DENVER – A high degree of unwarranted practice variation exists among pediatricians and family physicians with regard to screening children for obstructive sleep apnea in accord with current evidence-based practice guidelines, Sarah M. Honaker, Ph.D., said at the annual meeting of the Associated Professional Sleep Societies.

The American Academy of Pediatrics and American Academy of Sleep Medicine recommend that children with frequent snoring be referred for a sleep study or to a sleep specialist or otolaryngologist because of the damaging consequences of living with untreated obstructive sleep apnea (OSA). But Dr. Honaker’s study of 8,135 children aged 1-12 years seen at five university-affiliated urban primary care pediatric clinics demonstrated that the identification rate of suspected OSA was abysmally low, and physician practice on this score varied enormously.

Bruce Jancin/Frontline Medical News

“There is a critical need to develop enhanced implementation strategies to support primary care providers’ adherence to evidence-based practice for pediatric OSA,” declared Dr. Honaker of Indiana University in Indianapolis.

She and her coinvestigators have developed a computer decision support system designed to do just that. Known as CHICA, for Child Health Improvement through Computer Automation, the system works like this: While in the clinic waiting room, the parent is handed a computer tablet and asked to complete 20 yes/no items designed to identify priority areas for the primary care provider to address during the current visit. The items are individually tailored based upon the child’s age, past medical history, and previous responses.

One item asks if the child snores three or more nights per week, a well-established indicator of increased risk for OSA. If the answer is yes, CHICA instantly sends a prompt to the child’s electronic medical record noting that the parent reports the child is a frequent snorer and this might indicate OSA.

The primary care provider can either ignore the prompt or respond during or after the visit in one of three ways: “I am concerned about OSA,” “I do not suspect OSA,” or “The parent in the examining room denies hearing frequent snoring.”

The mean age of the patients in Dr. Honaker’s study was 5.8 years, and 83% of the 8,135 children had Medicaid coverage. Parental cooperation with CHICA was high: 98.5% of parents addressed the snoring question. They reported that 28.5% of the children snored at least 3 nights per week, generating a total of 1,094 CHICA prompts to the primary care providers. Forty-four percent of providers didn’t respond to the prompt, which Dr. Honaker said is a typical rate for this sort of computerized assist intervention. Of those who did respond, only 15.9% indicated they suspected OSA. Sixty-three percent declared they didn’t suspect OSA, and the remainder said the parent in the examining room didn’t report frequent snoring.

Although responding providers indicated they suspected OSA in 15.9% of the children, that’s a low figure for frequent snorers. Moreover, 31% of children who got the CHICA frequent snoring prompt were overweight or obese, and 17% had attention-deficit hyperactivity disorder symptoms, both known risk factors for OSA. Some of the kids had both risk factors, but 39% had at least one in addition to their frequent snoring, Dr. Honaker noted.

The investigators carried out multivariate logistic regression analyses of child, provider, and clinic characteristics in search of predictors associated with physician concern that a child might have OSA. It turned out that none of the provider characteristics had any bearing on this endpoint. It didn’t matter if a physician’s specialty was pediatrics or family medicine. Providers had been in practice for 3-42 years, with a mean of 15.1 years, but years in practice weren’t associated with a physician’s rate of identification of possible pediatric OSA. Individual provider rates varied enormously, though. Some physicians never suspected OSA, others did so in nearly 50% of children flagged by the CHICA prompt.

“It’s not clear that type of training plays a large role in this area,” she commented.

The only relevant patient factor was age: children aged 1-2.5 years were 73% less likely to generate physician suspicion of OSA.

“Surprisingly, none of the patient health factors were predictive. So having ADHD symptoms or being overweight or obese did not make it more likely that a child would elicit concern for OSA,” Dr. Honaker observed.

However, which of the five clinics the child attended turned out to make a big difference. Rates of suspected OSA in children with a CHICA snoring prompt ranged from a low of 5% at one clinic to 27% at another.

Dr. Honaker’s recent review of the literature led her to conclude that the Indiana University experience is hardly unique. Despite documented high rates of pediatric sleep disorders in primary care settings, screening and treatment rates are low. Primary care physicians receive little training in sleep medicine (Sleep Med Rev. 2016;25:31-9).

What’s next for CHICA?

Dr. Honaker and coworkers have developed a beefed up CHICA decision support system known as the CHICA OSA Module. In addition to generating a prompt in the medical record if a parent indicates the child snores three or more nights per week, additional OSA signs and symptoms, if present, will be noted on the screen, along with a comment that American Academy of Pediatrics guidelines recommend referral when OSA is suspected. Dr. Honaker plans to conduct a controlled trial in which some clinics get the CHICA OSA Module while others use the older CHICA system.

Her study was funded by the American Sleep Medicine Foundation. She reported having no financial conflicts.

bjancin@frontlinemedcom.com

DENVER – A high degree of unwarranted practice variation exists among pediatricians and family physicians with regard to screening children for obstructive sleep apnea in accord with current evidence-based practice guidelines, Sarah M. Honaker, Ph.D., said at the annual meeting of the Associated Professional Sleep Societies.

The American Academy of Pediatrics and American Academy of Sleep Medicine recommend that children with frequent snoring be referred for a sleep study or to a sleep specialist or otolaryngologist because of the damaging consequences of living with untreated obstructive sleep apnea (OSA). But Dr. Honaker’s study of 8,135 children aged 1-12 years seen at five university-affiliated urban primary care pediatric clinics demonstrated that the identification rate of suspected OSA was abysmally low, and physician practice on this score varied enormously.

Bruce Jancin/Frontline Medical News

“There is a critical need to develop enhanced implementation strategies to support primary care providers’ adherence to evidence-based practice for pediatric OSA,” declared Dr. Honaker of Indiana University in Indianapolis.

She and her coinvestigators have developed a computer decision support system designed to do just that. Known as CHICA, for Child Health Improvement through Computer Automation, the system works like this: While in the clinic waiting room, the parent is handed a computer tablet and asked to complete 20 yes/no items designed to identify priority areas for the primary care provider to address during the current visit. The items are individually tailored based upon the child’s age, past medical history, and previous responses.

One item asks if the child snores three or more nights per week, a well-established indicator of increased risk for OSA. If the answer is yes, CHICA instantly sends a prompt to the child’s electronic medical record noting that the parent reports the child is a frequent snorer and this might indicate OSA.

The primary care provider can either ignore the prompt or respond during or after the visit in one of three ways: “I am concerned about OSA,” “I do not suspect OSA,” or “The parent in the examining room denies hearing frequent snoring.”

The mean age of the patients in Dr. Honaker’s study was 5.8 years, and 83% of the 8,135 children had Medicaid coverage. Parental cooperation with CHICA was high: 98.5% of parents addressed the snoring question. They reported that 28.5% of the children snored at least 3 nights per week, generating a total of 1,094 CHICA prompts to the primary care providers. Forty-four percent of providers didn’t respond to the prompt, which Dr. Honaker said is a typical rate for this sort of computerized assist intervention. Of those who did respond, only 15.9% indicated they suspected OSA. Sixty-three percent declared they didn’t suspect OSA, and the remainder said the parent in the examining room didn’t report frequent snoring.

Although responding providers indicated they suspected OSA in 15.9% of the children, that’s a low figure for frequent snorers. Moreover, 31% of children who got the CHICA frequent snoring prompt were overweight or obese, and 17% had attention-deficit hyperactivity disorder symptoms, both known risk factors for OSA. Some of the kids had both risk factors, but 39% had at least one in addition to their frequent snoring, Dr. Honaker noted.

The investigators carried out multivariate logistic regression analyses of child, provider, and clinic characteristics in search of predictors associated with physician concern that a child might have OSA. It turned out that none of the provider characteristics had any bearing on this endpoint. It didn’t matter if a physician’s specialty was pediatrics or family medicine. Providers had been in practice for 3-42 years, with a mean of 15.1 years, but years in practice weren’t associated with a physician’s rate of identification of possible pediatric OSA. Individual provider rates varied enormously, though. Some physicians never suspected OSA, others did so in nearly 50% of children flagged by the CHICA prompt.

“It’s not clear that type of training plays a large role in this area,” she commented.

The only relevant patient factor was age: children aged 1-2.5 years were 73% less likely to generate physician suspicion of OSA.

“Surprisingly, none of the patient health factors were predictive. So having ADHD symptoms or being overweight or obese did not make it more likely that a child would elicit concern for OSA,” Dr. Honaker observed.

However, which of the five clinics the child attended turned out to make a big difference. Rates of suspected OSA in children with a CHICA snoring prompt ranged from a low of 5% at one clinic to 27% at another.

Dr. Honaker’s recent review of the literature led her to conclude that the Indiana University experience is hardly unique. Despite documented high rates of pediatric sleep disorders in primary care settings, screening and treatment rates are low. Primary care physicians receive little training in sleep medicine (Sleep Med Rev. 2016;25:31-9).

What’s next for CHICA?

Dr. Honaker and coworkers have developed a beefed up CHICA decision support system known as the CHICA OSA Module. In addition to generating a prompt in the medical record if a parent indicates the child snores three or more nights per week, additional OSA signs and symptoms, if present, will be noted on the screen, along with a comment that American Academy of Pediatrics guidelines recommend referral when OSA is suspected. Dr. Honaker plans to conduct a controlled trial in which some clinics get the CHICA OSA Module while others use the older CHICA system.

Her study was funded by the American Sleep Medicine Foundation. She reported having no financial conflicts.

bjancin@frontlinemedcom.com

DENVER – A high degree of unwarranted practice variation exists among pediatricians and family physicians with regard to screening children for obstructive sleep apnea in accord with current evidence-based practice guidelines, Sarah M. Honaker, Ph.D., said at the annual meeting of the Associated Professional Sleep Societies.

The American Academy of Pediatrics and American Academy of Sleep Medicine recommend that children with frequent snoring be referred for a sleep study or to a sleep specialist or otolaryngologist because of the damaging consequences of living with untreated obstructive sleep apnea (OSA). But Dr. Honaker’s study of 8,135 children aged 1-12 years seen at five university-affiliated urban primary care pediatric clinics demonstrated that the identification rate of suspected OSA was abysmally low, and physician practice on this score varied enormously.

Bruce Jancin/Frontline Medical News

“There is a critical need to develop enhanced implementation strategies to support primary care providers’ adherence to evidence-based practice for pediatric OSA,” declared Dr. Honaker of Indiana University in Indianapolis.

She and her coinvestigators have developed a computer decision support system designed to do just that. Known as CHICA, for Child Health Improvement through Computer Automation, the system works like this: While in the clinic waiting room, the parent is handed a computer tablet and asked to complete 20 yes/no items designed to identify priority areas for the primary care provider to address during the current visit. The items are individually tailored based upon the child’s age, past medical history, and previous responses.

One item asks if the child snores three or more nights per week, a well-established indicator of increased risk for OSA. If the answer is yes, CHICA instantly sends a prompt to the child’s electronic medical record noting that the parent reports the child is a frequent snorer and this might indicate OSA.

