Osteoarthritis hip pain follows four distinct paths

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Osteoarthritis hip pain follows four distinct paths

AMSTERDAM – There are four distinct patterns of pain in patients with early presumed hip osteoarthritis, and several factors could help identify patients most likely to experience more severe pain, according to analysis from a Dutch study.

The majority of the 545 patients included in the analysis from the Cohort Hip and Knee (CHECK) study experienced a low or a mild constant hip pain over a 5-year follow-up period (231 patients, 42.4%). Around one-quarter had moderate hip pain with moderate pain progression (132 patients, 24.2%), about one in six (88 patients, 16.1%) had moderate hip pain with moderate pain regression, and the remainder (94 patients, 17.2%) had constant, severe hip pain.

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Factors associated with these pain trajectories included the level of education achieved, ability to cope with pain, the Western Ontario and McMaster Universities Arthritis Index (WOMAC) physical function subscale, and pain experienced from internal rotation of the hip.

The findings were reported at the World Congress on Osteoarthritis sponsored by the Osteoarthritis Research Society International. They were also published online in Osteoarthritis and Cartilage (2106 Feb 5. doi: 10.1016/j.joca.2015.11.023).

Although prior studies examined progression predictors in hip OA, none looked specifically at how pain changes over time, noted study author Dr. Alex Bastick of Erasmus University Medical Center, Rotterdam, the Netherlands. Thus, the current aim was to define the trajectory of hip pain among individuals with early symptoms of hip OA, and identify any baseline factors that might help clinicians predict which pain trajectory patients may follow.

The CHECK study is a 10-year nationwide cohort study of 1,002 participants in the Netherlands with assumed early symptomatic OA of the knee, hip, or both. For the current analysis, Dr. Bastick and his associates considered only those patients with hip pain or stiffness who had completed 5 years of follow-up. At baseline, the mean age of the total population was 55.7 years, and 81% of participants were female. About one-quarter (26%) of participants had a clinical OA diagnosis according to American College of Rheumatology criteria.

Baseline radiographic severity was not associated with the various pain trajectories identified, Dr. Bastick observed, but patients who had achieved a lower level of education were roughly three times more likely to experience severe pain than mild or low constant pain. Patients experiencing severe pain were more likely to use pain transformation as a coping strategy, have higher activity limitation scores, and experience painful internal hip rotation.

Because around 60% of patients follow the mild or moderately progressing pain trajectories, conservative treatment in the early stages of hip OA appears appropriate, Dr. Bastick and his associates suggested. Their findings highlight the importance of a physical examination, and that reassessment of clinical symptoms should perhaps be undertaken in the first year of follow-up.

“Future research should be aimed at measuring symptomatic progression of hip OA with even more frequent symptom assessment,” the researchers proposed.

Reumafonds, the Dutch Arthritis Foundation, funded the study. Dr. Bastick did not have financial disclosures.

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AMSTERDAM – There are four distinct patterns of pain in patients with early presumed hip osteoarthritis, and several factors could help identify patients most likely to experience more severe pain, according to analysis from a Dutch study.

The majority of the 545 patients included in the analysis from the Cohort Hip and Knee (CHECK) study experienced a low or a mild constant hip pain over a 5-year follow-up period (231 patients, 42.4%). Around one-quarter had moderate hip pain with moderate pain progression (132 patients, 24.2%), about one in six (88 patients, 16.1%) had moderate hip pain with moderate pain regression, and the remainder (94 patients, 17.2%) had constant, severe hip pain.

©iStock/Thinkstock

Factors associated with these pain trajectories included the level of education achieved, ability to cope with pain, the Western Ontario and McMaster Universities Arthritis Index (WOMAC) physical function subscale, and pain experienced from internal rotation of the hip.

The findings were reported at the World Congress on Osteoarthritis sponsored by the Osteoarthritis Research Society International. They were also published online in Osteoarthritis and Cartilage (2106 Feb 5. doi: 10.1016/j.joca.2015.11.023).

Although prior studies examined progression predictors in hip OA, none looked specifically at how pain changes over time, noted study author Dr. Alex Bastick of Erasmus University Medical Center, Rotterdam, the Netherlands. Thus, the current aim was to define the trajectory of hip pain among individuals with early symptoms of hip OA, and identify any baseline factors that might help clinicians predict which pain trajectory patients may follow.

The CHECK study is a 10-year nationwide cohort study of 1,002 participants in the Netherlands with assumed early symptomatic OA of the knee, hip, or both. For the current analysis, Dr. Bastick and his associates considered only those patients with hip pain or stiffness who had completed 5 years of follow-up. At baseline, the mean age of the total population was 55.7 years, and 81% of participants were female. About one-quarter (26%) of participants had a clinical OA diagnosis according to American College of Rheumatology criteria.

Baseline radiographic severity was not associated with the various pain trajectories identified, Dr. Bastick observed, but patients who had achieved a lower level of education were roughly three times more likely to experience severe pain than mild or low constant pain. Patients experiencing severe pain were more likely to use pain transformation as a coping strategy, have higher activity limitation scores, and experience painful internal hip rotation.

Because around 60% of patients follow the mild or moderately progressing pain trajectories, conservative treatment in the early stages of hip OA appears appropriate, Dr. Bastick and his associates suggested. Their findings highlight the importance of a physical examination, and that reassessment of clinical symptoms should perhaps be undertaken in the first year of follow-up.

“Future research should be aimed at measuring symptomatic progression of hip OA with even more frequent symptom assessment,” the researchers proposed.

Reumafonds, the Dutch Arthritis Foundation, funded the study. Dr. Bastick did not have financial disclosures.

AMSTERDAM – There are four distinct patterns of pain in patients with early presumed hip osteoarthritis, and several factors could help identify patients most likely to experience more severe pain, according to analysis from a Dutch study.

The majority of the 545 patients included in the analysis from the Cohort Hip and Knee (CHECK) study experienced a low or a mild constant hip pain over a 5-year follow-up period (231 patients, 42.4%). Around one-quarter had moderate hip pain with moderate pain progression (132 patients, 24.2%), about one in six (88 patients, 16.1%) had moderate hip pain with moderate pain regression, and the remainder (94 patients, 17.2%) had constant, severe hip pain.

©iStock/Thinkstock

Factors associated with these pain trajectories included the level of education achieved, ability to cope with pain, the Western Ontario and McMaster Universities Arthritis Index (WOMAC) physical function subscale, and pain experienced from internal rotation of the hip.

The findings were reported at the World Congress on Osteoarthritis sponsored by the Osteoarthritis Research Society International. They were also published online in Osteoarthritis and Cartilage (2106 Feb 5. doi: 10.1016/j.joca.2015.11.023).

Although prior studies examined progression predictors in hip OA, none looked specifically at how pain changes over time, noted study author Dr. Alex Bastick of Erasmus University Medical Center, Rotterdam, the Netherlands. Thus, the current aim was to define the trajectory of hip pain among individuals with early symptoms of hip OA, and identify any baseline factors that might help clinicians predict which pain trajectory patients may follow.

The CHECK study is a 10-year nationwide cohort study of 1,002 participants in the Netherlands with assumed early symptomatic OA of the knee, hip, or both. For the current analysis, Dr. Bastick and his associates considered only those patients with hip pain or stiffness who had completed 5 years of follow-up. At baseline, the mean age of the total population was 55.7 years, and 81% of participants were female. About one-quarter (26%) of participants had a clinical OA diagnosis according to American College of Rheumatology criteria.

Baseline radiographic severity was not associated with the various pain trajectories identified, Dr. Bastick observed, but patients who had achieved a lower level of education were roughly three times more likely to experience severe pain than mild or low constant pain. Patients experiencing severe pain were more likely to use pain transformation as a coping strategy, have higher activity limitation scores, and experience painful internal hip rotation.

Because around 60% of patients follow the mild or moderately progressing pain trajectories, conservative treatment in the early stages of hip OA appears appropriate, Dr. Bastick and his associates suggested. Their findings highlight the importance of a physical examination, and that reassessment of clinical symptoms should perhaps be undertaken in the first year of follow-up.

“Future research should be aimed at measuring symptomatic progression of hip OA with even more frequent symptom assessment,” the researchers proposed.

Reumafonds, the Dutch Arthritis Foundation, funded the study. Dr. Bastick did not have financial disclosures.

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Osteoarthritis hip pain follows four distinct paths
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Key clinical point: Understanding how osteoarthritis hip pain changes over time may help manage those who experience severe pain.

Major finding: Four hip pain trajectories were identified: low, mild constant pain (42.4%, n = 231); moderate, with moderate pain progression (24.2%, n = 132); moderate, with moderate pain regression (16.1%, n = 88); and constant severe pain (17.2%, n = 94).

Data source: The Cohort Hip and Knee (CHECK) study, a Dutch, prospective, nationwide study of 1,002 participants with assumed early symptomatic osteoarthritis of the knee, hip, or both.

Disclosures: Reumafonds, the Dutch Arthritis Foundation, funded the study. Dr. Bastick did not have financial disclosures.

Stem cells show heart failure benefits in phase II trial

Results merit phase III trial follow-up
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CHICAGO – After rattling around in early-stage clinical studies for more than a decade, stem cell therapy for heart failure may have finally gained the efficacy evidence to send it to the next level: large-scale, phase III trials.

Patients with ischemic cardiomyopathy and severe heart failure showed a statistically significant 37% relative reduction in their combined rate of death and cardiovascular hospitalization during 1 year of follow-up after autologous stem cell injections to their left ventricular myocardium in a multicenter, fully blinded control, phase II trial with 109 North American patients.

Mitchel L. Zoler/Frontline Medical News
Dr. Timothy D. Henry

The treatment used a technique in commercial development by Vericel that selectively expands ex vivo bone marrow cells taken from the heart failure patient. Clinicians inject 0.4 mL aliquots of the expanded cells – enriched for mesenchymal stem cells and M2 macrophages – via a transcatheter approach into the left ventricular myocardium using 12-17 injections per patient. The bone marrow preparation during ex vivo expansion is called ixmyelocel-T.

This treatment now needs testing in more patients, Dr. Timothy D. Henry said at the annual meeting of the American College of Cardiology. “We need a new generation of cell trials in larger studies with completely double-blind, placebo controls using a more uniform preparation of cells,” said Dr. Henry.

“To the best of our knowledge, ixCELL-DCM is the largest randomized, double-blind clinical trial to date for cell therapy use in congestive heart failure,” said Dr. Henry and his associates in their report. The concept of stem cell therapy to replace damaged myocardium “has been very attractive, but most clinical trials to date have been small and unblinded, and used unselected bone marrow cells,” explained Dr. Henry, director of cardiology at the Cedars-Sinai Heart Institute in Los Angeles.

The ixCELL-DCM study ran at 31 sites in the United States and Canada. About 90% of patients had New York Heart Association class III disease, the average left ventricular ejection fraction was about 25%, patients on average would cover about 310 m during a 6-minute walk test, and the average serum level of NT-ProBNP was about 1,900 pg/L. Patients in the control arm all underwent the same bone marrow retrieval and transcatheter injection into the left ventricle, but the injections only contained carrier material without active cells.

The primary endpoint of death or a cardiovascular event, primarily hospitalization, occurred at a rate of 110 events per 100 patient years during 1-year follow-up of 51 patients in the sham-treatment group. In the active-treatment arm, the endpoint occurred at a rate of 70 events per 100 patient years among 58 patients. The difference was primarily driven by a 3% death rate with cell therapy, compared with a 14% rate in the controls, and a 38% hospitalization rate, compared with a 47% rate among controls.

The study results appeared online concurrent with Dr. Henry’s report (Lancet. 2016 Apr 5. doi: 10.1016/S0140-6736[16]30137-4).

The results showed no significant differences between the active and sham groups for changes in left ventricular size, ejection fraction, and 6-minute walk distance.

“This trial was designed to look at events. It is not a cause for concern that we did not see effects on heart function,” Dr. Henry said. The current results were also generally consistent with results from two earlier, controlled, phase II studies with a total of 61 patients (Circ Res. 2014 Sep 26;115[8]:730-7).

In the safety analysis, done in 114 patients, the rates of all adverse events and major adverse cardiovascular events were similar in the two arms. The rate of serious adverse events was significantly reduced in the patients treated with expanded bone marrow cells, compared with the controls.

The high rate of death and hospitalization of patients with severe heart failure “is a very large, unmet need, so it’s a natural to go to a larger trial,” Dr. Henry said. “The cell preparation was very safe and easy to do.”

Another pressing research issue is to try to understand the mechanism by which the cell treatment improves clinical outcomes, with improved heart function or improved exercise capacity apparently excluded as mechanisms.

The trial was sponsored by Vericel, the company developing the ex vivo protocol for selective marrow cell expansion. Dr. Henry has been a consultant to or received honoraria from Abbott Vascular, Baxter, Capricor, Cytori, Eli Lilly, and the Medicines Company, and he has received research grants from Aastrom, Baxter International, Mesoblast, and Vericel.

[email protected]

On Twitter @mitchelzoler

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The results reported by Dr. Henry come from one of the first trials of stem cell or bone marrow treatment of failing hearts that used clinical outcomes as the primary endpoint. In contrast, prior studies focused on changes in functional characteristics of patients, such as 6-minute walk distance or left ventricular ejection fraction or size. What makes Dr. Henry’s study distinctive is that it showed benefit for a clinical outcome: the rate of death or cardiovascular hospitalization.

Another distinct difference, compared with the vast majority of earlier trials, was the way the bone marrow was handled prior to placement in a heart. The bone marrow cells underwent a 12-day period of ex vivo treatment designed to expand the content of certain mesenchymal stem cells and macrophages.

The current study was also larger than most prior reported studies, with 114 randomized patients available for the safety analysis and 109 for the efficacy analysis. But by no means was this a large study; in fact, it is relatively small. Although it produced a statistically significant result for the primary endpoint, the efficacy needs expanded testing in larger numbers.

It’s currently unclear how the expanded bone marrow cell injections improve clinical status and lead to reduced deaths and hospitalization. The results show essentially no impact from the treatment on ejection fraction or 6-minute walk distance, raising the question of what alternative mechanisms link this treatment to improved clinical outcomes.

Until now, it has not been possible to move beyond early-stage trial designs for cell therapy of failing hearts. Now, for the first time, we have study results that suggest a phase III trial is indicated.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

Dr. John A. Jarcho is a deputy editor of the New England Journal of Medicine and a cardiologist at Brigham and Women’s Hospital, both in Boston. He had no disclosures. He made these comments as a discussant of Dr. Henry’s report and in an interview.

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The results reported by Dr. Henry come from one of the first trials of stem cell or bone marrow treatment of failing hearts that used clinical outcomes as the primary endpoint. In contrast, prior studies focused on changes in functional characteristics of patients, such as 6-minute walk distance or left ventricular ejection fraction or size. What makes Dr. Henry’s study distinctive is that it showed benefit for a clinical outcome: the rate of death or cardiovascular hospitalization.

Another distinct difference, compared with the vast majority of earlier trials, was the way the bone marrow was handled prior to placement in a heart. The bone marrow cells underwent a 12-day period of ex vivo treatment designed to expand the content of certain mesenchymal stem cells and macrophages.

The current study was also larger than most prior reported studies, with 114 randomized patients available for the safety analysis and 109 for the efficacy analysis. But by no means was this a large study; in fact, it is relatively small. Although it produced a statistically significant result for the primary endpoint, the efficacy needs expanded testing in larger numbers.

It’s currently unclear how the expanded bone marrow cell injections improve clinical status and lead to reduced deaths and hospitalization. The results show essentially no impact from the treatment on ejection fraction or 6-minute walk distance, raising the question of what alternative mechanisms link this treatment to improved clinical outcomes.

Until now, it has not been possible to move beyond early-stage trial designs for cell therapy of failing hearts. Now, for the first time, we have study results that suggest a phase III trial is indicated.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

Dr. John A. Jarcho is a deputy editor of the New England Journal of Medicine and a cardiologist at Brigham and Women’s Hospital, both in Boston. He had no disclosures. He made these comments as a discussant of Dr. Henry’s report and in an interview.

