User login
House committee debates single-payer health care design
House Budget Committee Chairman John Yarmuth (D-Ky.) opened a May 22 hearing on the prospect of moving to some kind of single-payer health care system with a bold prediction.
“I strongly believe it’s not a matter of if we will have universal coverage, but when,” Rep. Yarmuth said, adding that the “trick is closing the information gap on what single-payer health care truly is, so that we can close the health coverage gap for millions of American families.”
The hearing was held to review a Congressional Budget Office report ordered by Chairman Yarmuth, which examines the key design elements to be considered in establishing a single-payer system.
Mark Hadley, deputy director of the Congressional Budget Office, highlighted two key points with regard to establishing a single-payer system.
“First, moving to a single-payer system would be a major undertaking,” he said. “It would involve significant changes for all participants – individuals, providers, insurers, employers, and manufacturers of drugs and medical devices. Because health care spending currently accounts for about one-sixth of the nation’s economic activity, those changes could significantly affect the overall U.S. economy. And the transition toward a single-payer system could be complicated, challenging, and potentially disruptive.”
Mr. Hadley continued: “Second, to establish a single-payer system, lawmakers would need to make many decisions and would face complex trade-offs.”
And because of the multitude of trade-offs related to the design of a single-payer system, questions related to coverage, cost, and access to health care services were generally met with vague answers.
For example, would a single-payer system create access issues because of the potential increased burden on providers by providing health care coverage to all?
“Whether the supply of providers would be adequate to meet the greater demand would depend on various components of the system,” Mr. Hadley said. “If the supply of services was not sufficient to meet the demand for care, patients might face increased wait times and reduced access to care. The government, however, could implement policies to encourage the provision of services, and in the longer run, providers might deliver care more efficiently.”
Republican lawmakers on the panel focused on a detail lacking in the report: a cost estimate for implementing a single-payer system.
“What’s noticeably missing from the report is a cost estimate for specific proposals,” said Rep. Steve Womack (R-Ark.), the committee’s ranking member. “My friends across the aisle didn’t ask for one. I think I know why. While the score would be useful, we already know how much a one-size-fits-all health care system would cost the American people. Independent analyses from economists across the ideological spectrum, including George Mason University, the Urban Institute, [and] the American Action Forum have projected single-payer type proposals, such as Medicare-for-all, to cost at least $32 trillion.”
Rep. Womack also said that the report “has been especially helpful in showing that these ideas will never work in America.”
He noted that the report warns that a single-payer system could end up “reducing payment rates for providers. That is payments for doctors, hospitals, and so on. The report explains there will not only be a reduction in the quality of care, there would be a reduction in the supply of care, hampering access to the treatments and services people need.”
The report does caution that using cost-containment measures, such as global budgets and utilization management, “could adversely affect access to and quality of care by causing providers to supply less care to patients covered by the public plan. Less spending on medical services could also alter manufacturers’ incentive to develop new technologies or providers’ incentive to invest in capital, which could affect patients’ choices over the long term.”
Additionally, the report notes that the structure of a single-payer system could result in lower reimbursement for health care services. “Proposals like Medicare-for-all will chase a lot of doctors out of health care,” Rep. Womack said.
House Budget Committee Chairman John Yarmuth (D-Ky.) opened a May 22 hearing on the prospect of moving to some kind of single-payer health care system with a bold prediction.
“I strongly believe it’s not a matter of if we will have universal coverage, but when,” Rep. Yarmuth said, adding that the “trick is closing the information gap on what single-payer health care truly is, so that we can close the health coverage gap for millions of American families.”
The hearing was held to review a Congressional Budget Office report ordered by Chairman Yarmuth, which examines the key design elements to be considered in establishing a single-payer system.
Mark Hadley, deputy director of the Congressional Budget Office, highlighted two key points with regard to establishing a single-payer system.
“First, moving to a single-payer system would be a major undertaking,” he said. “It would involve significant changes for all participants – individuals, providers, insurers, employers, and manufacturers of drugs and medical devices. Because health care spending currently accounts for about one-sixth of the nation’s economic activity, those changes could significantly affect the overall U.S. economy. And the transition toward a single-payer system could be complicated, challenging, and potentially disruptive.”
Mr. Hadley continued: “Second, to establish a single-payer system, lawmakers would need to make many decisions and would face complex trade-offs.”
And because of the multitude of trade-offs related to the design of a single-payer system, questions related to coverage, cost, and access to health care services were generally met with vague answers.
For example, would a single-payer system create access issues because of the potential increased burden on providers by providing health care coverage to all?
“Whether the supply of providers would be adequate to meet the greater demand would depend on various components of the system,” Mr. Hadley said. “If the supply of services was not sufficient to meet the demand for care, patients might face increased wait times and reduced access to care. The government, however, could implement policies to encourage the provision of services, and in the longer run, providers might deliver care more efficiently.”
Republican lawmakers on the panel focused on a detail lacking in the report: a cost estimate for implementing a single-payer system.
“What’s noticeably missing from the report is a cost estimate for specific proposals,” said Rep. Steve Womack (R-Ark.), the committee’s ranking member. “My friends across the aisle didn’t ask for one. I think I know why. While the score would be useful, we already know how much a one-size-fits-all health care system would cost the American people. Independent analyses from economists across the ideological spectrum, including George Mason University, the Urban Institute, [and] the American Action Forum have projected single-payer type proposals, such as Medicare-for-all, to cost at least $32 trillion.”
Rep. Womack also said that the report “has been especially helpful in showing that these ideas will never work in America.”
He noted that the report warns that a single-payer system could end up “reducing payment rates for providers. That is payments for doctors, hospitals, and so on. The report explains there will not only be a reduction in the quality of care, there would be a reduction in the supply of care, hampering access to the treatments and services people need.”
The report does caution that using cost-containment measures, such as global budgets and utilization management, “could adversely affect access to and quality of care by causing providers to supply less care to patients covered by the public plan. Less spending on medical services could also alter manufacturers’ incentive to develop new technologies or providers’ incentive to invest in capital, which could affect patients’ choices over the long term.”
Additionally, the report notes that the structure of a single-payer system could result in lower reimbursement for health care services. “Proposals like Medicare-for-all will chase a lot of doctors out of health care,” Rep. Womack said.
House Budget Committee Chairman John Yarmuth (D-Ky.) opened a May 22 hearing on the prospect of moving to some kind of single-payer health care system with a bold prediction.
“I strongly believe it’s not a matter of if we will have universal coverage, but when,” Rep. Yarmuth said, adding that the “trick is closing the information gap on what single-payer health care truly is, so that we can close the health coverage gap for millions of American families.”
The hearing was held to review a Congressional Budget Office report ordered by Chairman Yarmuth, which examines the key design elements to be considered in establishing a single-payer system.
Mark Hadley, deputy director of the Congressional Budget Office, highlighted two key points with regard to establishing a single-payer system.
“First, moving to a single-payer system would be a major undertaking,” he said. “It would involve significant changes for all participants – individuals, providers, insurers, employers, and manufacturers of drugs and medical devices. Because health care spending currently accounts for about one-sixth of the nation’s economic activity, those changes could significantly affect the overall U.S. economy. And the transition toward a single-payer system could be complicated, challenging, and potentially disruptive.”
Mr. Hadley continued: “Second, to establish a single-payer system, lawmakers would need to make many decisions and would face complex trade-offs.”
And because of the multitude of trade-offs related to the design of a single-payer system, questions related to coverage, cost, and access to health care services were generally met with vague answers.
For example, would a single-payer system create access issues because of the potential increased burden on providers by providing health care coverage to all?
“Whether the supply of providers would be adequate to meet the greater demand would depend on various components of the system,” Mr. Hadley said. “If the supply of services was not sufficient to meet the demand for care, patients might face increased wait times and reduced access to care. The government, however, could implement policies to encourage the provision of services, and in the longer run, providers might deliver care more efficiently.”
Republican lawmakers on the panel focused on a detail lacking in the report: a cost estimate for implementing a single-payer system.
“What’s noticeably missing from the report is a cost estimate for specific proposals,” said Rep. Steve Womack (R-Ark.), the committee’s ranking member. “My friends across the aisle didn’t ask for one. I think I know why. While the score would be useful, we already know how much a one-size-fits-all health care system would cost the American people. Independent analyses from economists across the ideological spectrum, including George Mason University, the Urban Institute, [and] the American Action Forum have projected single-payer type proposals, such as Medicare-for-all, to cost at least $32 trillion.”
Rep. Womack also said that the report “has been especially helpful in showing that these ideas will never work in America.”
He noted that the report warns that a single-payer system could end up “reducing payment rates for providers. That is payments for doctors, hospitals, and so on. The report explains there will not only be a reduction in the quality of care, there would be a reduction in the supply of care, hampering access to the treatments and services people need.”
The report does caution that using cost-containment measures, such as global budgets and utilization management, “could adversely affect access to and quality of care by causing providers to supply less care to patients covered by the public plan. Less spending on medical services could also alter manufacturers’ incentive to develop new technologies or providers’ incentive to invest in capital, which could affect patients’ choices over the long term.”
Additionally, the report notes that the structure of a single-payer system could result in lower reimbursement for health care services. “Proposals like Medicare-for-all will chase a lot of doctors out of health care,” Rep. Womack said.
REPORTING FROM A HOUSE BUDGET COMMITTEE HEARING
Early cholecystectomy prevents recurrent biliary events
SAN DIEGO – In a retrospective study of 234 patients admitted for gallstone pancreatitis, almost 90% of recurrent biliary events occurred in patients who did not receive a cholecystectomy within 60 days of hospital discharge. The overall rate of recurrence was 19%, and over half of patients (59%) did not receive a cholecystectomy during their index hospitalization.
Additionally, none of the recurrent biliary events occurred in those patients who did receive a cholecystectomy during the index hospitalization or within the first 30 days after discharge. “It really is the case that, ‘if you snooze, you lose,’ ” said Vijay Dalapathi, MD, presenting the findings during an oral presentation at the annual Digestive Disease Week.
Dr. Dalapathi and colleagues had observed that cholecystectomy during an index hospitalization for mild biliary pancreatitis was a far from universal practice, despite guidelines recommending early cholecystectomy.
To delve further into practice patterns, Dr. Dalapathi, first author Mohammed Ullah, MD, and their coauthors at the University of Rochester (N.Y.) conducted a single-site retrospective study of patients who were admitted with gallstone pancreatitis over a 5-year period ending December 2017. Dr. Dalapathi and Dr. Ullah are both second-year gastroenterology fellows.
The study had twin primary outcome measures: cholecystectomy rates performed during an index hospitalization for gallstone pancreatitis and recurrent biliary events after hospitalization. Adult patients were included if they had a diagnosis of acute gallstone pancreatitis, with or without recurrent cholangitis, choledocholithiasis, or acute cholecystitis. Pediatric patients and those with prior cholecystectomy were excluded.
A total of 234 patients were included in the study. Their mean age was 58.3 years, and patients were mostly female (57.3%) and white (91.5%). Mean body mass index was 29.1 kg/m2. A total of 175 patients (74.8%) had endoscopic retrograde cholangiopancreatography.
Out of the entire cohort of patients, 138 (59%) did not have a cholecystectomy during the index hospitalization. Among the patients who did not receive a cholecystectomy, 33 (24%) were deemed unsuitable candidates for the procedure, either because they were critically ill or because they were poor candidates for surgery for other reasons. No reason was provided for the nonperformance of cholecystectomy for an additional 28 patients (20%).
The remaining 75 patients (54%) were deferred to outpatient management. Looking at this subgroup of patients, Dr. Dalapathi and his coinvestigators tracked the amount of time that passed before cholecystectomy.
The researchers found that 19 patients (25%) had not had a cholecystectomy within the study period. A total of 21 patients (28%) had the procedure more than 60 days from hospitalization, and another 23 (31%) had the procedure between 30 and 60 days after hospitalization. Just 12 patients (16%) of this subgroup had their cholecystectomy within 30 days of hospitalization.
Among patients who were discharged without a cholecystectomy, Dr. Dalapathi and his coauthors found 26 recurrent biliary events (19%): 15 were gallstone pancreatitis and 10 were cholecystitis; 1 patient developed cholangitis.
The crux of the study’s findings came when the investigators looked at the association between recurrent events and cholecystectomy timing. They found no recurrent biliary events among those who received cholecystectomy while hospitalized or within the first 30 days after discharge. Of the 26 events, 3 (12%) occurred in those whose cholecystectomies came 30-60 days after discharge. The remaining 23 events (88%) were seen in those receiving a cholecystectomy more than 60 days after discharge, or not at all.
Guidelines from the American Gastroenterological Association, the Society of American Gastrointestinal and Endoscopic Surgeons, and the American College of Gastroenterology all recommend early cholecystectomy after mild acute gallstone pancreatitis, said Dr. Dalapathi.
However, two separate systematic reviews including a total of 22 studies and over 3,000 patients showed that about half (48% and 51%) of patients admitted with mild acute biliary pancreatitis received a cholecystectomy during the index hospitalization or within 14 days of the hospitalization.
Further, he said, previous work had shown recurrent biliary event rates approaching 20% for patients whose biliary pancreatitis bout was not followed by cholecystectomy, a figure in line with the rate seen in the present study.
“Cholecystectomy should be performed during index hospitalization or as soon as possible within 30 days of mild biliary pancreatitis to minimize risk of recurrent biliary events,” said Dr. Dalapathi.
The authors reported no outside sources of funding and no conflicts of interest.
SOURCE: Ullah M. et al. DDW 2019, Abstract 24.
SAN DIEGO – In a retrospective study of 234 patients admitted for gallstone pancreatitis, almost 90% of recurrent biliary events occurred in patients who did not receive a cholecystectomy within 60 days of hospital discharge. The overall rate of recurrence was 19%, and over half of patients (59%) did not receive a cholecystectomy during their index hospitalization.