The primary care provider can either ignore the prompt or respond during or after the visit in one of three ways: “I am concerned about OSA,” “I do not suspect OSA,” or “The parent in the examining room denies hearing frequent snoring.”

The mean age of the patients in Dr. Honaker’s study was 5.8 years, and 83% of the 8,135 children had Medicaid coverage. Parental cooperation with CHICA was high: 98.5% of parents addressed the snoring question. They reported that 28.5% of the children snored at least 3 nights per week, generating a total of 1,094 CHICA prompts to the primary care providers. Forty-four percent of providers didn’t respond to the prompt, which Dr. Honaker said is a typical rate for this sort of computerized assist intervention. Of those who did respond, only 15.9% indicated they suspected OSA. Sixty-three percent declared they didn’t suspect OSA, and the remainder said the parent in the examining room didn’t report frequent snoring.

Although responding providers indicated they suspected OSA in 15.9% of the children, that’s a low figure for frequent snorers. Moreover, 31% of children who got the CHICA frequent snoring prompt were overweight or obese, and 17% had attention-deficit hyperactivity disorder symptoms, both known risk factors for OSA. Some of the kids had both risk factors, but 39% had at least one in addition to their frequent snoring, Dr. Honaker noted.

The investigators carried out multivariate logistic regression analyses of child, provider, and clinic characteristics in search of predictors associated with physician concern that a child might have OSA. It turned out that none of the provider characteristics had any bearing on this endpoint. It didn’t matter if a physician’s specialty was pediatrics or family medicine. Providers had been in practice for 3-42 years, with a mean of 15.1 years, but years in practice weren’t associated with a physician’s rate of identification of possible pediatric OSA. Individual provider rates varied enormously, though. Some physicians never suspected OSA, others did so in nearly 50% of children flagged by the CHICA prompt.

“It’s not clear that type of training plays a large role in this area,” she commented.

The only relevant patient factor was age: children aged 1-2.5 years were 73% less likely to generate physician suspicion of OSA.

“Surprisingly, none of the patient health factors were predictive. So having ADHD symptoms or being overweight or obese did not make it more likely that a child would elicit concern for OSA,” Dr. Honaker observed.

However, which of the five clinics the child attended turned out to make a big difference. Rates of suspected OSA in children with a CHICA snoring prompt ranged from a low of 5% at one clinic to 27% at another.

Dr. Honaker’s recent review of the literature led her to conclude that the Indiana University experience is hardly unique. Despite documented high rates of pediatric sleep disorders in primary care settings, screening and treatment rates are low. Primary care physicians receive little training in sleep medicine (Sleep Med Rev. 2016;25:31-9).

What’s next for CHICA?

Dr. Honaker and coworkers have developed a beefed up CHICA decision support system known as the CHICA OSA Module. In addition to generating a prompt in the medical record if a parent indicates the child snores three or more nights per week, additional OSA signs and symptoms, if present, will be noted on the screen, along with a comment that American Academy of Pediatrics guidelines recommend referral when OSA is suspected. Dr. Honaker plans to conduct a controlled trial in which some clinics get the CHICA OSA Module while others use the older CHICA system.

Her study was funded by the American Sleep Medicine Foundation. She reported having no financial conflicts.

bjancin@frontlinemedcom.com

PARIS – Intravascular ultrasound can reliably be used in lieu of multidetector computerized tomography for the key task of annular sizing in patients undergoing transcatheter aortic valve replacement, Dr. Diaa Hakim declared at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

Multidetector CT (MDCT) is considered the standard imaging method for this purpose. But the requirement for contrast media makes MDCT problematic for patients with chronic kidney disease, who can easily be driven into acute kidney injury through exposure to this material.

Bruce Jancin/Frontline Medical News

Moreover, renal failure is common among patients with a failing native aortic valve. Interventionalists who perform transaortic valve replacement (TAVR) are encountering renal failure more and more frequently as the nonsurgical treatment takes off in popularity. An alternative imaging method is sorely needed, observed Dr. Hakim of the University of Alabama at Birmingham.

Unlike MDCT, intravascular ultrasound (IVUS) doesn’t require contrast. And in Dr. Hakim’s head-to-head comparative trial conducted in 50 consecutive TAVR patients who underwent annular sizing by both methods, there were no significant differences between the two in measurements of maximum and minimum annular diameter, mean annular diameter, or annular area.

The decision as to the size of the replacement aortic valve was based upon MDCT, which was performed first. Then came IVUS carried out with a Boston Science Atlantis PV Peripheral IVUS catheter at 8-French and 15 Hz. The catheter was advanced over the guidewire, then pullback imaging was obtained automatically from the left ventricular outflow tract to the aortic root. The IVUS measurements were made at the level of basal attachment of the aortic valve cusps, which was quite close to the same point as the MDCT measurements.

Post TAVR, 37 of the 50 patients had no or trivial paravalvular regurgitation. Six patients developed acute kidney injury.

Asked if he believes IVUS now enables operators to routinely skip MDCT for TAVR patients, Dr. Hakim replied, “Not for the moment.” In patients with chronic kidney disease, yes, but in order for IVUS for annular sizing to expand beyond that population it will be necessary for device makers to develop an IVUS catheter with better visualization, a device designed specifically to see all the details of the aortic valve and annulus. He noted that the Atlantis PV Peripheral IVUS catheter employed in his study was designed for the aorta, not the aortic valve. It doesn’t provide optimal imaging of the valve cusps, nor can it measure paravalvular regurgitation after valve implantation.

How much time does IVUS for annular sizing add to the TAVR procedure? “Five minutes, no more,” according to Dr. Hakim.

He reported having no financial conflicts regarding this study, conducted free of commercial support.

bjancin@frontlinemedcom.com

PARIS – Intravascular ultrasound can reliably be used in lieu of multidetector computerized tomography for the key task of annular sizing in patients undergoing transcatheter aortic valve replacement, Dr. Diaa Hakim declared at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

Multidetector CT (MDCT) is considered the standard imaging method for this purpose. But the requirement for contrast media makes MDCT problematic for patients with chronic kidney disease, who can easily be driven into acute kidney injury through exposure to this material.

Bruce Jancin/Frontline Medical News

Moreover, renal failure is common among patients with a failing native aortic valve. Interventionalists who perform transaortic valve replacement (TAVR) are encountering renal failure more and more frequently as the nonsurgical treatment takes off in popularity. An alternative imaging method is sorely needed, observed Dr. Hakim of the University of Alabama at Birmingham.

Unlike MDCT, intravascular ultrasound (IVUS) doesn’t require contrast. And in Dr. Hakim’s head-to-head comparative trial conducted in 50 consecutive TAVR patients who underwent annular sizing by both methods, there were no significant differences between the two in measurements of maximum and minimum annular diameter, mean annular diameter, or annular area.

The decision as to the size of the replacement aortic valve was based upon MDCT, which was performed first. Then came IVUS carried out with a Boston Science Atlantis PV Peripheral IVUS catheter at 8-French and 15 Hz. The catheter was advanced over the guidewire, then pullback imaging was obtained automatically from the left ventricular outflow tract to the aortic root. The IVUS measurements were made at the level of basal attachment of the aortic valve cusps, which was quite close to the same point as the MDCT measurements.

Post TAVR, 37 of the 50 patients had no or trivial paravalvular regurgitation. Six patients developed acute kidney injury.

Asked if he believes IVUS now enables operators to routinely skip MDCT for TAVR patients, Dr. Hakim replied, “Not for the moment.” In patients with chronic kidney disease, yes, but in order for IVUS for annular sizing to expand beyond that population it will be necessary for device makers to develop an IVUS catheter with better visualization, a device designed specifically to see all the details of the aortic valve and annulus. He noted that the Atlantis PV Peripheral IVUS catheter employed in his study was designed for the aorta, not the aortic valve. It doesn’t provide optimal imaging of the valve cusps, nor can it measure paravalvular regurgitation after valve implantation.

How much time does IVUS for annular sizing add to the TAVR procedure? “Five minutes, no more,” according to Dr. Hakim.

He reported having no financial conflicts regarding this study, conducted free of commercial support.

bjancin@frontlinemedcom.com

PARIS – Intravascular ultrasound can reliably be used in lieu of multidetector computerized tomography for the key task of annular sizing in patients undergoing transcatheter aortic valve replacement, Dr. Diaa Hakim declared at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

Multidetector CT (MDCT) is considered the standard imaging method for this purpose. But the requirement for contrast media makes MDCT problematic for patients with chronic kidney disease, who can easily be driven into acute kidney injury through exposure to this material.

Bruce Jancin/Frontline Medical News

Moreover, renal failure is common among patients with a failing native aortic valve. Interventionalists who perform transaortic valve replacement (TAVR) are encountering renal failure more and more frequently as the nonsurgical treatment takes off in popularity. An alternative imaging method is sorely needed, observed Dr. Hakim of the University of Alabama at Birmingham.

Unlike MDCT, intravascular ultrasound (IVUS) doesn’t require contrast. And in Dr. Hakim’s head-to-head comparative trial conducted in 50 consecutive TAVR patients who underwent annular sizing by both methods, there were no significant differences between the two in measurements of maximum and minimum annular diameter, mean annular diameter, or annular area.

The decision as to the size of the replacement aortic valve was based upon MDCT, which was performed first. Then came IVUS carried out with a Boston Science Atlantis PV Peripheral IVUS catheter at 8-French and 15 Hz. The catheter was advanced over the guidewire, then pullback imaging was obtained automatically from the left ventricular outflow tract to the aortic root. The IVUS measurements were made at the level of basal attachment of the aortic valve cusps, which was quite close to the same point as the MDCT measurements.

Post TAVR, 37 of the 50 patients had no or trivial paravalvular regurgitation. Six patients developed acute kidney injury.

Asked if he believes IVUS now enables operators to routinely skip MDCT for TAVR patients, Dr. Hakim replied, “Not for the moment.” In patients with chronic kidney disease, yes, but in order for IVUS for annular sizing to expand beyond that population it will be necessary for device makers to develop an IVUS catheter with better visualization, a device designed specifically to see all the details of the aortic valve and annulus. He noted that the Atlantis PV Peripheral IVUS catheter employed in his study was designed for the aorta, not the aortic valve. It doesn’t provide optimal imaging of the valve cusps, nor can it measure paravalvular regurgitation after valve implantation.

How much time does IVUS for annular sizing add to the TAVR procedure? “Five minutes, no more,” according to Dr. Hakim.

He reported having no financial conflicts regarding this study, conducted free of commercial support.

bjancin@frontlinemedcom.com

SAN DIEGO – Endorectal balloons appeared to protect against rectal complications from prostate cancer radiation in a small randomized trial from Australia.

The balloons have been around for years, but the Australian study is likely the first randomized trial of long-term clinical outcomes. The balloons are inserted and inflated during radiation treatments, which in the study were daily for 6-7 weeks. They distend the rectum, reducing radiation exposure, and also stabilize the prostate. The investigators used the RectalPro balloon from Qlrad.

