Diabetes type 1: Can it be treated as an autoimmune disorder?

Type 1 Diabetes Mellitus (T1DM) is characterized by progressive autoimmune-mediated destruction of the pancreatic beta-cells leading to insulin deficiency and hyperglycemia. It is associated with significant treatment burden and necessitates life-long insulin therapy. The role of immunotherapy in the prevention and management of T1DM is an evolving area of interest which has the potential to alter the natural history of this disease.In this review, we give insight into recent clinical trials related to the use of immunotherapeutic approaches for T1DM, such as proinflammatory cytokine inhibition, cell-depletion and cell-therapy approaches, autoantigen-specific treatments and stem cell therapies. We highlight the timing of intervention, aspects of therapy including adverse effects and the emergence of a novel lymphocyte crucial in T1DM autoimmunity. We also discuss the role of cardiac autoimmunity and its link to excess CVD risk in T1DM.We conclude that significant advances have been made in development of immunotherapeutic targets and agents for the treatment and prevention of T1DM. These immune-based therapies promise preservation of beta-cells and decreasing insulin dependency. In their current state, immunotherapeutic approaches cannot yet halt the progression from a preclinical state to overt T1DM nor can they replace standard insulin therapy in existing T1DM. It remains to be seen whether immunotherapy will ultimately play a key role in the prevention of progression to overt T1DM and whether it may find a place in our therapeutic armamentarium to improve clinical outcomes and quality of life in established T1DM.

Patient safety education and perceptions of safety culture in American and Canadian urological residency training programs.

INTRODUCTION To assess the perception of patient safety culture and the infrastructure to support patient safety (PS) education within American and Canadian urological residency programs. MATERIALS AND METHODS: A needs assessment was developed by experts in patient safety. The survey contained items about prior PS education, perceived value of learning PS, components of an ideal PS curriculum, and desired resources to facilitate PS education. Select items from the validated AHRQ Survey on Patient Safety Culture (SOPS) were also included. The survey was distributed electronically (12/2018-2/2019) to all urology residents (RES) and program directors (PD) of urological residency programs via the Society of Academic Urologists. All responses were anonymous. RESULTS: A total of 26 PD (18.3%; 26/142) and 100 RES (6.7%; 100/1,491) completed the survey. Nearly all RES received PS training (79%), but this was lower for PD (42%). The majority of RES and PD felt that PS was an important educational competency (RES = 83%; PD = 89%) and a pathway for academic success (RES 74%; PD 84%). Both groups desired an online PS curriculum (RES = 69%; PD = 68%) with error causation models (RES = 42%; PD = 52%) as the primary topic to cover. Assessment of safety culture confirmed safety is a priority, but only 1 PD (5%; 1/19) and 25 RES (25%; 25/100) rated their residency program's overall safety grade as 'excellent'. CONCLUSIONS: PS education remains a priority for program directors and urological trainees. Both groups called for additional resources from urological professional societies for this education. To that end, an online, centralized, freely accessible PS curriculum is under development.

Implementing a patient safety culture survey to identify and target process improvements in academic ambulatory urology practices: a multi-institutional collaborative.

INTRODUCTION: A shared professional culture focused on patient safety is critical to delivering high-quality care. There is a need for objective metrics to help identify target areas for improvement in patient safety culture. The Medical Office Survey on Patient Safety Culture (SOPS) was developed and validated by the United States Agency for Healthcare Research and Quality to measure patient safety culture in the ambulatory setting. In this study we report on safety culture and practices in six academic urology clinics utilizing this validated questionnaire. MATERIALS AND METHODS: The SOPS was administered to all staff in ambulatory urology practices affiliated with participating centers. Percent positive responses were calculated for each of 10 validated composite domains and were compared between sites and respondent roles. Nonparametric statistical analyses were performed to identify differences between groups. RESULTS: The survey was administered to 185 staff members, with an overall response rate of 66%. Within each domain there was substantial variability between sites, with significant differences observed in staff training (p = 0.034), office processes/standardization (p = 0.008), patient care tracking (p = 0.047), communication about errors (p = 0.001), and organizational learning (p = 0.015). Similar variation was seen between respondent roles with significant differences for patient care tracking (p = 0.002) and communication about errors (p = 0.014). CONCLUSIONS: The SOPS is a clinically useful tool to identify issues impacting a practice's safety culture. Substantial variability was observed within each composite domain at the levels of practice site and respondent role. Comparing composite domain results between clinics will allow leadership to identify gaps and evaluate policies and resources of higher performing peer sites.

