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Pharmacist BP telemonitoring cut cardiovascular events, turned profit
PHILADELPHIA – A home blood pressure telemonitoring program featuring pharmacist management of patients with uncontrolled hypertension reduced cardiovascular events by half and was cost saving over the course of 5 years, even though the intervention ended after year 1, Karen L. Margolis, MD, reported at the American Heart Association scientific sessions.
“The return on investment was 126%. That means that for every dollar spent on the intervention, that dollar was recouped by $1.00 plus another $1.26,” explained Dr. Margolis, a general internist who serves as executive director for research at the HealthPartners Institute in Bloomington, Minn., and professor of medicine at the University of Minnesota, Minneapolis.
She presented 5-year follow-up data from the Hyperlink (Home Blood Pressure Telemonitoring and Case Management to Control Hypertension) study, a cluster randomized controlled trial involving 16 primary care clinics. Half of the clinics were randomized to the intervention, which entailed home blood pressure telemonitoring and pharmacist-led case management in collaboration with the primary care team. The other eight clinics provided usual care. The intervention portion of the trial, which lasted for 12 months, included 450 adults with uncontrolled hypertension as defined by repeated on-treatment blood pressure readings of 140/90 mm Hg or more. Participants’ baseline mean blood pressure was 148/85 mm Hg while on an average of one and a half antihypertensive drug classes. On average, pharmacists ended up adding one additional drug from a different antihypertensive drug class to achieve improved blood pressure control.
The details of the intervention and the short-term blood pressure results have previously been reported (JAMA. 2013 Jul 3;310[1]:46-56). Briefly, 6 months into the study, patients in the intervention arm averaged 11/6 mm Hg lower blood pressure than did the usual care controls. At 12 months – when the intervention ended – the between-group difference was similar at 10/5 mm Hg. At 18 months, the difference, while attenuated, remained significant at 7/3 mm Hg in favor of the intervention group. However, at 54 months, the intervention group’s advantage – a 3–mm Hg lower SBP and a 1–mm Hg lower DBP than in controls – was no longer significant.
The exciting new findings Dr. Margolis presented at the AHA scientific sessions focused on 5-year outcomes. Since HealthPartners is an integrated health care system, follow-up was essentially complete.
“None of the other telemetry studies I’m aware of have published anything on cardiovascular events. And we were somewhat surprised when we looked at our data to see fairly substantial differences in our primary outcome,” she noted.
That outcome was a composite of MI, stroke, heart failure, or cardiovascular death occurring over 5 years. The rate was 4.4% in the intervention group and nearly double at 8.6% in controls. That translated to a 51% relative risk reduction. The biggest difference was in stroke: 4 cases in the intervention arm, 12 in usual care controls.
The 5-year coronary revascularization rate was 5.3% in the intervention arm and 10.4% in controls, for a 52% relative risk reduction.
A major caveat regarding the Hyperlink trial was that, even at 450 patients and 5 years of follow-up, the study was underpowered to show significant differences in event rates, with P =.09 for the primary endpoint.
That being said, the financial results were striking. The intervention cost $1,511 per patient in 2017 U.S. dollars. The cost of treatment for major adverse cardiovascular events totaled $758,000 in the intervention group and $1,538,000 in usual care controls. That works out to $3,420 less per patient in the intervention arm. Offset by the cost of the intervention, that spells a net savings of $1,908 per patient achieved by implementing the year-long intervention. It’s a rare instance in health care of an intervention that actually makes money.
These results were unusual enough that Dr. Margolis and her coinvestigators decided to feed their wealth of SBP readings into a microsimulation model, which they ran 1,000 times. The model predicted – in light of the fact that patients in the intervention group were on average 2 years older than the controls were – that the expected reduction in the primary endpoint was 12% rather than the observed 51% relative risk reduction.
How to explain the discrepancy? The Hyperlink results could have been due to chance. Or it could be, Dr. Margolis surmised, that the pharmacists helped accomplish improvements in other cardiovascular risk factors, such as hyperlipidemia, smoking, or sedentary behavior. That’s unknown, since the investigators focused on changes in blood pressure only. Future studies of home telemonitoring and pharmacist case management of uncontrolled hypertension should be powered to detect significant differences in cardiovascular events and should track additional risk factors, she concluded.
She reported having no financial conflicts regarding the study.
SOURCE: Margolis KL. AHA 2019. Abstract MDP232.
PHILADELPHIA – A home blood pressure telemonitoring program featuring pharmacist management of patients with uncontrolled hypertension reduced cardiovascular events by half and was cost saving over the course of 5 years, even though the intervention ended after year 1, Karen L. Margolis, MD, reported at the American Heart Association scientific sessions.
“The return on investment was 126%. That means that for every dollar spent on the intervention, that dollar was recouped by $1.00 plus another $1.26,” explained Dr. Margolis, a general internist who serves as executive director for research at the HealthPartners Institute in Bloomington, Minn., and professor of medicine at the University of Minnesota, Minneapolis.
She presented 5-year follow-up data from the Hyperlink (Home Blood Pressure Telemonitoring and Case Management to Control Hypertension) study, a cluster randomized controlled trial involving 16 primary care clinics. Half of the clinics were randomized to the intervention, which entailed home blood pressure telemonitoring and pharmacist-led case management in collaboration with the primary care team. The other eight clinics provided usual care. The intervention portion of the trial, which lasted for 12 months, included 450 adults with uncontrolled hypertension as defined by repeated on-treatment blood pressure readings of 140/90 mm Hg or more. Participants’ baseline mean blood pressure was 148/85 mm Hg while on an average of one and a half antihypertensive drug classes. On average, pharmacists ended up adding one additional drug from a different antihypertensive drug class to achieve improved blood pressure control.
The details of the intervention and the short-term blood pressure results have previously been reported (JAMA. 2013 Jul 3;310[1]:46-56). Briefly, 6 months into the study, patients in the intervention arm averaged 11/6 mm Hg lower blood pressure than did the usual care controls. At 12 months – when the intervention ended – the between-group difference was similar at 10/5 mm Hg. At 18 months, the difference, while attenuated, remained significant at 7/3 mm Hg in favor of the intervention group. However, at 54 months, the intervention group’s advantage – a 3–mm Hg lower SBP and a 1–mm Hg lower DBP than in controls – was no longer significant.
The exciting new findings Dr. Margolis presented at the AHA scientific sessions focused on 5-year outcomes. Since HealthPartners is an integrated health care system, follow-up was essentially complete.
“None of the other telemetry studies I’m aware of have published anything on cardiovascular events. And we were somewhat surprised when we looked at our data to see fairly substantial differences in our primary outcome,” she noted.
That outcome was a composite of MI, stroke, heart failure, or cardiovascular death occurring over 5 years. The rate was 4.4% in the intervention group and nearly double at 8.6% in controls. That translated to a 51% relative risk reduction. The biggest difference was in stroke: 4 cases in the intervention arm, 12 in usual care controls.
The 5-year coronary revascularization rate was 5.3% in the intervention arm and 10.4% in controls, for a 52% relative risk reduction.
A major caveat regarding the Hyperlink trial was that, even at 450 patients and 5 years of follow-up, the study was underpowered to show significant differences in event rates, with P =.09 for the primary endpoint.
That being said, the financial results were striking. The intervention cost $1,511 per patient in 2017 U.S. dollars. The cost of treatment for major adverse cardiovascular events totaled $758,000 in the intervention group and $1,538,000 in usual care controls. That works out to $3,420 less per patient in the intervention arm. Offset by the cost of the intervention, that spells a net savings of $1,908 per patient achieved by implementing the year-long intervention. It’s a rare instance in health care of an intervention that actually makes money.
These results were unusual enough that Dr. Margolis and her coinvestigators decided to feed their wealth of SBP readings into a microsimulation model, which they ran 1,000 times. The model predicted – in light of the fact that patients in the intervention group were on average 2 years older than the controls were – that the expected reduction in the primary endpoint was 12% rather than the observed 51% relative risk reduction.
How to explain the discrepancy? The Hyperlink results could have been due to chance. Or it could be, Dr. Margolis surmised, that the pharmacists helped accomplish improvements in other cardiovascular risk factors, such as hyperlipidemia, smoking, or sedentary behavior. That’s unknown, since the investigators focused on changes in blood pressure only. Future studies of home telemonitoring and pharmacist case management of uncontrolled hypertension should be powered to detect significant differences in cardiovascular events and should track additional risk factors, she concluded.
She reported having no financial conflicts regarding the study.
SOURCE: Margolis KL. AHA 2019. Abstract MDP232.
PHILADELPHIA – A home blood pressure telemonitoring program featuring pharmacist management of patients with uncontrolled hypertension reduced cardiovascular events by half and was cost saving over the course of 5 years, even though the intervention ended after year 1, Karen L. Margolis, MD, reported at the American Heart Association scientific sessions.
“The return on investment was 126%. That means that for every dollar spent on the intervention, that dollar was recouped by $1.00 plus another $1.26,” explained Dr. Margolis, a general internist who serves as executive director for research at the HealthPartners Institute in Bloomington, Minn., and professor of medicine at the University of Minnesota, Minneapolis.
She presented 5-year follow-up data from the Hyperlink (Home Blood Pressure Telemonitoring and Case Management to Control Hypertension) study, a cluster randomized controlled trial involving 16 primary care clinics. Half of the clinics were randomized to the intervention, which entailed home blood pressure telemonitoring and pharmacist-led case management in collaboration with the primary care team. The other eight clinics provided usual care. The intervention portion of the trial, which lasted for 12 months, included 450 adults with uncontrolled hypertension as defined by repeated on-treatment blood pressure readings of 140/90 mm Hg or more. Participants’ baseline mean blood pressure was 148/85 mm Hg while on an average of one and a half antihypertensive drug classes. On average, pharmacists ended up adding one additional drug from a different antihypertensive drug class to achieve improved blood pressure control.
The details of the intervention and the short-term blood pressure results have previously been reported (JAMA. 2013 Jul 3;310[1]:46-56). Briefly, 6 months into the study, patients in the intervention arm averaged 11/6 mm Hg lower blood pressure than did the usual care controls. At 12 months – when the intervention ended – the between-group difference was similar at 10/5 mm Hg. At 18 months, the difference, while attenuated, remained significant at 7/3 mm Hg in favor of the intervention group. However, at 54 months, the intervention group’s advantage – a 3–mm Hg lower SBP and a 1–mm Hg lower DBP than in controls – was no longer significant.
The exciting new findings Dr. Margolis presented at the AHA scientific sessions focused on 5-year outcomes. Since HealthPartners is an integrated health care system, follow-up was essentially complete.
“None of the other telemetry studies I’m aware of have published anything on cardiovascular events. And we were somewhat surprised when we looked at our data to see fairly substantial differences in our primary outcome,” she noted.
That outcome was a composite of MI, stroke, heart failure, or cardiovascular death occurring over 5 years. The rate was 4.4% in the intervention group and nearly double at 8.6% in controls. That translated to a 51% relative risk reduction. The biggest difference was in stroke: 4 cases in the intervention arm, 12 in usual care controls.
The 5-year coronary revascularization rate was 5.3% in the intervention arm and 10.4% in controls, for a 52% relative risk reduction.
A major caveat regarding the Hyperlink trial was that, even at 450 patients and 5 years of follow-up, the study was underpowered to show significant differences in event rates, with P =.09 for the primary endpoint.
That being said, the financial results were striking. The intervention cost $1,511 per patient in 2017 U.S. dollars. The cost of treatment for major adverse cardiovascular events totaled $758,000 in the intervention group and $1,538,000 in usual care controls. That works out to $3,420 less per patient in the intervention arm. Offset by the cost of the intervention, that spells a net savings of $1,908 per patient achieved by implementing the year-long intervention. It’s a rare instance in health care of an intervention that actually makes money.
These results were unusual enough that Dr. Margolis and her coinvestigators decided to feed their wealth of SBP readings into a microsimulation model, which they ran 1,000 times. The model predicted – in light of the fact that patients in the intervention group were on average 2 years older than the controls were – that the expected reduction in the primary endpoint was 12% rather than the observed 51% relative risk reduction.
How to explain the discrepancy? The Hyperlink results could have been due to chance. Or it could be, Dr. Margolis surmised, that the pharmacists helped accomplish improvements in other cardiovascular risk factors, such as hyperlipidemia, smoking, or sedentary behavior. That’s unknown, since the investigators focused on changes in blood pressure only. Future studies of home telemonitoring and pharmacist case management of uncontrolled hypertension should be powered to detect significant differences in cardiovascular events and should track additional risk factors, she concluded.
She reported having no financial conflicts regarding the study.
SOURCE: Margolis KL. AHA 2019. Abstract MDP232.
REPORTING FROM THE AHA SCIENTIFIC SESSIONS
Consider hyperbaric oxygen for inflammatory ileal pouchitis
SAN ANTONIO – , Hamna Fahad, MD, reported at the annual meeting of the American College of Gastroenterology.
Dr. Fahad, of the Cleveland Clinic, presented a retrospective case series of 21 consecutive clinic patients who presented with inflammatory bowel disease, a surgically created ileal pouch–anal anastomosis, and medically refractory pouchitis. All patients received 30 hyperbaric oxygen treatment sessions, each an hour long, over the course of 2 months. This intensive regimen worked out to 3-5 sessions per week involving 100% oxygen pressurized to 2.4-3.0 ATA.
Overall, 19 of 21 patients experienced improvement in their modified Pouchitis Disease Activity Index (mPDAI) score. The mean total mPDAI at baseline was 8.71, improving significantly to 5 post treatment. The mPDAI symptoms subscore also showed significant improvement in response to a course of hyperbaric oxygen therapy, decreasing from 4 points to 2. The cuff subscore fell from 3 to 0, and the pouch body subscore improved from 3 to 2.
Thirteen of 21 patients reported subjective symptomatic improvement in stool frequency, bleeding, urgency, and fevers, including 6 with complete symptomatic remission. Seventeen patients demonstrated significant endoscopic improvement upon blinded assessment. Seven of 9 patients with fistulae experienced healing of the fistula tract.