Body

The results reported by Dr. Henry come from one of the first trials of stem cell or bone marrow treatment of failing hearts that used clinical outcomes as the primary endpoint. In contrast, prior studies focused on changes in functional characteristics of patients, such as 6-minute walk distance or left ventricular ejection fraction or size. What makes Dr. Henry’s study distinctive is that it showed benefit for a clinical outcome: the rate of death or cardiovascular hospitalization.

Another distinct difference, compared with the vast majority of earlier trials, was the way the bone marrow was handled prior to placement in a heart. The bone marrow cells underwent a 12-day period of ex vivo treatment designed to expand the content of certain mesenchymal stem cells and macrophages.

The current study was also larger than most prior reported studies, with 114 randomized patients available for the safety analysis and 109 for the efficacy analysis. But by no means was this a large study; in fact, it is relatively small. Although it produced a statistically significant result for the primary endpoint, the efficacy needs expanded testing in larger numbers.

It’s currently unclear how the expanded bone marrow cell injections improve clinical status and lead to reduced deaths and hospitalization. The results show essentially no impact from the treatment on ejection fraction or 6-minute walk distance, raising the question of what alternative mechanisms link this treatment to improved clinical outcomes.

Until now, it has not been possible to move beyond early-stage trial designs for cell therapy of failing hearts. Now, for the first time, we have study results that suggest a phase III trial is indicated.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

Dr. John A. Jarcho is a deputy editor of the New England Journal of Medicine and a cardiologist at Brigham and Women’s Hospital, both in Boston. He had no disclosures. He made these comments as a discussant of Dr. Henry’s report and in an interview.

Title
Results merit phase III trial follow-up
Results merit phase III trial follow-up

CHICAGO – After rattling around in early-stage clinical studies for more than a decade, stem cell therapy for heart failure may have finally gained the efficacy evidence to send it to the next level: large-scale, phase III trials.

Patients with ischemic cardiomyopathy and severe heart failure showed a statistically significant 37% relative reduction in their combined rate of death and cardiovascular hospitalization during 1 year of follow-up after autologous stem cell injections to their left ventricular myocardium in a multicenter, fully blinded control, phase II trial with 109 North American patients.

Mitchel L. Zoler/Frontline Medical News
Dr. Timothy D. Henry

The treatment used a technique in commercial development by Vericel that selectively expands ex vivo bone marrow cells taken from the heart failure patient. Clinicians inject 0.4 mL aliquots of the expanded cells – enriched for mesenchymal stem cells and M2 macrophages – via a transcatheter approach into the left ventricular myocardium using 12-17 injections per patient. The bone marrow preparation during ex vivo expansion is called ixmyelocel-T.

This treatment now needs testing in more patients, Dr. Timothy D. Henry said at the annual meeting of the American College of Cardiology. “We need a new generation of cell trials in larger studies with completely double-blind, placebo controls using a more uniform preparation of cells,” said Dr. Henry.

“To the best of our knowledge, ixCELL-DCM is the largest randomized, double-blind clinical trial to date for cell therapy use in congestive heart failure,” said Dr. Henry and his associates in their report. The concept of stem cell therapy to replace damaged myocardium “has been very attractive, but most clinical trials to date have been small and unblinded, and used unselected bone marrow cells,” explained Dr. Henry, director of cardiology at the Cedars-Sinai Heart Institute in Los Angeles.

The ixCELL-DCM study ran at 31 sites in the United States and Canada. About 90% of patients had New York Heart Association class III disease, the average left ventricular ejection fraction was about 25%, patients on average would cover about 310 m during a 6-minute walk test, and the average serum level of NT-ProBNP was about 1,900 pg/L. Patients in the control arm all underwent the same bone marrow retrieval and transcatheter injection into the left ventricle, but the injections only contained carrier material without active cells.

The primary endpoint of death or a cardiovascular event, primarily hospitalization, occurred at a rate of 110 events per 100 patient years during 1-year follow-up of 51 patients in the sham-treatment group. In the active-treatment arm, the endpoint occurred at a rate of 70 events per 100 patient years among 58 patients. The difference was primarily driven by a 3% death rate with cell therapy, compared with a 14% rate in the controls, and a 38% hospitalization rate, compared with a 47% rate among controls.

The study results appeared online concurrent with Dr. Henry’s report (Lancet. 2016 Apr 5. doi: 10.1016/S0140-6736[16]30137-4).

The results showed no significant differences between the active and sham groups for changes in left ventricular size, ejection fraction, and 6-minute walk distance.

“This trial was designed to look at events. It is not a cause for concern that we did not see effects on heart function,” Dr. Henry said. The current results were also generally consistent with results from two earlier, controlled, phase II studies with a total of 61 patients (Circ Res. 2014 Sep 26;115[8]:730-7).

In the safety analysis, done in 114 patients, the rates of all adverse events and major adverse cardiovascular events were similar in the two arms. The rate of serious adverse events was significantly reduced in the patients treated with expanded bone marrow cells, compared with the controls.

The high rate of death and hospitalization of patients with severe heart failure “is a very large, unmet need, so it’s a natural to go to a larger trial,” Dr. Henry said. “The cell preparation was very safe and easy to do.”

Another pressing research issue is to try to understand the mechanism by which the cell treatment improves clinical outcomes, with improved heart function or improved exercise capacity apparently excluded as mechanisms.

The trial was sponsored by Vericel, the company developing the ex vivo protocol for selective marrow cell expansion. Dr. Henry has been a consultant to or received honoraria from Abbott Vascular, Baxter, Capricor, Cytori, Eli Lilly, and the Medicines Company, and he has received research grants from Aastrom, Baxter International, Mesoblast, and Vericel.

[email protected]

On Twitter @mitchelzoler

CHICAGO – After rattling around in early-stage clinical studies for more than a decade, stem cell therapy for heart failure may have finally gained the efficacy evidence to send it to the next level: large-scale, phase III trials.

Patients with ischemic cardiomyopathy and severe heart failure showed a statistically significant 37% relative reduction in their combined rate of death and cardiovascular hospitalization during 1 year of follow-up after autologous stem cell injections to their left ventricular myocardium in a multicenter, fully blinded control, phase II trial with 109 North American patients.

Mitchel L. Zoler/Frontline Medical News
Dr. Timothy D. Henry

The treatment used a technique in commercial development by Vericel that selectively expands ex vivo bone marrow cells taken from the heart failure patient. Clinicians inject 0.4 mL aliquots of the expanded cells – enriched for mesenchymal stem cells and M2 macrophages – via a transcatheter approach into the left ventricular myocardium using 12-17 injections per patient. The bone marrow preparation during ex vivo expansion is called ixmyelocel-T.

This treatment now needs testing in more patients, Dr. Timothy D. Henry said at the annual meeting of the American College of Cardiology. “We need a new generation of cell trials in larger studies with completely double-blind, placebo controls using a more uniform preparation of cells,” said Dr. Henry.

“To the best of our knowledge, ixCELL-DCM is the largest randomized, double-blind clinical trial to date for cell therapy use in congestive heart failure,” said Dr. Henry and his associates in their report. The concept of stem cell therapy to replace damaged myocardium “has been very attractive, but most clinical trials to date have been small and unblinded, and used unselected bone marrow cells,” explained Dr. Henry, director of cardiology at the Cedars-Sinai Heart Institute in Los Angeles.

The ixCELL-DCM study ran at 31 sites in the United States and Canada. About 90% of patients had New York Heart Association class III disease, the average left ventricular ejection fraction was about 25%, patients on average would cover about 310 m during a 6-minute walk test, and the average serum level of NT-ProBNP was about 1,900 pg/L. Patients in the control arm all underwent the same bone marrow retrieval and transcatheter injection into the left ventricle, but the injections only contained carrier material without active cells.

The primary endpoint of death or a cardiovascular event, primarily hospitalization, occurred at a rate of 110 events per 100 patient years during 1-year follow-up of 51 patients in the sham-treatment group. In the active-treatment arm, the endpoint occurred at a rate of 70 events per 100 patient years among 58 patients. The difference was primarily driven by a 3% death rate with cell therapy, compared with a 14% rate in the controls, and a 38% hospitalization rate, compared with a 47% rate among controls.

The study results appeared online concurrent with Dr. Henry’s report (Lancet. 2016 Apr 5. doi: 10.1016/S0140-6736[16]30137-4).

The results showed no significant differences between the active and sham groups for changes in left ventricular size, ejection fraction, and 6-minute walk distance.

“This trial was designed to look at events. It is not a cause for concern that we did not see effects on heart function,” Dr. Henry said. The current results were also generally consistent with results from two earlier, controlled, phase II studies with a total of 61 patients (Circ Res. 2014 Sep 26;115[8]:730-7).

In the safety analysis, done in 114 patients, the rates of all adverse events and major adverse cardiovascular events were similar in the two arms. The rate of serious adverse events was significantly reduced in the patients treated with expanded bone marrow cells, compared with the controls.

The high rate of death and hospitalization of patients with severe heart failure “is a very large, unmet need, so it’s a natural to go to a larger trial,” Dr. Henry said. “The cell preparation was very safe and easy to do.”

Another pressing research issue is to try to understand the mechanism by which the cell treatment improves clinical outcomes, with improved heart function or improved exercise capacity apparently excluded as mechanisms.

The trial was sponsored by Vericel, the company developing the ex vivo protocol for selective marrow cell expansion. Dr. Henry has been a consultant to or received honoraria from Abbott Vascular, Baxter, Capricor, Cytori, Eli Lilly, and the Medicines Company, and he has received research grants from Aastrom, Baxter International, Mesoblast, and Vericel.

[email protected]

On Twitter @mitchelzoler

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Key clinical point: Severe, ischemic heart failure patients had a significant cut in death and cardiovascular hospitalizations 1 year after endovascular myocardial injection with selectively expanded autologous bone marrow cells in a fully blinded, placebo-controlled phase II study.

Major finding: Cell-treated patients had a 37% drop in death and cardiovascular hospitalization relative to controls in 1-year follow-up.

Data source: A multicenter, fully blinded study with 109 patients for the per protocol efficacy analysis, and 114 patients for the safety analysis.

Disclosures: The trial was sponsored by Vericel, the company developing the ex vivo protocol for selective marrow cell expansion. Dr. Henry has been a consultant to or received honoraria from Abbott Vascular, Baxter, Capricor, Cytori, Eli Lilly, and the Medicines Company, and he has received research grants from Aastrom, Baxter International, Mesoblast, and Vericel.

Addiction – how are we being played?

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Addiction – how are we being played?

Sometimes, you come across an article that makes you cringe. After this initial reaction – and if we are up for the challenge – we realize that this information can help us grow by pushing our clinical approach in new directions.

This is the experience I had with an article by Dr. Daniel Bouland and colleagues that explored the ways in which people struggling with addiction obtain prescription medications (J Addict Med. 2015 Jul-Aug;9[4]:281-5).

Dr. Jon O. Ebbert

In this semiquantitative qualitative study, investigators interviewed 36 patients in a residential addiction treatment program who obtained prescriptions from clinicians in support of an addiction. Types of medications obtained by respondents were opioids (97.2%), sedative hypnotics (47.4%), and amphetamines (5.5%).

Patients reported obtaining prescriptions from clinicians because it was perceived to be “legal” – even though 75% of them faked symptoms, several falsified MRI images of an injury, and some used old or forged prescriptions. One patient paid a physician outright for the medication.

Eight percent of patients physically harmed themselves to obtain prescriptions by doing things such as cutting themselves to put blood in the urine, hitting their head against the wall to the point of unconsciousness, and undergoing unnecessary surgery.

Primary care clinicians and pain specialists were viewed as the easiest sources of medication. Most patients used “mom and pop” pharmacies, visited multiple pharmacies, and paid in cash. Importantly, 67% of patients said that an intervention could have changed their behaviors.

I think I knew this, but it challenged me to see it in writing. I appreciated the honesty of these individuals and was struck by the fact that almost two-thirds suggested that an intervention could have transformed them.

But how to start this conversation?

The last time I expressed concern about a patient’s allergy to any pain medication – except oxycodone and the potentially toxic doses of ibuprofen and acetaminophen that didn’t “touch it” – I was the recipient of seething rage and hostility.

Addiction treatment is hard, diagnosing addiction in daily primary care practice is harder, and holding up a mirror to a patient’s prescription drug habits requires protective body armor. That’s why not many of us do it.

So, now that we have guidelines for chronic opioids, we need best practices for acute visits presenting with x-rays of broken animal bones labeled with their name handwritten on duct tape.

Are we up for urine drug screens for every controlled substance prescription on nonestablished patients every time? Probably not, but we have to start somewhere.

At least it might start a conversation when we can say: “We do this for all of our patients, we are not singling you out. Is there anything you would like to talk about before we complete this test?”

Most importantly, once we make a diagnosis of prescription drug abuse, we need resources to which to refer them and health insurance to help cover the cost for this care.

Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author and do not necessarily represent the views and opinions of the Mayo Clinic. The opinions expressed in this article should not be used to diagnose or treat any medical condition nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician. Dr. Ebbert has no relevant financial disclosures about this article.

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Sometimes, you come across an article that makes you cringe. After this initial reaction – and if we are up for the challenge – we realize that this information can help us grow by pushing our clinical approach in new directions.

This is the experience I had with an article by Dr. Daniel Bouland and colleagues that explored the ways in which people struggling with addiction obtain prescription medications (J Addict Med. 2015 Jul-Aug;9[4]:281-5).

Dr. Jon O. Ebbert

In this semiquantitative qualitative study, investigators interviewed 36 patients in a residential addiction treatment program who obtained prescriptions from clinicians in support of an addiction. Types of medications obtained by respondents were opioids (97.2%), sedative hypnotics (47.4%), and amphetamines (5.5%).

Patients reported obtaining prescriptions from clinicians because it was perceived to be “legal” – even though 75% of them faked symptoms, several falsified MRI images of an injury, and some used old or forged prescriptions. One patient paid a physician outright for the medication.

Eight percent of patients physically harmed themselves to obtain prescriptions by doing things such as cutting themselves to put blood in the urine, hitting their head against the wall to the point of unconsciousness, and undergoing unnecessary surgery.

Primary care clinicians and pain specialists were viewed as the easiest sources of medication. Most patients used “mom and pop” pharmacies, visited multiple pharmacies, and paid in cash. Importantly, 67% of patients said that an intervention could have changed their behaviors.

I think I knew this, but it challenged me to see it in writing. I appreciated the honesty of these individuals and was struck by the fact that almost two-thirds suggested that an intervention could have transformed them.

But how to start this conversation?

The last time I expressed concern about a patient’s allergy to any pain medication – except oxycodone and the potentially toxic doses of ibuprofen and acetaminophen that didn’t “touch it” – I was the recipient of seething rage and hostility.

Addiction treatment is hard, diagnosing addiction in daily primary care practice is harder, and holding up a mirror to a patient’s prescription drug habits requires protective body armor. That’s why not many of us do it.

So, now that we have guidelines for chronic opioids, we need best practices for acute visits presenting with x-rays of broken animal bones labeled with their name handwritten on duct tape.

Are we up for urine drug screens for every controlled substance prescription on nonestablished patients every time? Probably not, but we have to start somewhere.

At least it might start a conversation when we can say: “We do this for all of our patients, we are not singling you out. Is there anything you would like to talk about before we complete this test?”

Most importantly, once we make a diagnosis of prescription drug abuse, we need resources to which to refer them and health insurance to help cover the cost for this care.

Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author and do not necessarily represent the views and opinions of the Mayo Clinic. The opinions expressed in this article should not be used to diagnose or treat any medical condition nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician. Dr. Ebbert has no relevant financial disclosures about this article.

Sometimes, you come across an article that makes you cringe. After this initial reaction – and if we are up for the challenge – we realize that this information can help us grow by pushing our clinical approach in new directions.

This is the experience I had with an article by Dr. Daniel Bouland and colleagues that explored the ways in which people struggling with addiction obtain prescription medications (J Addict Med. 2015 Jul-Aug;9[4]:281-5).

