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.

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.

Association of obesity with arterial stiffness: The Multi-Ethnic Study of Atherosclerosis (MESA).

Arterial stiffness (AS) and obesity are recognized as important risk factors of cardiovascular disease (CVD). The purpose of this study was to investigate the relationship between AS and obesity. AS was defined as high augmentation index (AIx) and low elasticity (C1, large artery elasticity; C2, small artery elasticity) in participants enrolled in the Multi-Ethnic Study of Atherosclerosis at baseline. We compared AIx, C1, and C2 by body mass index (BMI) (< 25, 25-29.9, 30-39.9, ⩾ 40 kg/m2) and waist-hip ratio (WHR) (< 0.85, 0.85-0.99, ⩾ 1). The obesity-AS association was tested across 10-year age intervals. Among 6177 participants (62 ± 10 years old, 52% female), a significant inverse relationship was observed between obesity and AS. After adjustments for CVD risk factors, participants with a BMI > 40 kg/m2 had 5.4% lower AIx (mean difference [Δ] = -0.82%; 95% CI: -1.10, -0.53), 15.4% higher C1 (Δ = 1.66 mL/mmHg ×10; 95% CI: 1.00, 2.33), and 40.2% higher C2 (Δ = 1.49 mL/mmHg ×100; 95% CI: 1.15, 1.83) compared to those with a BMI < 25 kg/m2 (all p for trend < 0.001). Participants with a WHR ⩾ 1 had 5.6% higher C1 (∆ = 0.92 mL/mmHg ×10; 95% CI: 0.47, 1.37) compared to those with a WHR < 0.85. The WHR had a significant interaction with age on AIx and C2, but not with BMI; the inverse relationships of the WHR with AIx and C2 were observed only in participants < 55 years between the normal (WHR < 0.85) and the overweight (0.85 ⩽ WHR < 0.99) groups. Different associations of WHR and BMI with arterial stiffness among older adults should be further investigated.

Probabilistic sensitivity analysis on Markov models with uncertain transition probabilities: an application in evaluating treatment decisions for type 2 diabetes.

Markov models are commonly used for decision-making studies in many application domains; however, there are no widely adopted methods for performing sensitivity analysis on such models with uncertain transition probability matrices (TPMs). This article describes two simulation-based approaches for conducting probabilistic sensitivity analysis on a given discrete-time, finite-horizon, finite-state Markov model using TPMs that are sampled over a specified uncertainty set according to a relevant probability distribution. The first approach assumes no prior knowledge of the probability distribution, and each row of a TPM is independently sampled from the uniform distribution on the row's uncertainty set. The second approach involves random sampling from the (truncated) multivariate normal distribution of the TPM's maximum likelihood estimators for its rows subject to the condition that each row has nonnegative elements and sums to one. The two sampling methods are easily implemented and have reasonable computation times. A case study illustrates the application of these methods to a medical decision-making problem involving the evaluation of treatment guidelines for glycemic control of patients with type 2 diabetes, where natural variation in a patient's glycated hemoglobin (HbA1c) is modeled as a Markov chain, and the associated TPMs are subject to uncertainty.

Providing guidance for genomics-based cancer treatment decisions: insights from stakeholder engagement for post-prostatectomy radiation therapy.

