Organizations representing urologists are urging Congress to enact protections from medical liability lawsuits for medical professionals who volunteer during emergencies, such as natural disasters or other large-scale crises.

The AUA and the AACU are backing the Good Samaritan Health Professionals Act, which has been introduced by Rep. Marsha Blackburn (R-TN) and Sen. Bill Cassidy, MD (R-LA).

“When a national crisis or catastrophe such as a hurricane, wildfire, flood, or even a terrorist attack occurs, a prompt and adequate medical response can be the difference between life and death, especially for those victims in critical condition,” a statement by the AACU said. “But while physicians and other health care professionals are often willing and eager to assist disaster victims, many have been turned away or otherwise deterred from volunteering due to inconsistent and ambiguous state and federal laws.”

The proposed legislation seeks to address this situation by eliminating liability for health care professionals who serve as volunteers in response to a federally declared disaster. It would prevent a health care professional from being held liable under federal or state law for harm caused by any act or omission if:

the professional is serving as a volunteer in response to a disaster

the act or omission occurs during the period of the disaster, in the professional’s capacity as a volunteer, and in a good faith belief that the individual being treated is in need of health care services.

The bill limits its protections to individuals treating victims in an event that has officially been declared a federal disaster and will not apply in cases of willful, criminal, or reckless misconduct, gross negligence, conscious flagrant indifference, or intoxication by the professional while volunteering.

Urologists among specialists making mark on U.S. politics

“With bipartisan support, this bill will help ensure that victims of national disasters, such as the recent hurricanes in Puerto Rico, Texas, and Florida, will have access to the quality onsite care they need by enhancing clarity regarding the patchwork of state laws encouraging medical volunteerism and reducing risk and uncertainty for health care professionals,” the AACU said, urging members of Congress to cosponsor the legislation-HR. 1876 in the House and S. 781 in the Senate.

Meanwhile, the AUA said it is running a grassroots campaign asking its members to urge members of the House and Senate to support the legislation and to include it in the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPA), which would reauthorize a program first enacted in 2006.

“We are asking that you please contact your Senators and ask them to cosponsor S. 781… and to support including this bill language in the PAHPA. We are also asking that you share this information with your colleagues and have them reach out to their Senators as well,” the AUA said in a Policy and Advocacy Brief.

Bill was among subjects of recent Alliance of Specialty Medicine Fly-In

The AUA’s campaign follows up on 11 urologists’ visits to Capitol Hill on this bill and other issues during the Alliance of Specialty Medicine Fly-In in late July. Meeting with lawmakers in both the House and Senate were AUA Legislative Affairs Committee Chairman Tom Rechtschaffen, MD, and committee members Robert Bass, MD, Ron Davis, III, MD, Matt Gettman, MD, Jason Jameson, MD, Jeremy Shelton, MD, and C.J. Stimson, MD, JD; Holtgrewe Fellow Kevin Koo, MD; AUA Quality Improvement & Patient Safety (QIPS) Committee Chairman Tim Averch, MD, QIPS committee member John Lam, MD, and Ruchika Talwar, MD.

In introducing the Good Samaritan Health Professionals Act, Dr. Cassidy stressed the importance of medical volunteers in times of disaster.

“Volunteers were crucial in helping families begin recovering after last year’s flood,” Dr. Cassidy said. “Following Hurricane Katrina, medical professionals from across the U.S. came to Louisiana to help. The Good Samaritan Health Professionals Act provides medical professionals with legal protections that protect volunteers aiding disaster victims.”

Medicare proposed rule outlines significant changes

He pointed out that the Volunteer Protection Act of 1997 protects volunteers from nonprofit agencies and government entities from litigation and economic losses resulting from volunteerism, but does not apply to independent volunteers or those who cross state lines to volunteer.

Reauthorization of the PAHPA, to which the AUA hopes to add the Good Samaritan bill’s language, was the subject of a House Energy and Commerce Committee hearing in June.

Authored by Rep. Susan Brooks (R-IN) and Rep. Anna Eshoo (D-CA), it will reauthorize preparedness and response programs such as the Hospital Preparedness Program, Temporary Reassignment of Federally Funded Personnel, the National Advisory Committee on Children and Disasters, and the Emergency System for Advanced Registration of Volunteer Health Professionals.