Additionally, none of the recurrent biliary events occurred in those patients who did receive a cholecystectomy during the index hospitalization or within the first 30 days after discharge. “It really is the case that, ‘if you snooze, you lose,’ ” said Vijay Dalapathi, MD, presenting the findings during an oral presentation at the annual Digestive Disease Week.
Dr. Dalapathi and colleagues had observed that cholecystectomy during an index hospitalization for mild biliary pancreatitis was a far from universal practice, despite guidelines recommending early cholecystectomy.
To delve further into practice patterns, Dr. Dalapathi, first author Mohammed Ullah, MD, and their coauthors at the University of Rochester (N.Y.) conducted a single-site retrospective study of patients who were admitted with gallstone pancreatitis over a 5-year period ending December 2017. Dr. Dalapathi and Dr. Ullah are both second-year gastroenterology fellows.
The study had twin primary outcome measures: cholecystectomy rates performed during an index hospitalization for gallstone pancreatitis and recurrent biliary events after hospitalization. Adult patients were included if they had a diagnosis of acute gallstone pancreatitis, with or without recurrent cholangitis, choledocholithiasis, or acute cholecystitis. Pediatric patients and those with prior cholecystectomy were excluded.
A total of 234 patients were included in the study. Their mean age was 58.3 years, and patients were mostly female (57.3%) and white (91.5%). Mean body mass index was 29.1 kg/m2. A total of 175 patients (74.8%) had endoscopic retrograde cholangiopancreatography.
Out of the entire cohort of patients, 138 (59%) did not have a cholecystectomy during the index hospitalization. Among the patients who did not receive a cholecystectomy, 33 (24%) were deemed unsuitable candidates for the procedure, either because they were critically ill or because they were poor candidates for surgery for other reasons. No reason was provided for the nonperformance of cholecystectomy for an additional 28 patients (20%).
The remaining 75 patients (54%) were deferred to outpatient management. Looking at this subgroup of patients, Dr. Dalapathi and his coinvestigators tracked the amount of time that passed before cholecystectomy.
The researchers found that 19 patients (25%) had not had a cholecystectomy within the study period. A total of 21 patients (28%) had the procedure more than 60 days from hospitalization, and another 23 (31%) had the procedure between 30 and 60 days after hospitalization. Just 12 patients (16%) of this subgroup had their cholecystectomy within 30 days of hospitalization.
Among patients who were discharged without a cholecystectomy, Dr. Dalapathi and his coauthors found 26 recurrent biliary events (19%): 15 were gallstone pancreatitis and 10 were cholecystitis; 1 patient developed cholangitis.
The crux of the study’s findings came when the investigators looked at the association between recurrent events and cholecystectomy timing. They found no recurrent biliary events among those who received cholecystectomy while hospitalized or within the first 30 days after discharge. Of the 26 events, 3 (12%) occurred in those whose cholecystectomies came 30-60 days after discharge. The remaining 23 events (88%) were seen in those receiving a cholecystectomy more than 60 days after discharge, or not at all.
Guidelines from the American Gastroenterological Association, the Society of American Gastrointestinal and Endoscopic Surgeons, and the American College of Gastroenterology all recommend early cholecystectomy after mild acute gallstone pancreatitis, said Dr. Dalapathi.
However, two separate systematic reviews including a total of 22 studies and over 3,000 patients showed that about half (48% and 51%) of patients admitted with mild acute biliary pancreatitis received a cholecystectomy during the index hospitalization or within 14 days of the hospitalization.
Further, he said, previous work had shown recurrent biliary event rates approaching 20% for patients whose biliary pancreatitis bout was not followed by cholecystectomy, a figure in line with the rate seen in the present study.
“Cholecystectomy should be performed during index hospitalization or as soon as possible within 30 days of mild biliary pancreatitis to minimize risk of recurrent biliary events,” said Dr. Dalapathi.
The authors reported no outside sources of funding and no conflicts of interest.
SOURCE: Ullah M. et al. DDW 2019, Abstract 24.
SAN DIEGO – In a retrospective study of 234 patients admitted for gallstone pancreatitis, almost 90% of recurrent biliary events occurred in patients who did not receive a cholecystectomy within 60 days of hospital discharge. The overall rate of recurrence was 19%, and over half of patients (59%) did not receive a cholecystectomy during their index hospitalization.
Additionally, none of the recurrent biliary events occurred in those patients who did receive a cholecystectomy during the index hospitalization or within the first 30 days after discharge. “It really is the case that, ‘if you snooze, you lose,’ ” said Vijay Dalapathi, MD, presenting the findings during an oral presentation at the annual Digestive Disease Week.
Dr. Dalapathi and colleagues had observed that cholecystectomy during an index hospitalization for mild biliary pancreatitis was a far from universal practice, despite guidelines recommending early cholecystectomy.
To delve further into practice patterns, Dr. Dalapathi, first author Mohammed Ullah, MD, and their coauthors at the University of Rochester (N.Y.) conducted a single-site retrospective study of patients who were admitted with gallstone pancreatitis over a 5-year period ending December 2017. Dr. Dalapathi and Dr. Ullah are both second-year gastroenterology fellows.
The study had twin primary outcome measures: cholecystectomy rates performed during an index hospitalization for gallstone pancreatitis and recurrent biliary events after hospitalization. Adult patients were included if they had a diagnosis of acute gallstone pancreatitis, with or without recurrent cholangitis, choledocholithiasis, or acute cholecystitis. Pediatric patients and those with prior cholecystectomy were excluded.
A total of 234 patients were included in the study. Their mean age was 58.3 years, and patients were mostly female (57.3%) and white (91.5%). Mean body mass index was 29.1 kg/m2. A total of 175 patients (74.8%) had endoscopic retrograde cholangiopancreatography.
Out of the entire cohort of patients, 138 (59%) did not have a cholecystectomy during the index hospitalization. Among the patients who did not receive a cholecystectomy, 33 (24%) were deemed unsuitable candidates for the procedure, either because they were critically ill or because they were poor candidates for surgery for other reasons. No reason was provided for the nonperformance of cholecystectomy for an additional 28 patients (20%).
The remaining 75 patients (54%) were deferred to outpatient management. Looking at this subgroup of patients, Dr. Dalapathi and his coinvestigators tracked the amount of time that passed before cholecystectomy.
The researchers found that 19 patients (25%) had not had a cholecystectomy within the study period. A total of 21 patients (28%) had the procedure more than 60 days from hospitalization, and another 23 (31%) had the procedure between 30 and 60 days after hospitalization. Just 12 patients (16%) of this subgroup had their cholecystectomy within 30 days of hospitalization.
Among patients who were discharged without a cholecystectomy, Dr. Dalapathi and his coauthors found 26 recurrent biliary events (19%): 15 were gallstone pancreatitis and 10 were cholecystitis; 1 patient developed cholangitis.
The crux of the study’s findings came when the investigators looked at the association between recurrent events and cholecystectomy timing. They found no recurrent biliary events among those who received cholecystectomy while hospitalized or within the first 30 days after discharge. Of the 26 events, 3 (12%) occurred in those whose cholecystectomies came 30-60 days after discharge. The remaining 23 events (88%) were seen in those receiving a cholecystectomy more than 60 days after discharge, or not at all.
Guidelines from the American Gastroenterological Association, the Society of American Gastrointestinal and Endoscopic Surgeons, and the American College of Gastroenterology all recommend early cholecystectomy after mild acute gallstone pancreatitis, said Dr. Dalapathi.
However, two separate systematic reviews including a total of 22 studies and over 3,000 patients showed that about half (48% and 51%) of patients admitted with mild acute biliary pancreatitis received a cholecystectomy during the index hospitalization or within 14 days of the hospitalization.
Further, he said, previous work had shown recurrent biliary event rates approaching 20% for patients whose biliary pancreatitis bout was not followed by cholecystectomy, a figure in line with the rate seen in the present study.
“Cholecystectomy should be performed during index hospitalization or as soon as possible within 30 days of mild biliary pancreatitis to minimize risk of recurrent biliary events,” said Dr. Dalapathi.
The authors reported no outside sources of funding and no conflicts of interest.
SOURCE: Ullah M. et al. DDW 2019, Abstract 24.
REPORTING FROM DDW 2019
Preventing delayed genitourinary tract injury during benign hysterectomy
and the circumstances under which it should be performed. Procedures directed at prolapse and incontinence have rates of genitourinary injury as high as 11%-38%, and national guidelines affirm the importance of cystoscopy in these patients.1 However, for patients undergoing hysterectomy in the absence of these procedures, the optimal strategy is debated. One approach that has been advanced is a policy of universal cystoscopy at the time of hysterectomy. This policy, by which all women undergoing hysterectomy would undergo cystoscopy, aims to prevent the occurrence of an unrecognized genitourinary injury by diagnosing and treating the injury intraoperatively. However, cystoscopy is not the only method that can be used to evaluate the urinary tract. Retroperitoneal dissection also can be used to visually identify the pertinent structures and has been performed with high fidelity by generations of experienced and skilled pelvic surgeons.
Injuries that are not identified intraoperatively at the time of surgery, so-called delayed genitourinary tract injuries, are associated with serious postoperative consequences for patients and high costs for institutions. As surgeons strive to decrease complications and improve the quality of gynecologic surgery, the question of whether cystoscopy should routinely be performed at the time of hysterectomy for benign indications remains unanswered. Proponents argue that cystoscopy is a low-cost assessment and that 75% of genitourinary injuries occur in women without identifiable risk factors.2 Opponents point out that cystoscopy is not an entirely benign intervention; it is associated with increased rates of urinary tract infection, bladder and ureteral trauma, and additional operating room time. Furthermore, it is unclear that the use of cystoscopy will reduce the incidence of delayed genitourinary tract injury in clinical practice.
Ultimately, cystoscopy after hysterectomy is being used as a screening test for genitourinary injury, and this lens can be applied to provide more information about its usefulness. For screening tests, the sensitivity and false negative rate are of paramount importance. High sensitivity and resultant few false negatives are the characteristics of a robust screening test which has a low likelihood of missing a diagnosis. Unfortunately, the sensitivity of cystoscopy is not 100% for genitourinary tract injury; it ranges from 60% to 85% and can be as low as 43% for ureteral injury.3,4 This means that cystoscopy will falsely reassure the surgeon with normal results in greater than 50% of the cases in which the patient actually has a ureteral injury.
Some larger series call into question the usefulness of cystoscopy as a screening tool, finding that this evaluation is not associated with a decreased rate of delayed genitourinary injury. A recent publication by our group of a series of 39,529 women who underwent benign hysterectomy without procedures directed at incontinence and prolapse recorded in the National Surgical Quality Improvement Program (NSQIP) database between 2015 and 2017 found no difference in the rate of delayed genitourinary injury among women exposed to diagnostic cystoscopy and those who were not.5 These results are consistent with those of the largest systematic review and meta-analysis of 79 studies capturing 41,482 hysterectomies which found universal cystoscopy was not associated with a decreased rate of delayed genitourinary tract injury.6
Another consideration with the use of universal cystoscopy is cost. Although cystoscopy is typically a short procedure, the false positive rate is approximately 2%,2 often leading to additional interventions to evaluate the urinary tract which can be time consuming. In the limited available data regarding operative time, patients who underwent cystoscopy had a median operative time that was 17 minutes longer than it was among patients who did not.5 Moreover, there may be risks associated with this additional bladder instrumentation, evidenced by an increased incidence of urinary tract infection among women undergoing cystoscopy. In a recent cost-effectiveness analysis of cystoscopy at the time of benign hysterectomy, universal cystoscopy was found to add $51.39-$57.86 per case, and the risk of bladder injury would need to exceed 21%-47% and ureteral injury 27%-38% to be cost saving, compared with selective cystoscopy.7 A prior cost-effectiveness analysis concluded that universal cystoscopy is cost effective when the incidence of ureteral injury at the time of hysterectomy exceeds 1.5%-2.0%.8 Given these high thresholds, with a contemporary composite lower–genitourinary tract injury incidence of 0.24%-0.27%, it is unlikely that universal cystoscopy could be considered a cost-saving strategy in the majority of clinical settings.
Potential explanations for these results are many. Intraoperative cystoscopy is likely to be normal in the setting of nonobstructive and thermal injuries, which in the current era of minimally invasive surgery may be more prevalent mechanisms of injury. False positives can occur leading to unnecessary interventions, as well as overdiagnosis of asymptomatic urinary tract injuries that may have resolved spontaneously.9 It has been observed that cystoscopy is performed less frequently when hysterectomy is completed by a high-volume surgeon, which suggests that surgeon skill and experience play a significant role in the usefulness of this evaluation.9
Given these data, what is the best way forward regarding evaluation of the urinary tract at the time of benign hysterectomy? Ultimately, this is a clinical question that should be individualized, taking into account patient and surgical complexity, as well as surgeon training and individual rates of genitourinary injuries.9 Given its low sensitivity, caution should be exercised regarding the routine use of cystoscopy alone for evaluation of the urinary tract because false negatives occur with significant frequency. Benefits of cystoscopy in a given clinical scenario should be weighed against the risks of longer operative time, increased costs, and increased rate of urinary tract infection. In the absence of clinical scenarios with high rates of genitourinary injury (greater than 5%), selective rather than universal cystoscopy is the preferred strategy.7 Cystoscopy is fundamentally a form of secondary prevention that aims to mitigate damage that has already been done, and is no substitute for primary prevention of genitourinary tract injury itself through thorough knowledge of pelvic anatomy, comfort with retroperitoneal dissection, and awareness of the ureter and bladder at all times.
Dr. Polan is a resident in obstetrics and gynecology at Northwestern University, Chicago. Dr. Barber is an assistant professor of obstetrics and gynecology, specializing in gynecologic oncology, at the university. Neither of them have relevant financial disclosures. Email Dr. Polan and Dr. Barber at [email protected].
