Cheryl Guttman Krader, BS, Pharm

Cheryl Guttman Krader is a contributor to Dermatology Times, Ophthalmology Times, and Urology Times.

Investigators at the University of Michigan have developed a cloud-based, Health Insurance Portability and Accountability Act–compliant software solution to ensure timely ureteral stent removal and validated its performance in a pilot study.

The system’s development and pilot testing are described in an article accepted for publication in the 

John M. Hollingsworth, MD, MS, a professor of urology and health management and policy at the University of Michigan, is a senior author of the paper. He told 

®, “Retained ureteral stents are common, occurring in over 12% of the patients in whom they are placed. A retained stent is bad because it can lead to substantial morbidity and increased costs of care for the patient. Moreover, a retained stent can be a source of liability for the urologist who placed it.”

He continued, “The problem faced by urologists is a lack of reliable tools to facilitate the tracking of ureteral stents to ensure their timely removal. The solution that we created to address this problem leverages data captured in the electronic health record [EHR] to automatically log and follow patients across the care continuum. Notably, the solution facilitates patient tracking without disrupting existing provider workflows.”

Hollingsworth added that the software also overcomes limitations of existing ureteral stent–tracking software.

“One stent manufacturer has a mobile application that generates reminders about device removal, but the app is manufacturer specific and necessitates activities outside the normal workflow to maintain the stent log. There are also automated systems created by other provider organizations to capture information from the EHR, but these systems are EHR specific,” he said. “Our solution is agnostic to the device manufacturer, and we believe it can be seamlessly integrated into any EHR because it was built on Health Level Seven standards, which are common across all EHR platforms.”

For the pilot study, medical records of patients who underwent ureteral stent placement for any indication at University Hospital or 1 of its ambulatory surgery centers during a 1-month period were identified through medical record review. Information was extracted manually from the patient’s record to determine the accuracy of the software in identifying the placement procedure, scheduling follow-ups, and issuing alerts for patients without a return appointment.

The study included data from 46 patients who had a total of 51 stents placed during 49 procedures. The software captured all the procedures, correctly identified the 31 procedures in which a patient had a follow-up visit scheduled before the primary surgery, and alerted providers to the 18 procedures for which a return visit was not scheduled.

The review of the software’s performance for tracking patients who returned for stent removal showed that it registered all patients who attended their follow-up visit. Most important, it identified the ones who failed to show for their appointment.

Since submitting their manuscript, Hollingsworth and colleagues have been working to address the limitations of the initial software version tested. He explained that the initial version generated provider alerts when patients did not have a follow-up scheduled or had failed to arrive for or canceled an appointment, so an office staffer needed to contact those patients to reschedule an appointment. In addition, although the software could read the EHR, it could not write data for it. Therefore, the provider or a designee had to log in to the application outside the EHR to confirm ureteral stent removal.

“In the latest version of our software, patients receive secure text messages regarding appointment information, and we are developing the capacity for the software to be fully automated to remove the need for manual record closure, eliminating this step,” Hollingsworth said.

Further validation of the software is also ongoing. The software has been deployed at another academic medical center, which uses a different EHR from the 1 used at the University of Michigan, and at the University of Michigan’s interventional radiology clinic.

“Because our software uses electronic messages that are generated during the extraction of administration and clinical tasks, which are standardized across EHRs, it is potentially compatible with all major platforms. These recent deployments of our software will demonstrate its agnosticism to the EHR vendor and show its extensibility to other temporary implantable medical devices,” Hollingsworth said.

1. Tam C, Newman M, Dauw CA, et al. Developing and implementing a cloud-based software solution for tracking ureteral stents: a pilot study. 

Published online October 1, 2020. doi:10.1089/end.2020.0168

Articles

Investigators have developed a cloud-based, HIPAA–compliant software solution to ensure timely ureteral stent removal and validated its performance in a pilot study.

Ureteral stent–tracking software passes performance test in feasibility study

Men who receive care for erectile dysfunction (ED) from their primary care provider (PCP) are much less likely to receive advanced pharmacological therapies for management of their condition than those treated by urologists, according to a recently published study.

The investigators sought to evaluate the epidemiology, diagnosis, and outpatient treatment of ED by extracting data for a nationally representative sample of men using the National Ambulatory Medical Care Survey. Their sample of male visits recorded between 2006 and 2016 showed that 1.2% of 170,499 visits were associated with a diagnosis of ED, translating into about 3.4 million weighted visits annually.

The majority of visits for ED were to urologists (58%), but visits to family practitioners and internists accounted for most of the remaining encounters (36.6%). The review of pharmacological treatments for ED showed that a PDE5 inhibitor was ordered or reordered significantly more often by nonurologists than urologists (66.62% vs 50.77%

 <.05). Ordering of advanced pharmacological therapies—eg, intracavernosal injections and intraurethral injections—was done almost entirely by urologists vs nonurologists (2.72% vs 0.25%, 

Joshua A. Halpern, MD, an assistant professor of urology at Northwestern Medicine in Chicago, Illinois, is a corresponding author for the published paper. “Our study reinforces that ED is a very common problem for men in the United States, and it generates a high volume of visits to physicians,” he said. “We hope that both PCPs and specialists will continue to be proactive in asking their male patients about sexual health and function and in helping them pursue the wide array of treatments available to help men achieve a fulfilling sex life.”