M. Alexander Otto/Frontline Medical News

The 40 men were all undergoing image-guided radiation therapy; 20 got the balloon, 20 did not. At 2 years, four balloon patients (25%) had rectal bleeding, versus 10 (50%) of the controls (P less than .001). Balloon patients also had fewer bowel symptoms, less rectal hypersensitivity, and less reduction in internal anal sphincter thickness. Three (15%), versus six controls (30%), reported declines in physical function from their preradiation baseline, and one balloon patient (5%), versus three controls (15%) reported declines in role functioning (P less than .05 for both).

Rectal pain, however, was more common with the balloon at 2 years (six patients [30%] versus two [10%], P less than .001), and balloon patients had reduced anal squeeze pressures (P less than .05). They also reported a higher prevalence of urinary symptoms.

Further follow-up is needed to determine if benefits outweigh risks; if they do, then the balloon “will become standard procedure in our hospital,” said investigator Rochelle Botten, a research scientist in the department of radiation oncology at the Royal Adelaide Hospital.

Given the study’s small numbers, it’s unclear if urinary problems – for instance, incontinence, pain, frequency – are truly associated with the balloon, but it’s “something we’ve got to look at. We are going to study” the men “again at 3 years to see if they’ve resolved, and we’ll have more patients for 2-year follow-up. If we are pressing everything towards the bladder, it [could make] sense that the bladder is getting more radiation.

“We are hoping as the numbers increase, we’ll be able to look at how much of the bladder and how much of the rectum are actually irradiated, and if there’s a difference with the balloon,” she said at the annual Digestive Disease Week meeting.

Ms. Botten had no disclosures.

aotto@frontlinemedcom.com

SAN DIEGO – Endorectal balloons appeared to protect against rectal complications from prostate cancer radiation in a small randomized trial from Australia.

The balloons have been around for years, but the Australian study is likely the first randomized trial of long-term clinical outcomes. The balloons are inserted and inflated during radiation treatments, which in the study were daily for 6-7 weeks. They distend the rectum, reducing radiation exposure, and also stabilize the prostate. The investigators used the RectalPro balloon from Qlrad.

M. Alexander Otto/Frontline Medical News

The 40 men were all undergoing image-guided radiation therapy; 20 got the balloon, 20 did not. At 2 years, four balloon patients (25%) had rectal bleeding, versus 10 (50%) of the controls (P less than .001). Balloon patients also had fewer bowel symptoms, less rectal hypersensitivity, and less reduction in internal anal sphincter thickness. Three (15%), versus six controls (30%), reported declines in physical function from their preradiation baseline, and one balloon patient (5%), versus three controls (15%) reported declines in role functioning (P less than .05 for both).

Rectal pain, however, was more common with the balloon at 2 years (six patients [30%] versus two [10%], P less than .001), and balloon patients had reduced anal squeeze pressures (P less than .05). They also reported a higher prevalence of urinary symptoms.

Further follow-up is needed to determine if benefits outweigh risks; if they do, then the balloon “will become standard procedure in our hospital,” said investigator Rochelle Botten, a research scientist in the department of radiation oncology at the Royal Adelaide Hospital.

Given the study’s small numbers, it’s unclear if urinary problems – for instance, incontinence, pain, frequency – are truly associated with the balloon, but it’s “something we’ve got to look at. We are going to study” the men “again at 3 years to see if they’ve resolved, and we’ll have more patients for 2-year follow-up. If we are pressing everything towards the bladder, it [could make] sense that the bladder is getting more radiation.

“We are hoping as the numbers increase, we’ll be able to look at how much of the bladder and how much of the rectum are actually irradiated, and if there’s a difference with the balloon,” she said at the annual Digestive Disease Week meeting.

Ms. Botten had no disclosures.

aotto@frontlinemedcom.com

SAN DIEGO – Endorectal balloons appeared to protect against rectal complications from prostate cancer radiation in a small randomized trial from Australia.

The balloons have been around for years, but the Australian study is likely the first randomized trial of long-term clinical outcomes. The balloons are inserted and inflated during radiation treatments, which in the study were daily for 6-7 weeks. They distend the rectum, reducing radiation exposure, and also stabilize the prostate. The investigators used the RectalPro balloon from Qlrad.

M. Alexander Otto/Frontline Medical News

The 40 men were all undergoing image-guided radiation therapy; 20 got the balloon, 20 did not. At 2 years, four balloon patients (25%) had rectal bleeding, versus 10 (50%) of the controls (P less than .001). Balloon patients also had fewer bowel symptoms, less rectal hypersensitivity, and less reduction in internal anal sphincter thickness. Three (15%), versus six controls (30%), reported declines in physical function from their preradiation baseline, and one balloon patient (5%), versus three controls (15%) reported declines in role functioning (P less than .05 for both).

Rectal pain, however, was more common with the balloon at 2 years (six patients [30%] versus two [10%], P less than .001), and balloon patients had reduced anal squeeze pressures (P less than .05). They also reported a higher prevalence of urinary symptoms.

Further follow-up is needed to determine if benefits outweigh risks; if they do, then the balloon “will become standard procedure in our hospital,” said investigator Rochelle Botten, a research scientist in the department of radiation oncology at the Royal Adelaide Hospital.

Given the study’s small numbers, it’s unclear if urinary problems – for instance, incontinence, pain, frequency – are truly associated with the balloon, but it’s “something we’ve got to look at. We are going to study” the men “again at 3 years to see if they’ve resolved, and we’ll have more patients for 2-year follow-up. If we are pressing everything towards the bladder, it [could make] sense that the bladder is getting more radiation.

“We are hoping as the numbers increase, we’ll be able to look at how much of the bladder and how much of the rectum are actually irradiated, and if there’s a difference with the balloon,” she said at the annual Digestive Disease Week meeting.

Ms. Botten had no disclosures.

aotto@frontlinemedcom.com

SAN DIEGO – Embryo transfers are less likely to result in live births when women with ulcerative colitis (UC) have fertility treatments, and the risk of preterm birth is higher, at least for twins, according to a 20-year nationwide cohort study from Denmark. On a brighter note, UC did not increase the risk of low birth weight or birth defects, and prior UC surgeries did not diminish success.

The take home conclusions from the study are that “women with ulcerative colitis may [want] to initiate ART [assisted reproductive technology] treatment” sooner than other women because “they cannot expect the same success per embryo transfer.” The greater risk of preterm birth means that “increased prenatal observation in UC pregnancies after ART should be considered,” but “women with UC should be reassured that surgery before ART treatment does not impact the chance of live birth per embryo transfer,” said senior investigator Dr. Sonia Friedman, a gastroenterologist at Brigham and Women’s Hospital in Boston.

Although it’s known that UC diminishes fertility in general, it hasn’t been known until now how it affects assisted reproduction. The investigators turned to Denmark to find out because Denmark has one of the highest incidence rates of UC worldwide, especially among women and men 15-29 years old, and the country captures virtually every ART outcome in national databases.

The study included 1,360 embryo transfers in 432 women with UC and 149,094 in 52,661 women without UC from 1994 to 2013. Treatments included in vitro fertilization, intracytoplasmic sperm injection, and embryo transfers. Women in both groups were a median of 33 years old; women with UC had a median disease duration of 8 years.

The chance of live birth per embryo transfer was 22% less in women with UC (odds ratio, 0.78; 95% confidence interval, 0.67-0.91), after adjusting for age, infertility cause, body mass index (BMI), smoking, and other factors, including calendar year, to take into account changes in ART over the years.

The risk of preterm birth was five times higher when singletons and multiple births were considered together (adjusted OR, 5.29; 95% CI, 2.41-11.63), but not statistically elevated when singleton births were analyzed on their own (aOR, 1.80; 95% CI, 0.49-6.62).

About 35% of the women with UC had prior surgeries, most commonly total colon resections. There was no difference in odds of live birth per cycle versus women with UC and without surgery (OR, 0.97; 95% CI, 0.61-1.36) after adjusting for disease duration, comorbidities, year of treatment, and other factors.

The impact of UC is probably related to disease activity. “Even though gynecologists in Denmark tell us they really try to keep their patients in remission before ART, there is some disease activity,” Dr. Friedman said at the annual Digestive Disease Week.

Surgery for Crohn’s disease is known to reduce success in ART, so it was a bit surprising that it didn’t seem to do so in UC. Perhaps it’s because UC surgery is often curative, while Crohn’s operations often are not, so Crohn’s patients may be more likely to have continued disease activity during ART treatment, Dr. Friedman said.

The majority of women in both study groups were normal weight and didn’t smoke. Outside of UC, most were free of comorbidities. In the UC surgery group, about half the women had one procedure, and the rest two or three.

The work was funded by the Crohn’s and Colitis Foundation of America. Dr. Friedman has no disclosures.

aotto@frontlinemedcom.com

SAN DIEGO – Embryo transfers are less likely to result in live births when women with ulcerative colitis (UC) have fertility treatments, and the risk of preterm birth is higher, at least for twins, according to a 20-year nationwide cohort study from Denmark. On a brighter note, UC did not increase the risk of low birth weight or birth defects, and prior UC surgeries did not diminish success.

The take home conclusions from the study are that “women with ulcerative colitis may [want] to initiate ART [assisted reproductive technology] treatment” sooner than other women because “they cannot expect the same success per embryo transfer.” The greater risk of preterm birth means that “increased prenatal observation in UC pregnancies after ART should be considered,” but “women with UC should be reassured that surgery before ART treatment does not impact the chance of live birth per embryo transfer,” said senior investigator Dr. Sonia Friedman, a gastroenterologist at Brigham and Women’s Hospital in Boston.

Although it’s known that UC diminishes fertility in general, it hasn’t been known until now how it affects assisted reproduction. The investigators turned to Denmark to find out because Denmark has one of the highest incidence rates of UC worldwide, especially among women and men 15-29 years old, and the country captures virtually every ART outcome in national databases.

The study included 1,360 embryo transfers in 432 women with UC and 149,094 in 52,661 women without UC from 1994 to 2013. Treatments included in vitro fertilization, intracytoplasmic sperm injection, and embryo transfers. Women in both groups were a median of 33 years old; women with UC had a median disease duration of 8 years.

The chance of live birth per embryo transfer was 22% less in women with UC (odds ratio, 0.78; 95% confidence interval, 0.67-0.91), after adjusting for age, infertility cause, body mass index (BMI), smoking, and other factors, including calendar year, to take into account changes in ART over the years.

The risk of preterm birth was five times higher when singletons and multiple births were considered together (adjusted OR, 5.29; 95% CI, 2.41-11.63), but not statistically elevated when singleton births were analyzed on their own (aOR, 1.80; 95% CI, 0.49-6.62).

About 35% of the women with UC had prior surgeries, most commonly total colon resections. There was no difference in odds of live birth per cycle versus women with UC and without surgery (OR, 0.97; 95% CI, 0.61-1.36) after adjusting for disease duration, comorbidities, year of treatment, and other factors.