References
1. Am J Obstet Gynecol. 2018 Jul;219(1):75-7.
2. Obstet Gynecol. 2009 Jan;113(1):6-10.
3. Obstet Gynecol. 2016 Feb;127(2):369-75.
4. J Minim Invasive Gynecol. 2015 Nov-Dec;22(7):1278-86.
5. Obstet Gynecol. 2019 May;133(5):888-95.
6. Obstet Gynecol. 2015 Dec;126(6):1161-9.
7. Am J Obstet Gynecol. 2019 Apr;220(4):369.e1-7.
8. Obstet Gynecol. 2001 May;97(5 Pt 1):685-92.
9. Obstet Gynecol. 2012 Dec;120(6):1363-70.
and the circumstances under which it should be performed. Procedures directed at prolapse and incontinence have rates of genitourinary injury as high as 11%-38%, and national guidelines affirm the importance of cystoscopy in these patients.1 However, for patients undergoing hysterectomy in the absence of these procedures, the optimal strategy is debated. One approach that has been advanced is a policy of universal cystoscopy at the time of hysterectomy. This policy, by which all women undergoing hysterectomy would undergo cystoscopy, aims to prevent the occurrence of an unrecognized genitourinary injury by diagnosing and treating the injury intraoperatively. However, cystoscopy is not the only method that can be used to evaluate the urinary tract. Retroperitoneal dissection also can be used to visually identify the pertinent structures and has been performed with high fidelity by generations of experienced and skilled pelvic surgeons.
Injuries that are not identified intraoperatively at the time of surgery, so-called delayed genitourinary tract injuries, are associated with serious postoperative consequences for patients and high costs for institutions. As surgeons strive to decrease complications and improve the quality of gynecologic surgery, the question of whether cystoscopy should routinely be performed at the time of hysterectomy for benign indications remains unanswered. Proponents argue that cystoscopy is a low-cost assessment and that 75% of genitourinary injuries occur in women without identifiable risk factors.2 Opponents point out that cystoscopy is not an entirely benign intervention; it is associated with increased rates of urinary tract infection, bladder and ureteral trauma, and additional operating room time. Furthermore, it is unclear that the use of cystoscopy will reduce the incidence of delayed genitourinary tract injury in clinical practice.
Ultimately, cystoscopy after hysterectomy is being used as a screening test for genitourinary injury, and this lens can be applied to provide more information about its usefulness. For screening tests, the sensitivity and false negative rate are of paramount importance. High sensitivity and resultant few false negatives are the characteristics of a robust screening test which has a low likelihood of missing a diagnosis. Unfortunately, the sensitivity of cystoscopy is not 100% for genitourinary tract injury; it ranges from 60% to 85% and can be as low as 43% for ureteral injury.3,4 This means that cystoscopy will falsely reassure the surgeon with normal results in greater than 50% of the cases in which the patient actually has a ureteral injury.
Some larger series call into question the usefulness of cystoscopy as a screening tool, finding that this evaluation is not associated with a decreased rate of delayed genitourinary injury. A recent publication by our group of a series of 39,529 women who underwent benign hysterectomy without procedures directed at incontinence and prolapse recorded in the National Surgical Quality Improvement Program (NSQIP) database between 2015 and 2017 found no difference in the rate of delayed genitourinary injury among women exposed to diagnostic cystoscopy and those who were not.5 These results are consistent with those of the largest systematic review and meta-analysis of 79 studies capturing 41,482 hysterectomies which found universal cystoscopy was not associated with a decreased rate of delayed genitourinary tract injury.6
Another consideration with the use of universal cystoscopy is cost. Although cystoscopy is typically a short procedure, the false positive rate is approximately 2%,2 often leading to additional interventions to evaluate the urinary tract which can be time consuming. In the limited available data regarding operative time, patients who underwent cystoscopy had a median operative time that was 17 minutes longer than it was among patients who did not.5 Moreover, there may be risks associated with this additional bladder instrumentation, evidenced by an increased incidence of urinary tract infection among women undergoing cystoscopy. In a recent cost-effectiveness analysis of cystoscopy at the time of benign hysterectomy, universal cystoscopy was found to add $51.39-$57.86 per case, and the risk of bladder injury would need to exceed 21%-47% and ureteral injury 27%-38% to be cost saving, compared with selective cystoscopy.7 A prior cost-effectiveness analysis concluded that universal cystoscopy is cost effective when the incidence of ureteral injury at the time of hysterectomy exceeds 1.5%-2.0%.8 Given these high thresholds, with a contemporary composite lower–genitourinary tract injury incidence of 0.24%-0.27%, it is unlikely that universal cystoscopy could be considered a cost-saving strategy in the majority of clinical settings.
Potential explanations for these results are many. Intraoperative cystoscopy is likely to be normal in the setting of nonobstructive and thermal injuries, which in the current era of minimally invasive surgery may be more prevalent mechanisms of injury. False positives can occur leading to unnecessary interventions, as well as overdiagnosis of asymptomatic urinary tract injuries that may have resolved spontaneously.9 It has been observed that cystoscopy is performed less frequently when hysterectomy is completed by a high-volume surgeon, which suggests that surgeon skill and experience play a significant role in the usefulness of this evaluation.9
Given these data, what is the best way forward regarding evaluation of the urinary tract at the time of benign hysterectomy? Ultimately, this is a clinical question that should be individualized, taking into account patient and surgical complexity, as well as surgeon training and individual rates of genitourinary injuries.9 Given its low sensitivity, caution should be exercised regarding the routine use of cystoscopy alone for evaluation of the urinary tract because false negatives occur with significant frequency. Benefits of cystoscopy in a given clinical scenario should be weighed against the risks of longer operative time, increased costs, and increased rate of urinary tract infection. In the absence of clinical scenarios with high rates of genitourinary injury (greater than 5%), selective rather than universal cystoscopy is the preferred strategy.7 Cystoscopy is fundamentally a form of secondary prevention that aims to mitigate damage that has already been done, and is no substitute for primary prevention of genitourinary tract injury itself through thorough knowledge of pelvic anatomy, comfort with retroperitoneal dissection, and awareness of the ureter and bladder at all times.
Dr. Polan is a resident in obstetrics and gynecology at Northwestern University, Chicago. Dr. Barber is an assistant professor of obstetrics and gynecology, specializing in gynecologic oncology, at the university. Neither of them have relevant financial disclosures. Email Dr. Polan and Dr. Barber at [email protected].
References
1. Am J Obstet Gynecol. 2018 Jul;219(1):75-7.
2. Obstet Gynecol. 2009 Jan;113(1):6-10.
3. Obstet Gynecol. 2016 Feb;127(2):369-75.
4. J Minim Invasive Gynecol. 2015 Nov-Dec;22(7):1278-86.
5. Obstet Gynecol. 2019 May;133(5):888-95.
6. Obstet Gynecol. 2015 Dec;126(6):1161-9.
7. Am J Obstet Gynecol. 2019 Apr;220(4):369.e1-7.
8. Obstet Gynecol. 2001 May;97(5 Pt 1):685-92.
9. Obstet Gynecol. 2012 Dec;120(6):1363-70.
and the circumstances under which it should be performed. Procedures directed at prolapse and incontinence have rates of genitourinary injury as high as 11%-38%, and national guidelines affirm the importance of cystoscopy in these patients.1 However, for patients undergoing hysterectomy in the absence of these procedures, the optimal strategy is debated. One approach that has been advanced is a policy of universal cystoscopy at the time of hysterectomy. This policy, by which all women undergoing hysterectomy would undergo cystoscopy, aims to prevent the occurrence of an unrecognized genitourinary injury by diagnosing and treating the injury intraoperatively. However, cystoscopy is not the only method that can be used to evaluate the urinary tract. Retroperitoneal dissection also can be used to visually identify the pertinent structures and has been performed with high fidelity by generations of experienced and skilled pelvic surgeons.
Injuries that are not identified intraoperatively at the time of surgery, so-called delayed genitourinary tract injuries, are associated with serious postoperative consequences for patients and high costs for institutions. As surgeons strive to decrease complications and improve the quality of gynecologic surgery, the question of whether cystoscopy should routinely be performed at the time of hysterectomy for benign indications remains unanswered. Proponents argue that cystoscopy is a low-cost assessment and that 75% of genitourinary injuries occur in women without identifiable risk factors.2 Opponents point out that cystoscopy is not an entirely benign intervention; it is associated with increased rates of urinary tract infection, bladder and ureteral trauma, and additional operating room time. Furthermore, it is unclear that the use of cystoscopy will reduce the incidence of delayed genitourinary tract injury in clinical practice.
Ultimately, cystoscopy after hysterectomy is being used as a screening test for genitourinary injury, and this lens can be applied to provide more information about its usefulness. For screening tests, the sensitivity and false negative rate are of paramount importance. High sensitivity and resultant few false negatives are the characteristics of a robust screening test which has a low likelihood of missing a diagnosis. Unfortunately, the sensitivity of cystoscopy is not 100% for genitourinary tract injury; it ranges from 60% to 85% and can be as low as 43% for ureteral injury.3,4 This means that cystoscopy will falsely reassure the surgeon with normal results in greater than 50% of the cases in which the patient actually has a ureteral injury.
Some larger series call into question the usefulness of cystoscopy as a screening tool, finding that this evaluation is not associated with a decreased rate of delayed genitourinary injury. A recent publication by our group of a series of 39,529 women who underwent benign hysterectomy without procedures directed at incontinence and prolapse recorded in the National Surgical Quality Improvement Program (NSQIP) database between 2015 and 2017 found no difference in the rate of delayed genitourinary injury among women exposed to diagnostic cystoscopy and those who were not.5 These results are consistent with those of the largest systematic review and meta-analysis of 79 studies capturing 41,482 hysterectomies which found universal cystoscopy was not associated with a decreased rate of delayed genitourinary tract injury.6
Another consideration with the use of universal cystoscopy is cost. Although cystoscopy is typically a short procedure, the false positive rate is approximately 2%,2 often leading to additional interventions to evaluate the urinary tract which can be time consuming. In the limited available data regarding operative time, patients who underwent cystoscopy had a median operative time that was 17 minutes longer than it was among patients who did not.5 Moreover, there may be risks associated with this additional bladder instrumentation, evidenced by an increased incidence of urinary tract infection among women undergoing cystoscopy. In a recent cost-effectiveness analysis of cystoscopy at the time of benign hysterectomy, universal cystoscopy was found to add $51.39-$57.86 per case, and the risk of bladder injury would need to exceed 21%-47% and ureteral injury 27%-38% to be cost saving, compared with selective cystoscopy.7 A prior cost-effectiveness analysis concluded that universal cystoscopy is cost effective when the incidence of ureteral injury at the time of hysterectomy exceeds 1.5%-2.0%.8 Given these high thresholds, with a contemporary composite lower–genitourinary tract injury incidence of 0.24%-0.27%, it is unlikely that universal cystoscopy could be considered a cost-saving strategy in the majority of clinical settings.
Potential explanations for these results are many. Intraoperative cystoscopy is likely to be normal in the setting of nonobstructive and thermal injuries, which in the current era of minimally invasive surgery may be more prevalent mechanisms of injury. False positives can occur leading to unnecessary interventions, as well as overdiagnosis of asymptomatic urinary tract injuries that may have resolved spontaneously.9 It has been observed that cystoscopy is performed less frequently when hysterectomy is completed by a high-volume surgeon, which suggests that surgeon skill and experience play a significant role in the usefulness of this evaluation.9
Given these data, what is the best way forward regarding evaluation of the urinary tract at the time of benign hysterectomy? Ultimately, this is a clinical question that should be individualized, taking into account patient and surgical complexity, as well as surgeon training and individual rates of genitourinary injuries.9 Given its low sensitivity, caution should be exercised regarding the routine use of cystoscopy alone for evaluation of the urinary tract because false negatives occur with significant frequency. Benefits of cystoscopy in a given clinical scenario should be weighed against the risks of longer operative time, increased costs, and increased rate of urinary tract infection. In the absence of clinical scenarios with high rates of genitourinary injury (greater than 5%), selective rather than universal cystoscopy is the preferred strategy.7 Cystoscopy is fundamentally a form of secondary prevention that aims to mitigate damage that has already been done, and is no substitute for primary prevention of genitourinary tract injury itself through thorough knowledge of pelvic anatomy, comfort with retroperitoneal dissection, and awareness of the ureter and bladder at all times.
Dr. Polan is a resident in obstetrics and gynecology at Northwestern University, Chicago. Dr. Barber is an assistant professor of obstetrics and gynecology, specializing in gynecologic oncology, at the university. Neither of them have relevant financial disclosures. Email Dr. Polan and Dr. Barber at [email protected].
References
1. Am J Obstet Gynecol. 2018 Jul;219(1):75-7.
2. Obstet Gynecol. 2009 Jan;113(1):6-10.
3. Obstet Gynecol. 2016 Feb;127(2):369-75.
4. J Minim Invasive Gynecol. 2015 Nov-Dec;22(7):1278-86.
5. Obstet Gynecol. 2019 May;133(5):888-95.
6. Obstet Gynecol. 2015 Dec;126(6):1161-9.
7. Am J Obstet Gynecol. 2019 Apr;220(4):369.e1-7.
8. Obstet Gynecol. 2001 May;97(5 Pt 1):685-92.
9. Obstet Gynecol. 2012 Dec;120(6):1363-70.
Entrectinib exhibits activity in children with solid tumors
Entrectinib demonstrated “very promising” antitumor activity in children and adolescents with recurrent or refractory solid tumors, according to an investigator involved in a phase 1/1b trial.
Twelve of 29 patients enrolled in the trial have responded to entrectinib. All responders had fusions in genes targeted by the drug – NTRK1/2/3 (TRKA/B/C), ROS1, or ALK – or an ALK mutation.
Details of this study are scheduled to be presented at the annual meeting of the American Society of Clinical Oncology.
Giles W. Robinson, MD, of St. Jude Children’s Research Hospital in Memphis, Tenn., discussed the study during a press briefing in advance of the meeting.
“Entrectinib is an oral and potent inhibitor of the TRKA/B/C, ROS1, and ALK proteins, but it also penetrates into the brain to reach tumors in the brain and spine, which can be a hard area to get drugs to,” Dr. Robinson explained.