The treatment entailed no side effects. However, the benefits weren’t uniformly durable. Several patients underwent a second 30-session round of hyperbaric oxygen therapy within a year because of recurrent pouchitis symptoms refractory to corticosteroids, biologics, and other medications.
Dr. Fahad said the mechanism of benefit for hyperbaric oxygen in the treatment of chronic inflammatory pouchitis is probably severalfold: reversal of a disordered microbiome through inhibition of the growth of anaerobes, reduced production of tumor necrosis factor–alpha and other inflammatory cytokines, and increased plasma oxygen, which reduces ischemia at the tissue level, thereby promoting tissue healing.
Audience members had a practical question: How can they get this treatment paid for? One gastroenterologist said she has encountered considerable payer resistance when she has sought coverage of hyperbaric oxygen for patients with ulcerative colitis and fistulae, even though there is already published evidence of benefit. But Dr. Fahad’s groundbreaking study provides the first such evidence in pouchitis. So how did she and her coworkers do it? Eighty percent of the pouchitis patients obtained payer approval only upon appeal, which was readily granted, she explained.
Dr. Fahad reported having no financial conflicts regarding her study, conducted without commercial support.
SOURCE: Fahad H. ACG 2019 Abstract 38.
SAN ANTONIO – , Hamna Fahad, MD, reported at the annual meeting of the American College of Gastroenterology.
Dr. Fahad, of the Cleveland Clinic, presented a retrospective case series of 21 consecutive clinic patients who presented with inflammatory bowel disease, a surgically created ileal pouch–anal anastomosis, and medically refractory pouchitis. All patients received 30 hyperbaric oxygen treatment sessions, each an hour long, over the course of 2 months. This intensive regimen worked out to 3-5 sessions per week involving 100% oxygen pressurized to 2.4-3.0 ATA.
Overall, 19 of 21 patients experienced improvement in their modified Pouchitis Disease Activity Index (mPDAI) score. The mean total mPDAI at baseline was 8.71, improving significantly to 5 post treatment. The mPDAI symptoms subscore also showed significant improvement in response to a course of hyperbaric oxygen therapy, decreasing from 4 points to 2. The cuff subscore fell from 3 to 0, and the pouch body subscore improved from 3 to 2.
Thirteen of 21 patients reported subjective symptomatic improvement in stool frequency, bleeding, urgency, and fevers, including 6 with complete symptomatic remission. Seventeen patients demonstrated significant endoscopic improvement upon blinded assessment. Seven of 9 patients with fistulae experienced healing of the fistula tract.
The treatment entailed no side effects. However, the benefits weren’t uniformly durable. Several patients underwent a second 30-session round of hyperbaric oxygen therapy within a year because of recurrent pouchitis symptoms refractory to corticosteroids, biologics, and other medications.
Dr. Fahad said the mechanism of benefit for hyperbaric oxygen in the treatment of chronic inflammatory pouchitis is probably severalfold: reversal of a disordered microbiome through inhibition of the growth of anaerobes, reduced production of tumor necrosis factor–alpha and other inflammatory cytokines, and increased plasma oxygen, which reduces ischemia at the tissue level, thereby promoting tissue healing.
Audience members had a practical question: How can they get this treatment paid for? One gastroenterologist said she has encountered considerable payer resistance when she has sought coverage of hyperbaric oxygen for patients with ulcerative colitis and fistulae, even though there is already published evidence of benefit. But Dr. Fahad’s groundbreaking study provides the first such evidence in pouchitis. So how did she and her coworkers do it? Eighty percent of the pouchitis patients obtained payer approval only upon appeal, which was readily granted, she explained.
Dr. Fahad reported having no financial conflicts regarding her study, conducted without commercial support.
SOURCE: Fahad H. ACG 2019 Abstract 38.
SAN ANTONIO – , Hamna Fahad, MD, reported at the annual meeting of the American College of Gastroenterology.
Dr. Fahad, of the Cleveland Clinic, presented a retrospective case series of 21 consecutive clinic patients who presented with inflammatory bowel disease, a surgically created ileal pouch–anal anastomosis, and medically refractory pouchitis. All patients received 30 hyperbaric oxygen treatment sessions, each an hour long, over the course of 2 months. This intensive regimen worked out to 3-5 sessions per week involving 100% oxygen pressurized to 2.4-3.0 ATA.
Overall, 19 of 21 patients experienced improvement in their modified Pouchitis Disease Activity Index (mPDAI) score. The mean total mPDAI at baseline was 8.71, improving significantly to 5 post treatment. The mPDAI symptoms subscore also showed significant improvement in response to a course of hyperbaric oxygen therapy, decreasing from 4 points to 2. The cuff subscore fell from 3 to 0, and the pouch body subscore improved from 3 to 2.
Thirteen of 21 patients reported subjective symptomatic improvement in stool frequency, bleeding, urgency, and fevers, including 6 with complete symptomatic remission. Seventeen patients demonstrated significant endoscopic improvement upon blinded assessment. Seven of 9 patients with fistulae experienced healing of the fistula tract.
The treatment entailed no side effects. However, the benefits weren’t uniformly durable. Several patients underwent a second 30-session round of hyperbaric oxygen therapy within a year because of recurrent pouchitis symptoms refractory to corticosteroids, biologics, and other medications.
Dr. Fahad said the mechanism of benefit for hyperbaric oxygen in the treatment of chronic inflammatory pouchitis is probably severalfold: reversal of a disordered microbiome through inhibition of the growth of anaerobes, reduced production of tumor necrosis factor–alpha and other inflammatory cytokines, and increased plasma oxygen, which reduces ischemia at the tissue level, thereby promoting tissue healing.
Audience members had a practical question: How can they get this treatment paid for? One gastroenterologist said she has encountered considerable payer resistance when she has sought coverage of hyperbaric oxygen for patients with ulcerative colitis and fistulae, even though there is already published evidence of benefit. But Dr. Fahad’s groundbreaking study provides the first such evidence in pouchitis. So how did she and her coworkers do it? Eighty percent of the pouchitis patients obtained payer approval only upon appeal, which was readily granted, she explained.
Dr. Fahad reported having no financial conflicts regarding her study, conducted without commercial support.
SOURCE: Fahad H. ACG 2019 Abstract 38.
REPORTING FROM ACG 2019
FDA approves diazepam nasal spray for seizure clusters
The drug may be administered by a care partner outside of a medical setting for the treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern. The formulation is the first nasal spray approved by the FDA as a rescue treatment for people with epilepsy aged 6 years and older, according to Neurelis, the developer of the drug. Midazolam nasal spray, approved in May 2019, is indicated for patients with epilepsy aged 12 years and older.
Investigators evaluated the safety of diazepam nasal spray in a long-term, open-label, repeat-dose, clinical trial. The study enrolled 130 patients aged 6 years and older; more than 2,000 seizures were treated. The drug generally was safe and well tolerated, and the most common adverse reactions were somnolence, headache, and nasal discomfort.
The FDA has granted Valtoco 7 years of orphan drug exclusivity. In the United States, about 170,000 patients with epilepsy are at risk of cluster or acute repetitive seizures, the company said. Until recently, approved rescue medications had been rectally administered.
Patients may receive a second dose of diazepam nasal spray at least 4 hours after an initial dose if needed, but caregivers should not use more than two doses to treat a single episode, according to the prescribing information. In addition, the prescribing information recommends that diazepam nasal spray be used for no more than one episode every 5 days and no more than five episodes per month.
The drug may be administered by a care partner outside of a medical setting for the treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern. The formulation is the first nasal spray approved by the FDA as a rescue treatment for people with epilepsy aged 6 years and older, according to Neurelis, the developer of the drug. Midazolam nasal spray, approved in May 2019, is indicated for patients with epilepsy aged 12 years and older.
Investigators evaluated the safety of diazepam nasal spray in a long-term, open-label, repeat-dose, clinical trial. The study enrolled 130 patients aged 6 years and older; more than 2,000 seizures were treated. The drug generally was safe and well tolerated, and the most common adverse reactions were somnolence, headache, and nasal discomfort.
The FDA has granted Valtoco 7 years of orphan drug exclusivity. In the United States, about 170,000 patients with epilepsy are at risk of cluster or acute repetitive seizures, the company said. Until recently, approved rescue medications had been rectally administered.
Patients may receive a second dose of diazepam nasal spray at least 4 hours after an initial dose if needed, but caregivers should not use more than two doses to treat a single episode, according to the prescribing information. In addition, the prescribing information recommends that diazepam nasal spray be used for no more than one episode every 5 days and no more than five episodes per month.
The drug may be administered by a care partner outside of a medical setting for the treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern. The formulation is the first nasal spray approved by the FDA as a rescue treatment for people with epilepsy aged 6 years and older, according to Neurelis, the developer of the drug. Midazolam nasal spray, approved in May 2019, is indicated for patients with epilepsy aged 12 years and older.
Investigators evaluated the safety of diazepam nasal spray in a long-term, open-label, repeat-dose, clinical trial. The study enrolled 130 patients aged 6 years and older; more than 2,000 seizures were treated. The drug generally was safe and well tolerated, and the most common adverse reactions were somnolence, headache, and nasal discomfort.
The FDA has granted Valtoco 7 years of orphan drug exclusivity. In the United States, about 170,000 patients with epilepsy are at risk of cluster or acute repetitive seizures, the company said. Until recently, approved rescue medications had been rectally administered.
Patients may receive a second dose of diazepam nasal spray at least 4 hours after an initial dose if needed, but caregivers should not use more than two doses to treat a single episode, according to the prescribing information. In addition, the prescribing information recommends that diazepam nasal spray be used for no more than one episode every 5 days and no more than five episodes per month.
Prednisolone scores for hand OA
ATLANTA – Dutch investigators at the annual meeting of the American College of Rheumatology made a good case for 6 weeks of low-dose prednisolone to help people with hand osteoarthritis get over a particularly bad spell.
A total of 42 patients randomized to prednisolone 10 mg/day fell a mean of 21.5 mm at 6 weeks from a baseline visual analog hand pain score of 54 mm (out of a possible 100 mm), versus a drop of 5.2 mm from a baseline score of 53 mm among 46 randomized to placebo; the mean group difference was 16.5 mm. Patients taking prednisolone did better on function, quality of life, and physician global assessments, too.
“This trial provides evidence that local inflammation is a suitable target for drug treatment in hand OA. We think this study provides clinicians with a short-term treatment option for patients who have a flare of their disease,” said lead investigator Féline Kroon, MD, a rheumatologist at Leiden (the Netherlands) University Medical Center.
“The large beneficial effect size exceeded that of all available therapeutic options for hand osteoarthritis,” including NSAIDs, she and her team noted in the study write-up, which was published to coincide with the meeting (Lancet. 2019 Nov 30;394[10213]:1993-2001).
Many physicians already use short-course prednisolone for hand OA, but there was no clinical evidence that it helped until now. The study also adds weight to the idea that OA has an inflammatory component – an idea that has been building for a while, Dr. Kroon said.
Leiden investigators and others have previously shown that synovial inflammation is often present in hand OA and a main determinant of pain and radiographic progression.
The 92 patients in the Low-Dose Prednisolone in Patients with Painful Hand Osteoarthritis (HOPE) trial had to have at least four interphalangeal joints (IPJs) with osteoarthritic nodes, at least one IPJ with soft swelling or erythema, and at least one with a positive power Doppler signal or grade 2 or higher synovitis on ultrasound. They also had to have flared at least 20 mm on the pain scale with NSAID washout.
There were more responders in the prednisolone group at 6 weeks (72% versus 33%), and significantly greater improvement in synovial thickening. There was no difference in power Doppler score or synovitis score per joint on MRI, but bone marrow lesions appeared less severe with prednisolone.
All the between-group differences disappeared when prednisolone was tapered after 6 weeks.
Four patients discontinued the study because of an adverse event: a myocardial infarction in the prednisolone group, and, in the control arm, a bowel surgery, an infected leg hematoma, and a case of Lyme arthritis of the knee. Adverse events were otherwise mild and similar in both arms.
The mean age in the study was 64 years, and 79% of the subjects were women. Exclusion criteria included chronic inflammatory rheumatic diseases, psoriasis, use of immune-modulating drugs within 90 days of baseline, and predominantly thumb base pain instead of finger pain.
The approach “is for short course. Long-term steroids can have important side effects, like osteoporosis. We do not think this study should be used to encourage prolonged prescribing of glucocorticoids in patients with hand OA,” Dr. Kroon said.
Two previous trials of glucocorticoids for hand OA were inconclusive. A dose of prednisone 5 mg/day for 4 weeks did not separate from placebo in one, and the second showed pain improvements with a combination of prednisolone and dipyridamole versus placebo, but with more adverse events, particularly dipyridamole headaches.
The work was funded by the Dutch Arthritis Society. Dr. Kroon did not have any disclosures.
SOURCE: Kroon F et al. Arthritis Rheumatol. 2019;71(suppl 10), Abstract 1760.
ATLANTA – Dutch investigators at the annual meeting of the American College of Rheumatology made a good case for 6 weeks of low-dose prednisolone to help people with hand osteoarthritis get over a particularly bad spell.
A total of 42 patients randomized to prednisolone 10 mg/day fell a mean of 21.5 mm at 6 weeks from a baseline visual analog hand pain score of 54 mm (out of a possible 100 mm), versus a drop of 5.2 mm from a baseline score of 53 mm among 46 randomized to placebo; the mean group difference was 16.5 mm. Patients taking prednisolone did better on function, quality of life, and physician global assessments, too.
“This trial provides evidence that local inflammation is a suitable target for drug treatment in hand OA. We think this study provides clinicians with a short-term treatment option for patients who have a flare of their disease,” said lead investigator Féline Kroon, MD, a rheumatologist at Leiden (the Netherlands) University Medical Center.