He continued, “We believe there is great opportunity for collaboration between PCPs and urologists when it comes to the treatment of ED. On a broad scale, increasing the dialogue and partnership among professional societies in creating guidelines and educational materials for physicians and patients could be quite helpful. Locally, it is important to create and foster close relationships among PCPs, urologists, and cardiologists to optimize care for men suffering from ED.”

® that the motivation for undertaking the study stemmed from the observation that many men who were being seen for ED after receiving a diagnosis from a nonurologist had been prescribed medication without receiving appropriate counseling on its use. In addition, few men had received counseling about nonoral or nonpharmacological approaches to ED treatment.

“Our observations were consistent with previous reports and led us to study the inherent differences between the management of ED by urologists and nonurologist physicians,” Halpern said.

Analyses comparing differences in the characteristics of men treated by urologists and nonurologists showed that a significantly higher percentage of men who saw urologists were older than 65 years of age compared with the group seen by nonurologists (47.1% vs 22.6%; 

 <.05). Discussing the difference, the investigators postulated that one reason is established physician relationships: Older men are more likely to have other urological issues; therefore, they may already have a urologist. In contrast, younger men are less likely to have a urologist but may have a PCP.

Corresponding with the explanation, the investigators also found that nearly one-fourth of men seen by urologists had an active cancer diagnosis, compared with only 2.8% of men visiting nonurologists (

The investigators reviewed several limitations of their study. Of particular importance, they noted that the study sheds light only on differences between urologists and nonurologists in prescribing patterns for pharmacological therapy for ED.

“A strength of our study is that the database we used provides general data for ambulatory visits. However, it does not capture nonpharmacological therapies, such as vacuum erection devices, psychotherapy, and surgery,” Halpern said.

® that the study has been a catalyst for Northwestern Medicine urologists to work more closely with nonurology colleagues locally to optimize treatment for men with ED.

“We hope these efforts will ultimately lead to broader initiatives in both patient care and research,” he said.

1. Panken EJ, Fantus RJ, Chang C, et al. Epidemiology and diagnosis of erectile dysfunction by urologists versus non-urologists in the United States: an analysis of the National Ambulatory Medical Care Survey. 

Published online September 24, 2020. doi:10.1016/j.urology.2020.09.016

Men who receive care for erectile dysfunction from their primary care provider are much less likely to receive advanced pharmacological therapies for management of their condition than those treated by urologists.

Research suggests potential gaps in ED care delivered by nonurologists

Findings from analyses of data collected in the multicenter prospective Canary Prostate Cancer Active Surveillance Study are adding to the body of literature regarding the utility and shortcomings of prostate magnetic resonance imaging (MRI) in active surveillance of men with low grade prostate cancer.

Describing their study as the largest cohort data on this topic, the researchers concluded its evidence suggests that a negative MRI in a patient on active surveillance does not ensure a lack of tumor upgrading. Furthermore, based on the findings, they recommended that systematic biopsy be performed in patients with negative MRI and in addition to targeted biopsies in men with a positive MRI.

The follow-up protocol for men enrolled in the Canary study included quarterly PSA testing, semiannual digital rectal examination, and surveillance prostate biopsies at 1 and 2 years after initial diagnosis and biennially thereafter. The performance of prostate MRI was left to the clinician’s discretion as was the technique used for prostate biopsy (cognitive or MRI/ultrasound fusion image guidance and amount of systematic sampling added to targeted biopsy cores). MRI images were graded based on PI-RADS.

To evaluate the diagnostic performance of MRI in active surveillance, the investigators identified men who had Gleason Grade Group less than 2 and a prostate biopsy within 12 months of multiparametric MRI. Their study included a total of 361 men who had 395 MRI studies and a median follow-up of 4.1 years. Of the 395 imaging studies, 284 were classified as positive based on the presence of a PI-RADS 3-5 lesion.

Biopsy reclassification to Gleason Grade Group 2 or greater on post-MRI biopsy was evaluated as the primary outcome, and 108 (27%) of the biopsies met the criterion for reclassification. The evaluation of MRI diagnostic performance showed that it had a positive predictive value of 31% and a negative predictive value of 83%, indicating that a negative MRI would miss a substantial proportion of patients with higher grade cancer. The negative predictive value of MRI was 82% if the definition of a positive MRI was changed to include only PI-RADS 4 or 5 lesions.

The researchers also created multivariable logistic regression models to assess the value of MRI for predicting biopsy reclassification. A base model incorporated only clinical factors (age, body mass index, number of negative biopsies after diagnosis, percent of total biopsy cores containing cancer from the previous biopsy, log-transformed prostate size, and log-transformed serum PSA), and a second model incorporated PI-RADS score.

