Susan London

NEW ORLEANS – Patients undergoing coronary artery bypass graft (CABG) surgery do not see any 5-year survival advantage when their surgeon uses both internal mammary (thoracic) arteries for grafting rather than just one of them along with a vein, finds an interim analysis from the randomized Arterial Revascularization Trial (ART).

Overall, about 8.5% of the 3,102 patients randomized had died 5 years after surgery, with no significant difference between the bilateral graft and single graft groups, according to data reported at the American Heart Association scientific sessions and simultaneously published (N Engl J Med. 2016 Nov 14. doi: 10.1056/NEJMoa1610021). The former had roughly triple the rate of sternal reconstruction, mainly driven by complications in insulin-dependent diabetes patients having high body mass index.

Pointed questions

The lack of difference was possibly due to a very high level of guideline-based medical therapy in the trial (which may have especially protected the vein grafts) or to the fact that the annual failure rate of vein grafts is modest and steady up to 5 years but accelerates thereafter, Dr. Taggart proposed. The trial’s primary outcome of 10-year survival, expected in 2018, will likely differ, speculated Dr. Sellke, who is also program chair for the AHA scientific sessions.

“Do you think multiple arterial grafting is superior to single internal mammary artery grafting considering the lack of improvement in survival and other outcomes in the study, with the increase in sternal wound infections?” he asked.

“I personally, if I needed the operation, would insist on having bilateral internal mammary artery grafts done by an experienced operator because it is totally counterintuitive to believe that having more patent grafts in your heart at 10 to 20 years of follow-up is of no benefit,” Dr. Taggart maintained.

When data meet clinical practice

It may require time for the benefit of the bilateral artery graft to emerge, he agreed. “I’m undeterred from my belief that ... in patients who are getting CABG done in their 40s or 50s or early 60s, betting on a graft that’s going to outperform vein grafts is the better strategy.”

Until the trial’s 10-year results become available, physicians may wish to put these interim results in the context when counseling patients, according to Dr. Gardner.

“We have indisputable evidence that arterial grafts have better long-term patency than vein grafts,” he elaborated. “If we had a very sophisticated patient, we might tell them that we were a little surprised that this head-to-head trial of single versus double didn’t show any survival benefit at 5 years, but we still are persuaded by the data that shows the better patency, and we think in the situation that the patient’s in, that we would still recommend a double mammary, assuming that the patient doesn’t have comorbidities that would make that more dangerous.”

Trial details

ART enrolled patients from 28 cardiac surgical centers in seven countries. The patients, all of whom had multivessel coronary disease and were scheduled to undergo CABG, were randomized evenly to single or bilateral internal thoracic artery grafts.

The interim results showed differences in nonadherence to the randomized operation: 2.4% of patients in the single graft group ultimately underwent got bilateral grafts, whereas 14% of patients in the bilateral graft group ultimately got a single graft.

“This raises questions about how experienced some surgeons were with the use of bilateral internal mammary artery grafts,” Dr. Taggart commented.

At 5 years of follow-up, 8.7% of patients in the bilateral graft group and 8.4% of patients in the single graft group had died, a nonsignificant difference. “Those mortalities are similar to what has been observed in other contemporary trials of CABG,” he noted. There was no difference between diabetic and nondiabetic patients with respect to this outcome.

The rate of the composite outcome of death, myocardial infarction, or stroke was 12.2% in the bilateral graft group and 12.7% in the single graft group, also a nonsignificant difference.

On the other hand, patients in the bilateral graft group had higher rates of sternal wound complications (3.5% vs. 1.9%; P = .005) and sternal reconstruction (1.9% vs. 0.6%; P = .002).

The groups were statistically indistinguishable with respect to rates of mortality, major bleeding, or need for repeat revascularization, as well as angina status and quality of life measures, according to Dr. Taggart, who disclosed that he had no relevant conflicts of interest.

NEW ORLEANS – Patients undergoing coronary artery bypass graft (CABG) surgery do not see any 5-year survival advantage when their surgeon uses both internal mammary (thoracic) arteries for grafting rather than just one of them along with a vein, finds an interim analysis from the randomized Arterial Revascularization Trial (ART).

Overall, about 8.5% of the 3,102 patients randomized had died 5 years after surgery, with no significant difference between the bilateral graft and single graft groups, according to data reported at the American Heart Association scientific sessions and simultaneously published (N Engl J Med. 2016 Nov 14. doi: 10.1056/NEJMoa1610021). The former had roughly triple the rate of sternal reconstruction, mainly driven by complications in insulin-dependent diabetes patients having high body mass index.

Pointed questions

The lack of difference was possibly due to a very high level of guideline-based medical therapy in the trial (which may have especially protected the vein grafts) or to the fact that the annual failure rate of vein grafts is modest and steady up to 5 years but accelerates thereafter, Dr. Taggart proposed. The trial’s primary outcome of 10-year survival, expected in 2018, will likely differ, speculated Dr. Sellke, who is also program chair for the AHA scientific sessions.

“Do you think multiple arterial grafting is superior to single internal mammary artery grafting considering the lack of improvement in survival and other outcomes in the study, with the increase in sternal wound infections?” he asked.

“I personally, if I needed the operation, would insist on having bilateral internal mammary artery grafts done by an experienced operator because it is totally counterintuitive to believe that having more patent grafts in your heart at 10 to 20 years of follow-up is of no benefit,” Dr. Taggart maintained.

When data meet clinical practice

It may require time for the benefit of the bilateral artery graft to emerge, he agreed. “I’m undeterred from my belief that ... in patients who are getting CABG done in their 40s or 50s or early 60s, betting on a graft that’s going to outperform vein grafts is the better strategy.”

Until the trial’s 10-year results become available, physicians may wish to put these interim results in the context when counseling patients, according to Dr. Gardner.

“We have indisputable evidence that arterial grafts have better long-term patency than vein grafts,” he elaborated. “If we had a very sophisticated patient, we might tell them that we were a little surprised that this head-to-head trial of single versus double didn’t show any survival benefit at 5 years, but we still are persuaded by the data that shows the better patency, and we think in the situation that the patient’s in, that we would still recommend a double mammary, assuming that the patient doesn’t have comorbidities that would make that more dangerous.”

Trial details

ART enrolled patients from 28 cardiac surgical centers in seven countries. The patients, all of whom had multivessel coronary disease and were scheduled to undergo CABG, were randomized evenly to single or bilateral internal thoracic artery grafts.

The interim results showed differences in nonadherence to the randomized operation: 2.4% of patients in the single graft group ultimately underwent got bilateral grafts, whereas 14% of patients in the bilateral graft group ultimately got a single graft.

“This raises questions about how experienced some surgeons were with the use of bilateral internal mammary artery grafts,” Dr. Taggart commented.

At 5 years of follow-up, 8.7% of patients in the bilateral graft group and 8.4% of patients in the single graft group had died, a nonsignificant difference. “Those mortalities are similar to what has been observed in other contemporary trials of CABG,” he noted. There was no difference between diabetic and nondiabetic patients with respect to this outcome.

The rate of the composite outcome of death, myocardial infarction, or stroke was 12.2% in the bilateral graft group and 12.7% in the single graft group, also a nonsignificant difference.

On the other hand, patients in the bilateral graft group had higher rates of sternal wound complications (3.5% vs. 1.9%; P = .005) and sternal reconstruction (1.9% vs. 0.6%; P = .002).

The groups were statistically indistinguishable with respect to rates of mortality, major bleeding, or need for repeat revascularization, as well as angina status and quality of life measures, according to Dr. Taggart, who disclosed that he had no relevant conflicts of interest.

NEW ORLEANS – Patients undergoing coronary artery bypass graft (CABG) surgery do not see any 5-year survival advantage when their surgeon uses both internal mammary (thoracic) arteries for grafting rather than just one of them along with a vein, finds an interim analysis from the randomized Arterial Revascularization Trial (ART).

Overall, about 8.5% of the 3,102 patients randomized had died 5 years after surgery, with no significant difference between the bilateral graft and single graft groups, according to data reported at the American Heart Association scientific sessions and simultaneously published (N Engl J Med. 2016 Nov 14. doi: 10.1056/NEJMoa1610021). The former had roughly triple the rate of sternal reconstruction, mainly driven by complications in insulin-dependent diabetes patients having high body mass index.

Pointed questions

The lack of difference was possibly due to a very high level of guideline-based medical therapy in the trial (which may have especially protected the vein grafts) or to the fact that the annual failure rate of vein grafts is modest and steady up to 5 years but accelerates thereafter, Dr. Taggart proposed. The trial’s primary outcome of 10-year survival, expected in 2018, will likely differ, speculated Dr. Sellke, who is also program chair for the AHA scientific sessions.

“Do you think multiple arterial grafting is superior to single internal mammary artery grafting considering the lack of improvement in survival and other outcomes in the study, with the increase in sternal wound infections?” he asked.

“I personally, if I needed the operation, would insist on having bilateral internal mammary artery grafts done by an experienced operator because it is totally counterintuitive to believe that having more patent grafts in your heart at 10 to 20 years of follow-up is of no benefit,” Dr. Taggart maintained.

When data meet clinical practice

It may require time for the benefit of the bilateral artery graft to emerge, he agreed. “I’m undeterred from my belief that ... in patients who are getting CABG done in their 40s or 50s or early 60s, betting on a graft that’s going to outperform vein grafts is the better strategy.”

Until the trial’s 10-year results become available, physicians may wish to put these interim results in the context when counseling patients, according to Dr. Gardner.

“We have indisputable evidence that arterial grafts have better long-term patency than vein grafts,” he elaborated. “If we had a very sophisticated patient, we might tell them that we were a little surprised that this head-to-head trial of single versus double didn’t show any survival benefit at 5 years, but we still are persuaded by the data that shows the better patency, and we think in the situation that the patient’s in, that we would still recommend a double mammary, assuming that the patient doesn’t have comorbidities that would make that more dangerous.”

Trial details

ART enrolled patients from 28 cardiac surgical centers in seven countries. The patients, all of whom had multivessel coronary disease and were scheduled to undergo CABG, were randomized evenly to single or bilateral internal thoracic artery grafts.

The interim results showed differences in nonadherence to the randomized operation: 2.4% of patients in the single graft group ultimately underwent got bilateral grafts, whereas 14% of patients in the bilateral graft group ultimately got a single graft.

“This raises questions about how experienced some surgeons were with the use of bilateral internal mammary artery grafts,” Dr. Taggart commented.

At 5 years of follow-up, 8.7% of patients in the bilateral graft group and 8.4% of patients in the single graft group had died, a nonsignificant difference. “Those mortalities are similar to what has been observed in other contemporary trials of CABG,” he noted. There was no difference between diabetic and nondiabetic patients with respect to this outcome.

The rate of the composite outcome of death, myocardial infarction, or stroke was 12.2% in the bilateral graft group and 12.7% in the single graft group, also a nonsignificant difference.

On the other hand, patients in the bilateral graft group had higher rates of sternal wound complications (3.5% vs. 1.9%; P = .005) and sternal reconstruction (1.9% vs. 0.6%; P = .002).

The groups were statistically indistinguishable with respect to rates of mortality, major bleeding, or need for repeat revascularization, as well as angina status and quality of life measures, according to Dr. Taggart, who disclosed that he had no relevant conflicts of interest.

NEW ORLEANS – The cardiovascular safety profile of the nonsteroidal anti-inflammatory drug (NSAID) celecoxib, a selective inhibitor of COX-2, is no worse than those of the nonselective NSAIDs naproxen and ibuprofen, according to a trial reported at the American Heart Association scientific sessions.

The trial, known as PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety vs Ibuprofen Or Naproxen) was undertaken after another selective COX-2 inhibitor, rofecoxib (Vioxx), was withdrawn from the market because of associated cardiovascular events. It compared the three drugs among more than 24,000 patients with painful arthritis and elevated cardiovascular risk.
Main results showed that 2%-3% of patients experienced a cardiovascular event (cardiovascular death, myocardial infarction, or stroke) during a follow-up approaching 3 years, regardless of which drug they were assigned to take, with the slight differences falling within predefined margins for noninferiority of celecoxib, investigators reported in a session and related press conference.

Additionally, celecoxib yielded a lower rate of gastrointestinal events when compared with each of the other drugs and a lower rate of renal events when compared with ibuprofen.

“After the withdrawal of rofecoxib, everybody thought they knew the answer, that COX-2 inhibitors had an unfavorable cardiovascular profile,” commented first author Steven E. Nissen, MD, chair of cardiovascular medicine at the Cleveland Clinic in Ohio. “We didn’t find that. And this is the type of study that once again teaches us that if we jump to conclusions about this based on mechanistic considerations, we often make very bad decisions.”

A cautionary view

“The investigators addressed an extremely important question, which is what is the cardiovascular safety of agents that we administer for a general medical condition over the long term,” commented invited discussant Elliott M. Antman, MD, a senior physician at Brigham and Women’s Hospital and associate dean for Clinical and Translational Research at Harvard Medical School in Boston. “We don’t see a lot of trials like that, but we do need this information.”

Trial details

Patients were eligible for PRECISION, a Pfizer-funded trial, if they had osteoarthritis or rheumatoid arthritis and were at increased cardiovascular risk.

In all, 24,081 patients from 926 centers globally were randomly assigned to double-blind treatment with celecoxib, naproxen, or ibuprofen, all of which are now available as generics in the United States.

“Patients were randomized to the FDA-approved doses of these drugs, and they could have their dose increased if they had unrelieved pain up to the maximum allowed by regulatory authorities in the local jurisdictions where the study was done,” Dr. Nissen noted, pointing out that studies initially generating some concern about celecoxib used a supratherapeutic dose of 800 mg daily.

As COX-2 inhibitors are less likely than nonselective NSAIDs to cause ulcers, which might affect compliance and outcomes, all patients additionally received esomeprazole for gastroprotection “to try to level the playing field,” he explained.

The mean treatment duration was 20.3 months, and the mean follow-up duration was 34.1 months, according to data reported at the meeting and simultaneously published (N Engl J Med. 2016 Nov 13. doi: 10.1056/NEJMoa1611593). On average, the daily dose of drug received was 209 mg for celecoxib, 852 mg for naproxen, and 2,045 mg for ibuprofen.

In intention-to-treat analyses, the rate of the primary composite outcome of cardiovascular death (including hemorrhagic death), nonfatal myocardial infarction, or nonfatal stroke was 2.3% in the celecoxib group, 2.5% in the naproxen group, and 2.7% in the ibuprofen group. The hazard ratio was 0.93 for celecoxib versus naproxen (P less than .001 for noninferiority) and 0.85 for celecoxib versus ibuprofen (P less than .001 for noninferiority).

Differences were more marked in the on-treatment population. Here, the rate of the primary outcome was 1.7% in the celecoxib group, 1.8% in the naproxen group, and 1.9% in the ibuprofen group. The HR was 0.90 for celecoxib versus naproxen (P less than .001 for noninferiority) and 0.81 for celecoxib versus ibuprofen (P less than .001 for noninferiority).