Among its provisions, the bill prioritizes preparing for and responding to cyber threats and provides resources for the development of medical countermeasures for pandemic influenza and emergency infectious diseases within Biomedical Advanced Research and Development Authority.

In its appeal to members to contact lawmakers on behalf of the Good Samaritan legislation, the AUA positioned it as part of the medical liability reform initiative, which has been ongoing in Congress for many years.

Articles

AUA, AACU back Good Samaritan legislation

Urology Times reached out to three urologists (selected randomly) and asked them each the following question: What factors reduce the time you spend with patients?

“Our time with patients is very truncated. EMRs actually get in the way of good care. They consume huge amounts of time. They take away, directly, from being able to sit with the patient, listen to them, and provide all the needed care. We are not able to give quality time to patients.

During clinic, we actually took a close look at this and found that for every 15-minute clinic visit, we spend 9 minutes on the computer doing what’s required by regulation, billing, or administration to finish notes for that patient. So a 15-minute visit is consumed with 8 or 9 minutes on the computer, and patients end up getting the short end. To keep it from being even worse, we spend a couple of extra hours every night afterwards completing the charts.

What do you like/dislike about practicing in your state?

To try to keep patients from feeling shortchanged, I’ll sit and listen to them, and won’t start doing EMR for at least 4-5 minutes-just to hear them out. I’m consciously aware of the time crunch, because if I spend much more than that, I won’t have time to do what’s required on the EMR. If I had more time, I’d actually be able to listen to them-just be in the moment with them.”

"EMR is an obstacle to clear communication"

“The EMR, the urologic work force shortage, and an aging population-we’re seeing more and more patients and try to provide access to them. Also, EMR is an obstacle to clear communication. Those are the changes that have reduced our time with patients.

What traits are important to be a good urologist?

We’re big on patient education, making sure patients understand procedures, and informed consent. I felt I was getting hurried to provide that, so our group is making videos of the procedures we do-from vasectomy to radical prostatectomy to ESWL. They explain procedures, with animation, and even informed consent. A patient, either before I see them or right after, can watch these videos in our office. They go into more detail on the procedures they need [and explain] the risks and benefits.

Then I’ll go in and ask if they understand and if they have questions. So far, patients have really accepted them. They’re in laymen’s terms. They’re thorough and allow patients time to digest what they’ve heard, write down questions, and then follow up with the physician.

That gives me time to really communicate with patients. It’s always a challenge, but as far as trust and the rapport with patients-that hasn’t changed at all. The patient instruction video just enhanced that.

Our practice is also using more advanced practice providers-nurse practitioners and PAs. A lot of follow-up and educational visits are done with them. I explain to patients that we want to extend our access to them, to provide shorter wait times, more education, so we’re doing the team-based approach. Patients have really bought into what we’re doing. Patients like that at least two people know the details of their care. If the doctor’s not here, someone else knows about them. So far, it’s been a very positive experience for the patient.

Is it OK for physicians to hug their patients?

I like the team approach. Those are the two strategies Arkansas Urology has adopted.”

"Mostly two things interfere with our patient time: the volume of patients and EMRs"

“Mostly two things interfere with our patient time: the volume of patients and EMRs. We’re dealing with baby boomers and there are fewer urologists-more retiring with fewer coming out.

We’ve probably done two things to help us provide good patient care. We’ve embraced physician extenders to take some of the burden off, mainly to help patients who need to be seen on a more urgent basis. This allows more patients to get in. We’re still learning that process, but we’ve tried to embrace that.

How do you manage noncompliant OAB patients?

The other adjustment we’ve made-mostly when we start getting behind-is to put EMR documentation to the side and finish our notes once we’ve finished with clinic-a lot of after-hours work.

It’s harder to do the EMR after hours. You definitely have to take good notes while you’re talking to patients because if you put it off more than a few hours, your notes won’t be as thorough or as accurate. Depending on the volume of patients you see, it’s hard to remember what you said to which patient. You really need to do them that night so you can keep them straight. They have to be done at some point, but you don’t want to sacrifice taking care of the patient.”

“Our time with patients is very truncated. EMRs actually get in the way of good care. They consume huge amounts of time," says one urologist.

What factors reduce the time you spend with patients?