“Promising clinical activity was initially seen in the adult solid tumor patients with target rearrangements, and it was encouraging to see these patients also had responses when the tumors were located in their brains. And what got us really excited as pediatric oncologists was that a variety of pediatric cancers harbor these fusions and mutations within certain tumors.”
With this in mind, Dr. Robinson and colleagues conducted a phase 1/1b study (NCT02650401) of entrectinib in 29 patients with recurrent or refractory solid tumors, including central nervous system (CNS) tumors.
The patients’ median age was 7 years (range, 0-20 years), and roughly half of them were male (n = 15). Patients were diagnosed with neuroblastoma (n = 16), high-grade glioma (n = 5), inflammatory myofibroblastic tumors (n = 3), infantile fibrosarcoma (n = 2), CNS embryonal tumor (n = 1), melanoma (n = 1), and synovial sarcoma (n = 1).
In the dose-finding portion of the trial, patients received entrectinib at 250 mg/m2 (n = 3), 400 mg/m2 (n = 3), 550 mg/m2 (n = 7), or 750 mg/m2 (n = 3).
In the phase 1b portion, patients received entrectinib at 550 mg/m2 (n = 7) – the recommended dose – or 400 mg/m2 (n = 6) if they were unable to swallow intact capsules.
Dr. Robinson said entrectinib was “quite well tolerated” overall, but he did not present any data on adverse events. He did say dose-limiting toxicities included fatigue, elevated creatinine levels, dysgeusia resulting in loss of taste, weight gain, and, in one patient, pulmonary edema.
“Entrectinib produced striking, rapid, and durable responses in all children with refractory CNS and solid tumors that actually harbored these fusions in NTRK1/2/3, ROS1, or ALK,” Dr. Robinson said. “It also produced a significant response in one ALK-mutated neuroblastoma patient. [N]o responses were seen in tumors lacking aberrations in the target kinases.”
In all, 12 patients responded. The three complete responders had an ALK F1174L mutation, an ALK fusion, and an NTRK fusion, respectively. Five partial responders had NTRK fusions, three had ROS1 fusions, and one had an ALK fusion.
Three responders discontinued treatment. Ten patients were still receiving entrectinib at last follow-up, and 11 patients had died.
Progression-free survival was significantly longer among patients who had fusions than among those who did not (P less than .0001).
“To sum up, entrectinib really is very promising,” Dr. Robinson said. “It has very promising antitumor activity and progression-free survival but [only] in patients with target gene fusions.”
Dr. Robinson said this trial is ongoing, but it is now limited to patients with fusions targeted by entrectinib.
The trial is sponsored by Hoffman-La Roche Ltd. and supported by Alex’s Lemonade Stand Center of Excellence. Dr. Robinson has relationships with Lilly, Genentech/Roche, and Novartis.
SOURCE: Robinson GW et al. ASCO 2019. Abstract 10009.
Entrectinib demonstrated “very promising” antitumor activity in children and adolescents with recurrent or refractory solid tumors, according to an investigator involved in a phase 1/1b trial.
Twelve of 29 patients enrolled in the trial have responded to entrectinib. All responders had fusions in genes targeted by the drug – NTRK1/2/3 (TRKA/B/C), ROS1, or ALK – or an ALK mutation.
Details of this study are scheduled to be presented at the annual meeting of the American Society of Clinical Oncology.
Giles W. Robinson, MD, of St. Jude Children’s Research Hospital in Memphis, Tenn., discussed the study during a press briefing in advance of the meeting.
“Entrectinib is an oral and potent inhibitor of the TRKA/B/C, ROS1, and ALK proteins, but it also penetrates into the brain to reach tumors in the brain and spine, which can be a hard area to get drugs to,” Dr. Robinson explained.
“Promising clinical activity was initially seen in the adult solid tumor patients with target rearrangements, and it was encouraging to see these patients also had responses when the tumors were located in their brains. And what got us really excited as pediatric oncologists was that a variety of pediatric cancers harbor these fusions and mutations within certain tumors.”
With this in mind, Dr. Robinson and colleagues conducted a phase 1/1b study (NCT02650401) of entrectinib in 29 patients with recurrent or refractory solid tumors, including central nervous system (CNS) tumors.
The patients’ median age was 7 years (range, 0-20 years), and roughly half of them were male (n = 15). Patients were diagnosed with neuroblastoma (n = 16), high-grade glioma (n = 5), inflammatory myofibroblastic tumors (n = 3), infantile fibrosarcoma (n = 2), CNS embryonal tumor (n = 1), melanoma (n = 1), and synovial sarcoma (n = 1).
In the dose-finding portion of the trial, patients received entrectinib at 250 mg/m2 (n = 3), 400 mg/m2 (n = 3), 550 mg/m2 (n = 7), or 750 mg/m2 (n = 3).
In the phase 1b portion, patients received entrectinib at 550 mg/m2 (n = 7) – the recommended dose – or 400 mg/m2 (n = 6) if they were unable to swallow intact capsules.
Dr. Robinson said entrectinib was “quite well tolerated” overall, but he did not present any data on adverse events. He did say dose-limiting toxicities included fatigue, elevated creatinine levels, dysgeusia resulting in loss of taste, weight gain, and, in one patient, pulmonary edema.
“Entrectinib produced striking, rapid, and durable responses in all children with refractory CNS and solid tumors that actually harbored these fusions in NTRK1/2/3, ROS1, or ALK,” Dr. Robinson said. “It also produced a significant response in one ALK-mutated neuroblastoma patient. [N]o responses were seen in tumors lacking aberrations in the target kinases.”
In all, 12 patients responded. The three complete responders had an ALK F1174L mutation, an ALK fusion, and an NTRK fusion, respectively. Five partial responders had NTRK fusions, three had ROS1 fusions, and one had an ALK fusion.
Three responders discontinued treatment. Ten patients were still receiving entrectinib at last follow-up, and 11 patients had died.
Progression-free survival was significantly longer among patients who had fusions than among those who did not (P less than .0001).
“To sum up, entrectinib really is very promising,” Dr. Robinson said. “It has very promising antitumor activity and progression-free survival but [only] in patients with target gene fusions.”
Dr. Robinson said this trial is ongoing, but it is now limited to patients with fusions targeted by entrectinib.
The trial is sponsored by Hoffman-La Roche Ltd. and supported by Alex’s Lemonade Stand Center of Excellence. Dr. Robinson has relationships with Lilly, Genentech/Roche, and Novartis.
SOURCE: Robinson GW et al. ASCO 2019. Abstract 10009.
Entrectinib demonstrated “very promising” antitumor activity in children and adolescents with recurrent or refractory solid tumors, according to an investigator involved in a phase 1/1b trial.
Twelve of 29 patients enrolled in the trial have responded to entrectinib. All responders had fusions in genes targeted by the drug – NTRK1/2/3 (TRKA/B/C), ROS1, or ALK – or an ALK mutation.
Details of this study are scheduled to be presented at the annual meeting of the American Society of Clinical Oncology.
Giles W. Robinson, MD, of St. Jude Children’s Research Hospital in Memphis, Tenn., discussed the study during a press briefing in advance of the meeting.
“Entrectinib is an oral and potent inhibitor of the TRKA/B/C, ROS1, and ALK proteins, but it also penetrates into the brain to reach tumors in the brain and spine, which can be a hard area to get drugs to,” Dr. Robinson explained.
“Promising clinical activity was initially seen in the adult solid tumor patients with target rearrangements, and it was encouraging to see these patients also had responses when the tumors were located in their brains. And what got us really excited as pediatric oncologists was that a variety of pediatric cancers harbor these fusions and mutations within certain tumors.”
With this in mind, Dr. Robinson and colleagues conducted a phase 1/1b study (NCT02650401) of entrectinib in 29 patients with recurrent or refractory solid tumors, including central nervous system (CNS) tumors.
The patients’ median age was 7 years (range, 0-20 years), and roughly half of them were male (n = 15). Patients were diagnosed with neuroblastoma (n = 16), high-grade glioma (n = 5), inflammatory myofibroblastic tumors (n = 3), infantile fibrosarcoma (n = 2), CNS embryonal tumor (n = 1), melanoma (n = 1), and synovial sarcoma (n = 1).
In the dose-finding portion of the trial, patients received entrectinib at 250 mg/m2 (n = 3), 400 mg/m2 (n = 3), 550 mg/m2 (n = 7), or 750 mg/m2 (n = 3).
In the phase 1b portion, patients received entrectinib at 550 mg/m2 (n = 7) – the recommended dose – or 400 mg/m2 (n = 6) if they were unable to swallow intact capsules.
Dr. Robinson said entrectinib was “quite well tolerated” overall, but he did not present any data on adverse events. He did say dose-limiting toxicities included fatigue, elevated creatinine levels, dysgeusia resulting in loss of taste, weight gain, and, in one patient, pulmonary edema.
“Entrectinib produced striking, rapid, and durable responses in all children with refractory CNS and solid tumors that actually harbored these fusions in NTRK1/2/3, ROS1, or ALK,” Dr. Robinson said. “It also produced a significant response in one ALK-mutated neuroblastoma patient. [N]o responses were seen in tumors lacking aberrations in the target kinases.”
In all, 12 patients responded. The three complete responders had an ALK F1174L mutation, an ALK fusion, and an NTRK fusion, respectively. Five partial responders had NTRK fusions, three had ROS1 fusions, and one had an ALK fusion.
Three responders discontinued treatment. Ten patients were still receiving entrectinib at last follow-up, and 11 patients had died.
Progression-free survival was significantly longer among patients who had fusions than among those who did not (P less than .0001).
“To sum up, entrectinib really is very promising,” Dr. Robinson said. “It has very promising antitumor activity and progression-free survival but [only] in patients with target gene fusions.”
Dr. Robinson said this trial is ongoing, but it is now limited to patients with fusions targeted by entrectinib.
The trial is sponsored by Hoffman-La Roche Ltd. and supported by Alex’s Lemonade Stand Center of Excellence. Dr. Robinson has relationships with Lilly, Genentech/Roche, and Novartis.
SOURCE: Robinson GW et al. ASCO 2019. Abstract 10009.
REPORTING FROM ASCO 2019
Syncope during pregnancy increases risk for poor outcomes
a retrospective population-based cohort study finds. Risks appeared highest with first-trimester syncope.
“There are very limited data on the frequency of fainting during pregnancy,” Padma Kaul, Ph.D., senior study author and professor of medicine at the University of Alberta, Edmonton, said in a statement. “In our study, fainting during pregnancy occurred in about 1%, or 10 per 1,000 pregnancies, but appears to be increasing by 5% each year.”
“Fainting during pregnancy has previously been thought to follow a relatively benign course,” Dr. Kaul said. “The findings of our study suggest that timing of fainting during pregnancy may be important. When the faint happens early during pregnancy or multiple times during pregnancy, it may be associated with both short- and long-term health issues for the baby and the mother.”
First authors Safia Chatur, MD, of the University of Calgary (Alta.) and Sunjidatul Islam, MBBS, of the Canadian Vigour Centre, Edmonton, Alta., and associates analyzed 481,930 pregnancies occurring during 2005-2014 in the province.
Study results, reported in the Journal of the American Heart Association, showed that syncope occurred in almost 1% of pregnancies (9.7 episodes per 1,000 pregnancies) overall. Incidence increased by 5% per year during the study period.
Syncope episodes were distributed across the first trimester (32%), second trimester (44%), and third trimester (24%). Eight percent of pregnancies had more than one episode.
Compared with unaffected peers, women who experienced syncope were younger (age younger than 25 years, 35% vs. 21%; P less than .001) and more often primiparous (52% vs. 42%; P less than .001).
The rate of preterm birth was 18%, 16%, and 14% in pregnancies with an initial syncope episode during the first, second, and third trimester, respectively, compared with 15% in pregnancies without syncope (P less than .01 across groups).
With a median follow-up of about 5 years, compared with peers of syncope-free pregnancies, children of pregnancies complicated by syncope had a higher incidence of congenital anomalies (3.1% vs. 2.6%; P = .023). Incidence was highest in pregnancies with multiple episodes of syncope (5% vs. 3%; P less than .01).
In adjusted analyses that accounted for multiple pregnancies in individual women, relative to counterparts with no syncope during pregnancy, women who experienced syncope during the first trimester had higher odds of giving birth preterm (odds ratio, 1.3; P = .001) and of having an infant small for gestational age (OR, 1.2; P = .04) or with congenital anomalies (OR, 1.4; P = .036). Women with multiple syncope episodes versus none were twice as likely to have offspring with congenital anomalies (OR, 2.0; P = .003).
Relative to peers who did not experience syncope in pregnancy, women who did had higher incidences of cardiac arrhythmias (0.8% vs. 0.2%; P less than .01) and syncope episodes (1.4% vs. 0.2%; P less than .01) in the first year after delivery.
“Our data suggest that syncope during pregnancy may not be a benign occurrence,” Dr. Chatur and associates said. “More detailed clinical data are needed to identify potential causes for the observed increase in syncope during pregnancy in our study.“Whether women who experience syncope during pregnancy may benefit from closer monitoring during the obstetric and postpartum periods requires further study,” they concluded.
The investigators disclosed no relevant conflicts of interest. This study was funded by a grant from the Cardiac Arrhythmia Network of Canada.
SOURCE: Chatur S et al. J Am Heart Assoc. 2019;8:e011608.
a retrospective population-based cohort study finds. Risks appeared highest with first-trimester syncope.
“There are very limited data on the frequency of fainting during pregnancy,” Padma Kaul, Ph.D., senior study author and professor of medicine at the University of Alberta, Edmonton, said in a statement. “In our study, fainting during pregnancy occurred in about 1%, or 10 per 1,000 pregnancies, but appears to be increasing by 5% each year.”
