Randy Dotinga

Jodi Antonelli, MDOther key stone disease/endourology topics from the 2016 AUA annual meeting included the use of aspirin in percutaneous nephrolithotomy patients as well as the continuing debate over the benefit of medical expulsive therapy. The stone disease/endourology take-home messages were presented by Jodi Antonelli, MD, of the University of Texas Southwestern Medical Center, Dallas.

The new AUA/Endourological Society guideline on the surgical management of stones provides insight into imaging, preoperative testing, and the treatment of renal and ureteral stones in adults, children, and pregnant women. The guideline includes indications for active surveillance and surgical treatment, recommendations for surgical approach, and broadened indications for ureteroscopy over shock wave lithotripsy.

The learning curve for ultrasound-guided percutaneous nephrolithotomy may be as short as 20 cases, and adoption of this technique may dramatically reduce radiation exposure for patients and providers. Physicians improved over consecutive cases, with fluoroscopic screening time decreasing from 79.2 seconds over the first 20 cases to 11.1 seconds in the last 20 and success in puncture increasing from 30% over the first 20 cases to 100% in the last 20 cases.

The novel laser direct alignment radiation reduction technique for PCNL access showed impressively low access and total fluoroscopy times in an initial 25 cases. This may be a safe way to perform PCNL with reduced radiation exposure.

In patients with stones 5-20 mm in size, active basket extraction had a higher stone-free rate at 3 months compared to dusting but didn’t demonstrate a difference in other areas such as symptoms, reintervention, and readmission rates. Extended follow-up may provide more information.

PCNL may be safely performed in patients on aspirin. No significant differences in residual fragments, perioperative change in hemoglobin, hematocrit, and creatinine, or 30-day complication rate (bleeding or thrombotic events) were found in patients on aspirin therapy compared to those who were not.

Continue to the next page for more take-home messages.

The overall risk of bleeding was 3.3% in PCNL patients on anti-platelets and anticoagulants, with 18 of 540 PCNL cases experiencing significant bleeding, of whom 10 required embolization.

PCNL is safe in the super-obese population. Additionally, two separate studies found PCNL can be safely performed in the ambulatory setting.

Multiple abstracts evaluated the role of medical expulsive therapy in treating stones. One found that silodosin (Rapaflo) increased rate of stone expulsion and decreased time to passage in adults with distal stones 5-10 mm in size. A separate study found that in pediatric patients, silodosin had no benefit for rate of stone expulsion but decreased time to passage and pain.

A systematic review of alpha-blockers including more than 5,600 patients found no benefit for the use of medical expulsive therapy in small ureteral stones but showed a 58% higher rate of stone passage with larger stones, as well as a reduced likelihood of urologic intervention for patients with lower ureteral stones.

A systematic review of trials of alpha-blockers and nifedipine found that overall, these medications were statistically significantly more likely to lead to stone expulsion. However, a subgroup analysis of powered RCTs with low risk of bias found no benefit. Combining the overall studies and subgroup analysis, alpha-blockers showed a shorter time to passage and improved passage of larger distal stones.

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Other key stone disease/endourology topics from the 2016 AUA annual meeting included the use of aspirin in percutaneous nephrolithotomy patients as well as the continuing debate over the benefit of medical expulsive therapy.

Stone Disease: New AUA guide discusses SWL vs. URS

To Victor Cotton, MD, JD, an attorney and former practicing physician, practicing medicine means never having to say you’re sorry.  

	“In simple terms, a doctor who gives his or her best effort does not owe the patient an apology for anything,” he said.

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	For decades, however, apologies have been on the minds of researchers and lawmakers, if not necessarily on the lips of physicians themselves.

	First, a slew of new state laws attempted to make it easier for medical professionals to apologize without having to worry about making themselves vulnerable in malpractice lawsuits. The wave of legislation has waned. But now there’s a new trend: communication-and-resolution programs that encourage physicians and medical facilities to do much more than just say they’re sorry when mistakes happen.

	Meanwhile, two new studies-including one presented at the 2016 AUA annual meeting-offer conflicting perspectives on whether the laws are working, at least in terms of reducing litigation.

	All this makes for a complex apology landscape, one that continues to divide attorneys, doctors, and patient advocates. Are apology laws really “traps for the unwary physician,” as Dr. Cotton describes them? Should they be replaced by communication-and-resolution programs, seen by some as a kind of apology law-plus? Or perhaps the laws are serving a purpose by promoting openness, honesty, and accountability.

	Whatever the case, “Few physicians are familiar with apology law and even fewer understand the significance,” said Patrick McKenna, MD, chief of the division of pediatric urology at American Family Children’s Hospital and professor of urology at the University of Wisconsin, Madison.