The impact of UC is probably related to disease activity. “Even though gynecologists in Denmark tell us they really try to keep their patients in remission before ART, there is some disease activity,” Dr. Friedman said at the annual Digestive Disease Week.

Surgery for Crohn’s disease is known to reduce success in ART, so it was a bit surprising that it didn’t seem to do so in UC. Perhaps it’s because UC surgery is often curative, while Crohn’s operations often are not, so Crohn’s patients may be more likely to have continued disease activity during ART treatment, Dr. Friedman said.

The majority of women in both study groups were normal weight and didn’t smoke. Outside of UC, most were free of comorbidities. In the UC surgery group, about half the women had one procedure, and the rest two or three.

The work was funded by the Crohn’s and Colitis Foundation of America. Dr. Friedman has no disclosures.

aotto@frontlinemedcom.com

SAN DIEGO – Embryo transfers are less likely to result in live births when women with ulcerative colitis (UC) have fertility treatments, and the risk of preterm birth is higher, at least for twins, according to a 20-year nationwide cohort study from Denmark. On a brighter note, UC did not increase the risk of low birth weight or birth defects, and prior UC surgeries did not diminish success.

The take home conclusions from the study are that “women with ulcerative colitis may [want] to initiate ART [assisted reproductive technology] treatment” sooner than other women because “they cannot expect the same success per embryo transfer.” The greater risk of preterm birth means that “increased prenatal observation in UC pregnancies after ART should be considered,” but “women with UC should be reassured that surgery before ART treatment does not impact the chance of live birth per embryo transfer,” said senior investigator Dr. Sonia Friedman, a gastroenterologist at Brigham and Women’s Hospital in Boston.

Although it’s known that UC diminishes fertility in general, it hasn’t been known until now how it affects assisted reproduction. The investigators turned to Denmark to find out because Denmark has one of the highest incidence rates of UC worldwide, especially among women and men 15-29 years old, and the country captures virtually every ART outcome in national databases.

The study included 1,360 embryo transfers in 432 women with UC and 149,094 in 52,661 women without UC from 1994 to 2013. Treatments included in vitro fertilization, intracytoplasmic sperm injection, and embryo transfers. Women in both groups were a median of 33 years old; women with UC had a median disease duration of 8 years.

The chance of live birth per embryo transfer was 22% less in women with UC (odds ratio, 0.78; 95% confidence interval, 0.67-0.91), after adjusting for age, infertility cause, body mass index (BMI), smoking, and other factors, including calendar year, to take into account changes in ART over the years.

The risk of preterm birth was five times higher when singletons and multiple births were considered together (adjusted OR, 5.29; 95% CI, 2.41-11.63), but not statistically elevated when singleton births were analyzed on their own (aOR, 1.80; 95% CI, 0.49-6.62).

About 35% of the women with UC had prior surgeries, most commonly total colon resections. There was no difference in odds of live birth per cycle versus women with UC and without surgery (OR, 0.97; 95% CI, 0.61-1.36) after adjusting for disease duration, comorbidities, year of treatment, and other factors.

The impact of UC is probably related to disease activity. “Even though gynecologists in Denmark tell us they really try to keep their patients in remission before ART, there is some disease activity,” Dr. Friedman said at the annual Digestive Disease Week.

Surgery for Crohn’s disease is known to reduce success in ART, so it was a bit surprising that it didn’t seem to do so in UC. Perhaps it’s because UC surgery is often curative, while Crohn’s operations often are not, so Crohn’s patients may be more likely to have continued disease activity during ART treatment, Dr. Friedman said.

The majority of women in both study groups were normal weight and didn’t smoke. Outside of UC, most were free of comorbidities. In the UC surgery group, about half the women had one procedure, and the rest two or three.

The work was funded by the Crohn’s and Colitis Foundation of America. Dr. Friedman has no disclosures.

aotto@frontlinemedcom.com

U.S. hospitals may be getting paid for more of the care they actually provide thanks to the Affordable Care Act, if research from Michigan reflects the situation around the country.

While the study didn't look directly at hospital finances, researchers found that the proportion of uninsured adults discharged from Michigan hospitals fell after public insurance options expanded in 2014.

"What we found is that the overwhelming majority of hospitals experienced a decrease in the proportion of uninsured patients and an increase in Medicaid covered patients," said lead author Dr. Matthew Davis, deputy director of Institute for Healthcare Policy and Innovation at the University of Michigan Health System in Ann Arbor.

Under the Affordable Care Act, also known as Obamacare, some U.S. states - including Michigan - expanded Medicaid, which is the joint federal and state insurance program for the poor.

Previous studies showed many people who gained health insurance through the law were previously uninsured, Davis told Reuters Health.

For the new study, he and his colleagues analyzed data on young adults discharged from 130 Michigan hospitals before and after Medicaid became more broadly available in 2014.

About 6 percent of young adults discharged at those hospitals between April and December before the Medicaid expansion were uninsured, compared to about 2 percent during those months in 2014, according to the findings scheduled for online publication June 21 in JAMA.

The proportion of discharged young adults on Medicaid rose from 23 percent in 2012 and 24 percent in 2013 to 30 percent in 2014.

There was a small decline in the number of people discharged with private or other insurance, they found.

The researchers were surprised at how uniform the impact of Medicaid expansion seemed to be in hospitals across Michigan, Davis said.

"This impact wasn't limited to urban areas or population centers, or safety net hospitals," he said.

According to Davis, past research shows that decreases in the number of uninsured patients are tied to decreases in healthcare that goes unpaid for.

"As we have more and more years of the Affordable Care Act that have provided expanded coverage for millions of Americans, it's going to be important to understand how that coverage translates into positive health," he said.

"Coverage through insurance plans and programs like Medicaid is most (needed) when our health is at its worst and we need to be hospitalized," he said. "Yet, that coverage is also essential in times when our health is better and we need to be focused on preventing the next illness rather than just responding to it."

SOURCE: http://bit.ly/WddS8K JAMA 2016.

U.S. hospitals may be getting paid for more of the care they actually provide thanks to the Affordable Care Act, if research from Michigan reflects the situation around the country.

While the study didn't look directly at hospital finances, researchers found that the proportion of uninsured adults discharged from Michigan hospitals fell after public insurance options expanded in 2014.

"What we found is that the overwhelming majority of hospitals experienced a decrease in the proportion of uninsured patients and an increase in Medicaid covered patients," said lead author Dr. Matthew Davis, deputy director of Institute for Healthcare Policy and Innovation at the University of Michigan Health System in Ann Arbor.

Under the Affordable Care Act, also known as Obamacare, some U.S. states - including Michigan - expanded Medicaid, which is the joint federal and state insurance program for the poor.

Previous studies showed many people who gained health insurance through the law were previously uninsured, Davis told Reuters Health.

For the new study, he and his colleagues analyzed data on young adults discharged from 130 Michigan hospitals before and after Medicaid became more broadly available in 2014.

About 6 percent of young adults discharged at those hospitals between April and December before the Medicaid expansion were uninsured, compared to about 2 percent during those months in 2014, according to the findings scheduled for online publication June 21 in JAMA.

The proportion of discharged young adults on Medicaid rose from 23 percent in 2012 and 24 percent in 2013 to 30 percent in 2014.

There was a small decline in the number of people discharged with private or other insurance, they found.

The researchers were surprised at how uniform the impact of Medicaid expansion seemed to be in hospitals across Michigan, Davis said.

"This impact wasn't limited to urban areas or population centers, or safety net hospitals," he said.

According to Davis, past research shows that decreases in the number of uninsured patients are tied to decreases in healthcare that goes unpaid for.

"As we have more and more years of the Affordable Care Act that have provided expanded coverage for millions of Americans, it's going to be important to understand how that coverage translates into positive health," he said.

"Coverage through insurance plans and programs like Medicaid is most (needed) when our health is at its worst and we need to be hospitalized," he said. "Yet, that coverage is also essential in times when our health is better and we need to be focused on preventing the next illness rather than just responding to it."

SOURCE: http://bit.ly/WddS8K JAMA 2016.

U.S. hospitals may be getting paid for more of the care they actually provide thanks to the Affordable Care Act, if research from Michigan reflects the situation around the country.

While the study didn't look directly at hospital finances, researchers found that the proportion of uninsured adults discharged from Michigan hospitals fell after public insurance options expanded in 2014.

"What we found is that the overwhelming majority of hospitals experienced a decrease in the proportion of uninsured patients and an increase in Medicaid covered patients," said lead author Dr. Matthew Davis, deputy director of Institute for Healthcare Policy and Innovation at the University of Michigan Health System in Ann Arbor.

Under the Affordable Care Act, also known as Obamacare, some U.S. states - including Michigan - expanded Medicaid, which is the joint federal and state insurance program for the poor.

Previous studies showed many people who gained health insurance through the law were previously uninsured, Davis told Reuters Health.

For the new study, he and his colleagues analyzed data on young adults discharged from 130 Michigan hospitals before and after Medicaid became more broadly available in 2014.

About 6 percent of young adults discharged at those hospitals between April and December before the Medicaid expansion were uninsured, compared to about 2 percent during those months in 2014, according to the findings scheduled for online publication June 21 in JAMA.

The proportion of discharged young adults on Medicaid rose from 23 percent in 2012 and 24 percent in 2013 to 30 percent in 2014.

There was a small decline in the number of people discharged with private or other insurance, they found.

The researchers were surprised at how uniform the impact of Medicaid expansion seemed to be in hospitals across Michigan, Davis said.

"This impact wasn't limited to urban areas or population centers, or safety net hospitals," he said.

According to Davis, past research shows that decreases in the number of uninsured patients are tied to decreases in healthcare that goes unpaid for.

"As we have more and more years of the Affordable Care Act that have provided expanded coverage for millions of Americans, it's going to be important to understand how that coverage translates into positive health," he said.

"Coverage through insurance plans and programs like Medicaid is most (needed) when our health is at its worst and we need to be hospitalized," he said. "Yet, that coverage is also essential in times when our health is better and we need to be focused on preventing the next illness rather than just responding to it."

SOURCE: http://bit.ly/WddS8K JAMA 2016.

Hospitalists face ever-increasing pressure to reduce drug expenditures without compromising the quality of care provided to patients, and as a consequence, are creating new ways to approach the issue. A recent study published in the American Journal of Medical Quality assessed the effectiveness of computerized provider order entry alerts as one method. The alerts displayed the cost of a high-cost medication alongside a lower-cost alternative.

“We regularly scrutinize our drug budgets and look for medications that display changing costs/utilization,” says Gregory K. Gipson, PharmD, cardiothoracic surgery and cardiology pharmacist at the University of Washington and lead author of “Optimizing Prescribing Practices of High-Cost Medications with Computerized Alerts in the Inpatient Setting.”

“We were able to identify a few medications that were both high in cost and utilization but had lower-cost alternatives that could be substituted in certain situations,” Dr. Gipson says. “These higher-cost medications also had formulary restrictions for use; however, it was felt that very few people knew about these restrictions or had any idea how much any of these medications cost. In an attempt to reduce unnecessary use of these high-cost medications, we created alerts that informed providers of the cost of both high- and low-cost medications and restrictions for use, and we gave them the ability to convert the order to the lower-cost alternative.”