BACKGROUND: Despite the emergence of genomics-based risk prediction tools in oncology, there is not yet an established framework for communication of test results to cancer patients to support shared decision-making. We report findings from a stakeholder engagement program that aimed to develop a framework for using Markov models with individualized model inputs, including genomics-based estimates of cancer recurrence probability, to generate personalized decision aids for prostate cancer patients faced with radiation therapy treatment decisions after prostatectomy. METHODS: We engaged a total of 22 stakeholders, including: prostate cancer patients, urological surgeons, radiation oncologists, genomic testing industry representatives, and biomedical informatics faculty. Slides were at each meeting to provide background information regarding the analytical framework. Participants were invited to provide feedback during the meeting, including revising the overall project aims. Stakeholder meeting content was reviewed and summarized by stakeholder group and by theme. RESULTS: The majority of stakeholder suggestions focused on aspects of decision aid design and formatting. Stakeholders were enthusiastic about the potential value of using decision analysis modeling with personalized model inputs for cancer recurrence risk, as well as competing risks from age and comorbidities, to generate a patient-centered tool to assist decision-making. Stakeholders did not view privacy considerations as a major barrier to the proposed decision aid program. A common theme was that decision aids should be portable across multiple platforms (electronic and paper), should allow for interaction by the user to adjust model inputs iteratively, and available to patients both before and during consult appointments. Emphasis was placed on the challenge of explaining the model's composite result of quality-adjusted life years. CONCLUSIONS: A range of stakeholders provided valuable insights regarding the design of a personalized decision aid program, based upon Markov modeling with individualized model inputs, to provide a patient-centered framework to support for genomic-based treatment decisions for cancer patients. The guidance provided by our stakeholders may be broadly applicable to the communication of genomic test results to patients in a patient-centered fashion that supports effective shared decision-making that represents a spectrum of personal factors such as age, medical comorbidities, and individual priorities and values.

Comparison of Renal Cell Carcinoma Surveillance Guidelines: Competing Trade-Offs.

PURPOSE: We estimated the differences in intensity, cost, radiation exposure and cancer control of published surveillance guidelines screening for secondary renal cell carcinoma in patients treated with partial nephrectomy. MATERIALS AND METHODS: We developed a Monte Carlo simulation model to contrast the existing guidelines in terms of cost, radiation exposure and cancer control. Model inputs were extrapolated from the existing literature. Surveillance guidelines were analyzed from the AUA, CUA, EAU and NCCN®. Risk stratification among patients treated with partial nephrectomy was based on tumor characteristics. RESULTS: Expected costs during the 5 years after partial nephrectomy were $587 (CUA), $1,076 (AUA), $1,705 (EAU) and $1,768 (NCCN) for low risk patients, and $903 (CUA), $2,525 (EAU) and $3,904 (AUA and NCCN) for high risk patients. Radiation exposure ranged from 31.41 mSv (CUA) to 104.34 mSv (NCCN) for low risk patients and 46.88 mSv (CUA) to 231.61 mSv (AUA and NCCN) for high risk patients. The EAU and CUA guidelines led to the diagnosis of the highest percentage of low risk patients (more than 95%) while all guidelines diagnosed more than 92% of high risk patients with recurrence. CONCLUSIONS: Renal cell carcinoma surveillance guidelines differ greatly in terms of intensity, cost and radiation exposure. It is important for clinicians to adopt standardized surveillance strategies that limit unnecessary cost and radiation exposure without compromising cancer control.

Patient Satisfaction with a Novel Tele-Cystoscopy Model: Expanding Access to Bladder Cancer Surveillance for Rural Patients.

Background: Tele-cystoscopy involves trained advanced practice providers performing cystoscopy with real-time interpretation by an urologist. The goal of this externally validated care model is to expand the availability of cystoscopy to underserved rural areas. Herein we report on population demographics and describe the socioeconomic benefits of tele-cystoscopy for bladder cancer surveillance. Methods: Using an IRB-approved protocol, patients were consented for dual, sequential cystoscopy wherein they experienced a standard-of-care cystoscopy along with tele-cystoscopy. Patients completed a questionnaire that contained both subjective and objective health and socioeconomic-related questions as well as a satisfaction survey. Patients were also probed about factors associated with transportation to their cystoscopy appointments including gasoline costs, travel time, and time off work. Using the Distressed Community Index, patients were ascribed an economic resource category ranging from prosperous to distressed. Results: In total, 48 patients with a mean age of 55 completed surveys after completing dual cystoscopies. Thirteen patients (27%) were uninsured and 10 patients (20%) had Medicaid as primary insurance. The tele-cystoscopy clinic saved patients an average of 235 miles and 434 min of travel time. In total, 82% of patients resided in a distressed community indicating fewer economic resources. Satisfaction results showed a mean score of 31.38 (out of 32). Conclusions: Patients were satisfied with tele-cystoscopy, noting increased access to health care and fewer disruptions impacting bladder cancer surveillance. Tele-cystoscopy may be a viable option to expand access and improve adherence to guidelines for bladder cancer surveillance, particularly benefiting patients in rural areas and those of lower socioeconomic status.