Secondary outcomes, which tested for superiority, showed that the rate of major adverse cardiovascular events was 15% higher in the ibuprofen group as compared with the celecoxib group in the intent-to-treat population. The difference translated to a near-significant reduction in risk with the latter (HR, 0.87; P = .06) that appeared greater in the on-treatment population.

However, Dr. Nissen cautioned that he could not state that celecoxib was superior. “Secondary and tertiary endpoints in a clinical trial are hypothesis generating, and they are not considered definitive evidence,” he commented. At the same time, “the FDA is going to have to deal with that because what do they do with labeling? What do they do with over-the-counter access to these various drugs?”

The rate of all-cause mortality was 25% higher with naproxen than with celecoxib (HR, 0.80; P = .052).

The rate of gastrointestinal events was 54% higher with ibuprofen (HR, 0.65; P = .002) and 41% higher with naproxen (HR, 0.71; P = .01) as compared with celecoxib. And the rate of renal events was 64% higher with ibuprofen than with celecoxib (HR, 0.61; P = .004).

In a post hoc analysis of global safety, the rate of serious cardiovascular, gastrointestinal, and renal events was 28% higher with ibuprofen (HR, 0.78; P less than .001) and 15% higher with naproxen (HR, 0.87; P = .03) than with celecoxib.

Of note, the findings for the primary endpoint were similar regardless of whether patients were taking low-dose aspirin or not. “There was no interaction with aspirin use,” Dr. Nissen stated. “This was not about the interference of ibuprofen or naproxen with aspirin use.”

Analyses of pain relief using a visual analogue scale showed no clinically meaningful differences, suggesting that the drug doses used were equally analgesic, he said. Stopping of study drug because of lack of efficacy was slightly more common in the celecoxib group.

“We didn’t study the low-dose, intermittent use of these drugs that most of the public engages in, and it’s really important that we crisply communicate that to the public because somebody who takes occasionally ibuprofen or naproxen for a headache should not look at these comparative data in a way that should necessarily influence their behavior. We just don’t know the answer,” cautioned Dr. Nissen, who disclosed that he received grant support from Pfizer during the conduct of the trial.

But the findings are relevant for individuals who take over-the-counter NSAIDs at doses exceeding the label, a phenomenon known as dose creep. “We need to reemphasize to the public that the labeled over-the-counter dose is what you should take. You shouldn’t double up or triple up on the drugs because the issue of high-dose therapy, which is what we studied, suggests that there are really potentially important gastrointestinal, renal, and cardiovascular risks,” he said.

NEW ORLEANS – The cardiovascular safety profile of the nonsteroidal anti-inflammatory drug (NSAID) celecoxib, a selective inhibitor of COX-2, is no worse than those of the nonselective NSAIDs naproxen and ibuprofen, according to a trial reported at the American Heart Association scientific sessions.

The trial, known as PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety vs Ibuprofen Or Naproxen) was undertaken after another selective COX-2 inhibitor, rofecoxib (Vioxx), was withdrawn from the market because of associated cardiovascular events. It compared the three drugs among more than 24,000 patients with painful arthritis and elevated cardiovascular risk.
Main results showed that 2%-3% of patients experienced a cardiovascular event (cardiovascular death, myocardial infarction, or stroke) during a follow-up approaching 3 years, regardless of which drug they were assigned to take, with the slight differences falling within predefined margins for noninferiority of celecoxib, investigators reported in a session and related press conference.

Additionally, celecoxib yielded a lower rate of gastrointestinal events when compared with each of the other drugs and a lower rate of renal events when compared with ibuprofen.

“After the withdrawal of rofecoxib, everybody thought they knew the answer, that COX-2 inhibitors had an unfavorable cardiovascular profile,” commented first author Steven E. Nissen, MD, chair of cardiovascular medicine at the Cleveland Clinic in Ohio. “We didn’t find that. And this is the type of study that once again teaches us that if we jump to conclusions about this based on mechanistic considerations, we often make very bad decisions.”

A cautionary view

“The investigators addressed an extremely important question, which is what is the cardiovascular safety of agents that we administer for a general medical condition over the long term,” commented invited discussant Elliott M. Antman, MD, a senior physician at Brigham and Women’s Hospital and associate dean for Clinical and Translational Research at Harvard Medical School in Boston. “We don’t see a lot of trials like that, but we do need this information.”

Trial details

Patients were eligible for PRECISION, a Pfizer-funded trial, if they had osteoarthritis or rheumatoid arthritis and were at increased cardiovascular risk.

In all, 24,081 patients from 926 centers globally were randomly assigned to double-blind treatment with celecoxib, naproxen, or ibuprofen, all of which are now available as generics in the United States.

“Patients were randomized to the FDA-approved doses of these drugs, and they could have their dose increased if they had unrelieved pain up to the maximum allowed by regulatory authorities in the local jurisdictions where the study was done,” Dr. Nissen noted, pointing out that studies initially generating some concern about celecoxib used a supratherapeutic dose of 800 mg daily.

As COX-2 inhibitors are less likely than nonselective NSAIDs to cause ulcers, which might affect compliance and outcomes, all patients additionally received esomeprazole for gastroprotection “to try to level the playing field,” he explained.

The mean treatment duration was 20.3 months, and the mean follow-up duration was 34.1 months, according to data reported at the meeting and simultaneously published (N Engl J Med. 2016 Nov 13. doi: 10.1056/NEJMoa1611593). On average, the daily dose of drug received was 209 mg for celecoxib, 852 mg for naproxen, and 2,045 mg for ibuprofen.

In intention-to-treat analyses, the rate of the primary composite outcome of cardiovascular death (including hemorrhagic death), nonfatal myocardial infarction, or nonfatal stroke was 2.3% in the celecoxib group, 2.5% in the naproxen group, and 2.7% in the ibuprofen group. The hazard ratio was 0.93 for celecoxib versus naproxen (P less than .001 for noninferiority) and 0.85 for celecoxib versus ibuprofen (P less than .001 for noninferiority).

Differences were more marked in the on-treatment population. Here, the rate of the primary outcome was 1.7% in the celecoxib group, 1.8% in the naproxen group, and 1.9% in the ibuprofen group. The HR was 0.90 for celecoxib versus naproxen (P less than .001 for noninferiority) and 0.81 for celecoxib versus ibuprofen (P less than .001 for noninferiority).

Secondary outcomes, which tested for superiority, showed that the rate of major adverse cardiovascular events was 15% higher in the ibuprofen group as compared with the celecoxib group in the intent-to-treat population. The difference translated to a near-significant reduction in risk with the latter (HR, 0.87; P = .06) that appeared greater in the on-treatment population.

However, Dr. Nissen cautioned that he could not state that celecoxib was superior. “Secondary and tertiary endpoints in a clinical trial are hypothesis generating, and they are not considered definitive evidence,” he commented. At the same time, “the FDA is going to have to deal with that because what do they do with labeling? What do they do with over-the-counter access to these various drugs?”

The rate of all-cause mortality was 25% higher with naproxen than with celecoxib (HR, 0.80; P = .052).

The rate of gastrointestinal events was 54% higher with ibuprofen (HR, 0.65; P = .002) and 41% higher with naproxen (HR, 0.71; P = .01) as compared with celecoxib. And the rate of renal events was 64% higher with ibuprofen than with celecoxib (HR, 0.61; P = .004).

In a post hoc analysis of global safety, the rate of serious cardiovascular, gastrointestinal, and renal events was 28% higher with ibuprofen (HR, 0.78; P less than .001) and 15% higher with naproxen (HR, 0.87; P = .03) than with celecoxib.

Of note, the findings for the primary endpoint were similar regardless of whether patients were taking low-dose aspirin or not. “There was no interaction with aspirin use,” Dr. Nissen stated. “This was not about the interference of ibuprofen or naproxen with aspirin use.”

Analyses of pain relief using a visual analogue scale showed no clinically meaningful differences, suggesting that the drug doses used were equally analgesic, he said. Stopping of study drug because of lack of efficacy was slightly more common in the celecoxib group.

“We didn’t study the low-dose, intermittent use of these drugs that most of the public engages in, and it’s really important that we crisply communicate that to the public because somebody who takes occasionally ibuprofen or naproxen for a headache should not look at these comparative data in a way that should necessarily influence their behavior. We just don’t know the answer,” cautioned Dr. Nissen, who disclosed that he received grant support from Pfizer during the conduct of the trial.

But the findings are relevant for individuals who take over-the-counter NSAIDs at doses exceeding the label, a phenomenon known as dose creep. “We need to reemphasize to the public that the labeled over-the-counter dose is what you should take. You shouldn’t double up or triple up on the drugs because the issue of high-dose therapy, which is what we studied, suggests that there are really potentially important gastrointestinal, renal, and cardiovascular risks,” he said.

NEW ORLEANS – The cardiovascular safety profile of the nonsteroidal anti-inflammatory drug (NSAID) celecoxib, a selective inhibitor of COX-2, is no worse than those of the nonselective NSAIDs naproxen and ibuprofen, according to a trial reported at the American Heart Association scientific sessions.

The trial, known as PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety vs Ibuprofen Or Naproxen) was undertaken after another selective COX-2 inhibitor, rofecoxib (Vioxx), was withdrawn from the market because of associated cardiovascular events. It compared the three drugs among more than 24,000 patients with painful arthritis and elevated cardiovascular risk.
Main results showed that 2%-3% of patients experienced a cardiovascular event (cardiovascular death, myocardial infarction, or stroke) during a follow-up approaching 3 years, regardless of which drug they were assigned to take, with the slight differences falling within predefined margins for noninferiority of celecoxib, investigators reported in a session and related press conference.

Additionally, celecoxib yielded a lower rate of gastrointestinal events when compared with each of the other drugs and a lower rate of renal events when compared with ibuprofen.

“After the withdrawal of rofecoxib, everybody thought they knew the answer, that COX-2 inhibitors had an unfavorable cardiovascular profile,” commented first author Steven E. Nissen, MD, chair of cardiovascular medicine at the Cleveland Clinic in Ohio. “We didn’t find that. And this is the type of study that once again teaches us that if we jump to conclusions about this based on mechanistic considerations, we often make very bad decisions.”

A cautionary view

“The investigators addressed an extremely important question, which is what is the cardiovascular safety of agents that we administer for a general medical condition over the long term,” commented invited discussant Elliott M. Antman, MD, a senior physician at Brigham and Women’s Hospital and associate dean for Clinical and Translational Research at Harvard Medical School in Boston. “We don’t see a lot of trials like that, but we do need this information.”

Trial details

Patients were eligible for PRECISION, a Pfizer-funded trial, if they had osteoarthritis or rheumatoid arthritis and were at increased cardiovascular risk.

In all, 24,081 patients from 926 centers globally were randomly assigned to double-blind treatment with celecoxib, naproxen, or ibuprofen, all of which are now available as generics in the United States.

“Patients were randomized to the FDA-approved doses of these drugs, and they could have their dose increased if they had unrelieved pain up to the maximum allowed by regulatory authorities in the local jurisdictions where the study was done,” Dr. Nissen noted, pointing out that studies initially generating some concern about celecoxib used a supratherapeutic dose of 800 mg daily.

As COX-2 inhibitors are less likely than nonselective NSAIDs to cause ulcers, which might affect compliance and outcomes, all patients additionally received esomeprazole for gastroprotection “to try to level the playing field,” he explained.

The mean treatment duration was 20.3 months, and the mean follow-up duration was 34.1 months, according to data reported at the meeting and simultaneously published (N Engl J Med. 2016 Nov 13. doi: 10.1056/NEJMoa1611593). On average, the daily dose of drug received was 209 mg for celecoxib, 852 mg for naproxen, and 2,045 mg for ibuprofen.

In intention-to-treat analyses, the rate of the primary composite outcome of cardiovascular death (including hemorrhagic death), nonfatal myocardial infarction, or nonfatal stroke was 2.3% in the celecoxib group, 2.5% in the naproxen group, and 2.7% in the ibuprofen group. The hazard ratio was 0.93 for celecoxib versus naproxen (P less than .001 for noninferiority) and 0.85 for celecoxib versus ibuprofen (P less than .001 for noninferiority).

Differences were more marked in the on-treatment population. Here, the rate of the primary outcome was 1.7% in the celecoxib group, 1.8% in the naproxen group, and 1.9% in the ibuprofen group. The HR was 0.90 for celecoxib versus naproxen (P less than .001 for noninferiority) and 0.81 for celecoxib versus ibuprofen (P less than .001 for noninferiority).

Secondary outcomes, which tested for superiority, showed that the rate of major adverse cardiovascular events was 15% higher in the ibuprofen group as compared with the celecoxib group in the intent-to-treat population. The difference translated to a near-significant reduction in risk with the latter (HR, 0.87; P = .06) that appeared greater in the on-treatment population.

However, Dr. Nissen cautioned that he could not state that celecoxib was superior. “Secondary and tertiary endpoints in a clinical trial are hypothesis generating, and they are not considered definitive evidence,” he commented. At the same time, “the FDA is going to have to deal with that because what do they do with labeling? What do they do with over-the-counter access to these various drugs?”

The rate of all-cause mortality was 25% higher with naproxen than with celecoxib (HR, 0.80; P = .052).

The rate of gastrointestinal events was 54% higher with ibuprofen (HR, 0.65; P = .002) and 41% higher with naproxen (HR, 0.71; P = .01) as compared with celecoxib. And the rate of renal events was 64% higher with ibuprofen than with celecoxib (HR, 0.61; P = .004).

In a post hoc analysis of global safety, the rate of serious cardiovascular, gastrointestinal, and renal events was 28% higher with ibuprofen (HR, 0.78; P less than .001) and 15% higher with naproxen (HR, 0.87; P = .03) than with celecoxib.

Of note, the findings for the primary endpoint were similar regardless of whether patients were taking low-dose aspirin or not. “There was no interaction with aspirin use,” Dr. Nissen stated. “This was not about the interference of ibuprofen or naproxen with aspirin use.”

Analyses of pain relief using a visual analogue scale showed no clinically meaningful differences, suggesting that the drug doses used were equally analgesic, he said. Stopping of study drug because of lack of efficacy was slightly more common in the celecoxib group.

“We didn’t study the low-dose, intermittent use of these drugs that most of the public engages in, and it’s really important that we crisply communicate that to the public because somebody who takes occasionally ibuprofen or naproxen for a headache should not look at these comparative data in a way that should necessarily influence their behavior. We just don’t know the answer,” cautioned Dr. Nissen, who disclosed that he received grant support from Pfizer during the conduct of the trial.

But the findings are relevant for individuals who take over-the-counter NSAIDs at doses exceeding the label, a phenomenon known as dose creep. “We need to reemphasize to the public that the labeled over-the-counter dose is what you should take. You shouldn’t double up or triple up on the drugs because the issue of high-dose therapy, which is what we studied, suggests that there are really potentially important gastrointestinal, renal, and cardiovascular risks,” he said.

SAN FRANCISCO – Clinicians are likely to encounter diverse feeding problems in daily practice that will challenge their diagnostic and treatment acumen, Dr. Irene Chatoor told attendees of the annual meeting of the American Academy of Pediatrics.