“The large beneficial effect size exceeded that of all available therapeutic options for hand osteoarthritis,” including NSAIDs, she and her team noted in the study write-up, which was published to coincide with the meeting (Lancet. 2019 Nov 30;394[10213]:1993-2001).
Many physicians already use short-course prednisolone for hand OA, but there was no clinical evidence that it helped until now. The study also adds weight to the idea that OA has an inflammatory component – an idea that has been building for a while, Dr. Kroon said.
Leiden investigators and others have previously shown that synovial inflammation is often present in hand OA and a main determinant of pain and radiographic progression.
The 92 patients in the Low-Dose Prednisolone in Patients with Painful Hand Osteoarthritis (HOPE) trial had to have at least four interphalangeal joints (IPJs) with osteoarthritic nodes, at least one IPJ with soft swelling or erythema, and at least one with a positive power Doppler signal or grade 2 or higher synovitis on ultrasound. They also had to have flared at least 20 mm on the pain scale with NSAID washout.
There were more responders in the prednisolone group at 6 weeks (72% versus 33%), and significantly greater improvement in synovial thickening. There was no difference in power Doppler score or synovitis score per joint on MRI, but bone marrow lesions appeared less severe with prednisolone.
All the between-group differences disappeared when prednisolone was tapered after 6 weeks.
Four patients discontinued the study because of an adverse event: a myocardial infarction in the prednisolone group, and, in the control arm, a bowel surgery, an infected leg hematoma, and a case of Lyme arthritis of the knee. Adverse events were otherwise mild and similar in both arms.
The mean age in the study was 64 years, and 79% of the subjects were women. Exclusion criteria included chronic inflammatory rheumatic diseases, psoriasis, use of immune-modulating drugs within 90 days of baseline, and predominantly thumb base pain instead of finger pain.
The approach “is for short course. Long-term steroids can have important side effects, like osteoporosis. We do not think this study should be used to encourage prolonged prescribing of glucocorticoids in patients with hand OA,” Dr. Kroon said.
Two previous trials of glucocorticoids for hand OA were inconclusive. A dose of prednisone 5 mg/day for 4 weeks did not separate from placebo in one, and the second showed pain improvements with a combination of prednisolone and dipyridamole versus placebo, but with more adverse events, particularly dipyridamole headaches.
The work was funded by the Dutch Arthritis Society. Dr. Kroon did not have any disclosures.
SOURCE: Kroon F et al. Arthritis Rheumatol. 2019;71(suppl 10), Abstract 1760.
ATLANTA – Dutch investigators at the annual meeting of the American College of Rheumatology made a good case for 6 weeks of low-dose prednisolone to help people with hand osteoarthritis get over a particularly bad spell.
A total of 42 patients randomized to prednisolone 10 mg/day fell a mean of 21.5 mm at 6 weeks from a baseline visual analog hand pain score of 54 mm (out of a possible 100 mm), versus a drop of 5.2 mm from a baseline score of 53 mm among 46 randomized to placebo; the mean group difference was 16.5 mm. Patients taking prednisolone did better on function, quality of life, and physician global assessments, too.
“This trial provides evidence that local inflammation is a suitable target for drug treatment in hand OA. We think this study provides clinicians with a short-term treatment option for patients who have a flare of their disease,” said lead investigator Féline Kroon, MD, a rheumatologist at Leiden (the Netherlands) University Medical Center.
“The large beneficial effect size exceeded that of all available therapeutic options for hand osteoarthritis,” including NSAIDs, she and her team noted in the study write-up, which was published to coincide with the meeting (Lancet. 2019 Nov 30;394[10213]:1993-2001).
Many physicians already use short-course prednisolone for hand OA, but there was no clinical evidence that it helped until now. The study also adds weight to the idea that OA has an inflammatory component – an idea that has been building for a while, Dr. Kroon said.
Leiden investigators and others have previously shown that synovial inflammation is often present in hand OA and a main determinant of pain and radiographic progression.
The 92 patients in the Low-Dose Prednisolone in Patients with Painful Hand Osteoarthritis (HOPE) trial had to have at least four interphalangeal joints (IPJs) with osteoarthritic nodes, at least one IPJ with soft swelling or erythema, and at least one with a positive power Doppler signal or grade 2 or higher synovitis on ultrasound. They also had to have flared at least 20 mm on the pain scale with NSAID washout.
There were more responders in the prednisolone group at 6 weeks (72% versus 33%), and significantly greater improvement in synovial thickening. There was no difference in power Doppler score or synovitis score per joint on MRI, but bone marrow lesions appeared less severe with prednisolone.
All the between-group differences disappeared when prednisolone was tapered after 6 weeks.
Four patients discontinued the study because of an adverse event: a myocardial infarction in the prednisolone group, and, in the control arm, a bowel surgery, an infected leg hematoma, and a case of Lyme arthritis of the knee. Adverse events were otherwise mild and similar in both arms.
The mean age in the study was 64 years, and 79% of the subjects were women. Exclusion criteria included chronic inflammatory rheumatic diseases, psoriasis, use of immune-modulating drugs within 90 days of baseline, and predominantly thumb base pain instead of finger pain.
The approach “is for short course. Long-term steroids can have important side effects, like osteoporosis. We do not think this study should be used to encourage prolonged prescribing of glucocorticoids in patients with hand OA,” Dr. Kroon said.
Two previous trials of glucocorticoids for hand OA were inconclusive. A dose of prednisone 5 mg/day for 4 weeks did not separate from placebo in one, and the second showed pain improvements with a combination of prednisolone and dipyridamole versus placebo, but with more adverse events, particularly dipyridamole headaches.
The work was funded by the Dutch Arthritis Society. Dr. Kroon did not have any disclosures.
SOURCE: Kroon F et al. Arthritis Rheumatol. 2019;71(suppl 10), Abstract 1760.
REPORTING FROM ACR 2019
Methotrexate gives durable remission from idiopathic granulomatous mastitis
ATLANTA – Methotrexate, in combination with prednisone, might be emerging as the go-to option for idiopathic granulomatous mastitis, according to investigators from Oregon Health & Science University, Portland.
Idiopathic granulomatous mastitis (IGM) is an inflammatory disease in which granulomas form in breast tissue. It strikes mostly young to middle-aged women with painful, firm breast masses, sometimes with redness and drainage. Diagnosis is by biopsy with rule-out of known causes.
IGM does not respond to antibiotics. Prednisone and surgery have been the traditional approaches, but masses can recur after surgery, and a year or more of prednisone, with the weight gain and side effects, is problematic. As a result, cases are increasingly being referred to rheumatologists for other options, said lead investigator Sarah Ringsted, MD, a rheumatology fellow at the university.
A study she presented at the annual meeting of the American College of Rheumatology and previous work from others builds a case for methotrexate, which often seems to put the disease in remission and allows for shorter glucocorticoid courses. These days, “I offer this to patients as a great option. It’s really nice to have, instead of having women go on months and months of high-dose steroids, and I think we can save patients from unnecessary” surgery, Dr. Ringsted said.
Her usual regimen these days is methotrexate 15-20 mg/week for 12-18 months, with high-dose prednisone (greater than 20 mg/day) for the first 3 months, followed by a taper.
Dr. Ringsted and associates compared 23 women treated at the university during 2007-2018. Just 5 of the 12 women (42%) treated with high-dose prednisone alone went into remission and did not relapse over a mean follow-up of 27 months. Two out of three women who had both high-dose glucocorticoids and surgery achieved remission without relapse, as did all three women who received methotrexate and high-dose glucocorticoids (one also had surgery). Five other patients were treated with other options; just two had a durable remission.
The numbers are small, but they add to two previous reports. Among 19 women who had failed other treatments, 94% improved and 75% went into remission with 15 months of methotrexate in a review from Stanford (Calif.) University. An Iranian study of 17 patients treated with methotrexate, and also glucocorticoids in some, had a relapse rate of only 17.8%.
There were several cases of both inflammatory arthritis and erythema nodosum in the Oregon series, a higher incidence than what has been reported before for IGM. “It’s interesting because it makes me think of sarcoidosis. There have been cases of sarcoidosis causing mastitis, but mostly in patients with other features” of the disease. “It makes me wonder if any of these women will develop sarcoidosis later on; I think that’s an interesting question,” Dr. Ringsted said.
Women in the study were an average age of 32 years, and over half were Hispanic, which is associated with a higher risk for IGM. Almost all the women had been pregnant before and had breast fed in the previous 5 years. Cancer, tuberculosis, and fungal infections were among the things ruled out before mastitis was deemed idiopathic.
Women with IGM tend to be of childbearing age, and must be cautioned against the teratogenic effects of methotrexate, Dr. Ringsted noted.
There was no external funding, and the investigators didn’t report any disclosures.
SOURCE: Ringsted S et al. Arthritis Rheumatol. 2019;71(suppl 10), Abstract 386.
ATLANTA – Methotrexate, in combination with prednisone, might be emerging as the go-to option for idiopathic granulomatous mastitis, according to investigators from Oregon Health & Science University, Portland.
Idiopathic granulomatous mastitis (IGM) is an inflammatory disease in which granulomas form in breast tissue. It strikes mostly young to middle-aged women with painful, firm breast masses, sometimes with redness and drainage. Diagnosis is by biopsy with rule-out of known causes.
IGM does not respond to antibiotics. Prednisone and surgery have been the traditional approaches, but masses can recur after surgery, and a year or more of prednisone, with the weight gain and side effects, is problematic. As a result, cases are increasingly being referred to rheumatologists for other options, said lead investigator Sarah Ringsted, MD, a rheumatology fellow at the university.
A study she presented at the annual meeting of the American College of Rheumatology and previous work from others builds a case for methotrexate, which often seems to put the disease in remission and allows for shorter glucocorticoid courses. These days, “I offer this to patients as a great option. It’s really nice to have, instead of having women go on months and months of high-dose steroids, and I think we can save patients from unnecessary” surgery, Dr. Ringsted said.
Her usual regimen these days is methotrexate 15-20 mg/week for 12-18 months, with high-dose prednisone (greater than 20 mg/day) for the first 3 months, followed by a taper.
Dr. Ringsted and associates compared 23 women treated at the university during 2007-2018. Just 5 of the 12 women (42%) treated with high-dose prednisone alone went into remission and did not relapse over a mean follow-up of 27 months. Two out of three women who had both high-dose glucocorticoids and surgery achieved remission without relapse, as did all three women who received methotrexate and high-dose glucocorticoids (one also had surgery). Five other patients were treated with other options; just two had a durable remission.
The numbers are small, but they add to two previous reports. Among 19 women who had failed other treatments, 94% improved and 75% went into remission with 15 months of methotrexate in a review from Stanford (Calif.) University. An Iranian study of 17 patients treated with methotrexate, and also glucocorticoids in some, had a relapse rate of only 17.8%.
There were several cases of both inflammatory arthritis and erythema nodosum in the Oregon series, a higher incidence than what has been reported before for IGM. “It’s interesting because it makes me think of sarcoidosis. There have been cases of sarcoidosis causing mastitis, but mostly in patients with other features” of the disease. “It makes me wonder if any of these women will develop sarcoidosis later on; I think that’s an interesting question,” Dr. Ringsted said.
Women in the study were an average age of 32 years, and over half were Hispanic, which is associated with a higher risk for IGM. Almost all the women had been pregnant before and had breast fed in the previous 5 years. Cancer, tuberculosis, and fungal infections were among the things ruled out before mastitis was deemed idiopathic.
Women with IGM tend to be of childbearing age, and must be cautioned against the teratogenic effects of methotrexate, Dr. Ringsted noted.
There was no external funding, and the investigators didn’t report any disclosures.
SOURCE: Ringsted S et al. Arthritis Rheumatol. 2019;71(suppl 10), Abstract 386.
ATLANTA – Methotrexate, in combination with prednisone, might be emerging as the go-to option for idiopathic granulomatous mastitis, according to investigators from Oregon Health & Science University, Portland.
Idiopathic granulomatous mastitis (IGM) is an inflammatory disease in which granulomas form in breast tissue. It strikes mostly young to middle-aged women with painful, firm breast masses, sometimes with redness and drainage. Diagnosis is by biopsy with rule-out of known causes.
IGM does not respond to antibiotics. Prednisone and surgery have been the traditional approaches, but masses can recur after surgery, and a year or more of prednisone, with the weight gain and side effects, is problematic. As a result, cases are increasingly being referred to rheumatologists for other options, said lead investigator Sarah Ringsted, MD, a rheumatology fellow at the university.
A study she presented at the annual meeting of the American College of Rheumatology and previous work from others builds a case for methotrexate, which often seems to put the disease in remission and allows for shorter glucocorticoid courses. These days, “I offer this to patients as a great option. It’s really nice to have, instead of having women go on months and months of high-dose steroids, and I think we can save patients from unnecessary” surgery, Dr. Ringsted said.
Her usual regimen these days is methotrexate 15-20 mg/week for 12-18 months, with high-dose prednisone (greater than 20 mg/day) for the first 3 months, followed by a taper.
Dr. Ringsted and associates compared 23 women treated at the university during 2007-2018. Just 5 of the 12 women (42%) treated with high-dose prednisone alone went into remission and did not relapse over a mean follow-up of 27 months. Two out of three women who had both high-dose glucocorticoids and surgery achieved remission without relapse, as did all three women who received methotrexate and high-dose glucocorticoids (one also had surgery). Five other patients were treated with other options; just two had a durable remission.
The numbers are small, but they add to two previous reports. Among 19 women who had failed other treatments, 94% improved and 75% went into remission with 15 months of methotrexate in a review from Stanford (Calif.) University. An Iranian study of 17 patients treated with methotrexate, and also glucocorticoids in some, had a relapse rate of only 17.8%.
There were several cases of both inflammatory arthritis and erythema nodosum in the Oregon series, a higher incidence than what has been reported before for IGM. “It’s interesting because it makes me think of sarcoidosis. There have been cases of sarcoidosis causing mastitis, but mostly in patients with other features” of the disease. “It makes me wonder if any of these women will develop sarcoidosis later on; I think that’s an interesting question,” Dr. Ringsted said.