“Fainting during pregnancy has previously been thought to follow a relatively benign course,” Dr. Kaul said. “The findings of our study suggest that timing of fainting during pregnancy may be important. When the faint happens early during pregnancy or multiple times during pregnancy, it may be associated with both short- and long-term health issues for the baby and the mother.”
First authors Safia Chatur, MD, of the University of Calgary (Alta.) and Sunjidatul Islam, MBBS, of the Canadian Vigour Centre, Edmonton, Alta., and associates analyzed 481,930 pregnancies occurring during 2005-2014 in the province.
Study results, reported in the Journal of the American Heart Association, showed that syncope occurred in almost 1% of pregnancies (9.7 episodes per 1,000 pregnancies) overall. Incidence increased by 5% per year during the study period.
Syncope episodes were distributed across the first trimester (32%), second trimester (44%), and third trimester (24%). Eight percent of pregnancies had more than one episode.
Compared with unaffected peers, women who experienced syncope were younger (age younger than 25 years, 35% vs. 21%; P less than .001) and more often primiparous (52% vs. 42%; P less than .001).
The rate of preterm birth was 18%, 16%, and 14% in pregnancies with an initial syncope episode during the first, second, and third trimester, respectively, compared with 15% in pregnancies without syncope (P less than .01 across groups).
With a median follow-up of about 5 years, compared with peers of syncope-free pregnancies, children of pregnancies complicated by syncope had a higher incidence of congenital anomalies (3.1% vs. 2.6%; P = .023). Incidence was highest in pregnancies with multiple episodes of syncope (5% vs. 3%; P less than .01).
In adjusted analyses that accounted for multiple pregnancies in individual women, relative to counterparts with no syncope during pregnancy, women who experienced syncope during the first trimester had higher odds of giving birth preterm (odds ratio, 1.3; P = .001) and of having an infant small for gestational age (OR, 1.2; P = .04) or with congenital anomalies (OR, 1.4; P = .036). Women with multiple syncope episodes versus none were twice as likely to have offspring with congenital anomalies (OR, 2.0; P = .003).
Relative to peers who did not experience syncope in pregnancy, women who did had higher incidences of cardiac arrhythmias (0.8% vs. 0.2%; P less than .01) and syncope episodes (1.4% vs. 0.2%; P less than .01) in the first year after delivery.
“Our data suggest that syncope during pregnancy may not be a benign occurrence,” Dr. Chatur and associates said. “More detailed clinical data are needed to identify potential causes for the observed increase in syncope during pregnancy in our study.“Whether women who experience syncope during pregnancy may benefit from closer monitoring during the obstetric and postpartum periods requires further study,” they concluded.
The investigators disclosed no relevant conflicts of interest. This study was funded by a grant from the Cardiac Arrhythmia Network of Canada.
SOURCE: Chatur S et al. J Am Heart Assoc. 2019;8:e011608.
a retrospective population-based cohort study finds. Risks appeared highest with first-trimester syncope.
“There are very limited data on the frequency of fainting during pregnancy,” Padma Kaul, Ph.D., senior study author and professor of medicine at the University of Alberta, Edmonton, said in a statement. “In our study, fainting during pregnancy occurred in about 1%, or 10 per 1,000 pregnancies, but appears to be increasing by 5% each year.”
“Fainting during pregnancy has previously been thought to follow a relatively benign course,” Dr. Kaul said. “The findings of our study suggest that timing of fainting during pregnancy may be important. When the faint happens early during pregnancy or multiple times during pregnancy, it may be associated with both short- and long-term health issues for the baby and the mother.”
First authors Safia Chatur, MD, of the University of Calgary (Alta.) and Sunjidatul Islam, MBBS, of the Canadian Vigour Centre, Edmonton, Alta., and associates analyzed 481,930 pregnancies occurring during 2005-2014 in the province.
Study results, reported in the Journal of the American Heart Association, showed that syncope occurred in almost 1% of pregnancies (9.7 episodes per 1,000 pregnancies) overall. Incidence increased by 5% per year during the study period.
Syncope episodes were distributed across the first trimester (32%), second trimester (44%), and third trimester (24%). Eight percent of pregnancies had more than one episode.
Compared with unaffected peers, women who experienced syncope were younger (age younger than 25 years, 35% vs. 21%; P less than .001) and more often primiparous (52% vs. 42%; P less than .001).
The rate of preterm birth was 18%, 16%, and 14% in pregnancies with an initial syncope episode during the first, second, and third trimester, respectively, compared with 15% in pregnancies without syncope (P less than .01 across groups).
With a median follow-up of about 5 years, compared with peers of syncope-free pregnancies, children of pregnancies complicated by syncope had a higher incidence of congenital anomalies (3.1% vs. 2.6%; P = .023). Incidence was highest in pregnancies with multiple episodes of syncope (5% vs. 3%; P less than .01).
In adjusted analyses that accounted for multiple pregnancies in individual women, relative to counterparts with no syncope during pregnancy, women who experienced syncope during the first trimester had higher odds of giving birth preterm (odds ratio, 1.3; P = .001) and of having an infant small for gestational age (OR, 1.2; P = .04) or with congenital anomalies (OR, 1.4; P = .036). Women with multiple syncope episodes versus none were twice as likely to have offspring with congenital anomalies (OR, 2.0; P = .003).
Relative to peers who did not experience syncope in pregnancy, women who did had higher incidences of cardiac arrhythmias (0.8% vs. 0.2%; P less than .01) and syncope episodes (1.4% vs. 0.2%; P less than .01) in the first year after delivery.
“Our data suggest that syncope during pregnancy may not be a benign occurrence,” Dr. Chatur and associates said. “More detailed clinical data are needed to identify potential causes for the observed increase in syncope during pregnancy in our study.“Whether women who experience syncope during pregnancy may benefit from closer monitoring during the obstetric and postpartum periods requires further study,” they concluded.
The investigators disclosed no relevant conflicts of interest. This study was funded by a grant from the Cardiac Arrhythmia Network of Canada.
SOURCE: Chatur S et al. J Am Heart Assoc. 2019;8:e011608.
FROM THE JOURNAL OF THE AMERICAN HEART ASSOCIATION
Connected care
I previously shared my concerns about the compromises some physicians are making when they consent to practicing in a telemedicine arrangement in which the system’s technical limitations prevents them from obtaining information critical to making an accurate diagnosis. In the scenarios that I described, a physician would have great difficulty being a good steward of antibiotic usage if he were willing to make a diagnosis of otitis media or strep throat without access to tympanic membrane visualization or the results of a rapid strep test.
In response to my observation, I received an email from Dr. Kenneth McConnochie, a name out of my deep past from when we were teammates in college. Now a professor of pediatrics at University of Rochester (N.Y.) Medical Center, Dr. McConnochie has studied telemedicine in primary care extensively. He has thought a lot about telemedicine and more specifically about how it relates to quality. As he pointed out to me,
I suspect that like me, whenever you look at an article or study that has “telemedicine” in its title or headline, you are never sure what you’re going to be reading about. Is it going to be a discussion of telephone triaging in a suburban primary practice or will the article describe how a pediatric cardiologist in Anchorage can follow his little patients in the Aleutians via an audio/video hookup that provides him with the ability to auscultate and review electrocardiograms and radiographic images? Dr. McConnochie suggests that by using the broader term “connected care” for care that is delivered at a distance, and by clearly specifying different types or levels, we will be one big step closer to a more meaningful way to understand the usefulness of that care.
In the conceptual framework he proposes, level 1 is text-only care because it offers the physician the least capacity for the acquisition of (1) diagnostically relevant information and (2) interpersonal connection. Phone care can provide more and videoconferencing still more. Level 4 would be what Dr. McConnochie labels “information rich” care providing the most abundant capacity. Here, think of an arrangement in which someone at the patient’s end of the connection has been trained to use an electronic otoscope that can capture an image of the child’s tympanic membrane, an electronic stethoscope that can record heart and breath sounds, and a high resolution camera to capture images of the patient’s skin, throat, and eyes, then transmit them to the child’s electronic health record (EHR) in real time. Someone in the school or day care center where the child spends his day has been taught how to obtain and process a rapid strep test. The physician who has instant access to the child’s EHR can communicate “face to face” via teleconferencing with the day care providers and with the parent who is at work to discuss the diagnosis, treatment plan, and follow-up. If any of the parties feels the exchange of information is insufficiently robust, a traditional office visit can be arranged.
The challenge of assigning value to each level care still remains. Is the level 4 scenario I just described as valuable as a face to face traditional office visit? In some situations, it is likely to be more valuable than a visit with a physician in an urgent care clinic or emergency department who has never seen the patient and/or lacks access to the EHR because her computer doesn’t interface with the primary care physician’s EHR. It certainly may be more convenient for the family.
But who is going to assign value? A connected visit may be more efficient for the patient and the parent, but will it be more costly? And who is going to pay? Dr. McConnochie’s observations should be taken seriously by those folks who assign value and pay.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].
I previously shared my concerns about the compromises some physicians are making when they consent to practicing in a telemedicine arrangement in which the system’s technical limitations prevents them from obtaining information critical to making an accurate diagnosis. In the scenarios that I described, a physician would have great difficulty being a good steward of antibiotic usage if he were willing to make a diagnosis of otitis media or strep throat without access to tympanic membrane visualization or the results of a rapid strep test.
In response to my observation, I received an email from Dr. Kenneth McConnochie, a name out of my deep past from when we were teammates in college. Now a professor of pediatrics at University of Rochester (N.Y.) Medical Center, Dr. McConnochie has studied telemedicine in primary care extensively. He has thought a lot about telemedicine and more specifically about how it relates to quality. As he pointed out to me,
I suspect that like me, whenever you look at an article or study that has “telemedicine” in its title or headline, you are never sure what you’re going to be reading about. Is it going to be a discussion of telephone triaging in a suburban primary practice or will the article describe how a pediatric cardiologist in Anchorage can follow his little patients in the Aleutians via an audio/video hookup that provides him with the ability to auscultate and review electrocardiograms and radiographic images? Dr. McConnochie suggests that by using the broader term “connected care” for care that is delivered at a distance, and by clearly specifying different types or levels, we will be one big step closer to a more meaningful way to understand the usefulness of that care.
In the conceptual framework he proposes, level 1 is text-only care because it offers the physician the least capacity for the acquisition of (1) diagnostically relevant information and (2) interpersonal connection. Phone care can provide more and videoconferencing still more. Level 4 would be what Dr. McConnochie labels “information rich” care providing the most abundant capacity. Here, think of an arrangement in which someone at the patient’s end of the connection has been trained to use an electronic otoscope that can capture an image of the child’s tympanic membrane, an electronic stethoscope that can record heart and breath sounds, and a high resolution camera to capture images of the patient’s skin, throat, and eyes, then transmit them to the child’s electronic health record (EHR) in real time. Someone in the school or day care center where the child spends his day has been taught how to obtain and process a rapid strep test. The physician who has instant access to the child’s EHR can communicate “face to face” via teleconferencing with the day care providers and with the parent who is at work to discuss the diagnosis, treatment plan, and follow-up. If any of the parties feels the exchange of information is insufficiently robust, a traditional office visit can be arranged.
The challenge of assigning value to each level care still remains. Is the level 4 scenario I just described as valuable as a face to face traditional office visit? In some situations, it is likely to be more valuable than a visit with a physician in an urgent care clinic or emergency department who has never seen the patient and/or lacks access to the EHR because her computer doesn’t interface with the primary care physician’s EHR. It certainly may be more convenient for the family.
But who is going to assign value? A connected visit may be more efficient for the patient and the parent, but will it be more costly? And who is going to pay? Dr. McConnochie’s observations should be taken seriously by those folks who assign value and pay.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].
I previously shared my concerns about the compromises some physicians are making when they consent to practicing in a telemedicine arrangement in which the system’s technical limitations prevents them from obtaining information critical to making an accurate diagnosis. In the scenarios that I described, a physician would have great difficulty being a good steward of antibiotic usage if he were willing to make a diagnosis of otitis media or strep throat without access to tympanic membrane visualization or the results of a rapid strep test.
In response to my observation, I received an email from Dr. Kenneth McConnochie, a name out of my deep past from when we were teammates in college. Now a professor of pediatrics at University of Rochester (N.Y.) Medical Center, Dr. McConnochie has studied telemedicine in primary care extensively. He has thought a lot about telemedicine and more specifically about how it relates to quality. As he pointed out to me,
I suspect that like me, whenever you look at an article or study that has “telemedicine” in its title or headline, you are never sure what you’re going to be reading about. Is it going to be a discussion of telephone triaging in a suburban primary practice or will the article describe how a pediatric cardiologist in Anchorage can follow his little patients in the Aleutians via an audio/video hookup that provides him with the ability to auscultate and review electrocardiograms and radiographic images? Dr. McConnochie suggests that by using the broader term “connected care” for care that is delivered at a distance, and by clearly specifying different types or levels, we will be one big step closer to a more meaningful way to understand the usefulness of that care.
In the conceptual framework he proposes, level 1 is text-only care because it offers the physician the least capacity for the acquisition of (1) diagnostically relevant information and (2) interpersonal connection. Phone care can provide more and videoconferencing still more. Level 4 would be what Dr. McConnochie labels “information rich” care providing the most abundant capacity. Here, think of an arrangement in which someone at the patient’s end of the connection has been trained to use an electronic otoscope that can capture an image of the child’s tympanic membrane, an electronic stethoscope that can record heart and breath sounds, and a high resolution camera to capture images of the patient’s skin, throat, and eyes, then transmit them to the child’s electronic health record (EHR) in real time. Someone in the school or day care center where the child spends his day has been taught how to obtain and process a rapid strep test. The physician who has instant access to the child’s EHR can communicate “face to face” via teleconferencing with the day care providers and with the parent who is at work to discuss the diagnosis, treatment plan, and follow-up. If any of the parties feels the exchange of information is insufficiently robust, a traditional office visit can be arranged.