These problems run the gamut from the most prevalent but least serious picky eating, to the least prevalent but most serious feeding disorders, she noted. Correspondingly, management will range from simple reassurance of parents to more intensive behavioral and medical interventions.

Assessment

“When you assess a feeding problem, you have to look at both the mother and father, and the child,” she advised. The parents are evaluated for their feeding style, while the child is evaluated for three feeding problems: limited appetite, selective intake, and fear of feeding (Pediatrics. 2015;135[2]:344-53).

Clinicians must be alert for organic red flags, such as dysphagia, aspiration, and vomiting, and for behavioral red flags, such as food fixation, abrupt cessation of feeding after a trigger event, and anticipatory gagging. An overarching red flag is failure to thrive.

Sometimes, a child will have both an organic condition and a behavioral feeding disorder at the same time. “It’s very important that you don’t think one excludes the other,” she cautioned.

Diagnosis

“To delineate milder feeding difficulties from feeding disorders, there must be some form of impairment caused by the feeding problem,” Dr. Chatoor commented. “Why is this important? For two reasons. One is for the insurance companies, because they don’t pay unless there is a disorder. And then there is research: you cannot do research unless you clearly define what you are studying.”

Children are considered to have impairment if they have weight loss or growth faltering, considerable nutritional deficiency, or a marked interference with psychosocial functioning.

“When we diagnose feeding problems, it is best done with a multidisciplinary team,” Dr. Chatoor maintained. “I have learned many years ago that I’m not effective in helping parents deal with the feeding disorder if they are still in the back of their mind worried that the child has something organically wrong and that’s why the child does not want to eat.”

Accordingly, various team members perform a medical examination, a nutritional assessment, an oral motor and sensory evaluation, and a psychiatric or psychological assessment to identify the root cause or causes of the problem.

When it comes to behavioral etiologies, the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) now groups all feeding and eating disorders together in one section, reflecting the fact that disorders starting early in life can and often do track into adolescence and adulthood, according to Dr. Chatoor.

The manual also features a new diagnosis, avoidant/restrictive food intake disorder (ARFID). Key criteria include the presence of an eating or feeding disturbance that cannot be better explained by lack of available food, culturally sanctioned practices, or a concurrent medical condition or another mental disorder.

The child must have a persistent failure to meet appropriate nutritional and/or energy needs, associated with any of four findings: significant weight loss or failure to achieve expected weight gain or growth, significant nutritional deficiencies, dependence on enteral feeding or oral nutritional supplements, and marked interference with psychosocial functioning.

“You need to have at least one but often you have a combination of nutritional and emotional impairment in the same child,” she commented.

ARFID and its treatment

There are three subtypes of ARFID having different features, treatments, and prognosis, although they all share in common food refusal, according to Dr. Chatoor.

The first subtype – apparent lack of interest in eating or food – emerges by 3 years of age, most often during the transition to self-feeding between 9 and 18 months. Affected children refuse to eat an adequate amount of food for at least 1 month, rarely communicate hunger, lack interest in food, and prefer to play or talk. They typically present with growth deficiency.

“If you have a child who refuses to eat, it generates anxiety in the mother. The mother does things she would not normally do with the child who is eating well. She starts to distract, to cajole, to sometimes even force-feed the child,” Dr. Chatoor explained. “And the more she engages in these behaviors, the more resistant the child becomes. So they become trapped in this vicious cycle.”

Treatment is aimed at removing this conflict with three approaches: explaining to parents the infant’s special temperament (notably, high arousal and difficulty turning off excitement); addressing their background, including any eating issues of their own, and difficulty with setting limits; and providing specific feeding guidelines and a time-out procedure.

The guidelines stress regular feeding, withholding of all snacks, keeping the child at the table for 20 to 30 minutes, and not using any distractions or pressure. Also, importantly, the parents should have dinner with their child. “I always tell the parents what is good for the child is good for you. It’s good for your whole family,” she said. “If they have other children, these rules apply to everybody. Young children learn to eat by watching their parents eating.”

With early and consistent use of these interventions, about two-thirds of children outgrow this eating/feeding disturbance by mid-childhood, according to Dr. Chatoor.

Children with the second subtype of ARFID – avoidance based on the sensory characteristics of food – consistently refuse to eat certain foods having specific tastes, textures, temperatures, smells, and/or appearances. Onset occurs during the toddler years, when a new or different food is introduced.

“Not only do they refuse the same foods that were aversive, but they also generalize it. So these children are afraid to try other foods and they may end up limiting food groups – they don’t eat any vegetables and some of them don’t eat any meats,” she explained. “They are a challenge because this always causes a nutritional deficiency and they also have problems socially as they get older.”

Treatment varies by age, with gradual desensitization for infants and parent modeling of eating new foods for toddlers. A multifaceted approach is used for preschoolers, combining modeling, giving foods attractive shapes and names, having the child participate in food preparation, and using focused play therapy, such as feeding dolls who are “brave” and try new foods.

Clinicians can explain to affected school-aged children that they are “supertasters,” having more taste buds and therefore experiencing food more intensely, and that they can help their taste buds not react so strongly by starting to eat small amounts of new foods and gradually increasing over time. Parents can let the child make a list of 10 foods they would like to eat, and award them points for “courage” for every bite of a new food they try.

Prognosis of this type of ARFID varies, according to Dr. Chatoor. “Through gradual exposure, young children can expand the variety of foods they eat,” she elaborated. However, “some children become very rigid and brand sensitive in regard to the food they are willing to eat and begin to experience social problems during mid-childhood and adolescence. Some children grow up eating a limited diet, but finding ways to compensate nutritionally and socially.”

Children with the third subtype of ARFID – concern about aversive consequences of eating – have an acute onset of consistent food refusal at any age, from infancy onward, after experiencing a traumatic event or repeated traumatic insults to the oropharynx or gastrointestinal tract that trigger distress in the child. These children often have comorbidities such as gastroesophageal reflux, eosinophilic gastroenteritis, or anxiety disorder.

“Treatment involves gradual desensitization to feared objects: the highchair, bib, bottle, or spoon,” Dr. Chatoor explained. “It also involves training of the mother in behavioral techniques to feed the child in spite of the child’s fear and distress.”

Any underlying medical condition causing pain or distress should be treated. Additional measures may include, for example, use of a graduated approach, starting with liquids and progressing to purees, if the child fears solid foods, and prescribing anxiolytic medication in cases of severe anxiety.

Dr. Chatoor disclosed that she has lectured internationally at conferences on feeding disorders that were organized by Abbott Nutrition International and that the company provided a research grant for a study on feeding.

SAN FRANCISCO – Clinicians are likely to encounter diverse feeding problems in daily practice that will challenge their diagnostic and treatment acumen, Dr. Irene Chatoor told attendees of the annual meeting of the American Academy of Pediatrics.

These problems run the gamut from the most prevalent but least serious picky eating, to the least prevalent but most serious feeding disorders, she noted. Correspondingly, management will range from simple reassurance of parents to more intensive behavioral and medical interventions.

Assessment

“When you assess a feeding problem, you have to look at both the mother and father, and the child,” she advised. The parents are evaluated for their feeding style, while the child is evaluated for three feeding problems: limited appetite, selective intake, and fear of feeding (Pediatrics. 2015;135[2]:344-53).

Clinicians must be alert for organic red flags, such as dysphagia, aspiration, and vomiting, and for behavioral red flags, such as food fixation, abrupt cessation of feeding after a trigger event, and anticipatory gagging. An overarching red flag is failure to thrive.

Sometimes, a child will have both an organic condition and a behavioral feeding disorder at the same time. “It’s very important that you don’t think one excludes the other,” she cautioned.

Diagnosis

“To delineate milder feeding difficulties from feeding disorders, there must be some form of impairment caused by the feeding problem,” Dr. Chatoor commented. “Why is this important? For two reasons. One is for the insurance companies, because they don’t pay unless there is a disorder. And then there is research: you cannot do research unless you clearly define what you are studying.”

Children are considered to have impairment if they have weight loss or growth faltering, considerable nutritional deficiency, or a marked interference with psychosocial functioning.

“When we diagnose feeding problems, it is best done with a multidisciplinary team,” Dr. Chatoor maintained. “I have learned many years ago that I’m not effective in helping parents deal with the feeding disorder if they are still in the back of their mind worried that the child has something organically wrong and that’s why the child does not want to eat.”

Accordingly, various team members perform a medical examination, a nutritional assessment, an oral motor and sensory evaluation, and a psychiatric or psychological assessment to identify the root cause or causes of the problem.

When it comes to behavioral etiologies, the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) now groups all feeding and eating disorders together in one section, reflecting the fact that disorders starting early in life can and often do track into adolescence and adulthood, according to Dr. Chatoor.

The manual also features a new diagnosis, avoidant/restrictive food intake disorder (ARFID). Key criteria include the presence of an eating or feeding disturbance that cannot be better explained by lack of available food, culturally sanctioned practices, or a concurrent medical condition or another mental disorder.

The child must have a persistent failure to meet appropriate nutritional and/or energy needs, associated with any of four findings: significant weight loss or failure to achieve expected weight gain or growth, significant nutritional deficiencies, dependence on enteral feeding or oral nutritional supplements, and marked interference with psychosocial functioning.

“You need to have at least one but often you have a combination of nutritional and emotional impairment in the same child,” she commented.

ARFID and its treatment

There are three subtypes of ARFID having different features, treatments, and prognosis, although they all share in common food refusal, according to Dr. Chatoor.

The first subtype – apparent lack of interest in eating or food – emerges by 3 years of age, most often during the transition to self-feeding between 9 and 18 months. Affected children refuse to eat an adequate amount of food for at least 1 month, rarely communicate hunger, lack interest in food, and prefer to play or talk. They typically present with growth deficiency.

“If you have a child who refuses to eat, it generates anxiety in the mother. The mother does things she would not normally do with the child who is eating well. She starts to distract, to cajole, to sometimes even force-feed the child,” Dr. Chatoor explained. “And the more she engages in these behaviors, the more resistant the child becomes. So they become trapped in this vicious cycle.”

Treatment is aimed at removing this conflict with three approaches: explaining to parents the infant’s special temperament (notably, high arousal and difficulty turning off excitement); addressing their background, including any eating issues of their own, and difficulty with setting limits; and providing specific feeding guidelines and a time-out procedure.

The guidelines stress regular feeding, withholding of all snacks, keeping the child at the table for 20 to 30 minutes, and not using any distractions or pressure. Also, importantly, the parents should have dinner with their child. “I always tell the parents what is good for the child is good for you. It’s good for your whole family,” she said. “If they have other children, these rules apply to everybody. Young children learn to eat by watching their parents eating.”

With early and consistent use of these interventions, about two-thirds of children outgrow this eating/feeding disturbance by mid-childhood, according to Dr. Chatoor.

Children with the second subtype of ARFID – avoidance based on the sensory characteristics of food – consistently refuse to eat certain foods having specific tastes, textures, temperatures, smells, and/or appearances. Onset occurs during the toddler years, when a new or different food is introduced.

“Not only do they refuse the same foods that were aversive, but they also generalize it. So these children are afraid to try other foods and they may end up limiting food groups – they don’t eat any vegetables and some of them don’t eat any meats,” she explained. “They are a challenge because this always causes a nutritional deficiency and they also have problems socially as they get older.”

Treatment varies by age, with gradual desensitization for infants and parent modeling of eating new foods for toddlers. A multifaceted approach is used for preschoolers, combining modeling, giving foods attractive shapes and names, having the child participate in food preparation, and using focused play therapy, such as feeding dolls who are “brave” and try new foods.

Clinicians can explain to affected school-aged children that they are “supertasters,” having more taste buds and therefore experiencing food more intensely, and that they can help their taste buds not react so strongly by starting to eat small amounts of new foods and gradually increasing over time. Parents can let the child make a list of 10 foods they would like to eat, and award them points for “courage” for every bite of a new food they try.

Prognosis of this type of ARFID varies, according to Dr. Chatoor. “Through gradual exposure, young children can expand the variety of foods they eat,” she elaborated. However, “some children become very rigid and brand sensitive in regard to the food they are willing to eat and begin to experience social problems during mid-childhood and adolescence. Some children grow up eating a limited diet, but finding ways to compensate nutritionally and socially.”

Children with the third subtype of ARFID – concern about aversive consequences of eating – have an acute onset of consistent food refusal at any age, from infancy onward, after experiencing a traumatic event or repeated traumatic insults to the oropharynx or gastrointestinal tract that trigger distress in the child. These children often have comorbidities such as gastroesophageal reflux, eosinophilic gastroenteritis, or anxiety disorder.

“Treatment involves gradual desensitization to feared objects: the highchair, bib, bottle, or spoon,” Dr. Chatoor explained. “It also involves training of the mother in behavioral techniques to feed the child in spite of the child’s fear and distress.”

Any underlying medical condition causing pain or distress should be treated. Additional measures may include, for example, use of a graduated approach, starting with liquids and progressing to purees, if the child fears solid foods, and prescribing anxiolytic medication in cases of severe anxiety.

Dr. Chatoor disclosed that she has lectured internationally at conferences on feeding disorders that were organized by Abbott Nutrition International and that the company provided a research grant for a study on feeding.

SAN FRANCISCO – Clinicians are likely to encounter diverse feeding problems in daily practice that will challenge their diagnostic and treatment acumen, Dr. Irene Chatoor told attendees of the annual meeting of the American Academy of Pediatrics.

These problems run the gamut from the most prevalent but least serious picky eating, to the least prevalent but most serious feeding disorders, she noted. Correspondingly, management will range from simple reassurance of parents to more intensive behavioral and medical interventions.

Assessment

“When you assess a feeding problem, you have to look at both the mother and father, and the child,” she advised. The parents are evaluated for their feeding style, while the child is evaluated for three feeding problems: limited appetite, selective intake, and fear of feeding (Pediatrics. 2015;135[2]:344-53).

Clinicians must be alert for organic red flags, such as dysphagia, aspiration, and vomiting, and for behavioral red flags, such as food fixation, abrupt cessation of feeding after a trigger event, and anticipatory gagging. An overarching red flag is failure to thrive.

Sometimes, a child will have both an organic condition and a behavioral feeding disorder at the same time. “It’s very important that you don’t think one excludes the other,” she cautioned.

Diagnosis

“To delineate milder feeding difficulties from feeding disorders, there must be some form of impairment caused by the feeding problem,” Dr. Chatoor commented. “Why is this important? For two reasons. One is for the insurance companies, because they don’t pay unless there is a disorder. And then there is research: you cannot do research unless you clearly define what you are studying.”

Children are considered to have impairment if they have weight loss or growth faltering, considerable nutritional deficiency, or a marked interference with psychosocial functioning.

“When we diagnose feeding problems, it is best done with a multidisciplinary team,” Dr. Chatoor maintained. “I have learned many years ago that I’m not effective in helping parents deal with the feeding disorder if they are still in the back of their mind worried that the child has something organically wrong and that’s why the child does not want to eat.”

Accordingly, various team members perform a medical examination, a nutritional assessment, an oral motor and sensory evaluation, and a psychiatric or psychological assessment to identify the root cause or causes of the problem.

