Decisional Conflict Among Patients Newly Diagnosed With Clinical T1 Renal Masses: A Prospective Study.

PURPOSE: Because multiple management options exist for clinical T1 renal masses, patients may experience a state of uncertainty about the course of action to pursue (ie, decisional conflict). To better support patients, we examined patient, clinical, and decision-making factors associated with decisional conflict among patients newly diagnosed with clinical T1 renal masses suspicious for kidney cancer. MATERIALS AND METHODS: From a prospective clinical trial, participants completed the Decisional Conflict Scale (DCS), scored 0 to 100 with < 25 associated with implementing decisions, at 2 time points during the initial decision-making period. The trial further characterized patient demographics, health status, tumor burden, and patient-centered communication, while a subcohort completed additional questionnaires on decision-making. Associations of patient, clinical, and decision-making factors with DCS scores were evaluated using generalized estimating equations to account for repeated measures per patient. RESULTS: Of 274 enrollees, 250 completed a DCS survey; 74% had masses ≤ 4 cm in size, while 11% had high-complexity tumors. Model-based estimated mean DCS score across both time points was 17.6 (95% CI 16.0-19.3), though 50% reported a DCS score ≥ 25 at least once. On multivariable analysis, DCS scores increased with age (+2.64, 95% CI 1.04-4.23), high- vs low-complexity tumors (+6.50, 95% CI 0.35-12.65), and cystic vs solid masses (+9.78, 95% CI 5.27-14.28). Among decision-making factors, DCS scores decreased with higher self-efficacy (-3.31, 95% CI -5.77 to -0.86]) and information-seeking behavior (-4.44, 95% CI -7.32 to -1.56). DCS scores decreased with higher patient-centered communication scores (-8.89, 95% CI -11.85 to -5.94). CONCLUSIONS: In addition to patient and clinical factors, decision-making factors and patient-centered communication relate with decisional conflict, highlighting potential avenues to better support patient decision-making for clinical T1 renal masses.

Evaluation of forces applied to tissues during robotic-assisted surgical tasks using a novel force feedback technology.

BACKGROUND: The absence of force feedback (FFB) is considered a technical limitation in robotic-assisted surgery (RAS). This pre-clinical study aims to evaluate the forces applied to tissues using a novel integrated FFB technology, which allows surgeons to sense forces exerted at the instrument tips. METHODS: Twenty-eight surgeons with varying experience levels employed FFB instruments to perform three robotic-assisted surgical tasks, including retraction, dissection, and suturing, on inanimate or ex-vivo models, while the instrument sensors recorded and conveyed the applied forces to the surgeon hand controllers of the robotic system. Generalized Estimating Equations (GEE) models were used to analyze the mean and maximal forces applied during each task with the FFB sensor at the "Off" setting compared to the "High" sensitivity setting for retraction and to the "Low", "Medium", and "High" sensitivity settings for dissection and suturing. Sub-analysis was also performed on surgeon experience levels. RESULTS: The use of FFB at any of the sensitivity settings resulted in a significant reduction in both the mean and maximal forces exerted on tissue during all three robotic-assisted surgical tasks (p < 0.0001). The maximal force exerted, potentially associated with tissue damage, was decreased by 36%, 41%, and 55% with the use of FFB at the "High" sensitivity setting while performing retraction, dissection, and interrupted suturing tasks, respectively. Further, the use of FFB resulted in substantial reductions in force variance during the performance of all three types of tasks. In general, reductions in mean and maximal forces were observed among surgeons at all experience levels. The degree of force reduction depends on the sensitivity setting selected and the types of surgical tasks evaluated. CONCLUSIONS: Our findings demonstrate that the utilization of FFB technology integrated in the robotic surgical system significantly reduced the forces exerted on tissue during the performance of surgical tasks at all surgeon experience levels. The reduction in the force applied and a consistency of force application achieved with FFB use, could result in decreases in tissue trauma and blood loss, potentially leading to better clinical outcomes in patients undergoing RAS. Future studies will be important to determine the impact of FFB instruments in a live clinical environment.

Effect of Corneal Cross-linking versus Standard Care on Keratoconus Progression in Young Patients: The KERALINK Randomized Controlled Trial.