The study looked specifically at three high-cost medications and their utilization during the year prior to the intervention and compared it to usage in the year after implementation, and it found reduced utilization of high-cost medications.

“Ipratropium hydrofluoroalkane and fluticasone hydrofluoroalkane metered dose inhaler utilization were reduced by 29% and 62%, respectively (P

Overall, they saw this as a success. “This type of interruptive electronic order entry alert containing cost information and therapeutic alternatives is an effective educational tool that reduces medication costs,” Dr. Gipson says. “… This suggests that new computerized alerts can be implemented in thoughtful ways to minimize the interference with hospital workflow and alert fatigue yet still achieve their desired outcome.”

Reference

1. Gipson G, Kelly JL, McKinney CM, White AA. Optimizing prescribing practices of high-cost medications with computerized alerts in the inpatient setting. Am J Med Qual. doi:10.1177/1062860616649660.

Quick Byte

Telehealth Expansion

In 2014, reimbursements for telehealth accounted for less than $14 million out of the more than $600 billion spent through the Medicare program, according to “Integrating Health Care and Housing to Promote Healthy Aging,” a recent Health Affairs blog. But, the authors suggest, the Centers for Medicare & Medicaid Services and state Medicaid programs should encourage greater reimbursement of telehealth and other technologies that have the potential to improve health outcomes and reduce costs, especially for seniors who could remain at home. “The shift away from fee-for-service payment toward value-based delivery and payment models represents a key opportunity for broader integration of telehealth,” according to the post.

Reference

1. Schwartz A, Parekh A. Integrating health care and housing to promote healthy aging. Health Aff. Available at: http://healthaffairs.org/blog/2016/05/23/integrating-health-care-and-housing-to-promote-healthy-aging/. Accessed May 31, 2016.

Hospitalists face ever-increasing pressure to reduce drug expenditures without compromising the quality of care provided to patients, and as a consequence, are creating new ways to approach the issue. A recent study published in the American Journal of Medical Quality assessed the effectiveness of computerized provider order entry alerts as one method. The alerts displayed the cost of a high-cost medication alongside a lower-cost alternative.

“We regularly scrutinize our drug budgets and look for medications that display changing costs/utilization,” says Gregory K. Gipson, PharmD, cardiothoracic surgery and cardiology pharmacist at the University of Washington and lead author of “Optimizing Prescribing Practices of High-Cost Medications with Computerized Alerts in the Inpatient Setting.”

“We were able to identify a few medications that were both high in cost and utilization but had lower-cost alternatives that could be substituted in certain situations,” Dr. Gipson says. “These higher-cost medications also had formulary restrictions for use; however, it was felt that very few people knew about these restrictions or had any idea how much any of these medications cost. In an attempt to reduce unnecessary use of these high-cost medications, we created alerts that informed providers of the cost of both high- and low-cost medications and restrictions for use, and we gave them the ability to convert the order to the lower-cost alternative.”

The study looked specifically at three high-cost medications and their utilization during the year prior to the intervention and compared it to usage in the year after implementation, and it found reduced utilization of high-cost medications.

“Ipratropium hydrofluoroalkane and fluticasone hydrofluoroalkane metered dose inhaler utilization were reduced by 29% and 62%, respectively (P

Overall, they saw this as a success. “This type of interruptive electronic order entry alert containing cost information and therapeutic alternatives is an effective educational tool that reduces medication costs,” Dr. Gipson says. “… This suggests that new computerized alerts can be implemented in thoughtful ways to minimize the interference with hospital workflow and alert fatigue yet still achieve their desired outcome.”

Reference

1. Gipson G, Kelly JL, McKinney CM, White AA. Optimizing prescribing practices of high-cost medications with computerized alerts in the inpatient setting. Am J Med Qual. doi:10.1177/1062860616649660.

Quick Byte

Telehealth Expansion

In 2014, reimbursements for telehealth accounted for less than $14 million out of the more than $600 billion spent through the Medicare program, according to “Integrating Health Care and Housing to Promote Healthy Aging,” a recent Health Affairs blog. But, the authors suggest, the Centers for Medicare & Medicaid Services and state Medicaid programs should encourage greater reimbursement of telehealth and other technologies that have the potential to improve health outcomes and reduce costs, especially for seniors who could remain at home. “The shift away from fee-for-service payment toward value-based delivery and payment models represents a key opportunity for broader integration of telehealth,” according to the post.

Reference

1. Schwartz A, Parekh A. Integrating health care and housing to promote healthy aging. Health Aff. Available at: http://healthaffairs.org/blog/2016/05/23/integrating-health-care-and-housing-to-promote-healthy-aging/. Accessed May 31, 2016.

Hospitalists face ever-increasing pressure to reduce drug expenditures without compromising the quality of care provided to patients, and as a consequence, are creating new ways to approach the issue. A recent study published in the American Journal of Medical Quality assessed the effectiveness of computerized provider order entry alerts as one method. The alerts displayed the cost of a high-cost medication alongside a lower-cost alternative.

“We regularly scrutinize our drug budgets and look for medications that display changing costs/utilization,” says Gregory K. Gipson, PharmD, cardiothoracic surgery and cardiology pharmacist at the University of Washington and lead author of “Optimizing Prescribing Practices of High-Cost Medications with Computerized Alerts in the Inpatient Setting.”

“We were able to identify a few medications that were both high in cost and utilization but had lower-cost alternatives that could be substituted in certain situations,” Dr. Gipson says. “These higher-cost medications also had formulary restrictions for use; however, it was felt that very few people knew about these restrictions or had any idea how much any of these medications cost. In an attempt to reduce unnecessary use of these high-cost medications, we created alerts that informed providers of the cost of both high- and low-cost medications and restrictions for use, and we gave them the ability to convert the order to the lower-cost alternative.”

The study looked specifically at three high-cost medications and their utilization during the year prior to the intervention and compared it to usage in the year after implementation, and it found reduced utilization of high-cost medications.

“Ipratropium hydrofluoroalkane and fluticasone hydrofluoroalkane metered dose inhaler utilization were reduced by 29% and 62%, respectively (P

Overall, they saw this as a success. “This type of interruptive electronic order entry alert containing cost information and therapeutic alternatives is an effective educational tool that reduces medication costs,” Dr. Gipson says. “… This suggests that new computerized alerts can be implemented in thoughtful ways to minimize the interference with hospital workflow and alert fatigue yet still achieve their desired outcome.”

Reference

1. Gipson G, Kelly JL, McKinney CM, White AA. Optimizing prescribing practices of high-cost medications with computerized alerts in the inpatient setting. Am J Med Qual. doi:10.1177/1062860616649660.

Quick Byte

Telehealth Expansion

In 2014, reimbursements for telehealth accounted for less than $14 million out of the more than $600 billion spent through the Medicare program, according to “Integrating Health Care and Housing to Promote Healthy Aging,” a recent Health Affairs blog. But, the authors suggest, the Centers for Medicare & Medicaid Services and state Medicaid programs should encourage greater reimbursement of telehealth and other technologies that have the potential to improve health outcomes and reduce costs, especially for seniors who could remain at home. “The shift away from fee-for-service payment toward value-based delivery and payment models represents a key opportunity for broader integration of telehealth,” according to the post.

Reference

1. Schwartz A, Parekh A. Integrating health care and housing to promote healthy aging. Health Aff. Available at: http://healthaffairs.org/blog/2016/05/23/integrating-health-care-and-housing-to-promote-healthy-aging/. Accessed May 31, 2016.

“I recently discharged a complex patient from the hospital, and I was shocked to see the poor quality of his clinical summary,” says Erin Sarzynski, MD, MS, of Michigan State University’s Department of Family Medicine. This observation drove the research underlying the paper she co-wrote titled “Opportunities to Improve Clinical Summaries for Patients at Hospital Discharge,” published in BMJ Quality & Safety.

The problem, the paper lays out, is that, “presently, it is unclear whether clinical summaries include relevant content or whether healthcare organizations configure their EHRs to generate content in a way that promotes patient self-management after hospital discharge.”

As a first step toward improving these documents, Dr. Sarzynski worked with a team to evaluate 100 clinical summaries generated at two Michigan hospitals based on content, organization, and understandability. They became aware of systemic problems.

“Clinical summaries are produced from templates, but physicians’ workflows do not prompt them to preview the document before the nurse prints it to review with the patient,” Dr. Sarzynski says. “Clinical summaries are lengthy yet omit key discharge information. They are poorly organized, written at the 8th- to 12th-grade reading level, and score poorly on assessments of understandability and actionability.

“Medication lists illustrate a key safety issue resulting from poor-quality clinical summaries; for example, we routinely send patients home without parameters for sliding-scale insulin.”

The study highlights opportunities to improve clinical summaries for guiding patients’ post-discharge care.

“We developed an audit tool based on the Meaningful Use view-download-transmit objective and the SHM Discharge Checklist (content); the Institute of Medicine recommendations for distributing easy-to-understand print material (organization); and five readability formulas and the Patient Education Materials Assessment Tool,” the authors write.

“If possible, hospitalists should preview their patients’ clinical summaries before printing—it’s an opportunity to ensure key discharge information is correct and appropriately emphasized,” Dr. Sarzynski says.

Reference

1. Sarzynski E, Hashmi H, Subramanian J, et al. Opportunities to improve clinical summaries for patients at hospital discharge. BMJ Qual Saf. doi:10.1136/bmjqs-2015-005201.

“I recently discharged a complex patient from the hospital, and I was shocked to see the poor quality of his clinical summary,” says Erin Sarzynski, MD, MS, of Michigan State University’s Department of Family Medicine. This observation drove the research underlying the paper she co-wrote titled “Opportunities to Improve Clinical Summaries for Patients at Hospital Discharge,” published in BMJ Quality & Safety.

The problem, the paper lays out, is that, “presently, it is unclear whether clinical summaries include relevant content or whether healthcare organizations configure their EHRs to generate content in a way that promotes patient self-management after hospital discharge.”

As a first step toward improving these documents, Dr. Sarzynski worked with a team to evaluate 100 clinical summaries generated at two Michigan hospitals based on content, organization, and understandability. They became aware of systemic problems.

“Clinical summaries are produced from templates, but physicians’ workflows do not prompt them to preview the document before the nurse prints it to review with the patient,” Dr. Sarzynski says. “Clinical summaries are lengthy yet omit key discharge information. They are poorly organized, written at the 8th- to 12th-grade reading level, and score poorly on assessments of understandability and actionability.

“Medication lists illustrate a key safety issue resulting from poor-quality clinical summaries; for example, we routinely send patients home without parameters for sliding-scale insulin.”

The study highlights opportunities to improve clinical summaries for guiding patients’ post-discharge care.

“We developed an audit tool based on the Meaningful Use view-download-transmit objective and the SHM Discharge Checklist (content); the Institute of Medicine recommendations for distributing easy-to-understand print material (organization); and five readability formulas and the Patient Education Materials Assessment Tool,” the authors write.