When it comes to behavioral etiologies, the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) now groups all feeding and eating disorders together in one section, reflecting the fact that disorders starting early in life can and often do track into adolescence and adulthood, according to Dr. Chatoor.

The manual also features a new diagnosis, avoidant/restrictive food intake disorder (ARFID). Key criteria include the presence of an eating or feeding disturbance that cannot be better explained by lack of available food, culturally sanctioned practices, or a concurrent medical condition or another mental disorder.

The child must have a persistent failure to meet appropriate nutritional and/or energy needs, associated with any of four findings: significant weight loss or failure to achieve expected weight gain or growth, significant nutritional deficiencies, dependence on enteral feeding or oral nutritional supplements, and marked interference with psychosocial functioning.

“You need to have at least one but often you have a combination of nutritional and emotional impairment in the same child,” she commented.

ARFID and its treatment

There are three subtypes of ARFID having different features, treatments, and prognosis, although they all share in common food refusal, according to Dr. Chatoor.

The first subtype – apparent lack of interest in eating or food – emerges by 3 years of age, most often during the transition to self-feeding between 9 and 18 months. Affected children refuse to eat an adequate amount of food for at least 1 month, rarely communicate hunger, lack interest in food, and prefer to play or talk. They typically present with growth deficiency.

“If you have a child who refuses to eat, it generates anxiety in the mother. The mother does things she would not normally do with the child who is eating well. She starts to distract, to cajole, to sometimes even force-feed the child,” Dr. Chatoor explained. “And the more she engages in these behaviors, the more resistant the child becomes. So they become trapped in this vicious cycle.”

Treatment is aimed at removing this conflict with three approaches: explaining to parents the infant’s special temperament (notably, high arousal and difficulty turning off excitement); addressing their background, including any eating issues of their own, and difficulty with setting limits; and providing specific feeding guidelines and a time-out procedure.

The guidelines stress regular feeding, withholding of all snacks, keeping the child at the table for 20 to 30 minutes, and not using any distractions or pressure. Also, importantly, the parents should have dinner with their child. “I always tell the parents what is good for the child is good for you. It’s good for your whole family,” she said. “If they have other children, these rules apply to everybody. Young children learn to eat by watching their parents eating.”

With early and consistent use of these interventions, about two-thirds of children outgrow this eating/feeding disturbance by mid-childhood, according to Dr. Chatoor.

Children with the second subtype of ARFID – avoidance based on the sensory characteristics of food – consistently refuse to eat certain foods having specific tastes, textures, temperatures, smells, and/or appearances. Onset occurs during the toddler years, when a new or different food is introduced.

“Not only do they refuse the same foods that were aversive, but they also generalize it. So these children are afraid to try other foods and they may end up limiting food groups – they don’t eat any vegetables and some of them don’t eat any meats,” she explained. “They are a challenge because this always causes a nutritional deficiency and they also have problems socially as they get older.”

Treatment varies by age, with gradual desensitization for infants and parent modeling of eating new foods for toddlers. A multifaceted approach is used for preschoolers, combining modeling, giving foods attractive shapes and names, having the child participate in food preparation, and using focused play therapy, such as feeding dolls who are “brave” and try new foods.

Clinicians can explain to affected school-aged children that they are “supertasters,” having more taste buds and therefore experiencing food more intensely, and that they can help their taste buds not react so strongly by starting to eat small amounts of new foods and gradually increasing over time. Parents can let the child make a list of 10 foods they would like to eat, and award them points for “courage” for every bite of a new food they try.

Prognosis of this type of ARFID varies, according to Dr. Chatoor. “Through gradual exposure, young children can expand the variety of foods they eat,” she elaborated. However, “some children become very rigid and brand sensitive in regard to the food they are willing to eat and begin to experience social problems during mid-childhood and adolescence. Some children grow up eating a limited diet, but finding ways to compensate nutritionally and socially.”

Children with the third subtype of ARFID – concern about aversive consequences of eating – have an acute onset of consistent food refusal at any age, from infancy onward, after experiencing a traumatic event or repeated traumatic insults to the oropharynx or gastrointestinal tract that trigger distress in the child. These children often have comorbidities such as gastroesophageal reflux, eosinophilic gastroenteritis, or anxiety disorder.

“Treatment involves gradual desensitization to feared objects: the highchair, bib, bottle, or spoon,” Dr. Chatoor explained. “It also involves training of the mother in behavioral techniques to feed the child in spite of the child’s fear and distress.”

Any underlying medical condition causing pain or distress should be treated. Additional measures may include, for example, use of a graduated approach, starting with liquids and progressing to purees, if the child fears solid foods, and prescribing anxiolytic medication in cases of severe anxiety.

Dr. Chatoor disclosed that she has lectured internationally at conferences on feeding disorders that were organized by Abbott Nutrition International and that the company provided a research grant for a study on feeding.

SAN FRANCISCO – With a little number crunching and strategizing, pediatric practices can provide immunizations to their patients without getting financially soaked, according to Chip Hart, a pediatric practice management consultant.

He discussed various pitfalls and challenges when it comes to the business aspects of providing immunizations, and offered some solutions at the annual meeting of the American Academy of Pediatrics.

Spotting hidden costs

In its business case, the AAP determined that direct and indirect expenses for vaccine product total to 17% to 28% of the cost. In other words, “if you buy a vaccine for $100, you need to collect somewhere between $117 and $128, on average, just to break even,” Mr. Hart explained.

What accounts for that extra expense? Carrying costs that are commonly overlooked, namely, those myriad costs of providing immunizations that accrue before a child is given any vaccine and that can add up quickly.

They include the costs of the refrigerator and examination table; the sharps and waste management; insurance to cover vaccine loss; vaccine wastage and denials; and opportunity cost, that is, the cost of not being able to invest the funds tied up in vaccine sitting in the fridge – some $75,000 to $100,000 for the average practice – elsewhere.

Add to those personnel costs; costs related to activities such as ordering, inventory and storage management, registry input, and temperature monitoring; and malpractice coverage. And not to be forgotten is the inability to collect payment for some vaccines.

“You’re not paid for carrying costs. Unfortunately, society or the American health care system has given pediatricians this burden,” Mr. Hart commented.

Doing the math

Pediatricians can get a handle on the true costs to their practice of providing immunizations by spending just an hour or two crunching some key numbers, according to Mr. Hart.

They should start by ascertaining those carrying costs. For example, assuming hazardous waste costs run $3,500 per year, vaccines account for 50% of the waste, and the practice gives 13,000 vaccines annually, it averages out to $0.13 per vaccine.

Similar calculations are done to determine the costs of administering the shot (preparing, administering, counseling, billing, recording, putting it in the registry, and so on), arriving at about $12 per vaccine. The largest share here comes from clinicians, so calculations focus on their hourly wages and the percent of their time spent on vaccines.

Next is a calculation of the cost of the vaccine product. This calculation starts with the hypothetical invoiced amount of $100, factors in units that are wasted or go unpaid (at least 5%, according to AAP data), and tacks on the distributed carrying costs, arriving finally at an actual cost to the practice of about $120.

Last, all of these data are loaded into a payer-specific spreadsheet. Commonly, payers go by Red Book values and will therefore cover, for example, only $98 of that $100 invoice cost of the vaccine. But they will pay roughly $27 for its administration.

Taken together, the math suggests the practice bears a total cost of $132 for this vaccine ($120 for the product and $12 for its administration) but will collect only $125 from this payer ($98 for the product and $27 for its administration).

“You see over and over again that the payers underpay for the vaccines and pay you well for the administration, and it very often makes up the difference,” Mr. Hart noted. “But even with that boost on the admin side, this practice is losing money on this vaccine – they get $125 for something that costs them $132.”

Practices strapped for time can use some estimates in their spreadsheets instead, he said. “If you use an assumption of 25% over your invoice” – roughly the midpoint between the AAP’s 17% and 28% – “and $12 to $15 on your administration” – based on the value found in a study using time-motion analysis (Pediatrics. 2009 Dec;124 Suppl 5:S492-8) – “for your costs, all you need is your fee schedule, and you can make a spreadsheet to find out whether it makes sense to continue giving immunizations to this payer’s kids.”

Striving for profitability

“In all honesty, from what I see nationally, pediatricians break even on vaccines. It’s a break-even situation, on average,” Mr. Hart commented. “But who wants to be average? No one. We want you to actually be profitable with vaccines because it’s the only way you can continue to give them.”

Practices can take a variety of steps toward that goal. First, they should negotiate payments with payers, using the AAP’s business case and other literature. “Don’t listen to anybody” who says you can’t negotiate, he stressed. “You can negotiate. I don’t care if you’re a solo practice or you’ve just opened. If a payer says they can’t negotiate, they are fibbing to you. The only payers who don’t negotiate are the state Medicaid and Medicare. Everyone else can and does.”

Second, practices should ensure that they are using proper Current Procedural Terminology codes when submitting claims to payers to maximize payment.

“I still see too many practices who don’t bill for these properly,” Mr. Hart commented. “If you have a typical pediatric practice and you use more 90471s and 90472s than 90460s and 90461s, and frankly, if [the latter] aren’t two to three to four to five times more common… you are losing a lot of money.”

Third, practices should join or confirm that they belong to an effective group purchasing organization (GPO) to reduce their vaccine costs, with data suggesting that doing so will save the practice $10,000 to $15,000 per physician each year.

“If you are solo, out on the furthest edge of Alaska, you can see Russia from your house, and you have no leverage whatsoever, you can sign up with one of these GPOs and you are as strong as any hospital,” he said. The AAP helps here as well, by maintaining a list of GPOs on its website.

Fourth, practices should review their vaccine delivery work flow to look for money leaks, Mr. Hart advised. For example, physicians who get caught up in tasks such as ordering and inventorying are losing revenue that could come in from seeing patients.

“This is the sort of thing that affects your bottom line substantially. And it’s exactly the sort of thing that is an invisible expense: the business owners don’t consider their time as part of the expense of doing this administration,” he said.

Additionally, legacy procedures should be re-evaluated to see if they can be streamlined. Gains also may be made here from investing in better technology, such as a refrigerator with a glass door that saves time by allowing ready identification of vaccines.

Finally, practices should join the AAP’s Section on Administration and Practice Management (SOAPM) as it’s an invaluable, interactive resource in this area when questions or challenges arise, Mr. Hart recommended.

pdnews@frontlinemedcom.com

SAN FRANCISCO – With a little number crunching and strategizing, pediatric practices can provide immunizations to their patients without getting financially soaked, according to Chip Hart, a pediatric practice management consultant.

He discussed various pitfalls and challenges when it comes to the business aspects of providing immunizations, and offered some solutions at the annual meeting of the American Academy of Pediatrics.

Spotting hidden costs

In its business case, the AAP determined that direct and indirect expenses for vaccine product total to 17% to 28% of the cost. In other words, “if you buy a vaccine for $100, you need to collect somewhere between $117 and $128, on average, just to break even,” Mr. Hart explained.

What accounts for that extra expense? Carrying costs that are commonly overlooked, namely, those myriad costs of providing immunizations that accrue before a child is given any vaccine and that can add up quickly.

They include the costs of the refrigerator and examination table; the sharps and waste management; insurance to cover vaccine loss; vaccine wastage and denials; and opportunity cost, that is, the cost of not being able to invest the funds tied up in vaccine sitting in the fridge – some $75,000 to $100,000 for the average practice – elsewhere.

Add to those personnel costs; costs related to activities such as ordering, inventory and storage management, registry input, and temperature monitoring; and malpractice coverage. And not to be forgotten is the inability to collect payment for some vaccines.

“You’re not paid for carrying costs. Unfortunately, society or the American health care system has given pediatricians this burden,” Mr. Hart commented.

Doing the math

Pediatricians can get a handle on the true costs to their practice of providing immunizations by spending just an hour or two crunching some key numbers, according to Mr. Hart.

They should start by ascertaining those carrying costs. For example, assuming hazardous waste costs run $3,500 per year, vaccines account for 50% of the waste, and the practice gives 13,000 vaccines annually, it averages out to $0.13 per vaccine.

Similar calculations are done to determine the costs of administering the shot (preparing, administering, counseling, billing, recording, putting it in the registry, and so on), arriving at about $12 per vaccine. The largest share here comes from clinicians, so calculations focus on their hourly wages and the percent of their time spent on vaccines.

Next is a calculation of the cost of the vaccine product. This calculation starts with the hypothetical invoiced amount of $100, factors in units that are wasted or go unpaid (at least 5%, according to AAP data), and tacks on the distributed carrying costs, arriving finally at an actual cost to the practice of about $120.

Last, all of these data are loaded into a payer-specific spreadsheet. Commonly, payers go by Red Book values and will therefore cover, for example, only $98 of that $100 invoice cost of the vaccine. But they will pay roughly $27 for its administration.

Taken together, the math suggests the practice bears a total cost of $132 for this vaccine ($120 for the product and $12 for its administration) but will collect only $125 from this payer ($98 for the product and $27 for its administration).

“You see over and over again that the payers underpay for the vaccines and pay you well for the administration, and it very often makes up the difference,” Mr. Hart noted. “But even with that boost on the admin side, this practice is losing money on this vaccine – they get $125 for something that costs them $132.”

Practices strapped for time can use some estimates in their spreadsheets instead, he said. “If you use an assumption of 25% over your invoice” – roughly the midpoint between the AAP’s 17% and 28% – “and $12 to $15 on your administration” – based on the value found in a study using time-motion analysis (Pediatrics. 2009 Dec;124 Suppl 5:S492-8) – “for your costs, all you need is your fee schedule, and you can make a spreadsheet to find out whether it makes sense to continue giving immunizations to this payer’s kids.”

Striving for profitability

“In all honesty, from what I see nationally, pediatricians break even on vaccines. It’s a break-even situation, on average,” Mr. Hart commented. “But who wants to be average? No one. We want you to actually be profitable with vaccines because it’s the only way you can continue to give them.”

Practices can take a variety of steps toward that goal. First, they should negotiate payments with payers, using the AAP’s business case and other literature. “Don’t listen to anybody” who says you can’t negotiate, he stressed. “You can negotiate. I don’t care if you’re a solo practice or you’ve just opened. If a payer says they can’t negotiate, they are fibbing to you. The only payers who don’t negotiate are the state Medicaid and Medicare. Everyone else can and does.”

Second, practices should ensure that they are using proper Current Procedural Terminology codes when submitting claims to payers to maximize payment.

“I still see too many practices who don’t bill for these properly,” Mr. Hart commented. “If you have a typical pediatric practice and you use more 90471s and 90472s than 90460s and 90461s, and frankly, if [the latter] aren’t two to three to four to five times more common… you are losing a lot of money.”

Third, practices should join or confirm that they belong to an effective group purchasing organization (GPO) to reduce their vaccine costs, with data suggesting that doing so will save the practice $10,000 to $15,000 per physician each year.

“If you are solo, out on the furthest edge of Alaska, you can see Russia from your house, and you have no leverage whatsoever, you can sign up with one of these GPOs and you are as strong as any hospital,” he said. The AAP helps here as well, by maintaining a list of GPOs on its website.