PURPOSE: To examine the efficacy and safety of corneal cross-linking (CXL) for stabilization of progressive keratoconus. DESIGN: Observer-masked, randomized, controlled, parallel-group superiority trial. PARTICIPANTS: Sixty participants 10 to 16 years of age with progressive keratoconus, one eye of each deemed the study eye. METHODS: The study eye was randomized to either CXL plus standard care or standard care alone, with spectacle or contact lens correction as necessary for vision. MAIN OUTCOME MEASURES: The primary outcome was steep keratometry (K2) in the study eye as a measure of the steepness of the cornea at 18 months. Secondary outcomes included keratoconus progression defined as a 1.5-diopter (D) increase in K2, visual acuity, keratoconus apex corneal thickness, and quality of life. RESULTS: Of 60 participants, 30 were randomized to CXL and standard care groups. Of these, 30 patients in the CXL group and 28 patients in the standard care group were analyzed. Mean K2 in the study eye 18 months after randomization was 49.7 D (standard deviation [SD], 3.8 D) in the CXL group and 53.4 D (SD, 5.8 D) in the standard care group. The adjusted mean difference in K2 in the study eye was -3.0 D (95% confidence interval [CI], -4.9 to -1.1 D; P = 0.002), favoring CXL. Adjusted differences between groups in uncorrected and corrected vision favored eyes receiving CXL: -0.31 logarithm of the minimum angle of resolution (logMAR; 95% CI, -0.50 to -0.11 logMAR; P = 0.002) and -0.51 logMAR (95% CI, -1.37 to 0.35 logMAR; P = 0.002). Keratoconus progression in the study eye occurred in 2 patients (7%) randomized to CXL compared with 12 patients (43%) randomized to standard care. The unadjusted odds ratio suggests that on average, patients in the CXL arm had 90% (odds ratio, 0.1; 95% CI, 0.02-0.48; P = 0.004) lower odds of experiencing progression compared with those receiving standard care. CONCLUSIONS: CXL arrests progression of keratoconus in the majority of young patients. CXL should be considered as a first-line treatment in progressive disease. If the arrest of keratoconus progression induced by CXL is sustained in longer follow-up, particular benefit may be derived from avoiding a later requirement for contact lens wear or corneal transplantation.

Implementation of medical scribes in an academic urology practice: an analysis of productivity, revenue, and satisfaction.

PURPOSE: Pressure on physicians to increase productivity is rising in parallel with administrative tasks, regulations, and the use of electronic health records (EHRs). Physician extenders and clinical pathways are already in use to increase productivity and reduce costs and burnout, but other strategies are required. We evaluated whether implementation of medical scribes in an academic urology clinic would affect productivity, revenue, and patient/provider satisfaction. METHODS: Six academic urologists were assigned scribes for 1 clinic day per week for 3 months. Likert-type patient and provider surveys were developed to evaluate satisfaction with and without scribes. Matched clinic days in the year prior were used to evaluate changes in productivity and physician/hospital charges and revenue. RESULTS: After using scribes for 3 months, providers reported increased efficiency (p value = 0.03) and work satisfaction (p value = 0.03), while seeing a mean 2.15 more patients per session (+ 0.96 return visits, + 0.99 new patients, and + 0.22 procedures), contributing to an additional 2.6 wRVUs, $542 in physician charges, and $861 in hospital charges per clinic session. At a gross collection rate of 36%, actual combined revenue was + $506/session, representing a 26% increase in overall revenue. At a cost of $77/session, the net financial impact was + $429 per clinic session, resulting in a return-to-investment ratio greater than 6:1, while having no effect on patient satisfaction scores. Additionally, with scribes, clinic encounters were closed a mean 8.9 days earlier. CONCLUSIONS: Implementing medical scribes in academic urology practices may be useful in increasing productivity, revenue, and provider satisfaction, while maintaining high patient satisfaction.

Gender Differences in Compensation, Job Satisfaction and Other Practice Patterns in Urology.