Women in the study were an average age of 32 years, and over half were Hispanic, which is associated with a higher risk for IGM. Almost all the women had been pregnant before and had breast fed in the previous 5 years. Cancer, tuberculosis, and fungal infections were among the things ruled out before mastitis was deemed idiopathic.
Women with IGM tend to be of childbearing age, and must be cautioned against the teratogenic effects of methotrexate, Dr. Ringsted noted.
There was no external funding, and the investigators didn’t report any disclosures.
SOURCE: Ringsted S et al. Arthritis Rheumatol. 2019;71(suppl 10), Abstract 386.
REPORTING FROM ACR 2019
Researchers win funding for breast cancer studies
Five breast cancer researchers have won 3 years of funding from the National Comprehensive Cancer Network’s Oncology Research Program and Pfizer Global Medical Grants. The researchers will receive up to $1.4 million.
Allison Lipitz-Snyderman, PhD, and Erin Gillespie, MD, of Memorial Sloan Kettering Cancer Center in New York, have won funding for a project entitled, “Leveraging an academic-community partnership model to improve the quality of radiation treatment for metastatic breast cancer patients.”
Dr. Gillespie and Dr. Lipitz-Snyderman plan to use an existing partnership between Memorial Sloan Kettering and three community-based institutions to test a system for implementing best practices in radiation treatment. The system includes a web-based platform that disseminates expert recommendations as well as weekly conferences during which community radiation oncologists can consult with specialists on complex cases.
Aki Morikawa, MD, PhD, of the University of Michigan Rogel Cancer Center in Ann Arbor, won funding for a project entitled, “Personalized multi-care: A tailored approach to multidisciplinary care coordination delivery for metastatic breast cancer patients with central nervous system metastases.”
The goals of Dr. Morikawa’s project are to educate patients and providers on managing central nervous system metastases in the breast cancer setting, tailor care coordination and planning to patient and provider needs, and increase patient participation in studies.
Karen Lisa Smith, MD, of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Baltimore, won funding for a project entitled, “The Johns Hopkins Metastatic Breast Cancer Partners Program: Collaborating to improve metastatic breast cancer care.”
The goal of the Metastatic Breast Cancer Partners Program is for Johns Hopkins and mid-Atlantic regional practices to fight metastatic breast cancer together. To that end, Dr. Smith plans to create a multidisciplinary clinic that offers supportive care and treatment recommendations, a database for patient tracking and trial screening, educational resources, and new opportunities for provider collaboration.
Laura Spring, MD, of Massachusetts General Hospital Cancer Center in Boston, won funding for a project entitled, “Expanding precision medicine for patients with metastatic breast cancer in the community: Leveraging academic strength and community partnership.”
The goal of Dr. Spring’s project is to extend academic resources to affiliated network sites. This will involve increasing access to tissue-based and blood-based tumor genotyping for patients with metastatic breast cancer, creating a virtual molecular and precision medicine clinic that provides interpretation of genomic data and treatment recommendations, and offering clinical trial matching to metastatic breast cancer patients treated at network sites.
Five breast cancer researchers have won 3 years of funding from the National Comprehensive Cancer Network’s Oncology Research Program and Pfizer Global Medical Grants. The researchers will receive up to $1.4 million.
Allison Lipitz-Snyderman, PhD, and Erin Gillespie, MD, of Memorial Sloan Kettering Cancer Center in New York, have won funding for a project entitled, “Leveraging an academic-community partnership model to improve the quality of radiation treatment for metastatic breast cancer patients.”
Dr. Gillespie and Dr. Lipitz-Snyderman plan to use an existing partnership between Memorial Sloan Kettering and three community-based institutions to test a system for implementing best practices in radiation treatment. The system includes a web-based platform that disseminates expert recommendations as well as weekly conferences during which community radiation oncologists can consult with specialists on complex cases.
Aki Morikawa, MD, PhD, of the University of Michigan Rogel Cancer Center in Ann Arbor, won funding for a project entitled, “Personalized multi-care: A tailored approach to multidisciplinary care coordination delivery for metastatic breast cancer patients with central nervous system metastases.”
The goals of Dr. Morikawa’s project are to educate patients and providers on managing central nervous system metastases in the breast cancer setting, tailor care coordination and planning to patient and provider needs, and increase patient participation in studies.
Karen Lisa Smith, MD, of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Baltimore, won funding for a project entitled, “The Johns Hopkins Metastatic Breast Cancer Partners Program: Collaborating to improve metastatic breast cancer care.”
The goal of the Metastatic Breast Cancer Partners Program is for Johns Hopkins and mid-Atlantic regional practices to fight metastatic breast cancer together. To that end, Dr. Smith plans to create a multidisciplinary clinic that offers supportive care and treatment recommendations, a database for patient tracking and trial screening, educational resources, and new opportunities for provider collaboration.
Laura Spring, MD, of Massachusetts General Hospital Cancer Center in Boston, won funding for a project entitled, “Expanding precision medicine for patients with metastatic breast cancer in the community: Leveraging academic strength and community partnership.”
The goal of Dr. Spring’s project is to extend academic resources to affiliated network sites. This will involve increasing access to tissue-based and blood-based tumor genotyping for patients with metastatic breast cancer, creating a virtual molecular and precision medicine clinic that provides interpretation of genomic data and treatment recommendations, and offering clinical trial matching to metastatic breast cancer patients treated at network sites.
Five breast cancer researchers have won 3 years of funding from the National Comprehensive Cancer Network’s Oncology Research Program and Pfizer Global Medical Grants. The researchers will receive up to $1.4 million.
Allison Lipitz-Snyderman, PhD, and Erin Gillespie, MD, of Memorial Sloan Kettering Cancer Center in New York, have won funding for a project entitled, “Leveraging an academic-community partnership model to improve the quality of radiation treatment for metastatic breast cancer patients.”
Dr. Gillespie and Dr. Lipitz-Snyderman plan to use an existing partnership between Memorial Sloan Kettering and three community-based institutions to test a system for implementing best practices in radiation treatment. The system includes a web-based platform that disseminates expert recommendations as well as weekly conferences during which community radiation oncologists can consult with specialists on complex cases.
Aki Morikawa, MD, PhD, of the University of Michigan Rogel Cancer Center in Ann Arbor, won funding for a project entitled, “Personalized multi-care: A tailored approach to multidisciplinary care coordination delivery for metastatic breast cancer patients with central nervous system metastases.”
The goals of Dr. Morikawa’s project are to educate patients and providers on managing central nervous system metastases in the breast cancer setting, tailor care coordination and planning to patient and provider needs, and increase patient participation in studies.
Karen Lisa Smith, MD, of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Baltimore, won funding for a project entitled, “The Johns Hopkins Metastatic Breast Cancer Partners Program: Collaborating to improve metastatic breast cancer care.”
The goal of the Metastatic Breast Cancer Partners Program is for Johns Hopkins and mid-Atlantic regional practices to fight metastatic breast cancer together. To that end, Dr. Smith plans to create a multidisciplinary clinic that offers supportive care and treatment recommendations, a database for patient tracking and trial screening, educational resources, and new opportunities for provider collaboration.
Laura Spring, MD, of Massachusetts General Hospital Cancer Center in Boston, won funding for a project entitled, “Expanding precision medicine for patients with metastatic breast cancer in the community: Leveraging academic strength and community partnership.”
The goal of Dr. Spring’s project is to extend academic resources to affiliated network sites. This will involve increasing access to tissue-based and blood-based tumor genotyping for patients with metastatic breast cancer, creating a virtual molecular and precision medicine clinic that provides interpretation of genomic data and treatment recommendations, and offering clinical trial matching to metastatic breast cancer patients treated at network sites.
Unnecessary pelvic exams, Pap tests common in young women
according to estimates from a study published online in JAMA Internal Medicine.
Approximately 2.6 million young women – about a quarter of those in this age group – reported receiving a pelvic exam in the previous year even though fewer than 10% were pregnant or receiving treatment for a sexually transmitted infection (STI) at the time.
Similarly, an estimated three in four Pap tests given to women aged 15-20 years likely were unnecessary. Based on Medicare payments for screening Pap tests and pelvic exams, the unnecessary procedures represented an estimated $123 million in a year.
“The American College of Obstetricians and Gynecologists recognizes that no evidence supports routine speculum examination or BPE in healthy, asymptomatic women younger than 21 years and recommends that these examinations be performed only when medically indicated,” said Jin Qin, ScD, of the Centers for Disease Control and Prevention and colleagues.
“Our results showed that, despite the recommendation, many young women without discernible medical indication received potentially unnecessary BPE or Pap tests, which may be a reflection of a long-standing clinical practice in the United States.”
These findings “demonstrate what happens to vulnerable populations (in this case, girls and young women) when clinicians do not keep up with or do not adhere to new guidelines,” Melissa A. Simon, MD, MPH, wrote in an invited commentary. She acknowledged the challenges of keeping up with new guidelines but noted the potential for harm from unnecessary screening. Dr. Simon is vice chair for clinical research in the department of obstetrics and gynecology at Northwestern University, Chicago.
The researchers analyzed responses from 3,410 young women aged 15-20 years in the National Survey of Family Growth (NSFG) during 2011-2017 and extrapolated the results to estimate nationwide statistics. The researchers found that 23% of young women – 2.6 million in the United States – had received a bimanual pelvic exam during the previous year.
“This analysis focused on the bimanual component of the pelvic examination because it is the most invasive of the pelvic examination components and less likely to be confused with a speculum examination for cervical cancer or STI screening,” the authors note.
More than half of these pelvic exams (54%) – an estimated 1.4 million exams – potentially were unnecessary. The authors classified these pelvic exams as potentially unnecessary if it was not indicated for pregnancy, intrauterine device (IUD) use, or STI treatment in the past 12 months or for another medical problem.
Among the respondents, 5% were pregnant, 22% had been tested for an STI, and 5% had been treated for an STI during the previous year. About a third of respondents (33%) had used at least one type of hormonal contraception besides an IUD in the past year, but only 2% had used an IUD.
Dr. Simon said that some have advocated for routine bimanual pelvic exams to prompt women to see their provider every year, but without evidence to support the practice.
“In fact, many women (younger and older) associate the bimanual pelvic and speculum examinations with fear, anxiety, embarrassment, discomfort, and pain,” Dr. Simon emphasized. “Girls and women with a history of sexual violence may be more vulnerable to these harms. In addition, adolescent girls may delay starting contraception use or obtaining screening for sexually transmitted infections because of fear of pelvic examination, which thus creates unnecessary barriers to obtaining important screening and family-planning methods.”
The researchers also found that 19% of young women, about 2.2 million, had received a Pap test in the previous year. The majority of these (72%) likely were unnecessary, they wrote, explaining that cervical cancer screening is not recommended for those younger than 21 years unless they are HIV positive and sexually active.
“Because HIV infection status is not available in the NSFG, we estimated prevalence of Pap tests performed as part of a routine examination and considered them potentially unnecessary,” the authors explained.
Young women were seven times more likely to have undergone a bimanual pelvic exam if they received a Pap test (adjusted prevalence ratio [aPR], 7.12). In fact, the authors reported that nearly all potentially unnecessary bimanual pelvic exams (98%) occurred during the same visit as a Pap test that was potentially unnecessary as well.
Young women also were more likely to receive a bimanual pelvic exam if they underwent STI testing or used any hormonal contraception besides an IUD (aPR, 1.6 and 1.31, respectively). Those with public insurance or no insurance were less likely to receive a pelvic exam compared with those who had private insurance, although no associations were found with race/ethnicity.
Young women were about four times more likely to have a Pap test if they had STI testing (aPR, 3.77). Odds of a Pap test also were greater among those aged 18-20 years (aPR, 1.54), those with a pregnancy (aPR, 2.31), those with an IUD (aPR, 1.54), and those using any non-IUD hormonal contraception (aPR, 1.75).
Staying up to date on current guidelines and consistently delivering evidence-based care according to those guidelines “is not easy,” Dr. Simon commented. It involves building and maintaining a trusting clinician-patient relationship that centers on shared decision making, keeping up with research, and “unlearn[ing] deeply ingrained practices,” which is difficult.
“Clinicians are not well instructed on how to pivot or unlearn a practice,” Dr. Simon continued. “The science of deimplementation, especially with respect to guideline-concordant care, is in its infancy.” She also noted the value of annual visits, even without routine pelvic exams.
“Rethinking the goals of the annual health examination for young women and learning to unlearn will not put anyone out of business,” Dr. Simon concluded. “Rather, change can increase patients’ connectivity, trust, and engagement with primary care clinicians and, most importantly, avoid harms, especially to those who are most vulnerable.”
No external funding was used. The study authors and Dr. Simon have disclosed no relevant financial relationships.
SOURCE: Qin J et al. JAMA Intern Med. 2019 Jan 6. doi: 10.1001/jamainternmed.2019.5727.
An earlier version of this story appeared on Medscape.com.
A call for shared decision making
The experts who wrote American College of Obstetricians and Gynecologists’ clinical guideline on the pelvic exam (Obstet Gynecol. 2018 Oct;132[4]:e174-80) reviewed available evidence and found insufficient evidence to support routine screening for asymptomatic nonpregnant women who have no increased risk for specific gynecologic conditions (e.g., history of gynecologic cancer). Hence, ACOG recommends routine screening based on a shared decision between the asymptomatic woman and her doctor keeping in mind her medical and family history and her preference. This decision should be made after reviewing the limitations of the exam with regard to insufficient evidence to support its accuracy in screening for ovarian cancer, bacterial vaginosis, trichomoniasis, and genital herpes, plus lack of evidence for other gynecologic conditions.
In addition, we physicians must educate women, especially vulnerable populations, that deferring a pelvic exam for asymptomatic women entails judicious care. Deferring an exam does not mean that we are withholding medical care. If she wants an exam, understanding its limitations, then this preference is an indication itself for the exam as stated in our guideline.