Fourth, practices should review their vaccine delivery work flow to look for money leaks, Mr. Hart advised. For example, physicians who get caught up in tasks such as ordering and inventorying are losing revenue that could come in from seeing patients.

“This is the sort of thing that affects your bottom line substantially. And it’s exactly the sort of thing that is an invisible expense: the business owners don’t consider their time as part of the expense of doing this administration,” he said.

Additionally, legacy procedures should be re-evaluated to see if they can be streamlined. Gains also may be made here from investing in better technology, such as a refrigerator with a glass door that saves time by allowing ready identification of vaccines.

Finally, practices should join the AAP’s Section on Administration and Practice Management (SOAPM) as it’s an invaluable, interactive resource in this area when questions or challenges arise, Mr. Hart recommended.

pdnews@frontlinemedcom.com

SAN FRANCISCO – With a little number crunching and strategizing, pediatric practices can provide immunizations to their patients without getting financially soaked, according to Chip Hart, a pediatric practice management consultant.

He discussed various pitfalls and challenges when it comes to the business aspects of providing immunizations, and offered some solutions at the annual meeting of the American Academy of Pediatrics.

Spotting hidden costs

In its business case, the AAP determined that direct and indirect expenses for vaccine product total to 17% to 28% of the cost. In other words, “if you buy a vaccine for $100, you need to collect somewhere between $117 and $128, on average, just to break even,” Mr. Hart explained.

What accounts for that extra expense? Carrying costs that are commonly overlooked, namely, those myriad costs of providing immunizations that accrue before a child is given any vaccine and that can add up quickly.

They include the costs of the refrigerator and examination table; the sharps and waste management; insurance to cover vaccine loss; vaccine wastage and denials; and opportunity cost, that is, the cost of not being able to invest the funds tied up in vaccine sitting in the fridge – some $75,000 to $100,000 for the average practice – elsewhere.

Add to those personnel costs; costs related to activities such as ordering, inventory and storage management, registry input, and temperature monitoring; and malpractice coverage. And not to be forgotten is the inability to collect payment for some vaccines.

“You’re not paid for carrying costs. Unfortunately, society or the American health care system has given pediatricians this burden,” Mr. Hart commented.

Doing the math

Pediatricians can get a handle on the true costs to their practice of providing immunizations by spending just an hour or two crunching some key numbers, according to Mr. Hart.

They should start by ascertaining those carrying costs. For example, assuming hazardous waste costs run $3,500 per year, vaccines account for 50% of the waste, and the practice gives 13,000 vaccines annually, it averages out to $0.13 per vaccine.

Similar calculations are done to determine the costs of administering the shot (preparing, administering, counseling, billing, recording, putting it in the registry, and so on), arriving at about $12 per vaccine. The largest share here comes from clinicians, so calculations focus on their hourly wages and the percent of their time spent on vaccines.

Next is a calculation of the cost of the vaccine product. This calculation starts with the hypothetical invoiced amount of $100, factors in units that are wasted or go unpaid (at least 5%, according to AAP data), and tacks on the distributed carrying costs, arriving finally at an actual cost to the practice of about $120.

Last, all of these data are loaded into a payer-specific spreadsheet. Commonly, payers go by Red Book values and will therefore cover, for example, only $98 of that $100 invoice cost of the vaccine. But they will pay roughly $27 for its administration.

Taken together, the math suggests the practice bears a total cost of $132 for this vaccine ($120 for the product and $12 for its administration) but will collect only $125 from this payer ($98 for the product and $27 for its administration).

“You see over and over again that the payers underpay for the vaccines and pay you well for the administration, and it very often makes up the difference,” Mr. Hart noted. “But even with that boost on the admin side, this practice is losing money on this vaccine – they get $125 for something that costs them $132.”

Practices strapped for time can use some estimates in their spreadsheets instead, he said. “If you use an assumption of 25% over your invoice” – roughly the midpoint between the AAP’s 17% and 28% – “and $12 to $15 on your administration” – based on the value found in a study using time-motion analysis (Pediatrics. 2009 Dec;124 Suppl 5:S492-8) – “for your costs, all you need is your fee schedule, and you can make a spreadsheet to find out whether it makes sense to continue giving immunizations to this payer’s kids.”

Striving for profitability

“In all honesty, from what I see nationally, pediatricians break even on vaccines. It’s a break-even situation, on average,” Mr. Hart commented. “But who wants to be average? No one. We want you to actually be profitable with vaccines because it’s the only way you can continue to give them.”

Practices can take a variety of steps toward that goal. First, they should negotiate payments with payers, using the AAP’s business case and other literature. “Don’t listen to anybody” who says you can’t negotiate, he stressed. “You can negotiate. I don’t care if you’re a solo practice or you’ve just opened. If a payer says they can’t negotiate, they are fibbing to you. The only payers who don’t negotiate are the state Medicaid and Medicare. Everyone else can and does.”

Second, practices should ensure that they are using proper Current Procedural Terminology codes when submitting claims to payers to maximize payment.

“I still see too many practices who don’t bill for these properly,” Mr. Hart commented. “If you have a typical pediatric practice and you use more 90471s and 90472s than 90460s and 90461s, and frankly, if [the latter] aren’t two to three to four to five times more common… you are losing a lot of money.”

Third, practices should join or confirm that they belong to an effective group purchasing organization (GPO) to reduce their vaccine costs, with data suggesting that doing so will save the practice $10,000 to $15,000 per physician each year.

“If you are solo, out on the furthest edge of Alaska, you can see Russia from your house, and you have no leverage whatsoever, you can sign up with one of these GPOs and you are as strong as any hospital,” he said. The AAP helps here as well, by maintaining a list of GPOs on its website.

Fourth, practices should review their vaccine delivery work flow to look for money leaks, Mr. Hart advised. For example, physicians who get caught up in tasks such as ordering and inventorying are losing revenue that could come in from seeing patients.

“This is the sort of thing that affects your bottom line substantially. And it’s exactly the sort of thing that is an invisible expense: the business owners don’t consider their time as part of the expense of doing this administration,” he said.

Additionally, legacy procedures should be re-evaluated to see if they can be streamlined. Gains also may be made here from investing in better technology, such as a refrigerator with a glass door that saves time by allowing ready identification of vaccines.

Finally, practices should join the AAP’s Section on Administration and Practice Management (SOAPM) as it’s an invaluable, interactive resource in this area when questions or challenges arise, Mr. Hart recommended.

pdnews@frontlinemedcom.com

SAN FRANCISCO – At sleep time, infants should share their parents’ bedroom on a separate sleep surface without bed sharing, should be placed on their backs on a firm surface, and should have a sleep area free of blankets and soft objects, according to updated guidelines from the American Academy of Pediatrics aimed at reducing the risk of sudden infant death syndrome (SIDS) and other sleep-related infant deaths.

Drafted by a multidisciplinary task force, the set of 19 evidence-based recommendations largely reiterate messages that the academy has promoted for years such as “back to sleep for every sleep,” according to task force member Fern R. Hauck, MD, the Spencer P. Bass, MD, Twenty-First Century Professor of Family Medicine at the University of Virginia, Charlottesville. They were unveiled in a press briefing at the academy’s annual meeting and simultaneously published (Pediatrics. 2016;138[5]:e20162938).

Progress, but still a ways to go

Education campaigns that convey these and related messages to new parents and other caregivers have led to a more than halving of the rate of SIDS in recent decades. Yet, 3,500 infants are still lost each year to this syndrome and other sleep-related causes of infant death, such as unintentional suffocation, collectively called sudden unexpected infant death (SUID).

Catherine Cooper Nellist/Frontline Medical News

Breastfeeding issues

Although breastfeeding protects against SIDS, it can pose some problems for safe sleep practices, acknowledged Lori B. Feldman-Winter, MD, a liaison from the AAP section on breastfeeding to the task force, as well as head of the division of adolescent medicine and professor of pediatrics at Cooper University Health Care in Camden, N.J.

Catherine Cooper Nellist/Frontline Medical News

Raising awareness

“As a father and pediatrician, I want parents to know that their baby is safest following the AAP safe sleep recommendations, and spreading this message has become my life’s mission,” said Dr. Samuel P. Hanke, a pediatric cardiologist at the University of Cincinnati, who knows the heartbreak of SIDS firsthand.

Catherine Cooper Nellist/Frontline Medical News

Federal commitment

Since the 1970s, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) in Bethesda, Md., has been supporting and performing much of the research on which the updated recommendations are based. This research continues to help identify areas where greater efforts are needed, according to acting director Catherine Y. Spong, MD.

Catherine Cooper Nellist/Frontline Medical News

A closer look at setting

Published in conjunction with the guidelines is a study on risk factors that looked at the role of the setting in which sleep-related infant deaths occur (Pediatrics. 2016 Oct 24:e20161124).

The analysis of nearly 12,000 such deaths found that, relative to counterparts who died in their home, infants who died outside of their home were more likely to be in a stroller or car seat at the time (adjusted odds ratio, 2.6) and in other locations, such as on the floor or a futon (1.9), and to have been placed prone (1.1). They were less likely to have been sharing a bed (0.7).

The groups did not differ in terms of whether the infant was sleeping in an adult bed or on a person, on a couch or chair, or with any objects in their sleep environment.

“Caregivers should be educated on the importance of placing infants to sleep supine in cribs/bassinets to protect against sleep-related deaths, both in and out of the home,” conclude the investigators, one of whom disclosed serving as a paid expert witness in cases of sleep-related infant death.
 

SAN FRANCISCO – At sleep time, infants should share their parents’ bedroom on a separate sleep surface without bed sharing, should be placed on their backs on a firm surface, and should have a sleep area free of blankets and soft objects, according to updated guidelines from the American Academy of Pediatrics aimed at reducing the risk of sudden infant death syndrome (SIDS) and other sleep-related infant deaths.

Drafted by a multidisciplinary task force, the set of 19 evidence-based recommendations largely reiterate messages that the academy has promoted for years such as “back to sleep for every sleep,” according to task force member Fern R. Hauck, MD, the Spencer P. Bass, MD, Twenty-First Century Professor of Family Medicine at the University of Virginia, Charlottesville. They were unveiled in a press briefing at the academy’s annual meeting and simultaneously published (Pediatrics. 2016;138[5]:e20162938).

Progress, but still a ways to go

Education campaigns that convey these and related messages to new parents and other caregivers have led to a more than halving of the rate of SIDS in recent decades. Yet, 3,500 infants are still lost each year to this syndrome and other sleep-related causes of infant death, such as unintentional suffocation, collectively called sudden unexpected infant death (SUID).

Catherine Cooper Nellist/Frontline Medical News

Breastfeeding issues

Although breastfeeding protects against SIDS, it can pose some problems for safe sleep practices, acknowledged Lori B. Feldman-Winter, MD, a liaison from the AAP section on breastfeeding to the task force, as well as head of the division of adolescent medicine and professor of pediatrics at Cooper University Health Care in Camden, N.J.

Catherine Cooper Nellist/Frontline Medical News

Raising awareness

“As a father and pediatrician, I want parents to know that their baby is safest following the AAP safe sleep recommendations, and spreading this message has become my life’s mission,” said Dr. Samuel P. Hanke, a pediatric cardiologist at the University of Cincinnati, who knows the heartbreak of SIDS firsthand.

Catherine Cooper Nellist/Frontline Medical News

Federal commitment

Since the 1970s, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) in Bethesda, Md., has been supporting and performing much of the research on which the updated recommendations are based. This research continues to help identify areas where greater efforts are needed, according to acting director Catherine Y. Spong, MD.

Catherine Cooper Nellist/Frontline Medical News

A closer look at setting

Published in conjunction with the guidelines is a study on risk factors that looked at the role of the setting in which sleep-related infant deaths occur (Pediatrics. 2016 Oct 24:e20161124).

The analysis of nearly 12,000 such deaths found that, relative to counterparts who died in their home, infants who died outside of their home were more likely to be in a stroller or car seat at the time (adjusted odds ratio, 2.6) and in other locations, such as on the floor or a futon (1.9), and to have been placed prone (1.1). They were less likely to have been sharing a bed (0.7).

The groups did not differ in terms of whether the infant was sleeping in an adult bed or on a person, on a couch or chair, or with any objects in their sleep environment.

“Caregivers should be educated on the importance of placing infants to sleep supine in cribs/bassinets to protect against sleep-related deaths, both in and out of the home,” conclude the investigators, one of whom disclosed serving as a paid expert witness in cases of sleep-related infant death.
 

SAN FRANCISCO – At sleep time, infants should share their parents’ bedroom on a separate sleep surface without bed sharing, should be placed on their backs on a firm surface, and should have a sleep area free of blankets and soft objects, according to updated guidelines from the American Academy of Pediatrics aimed at reducing the risk of sudden infant death syndrome (SIDS) and other sleep-related infant deaths.

Drafted by a multidisciplinary task force, the set of 19 evidence-based recommendations largely reiterate messages that the academy has promoted for years such as “back to sleep for every sleep,” according to task force member Fern R. Hauck, MD, the Spencer P. Bass, MD, Twenty-First Century Professor of Family Medicine at the University of Virginia, Charlottesville. They were unveiled in a press briefing at the academy’s annual meeting and simultaneously published (Pediatrics. 2016;138[5]:e20162938).

Progress, but still a ways to go

Education campaigns that convey these and related messages to new parents and other caregivers have led to a more than halving of the rate of SIDS in recent decades. Yet, 3,500 infants are still lost each year to this syndrome and other sleep-related causes of infant death, such as unintentional suffocation, collectively called sudden unexpected infant death (SUID).

Catherine Cooper Nellist/Frontline Medical News

Breastfeeding issues

Although breastfeeding protects against SIDS, it can pose some problems for safe sleep practices, acknowledged Lori B. Feldman-Winter, MD, a liaison from the AAP section on breastfeeding to the task force, as well as head of the division of adolescent medicine and professor of pediatrics at Cooper University Health Care in Camden, N.J.

Catherine Cooper Nellist/Frontline Medical News

Raising awareness

“As a father and pediatrician, I want parents to know that their baby is safest following the AAP safe sleep recommendations, and spreading this message has become my life’s mission,” said Dr. Samuel P. Hanke, a pediatric cardiologist at the University of Cincinnati, who knows the heartbreak of SIDS firsthand.

Catherine Cooper Nellist/Frontline Medical News

Federal commitment

Since the 1970s, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) in Bethesda, Md., has been supporting and performing much of the research on which the updated recommendations are based. This research continues to help identify areas where greater efforts are needed, according to acting director Catherine Y. Spong, MD.

Catherine Cooper Nellist/Frontline Medical News

A closer look at setting

Published in conjunction with the guidelines is a study on risk factors that looked at the role of the setting in which sleep-related infant deaths occur (Pediatrics. 2016 Oct 24:e20161124).

The analysis of nearly 12,000 such deaths found that, relative to counterparts who died in their home, infants who died outside of their home were more likely to be in a stroller or car seat at the time (adjusted odds ratio, 2.6) and in other locations, such as on the floor or a futon (1.9), and to have been placed prone (1.1). They were less likely to have been sharing a bed (0.7).