PURPOSE: The proportion of women in urology has increased from less than 0.5% in 1981 to 10% today. Furthermore, 33% of students matching in urology are now female. In this analysis we characterize the female workforce in urology compared to that of men with regard to income, workload and job satisfaction. MATERIALS AND METHODS: We collaborated with the American Urological Association to survey its domestic membership of practicing urologists regarding socioeconomic, workforce and quality of life issues. A total of 6,511 survey invitations were sent via e-mail. The survey consisted of 26 questions and took approximately 13 minutes to complete. Linear regression models were used to evaluate bivariable and multivariable associations with job satisfaction and compensation. RESULTS: A total of 848 responses (660 or 90% male, 73 or 10% female) were collected for a total response rate of 13%. On bivariable analysis female urologists were younger (p <0.0001), more likely to be fellowship trained (p=0.002), worked in academics (p=0.008), were less likely to be self-employed and worked fewer hours (p=0.03) compared to male urologists. On multivariable analysis female gender was a significant predictor of lower compensation (p=0.001) when controlling for work hours, call frequency, age, practice setting and type, fellowship training and advance practice provider employment. Adjusted salaries among female urologists were $76,321 less than those of men. Gender was not a predictor of job satisfaction. CONCLUSIONS: Female urologists are significantly less compensated compared to male urologists after adjusting for several factors likely contributing to compensation. There is no difference in job satisfaction between male and female urologists.

Prostatic Artery Embolization Using Embosphere Microspheres for Prostates Measuring 80-150 cm(3): Early Results from a US Trial.

Between November 2014 and October 2015, 12 patients with prostates measuring 80-150 cm(3) and lower urinary tract symptoms (LUTSs) were enrolled in a prospective single-center US trial to evaluate Embosphere Microspheres for use in prostatic artery embolization (PAE). At 3 months, mean improvements in International Prostate Symptom Score and quality of life score were 18.3 points (range, 5-27) and 3.6 points (range, 1-6), respectively. One-month cystoscopies and anoscopies demonstrated no ischemic injuries. There were no major complications. In this cohort, Embosphere Microspheres, when used for PAE, were safe and effective in reducing LUTSs in the early follow-up period.

Preoperatively misclassified, surgically removed benign renal masses: a systematic review of surgical series and United States population level burden estimate.

PURPOSE: A significant proportion of renal masses removed for suspected malignancy are histologically benign with the probability inversely proportional to lesion size. To our knowledge the number of preoperatively misclassified benign renal masses treated with nephrectomy is currently unknown. Given the increasing incidence and decreasing average size of renal cell carcinoma, this burden is likely increasing. We estimated the population level burden of surgically removed, preoperatively misclassified benign renal masses in the United States. MATERIALS AND METHODS: We systematically reviewed the literature for studies of pathological findings of renal masses removed for suspected renal cell carcinoma based on preoperative imaging through July 1, 2014. We excluded studies that did not describe benign pathology and with masses not stratified by size, and in which pathology results were based on biopsy. SEER data were queried for the incidence of surgically removed renal cell carcinomas in 2000 to 2009. RESULTS: A total of 19 studies of tumor pathology based on size met criteria for review. Pooled estimates of the proportion of benign histology in our primary analysis (American studies only and 1 cm increments) were 40.4%, 20.9%, 19.6%, 17.2%, 9.2% and 6.4% for tumors less than 1, 1 to less than 2, 2 to less than 3, 3 to less than 4, 4 to 7 and greater than 7, respectively. The estimated number of surgically resected benign renal masses in the United States from 2000 to 2009 increased by 82% from 3,098 to 5,624. CONCLUSIONS: These estimates suggest that the population level burden of preoperatively misclassified benign renal masses is substantial and increasing rapidly, paralleling increases in surgically resected small renal cell carcinoma. This study illustrates an important and to our knowledge previously unstudied dimension of overtreatment that is not directly quantified in contemporary surveillance data.

Resident involvement and experience do not affect perioperative complications following robotic prostatectomy.

PURPOSE: Most urologic training programs use robotic prostatectomy (RP) as an introduction to teach residents appropriate robotic technique. However, concerns may exist regarding differences in RP outcomes with resident involvement. Our objective was therefore to evaluate whether resident involvement affects complications, operative time, or length of stay (LOS) following RP. METHODS: Using the National Surgical Quality Improvement Program database (2005-2011), we identified patients who underwent RP, stratified them by resident presence or absence during surgery, and compared hospital LOS, operative time, and postoperative complications using bivariable and multivariable analyses. A secondary analysis comparing outcomes of interest across postgraduate year (PGY) levels was also performed. RESULTS: A total of 5,087 patients who underwent RPs were identified, in which residents participated in 56%, during the study period. After controlling for potential confounders, resident present and absent groups were similar in 30-day mortality (0.0 vs. 0.2%, p = 0.08), serious morbidity (1.8 vs. 2.1%, p = 0.33), and overall morbidity (5.1 vs. 5.4%, p = 0.70). While resident involvement did not affect LOS, operative time was longer when residents were present (median 208 vs. 183 min, p < 0.001). Similar findings were noted when assessing individual PGY levels. CONCLUSIONS: Regardless of PGY level, resident involvement in RPs appears safe and does not appear to affect postoperative complications or LOS. While resident involvement in RPs does result in longer operative times, this is necessary for the learning process.

