Initial Experience and Clinical Assessment of the Karl Storz FLEX-XC1 Single-Use Flexible Ureteroscope.

INTRODUCTION: The Karl Storz FLEX-XC1 is a novel single-use flexible ureteroscope that uses the same videographics platform as its reusable digital counterpart. We evaluated the technical performance of the FLEX-XC1 in its initial clinical use. METHODS: We reviewed a series of consecutive ureteroscopy procedures performed by 2 endourologists using the FLEX-XC1 for indications for which we typically use a single-use device: total stone burden > 15 mm or > 10 mm in the lower pole, anticipated case duration > 60 minutes, bilateral procedure, or upper tract urothelial cancer procedures. We assessed device tip deflection, intraoperative mechanical failure, and clinical outcomes for each case. Surgeons rated visual clarity, image quality, and maneuverability on a 1 to 5 Likert scale. RESULTS: Of 29 procedures using FLEX-XC1, 27 (93%) were successfully completed. Preoperative upward deflection was < 270° in 6 (21%) cases, and downward deflection was < 270° in 9 (31%) cases. Three types of intraoperative malfunctions occurred: rotational twisting of deflectable tip (4 cases, 13%), device not advancing through distal ureter (1 case, 3%), and working channel not accommodating a 365-µm laser (1 case, 3%). Visual clarity, image quality, and maneuverability were rated as 5 "very good" or 4 "good" in 100%, 100%, and 97% of cases, respectively. No device-specific or general 30-day complications were observed. CONCLUSIONS: The FLEX-XC1 showed comparable image quality and maneuverability to reusable digital devices. We observed incomplete deflection in up to 31% of cases and mechanical failure in 2 cases. The FLEX-XC1 may be advantageous in prolonged cases where maintaining visual clarity is paramount.

Supporting Veteran's Administration Medical Center Directors' Decisions When Adopting Innovative Practices: Development and Implementation of the "QuickView" and "WishList" Tools.

Background Since 2015, the Veterans Health Administration (VHA) Diffusion of Excellence Program has supported spread of practices developed by frontline employees. Shark Tank-style competitions encourage "Sharks" nationwide (VHA medical center/regional directors) to bid for the opportunity to implement practices at their institutions. Methods The authors evaluated bidding strategies (2016-2020), developing the "QuickView" practice comparator to promote informed bidding. Program leaders distributed QuickView and revised versions in subsequent competitions. Our team utilized in-person observation, online chats after the competition, bidder interviews, and bid analysis to evaluate QuickView use. Bids were ranked based on demonstrated understanding of resources required for practice implementation. Results Sharks stated that QuickView supported preparation before the competition and suggested improvements. Our revised tool reported necessary staff time and incorporated a "WishList" from practice finalists detailing minimum requirements for successful implementation. Bids from later years reflected increased review of facilities' current states before the competition and increased understanding of the resources needed for implementation. Percentage of bids describing local need for the practice rose from 2016 to 2020: 4.7% (6/127); 62.1% (54/87); 78.3% (36/46); 80.6% (29/36); 89.7% (26/29). Percentage of bids committing specific resources rose following QuickView introduction: 81.1% (103/127) in 2016, 69.0% (60/87) in 2017, then 73.9% (34/46) in 2018, 88.9% (32/36) in 2019, and 89.7% (26/29) in 2020. Discussion In the years following QuickView/WishList implementation, bids reflected increased assessment before the competition of both local needs and available resources. Conclusion Selection of a new practice for implementation requires an understanding of local need, necessary resources, and fit. QuickView and WishList appear to support these determinations.

Participation in a Medicare advanced primary care model and the delivery of high-value services.