The groups did not differ in terms of whether the infant was sleeping in an adult bed or on a person, on a couch or chair, or with any objects in their sleep environment.

“Caregivers should be educated on the importance of placing infants to sleep supine in cribs/bassinets to protect against sleep-related deaths, both in and out of the home,” conclude the investigators, one of whom disclosed serving as a paid expert witness in cases of sleep-related infant death.
 

The timing of endoscopy may make the difference between life and death in sicker patients with peptic ulcer bleeding, according to an analysis of more than 12,000 patients treated in Denmark.

Patients who were hemodynamically stable but had a higher level of comorbidity were about half as likely to die during their hospital stay if they underwent endoscopy within 12-36 hours of presentation as compared with sooner or later, results showed (Gastrointest Endosc. 2016 Sep 10. doi: 10.1016/j.gie.2016.08.049). And hemodynamically unstable patients had a roughly one-fourth reduction in the odds of death if they underwent the procedure within 6-24 hours.
 

“Although caution should be applied when interpreting these data, the current recommendation of endoscopy within 0-24 hours may not be optimal for all patients,” wrote the investigators, who were led by Stig B. Laursen, PhD, department of medical gastroenterology, Odense (Denmark) University Hospital.

“Our data may suggest that in patients with major comorbidities, the first few hours of hospital admission might be best used for optimising treatment of comorbidities, which may include correction of severe anaemia, reversal of anticoagulants, and investigation for possible infection that requires rapid treatment with antibiotics,” they elaborate. “Likewise, in patients with hemodynamic instability, endoscopy between 6 and 24 hours from time of admission to hospital allows time for optimal resuscitation and initiating treatment of comorbid diseases before endoscopy. However, these data should not lead to delayed endoscopy in patients with severe hemodynamic instability not responding to intensive resuscitation.”

The investigators analyzed data from 12,601 consecutive patients with peptic ulcer bleeding admitted between January 2005 and September 2013 to Danish hospitals, where all patients had access to 24-hour endoscopy. Time to endoscopy was assessed from hospital admission, defined as arrival in the emergency department, or from symptom onset in patients who developed bleeding when already hospitalized.

For analyses, the patients were stratified by hemodynamic status (a marker for the severity of bleeding) and by American Society of Anesthesiologists score (a marker for the extent of comorbidity).
 

The timing of endoscopy did not significantly influence in-hospital or 30-day mortality in hemodynamically stable patients with an American Society of Anesthesiologists score of 1-2 as a whole, Dr. Laursen and his colleagues report. Subgroup analyses suggested a reduction of in-hospital mortality when it was done between 0 and 24 hours in those patients whose bleeding began outside the hospital (adjusted odds ratio, 0.48).

In contrast, analyses revealed a U-shaped association between timing and mortality for hemodynamically stable patients with an American Society of Anesthesiologists score of 3-5. For this group, in-hospital mortality was significantly lower when endoscopy was performed within 12-36 hours as compared with times outside this window (adjusted OR, 0.48), and 30-day mortality tended to be lower as well.

Similarly, timing appeared to influence outcome for hemodynamically unstable patients, having both systolic blood pressure below 100 mm Hg and heart rate above 100 beats/min. For this group, performance of endoscopy within 6-24 hours was associated with significantly lower in-hospital mortality (adjusted OR, 0.73) and also 30-day mortality (adjusted OR, 0.66). Patients’ American Society of Anesthesiologists score did not appear to play a role here.

The study’s findings may have been affected by unmeasured and unknown confounders, acknowledge the investigators, who declared that they have no competing interests related to the research.

“Although a well-powered randomized controlled trial represents the best way to account for these problems, randomizing patients with [peptic ulcer bleeding] to early versus late endoscopy will be very difficult, including from an ethical and methodological point of view,” they note.

The timing of endoscopy may make the difference between life and death in sicker patients with peptic ulcer bleeding, according to an analysis of more than 12,000 patients treated in Denmark.

Patients who were hemodynamically stable but had a higher level of comorbidity were about half as likely to die during their hospital stay if they underwent endoscopy within 12-36 hours of presentation as compared with sooner or later, results showed (Gastrointest Endosc. 2016 Sep 10. doi: 10.1016/j.gie.2016.08.049). And hemodynamically unstable patients had a roughly one-fourth reduction in the odds of death if they underwent the procedure within 6-24 hours.
 

“Although caution should be applied when interpreting these data, the current recommendation of endoscopy within 0-24 hours may not be optimal for all patients,” wrote the investigators, who were led by Stig B. Laursen, PhD, department of medical gastroenterology, Odense (Denmark) University Hospital.

“Our data may suggest that in patients with major comorbidities, the first few hours of hospital admission might be best used for optimising treatment of comorbidities, which may include correction of severe anaemia, reversal of anticoagulants, and investigation for possible infection that requires rapid treatment with antibiotics,” they elaborate. “Likewise, in patients with hemodynamic instability, endoscopy between 6 and 24 hours from time of admission to hospital allows time for optimal resuscitation and initiating treatment of comorbid diseases before endoscopy. However, these data should not lead to delayed endoscopy in patients with severe hemodynamic instability not responding to intensive resuscitation.”

The investigators analyzed data from 12,601 consecutive patients with peptic ulcer bleeding admitted between January 2005 and September 2013 to Danish hospitals, where all patients had access to 24-hour endoscopy. Time to endoscopy was assessed from hospital admission, defined as arrival in the emergency department, or from symptom onset in patients who developed bleeding when already hospitalized.

For analyses, the patients were stratified by hemodynamic status (a marker for the severity of bleeding) and by American Society of Anesthesiologists score (a marker for the extent of comorbidity).
 

The timing of endoscopy did not significantly influence in-hospital or 30-day mortality in hemodynamically stable patients with an American Society of Anesthesiologists score of 1-2 as a whole, Dr. Laursen and his colleagues report. Subgroup analyses suggested a reduction of in-hospital mortality when it was done between 0 and 24 hours in those patients whose bleeding began outside the hospital (adjusted odds ratio, 0.48).

In contrast, analyses revealed a U-shaped association between timing and mortality for hemodynamically stable patients with an American Society of Anesthesiologists score of 3-5. For this group, in-hospital mortality was significantly lower when endoscopy was performed within 12-36 hours as compared with times outside this window (adjusted OR, 0.48), and 30-day mortality tended to be lower as well.

Similarly, timing appeared to influence outcome for hemodynamically unstable patients, having both systolic blood pressure below 100 mm Hg and heart rate above 100 beats/min. For this group, performance of endoscopy within 6-24 hours was associated with significantly lower in-hospital mortality (adjusted OR, 0.73) and also 30-day mortality (adjusted OR, 0.66). Patients’ American Society of Anesthesiologists score did not appear to play a role here.

The study’s findings may have been affected by unmeasured and unknown confounders, acknowledge the investigators, who declared that they have no competing interests related to the research.

“Although a well-powered randomized controlled trial represents the best way to account for these problems, randomizing patients with [peptic ulcer bleeding] to early versus late endoscopy will be very difficult, including from an ethical and methodological point of view,” they note.

The timing of endoscopy may make the difference between life and death in sicker patients with peptic ulcer bleeding, according to an analysis of more than 12,000 patients treated in Denmark.

Patients who were hemodynamically stable but had a higher level of comorbidity were about half as likely to die during their hospital stay if they underwent endoscopy within 12-36 hours of presentation as compared with sooner or later, results showed (Gastrointest Endosc. 2016 Sep 10. doi: 10.1016/j.gie.2016.08.049). And hemodynamically unstable patients had a roughly one-fourth reduction in the odds of death if they underwent the procedure within 6-24 hours.
 

“Although caution should be applied when interpreting these data, the current recommendation of endoscopy within 0-24 hours may not be optimal for all patients,” wrote the investigators, who were led by Stig B. Laursen, PhD, department of medical gastroenterology, Odense (Denmark) University Hospital.

“Our data may suggest that in patients with major comorbidities, the first few hours of hospital admission might be best used for optimising treatment of comorbidities, which may include correction of severe anaemia, reversal of anticoagulants, and investigation for possible infection that requires rapid treatment with antibiotics,” they elaborate. “Likewise, in patients with hemodynamic instability, endoscopy between 6 and 24 hours from time of admission to hospital allows time for optimal resuscitation and initiating treatment of comorbid diseases before endoscopy. However, these data should not lead to delayed endoscopy in patients with severe hemodynamic instability not responding to intensive resuscitation.”

The investigators analyzed data from 12,601 consecutive patients with peptic ulcer bleeding admitted between January 2005 and September 2013 to Danish hospitals, where all patients had access to 24-hour endoscopy. Time to endoscopy was assessed from hospital admission, defined as arrival in the emergency department, or from symptom onset in patients who developed bleeding when already hospitalized.

For analyses, the patients were stratified by hemodynamic status (a marker for the severity of bleeding) and by American Society of Anesthesiologists score (a marker for the extent of comorbidity).
 

The timing of endoscopy did not significantly influence in-hospital or 30-day mortality in hemodynamically stable patients with an American Society of Anesthesiologists score of 1-2 as a whole, Dr. Laursen and his colleagues report. Subgroup analyses suggested a reduction of in-hospital mortality when it was done between 0 and 24 hours in those patients whose bleeding began outside the hospital (adjusted odds ratio, 0.48).

In contrast, analyses revealed a U-shaped association between timing and mortality for hemodynamically stable patients with an American Society of Anesthesiologists score of 3-5. For this group, in-hospital mortality was significantly lower when endoscopy was performed within 12-36 hours as compared with times outside this window (adjusted OR, 0.48), and 30-day mortality tended to be lower as well.

Similarly, timing appeared to influence outcome for hemodynamically unstable patients, having both systolic blood pressure below 100 mm Hg and heart rate above 100 beats/min. For this group, performance of endoscopy within 6-24 hours was associated with significantly lower in-hospital mortality (adjusted OR, 0.73) and also 30-day mortality (adjusted OR, 0.66). Patients’ American Society of Anesthesiologists score did not appear to play a role here.

The study’s findings may have been affected by unmeasured and unknown confounders, acknowledge the investigators, who declared that they have no competing interests related to the research.

“Although a well-powered randomized controlled trial represents the best way to account for these problems, randomizing patients with [peptic ulcer bleeding] to early versus late endoscopy will be very difficult, including from an ethical and methodological point of view,” they note.

SAN FRANCISCO – Telementoring empowers primary care pediatric providers (PCPs) to take on a greater role in managing their patients’ chronic diseases, new data suggest. Leaders in this emerging field gave a snapshot of early experience with the model at the annual meeting of the American Academy of Pediatrics.

“About a quarter of children live with chronic health conditions, and there is an increasing need for specialty care. But many children don’t have access to the quality specialty care that they really need, particularly in rural and medically underserved areas,” explained Dr. Sucheta M. Joshi, a pediatric neurologist and epileptologist at the University of Michigan, Ann Arbor. “The goal of telementoring is to build the capacity of primary care doctors.”

SAN FRANCISCO – Telementoring empowers primary care pediatric providers (PCPs) to take on a greater role in managing their patients’ chronic diseases, new data suggest. Leaders in this emerging field gave a snapshot of early experience with the model at the annual meeting of the American Academy of Pediatrics.

“About a quarter of children live with chronic health conditions, and there is an increasing need for specialty care. But many children don’t have access to the quality specialty care that they really need, particularly in rural and medically underserved areas,” explained Dr. Sucheta M. Joshi, a pediatric neurologist and epileptologist at the University of Michigan, Ann Arbor. “The goal of telementoring is to build the capacity of primary care doctors.”

SAN FRANCISCO – Telementoring empowers primary care pediatric providers (PCPs) to take on a greater role in managing their patients’ chronic diseases, new data suggest. Leaders in this emerging field gave a snapshot of early experience with the model at the annual meeting of the American Academy of Pediatrics.

“About a quarter of children live with chronic health conditions, and there is an increasing need for specialty care. But many children don’t have access to the quality specialty care that they really need, particularly in rural and medically underserved areas,” explained Dr. Sucheta M. Joshi, a pediatric neurologist and epileptologist at the University of Michigan, Ann Arbor. “The goal of telementoring is to build the capacity of primary care doctors.”

SAN FRANCISCO – By choosing your words carefully, counseling families about divorce can tactfully address sensitive issues and help parents and children better cope with this life transition, Nerissa S. Bauer, MD, said at the annual meeting of the American Academy of Pediatrics.

About one in five children born within a marriage and one in two of those born within a cohabiting union will experience breakup of that relationship by the age of 9 years, she said.

You must, therefore, be prepared to monitor for and identify outcomes that commonly result from divorce, and to counsel families about how to help children cope and manage. Yet, you may feel uneasy or ill-prepared to do so.

“Turn this thought of ‘I wasn’t trained for this’ into ‘I can help,’ ” recommended Dr. Bauer, who is a specialist in behavioral pediatrics at the Indiana University in Indianapolis.

Risk and protective factors

Divorce can have an impact on all facets of a child’s life: behavior, physical and mental health, academic performance, social relationships, delinquency, substance use, and more. A variety of factors determine how well kids adjust to this stressor, for better or worse.

Marital conflict, both during and after divorce, is a more important predictor than the divorce itself. “The biggest risk factor to consider is the ongoing parental fighting and how that plays out,” Dr. Bauer elaborated. Although parents may report that they try to limit altercations in front of their children, kids usually sense what is going on anyway.

“One of the ways that I like to phrase this when I’m trying to figure out how bad the conflict is in the household is, ‘Has Johnny ever witnessed your arguments, and if so, have those arguments ever been more than just yelling?’ Or another way to say it is, ‘How do adults in your home resolve conflicts?’ ” she shared.

Divorce may negatively affect children through its impact on the household’s socioeconomic status too. For example, the standard of living often declines and the mother’s economic resources can take a hit, possibly forcing a move to a less expensive neighborhood with weaker schools and more crime.

To sound parents out on this sensitive issue, “You can say something like, ‘I’m really sorry that you’re going through this right now. Sometimes, it can cause a lot of stress and strain, especially when it comes to making ends meet, making sure you can get food on the table, and making sure you’re paying the bills. Do you have worries like this now?’ ” Dr. Bauer suggested.

Factors that are known to protect children from adverse divorce outcomes include a good relationship with at least one parent or caregiver, parental warmth, sibling support, and for teens, good self-esteem and peer support. Joint custody with shared decision making and greater paternal involvement also are protective.

“I like to say, ‘So I can understand how this affects your daily life, can you describe what your current arrangements are between you and your ex?’ just to sort of probe into that custody situation,” she said. “Or, ‘How are you (parents) handling this?’ ”

Surveillance and monitoring

“Perform surveillance on family structure and conflict at all well-child visits, as well as with any new family that comes to your practice,” Dr. Bauer recommended. You can do this by simply chatting with the family or by using screening tools such as the Family Psychosocial Screen or the Finding Your ACE Score.

Once you know that a family is dealing with divorce, perform ongoing monitoring for warning signs in the child: sleep problems; school problems, such as poor concentration, acting out, or not doing schoolwork; angry outbursts; withdrawal; and no longer participating in activities once enjoyed.