Although presence of a PI-RADS 5 lesion versus a PI-RADS 1 or 2 lesion was found to be significantly associated with cancer reclassification to Gleason Grade Group 2 or greater, results of receiver operating curve analyses showed that discrimination between patients with and without biopsy reclassification improved only minimally by adding the PI-RADS score to the base model.

Another analysis evaluated the utility of MRI fusion biopsy by comparing the detection of high grade cancer in targeted versus systematic biopsies. It included data from 194 fusion biopsies and showed that the systematic biopsies detected a similar number of unique Gleason Grade Group 2 or higher cancers as the targeted biopsies (25 vs 21).

Commenting on these results, the investigators noted they are consistent with other research showing that targeted biopsies in men undergoing active surveillance may add little for predicting upgrading or reclassification. They stated, “if the goal of surveillance biopsy is to identify higher grade disease, systematic and targeted biopsies should be obtained for men with a region of interest identified on MRI.”

1. Liss MA, Newcomb LF, Zheng Y, et al.Magnetic resonance imaging for the detection of high grade cancer in the canary prostate active surveillance study. 

. 2020;204(4):701-706.doi: 10.1097/JU.0000000000001088

Based on the findings, investigators recommended that systematic biopsy be performed in patients with negative MRI and in addition to targeted biopsies in men with a positive MRI.

New report adds insight on prostate MRI for monitoring during active surveillance 

Tele-cystoscopy has the potential to expand the availability of cystoscopy for bladder cancer surveillance to patients living in underserved areas, according to findings from a pilot study published in the 

Tele-cystoscopy represents a collaborative approach to providing necessary surveillance for patients with urothelial bladder cancer in the face of urologist workforce shortages while also addressing liability and quality issues faced by urologists. It involves cystoscopy performed by an advanced practice provider (APP) with real-time monitoring and interpretation by a remote urologist.

Researchers from the University of Virginia and Cleveland Clinic conducted the pilot study to evaluate the clarity of the transmitted videos, APP proficiency, and diagnostic capability of the tele-cystoscopy. Analyses were based on cystoscopies performed in 6 patients seen at 3 telemedicine centers. Each patient underwent both tele-cystoscopy performed by a trained APP guided by a remote urologist and traditional cystoscopy done by an onsite urologist.

The onsite tele-cystoscopy video, transmitted video from the tele-cystoscopy procedure, and onsite video from the traditional cystoscopy were reviewed by 11 board-certified urologists who were blinded to the cystoscopy operator and location. According to their reviews, tele-cystoscopy provided reasonable image quality and excellent thoroughness of examination (92% for observes all regions, identifies ureteral orifices, and retroflexion).

Tele-cystoscopy was also found equivalent to traditional cystoscopy with respect to identification of abnormalities and action decisions. Neither the provider performing the cystoscopy nor the location of the procedure had a significant effect on ability to make a diagnosis using the video or the decision for action.

Safety was good. No patients developed a urinary tract infection nor any other complications. In addition, patient satisfaction with the experience was high.

Patients were eligible for enrollment in the pilot study if they had a history of microscopic hematuria, gross hematuria, urothelial cancer, or refractory lower urinary tract symptoms. Five of the 6 patients included in the analysis were undergoing surveillance for urothelial cancer. The urologists who reviewed the captured videos included 7 academic physicians and 4 who were in community practice.

Overall, 36 video recordings were captured, each urologist reviewed between 3 and 6 videos, and each video was evaluated twice by each reviewer.

Video clarity was assessed based on image resolution and speed of transmission and was found to be poorer for the transmitted video compared with the onsite video from traditional cystoscopy. The difference was attributed to video transmission rather than operator performance.

Practitioner proficiency ratings judged visualization of bladder landmarks, recognition of abnormalities, rating of overall technique, and postulation regarding whether the operator wasa physician or APP. Thoroughness of examination and identification of an abnormality were found to be similar for the procedures done by APPs and urologists. Overall technique score was higher for the urologists but the difference compared with the APPs was not statistically significant.

Diagnostic capability was assessed based on whether the cystoscopy thoroughly examined all major bladder landmarks, if a diagnosis could be made based on the video, and what action the reviewer would recommend taking after the examination. Comparison of reviewers’ action decisions showed high diagnostic agreement.

Of note, when the University of Virginia investigators were developing their tele-cystoscopy program, they first optimized the technical infrastructure needed so that the real-time video images would have sufficient clarity for remote interpretation. In addition, they created a cystoscopy training program for APPs that included a competency scoring system.

1. Lobo JM, Horton B, Jones RA, et al. Blinded comparison of clarity, proficiency and diagnostic capability of tele-cystoscopy compared to traditional cystoscopy: a pilot study. 

. 2020;204(4):811-817. doi: 10.1097/JU.0000000000001092

Tele-cystoscopy was found equivalent to traditional cystoscopy with respect to identification of abnormalities and action decisions. 

Author | Cheryl Guttman Krader, BS, Pharm

Articles

Ureteral stent–tracking software passes performance test in feasibility study

Research suggests potential gaps in ED care delivered by nonurologists

New report adds insight on prostate MRI for monitoring during active surveillance

Study shows viability of telemedicine approach to cystoscopy