I have an old 401(k) account with a former employer. Should I leave it there for as long as they’ll let me? If not, what are my options?

Generally, you have four options when it comes to your old employer-sponsored retirement plan. You may be able to leave it with the old employer, you can roll it into your new employer’s retirement plan (if eligible), you can roll the money into an Individual Retirement Account rollover account, or you can take a cash distribution. Each of these alternatives has advantages and disadvantages.

For many individuals, taking a cash distribution is the least desirable option since any distributed amount not rolled into a new plan will be subject to income taxes and a 10% penalty if you are under age 59½. The taxable portion will be counted as ordinary income during the year of distribution and could result in moving you into a higher tax bracket. Due to the severity of the taxes and penalty, cash distributions should only be considered in cases of true financial hardship such as foreclosure, eviction, or repossession.

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If the plan permits, leaving the retirement account with your former employer has some advantages, such as familiar investment options and possibly lower fees. Additionally, if it is a qualified retirement plan, it may offer protection from malpractice lawsuits and other creditors. Before making the asset protection feature a deciding factor, check if your new employer plan offers the same protections. Many of them do.

It may make more sense, however, to roll the funds into the qualified retirement plan provided by your new employer or into an IRA rollover. Retirement assets left with previous employers can be forgotten (yes, it happens!), or the previous employer may change names or be acquired down the road. This can make tracking down these old plans very difficult and time consuming. Therefore, consolidating your retirement accounts through a rollover may be the better option. It simplifies the management of your retirement savings by combining multiple accounts into just one or two.

When deciding whether to roll your account(s) into your new employer’s plan or an IRA, it is important to examine the differences between the two vehicles. Both will maintain the tax benefits of the previous account, and no taxes or penalties are incurred by moving the funds. The biggest difference between the two account types is the available investment options. Your new employer’s plan may only offer a limited selection of investment options. The number of funds could range from less than 10 investment options to dozens. These funds may have a history of strong performance with low fees or they could not.

It is important to review the options before committing to rolling the funds into that plan. An IRA rollover, on the other hand, allows you to invest in any publicly traded security. You may be able to find better-performing funds that have lower internal expense ratios.

"Another difference between the two rollover options is the cost"

Another difference between the two rollover options is the cost. When using your employer’s retirement plan, the cost may be assumed by the employer. This includes paying a record keeper, a third-party administrator, and often an investment adviser. The employee just needs to pay the internal expense ratio of the funds themselves. With an IRA rollover, the responsibility of paying an investment adviser may fall to the individual investor.

If an individual does not have extensive experience selecting funds and designing an investment allocation, working with an adviser is recommended. Most advisers charge a fee for their services and that should be factored into the decision.

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Due to the complexity of each option and the consequences involved, we recommend speaking with a financial adviser to determine the best option for you.

We have finally scheduled an appointment with our attorney to prepare an estate plan. What should we do in preparation for the meeting?

Estate planning can range from simple and straightforward to sophisticated and complex. The starting point, prior to meeting with the attorney, would be to prepare a complete list of assets, including investments, retirement accounts, insurance policies (death benefit as well as any cash value), real estate, and any business/practice interests. Next, decide what you want to do with those assets: who should inherit them, who should manage your estate, and who should make significant decisions if you become incapacitated. This will provide a nice framework for the attorney to begin the process.

Mr. Witz is educational program director at MEDIQUS Asset Advisors, Inc. in Chicago. He welcome readers’ questions and can be reached at 800-883-8555 or 

The information in this column is designed to be authoritative. The publisher is not engaged in rendering legal, investment, or tax advice.

Several strategies are available, each with their own pros and cons.

401(k) with a previous employer: What are your options?

Thank you for calling Urology Specialists of the Western Hemisphere. If this is an emergency, please hang up immediately and dial 9-1-1 or go to an emergency room. For prescription refills, please contact your pharmacy. Press 9 to…”

If this recorded greeting, which is unnecessary for most callers, sounds familiar, you may want to reevaluate how your practice manages the primary tool for patient engagement-the telephone call. Do you put your least experienced and lowest paid staff in this important role? Have you installed and configured phone systems that all but guarantee the first contact with the practice will not be a live voice or human touch?