It is important to emphasize to patients that we are deferring Pap smears until age 21 years per ACOG and the American Society for Colposcopy and Cervical Pathology, and that there is no need for a pelvic exam for sexually transmitted infection screening per the Centers for Disease Control and Prevention. Likewise, there is no need for a pelvic exam prior initiation of contraception except for intrauterine device insertion also according to the CDC.
Catherine Cansino, MD, MPH , is associate clinical professor of obstetrics and gynecology at the University of California, Davis. She was asked to comment on the Qin et al. article. Dr. Cansino is a coauthor of the ACOG 2018 guideline on the utility of pelvic exam. She also is a member of the Ob.Gyn. News editorial advisory board. She reported no relevant financial disclosures.
A call for shared decision making
The experts who wrote American College of Obstetricians and Gynecologists’ clinical guideline on the pelvic exam (Obstet Gynecol. 2018 Oct;132[4]:e174-80) reviewed available evidence and found insufficient evidence to support routine screening for asymptomatic nonpregnant women who have no increased risk for specific gynecologic conditions (e.g., history of gynecologic cancer). Hence, ACOG recommends routine screening based on a shared decision between the asymptomatic woman and her doctor keeping in mind her medical and family history and her preference. This decision should be made after reviewing the limitations of the exam with regard to insufficient evidence to support its accuracy in screening for ovarian cancer, bacterial vaginosis, trichomoniasis, and genital herpes, plus lack of evidence for other gynecologic conditions.
In addition, we physicians must educate women, especially vulnerable populations, that deferring a pelvic exam for asymptomatic women entails judicious care. Deferring an exam does not mean that we are withholding medical care. If she wants an exam, understanding its limitations, then this preference is an indication itself for the exam as stated in our guideline.
It is important to emphasize to patients that we are deferring Pap smears until age 21 years per ACOG and the American Society for Colposcopy and Cervical Pathology, and that there is no need for a pelvic exam for sexually transmitted infection screening per the Centers for Disease Control and Prevention. Likewise, there is no need for a pelvic exam prior initiation of contraception except for intrauterine device insertion also according to the CDC.
Catherine Cansino, MD, MPH , is associate clinical professor of obstetrics and gynecology at the University of California, Davis. She was asked to comment on the Qin et al. article. Dr. Cansino is a coauthor of the ACOG 2018 guideline on the utility of pelvic exam. She also is a member of the Ob.Gyn. News editorial advisory board. She reported no relevant financial disclosures.
A call for shared decision making
The experts who wrote American College of Obstetricians and Gynecologists’ clinical guideline on the pelvic exam (Obstet Gynecol. 2018 Oct;132[4]:e174-80) reviewed available evidence and found insufficient evidence to support routine screening for asymptomatic nonpregnant women who have no increased risk for specific gynecologic conditions (e.g., history of gynecologic cancer). Hence, ACOG recommends routine screening based on a shared decision between the asymptomatic woman and her doctor keeping in mind her medical and family history and her preference. This decision should be made after reviewing the limitations of the exam with regard to insufficient evidence to support its accuracy in screening for ovarian cancer, bacterial vaginosis, trichomoniasis, and genital herpes, plus lack of evidence for other gynecologic conditions.
In addition, we physicians must educate women, especially vulnerable populations, that deferring a pelvic exam for asymptomatic women entails judicious care. Deferring an exam does not mean that we are withholding medical care. If she wants an exam, understanding its limitations, then this preference is an indication itself for the exam as stated in our guideline.
It is important to emphasize to patients that we are deferring Pap smears until age 21 years per ACOG and the American Society for Colposcopy and Cervical Pathology, and that there is no need for a pelvic exam for sexually transmitted infection screening per the Centers for Disease Control and Prevention. Likewise, there is no need for a pelvic exam prior initiation of contraception except for intrauterine device insertion also according to the CDC.
Catherine Cansino, MD, MPH , is associate clinical professor of obstetrics and gynecology at the University of California, Davis. She was asked to comment on the Qin et al. article. Dr. Cansino is a coauthor of the ACOG 2018 guideline on the utility of pelvic exam. She also is a member of the Ob.Gyn. News editorial advisory board. She reported no relevant financial disclosures.
according to estimates from a study published online in JAMA Internal Medicine.
Approximately 2.6 million young women – about a quarter of those in this age group – reported receiving a pelvic exam in the previous year even though fewer than 10% were pregnant or receiving treatment for a sexually transmitted infection (STI) at the time.
Similarly, an estimated three in four Pap tests given to women aged 15-20 years likely were unnecessary. Based on Medicare payments for screening Pap tests and pelvic exams, the unnecessary procedures represented an estimated $123 million in a year.
“The American College of Obstetricians and Gynecologists recognizes that no evidence supports routine speculum examination or BPE in healthy, asymptomatic women younger than 21 years and recommends that these examinations be performed only when medically indicated,” said Jin Qin, ScD, of the Centers for Disease Control and Prevention and colleagues.
“Our results showed that, despite the recommendation, many young women without discernible medical indication received potentially unnecessary BPE or Pap tests, which may be a reflection of a long-standing clinical practice in the United States.”
These findings “demonstrate what happens to vulnerable populations (in this case, girls and young women) when clinicians do not keep up with or do not adhere to new guidelines,” Melissa A. Simon, MD, MPH, wrote in an invited commentary. She acknowledged the challenges of keeping up with new guidelines but noted the potential for harm from unnecessary screening. Dr. Simon is vice chair for clinical research in the department of obstetrics and gynecology at Northwestern University, Chicago.
The researchers analyzed responses from 3,410 young women aged 15-20 years in the National Survey of Family Growth (NSFG) during 2011-2017 and extrapolated the results to estimate nationwide statistics. The researchers found that 23% of young women – 2.6 million in the United States – had received a bimanual pelvic exam during the previous year.
“This analysis focused on the bimanual component of the pelvic examination because it is the most invasive of the pelvic examination components and less likely to be confused with a speculum examination for cervical cancer or STI screening,” the authors note.
More than half of these pelvic exams (54%) – an estimated 1.4 million exams – potentially were unnecessary. The authors classified these pelvic exams as potentially unnecessary if it was not indicated for pregnancy, intrauterine device (IUD) use, or STI treatment in the past 12 months or for another medical problem.
Among the respondents, 5% were pregnant, 22% had been tested for an STI, and 5% had been treated for an STI during the previous year. About a third of respondents (33%) had used at least one type of hormonal contraception besides an IUD in the past year, but only 2% had used an IUD.
Dr. Simon said that some have advocated for routine bimanual pelvic exams to prompt women to see their provider every year, but without evidence to support the practice.
“In fact, many women (younger and older) associate the bimanual pelvic and speculum examinations with fear, anxiety, embarrassment, discomfort, and pain,” Dr. Simon emphasized. “Girls and women with a history of sexual violence may be more vulnerable to these harms. In addition, adolescent girls may delay starting contraception use or obtaining screening for sexually transmitted infections because of fear of pelvic examination, which thus creates unnecessary barriers to obtaining important screening and family-planning methods.”
The researchers also found that 19% of young women, about 2.2 million, had received a Pap test in the previous year. The majority of these (72%) likely were unnecessary, they wrote, explaining that cervical cancer screening is not recommended for those younger than 21 years unless they are HIV positive and sexually active.
“Because HIV infection status is not available in the NSFG, we estimated prevalence of Pap tests performed as part of a routine examination and considered them potentially unnecessary,” the authors explained.
Young women were seven times more likely to have undergone a bimanual pelvic exam if they received a Pap test (adjusted prevalence ratio [aPR], 7.12). In fact, the authors reported that nearly all potentially unnecessary bimanual pelvic exams (98%) occurred during the same visit as a Pap test that was potentially unnecessary as well.
Young women also were more likely to receive a bimanual pelvic exam if they underwent STI testing or used any hormonal contraception besides an IUD (aPR, 1.6 and 1.31, respectively). Those with public insurance or no insurance were less likely to receive a pelvic exam compared with those who had private insurance, although no associations were found with race/ethnicity.
Young women were about four times more likely to have a Pap test if they had STI testing (aPR, 3.77). Odds of a Pap test also were greater among those aged 18-20 years (aPR, 1.54), those with a pregnancy (aPR, 2.31), those with an IUD (aPR, 1.54), and those using any non-IUD hormonal contraception (aPR, 1.75).
Staying up to date on current guidelines and consistently delivering evidence-based care according to those guidelines “is not easy,” Dr. Simon commented. It involves building and maintaining a trusting clinician-patient relationship that centers on shared decision making, keeping up with research, and “unlearn[ing] deeply ingrained practices,” which is difficult.
“Clinicians are not well instructed on how to pivot or unlearn a practice,” Dr. Simon continued. “The science of deimplementation, especially with respect to guideline-concordant care, is in its infancy.” She also noted the value of annual visits, even without routine pelvic exams.
“Rethinking the goals of the annual health examination for young women and learning to unlearn will not put anyone out of business,” Dr. Simon concluded. “Rather, change can increase patients’ connectivity, trust, and engagement with primary care clinicians and, most importantly, avoid harms, especially to those who are most vulnerable.”
No external funding was used. The study authors and Dr. Simon have disclosed no relevant financial relationships.
SOURCE: Qin J et al. JAMA Intern Med. 2019 Jan 6. doi: 10.1001/jamainternmed.2019.5727.
An earlier version of this story appeared on Medscape.com.
according to estimates from a study published online in JAMA Internal Medicine.
Approximately 2.6 million young women – about a quarter of those in this age group – reported receiving a pelvic exam in the previous year even though fewer than 10% were pregnant or receiving treatment for a sexually transmitted infection (STI) at the time.
Similarly, an estimated three in four Pap tests given to women aged 15-20 years likely were unnecessary. Based on Medicare payments for screening Pap tests and pelvic exams, the unnecessary procedures represented an estimated $123 million in a year.
“The American College of Obstetricians and Gynecologists recognizes that no evidence supports routine speculum examination or BPE in healthy, asymptomatic women younger than 21 years and recommends that these examinations be performed only when medically indicated,” said Jin Qin, ScD, of the Centers for Disease Control and Prevention and colleagues.
“Our results showed that, despite the recommendation, many young women without discernible medical indication received potentially unnecessary BPE or Pap tests, which may be a reflection of a long-standing clinical practice in the United States.”
These findings “demonstrate what happens to vulnerable populations (in this case, girls and young women) when clinicians do not keep up with or do not adhere to new guidelines,” Melissa A. Simon, MD, MPH, wrote in an invited commentary. She acknowledged the challenges of keeping up with new guidelines but noted the potential for harm from unnecessary screening. Dr. Simon is vice chair for clinical research in the department of obstetrics and gynecology at Northwestern University, Chicago.
The researchers analyzed responses from 3,410 young women aged 15-20 years in the National Survey of Family Growth (NSFG) during 2011-2017 and extrapolated the results to estimate nationwide statistics. The researchers found that 23% of young women – 2.6 million in the United States – had received a bimanual pelvic exam during the previous year.
“This analysis focused on the bimanual component of the pelvic examination because it is the most invasive of the pelvic examination components and less likely to be confused with a speculum examination for cervical cancer or STI screening,” the authors note.
More than half of these pelvic exams (54%) – an estimated 1.4 million exams – potentially were unnecessary. The authors classified these pelvic exams as potentially unnecessary if it was not indicated for pregnancy, intrauterine device (IUD) use, or STI treatment in the past 12 months or for another medical problem.
Among the respondents, 5% were pregnant, 22% had been tested for an STI, and 5% had been treated for an STI during the previous year. About a third of respondents (33%) had used at least one type of hormonal contraception besides an IUD in the past year, but only 2% had used an IUD.
Dr. Simon said that some have advocated for routine bimanual pelvic exams to prompt women to see their provider every year, but without evidence to support the practice.
“In fact, many women (younger and older) associate the bimanual pelvic and speculum examinations with fear, anxiety, embarrassment, discomfort, and pain,” Dr. Simon emphasized. “Girls and women with a history of sexual violence may be more vulnerable to these harms. In addition, adolescent girls may delay starting contraception use or obtaining screening for sexually transmitted infections because of fear of pelvic examination, which thus creates unnecessary barriers to obtaining important screening and family-planning methods.”
The researchers also found that 19% of young women, about 2.2 million, had received a Pap test in the previous year. The majority of these (72%) likely were unnecessary, they wrote, explaining that cervical cancer screening is not recommended for those younger than 21 years unless they are HIV positive and sexually active.
“Because HIV infection status is not available in the NSFG, we estimated prevalence of Pap tests performed as part of a routine examination and considered them potentially unnecessary,” the authors explained.
Young women were seven times more likely to have undergone a bimanual pelvic exam if they received a Pap test (adjusted prevalence ratio [aPR], 7.12). In fact, the authors reported that nearly all potentially unnecessary bimanual pelvic exams (98%) occurred during the same visit as a Pap test that was potentially unnecessary as well.
Young women also were more likely to receive a bimanual pelvic exam if they underwent STI testing or used any hormonal contraception besides an IUD (aPR, 1.6 and 1.31, respectively). Those with public insurance or no insurance were less likely to receive a pelvic exam compared with those who had private insurance, although no associations were found with race/ethnicity.
Young women were about four times more likely to have a Pap test if they had STI testing (aPR, 3.77). Odds of a Pap test also were greater among those aged 18-20 years (aPR, 1.54), those with a pregnancy (aPR, 2.31), those with an IUD (aPR, 1.54), and those using any non-IUD hormonal contraception (aPR, 1.75).
Staying up to date on current guidelines and consistently delivering evidence-based care according to those guidelines “is not easy,” Dr. Simon commented. It involves building and maintaining a trusting clinician-patient relationship that centers on shared decision making, keeping up with research, and “unlearn[ing] deeply ingrained practices,” which is difficult.