OBJECTIVE: To evaluate whether primary care providers' participation in the Comprehensive Primary Care Plus Initiative (CPC+) was associated with changes in their delivery of high-value services. DATA SOURCES: Medicare Physician & Other Practitioners public use files from 2013 to 2019, 2017 to 2019 Medicare Part B claims for a 5% random sample of Medicare Fee-for-Service (FFS) beneficiaries, the Area Health Resources File, the National Plan & Provider Enumeration System files, and public use datasets from the Centers for Medicare & Medicaid Services Physician Compare. STUDY DESIGN: We used a difference-in-difference approach with a propensity score-matched comparison group to estimate the association of CPC+ participation with the delivery of annual wellness visits (AWVs), advance care planning (ACP), flu shots, counseling to prevent tobacco use, and depression screening. These services are prominent examples of high-value services, providing benefits to patients at a reasonable cost. We examined both the likelihood of delivering these services within a year and the count of services delivered per 1000 Medicare FFS beneficiaries per year. DATA COLLECTION/EXTRACTION METHODS: Secondary data are linked at the provider level. PRINCIPAL FINDINGS: We find that CPC+ participation was associated with increases in the likelihood of delivering AWVs (13.03 percentage points by CPC+'s third year, p < 0.001) and the number of AWVs per 1000 Medicare FFS beneficiaries (44 more AWVs by CPC+'s third year, p < 0.001). We also find that CPC+ participation was associated with more flu shots per 1000 beneficiaries (52 more shots by CPC+'s third year, p < 0.001) but not with the likelihood of delivering flu shots. We did not find consistent evidence for the association between CPC+ participation and ACP services, counseling to prevent tobacco use, or depression screening. CONCLUSIONS: CPC+ participation was associated with increases in the delivery of AWVs and flu shots, but not other high-value services.

Public spending on acute and long-term care for Alzheimer's disease and related dementias.

INTRODUCTION: We estimate the spending attributable to Alzheimer's disease and related dementias (ADRD) to the United States government for the first 5 years post-diagnosis. METHODS: Using data from the Health and Retirement Study matched to Medicare and Medicaid claims, we identify a retrospective cohort of adults with a claims-based ADRD diagnosis along with matched controls. RESULTS: The costs attributable to ADRD are $15,632 for traditional Medicare and $8833 for Medicaid per dementia case over the first 5 years after diagnosis. Seventy percent of Medicare costs occur in the first 2 years; Medicaid costs are concentrated among the longer-lived beneficiaries who are more likely to need long-term care and become Medicaid eligible. DISCUSSION: Because the distribution of the incremental costs varies over time and between insurance programs, when interventions occur and the effect on the disease course will have implications for how much and which program reaps the benefits.

Pharmacologic restraint use for children experiencing mental health crises in pediatric hospitals.

BACKGROUND: Children in mental health crises are increasingly admitted to children's hospitals awaiting inpatient psychiatric placement. During hospitalization, patients may exhibit acute agitation prompting pharmacologic restraint use. OBJECTIVE: To determine hospital-level incidence and variation of pharmacologic restraint use among children admitted for mental health conditions in children's hospitals. DESIGN, SETTING, AND PARTICIPANTS: We examined data for children (5 to ≤18 years) admitted to children's hospitals with a primary mental health condition from 2018 to 2020 using the Pediatric Health Information System database. Hospital rates of parenteral pharmacologic restraint use per 1000 mental health bed days were determined and compared after adjusting for patient-level and demographic factors. Cluster analysis (k-means) was used to group hospitals based on overall restraint use (rate quartiles) and drug class. Hospital-level factors for pharmacologic restraint use were compared. RESULTS: Of 29,834 included encounters, 3747 (12.6%) had pharmacologic restraint use. Adjusted hospital rates ranged from 35 to 389 pharmacologic restraint use days per 1000 mental health bed days with a mean of 175 (standard deviation: 72). Cluster analysis revealed three hospitals were high utilizers of all drug classes. No significant differences in pharmacologic restraint use were found in the hospital-level analysis. CONCLUSIONS: Children's hospitals demonstrate wide variation in pharmacologic restraint rates for mental health hospitalizations, with a 10-fold difference in adjusted rates between highest and lowest utilizers, and high overall utilizers order medications across all drug classes.

Out-of-pocket costs attributable to dementia: A longitudinal analysis.