These common responses to the pressures and pace of a contemporary specialty practice may ultimately shape the first impression of a patient or referring physician’s office, impact patient and provider satisfaction, and even determine customer loyalty. In this article, I will discuss the concept of a “call center” in a modern urology practice.

Call centers come in different shapes and sizes. If you have one or more employees answering the phone during business hours, then you have a call center-whether you call it that or not. After hours, your answering service may be your “call center”-responsible for representing your practice in a professional and reliable way. Some large practices with multiple offices have centralized routing and distribution of some or all phone calls by staff in a dedicated physical space-a physical call center.

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No matter the size of your practice or location of your “call center,” the needs of your callers are the same. One author summed it up nicely: “We want to be treated well, we want the human on the other end of the line to correctly pronounce our name, we want them to be friendly even when we're not, and (most importantly) we want our problem solved” 

The goal of your call center is to get the caller’s problem solved in a dignified, professional, and respectful manner. The call center is the face of your practice.

Where do you begin in assessing the efficiency and quality of answering phone calls in your practice? There are basic measurements that can begin to answer this question and get you started. Many phone or call management systems have reporting capabilities. If you don’t have such a system, you may have to manually audit or observe the number of calls, the average length and type of calls (appointments, refills, medical concerns), the category of caller (new patient, established, physician, hospital, etc.), how many calls per hour your staff is completing, how many callers reach a human, and how many calls are abandoned.

The electronic health record may be an important secondary source of information as it may measure messages by provider, tasks, or refill requests. Interview one or more of your staff who answer the phones and get their perspective on what’s working and what is not working. If you measure patient satisfaction, drill down on any information related to experience on the phone; if you don’t measure satisfaction objectively, ask your patients about their experience interacting with the practice.

Go online to ratings sites and see if people are talking about your customer service. Call your practice posing as a new patient and see what happens. With minimal focused effort, you should be able to get a clear idea of whether there is an opportunity for improvement and how to target the solutions.

How do you know what is normal performance for your call center? There are three common benchmarks or key performance indicators to use for comparison. First, the average abandonment rate is the percentage of calls that were disconnected before being answered. Second, the average time in queue is the amount of time after a call has been answered before the caller speaks to an agent. Finally, the average time to answer measures how long it took the agent to answer the call. According to one source, these benchmarks for health care are 13%, 2.5 seconds, and 3.2 seconds, respectively 

If you are far off these benchmarks-especially abandoned call ratio-then you may be losing business and not even know it.

Once you have identified the opportunities, you can begin to apply targeted solutions.

The first-and often overlooked-category of solutions is to prevent inbound phone calls to begin with and reduce the load on the staff. Do you have a patient portal, online bill pay, virtual scheduling, live chat, secure email, or alternatives that can eliminate the need for phone calls? Are you anticipating questions in your patient literature, especially when preparing for a procedure? Are you accurately maintaining patient email and phone information so your patient reminder system actually works? Does your refill policy generate more daytime calls than after hours calls it prevents?

Also consider these questions: Are you returning morning messages promptly to prevent a second or third call back? Have you considered a dedicated phone number for physicians and hospitals, instead of routing it through the call center? Do one or more of your providers review their inbound lab results daily? Are you monitoring your failed outbound electronic prescriptions or faxes? Addressing these and other opportunities will return dividends in your call center performance.

The second major category of solutions is technology. If you don’t have a call management system, examine the economics and see if it makes sense-the return on investment should be tangible and significant in a busy practice of any size. If you do have a call management system, be sure it is properly configured to monitor and report call and staff activity. Examine settings in your appointment scheduling software to ensure the staff can easily find available appointment slots. Are the interfaces between systems working properly, or do the staff have to waste time with dual entry? Does the staff have access to all the systems they need (the EHR, for example)? Involve your IT staff in ensuring that some chronic problems in technology are not directly impacting your call center staff and customers.

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The third category of solutions is human resources. Just as you would not let your nurse administer BCG without proper training, you should work to ensure that the face of the practice-the call center-is properly trained and supervised. Some phone systems allow supervisors to monitor phone calls to assess the quality of calls; are they doing that? Do your staff know how to get the answers to basic common questions such as, “How long has Dr. Jones been in practice?” or “Does Dr. Smith take my insurance?”

Are staff held accountable to some of the benchmarks mentioned above? Do you have the right people in the call center? The call center can be the nerve center of the practice, but may not be getting the attention it deserves.