You may worry about getting dragged into the conflict. “You may feel that you’re in this position of being the mediator, but that’s not really your role. And you shouldn’t offer legal advice,” she cautioned. “You should make it clear that although you are there to support the child and the parents, your role is really to monitor how the child responds and adjusts.”

Parents will sometimes ask whether and how best to tell their children about the divorce. “I oftentimes coach parents to use kid-friendly terms, saying things such as, ‘Mommy and Daddy are having a hard time getting along, and you’ve probably noticed we argue or fight a lot.’ Just throwing it out there and pausing and waiting to see what the child says, and then always following that by answering their questions as they bring them up,” Dr. Bauer said.

Parents should be counseled not to rush children as they will vary in the time needed to process information. Additionally, they should be forewarned that children’s reactions can vary widely and that their feelings can change and resurface at any moment, particularly as they mature and at events that stir up emotions.

Messages of reassurance are essential. “The messages should always contain, ‘We are always going to be your parents no matter what’ and ‘We love you no matter what,’ and probably the most important, ‘This is not your fault.’ This is a message that kids need to hear again and again,” Dr. Bauer said.
 

Ongoing counseling

Over time, parents may consult you about specific situations that arise because of the divorce. For example, they may become frustrated by differences in how things are handled in the two households.

“The most important message to convey is that we can control only what we can control,” Dr. Bauer said. “Regardless of divorce or separation, kids thrive on structure and routine. Divorce is often messy, and it sometimes means that families have to find a new rhythm between households, but routines in each house should be as consistent as possible.”

Acrimony between the mother and father may persist or escalate. As children don’t want to have to choose between parents, parents should be encouraged not to undermine or talk negatively about each other in front of the child. If necessary, you can arrange to have time separately with parents to allow them to air their grievances.

If parents give permission to broach the topic of divorce, you can role model conversational strategies during visits. “You can say something like, ‘I understand there are a lot of changes going on. Through it all, your mom and dad will always be your parents. I know this isn’t easy for anybody, especially for you. Kids in this situation feel a lot of things from sadness to anger but know that you can always talk to me or your parents about your feelings,’” Dr. Bauer elaborated.

“Listening is key,” she stressed; therefore, parents should be encouraged to just sit in silence and let their children process their feelings. “In these types of situations, there’s no right or wrong: When the child has feelings, they have feelings. We can’t force them to feel a certain way, we have to acknowledge that. So tell parents to try this: ‘Thanks for telling me how you feel. I want you to know that you can always come to me when you feel this way.’ See what happens.”

Parents should be advised not to be too quick to dismiss their child’s concerns, Dr. Bauer recommended. “So, instead of saying, ‘Oh honey, you don’t have to worry about that, I’ll take care of it,’ try this: ‘It sounds like you are sad and upset right now. What can I do to help?’ Sometimes a kid will say, ‘I don’t know,’ but that’s okay. Then the parent can respond in kind and say, ‘I don’t know either, but how about a hug? Let’s start there.’ ”

Some kids simply aren’t talkers and shouldn’t be forced to share, she pointed out. This group can be given other ways to express their feelings, such as journaling, drawing, art, music, yoga, or writing a letter that they then throw away or put in a drawer.

Finally, “reminding parents that even giving children a little control with daily things – what they wear, how they do their chores, and homework, and what to make for dinner – can also help,” she noted. “Those little things can represent a lot for children who don’t feel like they have any control.”

Building resources

Explore various media and online tools to develop a set of resources on divorce for families, Dr. Bauer recommended.

Books on the topic can be great conversation starters, and many are available for various age-groups, she noted. Examples include “Was It the Chocolate Pudding? A Story for Little Kids About Divorce” (Washington: Magination Press, 2005) for ages 4-7 years, “Divorced but Still My Parents” (Longmont, Colo. : Springboard Publications, 1997) for ages 6-12 years, and “My Mom and Dad Don’t Live Together Anymore: A Drawing Book for Children of Separated or Divorced Parents” (Washington: Magination Press, 2002) for ages 8-12 years.

Sesame Street has a toolkit on divorce that offers printable materials, songs, and an app that features conversation starters and vignettes, according to Dr. Bauer; go to sesamestreet.org and type in “divorce.” Additionally, the documentary SPLIT at splitfilm.org follows real families going through divorce and helps show the child’s perspective.

When parents ask about legal references, they can be referred to the UpToParents website, a free resource and curriculum developed by attorneys on topics such as divorce, in both English and Spanish.

Finally, familiarize yourself with resources available in your local community, such as divorce education programs, and services offered for divorce and custody mediation, so that you can link parents to them as needed.

Dr. Bauer said she has no relevant financial disclosures.

SAN FRANCISCO – By choosing your words carefully, counseling families about divorce can tactfully address sensitive issues and help parents and children better cope with this life transition, Nerissa S. Bauer, MD, said at the annual meeting of the American Academy of Pediatrics.

About one in five children born within a marriage and one in two of those born within a cohabiting union will experience breakup of that relationship by the age of 9 years, she said.

You must, therefore, be prepared to monitor for and identify outcomes that commonly result from divorce, and to counsel families about how to help children cope and manage. Yet, you may feel uneasy or ill-prepared to do so.

“Turn this thought of ‘I wasn’t trained for this’ into ‘I can help,’ ” recommended Dr. Bauer, who is a specialist in behavioral pediatrics at the Indiana University in Indianapolis.

Risk and protective factors

Divorce can have an impact on all facets of a child’s life: behavior, physical and mental health, academic performance, social relationships, delinquency, substance use, and more. A variety of factors determine how well kids adjust to this stressor, for better or worse.

Marital conflict, both during and after divorce, is a more important predictor than the divorce itself. “The biggest risk factor to consider is the ongoing parental fighting and how that plays out,” Dr. Bauer elaborated. Although parents may report that they try to limit altercations in front of their children, kids usually sense what is going on anyway.

“One of the ways that I like to phrase this when I’m trying to figure out how bad the conflict is in the household is, ‘Has Johnny ever witnessed your arguments, and if so, have those arguments ever been more than just yelling?’ Or another way to say it is, ‘How do adults in your home resolve conflicts?’ ” she shared.

Divorce may negatively affect children through its impact on the household’s socioeconomic status too. For example, the standard of living often declines and the mother’s economic resources can take a hit, possibly forcing a move to a less expensive neighborhood with weaker schools and more crime.

To sound parents out on this sensitive issue, “You can say something like, ‘I’m really sorry that you’re going through this right now. Sometimes, it can cause a lot of stress and strain, especially when it comes to making ends meet, making sure you can get food on the table, and making sure you’re paying the bills. Do you have worries like this now?’ ” Dr. Bauer suggested.

Factors that are known to protect children from adverse divorce outcomes include a good relationship with at least one parent or caregiver, parental warmth, sibling support, and for teens, good self-esteem and peer support. Joint custody with shared decision making and greater paternal involvement also are protective.

“I like to say, ‘So I can understand how this affects your daily life, can you describe what your current arrangements are between you and your ex?’ just to sort of probe into that custody situation,” she said. “Or, ‘How are you (parents) handling this?’ ”

Surveillance and monitoring

“Perform surveillance on family structure and conflict at all well-child visits, as well as with any new family that comes to your practice,” Dr. Bauer recommended. You can do this by simply chatting with the family or by using screening tools such as the Family Psychosocial Screen or the Finding Your ACE Score.

Once you know that a family is dealing with divorce, perform ongoing monitoring for warning signs in the child: sleep problems; school problems, such as poor concentration, acting out, or not doing schoolwork; angry outbursts; withdrawal; and no longer participating in activities once enjoyed.

You may worry about getting dragged into the conflict. “You may feel that you’re in this position of being the mediator, but that’s not really your role. And you shouldn’t offer legal advice,” she cautioned. “You should make it clear that although you are there to support the child and the parents, your role is really to monitor how the child responds and adjusts.”

Parents will sometimes ask whether and how best to tell their children about the divorce. “I oftentimes coach parents to use kid-friendly terms, saying things such as, ‘Mommy and Daddy are having a hard time getting along, and you’ve probably noticed we argue or fight a lot.’ Just throwing it out there and pausing and waiting to see what the child says, and then always following that by answering their questions as they bring them up,” Dr. Bauer said.

Parents should be counseled not to rush children as they will vary in the time needed to process information. Additionally, they should be forewarned that children’s reactions can vary widely and that their feelings can change and resurface at any moment, particularly as they mature and at events that stir up emotions.

Messages of reassurance are essential. “The messages should always contain, ‘We are always going to be your parents no matter what’ and ‘We love you no matter what,’ and probably the most important, ‘This is not your fault.’ This is a message that kids need to hear again and again,” Dr. Bauer said.
 

Ongoing counseling

Over time, parents may consult you about specific situations that arise because of the divorce. For example, they may become frustrated by differences in how things are handled in the two households.

“The most important message to convey is that we can control only what we can control,” Dr. Bauer said. “Regardless of divorce or separation, kids thrive on structure and routine. Divorce is often messy, and it sometimes means that families have to find a new rhythm between households, but routines in each house should be as consistent as possible.”

Acrimony between the mother and father may persist or escalate. As children don’t want to have to choose between parents, parents should be encouraged not to undermine or talk negatively about each other in front of the child. If necessary, you can arrange to have time separately with parents to allow them to air their grievances.

If parents give permission to broach the topic of divorce, you can role model conversational strategies during visits. “You can say something like, ‘I understand there are a lot of changes going on. Through it all, your mom and dad will always be your parents. I know this isn’t easy for anybody, especially for you. Kids in this situation feel a lot of things from sadness to anger but know that you can always talk to me or your parents about your feelings,’” Dr. Bauer elaborated.

“Listening is key,” she stressed; therefore, parents should be encouraged to just sit in silence and let their children process their feelings. “In these types of situations, there’s no right or wrong: When the child has feelings, they have feelings. We can’t force them to feel a certain way, we have to acknowledge that. So tell parents to try this: ‘Thanks for telling me how you feel. I want you to know that you can always come to me when you feel this way.’ See what happens.”

Parents should be advised not to be too quick to dismiss their child’s concerns, Dr. Bauer recommended. “So, instead of saying, ‘Oh honey, you don’t have to worry about that, I’ll take care of it,’ try this: ‘It sounds like you are sad and upset right now. What can I do to help?’ Sometimes a kid will say, ‘I don’t know,’ but that’s okay. Then the parent can respond in kind and say, ‘I don’t know either, but how about a hug? Let’s start there.’ ”

Some kids simply aren’t talkers and shouldn’t be forced to share, she pointed out. This group can be given other ways to express their feelings, such as journaling, drawing, art, music, yoga, or writing a letter that they then throw away or put in a drawer.

Finally, “reminding parents that even giving children a little control with daily things – what they wear, how they do their chores, and homework, and what to make for dinner – can also help,” she noted. “Those little things can represent a lot for children who don’t feel like they have any control.”

Building resources

Explore various media and online tools to develop a set of resources on divorce for families, Dr. Bauer recommended.

Books on the topic can be great conversation starters, and many are available for various age-groups, she noted. Examples include “Was It the Chocolate Pudding? A Story for Little Kids About Divorce” (Washington: Magination Press, 2005) for ages 4-7 years, “Divorced but Still My Parents” (Longmont, Colo. : Springboard Publications, 1997) for ages 6-12 years, and “My Mom and Dad Don’t Live Together Anymore: A Drawing Book for Children of Separated or Divorced Parents” (Washington: Magination Press, 2002) for ages 8-12 years.

Sesame Street has a toolkit on divorce that offers printable materials, songs, and an app that features conversation starters and vignettes, according to Dr. Bauer; go to sesamestreet.org and type in “divorce.” Additionally, the documentary SPLIT at splitfilm.org follows real families going through divorce and helps show the child’s perspective.

When parents ask about legal references, they can be referred to the UpToParents website, a free resource and curriculum developed by attorneys on topics such as divorce, in both English and Spanish.

Finally, familiarize yourself with resources available in your local community, such as divorce education programs, and services offered for divorce and custody mediation, so that you can link parents to them as needed.

Dr. Bauer said she has no relevant financial disclosures.

SAN FRANCISCO – By choosing your words carefully, counseling families about divorce can tactfully address sensitive issues and help parents and children better cope with this life transition, Nerissa S. Bauer, MD, said at the annual meeting of the American Academy of Pediatrics.

About one in five children born within a marriage and one in two of those born within a cohabiting union will experience breakup of that relationship by the age of 9 years, she said.

You must, therefore, be prepared to monitor for and identify outcomes that commonly result from divorce, and to counsel families about how to help children cope and manage. Yet, you may feel uneasy or ill-prepared to do so.

“Turn this thought of ‘I wasn’t trained for this’ into ‘I can help,’ ” recommended Dr. Bauer, who is a specialist in behavioral pediatrics at the Indiana University in Indianapolis.

Risk and protective factors

Divorce can have an impact on all facets of a child’s life: behavior, physical and mental health, academic performance, social relationships, delinquency, substance use, and more. A variety of factors determine how well kids adjust to this stressor, for better or worse.

Marital conflict, both during and after divorce, is a more important predictor than the divorce itself. “The biggest risk factor to consider is the ongoing parental fighting and how that plays out,” Dr. Bauer elaborated. Although parents may report that they try to limit altercations in front of their children, kids usually sense what is going on anyway.

“One of the ways that I like to phrase this when I’m trying to figure out how bad the conflict is in the household is, ‘Has Johnny ever witnessed your arguments, and if so, have those arguments ever been more than just yelling?’ Or another way to say it is, ‘How do adults in your home resolve conflicts?’ ” she shared.

Divorce may negatively affect children through its impact on the household’s socioeconomic status too. For example, the standard of living often declines and the mother’s economic resources can take a hit, possibly forcing a move to a less expensive neighborhood with weaker schools and more crime.

To sound parents out on this sensitive issue, “You can say something like, ‘I’m really sorry that you’re going through this right now. Sometimes, it can cause a lot of stress and strain, especially when it comes to making ends meet, making sure you can get food on the table, and making sure you’re paying the bills. Do you have worries like this now?’ ” Dr. Bauer suggested.

Factors that are known to protect children from adverse divorce outcomes include a good relationship with at least one parent or caregiver, parental warmth, sibling support, and for teens, good self-esteem and peer support. Joint custody with shared decision making and greater paternal involvement also are protective.

“I like to say, ‘So I can understand how this affects your daily life, can you describe what your current arrangements are between you and your ex?’ just to sort of probe into that custody situation,” she said. “Or, ‘How are you (parents) handling this?’ ”

Surveillance and monitoring

“Perform surveillance on family structure and conflict at all well-child visits, as well as with any new family that comes to your practice,” Dr. Bauer recommended. You can do this by simply chatting with the family or by using screening tools such as the Family Psychosocial Screen or the Finding Your ACE Score.

Once you know that a family is dealing with divorce, perform ongoing monitoring for warning signs in the child: sleep problems; school problems, such as poor concentration, acting out, or not doing schoolwork; angry outbursts; withdrawal; and no longer participating in activities once enjoyed.