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	Judging by Dr. McKenna’s new research supporting the value of apologies, what physicians don’t know could hurt them after they hurt patients.

	Apologies and medicine are not bosom buddies. Throughout much of history, physicians simply didn’t say they were sorry, says Thomas H. Gallagher, MD, professor and associate chair of the department of medicine and professor in the department of bioethics and humanities at the University of Washington in Seattle.

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	“There was a sense that we can talk with our peers about things that have gone wrong, but it’s not good to air our dirty laundry outside of the profession,” he said. “Some of this was couched in terms of trying to promote trust. Sharing information about an error might diminish that trust.”

	Self-protection played a role too. “The profession was embarrassed to be open about the aspects of care that weren’t going well,” Dr. Gallagher said.

	And then there’s the matter of money. Malpractice law has its roots in the middle of the 19th century, not the 20th, Dr. Gallagher says. So there’s long been a real threat that openness-“I made a mistake, I hurt you, and I’m sorry”-could have real consequences.

	In 1986, Massachusetts adopted the first law designed to encourage physicians to apologize without having to worry that their words would be used against them. A total of 38 states now have apology laws on the books.

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	But the laws are anything but standard, meaning that your state’s apology law mileage may vary. Thirty-two states have so-called “partial” apology laws and six have “full” apology laws.

	“Partial and full apology laws differ in the type of communication protected, the sentiments protected, the types of providers that are protected, to whom the protected communication may be made, and the context in which a communication will be protected,” Dr. McKenna explained.

	The six states with full apology laws-Wisconsin, South Carolina, Georgia, Connecticut, Colorado, and Arizona-provide the most protection to physicians.

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	Wisconsin’s 2014 apology law, for example, allows statements of “apology, benevolence, compassion, condolence, fault, liability, remorse, responsibility, or sympathy.” The statements, however, must be made “before the commencement of the civil action, administrative hearing, disciplinary proceeding, mediation, or arbitration.”

	The Wisconsin law seems clear and easy to understand. But apology laws can be maddeningly complex and vague too.

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	For example, Florida’s partial apology law says “the portion of statements, writings, or benevolent gestures expressing sympathy or a general sense of benevolence relating to the pain, suffering, or death of a person involved in an accident and made to that person or to the family of that person shall be inadmissible as evidence in a civil action.”

	Clear as mud, it seems. Do medical mishaps count as “accidents”? It’s not clear. If they do count, can a urologist, for example, apologize and go on to admit responsibility for missing obvious signs of cancer? No: The law says a statement of fault is admissible.

	Researchers have been trying to understand the effects of apology laws, but their findings have been mixed.

	In an October 2011 study published in the 

 (2011; 43:141), researchers reported that apology laws seemed to reduce average malpractice payments and settlement time, especially in cases involving the worst harm.

	However, a 2016 Vanderbilt University study that has been presented to several academic audiences found that, “In general, apology laws increase the probability of malpractice lawsuits... Overall, the evidence suggests that apology laws do not effectively limit medical malpractice liability risk.”

	Now, a new study co-authored by a urologist, Dr. McKenna, offers a contrasting opinion. The study analyzed malpractice cases from 1991 to 2014. In states with apology laws, litigation length was 4.4±3.3 years before the laws were enacted (N=165,556) and 3.3±2.0 years afterwards (N=38,940) 

<.001). Litigation length was shorter (2.6±1.4 years, N=2,281) in states with full apology laws than in states with partial laws (3.3±2.0, N=36,659; 

	Why might there be a connection? According to other research, patients and their relatives say “an explanation and apology would prevent them from litigating,” Dr. McKenna said. “Additionally, apologies decrease patients’ anger toward their doctor and increase patients’ trust, strengthening the doctor-patient relationship.”

	Not so fast, says Dr. Cotton, the anti-apology attorney. Yes, he practices law in a state- Pennsylvania-that has a partial apology law. But he doesn’t think it’s worth anything.

	Empathy, compassion, and caring are part of doctoring, he believes. However, he said, “The idea that a doctor who inadvertently injures a nerve during a complex, 6-hour surgery has committed a moral wrong that violates the trust of the doctor-patient relationship is insulting.”

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	As for apologizing, he said, “It is very hard to find a real physician who has tried this approach. They value their licenses and careers.”

Dr. McKennaWhat if a doctor does actually want to apologize and wants to do it right?

	“Don’t apologize unless you know a mistake has been made,” Dr. McKenna advised. “Wait until the evidence clearly indicates a medical mistake before giving an apology.”

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	But keep in mind that “a patient deserves to know what happened in the event of a medical error,” Dr. McKenna said. “At the least, the doctor should disclose the error, as this is ethical.”