Bottom line: The customer experience will increasingly differentiate high-performing medical practices, and the phone will be an enduring interface between your practice and your customers. Don’t assume that no news is good news-take a look at how your “call center” is working and see if you can answer some of these questions as well as your callers.

Large or small, your ‘call center’ is essential to a good first impression.

Why your practice needs to track phone call quality

Physician ownership of intensity-modulated radiation therapy (IMRT) facilities appears to influence the way men with newly diagnosed prostate cancer are treated, according to a recent study presented at the AUA annual meeting in San Francisco.

Statins show benefit in Caucasian PCa patients

Previous studies have found an association between IMRT ownership and increased use of radiation therapy, Tudor Borza, MD, MS, explained. However, these studies have been criticized for their choice of control groups, lack of generalizability, and the fact that they did not evaluate IMRT ownership’s effect on overall treatment of prostate cancer, said Dr. Borza, who was a urologic oncology and health services research fellow at the University of Michigan, Ann Arbor, at the time of the study, working with Brent K. Hollenbeck, MD, MS, and colleagues.He is currently assistant professor of urology at the University of Wisconsin School of Medicine and Public Health, Madison.

For the current study, Dr. Borza presented data from a retrospective cohort of 19,063 men from a 20% Medicare sample. The authors sought to evaluate the effect of IMRT ownership on initial prostate cancer treatment (defined as receipt of radiation therapy, surgery, or cryotherapy within 1 year of diagnosis), treatment in men least likely to benefit (defined as treatment in patients with 10-year risk of non-cancer mortality >75%), and annual per-beneficiary price standardized spending. The men were age 66 years or older and were diagnosed with prostate cancer between 2010 and 2013, with 1-year follow-up through the end of 2014.

The men in the study were cared for by urologists representing 561 single-specialty groups. The authors performed Internet searches to determine IMRT ownership, looking for practices whose websites advertise IMRT services or who employed at least one radiation oncologist. They identified 88 practices.

The authors found wide variation in initial treatment, with treatment rates ranging from 47% to 87% and most of the IMRT-owning groups clustered “well above” the mean rate of 70%, according to Dr. Borza. Sixteen percent of IMRT-owning were groups were below the mean, while 57% were in the highest quartile.

For treatment in men least likely to benefit, the variation was greater, ranging from 15% to 80%. Fourteen percent of IMRT-owning groups were below the mean rate of treatment of 44%, while 43% were in the highest quartile.

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Annual spending ranged from $12,865 to $34,964, with a mean of $20,668. Eleven percent of IMRT-owning groups had spending below the mean, while 68% were in the highest quartile.

“These data are suggestive of the fact that IMRT ownership clearly plays a role in the way men with newly diagnosed prostate cancer are treated,” Dr. Borza said.

Retrospective cohort study identifies wide variation in treatment rates, spending.

IMRT ownership appears to influence PCa treatment

On May 21, a 28-year-old male presented to the hospital with significant upper back pain, with no history of injury. He reportedly informed the medical staff that he recently had an abdominal methicillin-resistant 

(MRSA) infection and that he was taking an antibiotic. He was discharged with a diagnosis of muscle strain.

On the evening of May 22, he returned to the emergency room with worsening thoracic pain, which was wrapping around to his left flank. He claimed he told the triage nurse of his recent MRSA infection and oral antibiotic. An ER doctor suspected a kidney stone, which was then ruled out by a pelvic computed tomography scan. The patient was administered intravenous morphine and an anti-inflammatory. He was discharged with a diagnosis of back pain.

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The following night, on May 23, he again returned to the hospital with continued back pain. While in the ER, he developed leg numbness and weakness that progressed to paralysis. He was diagnosed with a spinal epidural abscess and transferred to another hospital, where he underwent surgery to remove the abscess.

After the patient’s abscess was surgically removed, he remained hospitalized for 2 weeks. He was treated with inpatient rehabilitation for 6 weeks. He suffered incomplete paraplegia with muscle spasms and bowel and bladder dysfunction. Upon discharge, he was treated with physical therapy, which he will do indefinitely, and consulted with a physiatrist, neurologist, urologist, and hematologist.