The challenge of assigning value to each level care still remains. Is the level 4 scenario I just described as valuable as a face to face traditional office visit? In some situations, it is likely to be more valuable than a visit with a physician in an urgent care clinic or emergency department who has never seen the patient and/or lacks access to the EHR because her computer doesn’t interface with the primary care physician’s EHR. It certainly may be more convenient for the family.
But who is going to assign value? A connected visit may be more efficient for the patient and the parent, but will it be more costly? And who is going to pay? Dr. McConnochie’s observations should be taken seriously by those folks who assign value and pay.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].
N.J. law, EMR alerts appear effective at reducing opioid prescriptions
WASHINGTON –
Researchers looked at prescribing patterns of doctors in the Penn Medicine health system, which straddles both the Philadelphia area and southern New Jersey, following the implementation of prescribing limits in New Jersey.
The law in question is a 5-day limit on new opioid prescriptions, which was passed in February 2017 and implemented in May 2017. Penn Medicine implemented an EMR alert in their New Jersey locations to alert physicians within the Penn Medicine system of the change in their state law 2 months after the law went into effect. Researchers looked at prescribing patterns before passage, during the transition between passage and the implementation of the EMR alert and following implementation of the EMR alert, as well as secondary outcomes such as rate of refills, telephone calls, and utilization.
“The implementation of the prescribing limit and EMR alert was associated with a decrease in the volume of opioids prescribed in acute prescriptions without changes in the rates of refills, telephone calls or utilization,” Margaret Lowenstein, MD, of the University of Pennsylvania, Philadelphia, said at the annual meeting of the Society of General Internal Medicine.
“This combination of the policy and the EMR alert may be an effective strategy to influence prescriber behavior,” she added.
Researchers compared outcomes before and after the implementation of the law in New Jersey, using prescribing patterns in Pennsylvania as the control. The cohort of patients was those with a new opioid prescription within Penn Medicine ambulatory nonteaching practices. It excluded specialties not represented in both states as well as patients with cancer, those in hospice and palliative care and those in treatment for opioid use disorder, since the law does not apply to those groups.
In New Jersey, there were 434 patients receiving new prescriptions in the 12 months prior to the implementation of the law, with 234 patients receiving new prescriptions in the 9 months after the EMR alert was implemented in New Jersey. In Pennsylvania, the cohort included 2,961 patients prior to the law going into effect and 1,677 after the EMR intervention went live in New Jersey.
For New Jersey, the morphine milligram equivalent (MME) per prescription was steady at about 350 during the period prior to the law’s implementation, but dropped to nearly 250 by the end of the postintervention period examined. In Pennsylvania, the prelaw implementation period had an MME per prescription a little higher than 200, which leveled off at around 200 during the postintervention period.
“In New Jersey, there is a significantly higher MME than in Pennsylvania and this difference persists in the transition period but what you see in the post period is a significantly greater decline in the MME per prescription in New Jersey as compared to the rate of change in Pa.,” Dr. Lowenstein said. “That difference was statistically significant.”
She said similar results were seen regarding the quantity of tablets prescribed. In New Jersey before the law’s passage, the number of tablets per prescription was close to 50, dropping down to about 35 post period. Pennsylvania saw a slight decrease from about 35 pills per prescription to about 33 during the same period.
No significant changes occurred in the other outcomes measured following implementation of the EMR alert.
Dr. Lowenstein noted that, because the transition period between the law going into effect and the implementation of the EMR alert was so short, whether the greater decreases in opioid prescriptions in New Jersey relative to Pennsylvania was because of the law alone, the EMR alert alone, or both changes is unclear.
Based on the limited amount of change in prescribing patterns during the transition period, it appears that the EMR intervention may be driving the change, “but we weren’t powered to make that determination,” she added.
Dr. Lowenstein and her colleagues reported no disclosures.
WASHINGTON –
Researchers looked at prescribing patterns of doctors in the Penn Medicine health system, which straddles both the Philadelphia area and southern New Jersey, following the implementation of prescribing limits in New Jersey.
The law in question is a 5-day limit on new opioid prescriptions, which was passed in February 2017 and implemented in May 2017. Penn Medicine implemented an EMR alert in their New Jersey locations to alert physicians within the Penn Medicine system of the change in their state law 2 months after the law went into effect. Researchers looked at prescribing patterns before passage, during the transition between passage and the implementation of the EMR alert and following implementation of the EMR alert, as well as secondary outcomes such as rate of refills, telephone calls, and utilization.
“The implementation of the prescribing limit and EMR alert was associated with a decrease in the volume of opioids prescribed in acute prescriptions without changes in the rates of refills, telephone calls or utilization,” Margaret Lowenstein, MD, of the University of Pennsylvania, Philadelphia, said at the annual meeting of the Society of General Internal Medicine.
“This combination of the policy and the EMR alert may be an effective strategy to influence prescriber behavior,” she added.
Researchers compared outcomes before and after the implementation of the law in New Jersey, using prescribing patterns in Pennsylvania as the control. The cohort of patients was those with a new opioid prescription within Penn Medicine ambulatory nonteaching practices. It excluded specialties not represented in both states as well as patients with cancer, those in hospice and palliative care and those in treatment for opioid use disorder, since the law does not apply to those groups.
In New Jersey, there were 434 patients receiving new prescriptions in the 12 months prior to the implementation of the law, with 234 patients receiving new prescriptions in the 9 months after the EMR alert was implemented in New Jersey. In Pennsylvania, the cohort included 2,961 patients prior to the law going into effect and 1,677 after the EMR intervention went live in New Jersey.
For New Jersey, the morphine milligram equivalent (MME) per prescription was steady at about 350 during the period prior to the law’s implementation, but dropped to nearly 250 by the end of the postintervention period examined. In Pennsylvania, the prelaw implementation period had an MME per prescription a little higher than 200, which leveled off at around 200 during the postintervention period.
“In New Jersey, there is a significantly higher MME than in Pennsylvania and this difference persists in the transition period but what you see in the post period is a significantly greater decline in the MME per prescription in New Jersey as compared to the rate of change in Pa.,” Dr. Lowenstein said. “That difference was statistically significant.”
She said similar results were seen regarding the quantity of tablets prescribed. In New Jersey before the law’s passage, the number of tablets per prescription was close to 50, dropping down to about 35 post period. Pennsylvania saw a slight decrease from about 35 pills per prescription to about 33 during the same period.
No significant changes occurred in the other outcomes measured following implementation of the EMR alert.
Dr. Lowenstein noted that, because the transition period between the law going into effect and the implementation of the EMR alert was so short, whether the greater decreases in opioid prescriptions in New Jersey relative to Pennsylvania was because of the law alone, the EMR alert alone, or both changes is unclear.
Based on the limited amount of change in prescribing patterns during the transition period, it appears that the EMR intervention may be driving the change, “but we weren’t powered to make that determination,” she added.
Dr. Lowenstein and her colleagues reported no disclosures.
WASHINGTON –
Researchers looked at prescribing patterns of doctors in the Penn Medicine health system, which straddles both the Philadelphia area and southern New Jersey, following the implementation of prescribing limits in New Jersey.
The law in question is a 5-day limit on new opioid prescriptions, which was passed in February 2017 and implemented in May 2017. Penn Medicine implemented an EMR alert in their New Jersey locations to alert physicians within the Penn Medicine system of the change in their state law 2 months after the law went into effect. Researchers looked at prescribing patterns before passage, during the transition between passage and the implementation of the EMR alert and following implementation of the EMR alert, as well as secondary outcomes such as rate of refills, telephone calls, and utilization.
“The implementation of the prescribing limit and EMR alert was associated with a decrease in the volume of opioids prescribed in acute prescriptions without changes in the rates of refills, telephone calls or utilization,” Margaret Lowenstein, MD, of the University of Pennsylvania, Philadelphia, said at the annual meeting of the Society of General Internal Medicine.
“This combination of the policy and the EMR alert may be an effective strategy to influence prescriber behavior,” she added.
Researchers compared outcomes before and after the implementation of the law in New Jersey, using prescribing patterns in Pennsylvania as the control. The cohort of patients was those with a new opioid prescription within Penn Medicine ambulatory nonteaching practices. It excluded specialties not represented in both states as well as patients with cancer, those in hospice and palliative care and those in treatment for opioid use disorder, since the law does not apply to those groups.
In New Jersey, there were 434 patients receiving new prescriptions in the 12 months prior to the implementation of the law, with 234 patients receiving new prescriptions in the 9 months after the EMR alert was implemented in New Jersey. In Pennsylvania, the cohort included 2,961 patients prior to the law going into effect and 1,677 after the EMR intervention went live in New Jersey.
For New Jersey, the morphine milligram equivalent (MME) per prescription was steady at about 350 during the period prior to the law’s implementation, but dropped to nearly 250 by the end of the postintervention period examined. In Pennsylvania, the prelaw implementation period had an MME per prescription a little higher than 200, which leveled off at around 200 during the postintervention period.
“In New Jersey, there is a significantly higher MME than in Pennsylvania and this difference persists in the transition period but what you see in the post period is a significantly greater decline in the MME per prescription in New Jersey as compared to the rate of change in Pa.,” Dr. Lowenstein said. “That difference was statistically significant.”
She said similar results were seen regarding the quantity of tablets prescribed. In New Jersey before the law’s passage, the number of tablets per prescription was close to 50, dropping down to about 35 post period. Pennsylvania saw a slight decrease from about 35 pills per prescription to about 33 during the same period.
No significant changes occurred in the other outcomes measured following implementation of the EMR alert.
Dr. Lowenstein noted that, because the transition period between the law going into effect and the implementation of the EMR alert was so short, whether the greater decreases in opioid prescriptions in New Jersey relative to Pennsylvania was because of the law alone, the EMR alert alone, or both changes is unclear.
Based on the limited amount of change in prescribing patterns during the transition period, it appears that the EMR intervention may be driving the change, “but we weren’t powered to make that determination,” she added.
Dr. Lowenstein and her colleagues reported no disclosures.
REPORTING FROM SGIM 2019
Beyond symptom improvement: Practicing happiness
Kailah is a 13-year-old cisgender female with two working parents, two younger siblings, and a history of mild asthma and overweight who recently presented for a problem-focused visit related to increasing anxiety. An interview of Kailah and her parents led to a diagnosis of generalized anxiety disorder, and she was referred for cognitive-behavioral therapy (CBT) and started on a low-dose SSRI. She now presents 3 months later with decreased anxiety and is compliant with the SSRI and CBT. What next?
Positive psychology and psychiatry have emerged as scientific disciplines since Seligman et al.1 charged the field of psychology with reclaiming its stake in helping everyday people to thrive, as well as cultivating strengths and talents at each level of society – individual, family, institutional, and beyond. This call to action revealed the shift over time from mental health care toward a focus only on mental illness. And study after study confirmed that being “not depressed,” “not anxious” and so on was not the same as flourishing.2
Returning to Kailah, from a mental-health-as-usual approach, your job may be done. Her symptoms have responded to first-line treatments. Perhaps you even tracked her symptoms with a freely available standardized assessment tool like the Screen for Child Anxiety Related Disorders (SCARED)3 and noted a significant drop in her generalized anxiety score.
After a couple decades of research, the science of well-being has led to some consistent findings that can be translated into office practice with children and families. As with any new science, the first steps to building well-being are defining and measuring what we are talking about. I recommend the Flourishing Scale4 for its brevity, availability, and ease of use. It covers the domains included in Seligman’s formula for thriving: PERMA. This acronym represents a consolidation of the first decades of research on well-being, and stands for Positive Emotions, Engagement, (Positive) Relationships, Meaning, and Accomplishments. For a readable but deeper look at the science behind this, check out Seligman’s “Flourish.”5
With the Flourishing Scale total score as a starting point, the acronym PERMA itself can be a good rubric to guide assessment and treatment planning in the office. You can query each of the elements to understand a youth’s current status and areas for building strengths. What brings positive emotions? What activities bring a sense of harmonious engagement without self-consciousness or awareness of time (such as a flow state)? What supportive relationships exist? Where does the youth find meaning or purpose – connection to something larger than themselves (family, work, community, teams, religion, and so on)? And where does the youth derive a sense of competence or self-esteem – something they are good at (accomplishment)?
Your clinical recommendations can flow from this assessment discussion, melding the patient’s and family’s strengths and priorities with evidence-based interventions. “The Resilience Drive,” by Alexia Michiels,6 is a good source for the latter – each chapter has segments relating research to straightforward happiness practices. The Growing Happy card deck (available online) also has brief and usable recommendations suitable for many young people. You can use these during office visits, loan out cards, gift them to families, or recommend families purchase a deck.
To build relationships, I recommend the StoryCorps and 36 Questions To Fall In Love apps. They are free and can be used with parents, peers, or others to build relationship supports and positive intimacy. Try them out yourself first; they essentially provide a platform to generate vulnerable conversations.
Mindfulness is a great antidote to lack of engagement, and it can be practiced in a variety of forms. Card decks make good office props or giveaways, including Growing Mindful (mindfulness practices for all ages) and the YogaKids Toolbox. Plus, there’s an app for that – in fact, many. Two that are free and include materials accessible for younger age groups are Smiling Mind (a nonprofit) and Insight Timer (searchable). This can build engagement and counter negative emotions.
For increasing engagement and flow, I recommend patients and family members assess their character strengths at Strengths-Based Resilience by the University of Toronto SSQ72. Research shows that using your strengths in novel ways lowers depression risk, increases happiness,7 and may be a key to increasing engagement in everyday activities.
When Kailah came in for her next visit, a discussion of PERMA led to identifying time with her family and time with her dog as significant relationship supports that bring positive emotions. However, she struggled to identify a realm where she felt some sense of mastery or competence. Taking the strengths survey (SSQ72) brought out her strengths of love of learning and curiosity. This led to her volunteering at her local library – assisting with programs and eventually creating and leading a teens’ book group. Her CBT therapist supported her through these challenges, and she was able to taper the frequency of therapy sessions so that Kailah only returns for a booster session now every 6 months or so. While she still identifies as an anxious person, Kailah has broadened her self-image to include her resilience and love of learning as core strengths.