“Clinicians are not well instructed on how to pivot or unlearn a practice,” Dr. Simon continued. “The science of deimplementation, especially with respect to guideline-concordant care, is in its infancy.” She also noted the value of annual visits, even without routine pelvic exams.
“Rethinking the goals of the annual health examination for young women and learning to unlearn will not put anyone out of business,” Dr. Simon concluded. “Rather, change can increase patients’ connectivity, trust, and engagement with primary care clinicians and, most importantly, avoid harms, especially to those who are most vulnerable.”
No external funding was used. The study authors and Dr. Simon have disclosed no relevant financial relationships.
SOURCE: Qin J et al. JAMA Intern Med. 2019 Jan 6. doi: 10.1001/jamainternmed.2019.5727.
An earlier version of this story appeared on Medscape.com.
Pediatricians take on more mental health care
Assessment and treatment of many of the more common behavioral disorders in childhood, such as ADHD and anxiety, should be considered within a pediatrician’s scope of practice, a stance made very clear by a recent policy statement published by the American Academy of Pediatrics entitled “Mental health competencies for pediatric practice.”1 These competencies include medication treatment. As stated in the article, “certain disorders (ADHD, common anxiety disorders, depression), if associated with no more than moderate impairment, are amenable to primary care medication management because there are indicated medications with a well-established safety profile.”
This shift to shared ownership when it comes to mental health care is likely coming from multiple sources, not the least of them being necessity and an acknowledgment that there simply aren’t enough psychiatrists to take over the mental health care of every youth with a diagnosable psychiatric disorder. While the number of child and adolescent psychiatrists remains relatively flat, the youth suicide rate is rising, as are the numbers presenting to emergency departments in crisis – all for reasons still to be fully understood. And these trends all are occurring as the medical community overall is appreciating more and more that good mental health is a cornerstone of all health.
The response from the pediatric community, whether it be because of personal conviction or simply a lack of options, largely has been to step up to the plate and take on these new responsibilities and challenges while trying to get up to speed with the latest information about mental health best practices. From my own experience doing evaluations and consultations from area primary care clinicians for over 15 years, the shift is noticeable. The typical patient now coming in has already seen a mental health counselor and tried at least one medication, while evaluations for diagnosis and treatment recommendations for things like uncomplicated and treatment-naive ADHD symptoms, for example, are becoming much more infrequent – although still far from extinct.
Nevertheless, there remain concerns about the extent of these new charges. Joe Nasca, MD, an experienced pediatrician who has been practicing in rural Vermont for decades, is worried that there is simply too much already for pediatricians to know and do to be able to add extensive mental health care. “There is so much to know in general peds [pediatrics] that I would guess a year or more of additional residency and experience would adequately prepare me to take this on,” he said in an interview. In comparing psychiatric care to other specialties, Dr. Nasca went on to say that, “I would not presume to treat chronic renal failure without the help of a nephrologist or a dilated aortic arch without a cardiologist.”
In a similar vein, however, it also is true that a significant percentage of children presenting to pediatricians for orthopedic problems, infections, asthma, and rashes are managed without referrals to specialists. The right balance, of course, will vary from clinician to clinician based on that pediatrician’s level of interest, experience, and available resources in the community. The AAP position papers don’t mandate or even encourage the notion that all pediatricians need to be at the same place when it comes to competency in assessment and treatment of mental health problems, although it is probably fair to say that there is a push for the pediatric community as a whole to raise the collective bar at least a notch or two.
In response, the mental health community has moved to support the primary care community in their expanded role. These efforts have taken many forms, most notably the model of integrated care, in which mental health clinicians of various types see patients in primary care offices rather than making patients come to them. There also are new consultation programs that provide easy access to a child psychiatrist or other mental health professional for case-related questions delivered by phone, email, or for single in-person consultations. Additional training and educational offerings also are now available for pediatricians either in training and for those already in practice. These initiatives are bolstered by research showing that, not only can good mental health care be delivered in pediatric settings, but there are cost savings that can be realized, particularly for nonpsychiatric medical care.2 Despite these promising leads, however, there will remain some for whom anything less than the increased availability of a psychiatrist to “take over” a patient’s mental health care will be seen as a falling short of the clinical need.
To illustrate how things have and continue to change, consider the following three common clinical scenarios that generally present to a pediatrician:
- New presentation of ADHD symptoms.
- Anxiety or obsessive-compulsive problems.
- Return of a patient who has been psychiatrically hospitalized and now is taking multiple medications.
In the past, all three cases often would have resulted in a referral to a psychiatrist. Today, however, it is quite likely that only one of these cases would be referred because ADHD could be well diagnosed and managed within the primary care setting, and problems like anxiety and obsessive-compulsive disorder are sent first not to a psychiatrist but to a non-MD psychotherapist.
Moving forward, today’s pediatricians are expected to do more for the mental health care of patients themselves instead of referring to a psychiatrist. Most already do, despite having had little in the way of formal training. As the evidence grows that the promotion of mental well-being can be a key to future overall health, as well as to the cost of future health care, there are many reasons to be optimistic that support for pediatricians and collaborative care models for clinicians trying to fulfill these new responsibilities will get only stronger.
References
1. Pediatrics. 2019 Nov;144(5). pii: e20192757.
2. Pediatrics. 2019 Jul;144(1). pii: e20183243.
Dr. Rettew is a child and adolescent psychiatrist and associate professor of psychiatry and pediatrics at the University of Vermont, Burlington. Follow him on Twitter @PediPsych. Email him at [email protected]. Looking for more mental health training? Attend the 14th annual Child Psychiatry in Primary Care conference in Burlington on May 8, 2020 (http://www.med.uvm.edu/cme/conferences).
Assessment and treatment of many of the more common behavioral disorders in childhood, such as ADHD and anxiety, should be considered within a pediatrician’s scope of practice, a stance made very clear by a recent policy statement published by the American Academy of Pediatrics entitled “Mental health competencies for pediatric practice.”1 These competencies include medication treatment. As stated in the article, “certain disorders (ADHD, common anxiety disorders, depression), if associated with no more than moderate impairment, are amenable to primary care medication management because there are indicated medications with a well-established safety profile.”
This shift to shared ownership when it comes to mental health care is likely coming from multiple sources, not the least of them being necessity and an acknowledgment that there simply aren’t enough psychiatrists to take over the mental health care of every youth with a diagnosable psychiatric disorder. While the number of child and adolescent psychiatrists remains relatively flat, the youth suicide rate is rising, as are the numbers presenting to emergency departments in crisis – all for reasons still to be fully understood. And these trends all are occurring as the medical community overall is appreciating more and more that good mental health is a cornerstone of all health.
The response from the pediatric community, whether it be because of personal conviction or simply a lack of options, largely has been to step up to the plate and take on these new responsibilities and challenges while trying to get up to speed with the latest information about mental health best practices. From my own experience doing evaluations and consultations from area primary care clinicians for over 15 years, the shift is noticeable. The typical patient now coming in has already seen a mental health counselor and tried at least one medication, while evaluations for diagnosis and treatment recommendations for things like uncomplicated and treatment-naive ADHD symptoms, for example, are becoming much more infrequent – although still far from extinct.
Nevertheless, there remain concerns about the extent of these new charges. Joe Nasca, MD, an experienced pediatrician who has been practicing in rural Vermont for decades, is worried that there is simply too much already for pediatricians to know and do to be able to add extensive mental health care. “There is so much to know in general peds [pediatrics] that I would guess a year or more of additional residency and experience would adequately prepare me to take this on,” he said in an interview. In comparing psychiatric care to other specialties, Dr. Nasca went on to say that, “I would not presume to treat chronic renal failure without the help of a nephrologist or a dilated aortic arch without a cardiologist.”
In a similar vein, however, it also is true that a significant percentage of children presenting to pediatricians for orthopedic problems, infections, asthma, and rashes are managed without referrals to specialists. The right balance, of course, will vary from clinician to clinician based on that pediatrician’s level of interest, experience, and available resources in the community. The AAP position papers don’t mandate or even encourage the notion that all pediatricians need to be at the same place when it comes to competency in assessment and treatment of mental health problems, although it is probably fair to say that there is a push for the pediatric community as a whole to raise the collective bar at least a notch or two.
In response, the mental health community has moved to support the primary care community in their expanded role. These efforts have taken many forms, most notably the model of integrated care, in which mental health clinicians of various types see patients in primary care offices rather than making patients come to them. There also are new consultation programs that provide easy access to a child psychiatrist or other mental health professional for case-related questions delivered by phone, email, or for single in-person consultations. Additional training and educational offerings also are now available for pediatricians either in training and for those already in practice. These initiatives are bolstered by research showing that, not only can good mental health care be delivered in pediatric settings, but there are cost savings that can be realized, particularly for nonpsychiatric medical care.2 Despite these promising leads, however, there will remain some for whom anything less than the increased availability of a psychiatrist to “take over” a patient’s mental health care will be seen as a falling short of the clinical need.
To illustrate how things have and continue to change, consider the following three common clinical scenarios that generally present to a pediatrician:
- New presentation of ADHD symptoms.
- Anxiety or obsessive-compulsive problems.
- Return of a patient who has been psychiatrically hospitalized and now is taking multiple medications.
In the past, all three cases often would have resulted in a referral to a psychiatrist. Today, however, it is quite likely that only one of these cases would be referred because ADHD could be well diagnosed and managed within the primary care setting, and problems like anxiety and obsessive-compulsive disorder are sent first not to a psychiatrist but to a non-MD psychotherapist.
Moving forward, today’s pediatricians are expected to do more for the mental health care of patients themselves instead of referring to a psychiatrist. Most already do, despite having had little in the way of formal training. As the evidence grows that the promotion of mental well-being can be a key to future overall health, as well as to the cost of future health care, there are many reasons to be optimistic that support for pediatricians and collaborative care models for clinicians trying to fulfill these new responsibilities will get only stronger.
References
1. Pediatrics. 2019 Nov;144(5). pii: e20192757.
2. Pediatrics. 2019 Jul;144(1). pii: e20183243.
Dr. Rettew is a child and adolescent psychiatrist and associate professor of psychiatry and pediatrics at the University of Vermont, Burlington. Follow him on Twitter @PediPsych. Email him at [email protected]. Looking for more mental health training? Attend the 14th annual Child Psychiatry in Primary Care conference in Burlington on May 8, 2020 (http://www.med.uvm.edu/cme/conferences).
Assessment and treatment of many of the more common behavioral disorders in childhood, such as ADHD and anxiety, should be considered within a pediatrician’s scope of practice, a stance made very clear by a recent policy statement published by the American Academy of Pediatrics entitled “Mental health competencies for pediatric practice.”1 These competencies include medication treatment. As stated in the article, “certain disorders (ADHD, common anxiety disorders, depression), if associated with no more than moderate impairment, are amenable to primary care medication management because there are indicated medications with a well-established safety profile.”
This shift to shared ownership when it comes to mental health care is likely coming from multiple sources, not the least of them being necessity and an acknowledgment that there simply aren’t enough psychiatrists to take over the mental health care of every youth with a diagnosable psychiatric disorder. While the number of child and adolescent psychiatrists remains relatively flat, the youth suicide rate is rising, as are the numbers presenting to emergency departments in crisis – all for reasons still to be fully understood. And these trends all are occurring as the medical community overall is appreciating more and more that good mental health is a cornerstone of all health.
The response from the pediatric community, whether it be because of personal conviction or simply a lack of options, largely has been to step up to the plate and take on these new responsibilities and challenges while trying to get up to speed with the latest information about mental health best practices. From my own experience doing evaluations and consultations from area primary care clinicians for over 15 years, the shift is noticeable. The typical patient now coming in has already seen a mental health counselor and tried at least one medication, while evaluations for diagnosis and treatment recommendations for things like uncomplicated and treatment-naive ADHD symptoms, for example, are becoming much more infrequent – although still far from extinct.
Nevertheless, there remain concerns about the extent of these new charges. Joe Nasca, MD, an experienced pediatrician who has been practicing in rural Vermont for decades, is worried that there is simply too much already for pediatricians to know and do to be able to add extensive mental health care. “There is so much to know in general peds [pediatrics] that I would guess a year or more of additional residency and experience would adequately prepare me to take this on,” he said in an interview. In comparing psychiatric care to other specialties, Dr. Nasca went on to say that, “I would not presume to treat chronic renal failure without the help of a nephrologist or a dilated aortic arch without a cardiologist.”
In a similar vein, however, it also is true that a significant percentage of children presenting to pediatricians for orthopedic problems, infections, asthma, and rashes are managed without referrals to specialists. The right balance, of course, will vary from clinician to clinician based on that pediatrician’s level of interest, experience, and available resources in the community. The AAP position papers don’t mandate or even encourage the notion that all pediatricians need to be at the same place when it comes to competency in assessment and treatment of mental health problems, although it is probably fair to say that there is a push for the pediatric community as a whole to raise the collective bar at least a notch or two.
In response, the mental health community has moved to support the primary care community in their expanded role. These efforts have taken many forms, most notably the model of integrated care, in which mental health clinicians of various types see patients in primary care offices rather than making patients come to them. There also are new consultation programs that provide easy access to a child psychiatrist or other mental health professional for case-related questions delivered by phone, email, or for single in-person consultations. Additional training and educational offerings also are now available for pediatricians either in training and for those already in practice. These initiatives are bolstered by research showing that, not only can good mental health care be delivered in pediatric settings, but there are cost savings that can be realized, particularly for nonpsychiatric medical care.2 Despite these promising leads, however, there will remain some for whom anything less than the increased availability of a psychiatrist to “take over” a patient’s mental health care will be seen as a falling short of the clinical need.
To illustrate how things have and continue to change, consider the following three common clinical scenarios that generally present to a pediatrician:
- New presentation of ADHD symptoms.
- Anxiety or obsessive-compulsive problems.
- Return of a patient who has been psychiatrically hospitalized and now is taking multiple medications.