BACKGROUND: Alzheimer's disease and related dementias (ADRD) affect 5.7 million Americans, and are expensive despite the lack of a cure or even treatments effective in managing the disease. The literature thus far has tended to focus on the costs to Medicare, even though one of the main characteristics of ADRD (the loss of independence and ability to care for oneself) incurs costs not covered by Medicare. METHODS: In this paper, we use survey data for 2002-2016 from the Health and Retirement Study to estimate the out-of-pocket costs of ADRD for the patient and their family through the first 8 years after the onset of symptoms, as defined by a standardized 27-point scale of cognitive ability. A two-part model developed by Basu and Manning (2010) allows us to separate the costs attributable to ADRD into two components, one driven by differences in longevity and one driven by differences in utilization. RESULTS: We identified a cohort of 3619 incident dementia cases, 38.9% were male, and 66.9% were non-Hispanic White. Dementia onset was 77.7 years of age, on average. OOP costs attributable to dementia are $8751 over the first 8 years after the onset. These incremental costs are driven by nursing home expenditures, which are largely uninsured in the US. OOP spending is highest for whites and women. CONCLUSION: The financial burden of ADRD is significant, and largely attributable to the lack of wide-spread long-term care insurance.

Effects of Medicare advantage on patterns of end-of-life care among Medicare decedents.

OBJECTIVE: To examine the effects of Medicare Advantage (MA) enrollment on patterns of end-of-life care. DATA SOURCES: We used data from the Master Beneficiary Summary File, the Medicare Provider Analysis and Review, hospice claims, the Minimum Data Set, the Outcome and Assessment Information Set, the Area Health Resources File, and Geographic Variation Public Use File for 2012-2014. STUDY DESIGN: To address selective enrollment into MA, we exploited a discontinuity in payment rates by county population (urban floor payments) as an instrument. DATA COLLECTION/EXTRACTION METHODS: We identified Medicare beneficiaries continuously enrolled in MA or TM during their last year of life between 2012 and 2014 using Medicare administrative data. PRINCIPAL FINDINGS: We did not find evidence that MA enrollment led to a change in hospital admissions in the last 30 days of life, but MA enrollment decreased hospital as the site of death by 11.0 (95% CI: -13.9 to -8.1) percentage points. Once hospitalized, however, MA enrollment increased use of intensive care by 6.7 (95% CI: 0.3 to 13.1) percentage points and non-invasive mechanical ventilation by 9.2 (95% CI: 5.5 to 12.9) percentage points. MA enrollment increased hospice use by 6.2 (95% CI: 2.3 to 10.1) percentage points at time of death and 7.7 (95% CI: 3.8 to 11.6) percentage points in the last 30 days of life. Particularly, MA enrollment increased hospice admissions among those who were admitted to the hospital within 30 days prior to hospice admission by 18.8 (95% CI: 13.8 to 23.8) percentage points. However, MA enrollment decreased hospice admissions among those who were admitted to home health within 30 days prior to hospice admission by 18.6 (95% CI: -21.9 to -15.2) percentage points. CONCLUSIONS: MA plans may improve end-of-life care by reducing hospital death while also improving access to hospice, especially among recently hospitalized persons.

Observational study of patient characteristics associated with a timely diagnosis of dementia and mild cognitive impairment without dementia.

BACKGROUND: Timely diagnosis of cognitive impairment is a key goal of the National Plan to Address Alzheimer's Disease, but studies of factors associated with a timely diagnosis are limited. OBJECTIVE: To identify patient characteristics associated with a timely diagnosis of dementia and mild cognitive impairment (MCI). DESIGN: Retrospective observational study using survey data from the Health and Retirement Study (HRS) from 1995-2016 (interview waves 3-13). PARTICIPANTS: 4,760 respondents with incident dementia and 1,864 with incident MCI identified using longitudinal measures of cognitive functioning. MAIN MEASURES: Timely or delayed diagnosis based on the timing of a self or proxy report of a healthcare provider diagnosis in relation to respondents first dementia or MCI-qualifying cognitive score, sociodemographic characteristics, health status, health care utilization, insurance provider, and year of first qualifying score. KEY RESULTS: Only 26.0% of the 4,760 respondents with incident dementia and 11.4% of the 1,864 respondents with incident MCI received a timely diagnosis. Non-Hispanic Black respondents and respondents with less than a college degree were significantly less likely to receive a timely diagnosis of either dementia or MCI than Non-Hispanic White respondents (dementia odds ratio (OR): 0.61, 95% CI: 0.50, 0.75; MCI OR: 0.40, 95% CI: 0.23, 0.70) and those with a college degree (dementia OR for less than high school degree: 0.30, 95% CI: 0.23, 0.38; MCI OR: 0.36, 95% CI: 0.22, 0.60). Respondents that lived alone were also less likely to receive a timely diagnosis of dementia (OR: 0.69, 95% CI: 0.59, 0.81), though not MCI. Timely diagnosis of both conditions increased over time. CONCLUSIONS: Targeting resources for timely diagnosis of cognitive impairment to individuals from racial and ethnic minorities, lower educational attainment, and living alone may improve detection and reduce disparities around timely diagnosis of dementia and MCI.