Dr. Andrew J. Rosenfeld is an assistant professor in the departments of psychiatry and pediatrics at the University of Vermont Medical Center, Burlington. He said he has no relevant disclosures. Email him at [email protected].
References
1. Am Psychol. 2000;55(1):5-14.
2. Am Psychol. 2007 Feb-Mar;62(2):95-108.
3. J Am Acad Child Adolesc Psychiatry. 1999 Oct;38(10):1230-6.
4. Soc Indic Res. 2009; 39:247-66.
5. “Flourish: A visionary new understanding of happiness and well-being” (New York: Free Press, 2011).
6. “The Resilience Drive” (Switzerland: Favre, 2017).
7. Am Psychol. 2005 Jul-Aug;60(5):410-21.
Kailah is a 13-year-old cisgender female with two working parents, two younger siblings, and a history of mild asthma and overweight who recently presented for a problem-focused visit related to increasing anxiety. An interview of Kailah and her parents led to a diagnosis of generalized anxiety disorder, and she was referred for cognitive-behavioral therapy (CBT) and started on a low-dose SSRI. She now presents 3 months later with decreased anxiety and is compliant with the SSRI and CBT. What next?
Positive psychology and psychiatry have emerged as scientific disciplines since Seligman et al.1 charged the field of psychology with reclaiming its stake in helping everyday people to thrive, as well as cultivating strengths and talents at each level of society – individual, family, institutional, and beyond. This call to action revealed the shift over time from mental health care toward a focus only on mental illness. And study after study confirmed that being “not depressed,” “not anxious” and so on was not the same as flourishing.2
Returning to Kailah, from a mental-health-as-usual approach, your job may be done. Her symptoms have responded to first-line treatments. Perhaps you even tracked her symptoms with a freely available standardized assessment tool like the Screen for Child Anxiety Related Disorders (SCARED)3 and noted a significant drop in her generalized anxiety score.
After a couple decades of research, the science of well-being has led to some consistent findings that can be translated into office practice with children and families. As with any new science, the first steps to building well-being are defining and measuring what we are talking about. I recommend the Flourishing Scale4 for its brevity, availability, and ease of use. It covers the domains included in Seligman’s formula for thriving: PERMA. This acronym represents a consolidation of the first decades of research on well-being, and stands for Positive Emotions, Engagement, (Positive) Relationships, Meaning, and Accomplishments. For a readable but deeper look at the science behind this, check out Seligman’s “Flourish.”5
With the Flourishing Scale total score as a starting point, the acronym PERMA itself can be a good rubric to guide assessment and treatment planning in the office. You can query each of the elements to understand a youth’s current status and areas for building strengths. What brings positive emotions? What activities bring a sense of harmonious engagement without self-consciousness or awareness of time (such as a flow state)? What supportive relationships exist? Where does the youth find meaning or purpose – connection to something larger than themselves (family, work, community, teams, religion, and so on)? And where does the youth derive a sense of competence or self-esteem – something they are good at (accomplishment)?
Your clinical recommendations can flow from this assessment discussion, melding the patient’s and family’s strengths and priorities with evidence-based interventions. “The Resilience Drive,” by Alexia Michiels,6 is a good source for the latter – each chapter has segments relating research to straightforward happiness practices. The Growing Happy card deck (available online) also has brief and usable recommendations suitable for many young people. You can use these during office visits, loan out cards, gift them to families, or recommend families purchase a deck.
To build relationships, I recommend the StoryCorps and 36 Questions To Fall In Love apps. They are free and can be used with parents, peers, or others to build relationship supports and positive intimacy. Try them out yourself first; they essentially provide a platform to generate vulnerable conversations.
Mindfulness is a great antidote to lack of engagement, and it can be practiced in a variety of forms. Card decks make good office props or giveaways, including Growing Mindful (mindfulness practices for all ages) and the YogaKids Toolbox. Plus, there’s an app for that – in fact, many. Two that are free and include materials accessible for younger age groups are Smiling Mind (a nonprofit) and Insight Timer (searchable). This can build engagement and counter negative emotions.
For increasing engagement and flow, I recommend patients and family members assess their character strengths at Strengths-Based Resilience by the University of Toronto SSQ72. Research shows that using your strengths in novel ways lowers depression risk, increases happiness,7 and may be a key to increasing engagement in everyday activities.
When Kailah came in for her next visit, a discussion of PERMA led to identifying time with her family and time with her dog as significant relationship supports that bring positive emotions. However, she struggled to identify a realm where she felt some sense of mastery or competence. Taking the strengths survey (SSQ72) brought out her strengths of love of learning and curiosity. This led to her volunteering at her local library – assisting with programs and eventually creating and leading a teens’ book group. Her CBT therapist supported her through these challenges, and she was able to taper the frequency of therapy sessions so that Kailah only returns for a booster session now every 6 months or so. While she still identifies as an anxious person, Kailah has broadened her self-image to include her resilience and love of learning as core strengths.
Dr. Andrew J. Rosenfeld is an assistant professor in the departments of psychiatry and pediatrics at the University of Vermont Medical Center, Burlington. He said he has no relevant disclosures. Email him at [email protected].
References
1. Am Psychol. 2000;55(1):5-14.
2. Am Psychol. 2007 Feb-Mar;62(2):95-108.
3. J Am Acad Child Adolesc Psychiatry. 1999 Oct;38(10):1230-6.
4. Soc Indic Res. 2009; 39:247-66.
5. “Flourish: A visionary new understanding of happiness and well-being” (New York: Free Press, 2011).
6. “The Resilience Drive” (Switzerland: Favre, 2017).
7. Am Psychol. 2005 Jul-Aug;60(5):410-21.
Kailah is a 13-year-old cisgender female with two working parents, two younger siblings, and a history of mild asthma and overweight who recently presented for a problem-focused visit related to increasing anxiety. An interview of Kailah and her parents led to a diagnosis of generalized anxiety disorder, and she was referred for cognitive-behavioral therapy (CBT) and started on a low-dose SSRI. She now presents 3 months later with decreased anxiety and is compliant with the SSRI and CBT. What next?
Positive psychology and psychiatry have emerged as scientific disciplines since Seligman et al.1 charged the field of psychology with reclaiming its stake in helping everyday people to thrive, as well as cultivating strengths and talents at each level of society – individual, family, institutional, and beyond. This call to action revealed the shift over time from mental health care toward a focus only on mental illness. And study after study confirmed that being “not depressed,” “not anxious” and so on was not the same as flourishing.2
Returning to Kailah, from a mental-health-as-usual approach, your job may be done. Her symptoms have responded to first-line treatments. Perhaps you even tracked her symptoms with a freely available standardized assessment tool like the Screen for Child Anxiety Related Disorders (SCARED)3 and noted a significant drop in her generalized anxiety score.
After a couple decades of research, the science of well-being has led to some consistent findings that can be translated into office practice with children and families. As with any new science, the first steps to building well-being are defining and measuring what we are talking about. I recommend the Flourishing Scale4 for its brevity, availability, and ease of use. It covers the domains included in Seligman’s formula for thriving: PERMA. This acronym represents a consolidation of the first decades of research on well-being, and stands for Positive Emotions, Engagement, (Positive) Relationships, Meaning, and Accomplishments. For a readable but deeper look at the science behind this, check out Seligman’s “Flourish.”5
With the Flourishing Scale total score as a starting point, the acronym PERMA itself can be a good rubric to guide assessment and treatment planning in the office. You can query each of the elements to understand a youth’s current status and areas for building strengths. What brings positive emotions? What activities bring a sense of harmonious engagement without self-consciousness or awareness of time (such as a flow state)? What supportive relationships exist? Where does the youth find meaning or purpose – connection to something larger than themselves (family, work, community, teams, religion, and so on)? And where does the youth derive a sense of competence or self-esteem – something they are good at (accomplishment)?
Your clinical recommendations can flow from this assessment discussion, melding the patient’s and family’s strengths and priorities with evidence-based interventions. “The Resilience Drive,” by Alexia Michiels,6 is a good source for the latter – each chapter has segments relating research to straightforward happiness practices. The Growing Happy card deck (available online) also has brief and usable recommendations suitable for many young people. You can use these during office visits, loan out cards, gift them to families, or recommend families purchase a deck.
To build relationships, I recommend the StoryCorps and 36 Questions To Fall In Love apps. They are free and can be used with parents, peers, or others to build relationship supports and positive intimacy. Try them out yourself first; they essentially provide a platform to generate vulnerable conversations.
Mindfulness is a great antidote to lack of engagement, and it can be practiced in a variety of forms. Card decks make good office props or giveaways, including Growing Mindful (mindfulness practices for all ages) and the YogaKids Toolbox. Plus, there’s an app for that – in fact, many. Two that are free and include materials accessible for younger age groups are Smiling Mind (a nonprofit) and Insight Timer (searchable). This can build engagement and counter negative emotions.
For increasing engagement and flow, I recommend patients and family members assess their character strengths at Strengths-Based Resilience by the University of Toronto SSQ72. Research shows that using your strengths in novel ways lowers depression risk, increases happiness,7 and may be a key to increasing engagement in everyday activities.
When Kailah came in for her next visit, a discussion of PERMA led to identifying time with her family and time with her dog as significant relationship supports that bring positive emotions. However, she struggled to identify a realm where she felt some sense of mastery or competence. Taking the strengths survey (SSQ72) brought out her strengths of love of learning and curiosity. This led to her volunteering at her local library – assisting with programs and eventually creating and leading a teens’ book group. Her CBT therapist supported her through these challenges, and she was able to taper the frequency of therapy sessions so that Kailah only returns for a booster session now every 6 months or so. While she still identifies as an anxious person, Kailah has broadened her self-image to include her resilience and love of learning as core strengths.
Dr. Andrew J. Rosenfeld is an assistant professor in the departments of psychiatry and pediatrics at the University of Vermont Medical Center, Burlington. He said he has no relevant disclosures. Email him at [email protected].
References
1. Am Psychol. 2000;55(1):5-14.
2. Am Psychol. 2007 Feb-Mar;62(2):95-108.
3. J Am Acad Child Adolesc Psychiatry. 1999 Oct;38(10):1230-6.
4. Soc Indic Res. 2009; 39:247-66.
5. “Flourish: A visionary new understanding of happiness and well-being” (New York: Free Press, 2011).
6. “The Resilience Drive” (Switzerland: Favre, 2017).
7. Am Psychol. 2005 Jul-Aug;60(5):410-21.
Risk of suicide attempt is higher in children of opioid users
according to an evaluation of a medical claims database from which a sample of more than 200,00 privately insured parents was evaluated.
Based on data collected between the years 2010 and 2016, the study raises the possibility that rising rates of opioid prescriptions and rising rates of suicide in adolescents and children are linked, said David A. Brent, of the University of Pittsburgh, and associates.
The relationship was considered sufficiently strong that the authors recommended clinicians consider mental health screening of children whose parents are known to have had extensive opioid exposure.
Addressing both opioid use in parents and the mental health in their children “may help, at least in part, to reverse the current upward trend in mortality due to the twin epidemics of suicide and opioid overdose,” said Dr. Brent and associates, whose findings were published in JAMA Psychiatry.
From a pool of more than 1 million parents aged 30-50 years in the claims database, 121,306 parents with extensive opioid use – defined as receiving opioid prescriptions for more than 365 days between 2010 and 2016 – were matched with 121,306 controls in the same age range. Children aged 10-19 years in both groups were compared for suicide attempts.
Overall, the rate of prescription opioid use as defined for inclusion in this study was 5% in the target parent population evaluated in this claims database.
Of the 184,142 children with parents exposed to opioids, 678 (0.37%) attempted suicide versus 212 (0.14%) of the 148,395 children from the nonopioid group. Expressed as a rate per 10,000 person years, the figures were 11.7 and 5.9 for the opioid and nonopioid groups, respectively.
When translated into an odds ratio (OR), the increased risk of suicide was found to be almost twice as high (OR 1.99) among children with parents meeting the study criteria for prescription opioid use. The OR was only slightly reduced (OR 1.85) after adjustment for sex and age.
Suicide attempts overall were higher in daughters than sons and in older children (15 years of age or older) than younger (ages 10 to less than 15 years) whether or not parents were taking opioids, but the relative risk remained consistently higher across all these subgroups when comparing those whose parents were taking prescription opioids with those whose parents were not.
As in past studies, children were more likely to make a suicide attempt if they had a parent who had a history of attempting suicide. However, the authors reported a significantly elevated risk of a suicide attempt for children of prescription opioid users after adjustment for this factor as well as for child depression, parental depression, and parental substance use disorder (OR, 1.45).
The OR of a suicide attempt was not significantly higher for a suicide attempt among those children with both parents taking prescription opioids relative to opioid use in only one parent (OR 1.05).
Dr. Brent and associates acknowledged that these data do not confirm that the rising rate of prescription opioid use is linked to the recent parallel rise in suicide attempts among children. However, they did conclude that children of parents using opioid prescriptions are at risk and might be an appropriate target for suicide prevention.
“Recognition and treatment of patients with opioid use disorder, attendance to comorbid conditions in affected parents, and screening and appropriate referral of their children may help” address both major public health issues, they maintained.
The study was supported by a National Institutes of Health grant. Dr Brent reported receiving royalties from Guilford Press, eRT, and UpToDate. Dr. Gibbons has served as an expert witness in cases related to suicide involving pharmaceutical companies, such as Pfizer and GlaxoSmithKline.
SOURCE: Brent DA et al. JAMA Psychiatry. 2019 May 22 doi: 10.1001/jamapsychiatry.2019.0940.
according to an evaluation of a medical claims database from which a sample of more than 200,00 privately insured parents was evaluated.
Based on data collected between the years 2010 and 2016, the study raises the possibility that rising rates of opioid prescriptions and rising rates of suicide in adolescents and children are linked, said David A. Brent, of the University of Pittsburgh, and associates.
The relationship was considered sufficiently strong that the authors recommended clinicians consider mental health screening of children whose parents are known to have had extensive opioid exposure.