The safety and efficacy of transurethral microwave therapy in high-risk catheter-dependent men.

OBJECTIVE: Previous studies have demonstrated the efficacy of transurethral microwave therapy (TUMT) in the management of high-risk catheter-dependent men, although few have assessed safety in high-risk patients, including those continuing anticoagulation therapy during treatment. Our goal was to assess the safety and effectiveness of TUMT in a population of high-risk catheter-dependent men. MATERIAL AND METHODS: A retrospective analysis of patients who underwent TUMT at a single Veterans Affairs facility for the treatment of benign prostatic hyperplasia was completed. The primary outcome was 30-day postprocedural complications by Clavien-Dindo grade, including bleeding events. The secondary outcome was success in catheter removal. RESULTS: We performed TUMT in 157 men, 105 of whom had urinary retention-requiring an indwelling urethral catheter or clean intermittent catheterization. Overall, 86% of patients underwent TUMT while on anticoagulant therapy and 25% were treated while taking warfarin. The median age of the patients was 76.9 years (95% CI 74.9-78.8) median ASA-score was 3, and median follow-up was 26 months (range 1-65). Only two men experienced hematuria requiring treatment postoperatively and no transfusions were required. Only two patients (1.9%) required readmission within 30 days after treatment. There were 24 (22.9%) Clavien-Dindo grade I-II complications without grade III or higher complications. Urinary retention resolved in 63.7% of men after treatment. CONCLUSION: Our results suggest that TUMT is a safe and reasonably effective treatment for high-risk catheter-dependent men. Furthermore, the low incidence of adverse bleeding events suggests that TUMT is a safe treatment modality for men requiring uninterrupted anticoagulation.

Quality Improvement Summit 2016: Shared Decision Making and Prostate Cancer Screening.

INTRODUCTION: The American Urological Association Quality Improvement Summit occurs regularly to provide education and promote dialogue around the issues of quality improvement and patient safety. Nearly all prostate cancer screening guidelines recommend shared decision making strategies when determining whether prostate specific antigen testing is right for a specific patient. This summit, held in partnership with the Society for Medical Decision Making, focused on techniques to identify and understand patient values in relation to prostate cancer screening and treatment, and to promote incorporation of shared decision making into prostate cancer screening discussions. METHODS: Information presented at the Quality Improvement Summit was provided by physicians and leading experts in the field of shared decision making. The open forum of this summit encouraged contributions from participants about their personal experiences with shared decision making and their thoughts on the tools presented during the day. RESULTS: Shared decision making supports collaboration between physician and patient in situations where there are multiple preference sensitive options. CONCLUSIONS: Practitioners should include formal shared decision making procedures surrounding prostate specific antigen testing in their practices to ensure that testing is in accordance with patient values and desired outcomes. Tools and strategies like those reviewed in this Quality Improvement Summit are invaluable for alleviating potential burden on providers, ensuring communication and improving quality of care.

Educational Resources for Resident Training in Quality Improvement: A National Survey of Urology Residency Program Directors.

INTRODUCTION: A key physician competency outlined in the Urology Milestone Project is engagement in quality improvement. Despite this mandate little is known about the attitudes of urology residency program directors regarding the relative importance of quality improvement education. Therefore, we performed a national survey of program directors. METHODS: A 25-item survey was developed to investigate program director knowledge and training in quality improvement methodology, participation in quality improvement related activities, curriculum support for resident quality improvement educational activities, and attitudes regarding the relative importance of quality improvement education. The survey was sent via e-mail (November 1, 2016) to all program directors affiliated with the Society of Academic Urologists (sample size 116 of 134, 87% of Accreditation Council for Graduate Medical Education programs). RESULTS: A total of 36 program directors returned a completed survey for a response rate of 31%. Only 22% (8) of program directors reported receiving formal education or training in quality improvement methodology. Overall 44% (16) of program directors reported that their program offers formal education or a curriculum in quality improvement methodology for their trainees. Program directors expressed a strong desire for residents to learn quality improvement methodology (positive response 32 of 36, 89%) and understand how to apply it to conduct a quality improvement project (positive response 30 of 35, 86%). Program directors strongly believe that a urology oriented quality improvement curriculum would be a valuable resource (positive response 31 of 36, 86%) with a need for support from our professional society (positive response 29 of 36, 81%). CONCLUSIONS: A minority of programs have quality improvement education available for residents. However, program directors agree that quality improvement is an integral part of residency training that should be promoted by our profession.

AUA White Paper on the Beers Criteria for Potentially Inappropriate Medication Use in Older Adults.