Dr. Jon O. Ebbert

In this semiquantitative qualitative study, investigators interviewed 36 patients in a residential addiction treatment program who obtained prescriptions from clinicians in support of an addiction. Types of medications obtained by respondents were opioids (97.2%), sedative hypnotics (47.4%), and amphetamines (5.5%).

Patients reported obtaining prescriptions from clinicians because it was perceived to be “legal” – even though 75% of them faked symptoms, several falsified MRI images of an injury, and some used old or forged prescriptions. One patient paid a physician outright for the medication.

Eight percent of patients physically harmed themselves to obtain prescriptions by doing things such as cutting themselves to put blood in the urine, hitting their head against the wall to the point of unconsciousness, and undergoing unnecessary surgery.

Primary care clinicians and pain specialists were viewed as the easiest sources of medication. Most patients used “mom and pop” pharmacies, visited multiple pharmacies, and paid in cash. Importantly, 67% of patients said that an intervention could have changed their behaviors.

I think I knew this, but it challenged me to see it in writing. I appreciated the honesty of these individuals and was struck by the fact that almost two-thirds suggested that an intervention could have transformed them.

But how to start this conversation?

The last time I expressed concern about a patient’s allergy to any pain medication – except oxycodone and the potentially toxic doses of ibuprofen and acetaminophen that didn’t “touch it” – I was the recipient of seething rage and hostility.

Addiction treatment is hard, diagnosing addiction in daily primary care practice is harder, and holding up a mirror to a patient’s prescription drug habits requires protective body armor. That’s why not many of us do it.

So, now that we have guidelines for chronic opioids, we need best practices for acute visits presenting with x-rays of broken animal bones labeled with their name handwritten on duct tape.

Are we up for urine drug screens for every controlled substance prescription on nonestablished patients every time? Probably not, but we have to start somewhere.

At least it might start a conversation when we can say: “We do this for all of our patients, we are not singling you out. Is there anything you would like to talk about before we complete this test?”

Most importantly, once we make a diagnosis of prescription drug abuse, we need resources to which to refer them and health insurance to help cover the cost for this care.

Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author and do not necessarily represent the views and opinions of the Mayo Clinic. The opinions expressed in this article should not be used to diagnose or treat any medical condition nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician. Dr. Ebbert has no relevant financial disclosures about this article.

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U.S. flu activity continues to drop, but still widespread

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A third straight week of reduced influenza-like illness (ILI) left the U.S. with no states at the highest level of ILI activity for the first time since early February, according to the Centers for Disease Control and Prevention.

The states with the highest activity for the week ending April 2, 2016, were New Jersey and New Mexico, and both were at level 8 on the CDC’s 1-10 scale, putting them on the low end of the “high” range. States in the “moderate” range were Georgia and North Carolina at level 7 and Alabama, Alaska, Arkansas, Missouri, and Virginia at level 6, according to a report from the CDC’s Influenza-like Illness Surveillance Network (ILINet).

The proportion of outpatient visits for ILI was 2.4% for the week, down from 2.9% the week before but still above the national baseline of 2.1%, the CDC said. The CDC also reported a cumulative rate of 24.4 laboratory-confirmed influenza-associated hospitalizations per 100,000 population for the 2015-16 flu season.

There were seven flu-related pediatric deaths reported – all of them occurring during earlier weeks. So far, 40 flu-related pediatric deaths have been reported during the 2015-2016 season, with California having the highest number (9). The CDC said 7.4% of all deaths reported through the 122 Cities Mortality Reporting System were due to pneumonia and influenza. This percentage was above the epidemic threshold of 7.1% for week 13 of the flu season.

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A third straight week of reduced influenza-like illness (ILI) left the U.S. with no states at the highest level of ILI activity for the first time since early February, according to the Centers for Disease Control and Prevention.

The states with the highest activity for the week ending April 2, 2016, were New Jersey and New Mexico, and both were at level 8 on the CDC’s 1-10 scale, putting them on the low end of the “high” range. States in the “moderate” range were Georgia and North Carolina at level 7 and Alabama, Alaska, Arkansas, Missouri, and Virginia at level 6, according to a report from the CDC’s Influenza-like Illness Surveillance Network (ILINet).

The proportion of outpatient visits for ILI was 2.4% for the week, down from 2.9% the week before but still above the national baseline of 2.1%, the CDC said. The CDC also reported a cumulative rate of 24.4 laboratory-confirmed influenza-associated hospitalizations per 100,000 population for the 2015-16 flu season.

There were seven flu-related pediatric deaths reported – all of them occurring during earlier weeks. So far, 40 flu-related pediatric deaths have been reported during the 2015-2016 season, with California having the highest number (9). The CDC said 7.4% of all deaths reported through the 122 Cities Mortality Reporting System were due to pneumonia and influenza. This percentage was above the epidemic threshold of 7.1% for week 13 of the flu season.

[email protected]

A third straight week of reduced influenza-like illness (ILI) left the U.S. with no states at the highest level of ILI activity for the first time since early February, according to the Centers for Disease Control and Prevention.

The states with the highest activity for the week ending April 2, 2016, were New Jersey and New Mexico, and both were at level 8 on the CDC’s 1-10 scale, putting them on the low end of the “high” range. States in the “moderate” range were Georgia and North Carolina at level 7 and Alabama, Alaska, Arkansas, Missouri, and Virginia at level 6, according to a report from the CDC’s Influenza-like Illness Surveillance Network (ILINet).

The proportion of outpatient visits for ILI was 2.4% for the week, down from 2.9% the week before but still above the national baseline of 2.1%, the CDC said. The CDC also reported a cumulative rate of 24.4 laboratory-confirmed influenza-associated hospitalizations per 100,000 population for the 2015-16 flu season.

There were seven flu-related pediatric deaths reported – all of them occurring during earlier weeks. So far, 40 flu-related pediatric deaths have been reported during the 2015-2016 season, with California having the highest number (9). The CDC said 7.4% of all deaths reported through the 122 Cities Mortality Reporting System were due to pneumonia and influenza. This percentage was above the epidemic threshold of 7.1% for week 13 of the flu season.

[email protected]

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Tofacitinib succeeds as ulcerative colitis induction therapy

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A 10-mg dose of tofacitinib twice daily significantly improved remission, mucosal healing, and clinical response in adults with active ulcerative colitis (UC), based on data from a pair of identical phase III studies including nearly 900 patients. The findings were presented at the European Crohn’s and Colitis Organisation conference in Amsterdam.

“In up to one-third of patients with UC, treatment is not completely successful or complications arise,” study coauthor Dr. Geert D’Haens of the University of Amsterdam said in an interview. The goal of the studies was to evaluate the safety and efficacy of a 10-mg dose of oral tofacitinib twice daily in inducing remission in UC patients, he added. The OCTAVE (Oral Clinical Trials for Tofacitinib in Ulcerative Colitis) Induction 1 study included 476 patients taking tofacitinib and 122 patients taking placebo; the OCTAVE Induction 2 study included 429 patients on tofacitinib and 112 patients on placebo.

©selvanegra/thinkstockphotos.com

Overall, significantly more patients receiving tofacitinib 10 mg twice daily achieved remission, mucosal healing, and clinical response in both studies, compared with the placebo, at 8 weeks. In the OCTAVE Induction 1 and Induction 2 studies, remission at 8 weeks for tofacitinib compared with placebo was 19% vs. 8% and 17% vs. 4%, respectively. Mucosal healing rates in the Induction 1 and 2 studies for tofacitinib compared with placebo were 31% vs. 16% and 28% vs. 12%, respectively, and clinical response rates were 60% vs. 33% and 55% vs. 29%, respectively. Efficacy was similar for patients previously treated with tumor necrosis factor inhibitors and those who were not.

The incidence of adverse events and serious adverse events was not significantly different between treatment and placebo groups in either study. However, tofacitinib treatment was associated with increases in serum lipid (total cholesterol, low-density and high-density lipoprotein), and creatine kinase levels.

“The clinical trial data confirm our blinded observations,” Dr. D’Haens said. “Even when all other drugs have failed, tofacitinib can be effective. Since Janus kinase inhibitors reduce the production of many proinflammatory cytokines, the clinical findings are in line with what we expected. Fortunately, adverse events were limited and allowed prolonged treatment with this agent,” he noted.

Research on tofacitinib and UC is ongoing, said Dr. D’Haens. The two studies reported here, OCTAVE Induction 1 and 2, are part of the global OCTAVE program, he said. Other related studies include a third phase III study, OCTAVE Sustain, and a long-term extension trial called OCTAVE Open. “OCTAVE Sustain is a phase III placebo-controlled study evaluating oral tofacitinib 10 mg and 5 mg b.i.d. as maintenance therapy in adult patients with moderately to severely active UC. Top-line results for this study are anticipated at the end of this year,” he said. “OCTAVE Open is an ongoing open-label extension study designed to assess the safety and tolerability of tofacitinib 10 mg and 5 mg b.i.d. in patients who have completed or who have had treatment failure in OCTAVE Sustain or who were nonresponders upon completing OCTAVE Induction 1 or 2,” he added.

The study was supported in part by Pfizer. Dr. D’Haens disclosed financial relationships with multiple companies, including Pfizer.

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A 10-mg dose of tofacitinib twice daily significantly improved remission, mucosal healing, and clinical response in adults with active ulcerative colitis (UC), based on data from a pair of identical phase III studies including nearly 900 patients. The findings were presented at the European Crohn’s and Colitis Organisation conference in Amsterdam.

“In up to one-third of patients with UC, treatment is not completely successful or complications arise,” study coauthor Dr. Geert D’Haens of the University of Amsterdam said in an interview. The goal of the studies was to evaluate the safety and efficacy of a 10-mg dose of oral tofacitinib twice daily in inducing remission in UC patients, he added. The OCTAVE (Oral Clinical Trials for Tofacitinib in Ulcerative Colitis) Induction 1 study included 476 patients taking tofacitinib and 122 patients taking placebo; the OCTAVE Induction 2 study included 429 patients on tofacitinib and 112 patients on placebo.

©selvanegra/thinkstockphotos.com

Overall, significantly more patients receiving tofacitinib 10 mg twice daily achieved remission, mucosal healing, and clinical response in both studies, compared with the placebo, at 8 weeks. In the OCTAVE Induction 1 and Induction 2 studies, remission at 8 weeks for tofacitinib compared with placebo was 19% vs. 8% and 17% vs. 4%, respectively. Mucosal healing rates in the Induction 1 and 2 studies for tofacitinib compared with placebo were 31% vs. 16% and 28% vs. 12%, respectively, and clinical response rates were 60% vs. 33% and 55% vs. 29%, respectively. Efficacy was similar for patients previously treated with tumor necrosis factor inhibitors and those who were not.

The incidence of adverse events and serious adverse events was not significantly different between treatment and placebo groups in either study. However, tofacitinib treatment was associated with increases in serum lipid (total cholesterol, low-density and high-density lipoprotein), and creatine kinase levels.

“The clinical trial data confirm our blinded observations,” Dr. D’Haens said. “Even when all other drugs have failed, tofacitinib can be effective. Since Janus kinase inhibitors reduce the production of many proinflammatory cytokines, the clinical findings are in line with what we expected. Fortunately, adverse events were limited and allowed prolonged treatment with this agent,” he noted.

Research on tofacitinib and UC is ongoing, said Dr. D’Haens. The two studies reported here, OCTAVE Induction 1 and 2, are part of the global OCTAVE program, he said. Other related studies include a third phase III study, OCTAVE Sustain, and a long-term extension trial called OCTAVE Open. “OCTAVE Sustain is a phase III placebo-controlled study evaluating oral tofacitinib 10 mg and 5 mg b.i.d. as maintenance therapy in adult patients with moderately to severely active UC. Top-line results for this study are anticipated at the end of this year,” he said. “OCTAVE Open is an ongoing open-label extension study designed to assess the safety and tolerability of tofacitinib 10 mg and 5 mg b.i.d. in patients who have completed or who have had treatment failure in OCTAVE Sustain or who were nonresponders upon completing OCTAVE Induction 1 or 2,” he added.

The study was supported in part by Pfizer. Dr. D’Haens disclosed financial relationships with multiple companies, including Pfizer.

A 10-mg dose of tofacitinib twice daily significantly improved remission, mucosal healing, and clinical response in adults with active ulcerative colitis (UC), based on data from a pair of identical phase III studies including nearly 900 patients. The findings were presented at the European Crohn’s and Colitis Organisation conference in Amsterdam.

“In up to one-third of patients with UC, treatment is not completely successful or complications arise,” study coauthor Dr. Geert D’Haens of the University of Amsterdam said in an interview. The goal of the studies was to evaluate the safety and efficacy of a 10-mg dose of oral tofacitinib twice daily in inducing remission in UC patients, he added. The OCTAVE (Oral Clinical Trials for Tofacitinib in Ulcerative Colitis) Induction 1 study included 476 patients taking tofacitinib and 122 patients taking placebo; the OCTAVE Induction 2 study included 429 patients on tofacitinib and 112 patients on placebo.

©selvanegra/thinkstockphotos.com

Overall, significantly more patients receiving tofacitinib 10 mg twice daily achieved remission, mucosal healing, and clinical response in both studies, compared with the placebo, at 8 weeks. In the OCTAVE Induction 1 and Induction 2 studies, remission at 8 weeks for tofacitinib compared with placebo was 19% vs. 8% and 17% vs. 4%, respectively. Mucosal healing rates in the Induction 1 and 2 studies for tofacitinib compared with placebo were 31% vs. 16% and 28% vs. 12%, respectively, and clinical response rates were 60% vs. 33% and 55% vs. 29%, respectively. Efficacy was similar for patients previously treated with tumor necrosis factor inhibitors and those who were not.

The incidence of adverse events and serious adverse events was not significantly different between treatment and placebo groups in either study. However, tofacitinib treatment was associated with increases in serum lipid (total cholesterol, low-density and high-density lipoprotein), and creatine kinase levels.

“The clinical trial data confirm our blinded observations,” Dr. D’Haens said. “Even when all other drugs have failed, tofacitinib can be effective. Since Janus kinase inhibitors reduce the production of many proinflammatory cytokines, the clinical findings are in line with what we expected. Fortunately, adverse events were limited and allowed prolonged treatment with this agent,” he noted.

Research on tofacitinib and UC is ongoing, said Dr. D’Haens. The two studies reported here, OCTAVE Induction 1 and 2, are part of the global OCTAVE program, he said. Other related studies include a third phase III study, OCTAVE Sustain, and a long-term extension trial called OCTAVE Open. “OCTAVE Sustain is a phase III placebo-controlled study evaluating oral tofacitinib 10 mg and 5 mg b.i.d. as maintenance therapy in adult patients with moderately to severely active UC. Top-line results for this study are anticipated at the end of this year,” he said. “OCTAVE Open is an ongoing open-label extension study designed to assess the safety and tolerability of tofacitinib 10 mg and 5 mg b.i.d. in patients who have completed or who have had treatment failure in OCTAVE Sustain or who were nonresponders upon completing OCTAVE Induction 1 or 2,” he added.

The study was supported in part by Pfizer. Dr. D’Haens disclosed financial relationships with multiple companies, including Pfizer.

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Key clinical point: Oral tofacitinib reduced the symptoms of moderate to severe ulcerative colitis and induced remission and healing of the diseased colonic mucosa in patients previously treated with tumor necrosis factor inhibitors and those who were not.

Major finding: In the OCTAVE Induction 1 and Induction 2 studies, remission at 8 weeks for tofacitinib patients compared with placebo patients was 19% vs. 8% and 17% vs. 4%, respectively.

Data source: A pair of identical phase III studies including nearly 900 patients.

Disclosures: The study was supported in part by Pfizer. Dr. Geert D’Haens disclosed financial relationships with multiple companies, including Pfizer.

Sustained-release steroid provides prolonged OA pain relief

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AMSTERDAM – A single intra-articular injection of a novel corticosteroid formulation provided substantial and persistent pain relief for at least 12 weeks in patients with knee osteoarthritis in a phase III trial that was presented at the World Congress on Osteoarthritis.