He was treated with a neurotoxin for muscle spasms and underwent intrathecal baclofen therapy to control them. He further treats with self-catheterization and is on a bowel program. He can only walk a few steps with braces, and is primarily wheelchair-bound.

The patient sued the hospital and physicians who treated him, alleging they were negligent in failing to properly diagnose the spinal abscess. The ER doctor who suspected a kidney stone testified that a spinal abscess would have been high on his differential diagnosis if he had known of the recent MRSA infection. The plaintiff’s counsel introduced medical records in which the nurses and other physicians noted the recent MRSA infection, and the ER doctor conceded that he would have had access to those records at the time he treated the patient.

The plaintiff’s expert opined that the ER doctor should have ordered a magnetic resonance imaging scan on May 22, which would have revealed the abscess, allowing for timely and proper treatment, and would have likely avoided subsequent neurologic injury. The plaintiff’s expert criticized the ER doctor for failing to take an adequate history and physical examination of the patient, who had been diagnosed with a MRSA skin infection on his abdomen that had been recently drained. Had the physician known about the patient’s MRSA, the expert opined, it would have raised a red flag to suggest that the patient’s back pain was a potential infection, which would have necessitated an MRI.

The plaintiff’s expert further opined that when the ER doctor did not find any urinary/gallbladder stones on the CT scan, he assumed that the patient’s back pain was soft tissue/muscular in nature, without considering another source. “Abdominal stranding” was found on the scan, which can indicate inflammation moving toward the spine. However, according to the plaintiff’s expert, the ER doctor failed to look at the abdomen more carefully to determine the source of the inflammation.

The defendants denied liability and contended that standard-of-care treatment was provided. The ER doctor testified that the patient denied taking medications when asked. The defense expert maintained that a spinal abscess is exceedingly rare, and is not clinically diagnosable in the absence of a fever and neurologic deficits, which the patient did not have until his last hospital visit. The defense expert concluded that the MRSA skin infection would not have been an obvious sign of a spinal epidural abscess. The defense expert further testified that since the patient did not have a fever or other symptoms, there was not a high enough suspicion to order an MRI to look for an abscess or another condition in the patient’s spine.

The plaintiff, who is permanently disabled, testified about his daily restrictions and how he leads a sedentary lifestyle. He testified that he rarely sees his two daughters and said he has missed out on teaching them to ride bikes and coach them in sports. He sought damages for past and future medical bills and pain and suffering. His daughters sought damages for loss of services.

After a 2-week trial, a county jury deliberated and awarded the plaintiff $5,200,000 in damages, and $200,000 for each daughter, for a total award of $5,600,000.

This unfortunate outcome left this patient permanently debilitated, and at a young age. The factual question presented to the jury was whether the ER doctor breached the standard of care and whether that breach proximately caused the plaintiff’s injury. The jury heard testimony from the patient’s expert, who indicated that the ER doctor should have known about the MRSA infection, and should have ordered additional testing once he ruled out the kidney stone as a possible source of pain. The ER doctor himself testified that had he known about the MRSA infection, he would have performed additional testing.

The evidence that the MRSA infection was contained in the notes likely undercut the ER doctor’s defense, even though he testified that the patient did not exhibit other signs of an abscess, including a fever. The plaintiff presented testimony from a life care expert and economist who presented a life care plan with an approximate present value of $5 million. This testimony ultimately weighed in the patient’s favor.

"The factual question presented to the jury was whether the ER doctor breached the standard of care and whether that breach proximately caused the plaintiff’s injury," writes Acacia Brush Perko, Esq.

Delayed abscess Dx results in paralysis

Bacteriuria in patients using clean intermittent catheterization is a significant problem that can lead to overuse of antibiotics. 

of the University of Michigan, Ann Arbor, discusses when to treat and when not to treat these patients. Dr. Clemens was interviewed by 

professor of urology at Wake Forest Baptist Medical Center, Winston-Salem, NC.

Please briefly discuss the issue of bacteriuria and clean intermittent catheterization.

It’s a huge problem because it leads to over-treatment of patients, and we are becoming more and more aware of the risk of overuse of antibiotics. Patients who use a catheter to empty their bladder will have bacteriuria, and it’s surprising to me how many clinicians don’t seem to be aware of that. Patients need to be their own protectors and not let clinicians treat them with antibiotics if they’re not having bladder-specific symptoms.