In the past, all three cases often would have resulted in a referral to a psychiatrist. Today, however, it is quite likely that only one of these cases would be referred because ADHD could be well diagnosed and managed within the primary care setting, and problems like anxiety and obsessive-compulsive disorder are sent first not to a psychiatrist but to a non-MD psychotherapist.
Moving forward, today’s pediatricians are expected to do more for the mental health care of patients themselves instead of referring to a psychiatrist. Most already do, despite having had little in the way of formal training. As the evidence grows that the promotion of mental well-being can be a key to future overall health, as well as to the cost of future health care, there are many reasons to be optimistic that support for pediatricians and collaborative care models for clinicians trying to fulfill these new responsibilities will get only stronger.
References
1. Pediatrics. 2019 Nov;144(5). pii: e20192757.
2. Pediatrics. 2019 Jul;144(1). pii: e20183243.
Dr. Rettew is a child and adolescent psychiatrist and associate professor of psychiatry and pediatrics at the University of Vermont, Burlington. Follow him on Twitter @PediPsych. Email him at [email protected]. Looking for more mental health training? Attend the 14th annual Child Psychiatry in Primary Care conference in Burlington on May 8, 2020 (http://www.med.uvm.edu/cme/conferences).
Score predicts locoregional recurrence of breast cancer
The 21-gene assay recurrence score can aid decisions about radiotherapy for postmenopausal patients with node-positive breast cancer, according to researchers.
The researchers analyzed patients who underwent mastectomy or breast-conserving surgery (excision and radiation) and received chemotherapy plus tamoxifen or tamoxifen alone. Results showed that patients with an intermediate or high recurrence score, according to the 21-gene assay OncotypeDX, were more likely to have locoregional recurrence (LRR).
“We believe that the recurrence score adds independent prognostic information that could be used with standard clinical factors for identifying LRR risk and making radiotherapy decisions,” Wendy A. Woodward, MD, PhD, of the University of Texas MD Anderson Cancer Center, Houston, and coauthors wrote in JAMA Oncology.
Dr. Woodward and colleagues analyzed data from a phase 3 trial (NCT00929591) of postmenopausal women with estrogen or progesterone receptor–positive, node-positive breast cancer. There were 367 patients who received tamoxifen alone (n = 148) or cyclophosphamide, doxorubicin, and fluorouracil followed by tamoxifen (n = 219).
Of the 367 patients, 316 were included in the primary analysis. This includes 252 patients who underwent mastectomy without radiotherapy and 64 patients who underwent breast-conserving surgery with radiotherapy.
The researchers defined LRR as a recurrence in the breast; chest wall; or axillary, infraclavicular, supraclavicular, or internal mammary lymph nodes.
The LRR incidence was 5.8% (7/121) among patients with a low recurrence score and 13.8% (27/195) among patients with an intermediate or high recurrence score. The estimated 10-year cumulative LRR incidence rates were 9.7% and 16.5%, respectively (P = .02).
The researchers conducted a multivariable analysis for LRR, which included the recurrence score, randomized treatment (combination regimen vs. tamoxifen alone), number of positive nodes (three or fewer vs. four or more), and type of surgery (mastectomy vs. excision and radiation).
Having intermediate or high recurrence scores was a significant predictor of LRR, with a hazard ratio of 2.36 (P = .04). Having four or more involved nodes was a significant predictor of LRR as well (hazard ratio, 3.37; P = .001). Randomized treatment and surgery were not significantly associated with LRR.
The researchers also conducted an exploratory analysis and found that a recurrence score of 18 was the optimal cutoff for the association of recurrence score and LRR.
“This study found that higher recurrence scores were associated with increased LRR after adjustment for treatment, type of surgical procedure, and number of positive nodes,” Dr. Woodward and colleagues wrote. “This finding suggests that the recurrence score may be used, along with accepted clinical variables, to assess the risk of LRR during radiotherapy decision making. We recommend considering the recurrence score, when available, as one of the factors in selecting patients for postmastectomy radiotherapy.”
This research was funded by the National Cancer Institute of Canada, Canadian Cancer Society, and Genomic Health, which markets the 21-gene assay OncotypeDX. Dr. Woodward disclosed receiving personal fees from Genomic Health outside this research as well as an advisory fee from Merck.
SOURCE: Woodward WA et al. JAMA Oncol. 2020 Jan 9. doi: 10.1001/jamaoncol.2019.5559.
The 21-gene assay recurrence score can aid decisions about radiotherapy for postmenopausal patients with node-positive breast cancer, according to researchers.
The researchers analyzed patients who underwent mastectomy or breast-conserving surgery (excision and radiation) and received chemotherapy plus tamoxifen or tamoxifen alone. Results showed that patients with an intermediate or high recurrence score, according to the 21-gene assay OncotypeDX, were more likely to have locoregional recurrence (LRR).
“We believe that the recurrence score adds independent prognostic information that could be used with standard clinical factors for identifying LRR risk and making radiotherapy decisions,” Wendy A. Woodward, MD, PhD, of the University of Texas MD Anderson Cancer Center, Houston, and coauthors wrote in JAMA Oncology.
Dr. Woodward and colleagues analyzed data from a phase 3 trial (NCT00929591) of postmenopausal women with estrogen or progesterone receptor–positive, node-positive breast cancer. There were 367 patients who received tamoxifen alone (n = 148) or cyclophosphamide, doxorubicin, and fluorouracil followed by tamoxifen (n = 219).
Of the 367 patients, 316 were included in the primary analysis. This includes 252 patients who underwent mastectomy without radiotherapy and 64 patients who underwent breast-conserving surgery with radiotherapy.
The researchers defined LRR as a recurrence in the breast; chest wall; or axillary, infraclavicular, supraclavicular, or internal mammary lymph nodes.
The LRR incidence was 5.8% (7/121) among patients with a low recurrence score and 13.8% (27/195) among patients with an intermediate or high recurrence score. The estimated 10-year cumulative LRR incidence rates were 9.7% and 16.5%, respectively (P = .02).
The researchers conducted a multivariable analysis for LRR, which included the recurrence score, randomized treatment (combination regimen vs. tamoxifen alone), number of positive nodes (three or fewer vs. four or more), and type of surgery (mastectomy vs. excision and radiation).
Having intermediate or high recurrence scores was a significant predictor of LRR, with a hazard ratio of 2.36 (P = .04). Having four or more involved nodes was a significant predictor of LRR as well (hazard ratio, 3.37; P = .001). Randomized treatment and surgery were not significantly associated with LRR.
The researchers also conducted an exploratory analysis and found that a recurrence score of 18 was the optimal cutoff for the association of recurrence score and LRR.
“This study found that higher recurrence scores were associated with increased LRR after adjustment for treatment, type of surgical procedure, and number of positive nodes,” Dr. Woodward and colleagues wrote. “This finding suggests that the recurrence score may be used, along with accepted clinical variables, to assess the risk of LRR during radiotherapy decision making. We recommend considering the recurrence score, when available, as one of the factors in selecting patients for postmastectomy radiotherapy.”
This research was funded by the National Cancer Institute of Canada, Canadian Cancer Society, and Genomic Health, which markets the 21-gene assay OncotypeDX. Dr. Woodward disclosed receiving personal fees from Genomic Health outside this research as well as an advisory fee from Merck.
SOURCE: Woodward WA et al. JAMA Oncol. 2020 Jan 9. doi: 10.1001/jamaoncol.2019.5559.
The 21-gene assay recurrence score can aid decisions about radiotherapy for postmenopausal patients with node-positive breast cancer, according to researchers.
The researchers analyzed patients who underwent mastectomy or breast-conserving surgery (excision and radiation) and received chemotherapy plus tamoxifen or tamoxifen alone. Results showed that patients with an intermediate or high recurrence score, according to the 21-gene assay OncotypeDX, were more likely to have locoregional recurrence (LRR).
“We believe that the recurrence score adds independent prognostic information that could be used with standard clinical factors for identifying LRR risk and making radiotherapy decisions,” Wendy A. Woodward, MD, PhD, of the University of Texas MD Anderson Cancer Center, Houston, and coauthors wrote in JAMA Oncology.
Dr. Woodward and colleagues analyzed data from a phase 3 trial (NCT00929591) of postmenopausal women with estrogen or progesterone receptor–positive, node-positive breast cancer. There were 367 patients who received tamoxifen alone (n = 148) or cyclophosphamide, doxorubicin, and fluorouracil followed by tamoxifen (n = 219).
Of the 367 patients, 316 were included in the primary analysis. This includes 252 patients who underwent mastectomy without radiotherapy and 64 patients who underwent breast-conserving surgery with radiotherapy.
The researchers defined LRR as a recurrence in the breast; chest wall; or axillary, infraclavicular, supraclavicular, or internal mammary lymph nodes.
The LRR incidence was 5.8% (7/121) among patients with a low recurrence score and 13.8% (27/195) among patients with an intermediate or high recurrence score. The estimated 10-year cumulative LRR incidence rates were 9.7% and 16.5%, respectively (P = .02).
The researchers conducted a multivariable analysis for LRR, which included the recurrence score, randomized treatment (combination regimen vs. tamoxifen alone), number of positive nodes (three or fewer vs. four or more), and type of surgery (mastectomy vs. excision and radiation).
Having intermediate or high recurrence scores was a significant predictor of LRR, with a hazard ratio of 2.36 (P = .04). Having four or more involved nodes was a significant predictor of LRR as well (hazard ratio, 3.37; P = .001). Randomized treatment and surgery were not significantly associated with LRR.
The researchers also conducted an exploratory analysis and found that a recurrence score of 18 was the optimal cutoff for the association of recurrence score and LRR.
“This study found that higher recurrence scores were associated with increased LRR after adjustment for treatment, type of surgical procedure, and number of positive nodes,” Dr. Woodward and colleagues wrote. “This finding suggests that the recurrence score may be used, along with accepted clinical variables, to assess the risk of LRR during radiotherapy decision making. We recommend considering the recurrence score, when available, as one of the factors in selecting patients for postmastectomy radiotherapy.”
This research was funded by the National Cancer Institute of Canada, Canadian Cancer Society, and Genomic Health, which markets the 21-gene assay OncotypeDX. Dr. Woodward disclosed receiving personal fees from Genomic Health outside this research as well as an advisory fee from Merck.
SOURCE: Woodward WA et al. JAMA Oncol. 2020 Jan 9. doi: 10.1001/jamaoncol.2019.5559.
FROM JAMA ONCOLOGY
Treatment of heart failure with preserved ejection fraction is a work in progress
LOS ANGELES – When it comes to the optimal treatment of patients with heart failure with preserved ejection fraction and diabetes, cardiologists like Mark T. Kearney, MB ChB, MD, remain stumped.
“Over the years, the diagnosis of heart failure with preserved ejection fraction has been notoriously difficult [to treat], controversial, and ultimately involves aggressive catheterization of the heart to assess diastolic dysfunction, complex echocardiography, and invasive tests,” Dr. Kearney said at the World Congress on Insulin Resistance, Diabetes, and Cardiovascular Disease. “These patients have an ejection fraction of over 50% and classic signs and symptoms of heart failure. Studies of beta-blockers, angiotensin-converting enzyme inhibitors, and angiotensin II receptor blockers have been unsuccessful in this group of patients. We’re at the beginning of a journey in understanding this disorder, and it’s important, because more and more patients present to us with signs and symptoms of heart failure with an ejection fraction greater than 50%.”
In a recent analysis of 1,797 patients with chronic heart failure, Dr. Kearney, British Heart Foundation Professor of Cardiovascular and Diabetes Research at the Leeds (England) Institute of Cardiovascular and Metabolic Medicine, and colleagues examined whether beta-blockers and ACE inhibitors were associated with differential effects on mortality in patients with and without diabetes (Diabetes Care. 2018;41:136-42). Mean follow-up was 4 years.
For the ACE inhibitor component of the trial, the researchers correlated the dose of ramipril to outcomes and found that each milligram increase of ramipril reduced the risk of death by about 3%. “In the nondiabetic patients who did not receive an ACE inhibitor, mortality was about 60% – worse than most cancers,” Dr. Kearney said. “In patients with diabetes, there was a similar pattern. If you didn’t get an ACE inhibitor, mortality was 70%. So, if you get patients on an optimal dose of an ACE inhibitor, you improve their mortality substantially, whether they have diabetes or not.”
The beta-blocker component of the trial yielded similar results. “Among patients who did not receive a beta-blocker, the mortality was about 70% at 5 years – really terrible,” he said. “Every milligram of bisoprolol was associated with a reduction in mortality of about 9%. So, if a patient gets on an optimal dose of a beta-blocker and they have diabetes, it’s associated with prolongation of life over a year.”
Dr. Kearney said that patients often do not want to take an increased dose of a beta-blocker because of concerns about side effects, such as tiredness. “They ask me what the side effects of an increased dose would be. My answer is: ‘It will make you live longer.’ Usually, they’ll respond by agreeing to have a little bit more of the beta-blocker. The message here is, if you have a patient with ejection fraction heart failure and diabetes, get them on the optimal dose of a beta-blocker, even at the expense of an ACE inhibitor.”
In 2016, the European Society of Cardiology introduced guidelines for physicians to make a diagnosis of heart failure with preserved ejection fraction. The guidelines mandate that a diagnosis requires signs and symptoms of heart failure, elevated levels of natriuretic peptide, and echocardiographic abnormalities of cardiac structure and/or function in the presence of a left ventricular ejection fraction of 50% or more (Eur J Heart Fail. 2016;18[8]:891-975).
“Signs and symptoms of heart failure, elevated BNP [brain natriuretic peptide], and echocardiography allow us to make a diagnosis of heart failure with preserved ejection fraction,” Dr. Kearney, who is also dean of the Leeds University School of Medicine. “But we don’t know the outcome of these patients, we don’t know how to treat them, and we don’t know the impact on hospitalizations.”