The Veterans Health Administration (VHA) Innovators Network: Evaluation design, methods and lessons learned through an embedded research approach.

BACKGROUND: Collaboration between researchers, implementers and policymakers improves uptake of health systems research. In 2018, researchers and VHA Innovators Network (iNET) leadership used an embedded research model to conduct an evaluation of iNET. We describe our evaluation design, early results, and lessons learned. METHODS: This mixed-methods evaluation incorporated primary data collection via electronic survey, descriptive analysis using existing VA datasets (examining associations between facility characteristics and iNET participation), and qualitative interviews to support real-time program implementation and to probe perceived impacts, benefits and challenges of participation. RESULTS: We developed reporting tools and collected data regarding site participation, providing iNET leadership rapid access to needed information on projects (e.g., target populations reached, milestones achieved, and barriers encountered). Secondary data analyses indicated iNET membership was greater among larger, more complex VA facilities. Of the 37 iNET member sites, over half (n = 22) did not have any of the six major types of VA research centers; thus iNET is supporting VA sites not traditionally served by research innovation pathways. Qualitative findings highlighted enhanced engagement and perceived value of social and informational networks. CONCLUSIONS: Working alongside our iNET partners, we supported and influenced iNET's development through our embedded evaluation's preliminary findings. We also provided training and guidance aimed at building capacity among iNET participants. IMPLICATIONS: Embedded research can yield successful collaborative efforts between researchers and partners. An embedded research team can help programs pivot to ensure effective use of limited resources. Such models inform program development and expansion, supporting strategic planning and demonstrating value.

Merging Implementation Practice and Science to Scale Up Promising Practices: The Veterans Health Administration (VHA) Diffusion of Excellence (DoE) Program.

INTRODUCTION: The Veterans Health Administration (VHA) Diffusion of Excellence (DoE) program developed and manages a framework for identification, replication, and diffusion of promising practices throughout the nation's largest integrated health care system. DoE identifies promising practices through a "Shark Tank" competition with winning bidders receiving external implementation facilitation. DoE further supports diffusion of successful practices across the VHA. METHODS: This article presents results of a mixed methods implementation evaluation of DoE, focusing on program reach, program participation and decisions to adopt innovative practices, implementation processes, and practice sustainment. Data sources include practice adoption metrics, focus groups with bidders (two focus groups), observations of DoE events (seven events), surveys of stakeholders (five separate surveys), and semistructured interviews of facility directors, practice developers, implementation teams, and facilitators (133 participants). RESULTS: In the first four Shark Tank cohorts (2016-2018), 1,676 practices were submitted; 47 were designated Gold Status Practices (practices with facilitated implementation). Motivation for participation varied. Generally, staff led projects targeting problems they felt passionate about, facility directors focused on big-picture quality metrics and getting middle manager support, and frontline staff displayed variable motivation to implement new projects. Approximately half of facilitated implementation efforts were successful; barriers included insufficient infrastructure, staff, and resources. At the facility level, 73.3% of facilities originating or receiving facilitated implementation support have maintained the practice. VHA-wide, 834 decisions to adopt these practices were made. CONCLUSION: DoE has resulted in the identification of many candidate practices, promoted adoption of promising practices by facility directors, and supported practice implementation and diffusion across the VHA.

Comparing and Contrasting Peyronie's Disease Guidelines: Points of Consensus and Deviation.