The problem, of course, is sometimes the symptoms are non-specific, in which case I recommend getting a urine culture and holding off on treating until the culture results are back and then seeing if the symptoms go away. If they do go away, then they shouldn’t get antibiotics.

Some patients do in fact have recurrent symptomatic UTIs, at which point I recommend checking for structural or functional abnormalities. What does that mean? I have them get a renal/bladder ultrasound to check for kidney stones or bladder stones and potentially urodynamics if they haven’t had that recently.

If all of that looks OK, we’ve had great success using intravesical gentamicin to help prevent UTIs. It can be administered each evening; patients instill 50 or 60 cc and then leave it in overnight and remove it the next morning when they’re catheterized. It does not cause gentamicin resistance and it works very well to reduce UTIs without exposing them to systemic antibodies. I was a co-author of a study of this that was published in the 

Canadian Urological Association Journal 

We use 480 mg that is diluted in 1 liter of normal saline. Many pharmacists will tell patients it has to be refrigerated, but it can in fact be stored at room temperature.

Bacteriuria in patients using clean intermittent catheterization is a significant problem that can lead to overuse of antibiotics. J. Quentin Clemens, MD, of the University of Michigan, Ann Arbor, discusses when to treat and when not to treat these patients.

CIC-associated bacteriuria: When to treat-and not treat

Results of a prospective, multicenter study validate the clinical performance of a PSA isoform assay (IsoPSA) for predicting high-grade 

 Eric A. Klein, MD, reported at the AUA annual meeting in San Francisco.

“Current assays that measure PSA are prostate specific but not cancer specific, and therefore, they lead to a lot of unnecessary biopsies,” said Dr. Klein, Andrew C. Novick Distinguished Chair, Glickman Urological and Kidney Institute, and professor of surgery, Lerner College of Medicine of Cleveland Clinic, Cleveland.

“The IsoPSA assay is a novel biomarker that predicts cancer risk based on measuring the structure rather than the concentration of prostate cancer-specific isoforms. We believe that its use as a reflex test is likely to reduce over-detection of low-grade cancer and also the rate of unnecessary biopsies by an estimated 47%.”

Using a small sample of blood placed into a proprietary aqueous solution, IsoPSA measures PSA isoforms that arise because the disordered metabolism of cancer cells results in molecular truncation and glycosylation, causing changes in physical structure.

Its performance for predicting Gleason grade ≥7 disease was demonstrated in an initial study that included 261 men with PSA ≥2 ng/mL who were undergoing prostate biopsy within 30 days. The prevalence of high-grade disease in the study population was 33.7%, and the PSA isoform test had an area under the curve (AUC) of 0.81 for predicting Gleason grade ≥7, 96% sensitivity, and a negative predictive value (NPV) of 95%. The AUC for total PSA was 0.68, and there was no relationship between the IsoPSA value and serum PSA.

“A lot of men in the study cohort who had a very low PSA would be considered at high risk for having high-grade disease based on their IsoPSA result,” Dr. Klein said.

The validation study included 271 men with a PSA ≥2 ng/mL who had blood obtained within 30 days prior to prostate biopsy; the prevalence of high-grade disease in this cohort was 29.5%. The performance of IsoPSA in the validation study was statistically similar to the preliminary analysis. The AUC for predicting Gleason grade ≥7 disease was 0.79, and the test’s sensitivity and NPV were both 93%. The AUC for total PSA was 0.66.

Assay performs better in men undergoing MRI-guided Bx

Dr. Klein pointed out that the percentage of men undergoing magnetic resonance imaging-ultrasound fusion biopsy was higher in the validation study than in the initial study (42% vs. 4%). A subgroup analysis in the validation cohort with men categorized by biopsy type (MRI-guided or transrectal ultrasound) showed the assay performed better in men undergoing an MRI-guided biopsy than in those having a transrectal ultrasound-guided biopsy both for predicting the presence of any cancer (AUC 0.82 vs. 0.78) and Gleason grade ≥7 disease (AUC 0.86 vs 0.83).

“One would expect that a test that predicts the presence of high-grade disease should perform better when it is used in men who undergo biopsy with a technique that is more likely to find high-grade disease, and in fact, it did,” said Dr. Klein.