“If possible, hospitalists should preview their patients’ clinical summaries before printing—it’s an opportunity to ensure key discharge information is correct and appropriately emphasized,” Dr. Sarzynski says.

Reference

1. Sarzynski E, Hashmi H, Subramanian J, et al. Opportunities to improve clinical summaries for patients at hospital discharge. BMJ Qual Saf. doi:10.1136/bmjqs-2015-005201.

“I recently discharged a complex patient from the hospital, and I was shocked to see the poor quality of his clinical summary,” says Erin Sarzynski, MD, MS, of Michigan State University’s Department of Family Medicine. This observation drove the research underlying the paper she co-wrote titled “Opportunities to Improve Clinical Summaries for Patients at Hospital Discharge,” published in BMJ Quality & Safety.

The problem, the paper lays out, is that, “presently, it is unclear whether clinical summaries include relevant content or whether healthcare organizations configure their EHRs to generate content in a way that promotes patient self-management after hospital discharge.”

As a first step toward improving these documents, Dr. Sarzynski worked with a team to evaluate 100 clinical summaries generated at two Michigan hospitals based on content, organization, and understandability. They became aware of systemic problems.

“Clinical summaries are produced from templates, but physicians’ workflows do not prompt them to preview the document before the nurse prints it to review with the patient,” Dr. Sarzynski says. “Clinical summaries are lengthy yet omit key discharge information. They are poorly organized, written at the 8th- to 12th-grade reading level, and score poorly on assessments of understandability and actionability.

“Medication lists illustrate a key safety issue resulting from poor-quality clinical summaries; for example, we routinely send patients home without parameters for sliding-scale insulin.”

The study highlights opportunities to improve clinical summaries for guiding patients’ post-discharge care.

“We developed an audit tool based on the Meaningful Use view-download-transmit objective and the SHM Discharge Checklist (content); the Institute of Medicine recommendations for distributing easy-to-understand print material (organization); and five readability formulas and the Patient Education Materials Assessment Tool,” the authors write.

“If possible, hospitalists should preview their patients’ clinical summaries before printing—it’s an opportunity to ensure key discharge information is correct and appropriately emphasized,” Dr. Sarzynski says.

Reference

1. Sarzynski E, Hashmi H, Subramanian J, et al. Opportunities to improve clinical summaries for patients at hospital discharge. BMJ Qual Saf. doi:10.1136/bmjqs-2015-005201.

Ofatumumab (Arzerra)

Photo courtesy of GSK

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended against expanding the approved indication for ofatumumab (Arzerra).

Novartis, which is developing ofatumumab in cooperation with Genmab, had submitted an application requesting that ofatumumab be authorized as maintenance therapy for patients with relapsed chronic lymphocytic leukemia (CLL).

But the CHMP has advised the European Commission (EC) not to grant this authorization.

The CHMP noted that, in the phase 3 PROLONG trial, ofatumumab maintenance improved progression-free survival (PFS) in CLL patients.

However, the committee said the importance of this improvement is not clear because the PFS results were not supported by other measures, such as overall survival or a significant improvement in patients’ quality of life.

The CHMP also said the use of ofatumumab for maintenance treatment should be seen in the context of its side effects. Common side effects of ofatumumab in the PROLONG trial were infusion reactions, neutropenia, and upper respiratory tract infections.

In the end, the CHMP decided that the PROLONG data were not sufficient to conclude that maintenance treatment with ofatumumab is of more benefit than no treatment. So the committee recommended against expanding the drug’s marketing authorization.

This decision does not have any impact on ongoing clinical trials with ofatumumab.

About ofatumumab

Ofatumumab has been authorized for use in the European Union since April 2010.

The EC first granted ofatumumab conditional approval to treat CLL patients who are refractory to fludarabine and alemtuzumab.

Then, in 2014, the EC granted ofatumumab conditional approval for use in combination with chlorambucil or bendamustine in CLL patients who have not received prior therapy and are not eligible for fludarabine-based therapy.

Ofatumumab received conditional approval because the drug’s benefits appear to outweigh the risks it poses in the aforementioned indications. Ofatumumab will not receive full approval until the drug’s developers submit results of additional research to the EC.

About the PROLONG trial

The PROLONG trial was designed to compare ofatumumab maintenance to no further treatment in patients with a complete or partial response after second- or third-line treatment for CLL. Interim results of the study were presented at ASH 2014.

These results—in 474 patients—suggested that ofatumumab can significantly improve PFS. The median PFS was about 29 months in patients who received ofatumumab and about 15 months for patients who did not receive maintenance therapy (P<0.0001).

There was no significant difference in the median overall survival, which was not reached in either treatment arm.

The researchers said there were no unexpected safety findings. The most common adverse events (≥10%) were infusion reactions, neutropenia, and upper respiratory tract infection.

Ofatumumab (Arzerra)

Photo courtesy of GSK

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended against expanding the approved indication for ofatumumab (Arzerra).

Novartis, which is developing ofatumumab in cooperation with Genmab, had submitted an application requesting that ofatumumab be authorized as maintenance therapy for patients with relapsed chronic lymphocytic leukemia (CLL).

But the CHMP has advised the European Commission (EC) not to grant this authorization.

The CHMP noted that, in the phase 3 PROLONG trial, ofatumumab maintenance improved progression-free survival (PFS) in CLL patients.

However, the committee said the importance of this improvement is not clear because the PFS results were not supported by other measures, such as overall survival or a significant improvement in patients’ quality of life.

The CHMP also said the use of ofatumumab for maintenance treatment should be seen in the context of its side effects. Common side effects of ofatumumab in the PROLONG trial were infusion reactions, neutropenia, and upper respiratory tract infections.

In the end, the CHMP decided that the PROLONG data were not sufficient to conclude that maintenance treatment with ofatumumab is of more benefit than no treatment. So the committee recommended against expanding the drug’s marketing authorization.

This decision does not have any impact on ongoing clinical trials with ofatumumab.

About ofatumumab

Ofatumumab has been authorized for use in the European Union since April 2010.

The EC first granted ofatumumab conditional approval to treat CLL patients who are refractory to fludarabine and alemtuzumab.

Then, in 2014, the EC granted ofatumumab conditional approval for use in combination with chlorambucil or bendamustine in CLL patients who have not received prior therapy and are not eligible for fludarabine-based therapy.

Ofatumumab received conditional approval because the drug’s benefits appear to outweigh the risks it poses in the aforementioned indications. Ofatumumab will not receive full approval until the drug’s developers submit results of additional research to the EC.

About the PROLONG trial

The PROLONG trial was designed to compare ofatumumab maintenance to no further treatment in patients with a complete or partial response after second- or third-line treatment for CLL. Interim results of the study were presented at ASH 2014.

These results—in 474 patients—suggested that ofatumumab can significantly improve PFS. The median PFS was about 29 months in patients who received ofatumumab and about 15 months for patients who did not receive maintenance therapy (P<0.0001).

There was no significant difference in the median overall survival, which was not reached in either treatment arm.

The researchers said there were no unexpected safety findings. The most common adverse events (≥10%) were infusion reactions, neutropenia, and upper respiratory tract infection.

Ofatumumab (Arzerra)

Photo courtesy of GSK

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended against expanding the approved indication for ofatumumab (Arzerra).

Novartis, which is developing ofatumumab in cooperation with Genmab, had submitted an application requesting that ofatumumab be authorized as maintenance therapy for patients with relapsed chronic lymphocytic leukemia (CLL).

But the CHMP has advised the European Commission (EC) not to grant this authorization.

The CHMP noted that, in the phase 3 PROLONG trial, ofatumumab maintenance improved progression-free survival (PFS) in CLL patients.

However, the committee said the importance of this improvement is not clear because the PFS results were not supported by other measures, such as overall survival or a significant improvement in patients’ quality of life.

The CHMP also said the use of ofatumumab for maintenance treatment should be seen in the context of its side effects. Common side effects of ofatumumab in the PROLONG trial were infusion reactions, neutropenia, and upper respiratory tract infections.

In the end, the CHMP decided that the PROLONG data were not sufficient to conclude that maintenance treatment with ofatumumab is of more benefit than no treatment. So the committee recommended against expanding the drug’s marketing authorization.

This decision does not have any impact on ongoing clinical trials with ofatumumab.

About ofatumumab

Ofatumumab has been authorized for use in the European Union since April 2010.

The EC first granted ofatumumab conditional approval to treat CLL patients who are refractory to fludarabine and alemtuzumab.

Then, in 2014, the EC granted ofatumumab conditional approval for use in combination with chlorambucil or bendamustine in CLL patients who have not received prior therapy and are not eligible for fludarabine-based therapy.

Ofatumumab received conditional approval because the drug’s benefits appear to outweigh the risks it poses in the aforementioned indications. Ofatumumab will not receive full approval until the drug’s developers submit results of additional research to the EC.

About the PROLONG trial

The PROLONG trial was designed to compare ofatumumab maintenance to no further treatment in patients with a complete or partial response after second- or third-line treatment for CLL. Interim results of the study were presented at ASH 2014.

These results—in 474 patients—suggested that ofatumumab can significantly improve PFS. The median PFS was about 29 months in patients who received ofatumumab and about 15 months for patients who did not receive maintenance therapy (P<0.0001).

There was no significant difference in the median overall survival, which was not reached in either treatment arm.

The researchers said there were no unexpected safety findings. The most common adverse events (≥10%) were infusion reactions, neutropenia, and upper respiratory tract infection.

SAN DIEGO – Endoscopic and laparoscopic drainage worked about equally well for pancreatic pseudocysts and walled off necrosis in a small randomized trial from India, the first to compare the two options.

Both are in common use, but until now it wasn’t clear if one was better than the other. The findings mean that “in general, one could do either; the choice of treatment depends [largely] on the expertise available. As an endoscopist, I prefer endoscopic drainage,” said gastroenterologist Pramod Garg, of the All India Institute of Medical Sciences, New Delhi.

Laparoscopic drainage was a technical success in 23 of the 30 patients (76.6%) randomized to it, six of whom (20%) had symptomatic pseudocysts larger than 6 cm for more than 6 weeks; the rest had walled off necrosis (WON) containing less than 30% necrotic debris. Five of the other patients were converted to open surgery, and two underwent percutaneous drainage. One of the 30 patients required endoscopic lavage and necrosectomy for secondary infection.

Endoscopic drainage, meanwhile, was technically successful in 22 of 30 patients (73.3%) with similar distributions of pseudocysts and WON. Most of the other patients needed subsequent endoscopic lavage and necrosectomy for secondary infection.

Clinical success – defined as resolution by week 4 – was 100% in the laparoscopic and 97% (29/30) in the endoscopic groups; one endoscopic patient had a splenic artery pseudoaneurysm that required further surgery. The differences in technical and clinical success rates were not statistically significant. There were no recurrences and no deaths in either group after an average follow-up of 22 months.

