitions in sepsis illness severity scores can be useful in describing the variation in transitions made by patient and clinical characteristics.

A scoping review of racial/ethnic disparities in sleep.

BACKGROUND: Despite remarkable achievements in ensuring health equity, racial/ethnic disparities in sleep still persist and are emerging as a major area of concern. Accumulating evidence has not yet been well characterized from a broad perspective. We conducted a scoping review of studies on sleep disparities by race/ethnicity to summarize characteristics of existing studies and identify evidence gaps. METHODS: We searched PubMed, CINAHL, PsycINFO, and Web of Science databases for studies of racial/ethnic disparities in sleep. Studies that met inclusion criteria were retrieved and organized in a data charting form by study design, sleep measuring methods, sleep features, and racial/ethnic comparisons. RESULTS: One hundred sixteen studies were included in this review. Most studies focused on disparities between Whites and Blacks. Disproportionately fewer studies examined disparities for Hispanic, Asian, and other racial/ethnic groups. Self-reported sleep was most frequently used. Sleep duration, overall sleep quality, and sleep disordered breathing were frequently studied, whereas other features including sleep efficiency, latency, continuity, and architecture were understudied, particularly in racial minority groups in the US. Current study findings on racial/ethnic disparities in most of sleep features is mixed and inconclusive. CONCLUSIONS: This review identified significant evidence gaps in racial/ethnic disparities research on sleep. Our results suggest a need for more studies examining diverse sleep features using standardized and robust measuring methods for more valid comparisons of sleep health in diverse race/ethnicity groups.

Sleep time and efficiency in patients undergoing laboratory-based polysomnography.

STUDY OBJECTIVES: Sleep quality in patients studied with laboratory-based polysomnography may differ from sleep quality in patients studied at home but remains clinically relevant and important to describe. We assessed objective sleep quality and explored factors associated with poor sleep in patients undergoing laboratory-based polysomnography. METHODS: We reviewed diagnostic polysomnography studies from a 10-year period at a single sleep center. Total sleep time (TST) and sleep efficiency (SE) were assessed as markers of sleep quality. Poor sleep was defined as TST ≤ 4 hours or SE ≤ 50%. Multivariable analysis was performed to determine associations between objective sleep quality as an outcome and multiple candidate predictors including age, sex, race, body mass index, comorbidities, severity of obstructive sleep apnea, and central nervous system medications. RESULTS: Among 4957 patients (age 53 ± 15 years), average TST and median SE were 5.8 hours and 79%, respectively. There were 556 (11%) and 406 (8%) patients who had poor sleep based on TST and SE, respectively. In multivariable analysis, those who were older (per 10 years: 1.48 [1.34, 1.63]), male (1.38 [1.14,1.68]), and had severe obstructive sleep apnea (1.76 [1.28, 2.43]) were more likely to have short sleep. Antidepressant use was associated with lower odds of short sleep (0.77 [0.59,1.00]). Older age (per 10 years: 1.48 [1.34, 1.62]), male sex (1.34 [1.07,1.68]), and severe obstructive sleep apnea (2.16 [1.47, 3.21]) were associated with higher odds of poor SE. CONCLUSIONS: We describe TST and SE from a single sleep center cohort. Multiple demographic characteristics were associated with poor objective sleep in patients during laboratory-based polysomnography. CITATION: Harrison EI, Roth RH, Lobo JM, et al. Sleep time and efficiency in patients undergoing laboratory-based polysomnography. J Clin Sleep Med. 2021;17(8):1591-1598.

Visit-to-visit blood pressure variability and sleep architecture.

Visit-to-visit blood pressure (BP) variability (BPV) is an independent risk factor of cardiovascular disease (CVD). Sleep architecture characterizes the distribution of different stages of sleep and may be important in CVD development. We examined the association between visit-to-visit BPV and sleep architecture using in-lab polysomnographic data from 3,565 patients referred to an academic sleep center. BPV was calculated using the intra-individual coefficient of variation of BP measures collected 12 months before the sleep study. We conducted multiple linear regression analyses to assess the association of systolic and diastolic BPV with sleep architecture-rapid eye movement (REM) and non-rapid eye movement (NREM) sleep duration. Our results show that systolic BPV was inversely associated with REM sleep duration (p = .058). When patients were divided into tertile groups based on their BPV, those in the third tertile (highest variability) spent 2.7 fewer minutes in REM sleep than those in the first tertile (lowest variability, p = .032), after adjusting for covariates. We did not find an association of systolic BPV with other measures of sleep architecture. Diastolic BPV was not associated with sleep architecture either. In summary, our study showed that greater systolic BPV was associated with lower REM sleep duration. Future investigation is warranted to clarify the directionality, mechanism, and therapeutic implications.

Optimizing Telemedicine Technologic Infrastructure with Animal Models: A Case in Telecystoscopy.