	“In states with partial apology laws, physicians should be cognizant that giving an apology without admitting fault is still better than giving no apology at all,” he said. “In states with full apology laws, it is important to know that patients want to understand what happened, why it happened, how the error could impact their health, and plans for preventing future errors. All of this information should be offered in the apology.”

	You may also wish to look at relevant codes of ethics. An opinion from the American Medical Association says “physicians must offer professional and compassionate concern toward patients who have been harmed” and offer a “general explanation” regarding what happened and how future errors will be prevented.

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	The ethics code of the AUA tells urologists to “render services to humanity with full respect for human dignity.”

	Dr. Gallagher, the University of Washington professor who is a general internist, says he frequently apologizes to patients and uses the words “I’m sorry,” often repeatedly.

	“I’ve found that patients really appreciate an open and honest conversation and, when the harm was caused by an error, a really frank apology,” he said.

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	But be aware, he says, that just because patients appreciate an apology doesn’t mean they’re happy. Also understand that acknowledging an error could bring it to a patient’s attention and potentially prompt legal action.

	So what do patients want? “In all cases, they want empathy and understanding. They want someone to care,” said Sarah Armstrong, RN, MSN, JD, a health care communication and conflict resolution consultant at the University of Washington.

	But expressions of condolence, sympathy, and responsibility aren’t enough. “The majority of them want to know that this error will never happen again to anyone else,” Armstrong said. But too often, she said, “patients are left to wonder how an error happened and whether it will happen again.”

	Indeed, apologies focus on resolving a problem from the past, not fixing the future. That’s one reason why some health systems are embracing communication-and-resolution programs, which encourage medical professionals to do more than say they’re sorry. These programs promote apologies, explanations, and-in some cases-compensation.

	In May 2016, the federal Agency for Healthcare Research and Quality introduced the CANDOR (Communication and Optimal Resolution) tool kit, which encourages hospitals to be open to patients about errors. The kit is based in part on policies at the University of Michigan Health System in Ann Arbor, which says it’s seen reductions in lawsuits, malpractice cases that reach court, and settlement payments.

	Critics question whether these programs intend to divert patients with valid cases from suing. But others believe they not only prevent lawsuits but also lead to change because they emphasize preventing future errors.

	“No liability reform holds as much promise for improving safety,” Armstrong said.

	So which approach is best: No apologies, apologies, or apologies-plus?

	Dr. Cotton points to words attributed variously to Hippocrates and tuberculosis pioneer Edward Livingston Trudeau, MD: “To cure sometimes, to relieve often, to comfort always.” Comfort, as always, will be the hardest of those three verbs to define.

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“Few physicians are familiar with apology law and even fewer understand the significance,” said Patrick McKenna, MD, chief of the division of pediatric urology at American Family Children’s Hospital and professor of urology at the University of Wisconsin, Madison.

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	A new industry-funded study finds that sacral neuromodulation patients with urgency incontinence, urgency frequency, or both-almost all of whom were women-reported improvement in quality of life measures after 3 years of treatment. 

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	The patients had failed an average of two medications, said lead author Karen Noblett, MD, of the University of California Riverside School of Medicine, Riverside. According to Dr. Noblett, the findings “suggest we probably should move to third-line therapies more quickly and not prescribe medication after medication if they’ve failed a couple.”

	The InterStim system (Medtronic, Minneapolis) is FDA-approved for urinary incontinence, urgency-frequency, urinary retention, and fecal incontinence.

	“It’s a third-line therapy after behavioral therapy and medications,” Dr. Noblett told 

 and unique because patients can test the therapy over a trial period to see if it helps them. If the treatment works, then the device is implanted permanently in the body.

	“It’s a very minimally invasive outpatient procedure, done with just local anesthesia and IV sedation,” she said.

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	The new study, presented at the AUA annual meeting in San Diego, is a retrospective sub-analysis of a 5-year prospective study into the use of tined leads to hold the device in tissue. This research satisfies the FDA’s request for post-approval analysis, she noted.

	“We saw significant improvement,” Dr. Noblett said, “and we wanted to see if that would differ in patients with just urgency frequency versus those with urgency incontinence.”

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	The study examined 272 subjects, 91% of whom were female, with an average age of 57 years. Of the subjects, 104 (51%) had both incontinence and frequency symptoms, while 54 (27%) had incontinence only, and 44 (22%) had frequency symptoms only.

	All groups showed significant improvement over baseline at 36 months in Health Related Quality of Life and ICIQ-OABqol subscales of Concern, Coping, Sleep, Social, and Interference (all 

	“Not only are their diaries showing that they have fewer bladder symptoms, but these improvements are having a significant effect on their quality of life,” Dr. Noblett said.