Detection of Testicular Metastasis from Renal Cell Carcinoma on PSMA-PET Scan.

The use of prostate-specific membrane antigen-positron emission tomography (PSMA-PET) is becoming more widespread for the diagnosis and management of prostate cancer. Here we report a case of oligometastatic renal cell carcinoma (RCC) to the testes diagnosed incidentally on PSMA-PET imaging. This case demonstrates the potential for diagnosis of nonprostate disease with PSMA-PET imaging, as well as the promising nature of PSMA-PET for the diagnosis and surveillance of RCC. In addition, this case report discusses the rare occurrence of oligometastatic RCC to the testis.

Prevention and management of complications following robot-assisted radical cystectomy: lessons learned after >250 consecutive cases.

INTRODUCTION: Numerous case series of robot-assisted radical cystectomy have emerged which describe complication rates comparable to open series. However, various reports have outlined preoperative factors as predictors of postoperative complications. Understanding these factors and the methods to optimize the perioperative care of the robotic cystectomy patient is essential for successful outcomes. METHODS: In this topic paper, we briefly review the literature surrounding complication rates following robot-assisted radical cystectomy as well as describe our experience after >250 cases, outlining our suggestions for avoidance of surgical complications when building a practice that incorporates this technique. RESULTS: Due to numerous variables, there are a number of intra-operative considerations, including patient selection, perioperative care pathway, intra-operative technique, and equipment choice that we have found to decrease post-operative complications and improve patient outcomes. CONCLUSION: Through careful patient selection, use of appropriate equipment and perioperative surgical management, robotic cystectomy is a feasible procedure with excellent perioperative results.

Practice of immediate sequential bilateral cataract surgery (ISBCS): A teaching hospital experience in United Kingdom.

BACKGROUND / OBJECTIVES: Utilisation of ISBCS has been encouraged since COVID-19 in line with the RCOphth recommendations. This study aims to share experience from a UK teaching hospital on ISBCS and to evaluate pre-, intra- and post-operative outcomes from the ISBCS cohort. METHODS: Of 3402 cataract surgeries performed between July 2020 and July 2021 (1 year since the reopening of the cataract service from COVID-19), 208 eyes of 104 patients (6.1%) undergoing ISBCS were retrospectively studied on their demographics, biometry, surgeon grades, and pre-, intra- and post-operative data. RESULTS: The mean age was 74.5 ± 9.4 years and 62% were female. Eighty-nine percent of the eyes were performed under local anaesthesia and 70% were 'routine' cases. Other risk factors included: short eyes requiring pre-operative mannitol infusion (10%), high myopia (8%), poor dilation (2%) and a 'glaucoma' cohort [angle closure (2%) and prior trabeculectomy (1%)]. Three eyes (1%) had complications intra-operatively in second eye (1 case each: posterior capsule rupture, corneal oedema and zonular dehiscence). Two patients (1%) had complications in the first eye (1 case each: suprachoroidal haemorrhage, conjunctival & iris haemorrhage), hence had their second eye postponed. Twelve months post-operatively, 20 eyes (10%) had recorded post-op complications with cystoid macular oedema being the commonest (4.5%) and no endophthalmitis. Eighty-six percent were discharged with satisfaction. No significant differences were found in pre-operative features, complication rates and post-operative outcomes between consultant and non-consultant surgeons (p > 0.05). CONCLUSIONS: Our experience which included a cohort of high-risk patients showed safe and successful practice of ISBCS without having a negative impact on training.

Improving Staff Workflow in Urology Procedure Clinic Using the Model for Improvement.