You may worry about getting dragged into the conflict. “You may feel that you’re in this position of being the mediator, but that’s not really your role. And you shouldn’t offer legal advice,” she cautioned. “You should make it clear that although you are there to support the child and the parents, your role is really to monitor how the child responds and adjusts.”

Parents will sometimes ask whether and how best to tell their children about the divorce. “I oftentimes coach parents to use kid-friendly terms, saying things such as, ‘Mommy and Daddy are having a hard time getting along, and you’ve probably noticed we argue or fight a lot.’ Just throwing it out there and pausing and waiting to see what the child says, and then always following that by answering their questions as they bring them up,” Dr. Bauer said.

Parents should be counseled not to rush children as they will vary in the time needed to process information. Additionally, they should be forewarned that children’s reactions can vary widely and that their feelings can change and resurface at any moment, particularly as they mature and at events that stir up emotions.

Messages of reassurance are essential. “The messages should always contain, ‘We are always going to be your parents no matter what’ and ‘We love you no matter what,’ and probably the most important, ‘This is not your fault.’ This is a message that kids need to hear again and again,” Dr. Bauer said.
 

Ongoing counseling

Over time, parents may consult you about specific situations that arise because of the divorce. For example, they may become frustrated by differences in how things are handled in the two households.

“The most important message to convey is that we can control only what we can control,” Dr. Bauer said. “Regardless of divorce or separation, kids thrive on structure and routine. Divorce is often messy, and it sometimes means that families have to find a new rhythm between households, but routines in each house should be as consistent as possible.”

Acrimony between the mother and father may persist or escalate. As children don’t want to have to choose between parents, parents should be encouraged not to undermine or talk negatively about each other in front of the child. If necessary, you can arrange to have time separately with parents to allow them to air their grievances.

If parents give permission to broach the topic of divorce, you can role model conversational strategies during visits. “You can say something like, ‘I understand there are a lot of changes going on. Through it all, your mom and dad will always be your parents. I know this isn’t easy for anybody, especially for you. Kids in this situation feel a lot of things from sadness to anger but know that you can always talk to me or your parents about your feelings,’” Dr. Bauer elaborated.

“Listening is key,” she stressed; therefore, parents should be encouraged to just sit in silence and let their children process their feelings. “In these types of situations, there’s no right or wrong: When the child has feelings, they have feelings. We can’t force them to feel a certain way, we have to acknowledge that. So tell parents to try this: ‘Thanks for telling me how you feel. I want you to know that you can always come to me when you feel this way.’ See what happens.”

Parents should be advised not to be too quick to dismiss their child’s concerns, Dr. Bauer recommended. “So, instead of saying, ‘Oh honey, you don’t have to worry about that, I’ll take care of it,’ try this: ‘It sounds like you are sad and upset right now. What can I do to help?’ Sometimes a kid will say, ‘I don’t know,’ but that’s okay. Then the parent can respond in kind and say, ‘I don’t know either, but how about a hug? Let’s start there.’ ”

Some kids simply aren’t talkers and shouldn’t be forced to share, she pointed out. This group can be given other ways to express their feelings, such as journaling, drawing, art, music, yoga, or writing a letter that they then throw away or put in a drawer.

Finally, “reminding parents that even giving children a little control with daily things – what they wear, how they do their chores, and homework, and what to make for dinner – can also help,” she noted. “Those little things can represent a lot for children who don’t feel like they have any control.”

Building resources

Explore various media and online tools to develop a set of resources on divorce for families, Dr. Bauer recommended.

Books on the topic can be great conversation starters, and many are available for various age-groups, she noted. Examples include “Was It the Chocolate Pudding? A Story for Little Kids About Divorce” (Washington: Magination Press, 2005) for ages 4-7 years, “Divorced but Still My Parents” (Longmont, Colo. : Springboard Publications, 1997) for ages 6-12 years, and “My Mom and Dad Don’t Live Together Anymore: A Drawing Book for Children of Separated or Divorced Parents” (Washington: Magination Press, 2002) for ages 8-12 years.

Sesame Street has a toolkit on divorce that offers printable materials, songs, and an app that features conversation starters and vignettes, according to Dr. Bauer; go to sesamestreet.org and type in “divorce.” Additionally, the documentary SPLIT at splitfilm.org follows real families going through divorce and helps show the child’s perspective.

When parents ask about legal references, they can be referred to the UpToParents website, a free resource and curriculum developed by attorneys on topics such as divorce, in both English and Spanish.

Finally, familiarize yourself with resources available in your local community, such as divorce education programs, and services offered for divorce and custody mediation, so that you can link parents to them as needed.

Dr. Bauer said she has no relevant financial disclosures.

A strategy of conservatively controlling oxygen delivery to patients in the intensive care unit results in lower mortality than the conventional, more liberal approach whereby patients are often kept in a hyperoxemic state, finds a randomized controlled trial.

The trial, known as Oxygen-ICU, enrolled more than 400 adult ICU patients from an Italian center. Initially planned to last 2 years, it was terminated early because of slow enrollment after an earthquake reduced ICU capacity, with the decision supported by positive results of an interim analysis.

Patients had an absolute nearly 9% lower risk of dying in the ICU with use of the conservative oxygen strategy as compared with the conventional one, according to data reported at the annual congress of the European Society of Intensive Care Medicine and simultaneously published (JAMA. 2016 Oct 5. doi: 10.1001/jama.2016.11993).

“To our knowledge, this is the first randomized clinical trial to evaluate the effect of a conservative oxygen therapy on mortality compared with a standard, more liberal approach in a medical-surgical population of adult critically ill patients,” write the investigators, who were led by Massimo Girardis, MD, of the Intensive Care Unit, Department of Anesthesiology and Intensive Care, University Hospital of Modena (Italy).

Among critically ill patients with an ICU length of stay of 72 hours or longer, a conservative protocol for oxygen therapy compared with conventional therapy resulted in a lower ICU mortality,” they conclude. “However, these preliminary findings were based on unplanned early termination of the trial, and a larger multicenter trial is needed to evaluate the potential benefit of such conservative oxygen therapy in critically ill patients.”

In the trial, consecutive patients were randomized evenly to receive conservative oxygen therapy (maintenance of PaO₂ between 70 and 100 mm Hg or arterial oxyhemoglobin saturation [SpO₂] between 94% and 98%) or conventional oxygen therapy (allowance of PaO₂ values up to 150 mm Hg or SpO₂ values between 97% and 100%) on an open-label basis.

The originally targeted enrollment was 660 patients, but the study was stopped early after only 480 patients had been enrolled.

Results of modified intent-to-treat analyses showed that daily time-weighted PaO₂ averages during patients’ ICU stays were higher in the conventional group than in the conservative group (median PaO₂, 102 vs. 87 mm Hg; P less than .001).

The rate of ICU mortality, the trial’s primary endpoint, was 11.6% with conservative therapy, about half of the 20.2% seen with conventional therapy (absolute mean difference, 0.086; P = .01).

The conservative group also had lower rates of shock (3.7% vs. 10.6%, P = .006), liver failure (1.9% vs. 6.4%, P = .02), and bacteremia (5.1% vs. 10.1%, P = .049). And they spent a day less on the ventilator (median mechanical ventilation–free hours, 72 vs. 48; P = .02).

Lengths of ICU stay and hospital stay did not differ between the two groups.

One of the study authors reports serving as the data monitoring chair for a phase II study sponsored by InflaRx, on the antibiotic advisory board for Bayer, and on sepsis advisory boards for Biotest and Merck. The study was supported by the National Fund for Scientific Research of the University of Modena and Reggio Emilia.

A strategy of conservatively controlling oxygen delivery to patients in the intensive care unit results in lower mortality than the conventional, more liberal approach whereby patients are often kept in a hyperoxemic state, finds a randomized controlled trial.

The trial, known as Oxygen-ICU, enrolled more than 400 adult ICU patients from an Italian center. Initially planned to last 2 years, it was terminated early because of slow enrollment after an earthquake reduced ICU capacity, with the decision supported by positive results of an interim analysis.

Patients had an absolute nearly 9% lower risk of dying in the ICU with use of the conservative oxygen strategy as compared with the conventional one, according to data reported at the annual congress of the European Society of Intensive Care Medicine and simultaneously published (JAMA. 2016 Oct 5. doi: 10.1001/jama.2016.11993).

“To our knowledge, this is the first randomized clinical trial to evaluate the effect of a conservative oxygen therapy on mortality compared with a standard, more liberal approach in a medical-surgical population of adult critically ill patients,” write the investigators, who were led by Massimo Girardis, MD, of the Intensive Care Unit, Department of Anesthesiology and Intensive Care, University Hospital of Modena (Italy).

Among critically ill patients with an ICU length of stay of 72 hours or longer, a conservative protocol for oxygen therapy compared with conventional therapy resulted in a lower ICU mortality,” they conclude. “However, these preliminary findings were based on unplanned early termination of the trial, and a larger multicenter trial is needed to evaluate the potential benefit of such conservative oxygen therapy in critically ill patients.”

In the trial, consecutive patients were randomized evenly to receive conservative oxygen therapy (maintenance of PaO₂ between 70 and 100 mm Hg or arterial oxyhemoglobin saturation [SpO₂] between 94% and 98%) or conventional oxygen therapy (allowance of PaO₂ values up to 150 mm Hg or SpO₂ values between 97% and 100%) on an open-label basis.

The originally targeted enrollment was 660 patients, but the study was stopped early after only 480 patients had been enrolled.

Results of modified intent-to-treat analyses showed that daily time-weighted PaO₂ averages during patients’ ICU stays were higher in the conventional group than in the conservative group (median PaO₂, 102 vs. 87 mm Hg; P less than .001).

The rate of ICU mortality, the trial’s primary endpoint, was 11.6% with conservative therapy, about half of the 20.2% seen with conventional therapy (absolute mean difference, 0.086; P = .01).

The conservative group also had lower rates of shock (3.7% vs. 10.6%, P = .006), liver failure (1.9% vs. 6.4%, P = .02), and bacteremia (5.1% vs. 10.1%, P = .049). And they spent a day less on the ventilator (median mechanical ventilation–free hours, 72 vs. 48; P = .02).

Lengths of ICU stay and hospital stay did not differ between the two groups.

One of the study authors reports serving as the data monitoring chair for a phase II study sponsored by InflaRx, on the antibiotic advisory board for Bayer, and on sepsis advisory boards for Biotest and Merck. The study was supported by the National Fund for Scientific Research of the University of Modena and Reggio Emilia.

A strategy of conservatively controlling oxygen delivery to patients in the intensive care unit results in lower mortality than the conventional, more liberal approach whereby patients are often kept in a hyperoxemic state, finds a randomized controlled trial.

The trial, known as Oxygen-ICU, enrolled more than 400 adult ICU patients from an Italian center. Initially planned to last 2 years, it was terminated early because of slow enrollment after an earthquake reduced ICU capacity, with the decision supported by positive results of an interim analysis.

Patients had an absolute nearly 9% lower risk of dying in the ICU with use of the conservative oxygen strategy as compared with the conventional one, according to data reported at the annual congress of the European Society of Intensive Care Medicine and simultaneously published (JAMA. 2016 Oct 5. doi: 10.1001/jama.2016.11993).

“To our knowledge, this is the first randomized clinical trial to evaluate the effect of a conservative oxygen therapy on mortality compared with a standard, more liberal approach in a medical-surgical population of adult critically ill patients,” write the investigators, who were led by Massimo Girardis, MD, of the Intensive Care Unit, Department of Anesthesiology and Intensive Care, University Hospital of Modena (Italy).

Among critically ill patients with an ICU length of stay of 72 hours or longer, a conservative protocol for oxygen therapy compared with conventional therapy resulted in a lower ICU mortality,” they conclude. “However, these preliminary findings were based on unplanned early termination of the trial, and a larger multicenter trial is needed to evaluate the potential benefit of such conservative oxygen therapy in critically ill patients.”

In the trial, consecutive patients were randomized evenly to receive conservative oxygen therapy (maintenance of PaO₂ between 70 and 100 mm Hg or arterial oxyhemoglobin saturation [SpO₂] between 94% and 98%) or conventional oxygen therapy (allowance of PaO₂ values up to 150 mm Hg or SpO₂ values between 97% and 100%) on an open-label basis.

The originally targeted enrollment was 660 patients, but the study was stopped early after only 480 patients had been enrolled.

Results of modified intent-to-treat analyses showed that daily time-weighted PaO₂ averages during patients’ ICU stays were higher in the conventional group than in the conservative group (median PaO₂, 102 vs. 87 mm Hg; P less than .001).

The rate of ICU mortality, the trial’s primary endpoint, was 11.6% with conservative therapy, about half of the 20.2% seen with conventional therapy (absolute mean difference, 0.086; P = .01).

The conservative group also had lower rates of shock (3.7% vs. 10.6%, P = .006), liver failure (1.9% vs. 6.4%, P = .02), and bacteremia (5.1% vs. 10.1%, P = .049). And they spent a day less on the ventilator (median mechanical ventilation–free hours, 72 vs. 48; P = .02).

Lengths of ICU stay and hospital stay did not differ between the two groups.

One of the study authors reports serving as the data monitoring chair for a phase II study sponsored by InflaRx, on the antibiotic advisory board for Bayer, and on sepsis advisory boards for Biotest and Merck. The study was supported by the National Fund for Scientific Research of the University of Modena and Reggio Emilia.

Four pivotal breast cancer trials were presented at the 2016 annual meeting of the American Society of Clinical Oncology in Chicago. The MA.17R trial, which was the plenary talk by Dr Paul Goss, looked at extending adjuvant aromatase inhibitors to 10 years or beyond in postmenopausal women; two presentations reported on mutations after progression in metastatic breast cancer, one on first-line AIs and the other on prior endocrine therapy (PALOMA-3); and results from the Z0011 trial showed that sentinel lymph node dissection without axillary lymph node dissection might show promising 10-year loco-regional control and survival outcomes.

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Four pivotal breast cancer trials were presented at the 2016 annual meeting of the American Society of Clinical Oncology in Chicago. The MA.17R trial, which was the plenary talk by Dr Paul Goss, looked at extending adjuvant aromatase inhibitors to 10 years or beyond in postmenopausal women; two presentations reported on mutations after progression in metastatic breast cancer, one on first-line AIs and the other on prior endocrine therapy (PALOMA-3); and results from the Z0011 trial showed that sentinel lymph node dissection without axillary lymph node dissection might show promising 10-year loco-regional control and survival outcomes.

Click on the PDF icon at the top of this introduction to read the full article.

Four pivotal breast cancer trials were presented at the 2016 annual meeting of the American Society of Clinical Oncology in Chicago. The MA.17R trial, which was the plenary talk by Dr Paul Goss, looked at extending adjuvant aromatase inhibitors to 10 years or beyond in postmenopausal women; two presentations reported on mutations after progression in metastatic breast cancer, one on first-line AIs and the other on prior endocrine therapy (PALOMA-3); and results from the Z0011 trial showed that sentinel lymph node dissection without axillary lymph node dissection might show promising 10-year loco-regional control and survival outcomes.

Click on the PDF icon at the top of this introduction to read the full article.