FX006 (Zilretta), given at a dose of 40 mg, significantly (P less than .05) reduced the mean daily pain intensity score from around 2 weeks onwards in the region of 3.0 to 3.5 points on a 0-10 scale compared with a reduction of around 1.5 to 2.0 points for placebo. There were also significant reductions in additional efficacy outcomes such as Western Ontario and McMaster Universities Index (WOMAC) pain and function versus placebo and a standard formulation of triamcinolone acetate (TCA).

Dr. Philip Conaghan

Data from a phase IIb trial had originally been scheduled to be presented at the meeting – which is sponsored by the Osteoarthritis Research Society International – but the phase III findings had just become available, said Dr. Philip Conaghan of the University of Leeds (England). The phase II findings showed that there was a substantial and persistent pain relieving effect of FX006 versus placebo and that there was evidence of a dose response.

These data provide “proof of concept that we can develop long-acting steroids that have real potential for changing how we might manage knee OA,” said Dr. Conaghan, professor of musculoskeletal medicine and deputy director of the Leeds Musculoskeletal Biomedical Research Unit.

Intra-articular steroids have long been used to treat OA and they can be effective, albeit for a short period of time. FX006 is an investigational formulation of TCA in polylactic-co-glycolic acid microspheres that has been designed to try to extend the analgesic effects of the steroid and to reduce overall systemic exposure and thus side effects. Each microsphere is around 45 microns in diameter.

The aim of the phase IIb study was to examine the efficacy of two doses of FX006 (20 mg and 40 mg) versus placebo in patients with moderate to severe OA knee pain. The double-blind, randomized trial involved 310 patients who were followed for 24 weeks. The primary outcome was the change from baseline to week 12 in the weekly mean of the average daily pain intensity scores, compared with placebo.

There was evidence of a dose response, with the 40-mg dose of FX006 producing statistically significantly greater changes in pain scores versus placebo. Although the primary endpoint of a statistical difference at 12 weeks was not met, there were significant differences at all other time points from week 1 to 13. WOMAC pain and function scores were also significantly reduced with the 40-mg dose versus placebo.

The phase III trial involved 484 patients who were randomized to intra-articular injections of FX006 40 mg, standard TCA 40 mg, or placebo. As in the phase IIb trial patients were well matched at baseline, with a mean overall age of 62 years, a body mass index of 30 kg/m2 and around two-thirds having OA in both knees.

Dr. Conaghan reported that there were “no unexpected safety signals” during the trials. A combined safety summary showed that treatment-emergent adverse events occurred in 42.2% and 50.9% of patients treated with FX006 20 mg and 40 mg, respectively, in 49.2% of placebo-treated patients, and in 56.5% of TCA-treated patients. Serious adverse event rates were 1%, 3%, 1.1%, and 2.5%, respectively, and were assessed as being unrelated to treatment. Adverse events related to the knee occurred in 14.7%, 16.6%, 14.1%, and 9.9%, and injection-related adverse events in 2%, 1.9%, 4.2%, and 1.9%, respectively.

The studies were funded by Flexion Therapeutics. Dr. Conaghan did not report his financial disclosures.

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AMSTERDAM – A single intra-articular injection of a novel corticosteroid formulation provided substantial and persistent pain relief for at least 12 weeks in patients with knee osteoarthritis in a phase III trial that was presented at the World Congress on Osteoarthritis.

FX006 (Zilretta), given at a dose of 40 mg, significantly (P less than .05) reduced the mean daily pain intensity score from around 2 weeks onwards in the region of 3.0 to 3.5 points on a 0-10 scale compared with a reduction of around 1.5 to 2.0 points for placebo. There were also significant reductions in additional efficacy outcomes such as Western Ontario and McMaster Universities Index (WOMAC) pain and function versus placebo and a standard formulation of triamcinolone acetate (TCA).

Dr. Philip Conaghan

Data from a phase IIb trial had originally been scheduled to be presented at the meeting – which is sponsored by the Osteoarthritis Research Society International – but the phase III findings had just become available, said Dr. Philip Conaghan of the University of Leeds (England). The phase II findings showed that there was a substantial and persistent pain relieving effect of FX006 versus placebo and that there was evidence of a dose response.

These data provide “proof of concept that we can develop long-acting steroids that have real potential for changing how we might manage knee OA,” said Dr. Conaghan, professor of musculoskeletal medicine and deputy director of the Leeds Musculoskeletal Biomedical Research Unit.

Intra-articular steroids have long been used to treat OA and they can be effective, albeit for a short period of time. FX006 is an investigational formulation of TCA in polylactic-co-glycolic acid microspheres that has been designed to try to extend the analgesic effects of the steroid and to reduce overall systemic exposure and thus side effects. Each microsphere is around 45 microns in diameter.

The aim of the phase IIb study was to examine the efficacy of two doses of FX006 (20 mg and 40 mg) versus placebo in patients with moderate to severe OA knee pain. The double-blind, randomized trial involved 310 patients who were followed for 24 weeks. The primary outcome was the change from baseline to week 12 in the weekly mean of the average daily pain intensity scores, compared with placebo.

There was evidence of a dose response, with the 40-mg dose of FX006 producing statistically significantly greater changes in pain scores versus placebo. Although the primary endpoint of a statistical difference at 12 weeks was not met, there were significant differences at all other time points from week 1 to 13. WOMAC pain and function scores were also significantly reduced with the 40-mg dose versus placebo.

The phase III trial involved 484 patients who were randomized to intra-articular injections of FX006 40 mg, standard TCA 40 mg, or placebo. As in the phase IIb trial patients were well matched at baseline, with a mean overall age of 62 years, a body mass index of 30 kg/m2 and around two-thirds having OA in both knees.

Dr. Conaghan reported that there were “no unexpected safety signals” during the trials. A combined safety summary showed that treatment-emergent adverse events occurred in 42.2% and 50.9% of patients treated with FX006 20 mg and 40 mg, respectively, in 49.2% of placebo-treated patients, and in 56.5% of TCA-treated patients. Serious adverse event rates were 1%, 3%, 1.1%, and 2.5%, respectively, and were assessed as being unrelated to treatment. Adverse events related to the knee occurred in 14.7%, 16.6%, 14.1%, and 9.9%, and injection-related adverse events in 2%, 1.9%, 4.2%, and 1.9%, respectively.

The studies were funded by Flexion Therapeutics. Dr. Conaghan did not report his financial disclosures.

AMSTERDAM – A single intra-articular injection of a novel corticosteroid formulation provided substantial and persistent pain relief for at least 12 weeks in patients with knee osteoarthritis in a phase III trial that was presented at the World Congress on Osteoarthritis.

FX006 (Zilretta), given at a dose of 40 mg, significantly (P less than .05) reduced the mean daily pain intensity score from around 2 weeks onwards in the region of 3.0 to 3.5 points on a 0-10 scale compared with a reduction of around 1.5 to 2.0 points for placebo. There were also significant reductions in additional efficacy outcomes such as Western Ontario and McMaster Universities Index (WOMAC) pain and function versus placebo and a standard formulation of triamcinolone acetate (TCA).

Dr. Philip Conaghan

Data from a phase IIb trial had originally been scheduled to be presented at the meeting – which is sponsored by the Osteoarthritis Research Society International – but the phase III findings had just become available, said Dr. Philip Conaghan of the University of Leeds (England). The phase II findings showed that there was a substantial and persistent pain relieving effect of FX006 versus placebo and that there was evidence of a dose response.

These data provide “proof of concept that we can develop long-acting steroids that have real potential for changing how we might manage knee OA,” said Dr. Conaghan, professor of musculoskeletal medicine and deputy director of the Leeds Musculoskeletal Biomedical Research Unit.

Intra-articular steroids have long been used to treat OA and they can be effective, albeit for a short period of time. FX006 is an investigational formulation of TCA in polylactic-co-glycolic acid microspheres that has been designed to try to extend the analgesic effects of the steroid and to reduce overall systemic exposure and thus side effects. Each microsphere is around 45 microns in diameter.

The aim of the phase IIb study was to examine the efficacy of two doses of FX006 (20 mg and 40 mg) versus placebo in patients with moderate to severe OA knee pain. The double-blind, randomized trial involved 310 patients who were followed for 24 weeks. The primary outcome was the change from baseline to week 12 in the weekly mean of the average daily pain intensity scores, compared with placebo.

There was evidence of a dose response, with the 40-mg dose of FX006 producing statistically significantly greater changes in pain scores versus placebo. Although the primary endpoint of a statistical difference at 12 weeks was not met, there were significant differences at all other time points from week 1 to 13. WOMAC pain and function scores were also significantly reduced with the 40-mg dose versus placebo.

The phase III trial involved 484 patients who were randomized to intra-articular injections of FX006 40 mg, standard TCA 40 mg, or placebo. As in the phase IIb trial patients were well matched at baseline, with a mean overall age of 62 years, a body mass index of 30 kg/m2 and around two-thirds having OA in both knees.

Dr. Conaghan reported that there were “no unexpected safety signals” during the trials. A combined safety summary showed that treatment-emergent adverse events occurred in 42.2% and 50.9% of patients treated with FX006 20 mg and 40 mg, respectively, in 49.2% of placebo-treated patients, and in 56.5% of TCA-treated patients. Serious adverse event rates were 1%, 3%, 1.1%, and 2.5%, respectively, and were assessed as being unrelated to treatment. Adverse events related to the knee occurred in 14.7%, 16.6%, 14.1%, and 9.9%, and injection-related adverse events in 2%, 1.9%, 4.2%, and 1.9%, respectively.

The studies were funded by Flexion Therapeutics. Dr. Conaghan did not report his financial disclosures.

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AT OARSI 2016

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Key clinical point: A single intra-articular injection of FX006 provided pain relief for up to 12 weeks.

Major finding: The mean daily pain intensity score was significantly reduced by 3.0 to 3.5 points with FX006 versus 1.5 to 2.0 points for placebo.

Data source: A phase IIb (n = 310) and a phase III (n = 454) study conducted in patients with moderate to severe knee OA.

Disclosures: The studies were funded by Flexion Therapeutics. Dr. Conaghan did not report his financial disclosures.

Three things hospitalists ‘do for no reason’... and should stop

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Three things hospitalists ‘do for no reason’... and should stop

SAN DIEGO – Head CTs for patients with in-hospital delirium. Ammonia tests to check for hepatic encephalopathy in chronic liver disease. Renal ultrasounds for acute kidney injury.

Those are three low value tests highlighted in hospitalist Dr. Leonard Feldman’s latest iteration of his lecture series “Things We Do for No Reason.”

Dr. Leonard Feldman

Dr. Feldman, associate professor of internal medicine and pediatrics at Johns Hopkins University, Baltimore, has presented his list of usually unnecessary hospitalist practices for five years at the Society of Hospital Medicine’s annual meetings. With three new ones explained during the 2016 meeting, there are now 19 on the list and more to come, he said.

“So far, I’ve picked things that are relatively low-hanging fruit, things for which there’s good evidence we shouldn’t be doing and if you saw the evidence, you’d say ‘that’s right, we shouldn’t,’” he said.

Dr. Feldman’s intent is to help clinicians stop certain “learned behaviors,” tests and procedures which research and experience now show “are not helping people, sometimes harm people, and often result in a cascade” of further unnecessary tests and care.

The conference presentations have been so popular, the Journal of Hospital Medicine in October 2015 started a “Things We Do for No Reason” series.

Here are the three most recent tests hospitalists should avoid:

Ammonia levels for chronic liver disease

Dr. Feldman said doctors were taught in medical school that ammonia levels rise in patients with cirrhosis and when they rise too high, the patient may develop hepatic encephalopathy. They also learned that if levels are normal, the patient should not have hepatic encephalopathy.

But a number of studies have found “neither of those is true,” he said. What’s possibly worse is that “you close your mind to other possible diagnoses way too early.” Nevertheless, the practice at many hospitals is to perform multiple tests to trend those levels.”

“I had a patient who had an ammonia test sent the other day while in the emergency room, and it was elevated,” Dr. Feldman recalled in a recent phone interview. “The patient got admitted, but when we re-tested, it wasn’t.”

Part of the problem is that blood samples are often incorrectly processed. “When you draw the blood, you have to put it on ice and it needs to get to the lab very quickly. And I think we do neither of those things on a regular basis,” he said. Also, if the patient has a tourniquet or is clenching a fist, use of muscle creates ammonia.

Dr. Feldman said that at a hospital like Johns Hopkins in Baltimore, where there are high rates of hepatitis C, there might be 50 patients with chronic liver disease, or 20% of patients on medicine service. It’s not the cost of the blood test that he’s worried about because that’s probably minimal. Rather, it’s the test’s downstream provocation of more unnecessary care “and missed opportunities to intervene with a treatable diagnosis.”

In general, he said, “for patients with chronic liver disease, we shouldn’t be checking ammonia.”

Head CTs for inpatients with new onset delirium

Performing a costly head CT scan on a patient who presents in the emergency department with delirium is appropriate. But for low-risk patients who develop delirium inside the hospital without a clear reason, such as a fall or focal neurologic symptoms suggesting a stroke, a head CT is probably not necessary, Dr. Feldman said.

“But we have this knee-jerk reaction, this reflex, that when a patient becomes delirious, we probably should run a head CT on them,” he added.

Dr. Feldman acknowledged that the frequency of head CTs on inpatients with delirium has been hard to tease out.

“But all the studies indicate that patients who develop delirium while in the hospital, without any sort of risk factor, are very unlikely to have pathology found on a head CT,” he said, noting that the cause of their delirium is likely something else, like dehydration, an infection, disruption of sleep, urinary retention, or medication effect.

Of course, if patients aren’t getting better without the CT, order the CT, he said. “Even if the patient has no risk factor, there’s still a 3% chance of having an abnormality like a tumor or stroke.”

Renal ultrasound for patients with new acute kidney injury

To determine if an acute kidney injury is caused by a treatable obstruction, such as a large prostate causing urinary retention, doctors often first order a renal ultrasound, a test that can cost $300, and must be read by a radiologist.

 

 

But a much less expensive simple bladder scan, which can be performed by a nurse, is a much better substitute for the first pass, Dr. Feldman said. He said it’s logical that “a bladder scan is a much higher value test” in the early diagnostic process.

“The studies have been pretty clear. If you don’t have risk factors for having an obstruction, a history of kidney stones, it hasn’t happened before, or other reasons kidneys aren’t working, it’s extraordinarily unlikely you’re going to find anything on that renal ultrasound that could be intervened to fix that acute kidney injury,” Dr. Feldman said. He pointed to a study that found 223 renal ultrasounds were necessary to find one patient who needed an intervention.

“You can probably get a good sense from the history and physical” and start to treat them, he said, and if they’re not getting better, then order the ultrasound.

Each of the items on Feldman’s list don’t necessarily save a lot of money, but they add up. “The more we ask ‘Why are we doing this? Can we stop it if it’s not helping people, and particularly if it’s harming people?’ the more we can prevent the cascade that happens because you did one unnecessary diagnostic test,” he concluded.

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SAN DIEGO – Head CTs for patients with in-hospital delirium. Ammonia tests to check for hepatic encephalopathy in chronic liver disease. Renal ultrasounds for acute kidney injury.

Those are three low value tests highlighted in hospitalist Dr. Leonard Feldman’s latest iteration of his lecture series “Things We Do for No Reason.”

Dr. Leonard Feldman

Dr. Feldman, associate professor of internal medicine and pediatrics at Johns Hopkins University, Baltimore, has presented his list of usually unnecessary hospitalist practices for five years at the Society of Hospital Medicine’s annual meetings. With three new ones explained during the 2016 meeting, there are now 19 on the list and more to come, he said.

“So far, I’ve picked things that are relatively low-hanging fruit, things for which there’s good evidence we shouldn’t be doing and if you saw the evidence, you’d say ‘that’s right, we shouldn’t,’” he said.

Dr. Feldman’s intent is to help clinicians stop certain “learned behaviors,” tests and procedures which research and experience now show “are not helping people, sometimes harm people, and often result in a cascade” of further unnecessary tests and care.

The conference presentations have been so popular, the Journal of Hospital Medicine in October 2015 started a “Things We Do for No Reason” series.

Here are the three most recent tests hospitalists should avoid:

Ammonia levels for chronic liver disease

Dr. Feldman said doctors were taught in medical school that ammonia levels rise in patients with cirrhosis and when they rise too high, the patient may develop hepatic encephalopathy. They also learned that if levels are normal, the patient should not have hepatic encephalopathy.