Although it seems okay to opt for either approach, “it’s very important for us to assess the amount of necrotic debris. If the amount is sizable, say 50% or more of the volume, one should hesitate before doing purely endoscopic drainage.” As seen in the study, “the chances of developing an infection are pretty high, especially if,” like the investigators, “you place only a plastic stent,” Dr. Garg said at the annual Digestive Disease Week.

Laparoscopic drainage would probably be better when there’s a lot of necrotic tissue, and certainly so if patients need their gallbladder removed, because it can be taken out at the same time. If endoscopy is still the choice, “you should be prepared to do repeat procedures for endoscopic lavage and necrosectomy. The chance of infection may be less if you use a metal stent with a wide diameter,” Dr. Garg said. Before tackling WON with endoscopy, he suggested getting input from a radiologist and surgeon.

Laparoscopic cystogastrostomy was done in the usual manner, with an endostapler to create a wide cystogastrostomy, necrotic debris suction, and concomitant cholecystectomies as needed.

Endoscopic drainage was performed under endosonographic guidance in the 13 patients without bulging cysts, and directly in the 17 patients whose cysts bulged. A balloon was used to dilate the cystogastrostomy tract to 12-15 mm, and a 10 F double pigtail plastic stent placed to keep it open.

Patients in both groups received perioperative antibiotics. The demographic, clinical, and laboratory parameters and etiology of acute pancreatitis were comparable between the two groups. Patients tended to be in their mid-30s, and about 75% in both groups were women. Over a third in each group had gallstone disease. The median hospital stay in both groups was about a week. Fever was more common following endoscopic drainage, probably because of the higher incidence of secondary infection.

Patients with complicated pseudocysts, coagulopathies, or organ failure were excluded from the investigation, as well as those otherwise unfit for surgery.

There was no industry funding for the work, and Dr. Garg had no disclosures.

aotto@frontlinemedcom.com

SAN DIEGO – Endoscopic and laparoscopic drainage worked about equally well for pancreatic pseudocysts and walled off necrosis in a small randomized trial from India, the first to compare the two options.

Both are in common use, but until now it wasn’t clear if one was better than the other. The findings mean that “in general, one could do either; the choice of treatment depends [largely] on the expertise available. As an endoscopist, I prefer endoscopic drainage,” said gastroenterologist Pramod Garg, of the All India Institute of Medical Sciences, New Delhi.

Laparoscopic drainage was a technical success in 23 of the 30 patients (76.6%) randomized to it, six of whom (20%) had symptomatic pseudocysts larger than 6 cm for more than 6 weeks; the rest had walled off necrosis (WON) containing less than 30% necrotic debris. Five of the other patients were converted to open surgery, and two underwent percutaneous drainage. One of the 30 patients required endoscopic lavage and necrosectomy for secondary infection.

Endoscopic drainage, meanwhile, was technically successful in 22 of 30 patients (73.3%) with similar distributions of pseudocysts and WON. Most of the other patients needed subsequent endoscopic lavage and necrosectomy for secondary infection.

Clinical success – defined as resolution by week 4 – was 100% in the laparoscopic and 97% (29/30) in the endoscopic groups; one endoscopic patient had a splenic artery pseudoaneurysm that required further surgery. The differences in technical and clinical success rates were not statistically significant. There were no recurrences and no deaths in either group after an average follow-up of 22 months.

Although it seems okay to opt for either approach, “it’s very important for us to assess the amount of necrotic debris. If the amount is sizable, say 50% or more of the volume, one should hesitate before doing purely endoscopic drainage.” As seen in the study, “the chances of developing an infection are pretty high, especially if,” like the investigators, “you place only a plastic stent,” Dr. Garg said at the annual Digestive Disease Week.

Laparoscopic drainage would probably be better when there’s a lot of necrotic tissue, and certainly so if patients need their gallbladder removed, because it can be taken out at the same time. If endoscopy is still the choice, “you should be prepared to do repeat procedures for endoscopic lavage and necrosectomy. The chance of infection may be less if you use a metal stent with a wide diameter,” Dr. Garg said. Before tackling WON with endoscopy, he suggested getting input from a radiologist and surgeon.

Laparoscopic cystogastrostomy was done in the usual manner, with an endostapler to create a wide cystogastrostomy, necrotic debris suction, and concomitant cholecystectomies as needed.

Endoscopic drainage was performed under endosonographic guidance in the 13 patients without bulging cysts, and directly in the 17 patients whose cysts bulged. A balloon was used to dilate the cystogastrostomy tract to 12-15 mm, and a 10 F double pigtail plastic stent placed to keep it open.

Patients in both groups received perioperative antibiotics. The demographic, clinical, and laboratory parameters and etiology of acute pancreatitis were comparable between the two groups. Patients tended to be in their mid-30s, and about 75% in both groups were women. Over a third in each group had gallstone disease. The median hospital stay in both groups was about a week. Fever was more common following endoscopic drainage, probably because of the higher incidence of secondary infection.

Patients with complicated pseudocysts, coagulopathies, or organ failure were excluded from the investigation, as well as those otherwise unfit for surgery.

There was no industry funding for the work, and Dr. Garg had no disclosures.

aotto@frontlinemedcom.com

SAN DIEGO – Endoscopic and laparoscopic drainage worked about equally well for pancreatic pseudocysts and walled off necrosis in a small randomized trial from India, the first to compare the two options.

Both are in common use, but until now it wasn’t clear if one was better than the other. The findings mean that “in general, one could do either; the choice of treatment depends [largely] on the expertise available. As an endoscopist, I prefer endoscopic drainage,” said gastroenterologist Pramod Garg, of the All India Institute of Medical Sciences, New Delhi.

Laparoscopic drainage was a technical success in 23 of the 30 patients (76.6%) randomized to it, six of whom (20%) had symptomatic pseudocysts larger than 6 cm for more than 6 weeks; the rest had walled off necrosis (WON) containing less than 30% necrotic debris. Five of the other patients were converted to open surgery, and two underwent percutaneous drainage. One of the 30 patients required endoscopic lavage and necrosectomy for secondary infection.

Endoscopic drainage, meanwhile, was technically successful in 22 of 30 patients (73.3%) with similar distributions of pseudocysts and WON. Most of the other patients needed subsequent endoscopic lavage and necrosectomy for secondary infection.

Clinical success – defined as resolution by week 4 – was 100% in the laparoscopic and 97% (29/30) in the endoscopic groups; one endoscopic patient had a splenic artery pseudoaneurysm that required further surgery. The differences in technical and clinical success rates were not statistically significant. There were no recurrences and no deaths in either group after an average follow-up of 22 months.

Although it seems okay to opt for either approach, “it’s very important for us to assess the amount of necrotic debris. If the amount is sizable, say 50% or more of the volume, one should hesitate before doing purely endoscopic drainage.” As seen in the study, “the chances of developing an infection are pretty high, especially if,” like the investigators, “you place only a plastic stent,” Dr. Garg said at the annual Digestive Disease Week.

Laparoscopic drainage would probably be better when there’s a lot of necrotic tissue, and certainly so if patients need their gallbladder removed, because it can be taken out at the same time. If endoscopy is still the choice, “you should be prepared to do repeat procedures for endoscopic lavage and necrosectomy. The chance of infection may be less if you use a metal stent with a wide diameter,” Dr. Garg said. Before tackling WON with endoscopy, he suggested getting input from a radiologist and surgeon.

Laparoscopic cystogastrostomy was done in the usual manner, with an endostapler to create a wide cystogastrostomy, necrotic debris suction, and concomitant cholecystectomies as needed.

Endoscopic drainage was performed under endosonographic guidance in the 13 patients without bulging cysts, and directly in the 17 patients whose cysts bulged. A balloon was used to dilate the cystogastrostomy tract to 12-15 mm, and a 10 F double pigtail plastic stent placed to keep it open.

Patients in both groups received perioperative antibiotics. The demographic, clinical, and laboratory parameters and etiology of acute pancreatitis were comparable between the two groups. Patients tended to be in their mid-30s, and about 75% in both groups were women. Over a third in each group had gallstone disease. The median hospital stay in both groups was about a week. Fever was more common following endoscopic drainage, probably because of the higher incidence of secondary infection.

Patients with complicated pseudocysts, coagulopathies, or organ failure were excluded from the investigation, as well as those otherwise unfit for surgery.

There was no industry funding for the work, and Dr. Garg had no disclosures.

aotto@frontlinemedcom.com

LONDON – Patients with psoriatic arthritis appear less likely to achieve a good response to their first anti–tumor necrosis factor (anti-TNF) therapy if they are obese, according to data taken from two Nordic registries.

In a large observational cohort study, obese individuals with psoriatic arthritis (PsA) were significantly less likely than their nonobese counterparts to achieve a European League Against Rheumatism (EULAR) good or moderate response at 6 months (55% vs. 65%, P = .02). The overall odds ratio for achieving a good or moderate response was 0.47 when comparing obese with nonobese individuals.

James Heilman, MD/Wikimedia Commons/CC BY-SA 3.0

The findings are potentially important because, with the exception of infliximab, anti-TNF therapy is not currently adjusted according to body weight, said presenting study author Pil Højgaard in an interview at the European Congress of Rheumatology.

Ms. Højgaard, who is an M.D. Ph.D. student at the department of rheumatology, Copenhagen University Hospital Gentofte, Rigshospitalet and the Parker Institute in Copenhagen, noted that obesity was a frequent comorbid condition in patients with PsA and that it is a known proinflammatory condition. As such, obesity could potentially affect immunologic processes, the pharmacokinetics of treatments, and ultimately patient outcomes.

Since TNF-alpha inhibitor (TNFi) treatment fails in around half of all patients with PsA treated in routine care, Ms. Højgaard noted that the aim of the cohort study was to investigate whether obesity could be having any influence on this.

Data on baseline characteristics, EULAR response rates, and drug adherence were obtained for 1,943 patients with PsA prescribed their anti-TNF therapy from two nationwide registries of disease-modifying therapies being used to treat rheumatic conditions in Denmark and Iceland, DANBIO (Rheumatology. 2011;50:69–77) and ICEBIO, respectively.

At baseline, body mass index (BMI) data were available for 1,271 patients and 408 (32%) of these had a BMI of 30 kg/m² or more and were classed as being obese. The majority (39%) had received a first prescription for adalimumab, with around a quarter each prescribed etanercept (26%) or infliximab (24%), and the remainder prescribed golimumab (7%) and certolizumab (4%).

Compared to the 863 (68%) nonobese individuals, the obese patients were older (47 vs. 49 years, P = .01), less likely to smoke (30% vs. 23%, P = .01), and had higher disease activity measured on the Disease Activity Score 28 (DAS28) (4.4 vs. 4.6, P = .01). Health Assessment Questionnaire scores were also higher in obese than in nonobese individuals (1.1 vs. 0.9, P less than .01), and there were higher tender joint counts (6 vs. 5, P = .01), and higher pain levels assessed on a visual analog scale (VAS). Obese patients also had higher scores on a VAS patient global scale. The median follow-up time was 1.5 years.