Background: Rapid evolution of telemedicine technology requires procedures in telemedicine to adapt frequently. An example in urology, telecystoscopy, allows certified advanced practice providers to perform cystoscopy, endoscopic examination of the bladder, in rural areas with real-time interpretation and guidance by an off-site urologist. We have previously shown the technological infrastructure for optimized video quality. Introduction: Newer models of cystoscope and coder/decoder (codec) are available with anticipation that components used in our original model will become unavailable. Our objective is to assess the diagnostic ability of two cystoscopes (Storz, Wolf) with old (SX20) and new (DX70) codecs. Materials and Methods: A single urologist performed flexible cystoscopy on an ex vivo porcine bladder. Combinations of cystoscope (Storz vs. Wolf), codec (SX20 vs. DX70), and internet transmission speed were used to create eight distinct recordings. Deidentified videos were reviewed by expert urologist reviewers via electronic survey with questions on video quality and diagnostic ability. A logistic regression model was used to assess the ability to make a diagnosis. Results: Eight transmitted cystoscopy videos were reviewed by 16 urologists. Despite new technology, the Storz cystoscope combined with the SX20 codec (the original combination) provides the best diagnostic capacity. Discussion: Technical infrastructure must be routinely validated to assess the component impact on overall quality because newer is not always better. Should the SX20 become obsolete, ex vivo animal models are safe, inexpensive anatomic models for testing. Conclusions: As technology continues to evolve, procedures in telemedicine must critically scrutinize the impact of new technologic components to uphold quality.

Clinical and Economic Outcomes of Patients Undergoing Guideline-Directed Management of Pancreatic Cysts.

INTRODUCTION: Numerous guidelines exist for the management of pancreatic cysts. We sought to compare the guideline-directed management strategies for pancreatic cysts by comparing 2 approaches (2017 International Consensus Guidelines and 2015 American Gastroenterological Association Guidelines) that differ significantly in their thresholds for imaging, surveillance, and surgery. METHODS: We developed a Monte Carlo model to evaluate the outcomes for a cohort of 10,000 patients managed per each guideline. The primary outcome was mortality related to pancreatic cyst management. Secondary outcomes included all-cause mortality, missed cancers, number of surgeries, number of imaging studies, cumulative cost, and quality-adjusted life years. RESULTS: Deaths because of pancreatic cyst management and quality-adjusted life years were similar in both guidelines at a significantly higher cost of $3.6 million per additional cancer detected in the Consensus Guidelines. Deaths from "unrelated" causes (1,422) vastly outnumbered deaths related to pancreatic cysts (125). Secondary outcomes included more missed cancers in the American Gastroenterological Association guideline (71 vs 49), more surgeries and imaging studies in the Consensus guideline (711 vs 163; 116,997 vs 68,912), and higher cost in the Consensus guideline ($168.3 million vs $89.4 million). As the rate of malignant transformation increases, a more-intensive guideline resulted in fewer deaths related to pancreatic cyst management. DISCUSSION: Our study demonstrates trade-offs between more- and less-intensive management strategies for pancreatic cysts. Although deaths related to pancreatic cyst management were similar in each strategy, fewer missed cancers in the more-intensive surveillance strategy is offset by a greater number of surgical deaths and higher cost. In conclusion, our study identifies that if the rate malignant transformation of pancreatic cysts is low (0.12% annually), a less-intensive guideline will result in similar deaths to a more-intensive guideline at a much lower cost.

Blinded Comparison of Clarity, Proficiency and Diagnostic Capability of Tele-Cystoscopy Compared to Traditional Cystoscopy: A Pilot Study.

PURPOSE: In order to expand the availability of cystoscopy to underserved areas we have proposed using advanced practice providers to perform cystoscopy with real-time interpretation by the urologist on a telemedicine platform, termed "tele-cystoscopy." The purpose of this study is to have blinded external reviewers retrospectively compare multisite, prospectively collected video data from tele-cystoscopy with the video of traditional cystoscopy in terms of video clarity, practitioner proficiency and diagnostic capability. MATERIALS AND METHODS: Each patient underwent tele-cystoscopy by a trained advanced practice provider and traditional cystoscopy with an onsite urologist. Prospectively collected tele-cystoscopy transmitted video, tele-cystoscopy onsite video and traditional cystoscopy video were de-identified and blinded to external reviewers. Each video was evaluated and rated twice by independent reviewers and diagnostic agreement was quantified. RESULTS: Six tele-cystoscopy encounters were reviewed for a total of 36 assessments. Video clarity, defined by speed of transmission and image resolution, was better for onsite compared to transmitted tele-cystoscopy. Practitioner proficiency for thoroughness of inspection was rated at 92% for tele-cystoscopy and 100% for traditional cystoscopy. Confidence in identification of an abnormality was equivalent. Four of 6 videos had 100% agreement between reviewers for next action taken, indicating high diagnostic agreement. Additionally, provider performing cystoscopy and location did not statistically influence the ability to make a diagnosis or action taken. CONCLUSIONS: This model has excellent completeness of examination, equivalent ability to identify abnormalities and external validation of action taken. This pilot study demonstrates that tele-cystoscopy may expand access to bladder cancer surveillance.