But a number of studies have found “neither of those is true,” he said. What’s possibly worse is that “you close your mind to other possible diagnoses way too early.” Nevertheless, the practice at many hospitals is to perform multiple tests to trend those levels.”

“I had a patient who had an ammonia test sent the other day while in the emergency room, and it was elevated,” Dr. Feldman recalled in a recent phone interview. “The patient got admitted, but when we re-tested, it wasn’t.”

Part of the problem is that blood samples are often incorrectly processed. “When you draw the blood, you have to put it on ice and it needs to get to the lab very quickly. And I think we do neither of those things on a regular basis,” he said. Also, if the patient has a tourniquet or is clenching a fist, use of muscle creates ammonia.

Dr. Feldman said that at a hospital like Johns Hopkins in Baltimore, where there are high rates of hepatitis C, there might be 50 patients with chronic liver disease, or 20% of patients on medicine service. It’s not the cost of the blood test that he’s worried about because that’s probably minimal. Rather, it’s the test’s downstream provocation of more unnecessary care “and missed opportunities to intervene with a treatable diagnosis.”

In general, he said, “for patients with chronic liver disease, we shouldn’t be checking ammonia.”

Head CTs for inpatients with new onset delirium

Performing a costly head CT scan on a patient who presents in the emergency department with delirium is appropriate. But for low-risk patients who develop delirium inside the hospital without a clear reason, such as a fall or focal neurologic symptoms suggesting a stroke, a head CT is probably not necessary, Dr. Feldman said.

“But we have this knee-jerk reaction, this reflex, that when a patient becomes delirious, we probably should run a head CT on them,” he added.

Dr. Feldman acknowledged that the frequency of head CTs on inpatients with delirium has been hard to tease out.

“But all the studies indicate that patients who develop delirium while in the hospital, without any sort of risk factor, are very unlikely to have pathology found on a head CT,” he said, noting that the cause of their delirium is likely something else, like dehydration, an infection, disruption of sleep, urinary retention, or medication effect.

Of course, if patients aren’t getting better without the CT, order the CT, he said. “Even if the patient has no risk factor, there’s still a 3% chance of having an abnormality like a tumor or stroke.”

Renal ultrasound for patients with new acute kidney injury

To determine if an acute kidney injury is caused by a treatable obstruction, such as a large prostate causing urinary retention, doctors often first order a renal ultrasound, a test that can cost $300, and must be read by a radiologist.

 

 

But a much less expensive simple bladder scan, which can be performed by a nurse, is a much better substitute for the first pass, Dr. Feldman said. He said it’s logical that “a bladder scan is a much higher value test” in the early diagnostic process.

“The studies have been pretty clear. If you don’t have risk factors for having an obstruction, a history of kidney stones, it hasn’t happened before, or other reasons kidneys aren’t working, it’s extraordinarily unlikely you’re going to find anything on that renal ultrasound that could be intervened to fix that acute kidney injury,” Dr. Feldman said. He pointed to a study that found 223 renal ultrasounds were necessary to find one patient who needed an intervention.

“You can probably get a good sense from the history and physical” and start to treat them, he said, and if they’re not getting better, then order the ultrasound.

Each of the items on Feldman’s list don’t necessarily save a lot of money, but they add up. “The more we ask ‘Why are we doing this? Can we stop it if it’s not helping people, and particularly if it’s harming people?’ the more we can prevent the cascade that happens because you did one unnecessary diagnostic test,” he concluded.

SAN DIEGO – Head CTs for patients with in-hospital delirium. Ammonia tests to check for hepatic encephalopathy in chronic liver disease. Renal ultrasounds for acute kidney injury.

Those are three low value tests highlighted in hospitalist Dr. Leonard Feldman’s latest iteration of his lecture series “Things We Do for No Reason.”

Dr. Leonard Feldman

Dr. Feldman, associate professor of internal medicine and pediatrics at Johns Hopkins University, Baltimore, has presented his list of usually unnecessary hospitalist practices for five years at the Society of Hospital Medicine’s annual meetings. With three new ones explained during the 2016 meeting, there are now 19 on the list and more to come, he said.

“So far, I’ve picked things that are relatively low-hanging fruit, things for which there’s good evidence we shouldn’t be doing and if you saw the evidence, you’d say ‘that’s right, we shouldn’t,’” he said.

Dr. Feldman’s intent is to help clinicians stop certain “learned behaviors,” tests and procedures which research and experience now show “are not helping people, sometimes harm people, and often result in a cascade” of further unnecessary tests and care.

The conference presentations have been so popular, the Journal of Hospital Medicine in October 2015 started a “Things We Do for No Reason” series.

Here are the three most recent tests hospitalists should avoid:

Ammonia levels for chronic liver disease

Dr. Feldman said doctors were taught in medical school that ammonia levels rise in patients with cirrhosis and when they rise too high, the patient may develop hepatic encephalopathy. They also learned that if levels are normal, the patient should not have hepatic encephalopathy.

But a number of studies have found “neither of those is true,” he said. What’s possibly worse is that “you close your mind to other possible diagnoses way too early.” Nevertheless, the practice at many hospitals is to perform multiple tests to trend those levels.”

“I had a patient who had an ammonia test sent the other day while in the emergency room, and it was elevated,” Dr. Feldman recalled in a recent phone interview. “The patient got admitted, but when we re-tested, it wasn’t.”

Part of the problem is that blood samples are often incorrectly processed. “When you draw the blood, you have to put it on ice and it needs to get to the lab very quickly. And I think we do neither of those things on a regular basis,” he said. Also, if the patient has a tourniquet or is clenching a fist, use of muscle creates ammonia.

Dr. Feldman said that at a hospital like Johns Hopkins in Baltimore, where there are high rates of hepatitis C, there might be 50 patients with chronic liver disease, or 20% of patients on medicine service. It’s not the cost of the blood test that he’s worried about because that’s probably minimal. Rather, it’s the test’s downstream provocation of more unnecessary care “and missed opportunities to intervene with a treatable diagnosis.”

In general, he said, “for patients with chronic liver disease, we shouldn’t be checking ammonia.”

Head CTs for inpatients with new onset delirium

Performing a costly head CT scan on a patient who presents in the emergency department with delirium is appropriate. But for low-risk patients who develop delirium inside the hospital without a clear reason, such as a fall or focal neurologic symptoms suggesting a stroke, a head CT is probably not necessary, Dr. Feldman said.

“But we have this knee-jerk reaction, this reflex, that when a patient becomes delirious, we probably should run a head CT on them,” he added.

Dr. Feldman acknowledged that the frequency of head CTs on inpatients with delirium has been hard to tease out.

“But all the studies indicate that patients who develop delirium while in the hospital, without any sort of risk factor, are very unlikely to have pathology found on a head CT,” he said, noting that the cause of their delirium is likely something else, like dehydration, an infection, disruption of sleep, urinary retention, or medication effect.

Of course, if patients aren’t getting better without the CT, order the CT, he said. “Even if the patient has no risk factor, there’s still a 3% chance of having an abnormality like a tumor or stroke.”

Renal ultrasound for patients with new acute kidney injury

To determine if an acute kidney injury is caused by a treatable obstruction, such as a large prostate causing urinary retention, doctors often first order a renal ultrasound, a test that can cost $300, and must be read by a radiologist.

 

 

But a much less expensive simple bladder scan, which can be performed by a nurse, is a much better substitute for the first pass, Dr. Feldman said. He said it’s logical that “a bladder scan is a much higher value test” in the early diagnostic process.

“The studies have been pretty clear. If you don’t have risk factors for having an obstruction, a history of kidney stones, it hasn’t happened before, or other reasons kidneys aren’t working, it’s extraordinarily unlikely you’re going to find anything on that renal ultrasound that could be intervened to fix that acute kidney injury,” Dr. Feldman said. He pointed to a study that found 223 renal ultrasounds were necessary to find one patient who needed an intervention.

“You can probably get a good sense from the history and physical” and start to treat them, he said, and if they’re not getting better, then order the ultrasound.

Each of the items on Feldman’s list don’t necessarily save a lot of money, but they add up. “The more we ask ‘Why are we doing this? Can we stop it if it’s not helping people, and particularly if it’s harming people?’ the more we can prevent the cascade that happens because you did one unnecessary diagnostic test,” he concluded.

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Health Information Technology Ramps Up Its Presence

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SAN DIEGO — To talk to Nancy Allen, MD, a locum tenens physician who works in Portland, Me., is to get a sense of that head-spinning sensation you can have in the digital age. For hospitalists, it’s an endless stream of patients, diagnoses, documentation, and performance metrics. Following an HM16 session here, it’s also an endless litany of ways to try to make all of it more manageable.

Hospitalist Shaheen Khan, MD, (center) checks out a portable ultrasound gadget in the exhibit hall.

Looking for on-the-job shortcuts, Dr. Allen attended the session “There Is an App for That, 2016: Update in Hospital Medicine Mobile Applications.”

“You always feel like there’s too much information,” she said. “I do 14-hour days. To add anything that takes time is crippling.”

The session was helpful, she said, with eye-opening presentations on apps Dr. Allen never knew existed. Most important, the recommendations came with the seal of approval of practicing hospitalists. But even the information presented in the session felt perhaps too much, she said.

“They seemed really doable,” Dr. Allen said. “But I felt like by the end, I’m overwhelmed.”

Health information technology (IT) had its own educational track for the first time at the annual meeting, with offerings on using technology for better documentation, social media, and clinical informatics.

In the apps session, presenters Bradley Benson, MD, professor of internal medicine and pediatrics at the University of Minnesota, and J. Richard Pittman Jr., MD, assistant professor of medicine at Emory University, cautioned that FDA regulation of mobile apps will be getting more stringent. They encouraged physicians to stay ahead of the game, using apps that are based on sound research so that they don’t begin to rely on apps that will eventually no longer be options.

Their recommendations were based on personal experience, some admittedly biased published reviews, objective criterion-referenced reviews, and peer-reviewed study data.

Dr. Allen said she was especially interested in MedCalX, an app designed for physicians and featuring medical formulas, scores, and classifications. She also liked that the presenters gave a lesson, short but complete, on how to get a Web-based app that you find on a browser to appear as an icon on your phone, just like any other app.

Presenter recommendations ranged from the nifty (GoodRx allows you to type in a medication and map both local pharmacies and what they charge for the drug) to those that help with basic life and job logistics (Evernote makes it easy to file away emails, attachments, and images). Evernote is the app Dr. Pittman said he’d keep if he could only use one.

As dizzying as it was, the session seemed to lift Dr. Allen’s hopes that she’d be able to incorporate apps more into her work.

“You have to make a decision on the fly a lot of the time,” she said. “You have to do it in real time. … In theory, apps should be able to do that.”

Teri Dyess, MD, director of hospital medicine at St. Dominic Hospital in Jackson, Miss., said that the “Optimizing IT for Documentation and Handoffs” session underscored a problem she has noticed in her department: doctors cutting and pasting too much information in their progress notes. That includes CT reports, labs, pretty much everything, she said.

“It’s just one long note,” she said, adding some notes “get out of hand.” Now, she has information—and reinforcement of her own concerns—that she can take back to her center.

Presenters said that physicians should remember that notes primarily serve the needs of patients and providers and should focus on quality and clarity rather than excessive detail. They recommended the “APSO” format, with the assessment and plan at the beginning, then the subjective history next, then the objective info such as vital signs and physical exam details. Studies have found this tends to work better than the “SOAP” method, with subjective history first.

 

 

Katherine Chretien, MD, chief of the hospitalist section at the Washington, D.C., VA Medical Center, described the growing use of crowd-sourcing and social media in medicine, by both physicians and patients. More than half of patients, a survey found, said that they are comfortable or very comfortable with their doctor seeking advice online. And about half of hospitals have a presence on Facebook, Twitter, Yelp, and Foursquare.

With the growing use of social media, though, comes the importance of knowing etiquette and being aware of the legal pitfalls, Dr. Chretien said. Posting specifics, even without names, about a case might violate patient privacy laws simply because the date of the post might give away too much information, she warned. Mixing the personal and the professional is not advised.

Peter Balingit, MD, a hospitalist at Olive View-UCLA Medical Center who said he doesn’t use social media for his work, said the session raised his confidence, and he might start a Facebook page or begin interacting through a patient portal.

“After hearing this, I think I’m more comfortable trying to develop more of an online presence,” he said. “My biggest fear is trying to keep my personal life and my professional life separate.” TH

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SAN DIEGO — To talk to Nancy Allen, MD, a locum tenens physician who works in Portland, Me., is to get a sense of that head-spinning sensation you can have in the digital age. For hospitalists, it’s an endless stream of patients, diagnoses, documentation, and performance metrics. Following an HM16 session here, it’s also an endless litany of ways to try to make all of it more manageable.

Hospitalist Shaheen Khan, MD, (center) checks out a portable ultrasound gadget in the exhibit hall.

Looking for on-the-job shortcuts, Dr. Allen attended the session “There Is an App for That, 2016: Update in Hospital Medicine Mobile Applications.”

“You always feel like there’s too much information,” she said. “I do 14-hour days. To add anything that takes time is crippling.”

The session was helpful, she said, with eye-opening presentations on apps Dr. Allen never knew existed. Most important, the recommendations came with the seal of approval of practicing hospitalists. But even the information presented in the session felt perhaps too much, she said.

“They seemed really doable,” Dr. Allen said. “But I felt like by the end, I’m overwhelmed.”

Health information technology (IT) had its own educational track for the first time at the annual meeting, with offerings on using technology for better documentation, social media, and clinical informatics.

In the apps session, presenters Bradley Benson, MD, professor of internal medicine and pediatrics at the University of Minnesota, and J. Richard Pittman Jr., MD, assistant professor of medicine at Emory University, cautioned that FDA regulation of mobile apps will be getting more stringent. They encouraged physicians to stay ahead of the game, using apps that are based on sound research so that they don’t begin to rely on apps that will eventually no longer be options.

Their recommendations were based on personal experience, some admittedly biased published reviews, objective criterion-referenced reviews, and peer-reviewed study data.

Dr. Allen said she was especially interested in MedCalX, an app designed for physicians and featuring medical formulas, scores, and classifications. She also liked that the presenters gave a lesson, short but complete, on how to get a Web-based app that you find on a browser to appear as an icon on your phone, just like any other app.

Presenter recommendations ranged from the nifty (GoodRx allows you to type in a medication and map both local pharmacies and what they charge for the drug) to those that help with basic life and job logistics (Evernote makes it easy to file away emails, attachments, and images). Evernote is the app Dr. Pittman said he’d keep if he could only use one.

As dizzying as it was, the session seemed to lift Dr. Allen’s hopes that she’d be able to incorporate apps more into her work.

“You have to make a decision on the fly a lot of the time,” she said. “You have to do it in real time. … In theory, apps should be able to do that.”

Teri Dyess, MD, director of hospital medicine at St. Dominic Hospital in Jackson, Miss., said that the “Optimizing IT for Documentation and Handoffs” session underscored a problem she has noticed in her department: doctors cutting and pasting too much information in their progress notes. That includes CT reports, labs, pretty much everything, she said.

“It’s just one long note,” she said, adding some notes “get out of hand.” Now, she has information—and reinforcement of her own concerns—that she can take back to her center.

Presenters said that physicians should remember that notes primarily serve the needs of patients and providers and should focus on quality and clarity rather than excessive detail. They recommended the “APSO” format, with the assessment and plan at the beginning, then the subjective history next, then the objective info such as vital signs and physical exam details. Studies have found this tends to work better than the “SOAP” method, with subjective history first.

 

 

Katherine Chretien, MD, chief of the hospitalist section at the Washington, D.C., VA Medical Center, described the growing use of crowd-sourcing and social media in medicine, by both physicians and patients. More than half of patients, a survey found, said that they are comfortable or very comfortable with their doctor seeking advice online. And about half of hospitals have a presence on Facebook, Twitter, Yelp, and Foursquare.