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	However, incontinence-only patients showed less improvement than the other groups in the Sleep subscale 

<.02), and they scored lower on the Coping subscale than those with both conditions.

	On the Interference measure, which refers to interference with daily activities, about 80% of the subjects in all three groups reported they improved or greatly improved. This is an intriguing finding because some observers might assume that patients with incontinence would experience the greatest benefit due to the effects of leaking urine, Dr. Noblett said.

Data offer new insight on HIFU’s use in low-risk PCa

	While patients often don’t have full relief from urinary symptoms, she said, patients are often still pleased.

	“They’ve gone from wearing a diaper to a panty liner. If you’re an adult woman, and you don’t have a diaper anymore, that will have a significant impact on quality of life.”

	Overall, she said, “We were very happy to see the response was so robust and well-maintained over the 48 months we’ve collected the data,” she said. “We’ll continue to compile outcome data at 48 months and at 60 months of the 5-year period. We want to identify the ideal candidates for this therapy and predict who may respond more than others.”

	The study was funded by Medtronic, and Dr. Noblett serves on the advisory board for Medtronic and was a participant in the InSite trial of the InterStim system. Several of Dr. Noblett’s co-authors were consultants/advisers and/or investigators for or employees of Medtronic.

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Evaluation of the InterStim system in patients with urgency incontinence, urgency frequency, or both suggests benefits beyond urinary symptom relief.

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	As the controversy over the use of high-intensity focused ultrasound (HIFU) continues, efficacy research from a device manufacturer offers new insight into how low-risk, low-grade 

AS success rate strong in appropriate PCa patients

	The researchers reported that transrectal HIFU produced a statistically significant increase-from 70.8% to 92.3%-in per-core negative biopsy rates. But lead study author Cary Robertson, MD, cautioned that the findings, from 2007 to 2010, shouldn’t necessarily encourage urologists to embrace HIFU treatment for low-risk patients.

	“The landscape is changed, and the patient with intermediate cancer is probably the ideal patient,” said Dr. Robertson, of Duke University Medical Center and Duke Cancer Institute, Durham, NC. He spoke with 

 about his study, which was presented at the AUA annual meeting in San Diego.

	Last fall, the FDA cleared SonaCare Medical to market its Sonablate 450 device for ablation of prostate tissue. It later approved the marketing of EDAP TMS SA’s Ablatherm device for the same indication.

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	The new study findings are being released as urologists continue to debate the value of HIFU in light of the FDA rulings. It’s not a new controversy: In January 2014, a 

 online poll found that 46% of respondents didn’t believe HIFU for prostate cancer had a future in the United States. The other 54% thought it did.

Next: 24-month study enrolled 135 patients

	The 24-month, prospective, non-randomized study enrolled 135 patients aged 50 years and over with low-risk, localized prostate cancer (stage T1-T2a, PSA <10.0 ng/mL, Gleason score <6) and prostate AP diameter <25 mm. The patients were treated with HIFU via Ablatherm and analyzed via prostate biopsy for cause, 24-month post-HIFU biopsy, and serum PSA.

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	The biopsies are unusual, Dr. Robertson said, since surgeons typically rely on PSA results after procedures.

	The results: Of 1,251 baseline pre-HIFU biopsy cores, 365 (29.2%) were positive for prostate cancer. After the procedure, 87 (7.7%) of 1,127 biopsy cores were positive.

	Before the procedure, mean PSA was 4.60 ng/mL. At 6 months after the procedure, the mean PSA nadir was 0.53 ng/mL.

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	As for side effects, “Some patients had inflammatory changes on urinalysis since you’ll get some shedding of some cells,” Dr. Robertson told 

 “Most of the patients didn’t really have any real issues. They had their treatments and a temporary indwelling catheter, and they had that taken out.”

Next: What should urologists take from the research?

	What should urologists take from the research? The relevance is limited due to the patient population. According to Dr. Robertson, patients with low-risk, low-grade prostate cancer are “not considered a great treatment category” for HIFU.

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	EDAP TMS says HIFU “is generally recommended for patients with localized prostate cancer (stages T1-T2) who are not candidates for surgery or who prefer an alternative option, or for patients who failed radiotherapy treatment.”

	Dr. Robertson is a consultant and principal investigator for EDAP TMS.

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Author | Randy Dotinga

Articles

Stone Disease: New AUA guide discusses SWL vs. URS

Sorry, not sorry: Medicine’s apology dilemma evolves

Data weigh neuromodulation’s impact on QoL at 3 years

Data offer new insight on HIFU’s use in low-risk PCa