INTRODUCTION: Medication related problems are common but may be preventable outcomes of prescribing choices. Risks associated with medications in the older adult population are greater due to changes in physiological function with age or disease. Older adults and those with significant comorbidities are often excluded from the clinical trials used to develop medications. In 2012 the American Geriatrics Society published the most recent update of the Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. Several medications included in sections of the Beers Criteria are frequently used in clinical urology, including nitrofurantoin, alpha-1 blocker medications, and antimuscarinic anticholinergic medications for the treatment of urge incontinence and overactive bladder. We describe the challenges and considerations that are useful in prescribing medications for geriatric patients. METHODS: A literature review was performed targeting publications from 2003 to 2013 on the topics of the Beers Criteria, potentially inappropriate medications and specific urological medications included in the current version of the Beers Criteria. An expert panel was convened to evaluate this information and create this white paper with the purpose of educating the urological community on these issues. RESULTS: The rationale for the creation and implementation of the Beers Criteria and its implications for urological practice are reviewed. Careful examination of the Beers Criteria can help clinicians avoid potentially inappropriate prescribing choices for their geriatric patients. We also identified that the HEDIS® high risk medications list of potentially inappropriate medications has been implemented as a negative quality indicator, even though this was not an original purpose of the Beers Criteria. In other words, decisions of denial of coverage and/or requirements for preauthorization are being made using the Beers Criteria as justification by third party payers and other entities. CONCLUSIONS: The Beers Criteria were developed to improve prescribing practices for older adult patients to reduce or avoid potential risks and complications. We encourage clinicians to educate themselves about the Beers Criteria recommendations and associated initiatives that are aimed at improving the care of older adult patients. Urologists should have a key role in the development, evaluation, implementation and analysis of practice measures and the resulting policies.

AUA White Paper on Implementation of Shared Decision Making into Urological Practice.

INTRODUCTION: Shared decision making is a collaborative approach to care that seeks to improve the quality of medical decisions by helping patients choose options concordant with their values and in accordance with the best available scientific evidence. METHODS: A literature review was performed targeting publications between 2003 and 2014 on the topic of shared decision making and decision aids for urological conditions. An expert panel was convened to evaluate this information and create this white paper with the purpose of educating the urological community on these issues. RESULTS: Shared decision making represents the state of the art in patient counseling. Patients who have engaged in shared decision making have greater knowledge and satisfaction as well as greater engagement with care. Numerous organizations make available free resources for shared decision making including decision aids and tools to evaluate the quality of shared decision making. CONCLUSIONS: Shared decision making is an important component of high quality health care delivery and future reimbursement models. In appropriate circumstances urologists should adopt shared decision making into routine clinical practice.

Quality Metrics in Urology.

INTRODUCTION: The focus of quality metrics is to ensure that physicians provide and practice within a standard of care, and to maximize patient benefit and safety. Several quality reporting programs in urology such as SCIP (Surgical Care Improvement Project, PQRS (Physician Quality Reporting System) and OPPE (Ongoing Professional Practice Evaluation)/FPPE (Focused Professional Practice Evaluation) have been used to review and monitor standards of care and improve medical care quality. Urological databases are emerging with the main focus of reviewing and assessing health care delivery quality and patient outcomes. Such data will likely influence future quality improvement measures and standards. Awareness and understanding of these programs and measurements are vital to continued successful urological practice. METHODS: AUA (American Urological Association) and CMS (Centers for Medicare and Medicaid Services) documents were used. We reviewed program specific requirements, including minimal required data, timeline requirements, and specific incentives and penalties. RESULTS: Quality measures and programs in urology aim to monitor, standardize and improve medical care delivery in the United States. Since the implementation of electronic health records, the ability to review individual and group medical practices has become available and reviewable by outside agencies. Universal practice standards and government monitoring of individual and group achievement of those expectations are the current direction of health care. This is exemplified by the United States DHHS (Department of Health and Human Services) announcement of transitioning Medicare to a value based reimbursement model and the 9 HCTTF (Health Care Transformation Task Force) principles for accountable care organization footprint expansion. CONCLUSIONS: The quality era has arrived. Its continued impact on health care delivery will be noted as public reporting and payment modifications based on quality indicators and performance metrics.

AUA Quality Improvement Summit 2014: Conference Proceedings on Infectious Complications of Transrectal Prostate Needle Biopsy.