With the growing use of social media, though, comes the importance of knowing etiquette and being aware of the legal pitfalls, Dr. Chretien said. Posting specifics, even without names, about a case might violate patient privacy laws simply because the date of the post might give away too much information, she warned. Mixing the personal and the professional is not advised.

Peter Balingit, MD, a hospitalist at Olive View-UCLA Medical Center who said he doesn’t use social media for his work, said the session raised his confidence, and he might start a Facebook page or begin interacting through a patient portal.

“After hearing this, I think I’m more comfortable trying to develop more of an online presence,” he said. “My biggest fear is trying to keep my personal life and my professional life separate.” TH

SAN DIEGO — To talk to Nancy Allen, MD, a locum tenens physician who works in Portland, Me., is to get a sense of that head-spinning sensation you can have in the digital age. For hospitalists, it’s an endless stream of patients, diagnoses, documentation, and performance metrics. Following an HM16 session here, it’s also an endless litany of ways to try to make all of it more manageable.

Hospitalist Shaheen Khan, MD, (center) checks out a portable ultrasound gadget in the exhibit hall.

Looking for on-the-job shortcuts, Dr. Allen attended the session “There Is an App for That, 2016: Update in Hospital Medicine Mobile Applications.”

“You always feel like there’s too much information,” she said. “I do 14-hour days. To add anything that takes time is crippling.”

The session was helpful, she said, with eye-opening presentations on apps Dr. Allen never knew existed. Most important, the recommendations came with the seal of approval of practicing hospitalists. But even the information presented in the session felt perhaps too much, she said.

“They seemed really doable,” Dr. Allen said. “But I felt like by the end, I’m overwhelmed.”

Health information technology (IT) had its own educational track for the first time at the annual meeting, with offerings on using technology for better documentation, social media, and clinical informatics.

In the apps session, presenters Bradley Benson, MD, professor of internal medicine and pediatrics at the University of Minnesota, and J. Richard Pittman Jr., MD, assistant professor of medicine at Emory University, cautioned that FDA regulation of mobile apps will be getting more stringent. They encouraged physicians to stay ahead of the game, using apps that are based on sound research so that they don’t begin to rely on apps that will eventually no longer be options.

Their recommendations were based on personal experience, some admittedly biased published reviews, objective criterion-referenced reviews, and peer-reviewed study data.

Dr. Allen said she was especially interested in MedCalX, an app designed for physicians and featuring medical formulas, scores, and classifications. She also liked that the presenters gave a lesson, short but complete, on how to get a Web-based app that you find on a browser to appear as an icon on your phone, just like any other app.

Presenter recommendations ranged from the nifty (GoodRx allows you to type in a medication and map both local pharmacies and what they charge for the drug) to those that help with basic life and job logistics (Evernote makes it easy to file away emails, attachments, and images). Evernote is the app Dr. Pittman said he’d keep if he could only use one.

As dizzying as it was, the session seemed to lift Dr. Allen’s hopes that she’d be able to incorporate apps more into her work.

“You have to make a decision on the fly a lot of the time,” she said. “You have to do it in real time. … In theory, apps should be able to do that.”

Teri Dyess, MD, director of hospital medicine at St. Dominic Hospital in Jackson, Miss., said that the “Optimizing IT for Documentation and Handoffs” session underscored a problem she has noticed in her department: doctors cutting and pasting too much information in their progress notes. That includes CT reports, labs, pretty much everything, she said.

“It’s just one long note,” she said, adding some notes “get out of hand.” Now, she has information—and reinforcement of her own concerns—that she can take back to her center.

Presenters said that physicians should remember that notes primarily serve the needs of patients and providers and should focus on quality and clarity rather than excessive detail. They recommended the “APSO” format, with the assessment and plan at the beginning, then the subjective history next, then the objective info such as vital signs and physical exam details. Studies have found this tends to work better than the “SOAP” method, with subjective history first.

 

 

Katherine Chretien, MD, chief of the hospitalist section at the Washington, D.C., VA Medical Center, described the growing use of crowd-sourcing and social media in medicine, by both physicians and patients. More than half of patients, a survey found, said that they are comfortable or very comfortable with their doctor seeking advice online. And about half of hospitals have a presence on Facebook, Twitter, Yelp, and Foursquare.

With the growing use of social media, though, comes the importance of knowing etiquette and being aware of the legal pitfalls, Dr. Chretien said. Posting specifics, even without names, about a case might violate patient privacy laws simply because the date of the post might give away too much information, she warned. Mixing the personal and the professional is not advised.

Peter Balingit, MD, a hospitalist at Olive View-UCLA Medical Center who said he doesn’t use social media for his work, said the session raised his confidence, and he might start a Facebook page or begin interacting through a patient portal.

“After hearing this, I think I’m more comfortable trying to develop more of an online presence,” he said. “My biggest fear is trying to keep my personal life and my professional life separate.” TH

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New Ideas Showcased in Research at RIV Competition

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Standing adjacent Poster 391 in a loud, crowded meeting hall, Monika Wells, MD, MPH, a resident in internal medicine at Virginia Mason Medical Center in Seattle, chatted with a colleague. A few feet away, a group of doctors and healthcare professionals huddled dramatically, just barely out of earshot.

The fate of Dr. Wells’ scientific abstract hung in the balance.

Her study, a look at scheduling the start and stop times of hospitalist shifts around expected demand to reduce costs and patient wait times, was a short-list finalist in the Innovations category of HM16’s annual Research, Innovation, and Clinical Vignettes scientific abstract competition. With her work done—she had already made presentations to first a pair of semifinalist judges and then to a herd of all 10 of the category judges—Dr. Wells looked remarkably calm as she waited for the announcement of the winners.

Either way, she said, the competition had been an invigorating, exciting experience.

“I’m a doctor, so I like to compete,” she half-joked. “It definitely has been motivating.”

RIV ribbons this year were handed out to seven winners in four categories. The competition garnered 914 abstracts accepted for presentation.

Dr. Wells ended up being one of them. She was named Innovations’ trainee winner. In her study, researchers found that analyzing the flow of admissions and redistributing hospitalists to better conform to that flow reduced patient wait times and costs as well as improved the subjective experience of hospitalists even as volume increased.

The overall winner in the Innovations category also went to a trainee, Baely Crockett, PharmD, a resident at Eskenazi Health in Indianapolis. Her study looked at a pharmacist-managed rivaroxaban clinic for the treatment of venous thromboembolism (VTE). It was the first time, as far as the judges knew, that an award had gone to a pharmacist.

Dr. Crockett’s abstract showed that patients diagnosed in the ED with low-risk VTE are given a prescription scheduled to be seen in the follow-up clinic within two to five days, at which point the pharmacist sees the patients and reviews their case with them and determines treatment duration.

Dr. Crockett said the pharmacists involved are especially suitable for the role not only because of their expertise in the medication and the handling of time-consuming co-pay issues and other concerns but also because they shadowed ED physicians for six months to get training and experience.

“We’re able to fill in gaps that are true challenges to the patient’s success in finishing therapy,” she said.

One of the Innovations judges, Michael Craig, MD, MPH, FHM, associate professor of medicine at the University of North Carolina in Chapel Hill, said the research hit on an area of growing interest.

“The movement toward outpatient treatment of VTE is a pretty big topic that lots of people are working on,” he said. “It’s very relevant. The whole idea of having a pharmacist-driven intervention is unique; nobody had thought of or heard of before.”

The winner in the Research category was Vineet Chopra, MD, MSc, FHM, assistant professor at the University of Michigan in Ann Arbor, whose work set out to quantify how to prevent bloodstream infection and blood clots from the use of peripherally inserted central catheters, or PICC lines. Researchers created a simulation model, based on data from the literature, looking at what would happen to a hospital if the use of certain types of PICCs was increased while use of other types was decreased—the rationale being that PICCs with just one channel, or port, have a lower risk of infection or blood clots than those with multiple ports.

 

 

It is a risk that is often unrecognized, and PICC lines with multiple ports are often ordered as a just-in-case measure in the event that the first port gets clogged.

Chopra and colleagues found that, at the average hospital, about 75% of all PICCs used tend to be multichannel and 25% single-channel. They found every 5% increase in single-channel PICC use could prevent almost 1.5 infections per 1,000 patients, and 0.5 blood clots, with a corresponding cost savings of $13,000 per event. That can add up to hundreds of thousands of dollars a year at large hospitals.

And those calculations, Dr. Chopra noted, do not include penalties for infections or the financial effects of having those results publicly reported. Researchers are now creating an online tool— at improvepicc.com—that will allow users to calculate their own costs and potential savings.

“The hope of this is that it will give hospital administrators and hospital leadership and quality officers the momentum, perhaps, to overcome the inertia of not thinking actively,” said Dr. Chopra, who notched his first win after 10 years of participating in the RIV competition. “I think we don’t think actively about the choices we make when it comes to these devices.”

In the Clinical Vignettes category, winner Molly Kantor, MD, assistant clinical professor at the University of California, San Diego, recounted the case of a sickle-cell disease patient whose diagnosis, and hence treatment, was delayed and who ultimately died. She outlined a series of missteps, including taking at face-value a patient-reported past medical disease, which turned out to be wrong; making certain diagnoses based on lab tests and stopping there; and anchoring on the original diagnosis when the thought process was later reevaluated.

Dr. Kantor said the case is a caution flag to hospitalists, reinforcing the need for “a broad differential diagnosis.”

“[Make] sure that the data fits together and that you’re not using just one isolated piece of information to cinch everything, including the past medical history or a certain lab test, when the whole picture doesn’t quite fit together,” she said. “Looking back at this case, it’s pretty clear that the puzzle pieces probably weren’t quite fitting together, but there was enough that the easier thing to do was to make the diagnosis and move on.”

In the Pediatric Clinical Vignettes category, winner Jennifer Ladd, MD, a resident at Duke University, won for a study of a vexing case of a 2-year-old who was irritable and stalled on developmental milestones. At the hospital, the thought was that it could likely be a recurrence of herpes simplex (HSV) encephalitis, but the spinal fluid showed no signs of that and the acyclovir, which nearly always works for the disorder, was having no effect and the symptoms worsened.

The key in the case, said Alyssa Stephany, MD, then assistant professor at Duke University and now section chief of pediatric hospital medicine at Children’s Hospital of Wisconsin, who presented the case in Dr. Ladd’s absence, was that the team reopened the diagnosis and didn’t get ensnared in cognitive bias. A biopsy ultimately showed HSV in the brain tissue; it was a case of recurrence, despite signs to the contrary. Foscarnet was used to effectively treat the child; it is unknown why acyclovir didn’t work in this case.

“It kind of brings to the surface that that’s what a hospitalist is—a hospitalist is that person who sits and thinks, and really thinks, about the patient and doesn’t just do their rote work of input and output of a patient through the hospital system,” Dr. Stephany said. “When you get a case like this, it makes you take pause.”

 

 

The trainee winner in the Research category was N. Lance Downing, MD, of Stanford University School of Medicine, for work on an EHR-based severe sepsis alert. The trainee winner in Clinical Vignettes was Bhakti Shah, MD, of North Shore-LIJ Health System, now Northwell Health, on a rare case of autoimmune NMDA receptor encephalitis. TH


Thomas R. Collins is a freelance writer in South Florida.

2016 RIV Finalists, Winners

Research Category

WINNER:

Dr. Chopra

Vineet Chopra, MD, MSc, FHM, LIMITING THE NUMBER OF LUMENS IN PERIPHERALLY INSERTED CENTRAL CATHETERS TO IMPROVE OUTCOMES AND REDUCE COST: A SIMULATION STUDY

TRAINEE WINNER:

N. Downing, MD, AN ELECTRONIC HEALTH RECORD-BASED SEVERE SEPSIS ALERT TO IMPROVE SEPSIS TREATMENT PERFORMANCE: RANDOMIZED EVALUATION

FINALISTS:

Waseem Khaliq, MD, MPH, PREVALENCE AND PREDICTORS OF NON-ADHERENCE TO BREAST CANCER SCREENING: PERSPECTIVE AND PREFERENCES OF HOSPITALIZED WOMEN

Dilli Poudel, MD, SYSTEMIC SCLEROSIS AS A RISK FACTOR OF ACUTE MYOCARDIAL INFARCTION: A US POPULATION BASED STUDY

Aiham Albaeni, MD, REGIONAL VARIATION IN RESOURCES UTILIZATION AND OUTCOMES FOLLOWING OUT-OF-HOSPITAL CARDIAC ARREST IN THE UNITED STATES

Poushali Bhattacharjee, MD, DETECTING SEPSIS: ARE TWO OPINIONS BETTER THAN ONE?

Vineet Chopra, MD, MSc, FHM, THE INFLUENCE OF RED BLOOD CELL TRANSFUSION ON VENOUS THROMBOEMBOLISM IN PATIENTS WITH PERIPHERALLY-INSERTED CENTRAL CATHETERS

Shaker Eid, MD, MBA, IMPACT OF HOSPITAL TEACHING STATUS ON OUT-OF-HOSPITAL CARDIAC ARREST OUTCOMES AND RESOURCE UTILIZATION IN THE UNITED STATES: 2000-2012

Tarun Jain, MD, CONTRAST-INDUCED NEPHROPATHY IN STEMI PATIENTS WITH AND WITHOUT CHRONIC KIDNEY DISEASE

Mona Beier, MD, CREATING A PATIENT SAFETY CULTURE ONE INCIDENT REPORT AT A TIME

Charles Pollack, MD, REINITIATION OF ANTITHROMBOTIC THERAPY AFTER EMERGENCY PROCEDURES OR AFTER AN EMERGENT BLEEDING EVENT: ADDITIONAL INTERIM EXPERIENCE FROM THE RE-VERSE AD TRIAL

Robert Boxer, MD, PhD, SAVING TIME: A TIME-MOTION ANALYSIS OF THE IMPACT OF REGIONALIZATION AND DAILY ADMITTING ON INTERN WORKFLOW

Kaleigh Evans, MD, THIRD TROPONIN ORDER OVERUSE IN THE SETTING OF CLINICAL STABILITY

David Paje, MD, SFHM, RISK OF VENOUS THROMBOEMBOLISM IN HOSPITALIZED PATIENTS WITH INFLAMMATORY BOWEL DISEASE

Rehan Qayyum, MD, COMPARISON OF TIME-TRENDS IN PATIENT SATISFACTION BETWEEN TEACHING AND NONTEACHING HOSPITAL

Joshua Rolnick, MD, VALIDATION OF TEST PERFORMANCE AND CLINICAL TIME ZERO FOR AN ELECTRONIC HEALTH RECORD-EMBEDDED SEVERE SEPSIS ALERT

Allison Louis, MD, BLIND SIDED: MISSING POOR VISUAL ACUITY AND DECREASED SELF-EFFICACY IN HOSPITALIZED PATIENTS WITH DIABETES

G. Randy Smith, MD, MS, SFHM, ASSOCIATION OF HOSPITAL ADMISSION SERVICE STRUCTURE WITH EARLY TRANSFER TO CRITICAL CARE, HOSPITAL READMISSION, AND LENGTH OF STAY

Kathleene Wooldridge, MD, R-VA-MARQUIS: IMPLEMENTING BEST PRACTICES IN MEDICATION RECONCILIATION FOR RURAL VETERANS

INNOVATION CATEGORY

WINNER:

Dr. Crockett

Baely Crockett, PharmD, NOVEL PHARMACIST-MANAGED RIVAROXABAN CLINIC FOR OUTPATIENT TREATMENT OF VENOUS THROMBOEMBOLISM

TRAINEE WINNER:

Wells

Monika Wells, MD, MPH, DESIGNING HOSPITALIST SHIFTS AROUND ADMISSION DEMAND REDUCES PATIENT WAIT TIMES AND COST

FINALISTS:

Jessica Dong, WHO MOVED MY EHR CHEESE? A NEW APPROACH TO CURATING AND INDIVIDUALIZING COMMUNICATIONS TO PHYSICIANS ABOUT EHR SOFTWARE UPDATES

Stephanie Rennke, MD, MED REC: A SKILLS-BASED CURRICULUM ON MEDICATION SAFETY AND MEDICATION RECONCILIATION FOR MEDICAL STUDENTS