OBJECTIVE: To maximize procedure volume and minimize workflow inefficiency in our urological procedure clinic, we hypothesized that for staff (nurses/medical assistants) and patient teams, team workflow duration (TWD) (the time required to complete team duties for a single appointment) could be reduced by 50% with a targeted workflow intervention developed using the Model for Improvement and Plan-Do-Study-Act cycles. Workflow inefficiency leads to wasted time and workplace dissatisfaction, resulting in lost revenue due to low procedure volume and high staff turnover. METHODS: A baseline time study was performed to measure TWD for clinical teams, including the front desk, physician, staff, and patient teams. Implementation of previously identified interventions was also recorded. A workflow intervention was developed in which staff duties were split among two roles: staffer and triager. TWD and intervention implementation were remeasured over six Plan-Do-Study-Act cycles. Semistructured interviews were conducted as a balance measure to assess impact on staff workflow and wellness. RESULTS: Our workflow intervention resulted in a 44% and 42% reduction in staff and patient TWD, saving nearly 17 minutes per appointment on average. Thematic analysis revealed that time saved could be best used to protect lunch breaks and allow time to complete nonclinical duties such as patient calls, which had previously been performed after-hours. CONCLUSION: Introduction of staffer and triager roles to staff workflow increased clinic efficiency by reducing workflow and procedure appointment duration. Time saved was used to increase procedure volume while also supporting staff wellness.

Dorsal penile nerve block prior to inflatable penile prosthesis placement: a randomized, placebo-controlled trial.

INTRODUCTION: Dorsal penile nerve block (DPNB) has been previously shown to provide effective analgesia for penile surgeries. To date, few studies have examined the role of DPNB prior to inflatable penile prosthesis (IPP) implantation. AIM: The purpose of this study was to assess the efficacy of local penile nerve block prior to IPP implantation for postoperative pain control. MAIN OUTCOME MEASURES: The primary outcome was postoperative pain rated using the visual analog scale (VAS). Secondary outcome measures included total narcotic usage during hospitalization. METHODS: Institutional Review Board approval was obtained. Patients with erectile dysfunction scheduled for IPP implantation were approached for study participation. Patients were excluded if they had a previous IPP scheduled for revision or replacement or were undergoing additional procedures during the same operative session. Patients were then randomized to either DPNB with 1% lidocaine and 0.5% bupivacaine without epinephrine or injectable saline placebo. Only the resident surgeon assisting in the case was aware of randomization. All procedures were performed by a single surgeon (C.C.C.). Postoperatively, patients were asked to rate their pain using a VAS hourly while in recovery, at 4 hours, and at 23 hours postoperatively. Total narcotic usage was also measured. RESULTS: A total of 30 patients underwent randomization with 15 patients in each group. Baseline demographic data were similar in each group. There was a significant reduction in pain in the immediate postoperative period and at 4 hours after surgery in the treatment group when compared with placebo (VAS 2.5 vs. 5.3, P = 0.009 at 0 hours; VAS 2.8 vs. 5.1, P = 0.011 at 4 hours). Narcotic usage was similar among both groups. There were no perioperative or early postoperative complications in either group. CONCLUSIONS: DPNB is safe and effective for reducing pain in the early postoperative period following penile prosthesis implantation.

Peri- and postoperative outcomes of robot-assisted radical cystectomy (RARC).

OBJECTIVE: • To assess peri-and postoperative outcomes of robot-assisted radical cystectomy (RARC) with pelvic lymph node dissection (PLND) and urinary diversion for the treatment of bladder cancer. MATERIALS AND METHODS: • We review our previously described surgical technique for RARC and its development over recent years, with an accompanied video illustration. • We also focus on peri- and postoperative outcomes of RARC and compare this with the 'gold standard' of open RC. RESULTS: • RARC has been steadily growing since 2003, with acceptable peri-and postoperative outcomes. • Most studies report decreased blood loss, return of bowel function, and shorter length of hospital stay. Furthermore, complication rates have been shown to be similar to that of open series. • Most importantly, oncological outcomes appear to be favourable in terms of margin status, LND and disease-specific survival, although data may be affected by the lack of long-term results and a randomized clinical trial assessing overall survival. CONCLUSIONS: • RARC with PLND and urinary diversion is an increasingly used strategy in the treatment armamentarium for bladder cancer. • Perioperative and oncological outcomes from existing data have been favourable thus far, but are limited by relatively short follow-up. • Randomized clinical trials with extended patient follow-up are needed to fully assess outcomes related to RARC.

Implementation of Postoperative Standard Opioid Prescribing Schedules Reduces Opioid Prescriptions Without Change in Patient-reported Pain Outcomes.