BACKGROUND: Peyronie's disease (PD) is a challenging clinical entity. To assist clinicians with diagnosis and management, four separate organizations have published PD guidelines over the past five years, but there remains a lack of consensus and data-driven recommendations for many aspects of diagnosis and treatment. AIM: To compare and contrast PD guidelines, highlighting key similarities and differences among the guideline panel recommendations and identify areas for further research. METHODS: We performed an extensive review to compare and contrast diagnosis and treatment recommendations from publically available published PD guidelines from four different organizations: American Urological Association, European Association of Urology, Canadian Urologic Association, and the International Society of Sexual Medicine. OUTCOMES: Key similarities and differences with regards to definition, evaluation, nonsurgical and surgical treatments were compared. RESULTS: Points of general consensus among the guideline panels included: History is adequate for diagnosis of PD, and intracavernosal injection is a gold standard to evaluate penile deformity prior to invasive intervention. Careful counseling with shared decision-making is required prior to treatment. In general, plication and incision and/or grafting surgery is reserved for patients with preserved erectile function whereas penile prosthesis implantation is the only surgical option for PD patients with erectile dysfunction. Overall, nonsurgical treatments have inferior evidence of efficacy with these being the main area of controversy; however, all societies recognize that intralesional injections may be used. 0Further research into the pathophysiology of PD may direct novel treatments targeted towards early intervention and rigorous outcomes research may direct best practices for the surgical treatment of PD in the future. CLINICAL IMPLICATIONS: PD is a challenging clinical entity. Direct comparison of the published PD guidelines highlights clear standards of care as well as areas where more research is needed to promote higher levels of evidence-based practice. STRENGTHS & LIMITATIONS: To our knowledge this is the first report to directly compare and contrast published guidelines pertaining to the diagnosis and management of PD. Limitations include the lack of evidence-quality review pertaining to individual guideline recommendations, although this was not the aim of this review. CONCLUSION: We highlight consensus of major urologic societies on many aspects of work up and management of PD with notable exceptions which may guide further research. Manka MG, White LA, Yafi FA, et al. Comparing and Contrasting Peyronie's Disease Guidelines: Points of Consensus and Deviation. J Sex Med 2021;18:363-375.

A modern review of penile traction monotherapy and combination therapy for the treatment of peyronie's disease.

Peyronie's disease (PD)-related penile deformity is managed with multiple treatment modalities including oral medications, intralesional injections, and surgery. Penile traction therapy (PTT) is one such modality with purported benefits, albeit with notable differences in the characteristics of available traction devices and published study protocols. We provide a comprehensive review of the available data supporting PTT for PD treatment. We performed a rigorous database search to identify all studies pertaining to PTT for the treatment of PD through November 2019. Seventeen trials explored use of PTT as monotherapy or in combination with surgical or nonsurgical treatment, using over five different commercially available devices. All devices were well tolerated, although compliance and daily duration of use were highly variable. PTT resulted in variable improvements in stretched penile length and penile curvature, depending on study protocol, patient population, and device. PTT appears to be a safe and well-tolerated treatment for PD as monotherapy or in combination with other nonsurgical and surgical treatments, and for men in both the acute and chronic phases. Further studies are needed to compare available devices, evaluate device characteristics associated with treatment success, differentiate outcomes in acute vs. chronic PD populations, and determine the optimal duration of use.

Difficulty with Taking Medications Is Associated with Future Diagnosis of Alzheimer's Disease and Related Dementias.

BACKGROUND: Medication management requires complex cognitive functioning, and therefore, difficulty taking medications might be an early sign of cognitive impairment and could be a risk factor for Alzheimer's disease and related dementias (ADRD). Accordingly, people with difficulty taking medications may benefit from more detailed cognitive screening, potentially aiding in the diagnosis of ADRD, which is underdiagnosed. We are unaware of evidence on medication management difficulties that precede a real-world ADRD diagnosis in the USA. OBJECTIVE: Examine the association between difficulty taking medications and subsequent real-world ADRD diagnoses. DESIGN: Case-control study, using Health and Retirement Study (HRS) survey data linked to Medicare claims. PARTICIPANTS: A total of 1461 HRS respondents with an ADRD diagnosis observed from 1993 to 2012 (cases), matched by year of birth, wave of HRS entry, and sex to 3771 controls with no ADRD diagnosis. MAIN MEASURES: We examined the association between diagnosis of ADRD and self-reported difficulty taking medications in the preceding years (1-2 and 3-4 years prior to case definition). Control individuals were assigned the index date from their matched case. Conditional logistic regressions adjusted for age, sex, race, education, and comorbidities. KEY RESULTS: Compared with matched controls, cases had higher prevalence of difficulty taking medications 1-2 years prior to diagnosis (11.0% versus 2.3%), and 3-4 years prior to diagnosis (5.8% versus 2.3%). Adjusted analyses showed that compared with individuals without ADRD, those with an ADRD diagnosis had more than four times higher odds of difficulty taking medications 1-2 years prior (OR = 4.56 (CI 3.30-6.31)), and more than two times higher odds of difficulty taking medications 3-4 years prior (OR = 2.41 (CI 1.61-3.59)). CONCLUSIONS: Odds of medication difficulty 1-2 years prior were more than four times greater for individuals with ADRD diagnoses compared with those without ADRD. Medication management difficulties may prompt further cognitive screening, potentially aiding in earlier recognition of ADRD.