Results of a multivariable analysis found that the IsoPSA result was the only variable that independently predicted Gleason grade ≥7 disease in both the initial and validation studies. Age was a significant variable in the initial study only, and there were no significant associations between presence of high-grade disease and total PSA, prostate volume, or race in either study.

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“This finding suggests that IsoPSA will be a very simple test to use,” Dr. Klein said.

Based on the findings from the initial and validation studies, Dr. Klein proposed a screening algorithm in which IsoPSA would be ordered as the next step for all men with a worrisome total serum PSA. Men with a negative IsoPSA would be monitored while those with a positive test result would be considered candidates for MRI-ultrasound fusion biopsy.

“The role of MRI-ultrasound fusion biopsy for prostate cancer detection in the setting of PSA screening is controversial, in part because it misses about 20% of high-grade disease. I would argue that a biopsy is justified in a patient who tests positive with an assay that has high sensitivity for detecting the presence of Gleason grade 7 or higher prostate cancer, even if the MRI is negative,” he said.

Cleveland Clinic has a financial interest in Cleveland Diagnostics, which owns the intellectual property for IsoPSA with AnalizaDx. Genomic Health has licensed this intellectual property for commercial development.

Results of a prospective, multicenter study validate the clinical performance of a PSA isoform assay (IsoPSA) for predicting high-grade prostate cancer, Eric A. Klein, MD, reported at the AUA annual meeting in San Francisco.

PSA isoform assay predicts high-grade PCa

is assistant attending epidemiologist, departments of surgery (urology service) and epidemiology and biostatistics, Memorial Sloan Kettering Cancer Center, New York, and department of urology, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.

 by measuring the concentration of PSA in blood is a contentious issue, as the specificity of the PSA test is modest. The scientific community is working to develop novel methods to distinguish aggressive from indolent prostate cancer.

The list of methods and biomarkers to help patients and physicians decide whether to perform biopsy is continuously evolving. The 2018 National Comprehensive Cancer Network 

Prostate Cancer Early Detection guideline

4Kscore, and PCA3-tests that have been evaluated in dozens of scientific papers and thousands of patients, including prospective multicenter evaluations. When any of these methods are used as a “reflex” test in men with an indication for biopsy, they have shown improved accuracy over the PSA test and have significantly reduced the need for biopsy.

Multiparametric magnetic resonance imaging (MRI) is gaining traction as a diagnostic tool in the pre-biopsy setting and has been shown in several large-scale randomized controlled trials to improve the cancer detection rate when combined with transrectal ultrasound fusion biopsies compared to systematic biopsy alone.

Midlife PSA strongly predicts PCa in African-American men

I commend Dr. Klein and colleagues for evaluating a new diagnostic tool that could enhance the field of prostate cancer detection: the IsoPSA assay (see article 

 This test utilizes an intriguing laboratory technique that measures the protein structure of free and complex PSA, which is then mathematically converted to a predicted risk of high-grade cancer. In the initial prospective study of 261 men with biopsies and total PSA levels ≥2.0 ng/mL, IsoPSA outperformed total PSA in predicting high-grade prostate cancer (area under the curve [AUC]: 0.81 [95% CI: 0.74–0.86]) and had a favorable “net benefit” (ie, balancing caught vs. missed cancers as well as risks with biopsy) compared to performing biopsies based on a risk calculator 

A small prospective validation study of 123 biopsied men with total PSA levels ≥2.0 ng/mL, of whom many had an MRI-guided biopsy in addition to systematic biopsy, confirmed an AUC of 0.82, with a reduction in unnecessary biopsies by 47% and missed/delayed detection of 2% of high-grade cancers 

While these initial studies are interesting, there is a critically important need for additional large-scale, prospective and comparative studies before we can determine the clinical utility of IsoPSA. For instance, how does the test perform as compared to free/total PSA or other biomarkers based on isoform concentrations, with/without the use of MRI and with/without clinical information in the mathematical model? Answers to this and other questions will decide whether IsoPSA could be a notable addition in our diagnostic arsenal to distinguish aggressive from indolent prostate cancer.

"The list of methods and biomarkers to help patients and physicians decide whether to perform biopsy is continuously evolving," writes Sigrid Carlsson, MD, PhD, MPH.

Vol. 46 No. 10