OBJECTIVE: To implement Standard Opioid Prescribing Schedules (SOPS) based on opioid use following urologic surgeries and to evaluate how evidence-based prescribing schedules affect opioid use and patient reported outcomes. METHODS: Patients who underwent urologic surgeries within 6 procedure subtypes at UNC Health during the 2 study time periods ("pre-SOPS": 7/2017-1/2018, "post-SOPS": 7/2018-1/2019) were invited to complete a survey analyzing postoperative opioid usage, storage and disposal, and patient reported outcomes (including pain interference using a validated questionnaire). A pharmacy database provided medication prescribing data and patient demographics. During the pre-SOPS time period, baseline outcomes were measured. Following the pre-SOPS period, usage amounts were analyzed and Standard Opioid Prescribing Schedules were developed to guide prescriptions during the post-SOPS period. Descriptive summary statistics and appropriate t test or r2 were calculated. RESULTS: A total of 438 patients within 6 procedure types completed the survey (pre-SOPS: 282 patients, post-SOPS: 156 patients). Pre-SOPS, patients were prescribed significantly more 5-mg oxycodone tablets than used (20.9 vs 7.8, P <.001). Post-SOPS, compared to pre-SOPS amounts, patients were prescribed significantly fewer tablets (12.7 vs 20.9, P <.001) and used fewer tablets (5.3 vs 7.8, P = .003). No difference was observed in pain interference (average t-score (standard deviation): 54.33 (10.9) pre-SOPS vs 55.89 (9.1) post-SOPS, P = .125) or patient satisfaction (95% pre-SOPS vs 94% post-SOPS). CONCLUSION: Adherence to data-driven postoperative opioid prescribing schedules reduce opioid prescriptions and use without compromising pain interference or patient satisfaction. These results have important implications for urologists' ability to decrease opioid prescriptions and fight the opioid epidemic.

Robot-assisted vessel harvesting for penile revascularization.

INTRODUCTION: Ideal candidates for penile revascularization include young patients with documented vasculogenic erectile dysfunction usually resulting from pelvic trauma. Historically, large midline incisions were necessary to harvest the epigastric vessels for penile revascularization. We report our experience with robot-assisted epigastric vessel harvesting for use in penile revascularization procedures. AIM: To describe our technique and experience with robot-assisted vessel harvesting for use in penile revascularization. METHODS: Five patients were selected for penile revascularization. Each patient suffered pelvic crush injuries resulting in post-traumatic erectile dysfunction. Each patient had no significant prior medical history and had normal erectile function prior to injury. Penile duplex Doppler ultrasound studies using vasoactive agents demonstrated decreased arterial inflow. Complementary pelvic angiography documented the corresponding arterial lesions. Each patient underwent attempted penile revascularization using a modified Virag-V technique. The epigastric artery was harvested robotically and transposed through a 3 cm incision at the base of the penis. Microscopic revascularization was performed by anastamosing the epigastric artery to the deep dorsal vein. Distal dorsal vein ligation of the subcoronal plexus was performed to limit glans hyperemia. MAIN OUTCOME MEASURES: Description of a new method of vessel harvesting for penile revascularization. RESULTS: Penile revascularization was successful in four out of five patients. One patient had complete thrombosis of the deep dorsal penile vein and underwent subsequent penile prosthesis implantation. Each patient undergoing successful revascularization was discharged home two days postoperatively and has reported resumption of sexual activity. CONCLUSIONS: The robot-assisted approach to epigastric vessel harvesting is an ideal minimally-invasive complement to penile revascularization. This procedure negates the need for a large midline incision and may shorten recovery time. Our described technique offers a novel option for the application of minimally-invasive technology, but longer-term follow-up is needed to further evaluate the success of penile revascularization.

A randomised, controlled, observer-masked trial of corneal cross-linking for progressive keratoconus in children: the KERALINK protocol.