Patients who were obese were found to adhere to TNFi treatment for shorter periods of time than nonobese patients, with median durations of 1.76 and 3.08 years, respectively (P less than .001). This discrepancy was most pronounced among men, a finding that may account for the fact that they were less likely to achieve a good EULAR response than their nonobese counterparts (OR = 0.5).

Being obese versus not being obese independently predicted TNFi withdrawal overall (hazard ratio, 1.6), especially in men (HR, 1.8; HR, 1.5 in women). TNFi withdrawal was more likely in obese than in nonobese patients even when individual treatments were considered; adalimumab: HR, 1.6; etanercept: HR, 2.0; infliximab: HR, 1.6.

An association between obesity and reduced response to anti-TNF therapy has also been observed in patients with rheumatoid arthritis, Ms. Højgaard acknowledged. There have also been a few studies of PsA and psoriasis “but to my knowledge, I think in the field of psoriatic arthritis, we are one of the few that have been looking at long-time drug survival,” she said. “We also include quite a lot of patients.”

“Of course this is not a randomized clinical study, so there could be residual confounding factors,” Ms. Højgaard cautioned. “It is always a bit difficult to say something about causality when it is a database study,” she added. “I think what we can see here is that there is an association, but in order to recommend weight loss we need some prospective studies.”

She noted that there was one published clinical study (Ann Rheum Dis. 2014;73:1157–62) that had looked at the benefit of a weight reduction program started at the same time as TNFi initiation in patients with PsA. This found there was a benefit of weight loss on response to TNFis, regardless of the type of diet.

DANBIO is supported by unrestricted grants from Abbott, Pfizer, MSD, Bristol-Myers Squibb, Roche, and UCB-Nordic. The sponsors have had no influence on data collection, analysis, or publication. ICEBIO is part of the electronic medical record system held by the University of Reykjavik and receives no industrial funding. Ms. Højgaard has received speaking fees from Celgene and UCB not related to this work.

LONDON – Patients with psoriatic arthritis appear less likely to achieve a good response to their first anti–tumor necrosis factor (anti-TNF) therapy if they are obese, according to data taken from two Nordic registries.

In a large observational cohort study, obese individuals with psoriatic arthritis (PsA) were significantly less likely than their nonobese counterparts to achieve a European League Against Rheumatism (EULAR) good or moderate response at 6 months (55% vs. 65%, P = .02). The overall odds ratio for achieving a good or moderate response was 0.47 when comparing obese with nonobese individuals.

James Heilman, MD/Wikimedia Commons/CC BY-SA 3.0

The findings are potentially important because, with the exception of infliximab, anti-TNF therapy is not currently adjusted according to body weight, said presenting study author Pil Højgaard in an interview at the European Congress of Rheumatology.

Ms. Højgaard, who is an M.D. Ph.D. student at the department of rheumatology, Copenhagen University Hospital Gentofte, Rigshospitalet and the Parker Institute in Copenhagen, noted that obesity was a frequent comorbid condition in patients with PsA and that it is a known proinflammatory condition. As such, obesity could potentially affect immunologic processes, the pharmacokinetics of treatments, and ultimately patient outcomes.

Since TNF-alpha inhibitor (TNFi) treatment fails in around half of all patients with PsA treated in routine care, Ms. Højgaard noted that the aim of the cohort study was to investigate whether obesity could be having any influence on this.

Data on baseline characteristics, EULAR response rates, and drug adherence were obtained for 1,943 patients with PsA prescribed their anti-TNF therapy from two nationwide registries of disease-modifying therapies being used to treat rheumatic conditions in Denmark and Iceland, DANBIO (Rheumatology. 2011;50:69–77) and ICEBIO, respectively.

At baseline, body mass index (BMI) data were available for 1,271 patients and 408 (32%) of these had a BMI of 30 kg/m² or more and were classed as being obese. The majority (39%) had received a first prescription for adalimumab, with around a quarter each prescribed etanercept (26%) or infliximab (24%), and the remainder prescribed golimumab (7%) and certolizumab (4%).

Compared to the 863 (68%) nonobese individuals, the obese patients were older (47 vs. 49 years, P = .01), less likely to smoke (30% vs. 23%, P = .01), and had higher disease activity measured on the Disease Activity Score 28 (DAS28) (4.4 vs. 4.6, P = .01). Health Assessment Questionnaire scores were also higher in obese than in nonobese individuals (1.1 vs. 0.9, P less than .01), and there were higher tender joint counts (6 vs. 5, P = .01), and higher pain levels assessed on a visual analog scale (VAS). Obese patients also had higher scores on a VAS patient global scale. The median follow-up time was 1.5 years.

Patients who were obese were found to adhere to TNFi treatment for shorter periods of time than nonobese patients, with median durations of 1.76 and 3.08 years, respectively (P less than .001). This discrepancy was most pronounced among men, a finding that may account for the fact that they were less likely to achieve a good EULAR response than their nonobese counterparts (OR = 0.5).

Being obese versus not being obese independently predicted TNFi withdrawal overall (hazard ratio, 1.6), especially in men (HR, 1.8; HR, 1.5 in women). TNFi withdrawal was more likely in obese than in nonobese patients even when individual treatments were considered; adalimumab: HR, 1.6; etanercept: HR, 2.0; infliximab: HR, 1.6.

An association between obesity and reduced response to anti-TNF therapy has also been observed in patients with rheumatoid arthritis, Ms. Højgaard acknowledged. There have also been a few studies of PsA and psoriasis “but to my knowledge, I think in the field of psoriatic arthritis, we are one of the few that have been looking at long-time drug survival,” she said. “We also include quite a lot of patients.”

“Of course this is not a randomized clinical study, so there could be residual confounding factors,” Ms. Højgaard cautioned. “It is always a bit difficult to say something about causality when it is a database study,” she added. “I think what we can see here is that there is an association, but in order to recommend weight loss we need some prospective studies.”

She noted that there was one published clinical study (Ann Rheum Dis. 2014;73:1157–62) that had looked at the benefit of a weight reduction program started at the same time as TNFi initiation in patients with PsA. This found there was a benefit of weight loss on response to TNFis, regardless of the type of diet.

DANBIO is supported by unrestricted grants from Abbott, Pfizer, MSD, Bristol-Myers Squibb, Roche, and UCB-Nordic. The sponsors have had no influence on data collection, analysis, or publication. ICEBIO is part of the electronic medical record system held by the University of Reykjavik and receives no industrial funding. Ms. Højgaard has received speaking fees from Celgene and UCB not related to this work.

LONDON – Patients with psoriatic arthritis appear less likely to achieve a good response to their first anti–tumor necrosis factor (anti-TNF) therapy if they are obese, according to data taken from two Nordic registries.

In a large observational cohort study, obese individuals with psoriatic arthritis (PsA) were significantly less likely than their nonobese counterparts to achieve a European League Against Rheumatism (EULAR) good or moderate response at 6 months (55% vs. 65%, P = .02). The overall odds ratio for achieving a good or moderate response was 0.47 when comparing obese with nonobese individuals.

James Heilman, MD/Wikimedia Commons/CC BY-SA 3.0

The findings are potentially important because, with the exception of infliximab, anti-TNF therapy is not currently adjusted according to body weight, said presenting study author Pil Højgaard in an interview at the European Congress of Rheumatology.

Ms. Højgaard, who is an M.D. Ph.D. student at the department of rheumatology, Copenhagen University Hospital Gentofte, Rigshospitalet and the Parker Institute in Copenhagen, noted that obesity was a frequent comorbid condition in patients with PsA and that it is a known proinflammatory condition. As such, obesity could potentially affect immunologic processes, the pharmacokinetics of treatments, and ultimately patient outcomes.

Since TNF-alpha inhibitor (TNFi) treatment fails in around half of all patients with PsA treated in routine care, Ms. Højgaard noted that the aim of the cohort study was to investigate whether obesity could be having any influence on this.

Data on baseline characteristics, EULAR response rates, and drug adherence were obtained for 1,943 patients with PsA prescribed their anti-TNF therapy from two nationwide registries of disease-modifying therapies being used to treat rheumatic conditions in Denmark and Iceland, DANBIO (Rheumatology. 2011;50:69–77) and ICEBIO, respectively.

At baseline, body mass index (BMI) data were available for 1,271 patients and 408 (32%) of these had a BMI of 30 kg/m² or more and were classed as being obese. The majority (39%) had received a first prescription for adalimumab, with around a quarter each prescribed etanercept (26%) or infliximab (24%), and the remainder prescribed golimumab (7%) and certolizumab (4%).

Compared to the 863 (68%) nonobese individuals, the obese patients were older (47 vs. 49 years, P = .01), less likely to smoke (30% vs. 23%, P = .01), and had higher disease activity measured on the Disease Activity Score 28 (DAS28) (4.4 vs. 4.6, P = .01). Health Assessment Questionnaire scores were also higher in obese than in nonobese individuals (1.1 vs. 0.9, P less than .01), and there were higher tender joint counts (6 vs. 5, P = .01), and higher pain levels assessed on a visual analog scale (VAS). Obese patients also had higher scores on a VAS patient global scale. The median follow-up time was 1.5 years.

Patients who were obese were found to adhere to TNFi treatment for shorter periods of time than nonobese patients, with median durations of 1.76 and 3.08 years, respectively (P less than .001). This discrepancy was most pronounced among men, a finding that may account for the fact that they were less likely to achieve a good EULAR response than their nonobese counterparts (OR = 0.5).

Being obese versus not being obese independently predicted TNFi withdrawal overall (hazard ratio, 1.6), especially in men (HR, 1.8; HR, 1.5 in women). TNFi withdrawal was more likely in obese than in nonobese patients even when individual treatments were considered; adalimumab: HR, 1.6; etanercept: HR, 2.0; infliximab: HR, 1.6.

An association between obesity and reduced response to anti-TNF therapy has also been observed in patients with rheumatoid arthritis, Ms. Højgaard acknowledged. There have also been a few studies of PsA and psoriasis “but to my knowledge, I think in the field of psoriatic arthritis, we are one of the few that have been looking at long-time drug survival,” she said. “We also include quite a lot of patients.”

“Of course this is not a randomized clinical study, so there could be residual confounding factors,” Ms. Højgaard cautioned. “It is always a bit difficult to say something about causality when it is a database study,” she added. “I think what we can see here is that there is an association, but in order to recommend weight loss we need some prospective studies.”

She noted that there was one published clinical study (Ann Rheum Dis. 2014;73:1157–62) that had looked at the benefit of a weight reduction program started at the same time as TNFi initiation in patients with PsA. This found there was a benefit of weight loss on response to TNFis, regardless of the type of diet.

DANBIO is supported by unrestricted grants from Abbott, Pfizer, MSD, Bristol-Myers Squibb, Roche, and UCB-Nordic. The sponsors have had no influence on data collection, analysis, or publication. ICEBIO is part of the electronic medical record system held by the University of Reykjavik and receives no industrial funding. Ms. Højgaard has received speaking fees from Celgene and UCB not related to this work.