Addressing both opioid use in parents and the mental health in their children “may help, at least in part, to reverse the current upward trend in mortality due to the twin epidemics of suicide and opioid overdose,” said Dr. Brent and associates, whose findings were published in JAMA Psychiatry.
From a pool of more than 1 million parents aged 30-50 years in the claims database, 121,306 parents with extensive opioid use – defined as receiving opioid prescriptions for more than 365 days between 2010 and 2016 – were matched with 121,306 controls in the same age range. Children aged 10-19 years in both groups were compared for suicide attempts.
Overall, the rate of prescription opioid use as defined for inclusion in this study was 5% in the target parent population evaluated in this claims database.
Of the 184,142 children with parents exposed to opioids, 678 (0.37%) attempted suicide versus 212 (0.14%) of the 148,395 children from the nonopioid group. Expressed as a rate per 10,000 person years, the figures were 11.7 and 5.9 for the opioid and nonopioid groups, respectively.
When translated into an odds ratio (OR), the increased risk of suicide was found to be almost twice as high (OR 1.99) among children with parents meeting the study criteria for prescription opioid use. The OR was only slightly reduced (OR 1.85) after adjustment for sex and age.
Suicide attempts overall were higher in daughters than sons and in older children (15 years of age or older) than younger (ages 10 to less than 15 years) whether or not parents were taking opioids, but the relative risk remained consistently higher across all these subgroups when comparing those whose parents were taking prescription opioids with those whose parents were not.
As in past studies, children were more likely to make a suicide attempt if they had a parent who had a history of attempting suicide. However, the authors reported a significantly elevated risk of a suicide attempt for children of prescription opioid users after adjustment for this factor as well as for child depression, parental depression, and parental substance use disorder (OR, 1.45).
The OR of a suicide attempt was not significantly higher for a suicide attempt among those children with both parents taking prescription opioids relative to opioid use in only one parent (OR 1.05).
Dr. Brent and associates acknowledged that these data do not confirm that the rising rate of prescription opioid use is linked to the recent parallel rise in suicide attempts among children. However, they did conclude that children of parents using opioid prescriptions are at risk and might be an appropriate target for suicide prevention.
“Recognition and treatment of patients with opioid use disorder, attendance to comorbid conditions in affected parents, and screening and appropriate referral of their children may help” address both major public health issues, they maintained.
The study was supported by a National Institutes of Health grant. Dr Brent reported receiving royalties from Guilford Press, eRT, and UpToDate. Dr. Gibbons has served as an expert witness in cases related to suicide involving pharmaceutical companies, such as Pfizer and GlaxoSmithKline.
SOURCE: Brent DA et al. JAMA Psychiatry. 2019 May 22 doi: 10.1001/jamapsychiatry.2019.0940.
according to an evaluation of a medical claims database from which a sample of more than 200,00 privately insured parents was evaluated.
Based on data collected between the years 2010 and 2016, the study raises the possibility that rising rates of opioid prescriptions and rising rates of suicide in adolescents and children are linked, said David A. Brent, of the University of Pittsburgh, and associates.
The relationship was considered sufficiently strong that the authors recommended clinicians consider mental health screening of children whose parents are known to have had extensive opioid exposure.
Addressing both opioid use in parents and the mental health in their children “may help, at least in part, to reverse the current upward trend in mortality due to the twin epidemics of suicide and opioid overdose,” said Dr. Brent and associates, whose findings were published in JAMA Psychiatry.
From a pool of more than 1 million parents aged 30-50 years in the claims database, 121,306 parents with extensive opioid use – defined as receiving opioid prescriptions for more than 365 days between 2010 and 2016 – were matched with 121,306 controls in the same age range. Children aged 10-19 years in both groups were compared for suicide attempts.
Overall, the rate of prescription opioid use as defined for inclusion in this study was 5% in the target parent population evaluated in this claims database.
Of the 184,142 children with parents exposed to opioids, 678 (0.37%) attempted suicide versus 212 (0.14%) of the 148,395 children from the nonopioid group. Expressed as a rate per 10,000 person years, the figures were 11.7 and 5.9 for the opioid and nonopioid groups, respectively.
When translated into an odds ratio (OR), the increased risk of suicide was found to be almost twice as high (OR 1.99) among children with parents meeting the study criteria for prescription opioid use. The OR was only slightly reduced (OR 1.85) after adjustment for sex and age.
Suicide attempts overall were higher in daughters than sons and in older children (15 years of age or older) than younger (ages 10 to less than 15 years) whether or not parents were taking opioids, but the relative risk remained consistently higher across all these subgroups when comparing those whose parents were taking prescription opioids with those whose parents were not.
As in past studies, children were more likely to make a suicide attempt if they had a parent who had a history of attempting suicide. However, the authors reported a significantly elevated risk of a suicide attempt for children of prescription opioid users after adjustment for this factor as well as for child depression, parental depression, and parental substance use disorder (OR, 1.45).
The OR of a suicide attempt was not significantly higher for a suicide attempt among those children with both parents taking prescription opioids relative to opioid use in only one parent (OR 1.05).
Dr. Brent and associates acknowledged that these data do not confirm that the rising rate of prescription opioid use is linked to the recent parallel rise in suicide attempts among children. However, they did conclude that children of parents using opioid prescriptions are at risk and might be an appropriate target for suicide prevention.
“Recognition and treatment of patients with opioid use disorder, attendance to comorbid conditions in affected parents, and screening and appropriate referral of their children may help” address both major public health issues, they maintained.
The study was supported by a National Institutes of Health grant. Dr Brent reported receiving royalties from Guilford Press, eRT, and UpToDate. Dr. Gibbons has served as an expert witness in cases related to suicide involving pharmaceutical companies, such as Pfizer and GlaxoSmithKline.
SOURCE: Brent DA et al. JAMA Psychiatry. 2019 May 22 doi: 10.1001/jamapsychiatry.2019.0940.
FROM JAMA PSYCHIATRY
Risk factors for foot ulcers differ for type 1 and type 2 diabetes
Danish researchers have linked multiple factors to higher risk of first-time diabetic foot ulcers (DFUs) in patients with type 1 and type 2 diabetes, although some of the factors – according to the new study findings.
The authors suggest that since clinical information gathered from patients during routine follow-up visits often includes mention of the risk factors for first-time DFU, it could form the basis of a risk stratification process for first-time DFU that can be integrated into the electronic record system and easily incorporated into routine care.
DFU is a significant complication for both type 1 and type 2 diabetes, but no previous research has stratified the risk factors for first-time DFUs by type of diabetes, emphasized the study authors, led by Sine Hangaard, MSc, of Steno Diabetes Center Copenhagen.
For the new study, the researchers tracked 5,588 patients with type 1 diabetes and 7,113 with type 2, all of whom were treated at a hospital clinic in Denmark between 2001 and 2015. The authors noted that the patients with type 2 disease who were treated at the center were clinically more complicated and had a longer disease duration than average type 2 patients, whereas the patients with type 1 diabetes did not differ from average type 1 patients.
Several factors boosted the risk of first-time DFU in both types of disease, including high or low levels of albumin excretion, advanced diabetic retinopathy, limited or nonexistent vibration sense, symptoms of neuropathy, and absence of foot pulses per univariable regression (all P less than .01). The researchers linked the neuropathy and absences of foot pulses to especially high spikes in risk.
Female gender was protective for type 1 and type 2 disease (hazard ratios, 0.7 and 0.5, respectively; P = .0000). Various body mass index levels seemed to have no impact on risk.
Three factors that posed a higher risk for first-time DFU in type 1 disease, but not type 2, were: smoking (HR, 1.4 vs. no smoking, P = .0220), age of 60-79 years (HR, 1.7 vs. age 40-59; P = .0000), cardiovascular disease (HR, 2.2 vs. no cardiovascular disease; P = .0000), and diabetes duration of between 5 and 20 years (HR, 2.2 vs. less than 5 years; P = .0027) or 20 years or more (HR, 5.2 vs. less than 5 years; P = .0000).
The authors noted that “25% of all patients with diabetes develop DFU during their lifetime, and DFUs precede 80% of all lower leg amputations in patients with diabetes.” In addition, DFU often occurs in feet already compromised by neuropathy or peripheral vascular disease, and is therefore associated with greater risk for infection, poorer outcomes, recurrent ulceration, amputation, and increased mortality. These risks underscore the need for the earliest-possible identification of first-time DFU and timely adoption of effective, preventative strategies, they wrote.
The study was not funded. Several of the authors reported that they own shares in Novo Nordisk.
SOURCE: Hangaard S et al. Diabetes Res Clin Pract. 2019 Apr 18;151:177-86.
Danish researchers have linked multiple factors to higher risk of first-time diabetic foot ulcers (DFUs) in patients with type 1 and type 2 diabetes, although some of the factors – according to the new study findings.
The authors suggest that since clinical information gathered from patients during routine follow-up visits often includes mention of the risk factors for first-time DFU, it could form the basis of a risk stratification process for first-time DFU that can be integrated into the electronic record system and easily incorporated into routine care.
DFU is a significant complication for both type 1 and type 2 diabetes, but no previous research has stratified the risk factors for first-time DFUs by type of diabetes, emphasized the study authors, led by Sine Hangaard, MSc, of Steno Diabetes Center Copenhagen.
For the new study, the researchers tracked 5,588 patients with type 1 diabetes and 7,113 with type 2, all of whom were treated at a hospital clinic in Denmark between 2001 and 2015. The authors noted that the patients with type 2 disease who were treated at the center were clinically more complicated and had a longer disease duration than average type 2 patients, whereas the patients with type 1 diabetes did not differ from average type 1 patients.
Several factors boosted the risk of first-time DFU in both types of disease, including high or low levels of albumin excretion, advanced diabetic retinopathy, limited or nonexistent vibration sense, symptoms of neuropathy, and absence of foot pulses per univariable regression (all P less than .01). The researchers linked the neuropathy and absences of foot pulses to especially high spikes in risk.
Female gender was protective for type 1 and type 2 disease (hazard ratios, 0.7 and 0.5, respectively; P = .0000). Various body mass index levels seemed to have no impact on risk.
Three factors that posed a higher risk for first-time DFU in type 1 disease, but not type 2, were: smoking (HR, 1.4 vs. no smoking, P = .0220), age of 60-79 years (HR, 1.7 vs. age 40-59; P = .0000), cardiovascular disease (HR, 2.2 vs. no cardiovascular disease; P = .0000), and diabetes duration of between 5 and 20 years (HR, 2.2 vs. less than 5 years; P = .0027) or 20 years or more (HR, 5.2 vs. less than 5 years; P = .0000).
The authors noted that “25% of all patients with diabetes develop DFU during their lifetime, and DFUs precede 80% of all lower leg amputations in patients with diabetes.” In addition, DFU often occurs in feet already compromised by neuropathy or peripheral vascular disease, and is therefore associated with greater risk for infection, poorer outcomes, recurrent ulceration, amputation, and increased mortality. These risks underscore the need for the earliest-possible identification of first-time DFU and timely adoption of effective, preventative strategies, they wrote.
The study was not funded. Several of the authors reported that they own shares in Novo Nordisk.
SOURCE: Hangaard S et al. Diabetes Res Clin Pract. 2019 Apr 18;151:177-86.
Danish researchers have linked multiple factors to higher risk of first-time diabetic foot ulcers (DFUs) in patients with type 1 and type 2 diabetes, although some of the factors – according to the new study findings.
The authors suggest that since clinical information gathered from patients during routine follow-up visits often includes mention of the risk factors for first-time DFU, it could form the basis of a risk stratification process for first-time DFU that can be integrated into the electronic record system and easily incorporated into routine care.
DFU is a significant complication for both type 1 and type 2 diabetes, but no previous research has stratified the risk factors for first-time DFUs by type of diabetes, emphasized the study authors, led by Sine Hangaard, MSc, of Steno Diabetes Center Copenhagen.
For the new study, the researchers tracked 5,588 patients with type 1 diabetes and 7,113 with type 2, all of whom were treated at a hospital clinic in Denmark between 2001 and 2015. The authors noted that the patients with type 2 disease who were treated at the center were clinically more complicated and had a longer disease duration than average type 2 patients, whereas the patients with type 1 diabetes did not differ from average type 1 patients.
Several factors boosted the risk of first-time DFU in both types of disease, including high or low levels of albumin excretion, advanced diabetic retinopathy, limited or nonexistent vibration sense, symptoms of neuropathy, and absence of foot pulses per univariable regression (all P less than .01). The researchers linked the neuropathy and absences of foot pulses to especially high spikes in risk.
Female gender was protective for type 1 and type 2 disease (hazard ratios, 0.7 and 0.5, respectively; P = .0000). Various body mass index levels seemed to have no impact on risk.
Three factors that posed a higher risk for first-time DFU in type 1 disease, but not type 2, were: smoking (HR, 1.4 vs. no smoking, P = .0220), age of 60-79 years (HR, 1.7 vs. age 40-59; P = .0000), cardiovascular disease (HR, 2.2 vs. no cardiovascular disease; P = .0000), and diabetes duration of between 5 and 20 years (HR, 2.2 vs. less than 5 years; P = .0027) or 20 years or more (HR, 5.2 vs. less than 5 years; P = .0000).
The authors noted that “25% of all patients with diabetes develop DFU during their lifetime, and DFUs precede 80% of all lower leg amputations in patients with diabetes.” In addition, DFU often occurs in feet already compromised by neuropathy or peripheral vascular disease, and is therefore associated with greater risk for infection, poorer outcomes, recurrent ulceration, amputation, and increased mortality. These risks underscore the need for the earliest-possible identification of first-time DFU and timely adoption of effective, preventative strategies, they wrote.
The study was not funded. Several of the authors reported that they own shares in Novo Nordisk.
SOURCE: Hangaard S et al. Diabetes Res Clin Pract. 2019 Apr 18;151:177-86.
FROM DIABETES RESEARCH AND CLINICAL PRACTICE