Intraureteral indocyanine green augments ureteral identification and avoidance during complex robotic-assisted colorectal surgery.

AIM: Up to 10% of patients who undergo nonurological abdominopelvic operations suffer a ureteral injury. While preoperative ureteral stenting to facilitate identification of the ureter is common, it does not reduce the incidence of intraoperative ureteral injury and is not without risk. As we continue to broaden the application of minimally invasive surgical techniques, a new form of ureteral identification and avoidance that does not rely on tactile feedback is needed. We report our initial experience with intraureteral indocyanine green (ICG) for ureteral identification and avoidance during complex robotic-assisted colorectal surgery. METHOD: Patients undergoing adjunctive ureteral identification during robotic-assisted colorectal surgery were prospectively identified. Each patient underwent intraureteral ICG administration using rigid cystoscopy (22 Fr). A 5-Fr open-ended ureteral catheter was inserted up to 20 cm and used to inject 5 ml of 2.5 mg/ml ICG as the catheter was withdrawn to the ureteral orifice. Intraureteral ICG was then detected using near-infrared laser fluorescence technology (Firefly®). RESULTS: Successful ICG-enhanced ureteral identification and avoidance was performed in 15 of 16 (94%) patients undergoing robotic-assisted colorectal surgery. The median ICG instillation time was 11.5 min (range 4-21 min) and the median operative time with ICG visualization was 489 min (8 h 9 min) [range 268-738 min (4 h 28 min-12 h 18 min)]. No patient experienced intraoperative ureteral injury and there were no adverse sequelae or complications associated with intraureteral ICG administration. CONCLUSION: Intraureteral ICG is a safe and effective method of intraoperative ureteral identification and avoidance during complex robotic-assisted colorectal surgery. Precise and prolonged ureteral visualization was achieved, allowing for long operative times compatible with complex robotic-assisted operations.

Differences in Health Care Utilization, Process of Diabetes Care, Care Satisfaction, and Health Status in Patients With Diabetes in Medicare Advantage Versus Traditional Medicare.

OBJECTIVE: The objective of this study was to determine differences in health care utilization, process of diabetes care, care satisfaction, and health status for Medicare Advantage (MA) and traditional Medicare (TM) beneficiaries with and without diabetes. METHODS: Using the 2010-2016 Medicare Current Beneficiary Survey, we identified MA and TM beneficiaries with and without diabetes. To address the endogenous plan choice between MA and TM, we used an instrumental variable approach. Using marginal effects, we estimated differences in the outcomes between MA and TM beneficiaries with and without diabetes. RESULTS: Our instrumental variable analysis showed that compared with TM beneficiaries with diabetes, MA beneficiaries with diabetes had less annual health care utilization, including -22.4 medical provider visits [95% confidence interval (CI): -23.6 to -21.1] and -3.4 outpatient hospital visits (95% CI: -3.8 to -3.0). A significant difference between MA and TM beneficiaries without diabetes was only observed in medical provider visits and the difference was greater among beneficiaries with diabetes than beneficiaries without diabetes (-12.5 medical provider visits; 95% CI: -15.9 to -9.2). While we did not detect significant differences in 5 measures of the process of diabetes care between MA and TM beneficiaries with diabetes, there were inconsistent results in the other 3 measures. There were no or marginal differences in care satisfaction and health status between MA and TM beneficiaries with and without diabetes. CONCLUSIONS: MA enrollment was associated with lower health care utilization without compromising care satisfaction and health status, particularly for beneficiaries with diabetes. MA may have a more efficient care delivery system for beneficiaries with diabetes.