Jens Langsjoen, MD, DEVELOPING AN INPATIENT DELIRIUM PREVENTION PROTOCOL

Mark Goldin, MD, BUILDING PARALLEL CO-MANAGEMENT SERVICES IN A LARGE ACADEMIC HOSPITALIST GROUP

Brian Lichtenstein, MD, IMPROVING RISK-ADJUSTED OUTCOME MEASURES WITH PHYSICIAN-ORIENTED DOCUMENTATION INTERVENTIONS

Matthew Cerasale, MD, REAL-TIME PADUA: AN AUTOMATED EHR INTEGRATED VENOUS THROMBOEMBOLISM RISK ASSESSMENT TOOL

Franziska Jovin, MD, MMM, FHM, IMPLEMENTATION OF A PAY-FOR-PERFOMANCE STRUCTURE FOR HOSPITALIST-LED QUALITY IMPROVEMENT PROJECTS

Arpit Khandelwal, MD, MANAGING CHALLENGING PATIENTS: FROM CONFLICT TO TEACHING OPPORTUNITY

Justin Lotfi, MD, MAKING IT SIMPLE - PROCESS IMPROVEMENT FOR OUTSIDE MEDICAL RECORDS

David McCollum, MD, FIXING WHAT IS BROKEN: QUALITY IMPROVEMENT IN THE CRITICAL LAB VALUE PROCESS

Nidhi Rohatgi, MD, MS, A NOVEL MD-RN COLLABORATIVE PROTOCOL TO PREVENT AND MANAGE ACUTE DELIRIUM IN INPATIENT WARDS

Lesley Schmaltz, MD, UNNECESSARY TRANSFUSIONS: HOSPITAL MEDICINE LEADING INSTITUTION-WIDE CHANGE

Anuj Dalal, MD, FHM, IMPLEMENTATION OF A PATIENT-CENTERED ‘MICROBLOG' MESSAGING PLATFORM TO IMPROVE CARE TEAM COMMUNICATION

Willard Ellis, MD, PhD, FHM, INTENSIVE FOLLOW UP AFTER PALLIATIVE CARE CONSULTATIONS TO REDUCE READMISSIONS

Lakshmi Swaminathan, MD, MHSA, FHM, USING “MAGIC” TO FACILITATE APPROPRIATE PICC USE: RESULTS OF IMPLEMENTATION OF A PICC APPROPRIATENESS ASSESSMENT TOOL

Charles Coffey, MD, MSc, FHM, IMPLEMENTING GUIDELINE-BASED INDICATIONS FOR CARDIAC MONITORING AT CEDARS-SINAI MEDICAL CENTER

Erik Hoyer, MD, USE OF A HOSPITALIST CLINICAL COMMUNITY TO FACILITATE DISSEMINATION OF AN EARLY MOBILITY QUALITY IMPROVEMENT PROGRAM

Elizabeth Stewart, MD, A MULTIDISCIPLINARY APPROACH TO HIGH VALUE CARDIAC BIOMARKER

CLINICAL VIGNETTES CATEGORY

WINNER (ADULT):

Kantor

Molly Kantor, MD, THE TIP OF THE ICEBERG: A RARE CAUSE OF ACUTE LIVER FAILURE

WINNER (PEDIATRIC):

Ladd

Jennifer Ladd, MD, MORE THAN JUST THE “TERRIBLE TWOS”: A CASE OF RESISTANT HSV ENCEPHALITIS

TRAINEE WINNER:

Shah

Bhakti Shah, MD, UNMASKING THE TERATOMA

FINALISTS:

Weijen Chang, MD, SFHM, UNCOILING A PROBLEMATIC TICKLE IN THE THROAT

Kenton Dover, MD, KEEPING AN EYE OUT FOR THE DIAGNOSIS

Stephanie Royer, MD, THE YOUNGEST REPORTED CASE OF EOSINOPHILIC CHOLANGITIS

Oluremi Ajala, MD, ANGINA OF ABDOMINAL ORIGIN

Asana Anderson, MBBS, A PARATHYROID CRISIS BURIED IN A SEPTIC OTOMASTOIDITIS

Kyle Bennett, DO, BULLS-EYE MARKS THE SPOT: LYME CARDITIS PRESENTING AS RASH AND PRESYNCOPE

John Biebelhausen, MD, MBA, CROSSFIT CATASTROPHE: CHEST PAIN IN A HEALTHY YOUNG WOMAN

Xuan Gao, MD, A CASE OF THE UNSEEN: KLEBSIELLA PNEUMONIA PYOGENIC LIVER ABSCESS WITH PNEUMONIA AND SEPTIC ENDOPHTHALMITIS IN A NON-ASIAN U.S. RESIDENT

Sana Grover, MBBS, 'ABSTINENT AND INTOXICATED'. A RARE CASE OF AUTO-BREWERY SYNDROME

Andrew Hawrylak, MD, WHEN IT'S NOT AN ALLERGIC REACTION: AN UNUSUAL CASE OF ECTHYEMA GANGRENOSUM ASSOCIATED WITH PROTEUS BACTEREMIA

Rasheen Imtiaz, MD, LACTIC ACIDOSIS IN ASTHMA

Jessie King, MD, PhD, THE SMOKING WOMAN

Bradley Manning, MD, A SUPER-ANTIGEN-MEDIATED MIMIC OF ACUTE APPENDICITIS

Hiroki Matsuura, IMPAIRED CONSCIOUSNESS WITH INDOLENT BREAST MASS

Niharika Singh, MD, LOWER EXTREMITY NECROTIZING FASCIITIS: AN UNUSUAL PRESENTATION OF PERFORATED SIGMOID DIVERTICULITIS

Vivan Tran, DO, PUTTING THE PEE IN PREGNANCY: A CASE OF GESTATIONAL DIABETES INSIPIDUS YOU DON'T WANT TO MISS

Kristen Welch, THE MYSTERIOUS DANCE: A RARE CASE OF DELAYED ONSET DIABETIC STRIATOPATHY

Issue
The Hospitalist - 2016(04)
Publications
Sections

Standing adjacent Poster 391 in a loud, crowded meeting hall, Monika Wells, MD, MPH, a resident in internal medicine at Virginia Mason Medical Center in Seattle, chatted with a colleague. A few feet away, a group of doctors and healthcare professionals huddled dramatically, just barely out of earshot.

The fate of Dr. Wells’ scientific abstract hung in the balance.

Her study, a look at scheduling the start and stop times of hospitalist shifts around expected demand to reduce costs and patient wait times, was a short-list finalist in the Innovations category of HM16’s annual Research, Innovation, and Clinical Vignettes scientific abstract competition. With her work done—she had already made presentations to first a pair of semifinalist judges and then to a herd of all 10 of the category judges—Dr. Wells looked remarkably calm as she waited for the announcement of the winners.

Either way, she said, the competition had been an invigorating, exciting experience.

“I’m a doctor, so I like to compete,” she half-joked. “It definitely has been motivating.”

RIV ribbons this year were handed out to seven winners in four categories. The competition garnered 914 abstracts accepted for presentation.

Dr. Wells ended up being one of them. She was named Innovations’ trainee winner. In her study, researchers found that analyzing the flow of admissions and redistributing hospitalists to better conform to that flow reduced patient wait times and costs as well as improved the subjective experience of hospitalists even as volume increased.

The overall winner in the Innovations category also went to a trainee, Baely Crockett, PharmD, a resident at Eskenazi Health in Indianapolis. Her study looked at a pharmacist-managed rivaroxaban clinic for the treatment of venous thromboembolism (VTE). It was the first time, as far as the judges knew, that an award had gone to a pharmacist.

Dr. Crockett’s abstract showed that patients diagnosed in the ED with low-risk VTE are given a prescription scheduled to be seen in the follow-up clinic within two to five days, at which point the pharmacist sees the patients and reviews their case with them and determines treatment duration.

Dr. Crockett said the pharmacists involved are especially suitable for the role not only because of their expertise in the medication and the handling of time-consuming co-pay issues and other concerns but also because they shadowed ED physicians for six months to get training and experience.

“We’re able to fill in gaps that are true challenges to the patient’s success in finishing therapy,” she said.

One of the Innovations judges, Michael Craig, MD, MPH, FHM, associate professor of medicine at the University of North Carolina in Chapel Hill, said the research hit on an area of growing interest.

“The movement toward outpatient treatment of VTE is a pretty big topic that lots of people are working on,” he said. “It’s very relevant. The whole idea of having a pharmacist-driven intervention is unique; nobody had thought of or heard of before.”

The winner in the Research category was Vineet Chopra, MD, MSc, FHM, assistant professor at the University of Michigan in Ann Arbor, whose work set out to quantify how to prevent bloodstream infection and blood clots from the use of peripherally inserted central catheters, or PICC lines. Researchers created a simulation model, based on data from the literature, looking at what would happen to a hospital if the use of certain types of PICCs was increased while use of other types was decreased—the rationale being that PICCs with just one channel, or port, have a lower risk of infection or blood clots than those with multiple ports.

 

 

It is a risk that is often unrecognized, and PICC lines with multiple ports are often ordered as a just-in-case measure in the event that the first port gets clogged.

Chopra and colleagues found that, at the average hospital, about 75% of all PICCs used tend to be multichannel and 25% single-channel. They found every 5% increase in single-channel PICC use could prevent almost 1.5 infections per 1,000 patients, and 0.5 blood clots, with a corresponding cost savings of $13,000 per event. That can add up to hundreds of thousands of dollars a year at large hospitals.

And those calculations, Dr. Chopra noted, do not include penalties for infections or the financial effects of having those results publicly reported. Researchers are now creating an online tool— at improvepicc.com—that will allow users to calculate their own costs and potential savings.

“The hope of this is that it will give hospital administrators and hospital leadership and quality officers the momentum, perhaps, to overcome the inertia of not thinking actively,” said Dr. Chopra, who notched his first win after 10 years of participating in the RIV competition. “I think we don’t think actively about the choices we make when it comes to these devices.”

In the Clinical Vignettes category, winner Molly Kantor, MD, assistant clinical professor at the University of California, San Diego, recounted the case of a sickle-cell disease patient whose diagnosis, and hence treatment, was delayed and who ultimately died. She outlined a series of missteps, including taking at face-value a patient-reported past medical disease, which turned out to be wrong; making certain diagnoses based on lab tests and stopping there; and anchoring on the original diagnosis when the thought process was later reevaluated.

Dr. Kantor said the case is a caution flag to hospitalists, reinforcing the need for “a broad differential diagnosis.”

“[Make] sure that the data fits together and that you’re not using just one isolated piece of information to cinch everything, including the past medical history or a certain lab test, when the whole picture doesn’t quite fit together,” she said. “Looking back at this case, it’s pretty clear that the puzzle pieces probably weren’t quite fitting together, but there was enough that the easier thing to do was to make the diagnosis and move on.”

In the Pediatric Clinical Vignettes category, winner Jennifer Ladd, MD, a resident at Duke University, won for a study of a vexing case of a 2-year-old who was irritable and stalled on developmental milestones. At the hospital, the thought was that it could likely be a recurrence of herpes simplex (HSV) encephalitis, but the spinal fluid showed no signs of that and the acyclovir, which nearly always works for the disorder, was having no effect and the symptoms worsened.

The key in the case, said Alyssa Stephany, MD, then assistant professor at Duke University and now section chief of pediatric hospital medicine at Children’s Hospital of Wisconsin, who presented the case in Dr. Ladd’s absence, was that the team reopened the diagnosis and didn’t get ensnared in cognitive bias. A biopsy ultimately showed HSV in the brain tissue; it was a case of recurrence, despite signs to the contrary. Foscarnet was used to effectively treat the child; it is unknown why acyclovir didn’t work in this case.

“It kind of brings to the surface that that’s what a hospitalist is—a hospitalist is that person who sits and thinks, and really thinks, about the patient and doesn’t just do their rote work of input and output of a patient through the hospital system,” Dr. Stephany said. “When you get a case like this, it makes you take pause.”

 

 

The trainee winner in the Research category was N. Lance Downing, MD, of Stanford University School of Medicine, for work on an EHR-based severe sepsis alert. The trainee winner in Clinical Vignettes was Bhakti Shah, MD, of North Shore-LIJ Health System, now Northwell Health, on a rare case of autoimmune NMDA receptor encephalitis. TH


Thomas R. Collins is a freelance writer in South Florida.

2016 RIV Finalists, Winners

Research Category

WINNER:

Dr. Chopra

Vineet Chopra, MD, MSc, FHM, LIMITING THE NUMBER OF LUMENS IN PERIPHERALLY INSERTED CENTRAL CATHETERS TO IMPROVE OUTCOMES AND REDUCE COST: A SIMULATION STUDY

TRAINEE WINNER:

N. Downing, MD, AN ELECTRONIC HEALTH RECORD-BASED SEVERE SEPSIS ALERT TO IMPROVE SEPSIS TREATMENT PERFORMANCE: RANDOMIZED EVALUATION

FINALISTS:

Waseem Khaliq, MD, MPH, PREVALENCE AND PREDICTORS OF NON-ADHERENCE TO BREAST CANCER SCREENING: PERSPECTIVE AND PREFERENCES OF HOSPITALIZED WOMEN

Dilli Poudel, MD, SYSTEMIC SCLEROSIS AS A RISK FACTOR OF ACUTE MYOCARDIAL INFARCTION: A US POPULATION BASED STUDY

Aiham Albaeni, MD, REGIONAL VARIATION IN RESOURCES UTILIZATION AND OUTCOMES FOLLOWING OUT-OF-HOSPITAL CARDIAC ARREST IN THE UNITED STATES

Poushali Bhattacharjee, MD, DETECTING SEPSIS: ARE TWO OPINIONS BETTER THAN ONE?

Vineet Chopra, MD, MSc, FHM, THE INFLUENCE OF RED BLOOD CELL TRANSFUSION ON VENOUS THROMBOEMBOLISM IN PATIENTS WITH PERIPHERALLY-INSERTED CENTRAL CATHETERS

Shaker Eid, MD, MBA, IMPACT OF HOSPITAL TEACHING STATUS ON OUT-OF-HOSPITAL CARDIAC ARREST OUTCOMES AND RESOURCE UTILIZATION IN THE UNITED STATES: 2000-2012

Tarun Jain, MD, CONTRAST-INDUCED NEPHROPATHY IN STEMI PATIENTS WITH AND WITHOUT CHRONIC KIDNEY DISEASE

Mona Beier, MD, CREATING A PATIENT SAFETY CULTURE ONE INCIDENT REPORT AT A TIME

Charles Pollack, MD, REINITIATION OF ANTITHROMBOTIC THERAPY AFTER EMERGENCY PROCEDURES OR AFTER AN EMERGENT BLEEDING EVENT: ADDITIONAL INTERIM EXPERIENCE FROM THE RE-VERSE AD TRIAL

Robert Boxer, MD, PhD, SAVING TIME: A TIME-MOTION ANALYSIS OF THE IMPACT OF REGIONALIZATION AND DAILY ADMITTING ON INTERN WORKFLOW

Kaleigh Evans, MD, THIRD TROPONIN ORDER OVERUSE IN THE SETTING OF CLINICAL STABILITY

David Paje, MD, SFHM, RISK OF VENOUS THROMBOEMBOLISM IN HOSPITALIZED PATIENTS WITH INFLAMMATORY BOWEL DISEASE

Rehan Qayyum, MD, COMPARISON OF TIME-TRENDS IN PATIENT SATISFACTION BETWEEN TEACHING AND NONTEACHING HOSPITAL

Joshua Rolnick, MD, VALIDATION OF TEST PERFORMANCE AND CLINICAL TIME ZERO FOR AN ELECTRONIC HEALTH RECORD-EMBEDDED SEVERE SEPSIS ALERT

Allison Louis, MD, BLIND SIDED: MISSING POOR VISUAL ACUITY AND DECREASED SELF-EFFICACY IN HOSPITALIZED PATIENTS WITH DIABETES

G. Randy Smith, MD, MS, SFHM, ASSOCIATION OF HOSPITAL ADMISSION SERVICE STRUCTURE WITH EARLY TRANSFER TO CRITICAL CARE, HOSPITAL READMISSION, AND LENGTH OF STAY