INTRODUCTION: The KERALINK trial tests the hypothesis that corneal cross-linking (CXL) treatment reduces the progression of keratoconus in comparison to standard care in patients under 17 years old. KERALINK is a randomised controlled, observer-masked, multicentre trial in progressive keratoconus comparing epithelium-off CXL with standard care, including spectacles or contact lenses as necessary for best-corrected acuity. METHODS AND ANALYSIS: A total of 30 participants will be randomised per group. Eligible participants aged 10-16 years with progressive keratoconus in one or both eyes will be recruited. Following randomisation, participants will be followed up 3-monthly for 18 months. The effect on progression will be determined by K2 on corneal topography. The primary outcome measure is between-group difference in K2 at 18 months adjusted for K2 at baseline examination. Secondary outcomes are the effect of CXL on (1) keratoconus progression, (2) time to keratoconus progression, (3) visual acuity, (4) refraction, (5) apical corneal thickness and (6) adverse events. Patient-reported effects will be explored by questionnaires. ETHICS AND DISSEMINATION: Research Ethics Committee Approval was obtained on 30 June 2016 (ref: 14/LO/1937). Current protocol: V.5.0 (08/11/2017). Study findings will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: European Union clinial trials register (EudraCT) 2016-001460-11.

Comparison of the Harms, Advantages, and Costs Associated With Alternative Guidelines for the Evaluation of Hematuria.

IMPORTANCE: Existing recommendations for the diagnostic testing of hematuria range from uniform evaluation of varying intensity to patient-level risk stratification. Concerns have been raised about not only the costs and advantages of computed tomography (CT) scans but also the potential harms of CT radiation exposure. OBJECTIVE: To compare the advantages, harms, and costs associated with 5 guidelines for hematuria evaluation. DESIGN, SETTING, AND PARTICIPANTS: A microsimulation model was developed to assess each of the following guidelines (listed in order of increasing intensity) for initial evaluation of hematuria: Dutch, Canadian Urological Association (CUA), Kaiser Permanente (KP), Hematuria Risk Index (HRI), and American Urological Association (AUA). Participants comprised a hypothetical cohort of patients (n = 100 000) with hematuria aged 35 years or older. This study was conducted from August 2017 through November 2018. EXPOSURES: Under the Dutch and CUA guidelines, patients received cystoscopy and ultrasonography if they were 50 years or older (Dutch) or 40 years or older (CUA). Under the KP and HRI guidelines, patients received different combinations of cystoscopy, ultrasonography, and CT urography or no evaluation on the basis of risk factors. Under the AUA guidelines, all patients 35 years or older received cystoscopy and CT urography. MAIN OUTCOMES AND MEASURES: Urinary tract cancer detection rates, radiation-induced secondary cancers (from CT radiation exposure), procedural complications, false-positive rates per 100 000 patients, and incremental cost per additional urinary tract cancer detected. RESULTS: The simulated cohort included 100 000 patients with hematuria, aged 35 years or older. A total of 3514 patients had urinary tract cancers (estimated prevalence, 3.5%; 95% CI, 3.0%-4.0%). The AUA guidelines missed detection for the fewest number of cancers (82 [2.3%]) compared with the detection rate of the HRI (116 [3.3%]) and KP (130 [3.7%]) guidelines. However, the simulation model projected 108 (95% CI, 34-201) radiation-induced cancers under the KP guidelines, 136 (95% CI, 62-229) under the HRI guidelines, and 575 (95% CI, 184-1069) under the AUA guidelines per 100 000 patients. The CUA and Dutch guidelines missed detection for a larger number of cancers (172 [4.9%] and 251 [7.1%]) but had 0 radiation-induced secondary cancers. The AUA guidelines cost approximately double the other 4 guidelines ($939/person vs $443/person for Dutch guidelines), with an incremental cost of $1 034 374 per urinary tract cancer detected compared with that of the HRI guidelines. CONCLUSIONS AND RELEVANCE: In this simulation study, uniform CT imaging for patients with hematuria was associated with increased costs and harms of secondary cancers, procedural complications, and false positives, with only a marginal increase in cancer detection. Risk stratification may optimize the balance of advantages, harms, and costs of CT.

Androgen deficiency in the aging male: a guide to diagnosis and testosterone replacement therapy.

A steady decline in androgen levels occurs in males as they age. Evidence suggests that this decline may be at least partially responsible for a variety of physical and mental changes associated with the aging process. For instance, abnormally low levels of androgens can lead to profound changes in bone density, body composition, as well as sexual and cognitive function. Testosterone replacement has been shown to produce improvements in many of these areas. However, this practice is not without risks, both proven and theoretic. Also, the diagnosis of androgen deficiency and the decision to treat is not always straightforward. The purpose of this article is to familiarize the clinician with issues associated with androgen deficiency in the aging male. The clinical symptoms of androgen deficiency as well as the risks and benefits of androgen replacement will be discussed. This should help clinicians better identify those patients in whom testosterone replacement therapy should be considered.