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.

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 (RMB) 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 RMB 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 RMB 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 RMB ($1629 vs $1966). Sensitivity analysis found that the nondiagnostic rate of RMB 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. CONCLUSION: The clear cell likelihood score is a more cost-effective option than RMB alone for evaluating small renal masses for clear cell renal carcinoma.

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.

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.

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.

Regional and racial disparities in major amputation rates among medicare beneficiaries with diabetes: a retrospective study in the southeastern USA.

Objective: While rates for non-traumatic lower extremity amputations (LEA) have been declining, concerns exist over disparities. Our objectives are to track major LEA (MLEA) rates over time among Medicare beneficiaries residing in a high diabetes prevalence region in the southeastern USA (the diabetes belt) and surrounding areas. Methods: We used Medicare claims files for ~900 000 fee-for-service beneficiaries aged ≥65 years in 2006-2015 to track MLEA rates per 1000 patients with diabetes. We additionally conducted a cross-sectional analysis of data for 2015 to compare regional and racial disparities in major amputation risks after adjusting for demographic, socioeconomic, access-to-care and foot complications and other health factors. The Centers for Disease Control and Prevention defined the diabetes belt as 644 counties across Appalachian and southeastern US counties with high prevalence. Results: MLEA rates were 3.9 per 1000 in the Belt compared with 2.8 in the surrounding counties in 2006 and decreased to 2.3 and 1.6 in 2015. Non-Hispanic black patients had 8.5 and 6.9 MLEAs per 1000 in 2006 and 4.8 and 3.5 in 2015 in the Belt and surrounding counties, respectively, while the rates were similar for non-Hispanic white patients in the two areas. Although amputation rates declined rapidly in both areas, non-Hispanic black patients in the Belt consistently had >3 times higher rates than non-Hispanic whites in the Belt. After adjusting for patient demographics, foot complications and healthcare access, non-Hispanic blacks in the Belt had about twice higher odds of MLEAs compared with non-Hispanic whites in the surrounding areas. Discussion: Our data show persistent disparities in major amputation rates between the diabetes belt and surrounding counties. Racial disparities were much larger in the Belt. Targeted policies to prevent MLEAs among non-Hispanic black patients are needed to reduce persistent disparities in the Belt.

Associations between specialty care and improved outcomes among patients with diabetic foot ulcers.

OBJECTIVE: Specialty care may improve diabetic foot ulcer outcomes. Medically underserved populations receive less specialty care. We aimed to determine the association between specialty care and ulcer progression, major amputation, or death. If a beneficial association is found, increasing access to specialty care might help advance health equity. RESEARCH DESIGN AND METHODS: We retrospectively analyzed a cohort of Wisconsin and Illinois Medicare patients with diabetic foot ulcers (n = 55,409), stratified by ulcer severity (i.e., early stage, osteomyelitis, or gangrene). Within each stratum, we constructed Kaplan-Meier curves for event-free survival, defining events as: ulcer progression, major amputation, or death. Patients were grouped based on whether they received specialty care from at least one of six disciplines: endocrinology, infectious disease, orthopedic surgery, plastic surgery, podiatry, and vascular surgery. Multivariate Cox proportional hazard models estimated the association between specialty care and event-free survival, adjusting for sociodemographic factors and comorbidities, and stratifying on ulcer severity. RESULTS: Patients who received specialty care had longer event-free survival compared to those who did not (log-rank p<0.001 for all ulcer severity strata). After adjusting, receipt of specialty care, compared to never, remained associated with improved outcomes for all ulcer severities (early stage adjusted hazard ratio 0.34, 95% CI 0.33-0.35, p<0.001; osteomyelitis aHR 0.22, 95% CI 0.20-0.23, p<0.001; gangrene aHR 0.22, 95% CI 0.20-0.24, p<0.001). CONCLUSIONS: Specialty care was associated with longer event-free survivals for patients with diabetic foot ulcers. Increased, equitable access to specialty care might improve diabetic foot ulcer outcomes and disparities.

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.

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.