INTRODUCTION: The AUA Quality Improvement Summit is a continuing AUA effort to provide education around issues related to quality improvement and patient safety. Due to the rapidly increasing rates of hospitalization following prostate needle biopsy, Infectious Complications of Transrectal Prostate Needle Biopsy was selected as the inaugural topic. METHODS: The information is largely unpublished data provided by the presenting physicians. Infection rates are predominantly self-reported with protocols specified by the physicians' home institutions. Beyond the identified speakers, the open forum of this summit allowed for input from a majority of the participants. RESULTS: Current hospitalization rates for transrectal prostate needle biopsy infections vary widely from 0.5% to 6%. Antibiotic resistance of coliform organisms appears to be a major risk of these infectious complications. Prophylactic protocols also vary widely among the represented institutions. Antibiotic resistance profiles showed extreme regional variation and, as such, a prophylactic antibiotic protocol should be based on the current local antibiogram in order to reduce infection rates. Opinions vary in relation to the specific antibiotics appropriate for an augmented antibiotic prophylaxis, in the use of rectal swab and prebiopsy enema, and povidone-iodine preparation of the rectal vault. Standardization of the transrectal antibiotic prophylaxis across practices has been proven to reduce the infectious complications rates. CONCLUSIONS: Urologists should monitor the prostate biopsy infection rates of the practice and consult the current local antibiogram. Physicians should query patients to assess whether they are at high risk for resistant organisms. If so, prophylactic protocols might be intensified.

Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline.

PURPOSE: The purpose of this guideline is to provide a clinical framework for the diagnosis and treatment of non-neurogenic overactive bladder (OAB). MATERIALS AND METHODS: The primary source of evidence for this guideline is the systematic review and data extraction conducted as part of the Agency for Healthcare Research and Quality (AHRQ) Evidence Report/Technology Assessment Number 187 titled Treatment of Overactive Bladder in Women (2009). That report searched PubMed, MEDLINE®, EMBASE and CINAHL for English-language studies published from January 1966 to October 2008. The AUA conducted additional literature searches to capture treatments not covered in detail by the AHRQ report and relevant articles published between October 2008 and December 2011. The review yielded an evidence base of 151 treatment articles after application of inclusion/exclusion criteria. When sufficient evidence existed, the body of evidence for a particular treatment was assigned a strength rating of A (high), B (moderate) or C (low). Additional treatment information is provided as Clinical Principles and Expert Opinions when insufficient evidence existed. RESULTS: The evidence-based guideline statements are provided for diagnosis and overall management of the adult with OAB symptoms as well as for various treatments. The panel identified first through third line treatments as well as non-FDA approved, rarely applicable and treatments that should not be offered. CONCLUSIONS: The evidence-based statements are provided for diagnosis and overall management of OAB, as well as for the various treatments. Diagnosis and treatment methodologies can be expected to change as the evidence base grows and as new treatment strategies become obtainable.

Joint AUA/SUNA white paper on reprocessing of flexible cystoscopes.

PURPOSE: Numerous federal bodies and professional societies have produced guidelines and standards for the reprocessing of endoscopes, but few specifically address the reprocessing of cystoscopes. MATERIALS AND METHODS: This document presents a summary of the current recommendations for reprocessing flexible cystoscopes, and highlights particular aspects of instrument reprocessing that are unique to cystoscopy. RESULTS: Cystoscopes are classified as "semi-critical" devices. Such devices require high-level disinfection or sterilization between patients. High-level disinfection differs from sterilization in that high-level disinfection does not kill large numbers of bacterial spores, while sterilization involves the complete destruction of all microbial life. In the office setting, high-level disinfection (using glutaraldehyde or another chemical disinfectant) is commonly employed for the reprocessing of flexible cystoscopes. During high-level disinfection, standard reprocessing steps should be followed to prevent contamination of the cystoscope between uses. These include precleaning, leak testing, cleaning, disinfection, rinsing, and drying. Recommended "soak times" for glutaraldehyde vary from 20 to 45 minutes, depending upon the degree to which these steps are followed. If no precleaning is performed, a 45-minute glutaraldehyde soak is required to achieve high-level disinfection. Conversely, a 20-minute soak is adequate to achieve high-level disinfection if recommended reprocessing steps are followed prior to immersion in the glutaraldehyde. One chemical disinfectant (ortho-phthalaldehyde) has been associated with anaphylaxis in bladder cancer patients, and should be avoided in these patients. CONCLUSIONS: This white paper provides a concise reference document for the reprocessing of flexible cystoscopes. In addition, references and links to more comprehensive resources are provided. This document may be useful for clinicians and others who are in search of guidance in this area.