In a large, unpublished cohort study conducted at Leeds, Dr. Kearney and colleagues evaluated how many patients met criteria for heart failure with reduced ejection fraction or heart failure with preserved ejection fraction after undergoing a BNP measurement. Ultimately, 959 patients met criteria. After assessment, 23% had no heart failure, 44% had heart failure with preserved ejection fraction, and 33% had heart failure with reduced ejection fraction. They found that patients with preserved ejection fraction were older (mean age, 84 years); were more likely to be female; and had less ischemia, less diabetes, and more hypertension. In addition, patients with preserved ejection fraction had significantly better survival than patients with reduced ejection fraction over 5 years follow-up.
“What was really interesting were the findings related to hospitalization,” he said. “All 959 patients accounted for 20,517 days in the hospital over 5 years, which is the equivalent of 1 patient occupying a hospital bed for 56 years. This disorder [heart failure with preserved ejection fraction], despite having a lower mortality than heart failure with reduced ejection fraction, leads to a significant burden on health care systems.”
Among patients with preserved ejection fraction, 82% were hospitalized for a noncardiovascular cause, 6.9% because of heart failure, and 11% were caused by other cardiovascular causes. Most of the hospital admissions were because of chest infections, falls, and other frailty-linked causes. “This link between systemic frailty and heart failure with preserved ejection fraction warrants further investigation,” Dr. Kearney said. “This is a major burden on patient hospital care.”
When the researchers examined outcomes in patients with and without diabetes, those with diabetes were younger, more likely to be male, and have a higher body mass index. They found that, in the presence of diabetes, mortality was increased in heart failure with preserved and reduced ejection fraction. “So, even at the age of 81 or 82, diabetes changes the pathophysiology of mortality in what was previously believed to be a benign disease,” he said.
In a subset analysis of patients with and without diabetes who were not taking a beta-blocker, there did not seem to be increased sympathetic activation in the patients with diabetes and heart failure with preserved ejection fraction, nor a difference in heart rate between the nondiabetic patients and patients with diabetes. However, among patients with heart failure with reduced ejection fraction, those with diabetes had an increased heart rate.
“Is heart failure with preserved ejection fraction in diabetes benign? I think the answer is no,” Dr. Kearney said. “It increases hospitalization and is a major burden on health care systems. What should we do? We deal with comorbidity and fall risk. It’s good old-fashioned doctoring, really. We address frailty and respiratory tract infections, but the key thing here is that we need more research.”
Dr. Kearney reported having no relevant financial disclosures.
LOS ANGELES – When it comes to the optimal treatment of patients with heart failure with preserved ejection fraction and diabetes, cardiologists like Mark T. Kearney, MB ChB, MD, remain stumped.
“Over the years, the diagnosis of heart failure with preserved ejection fraction has been notoriously difficult [to treat], controversial, and ultimately involves aggressive catheterization of the heart to assess diastolic dysfunction, complex echocardiography, and invasive tests,” Dr. Kearney said at the World Congress on Insulin Resistance, Diabetes, and Cardiovascular Disease. “These patients have an ejection fraction of over 50% and classic signs and symptoms of heart failure. Studies of beta-blockers, angiotensin-converting enzyme inhibitors, and angiotensin II receptor blockers have been unsuccessful in this group of patients. We’re at the beginning of a journey in understanding this disorder, and it’s important, because more and more patients present to us with signs and symptoms of heart failure with an ejection fraction greater than 50%.”
In a recent analysis of 1,797 patients with chronic heart failure, Dr. Kearney, British Heart Foundation Professor of Cardiovascular and Diabetes Research at the Leeds (England) Institute of Cardiovascular and Metabolic Medicine, and colleagues examined whether beta-blockers and ACE inhibitors were associated with differential effects on mortality in patients with and without diabetes (Diabetes Care. 2018;41:136-42). Mean follow-up was 4 years.
For the ACE inhibitor component of the trial, the researchers correlated the dose of ramipril to outcomes and found that each milligram increase of ramipril reduced the risk of death by about 3%. “In the nondiabetic patients who did not receive an ACE inhibitor, mortality was about 60% – worse than most cancers,” Dr. Kearney said. “In patients with diabetes, there was a similar pattern. If you didn’t get an ACE inhibitor, mortality was 70%. So, if you get patients on an optimal dose of an ACE inhibitor, you improve their mortality substantially, whether they have diabetes or not.”
The beta-blocker component of the trial yielded similar results. “Among patients who did not receive a beta-blocker, the mortality was about 70% at 5 years – really terrible,” he said. “Every milligram of bisoprolol was associated with a reduction in mortality of about 9%. So, if a patient gets on an optimal dose of a beta-blocker and they have diabetes, it’s associated with prolongation of life over a year.”
Dr. Kearney said that patients often do not want to take an increased dose of a beta-blocker because of concerns about side effects, such as tiredness. “They ask me what the side effects of an increased dose would be. My answer is: ‘It will make you live longer.’ Usually, they’ll respond by agreeing to have a little bit more of the beta-blocker. The message here is, if you have a patient with ejection fraction heart failure and diabetes, get them on the optimal dose of a beta-blocker, even at the expense of an ACE inhibitor.”
In 2016, the European Society of Cardiology introduced guidelines for physicians to make a diagnosis of heart failure with preserved ejection fraction. The guidelines mandate that a diagnosis requires signs and symptoms of heart failure, elevated levels of natriuretic peptide, and echocardiographic abnormalities of cardiac structure and/or function in the presence of a left ventricular ejection fraction of 50% or more (Eur J Heart Fail. 2016;18[8]:891-975).
“Signs and symptoms of heart failure, elevated BNP [brain natriuretic peptide], and echocardiography allow us to make a diagnosis of heart failure with preserved ejection fraction,” Dr. Kearney, who is also dean of the Leeds University School of Medicine. “But we don’t know the outcome of these patients, we don’t know how to treat them, and we don’t know the impact on hospitalizations.”
In a large, unpublished cohort study conducted at Leeds, Dr. Kearney and colleagues evaluated how many patients met criteria for heart failure with reduced ejection fraction or heart failure with preserved ejection fraction after undergoing a BNP measurement. Ultimately, 959 patients met criteria. After assessment, 23% had no heart failure, 44% had heart failure with preserved ejection fraction, and 33% had heart failure with reduced ejection fraction. They found that patients with preserved ejection fraction were older (mean age, 84 years); were more likely to be female; and had less ischemia, less diabetes, and more hypertension. In addition, patients with preserved ejection fraction had significantly better survival than patients with reduced ejection fraction over 5 years follow-up.
“What was really interesting were the findings related to hospitalization,” he said. “All 959 patients accounted for 20,517 days in the hospital over 5 years, which is the equivalent of 1 patient occupying a hospital bed for 56 years. This disorder [heart failure with preserved ejection fraction], despite having a lower mortality than heart failure with reduced ejection fraction, leads to a significant burden on health care systems.”
Among patients with preserved ejection fraction, 82% were hospitalized for a noncardiovascular cause, 6.9% because of heart failure, and 11% were caused by other cardiovascular causes. Most of the hospital admissions were because of chest infections, falls, and other frailty-linked causes. “This link between systemic frailty and heart failure with preserved ejection fraction warrants further investigation,” Dr. Kearney said. “This is a major burden on patient hospital care.”
When the researchers examined outcomes in patients with and without diabetes, those with diabetes were younger, more likely to be male, and have a higher body mass index. They found that, in the presence of diabetes, mortality was increased in heart failure with preserved and reduced ejection fraction. “So, even at the age of 81 or 82, diabetes changes the pathophysiology of mortality in what was previously believed to be a benign disease,” he said.
In a subset analysis of patients with and without diabetes who were not taking a beta-blocker, there did not seem to be increased sympathetic activation in the patients with diabetes and heart failure with preserved ejection fraction, nor a difference in heart rate between the nondiabetic patients and patients with diabetes. However, among patients with heart failure with reduced ejection fraction, those with diabetes had an increased heart rate.
“Is heart failure with preserved ejection fraction in diabetes benign? I think the answer is no,” Dr. Kearney said. “It increases hospitalization and is a major burden on health care systems. What should we do? We deal with comorbidity and fall risk. It’s good old-fashioned doctoring, really. We address frailty and respiratory tract infections, but the key thing here is that we need more research.”
Dr. Kearney reported having no relevant financial disclosures.
LOS ANGELES – When it comes to the optimal treatment of patients with heart failure with preserved ejection fraction and diabetes, cardiologists like Mark T. Kearney, MB ChB, MD, remain stumped.
“Over the years, the diagnosis of heart failure with preserved ejection fraction has been notoriously difficult [to treat], controversial, and ultimately involves aggressive catheterization of the heart to assess diastolic dysfunction, complex echocardiography, and invasive tests,” Dr. Kearney said at the World Congress on Insulin Resistance, Diabetes, and Cardiovascular Disease. “These patients have an ejection fraction of over 50% and classic signs and symptoms of heart failure. Studies of beta-blockers, angiotensin-converting enzyme inhibitors, and angiotensin II receptor blockers have been unsuccessful in this group of patients. We’re at the beginning of a journey in understanding this disorder, and it’s important, because more and more patients present to us with signs and symptoms of heart failure with an ejection fraction greater than 50%.”
In a recent analysis of 1,797 patients with chronic heart failure, Dr. Kearney, British Heart Foundation Professor of Cardiovascular and Diabetes Research at the Leeds (England) Institute of Cardiovascular and Metabolic Medicine, and colleagues examined whether beta-blockers and ACE inhibitors were associated with differential effects on mortality in patients with and without diabetes (Diabetes Care. 2018;41:136-42). Mean follow-up was 4 years.
For the ACE inhibitor component of the trial, the researchers correlated the dose of ramipril to outcomes and found that each milligram increase of ramipril reduced the risk of death by about 3%. “In the nondiabetic patients who did not receive an ACE inhibitor, mortality was about 60% – worse than most cancers,” Dr. Kearney said. “In patients with diabetes, there was a similar pattern. If you didn’t get an ACE inhibitor, mortality was 70%. So, if you get patients on an optimal dose of an ACE inhibitor, you improve their mortality substantially, whether they have diabetes or not.”
The beta-blocker component of the trial yielded similar results. “Among patients who did not receive a beta-blocker, the mortality was about 70% at 5 years – really terrible,” he said. “Every milligram of bisoprolol was associated with a reduction in mortality of about 9%. So, if a patient gets on an optimal dose of a beta-blocker and they have diabetes, it’s associated with prolongation of life over a year.”
Dr. Kearney said that patients often do not want to take an increased dose of a beta-blocker because of concerns about side effects, such as tiredness. “They ask me what the side effects of an increased dose would be. My answer is: ‘It will make you live longer.’ Usually, they’ll respond by agreeing to have a little bit more of the beta-blocker. The message here is, if you have a patient with ejection fraction heart failure and diabetes, get them on the optimal dose of a beta-blocker, even at the expense of an ACE inhibitor.”
In 2016, the European Society of Cardiology introduced guidelines for physicians to make a diagnosis of heart failure with preserved ejection fraction. The guidelines mandate that a diagnosis requires signs and symptoms of heart failure, elevated levels of natriuretic peptide, and echocardiographic abnormalities of cardiac structure and/or function in the presence of a left ventricular ejection fraction of 50% or more (Eur J Heart Fail. 2016;18[8]:891-975).
“Signs and symptoms of heart failure, elevated BNP [brain natriuretic peptide], and echocardiography allow us to make a diagnosis of heart failure with preserved ejection fraction,” Dr. Kearney, who is also dean of the Leeds University School of Medicine. “But we don’t know the outcome of these patients, we don’t know how to treat them, and we don’t know the impact on hospitalizations.”
In a large, unpublished cohort study conducted at Leeds, Dr. Kearney and colleagues evaluated how many patients met criteria for heart failure with reduced ejection fraction or heart failure with preserved ejection fraction after undergoing a BNP measurement. Ultimately, 959 patients met criteria. After assessment, 23% had no heart failure, 44% had heart failure with preserved ejection fraction, and 33% had heart failure with reduced ejection fraction. They found that patients with preserved ejection fraction were older (mean age, 84 years); were more likely to be female; and had less ischemia, less diabetes, and more hypertension. In addition, patients with preserved ejection fraction had significantly better survival than patients with reduced ejection fraction over 5 years follow-up.
“What was really interesting were the findings related to hospitalization,” he said. “All 959 patients accounted for 20,517 days in the hospital over 5 years, which is the equivalent of 1 patient occupying a hospital bed for 56 years. This disorder [heart failure with preserved ejection fraction], despite having a lower mortality than heart failure with reduced ejection fraction, leads to a significant burden on health care systems.”
Among patients with preserved ejection fraction, 82% were hospitalized for a noncardiovascular cause, 6.9% because of heart failure, and 11% were caused by other cardiovascular causes. Most of the hospital admissions were because of chest infections, falls, and other frailty-linked causes. “This link between systemic frailty and heart failure with preserved ejection fraction warrants further investigation,” Dr. Kearney said. “This is a major burden on patient hospital care.”
When the researchers examined outcomes in patients with and without diabetes, those with diabetes were younger, more likely to be male, and have a higher body mass index. They found that, in the presence of diabetes, mortality was increased in heart failure with preserved and reduced ejection fraction. “So, even at the age of 81 or 82, diabetes changes the pathophysiology of mortality in what was previously believed to be a benign disease,” he said.
In a subset analysis of patients with and without diabetes who were not taking a beta-blocker, there did not seem to be increased sympathetic activation in the patients with diabetes and heart failure with preserved ejection fraction, nor a difference in heart rate between the nondiabetic patients and patients with diabetes. However, among patients with heart failure with reduced ejection fraction, those with diabetes had an increased heart rate.
“Is heart failure with preserved ejection fraction in diabetes benign? I think the answer is no,” Dr. Kearney said. “It increases hospitalization and is a major burden on health care systems. What should we do? We deal with comorbidity and fall risk. It’s good old-fashioned doctoring, really. We address frailty and respiratory tract infections, but the key thing here is that we need more research.”
Dr. Kearney reported having no relevant financial disclosures.
EXPERT ANALYSIS FROM WCIRDC 2019