Kathleene Wooldridge, MD, R-VA-MARQUIS: IMPLEMENTING BEST PRACTICES IN MEDICATION RECONCILIATION FOR RURAL VETERANS

INNOVATION CATEGORY

WINNER:

Dr. Crockett

Baely Crockett, PharmD, NOVEL PHARMACIST-MANAGED RIVAROXABAN CLINIC FOR OUTPATIENT TREATMENT OF VENOUS THROMBOEMBOLISM

TRAINEE WINNER:

Wells

Monika Wells, MD, MPH, DESIGNING HOSPITALIST SHIFTS AROUND ADMISSION DEMAND REDUCES PATIENT WAIT TIMES AND COST

FINALISTS:

Jessica Dong, WHO MOVED MY EHR CHEESE? A NEW APPROACH TO CURATING AND INDIVIDUALIZING COMMUNICATIONS TO PHYSICIANS ABOUT EHR SOFTWARE UPDATES

Stephanie Rennke, MD, MED REC: A SKILLS-BASED CURRICULUM ON MEDICATION SAFETY AND MEDICATION RECONCILIATION FOR MEDICAL STUDENTS

Jens Langsjoen, MD, DEVELOPING AN INPATIENT DELIRIUM PREVENTION PROTOCOL

Mark Goldin, MD, BUILDING PARALLEL CO-MANAGEMENT SERVICES IN A LARGE ACADEMIC HOSPITALIST GROUP

Brian Lichtenstein, MD, IMPROVING RISK-ADJUSTED OUTCOME MEASURES WITH PHYSICIAN-ORIENTED DOCUMENTATION INTERVENTIONS

Matthew Cerasale, MD, REAL-TIME PADUA: AN AUTOMATED EHR INTEGRATED VENOUS THROMBOEMBOLISM RISK ASSESSMENT TOOL

Franziska Jovin, MD, MMM, FHM, IMPLEMENTATION OF A PAY-FOR-PERFOMANCE STRUCTURE FOR HOSPITALIST-LED QUALITY IMPROVEMENT PROJECTS

Arpit Khandelwal, MD, MANAGING CHALLENGING PATIENTS: FROM CONFLICT TO TEACHING OPPORTUNITY

Justin Lotfi, MD, MAKING IT SIMPLE - PROCESS IMPROVEMENT FOR OUTSIDE MEDICAL RECORDS

David McCollum, MD, FIXING WHAT IS BROKEN: QUALITY IMPROVEMENT IN THE CRITICAL LAB VALUE PROCESS

Nidhi Rohatgi, MD, MS, A NOVEL MD-RN COLLABORATIVE PROTOCOL TO PREVENT AND MANAGE ACUTE DELIRIUM IN INPATIENT WARDS

Lesley Schmaltz, MD, UNNECESSARY TRANSFUSIONS: HOSPITAL MEDICINE LEADING INSTITUTION-WIDE CHANGE

Anuj Dalal, MD, FHM, IMPLEMENTATION OF A PATIENT-CENTERED ‘MICROBLOG' MESSAGING PLATFORM TO IMPROVE CARE TEAM COMMUNICATION

Willard Ellis, MD, PhD, FHM, INTENSIVE FOLLOW UP AFTER PALLIATIVE CARE CONSULTATIONS TO REDUCE READMISSIONS

Lakshmi Swaminathan, MD, MHSA, FHM, USING “MAGIC” TO FACILITATE APPROPRIATE PICC USE: RESULTS OF IMPLEMENTATION OF A PICC APPROPRIATENESS ASSESSMENT TOOL

Charles Coffey, MD, MSc, FHM, IMPLEMENTING GUIDELINE-BASED INDICATIONS FOR CARDIAC MONITORING AT CEDARS-SINAI MEDICAL CENTER

Erik Hoyer, MD, USE OF A HOSPITALIST CLINICAL COMMUNITY TO FACILITATE DISSEMINATION OF AN EARLY MOBILITY QUALITY IMPROVEMENT PROGRAM

Elizabeth Stewart, MD, A MULTIDISCIPLINARY APPROACH TO HIGH VALUE CARDIAC BIOMARKER

CLINICAL VIGNETTES CATEGORY

WINNER (ADULT):

Kantor

Molly Kantor, MD, THE TIP OF THE ICEBERG: A RARE CAUSE OF ACUTE LIVER FAILURE

WINNER (PEDIATRIC):

Ladd

Jennifer Ladd, MD, MORE THAN JUST THE “TERRIBLE TWOS”: A CASE OF RESISTANT HSV ENCEPHALITIS

TRAINEE WINNER:

Shah

Bhakti Shah, MD, UNMASKING THE TERATOMA

FINALISTS:

Weijen Chang, MD, SFHM, UNCOILING A PROBLEMATIC TICKLE IN THE THROAT

Kenton Dover, MD, KEEPING AN EYE OUT FOR THE DIAGNOSIS

Stephanie Royer, MD, THE YOUNGEST REPORTED CASE OF EOSINOPHILIC CHOLANGITIS

Oluremi Ajala, MD, ANGINA OF ABDOMINAL ORIGIN

Asana Anderson, MBBS, A PARATHYROID CRISIS BURIED IN A SEPTIC OTOMASTOIDITIS

Kyle Bennett, DO, BULLS-EYE MARKS THE SPOT: LYME CARDITIS PRESENTING AS RASH AND PRESYNCOPE

John Biebelhausen, MD, MBA, CROSSFIT CATASTROPHE: CHEST PAIN IN A HEALTHY YOUNG WOMAN

Xuan Gao, MD, A CASE OF THE UNSEEN: KLEBSIELLA PNEUMONIA PYOGENIC LIVER ABSCESS WITH PNEUMONIA AND SEPTIC ENDOPHTHALMITIS IN A NON-ASIAN U.S. RESIDENT

Sana Grover, MBBS, 'ABSTINENT AND INTOXICATED'. A RARE CASE OF AUTO-BREWERY SYNDROME

Andrew Hawrylak, MD, WHEN IT'S NOT AN ALLERGIC REACTION: AN UNUSUAL CASE OF ECTHYEMA GANGRENOSUM ASSOCIATED WITH PROTEUS BACTEREMIA

Rasheen Imtiaz, MD, LACTIC ACIDOSIS IN ASTHMA

Jessie King, MD, PhD, THE SMOKING WOMAN

Bradley Manning, MD, A SUPER-ANTIGEN-MEDIATED MIMIC OF ACUTE APPENDICITIS

Hiroki Matsuura, IMPAIRED CONSCIOUSNESS WITH INDOLENT BREAST MASS

Niharika Singh, MD, LOWER EXTREMITY NECROTIZING FASCIITIS: AN UNUSUAL PRESENTATION OF PERFORATED SIGMOID DIVERTICULITIS

Vivan Tran, DO, PUTTING THE PEE IN PREGNANCY: A CASE OF GESTATIONAL DIABETES INSIPIDUS YOU DON'T WANT TO MISS

Kristen Welch, THE MYSTERIOUS DANCE: A RARE CASE OF DELAYED ONSET DIABETIC STRIATOPATHY

Standing adjacent Poster 391 in a loud, crowded meeting hall, Monika Wells, MD, MPH, a resident in internal medicine at Virginia Mason Medical Center in Seattle, chatted with a colleague. A few feet away, a group of doctors and healthcare professionals huddled dramatically, just barely out of earshot.

The fate of Dr. Wells’ scientific abstract hung in the balance.

Her study, a look at scheduling the start and stop times of hospitalist shifts around expected demand to reduce costs and patient wait times, was a short-list finalist in the Innovations category of HM16’s annual Research, Innovation, and Clinical Vignettes scientific abstract competition. With her work done—she had already made presentations to first a pair of semifinalist judges and then to a herd of all 10 of the category judges—Dr. Wells looked remarkably calm as she waited for the announcement of the winners.

Either way, she said, the competition had been an invigorating, exciting experience.

“I’m a doctor, so I like to compete,” she half-joked. “It definitely has been motivating.”

RIV ribbons this year were handed out to seven winners in four categories. The competition garnered 914 abstracts accepted for presentation.

Dr. Wells ended up being one of them. She was named Innovations’ trainee winner. In her study, researchers found that analyzing the flow of admissions and redistributing hospitalists to better conform to that flow reduced patient wait times and costs as well as improved the subjective experience of hospitalists even as volume increased.

The overall winner in the Innovations category also went to a trainee, Baely Crockett, PharmD, a resident at Eskenazi Health in Indianapolis. Her study looked at a pharmacist-managed rivaroxaban clinic for the treatment of venous thromboembolism (VTE). It was the first time, as far as the judges knew, that an award had gone to a pharmacist.

Dr. Crockett’s abstract showed that patients diagnosed in the ED with low-risk VTE are given a prescription scheduled to be seen in the follow-up clinic within two to five days, at which point the pharmacist sees the patients and reviews their case with them and determines treatment duration.

Dr. Crockett said the pharmacists involved are especially suitable for the role not only because of their expertise in the medication and the handling of time-consuming co-pay issues and other concerns but also because they shadowed ED physicians for six months to get training and experience.

“We’re able to fill in gaps that are true challenges to the patient’s success in finishing therapy,” she said.

One of the Innovations judges, Michael Craig, MD, MPH, FHM, associate professor of medicine at the University of North Carolina in Chapel Hill, said the research hit on an area of growing interest.

“The movement toward outpatient treatment of VTE is a pretty big topic that lots of people are working on,” he said. “It’s very relevant. The whole idea of having a pharmacist-driven intervention is unique; nobody had thought of or heard of before.”

The winner in the Research category was Vineet Chopra, MD, MSc, FHM, assistant professor at the University of Michigan in Ann Arbor, whose work set out to quantify how to prevent bloodstream infection and blood clots from the use of peripherally inserted central catheters, or PICC lines. Researchers created a simulation model, based on data from the literature, looking at what would happen to a hospital if the use of certain types of PICCs was increased while use of other types was decreased—the rationale being that PICCs with just one channel, or port, have a lower risk of infection or blood clots than those with multiple ports.

 

 

It is a risk that is often unrecognized, and PICC lines with multiple ports are often ordered as a just-in-case measure in the event that the first port gets clogged.

Chopra and colleagues found that, at the average hospital, about 75% of all PICCs used tend to be multichannel and 25% single-channel. They found every 5% increase in single-channel PICC use could prevent almost 1.5 infections per 1,000 patients, and 0.5 blood clots, with a corresponding cost savings of $13,000 per event. That can add up to hundreds of thousands of dollars a year at large hospitals.

And those calculations, Dr. Chopra noted, do not include penalties for infections or the financial effects of having those results publicly reported. Researchers are now creating an online tool— at improvepicc.com—that will allow users to calculate their own costs and potential savings.

“The hope of this is that it will give hospital administrators and hospital leadership and quality officers the momentum, perhaps, to overcome the inertia of not thinking actively,” said Dr. Chopra, who notched his first win after 10 years of participating in the RIV competition. “I think we don’t think actively about the choices we make when it comes to these devices.”

In the Clinical Vignettes category, winner Molly Kantor, MD, assistant clinical professor at the University of California, San Diego, recounted the case of a sickle-cell disease patient whose diagnosis, and hence treatment, was delayed and who ultimately died. She outlined a series of missteps, including taking at face-value a patient-reported past medical disease, which turned out to be wrong; making certain diagnoses based on lab tests and stopping there; and anchoring on the original diagnosis when the thought process was later reevaluated.

Dr. Kantor said the case is a caution flag to hospitalists, reinforcing the need for “a broad differential diagnosis.”

“[Make] sure that the data fits together and that you’re not using just one isolated piece of information to cinch everything, including the past medical history or a certain lab test, when the whole picture doesn’t quite fit together,” she said. “Looking back at this case, it’s pretty clear that the puzzle pieces probably weren’t quite fitting together, but there was enough that the easier thing to do was to make the diagnosis and move on.”

In the Pediatric Clinical Vignettes category, winner Jennifer Ladd, MD, a resident at Duke University, won for a study of a vexing case of a 2-year-old who was irritable and stalled on developmental milestones. At the hospital, the thought was that it could likely be a recurrence of herpes simplex (HSV) encephalitis, but the spinal fluid showed no signs of that and the acyclovir, which nearly always works for the disorder, was having no effect and the symptoms worsened.

The key in the case, said Alyssa Stephany, MD, then assistant professor at Duke University and now section chief of pediatric hospital medicine at Children’s Hospital of Wisconsin, who presented the case in Dr. Ladd’s absence, was that the team reopened the diagnosis and didn’t get ensnared in cognitive bias. A biopsy ultimately showed HSV in the brain tissue; it was a case of recurrence, despite signs to the contrary. Foscarnet was used to effectively treat the child; it is unknown why acyclovir didn’t work in this case.

“It kind of brings to the surface that that’s what a hospitalist is—a hospitalist is that person who sits and thinks, and really thinks, about the patient and doesn’t just do their rote work of input and output of a patient through the hospital system,” Dr. Stephany said. “When you get a case like this, it makes you take pause.”

 

 

The trainee winner in the Research category was N. Lance Downing, MD, of Stanford University School of Medicine, for work on an EHR-based severe sepsis alert. The trainee winner in Clinical Vignettes was Bhakti Shah, MD, of North Shore-LIJ Health System, now Northwell Health, on a rare case of autoimmune NMDA receptor encephalitis. TH


Thomas R. Collins is a freelance writer in South Florida.

2016 RIV Finalists, Winners

Research Category

WINNER:

Dr. Chopra

Vineet Chopra, MD, MSc, FHM, LIMITING THE NUMBER OF LUMENS IN PERIPHERALLY INSERTED CENTRAL CATHETERS TO IMPROVE OUTCOMES AND REDUCE COST: A SIMULATION STUDY

TRAINEE WINNER:

N. Downing, MD, AN ELECTRONIC HEALTH RECORD-BASED SEVERE SEPSIS ALERT TO IMPROVE SEPSIS TREATMENT PERFORMANCE: RANDOMIZED EVALUATION

FINALISTS:

Waseem Khaliq, MD, MPH, PREVALENCE AND PREDICTORS OF NON-ADHERENCE TO BREAST CANCER SCREENING: PERSPECTIVE AND PREFERENCES OF HOSPITALIZED WOMEN

Dilli Poudel, MD, SYSTEMIC SCLEROSIS AS A RISK FACTOR OF ACUTE MYOCARDIAL INFARCTION: A US POPULATION BASED STUDY

Aiham Albaeni, MD, REGIONAL VARIATION IN RESOURCES UTILIZATION AND OUTCOMES FOLLOWING OUT-OF-HOSPITAL CARDIAC ARREST IN THE UNITED STATES

Poushali Bhattacharjee, MD, DETECTING SEPSIS: ARE TWO OPINIONS BETTER THAN ONE?

Vineet Chopra, MD, MSc, FHM, THE INFLUENCE OF RED BLOOD CELL TRANSFUSION ON VENOUS THROMBOEMBOLISM IN PATIENTS WITH PERIPHERALLY-INSERTED CENTRAL CATHETERS

Shaker Eid, MD, MBA, IMPACT OF HOSPITAL TEACHING STATUS ON OUT-OF-HOSPITAL CARDIAC ARREST OUTCOMES AND RESOURCE UTILIZATION IN THE UNITED STATES: 2000-2012

Tarun Jain, MD, CONTRAST-INDUCED NEPHROPATHY IN STEMI PATIENTS WITH AND WITHOUT CHRONIC KIDNEY DISEASE

Mona Beier, MD, CREATING A PATIENT SAFETY CULTURE ONE INCIDENT REPORT AT A TIME

Charles Pollack, MD, REINITIATION OF ANTITHROMBOTIC THERAPY AFTER EMERGENCY PROCEDURES OR AFTER AN EMERGENT BLEEDING EVENT: ADDITIONAL INTERIM EXPERIENCE FROM THE RE-VERSE AD TRIAL

Robert Boxer, MD, PhD, SAVING TIME: A TIME-MOTION ANALYSIS OF THE IMPACT OF REGIONALIZATION AND DAILY ADMITTING ON INTERN WORKFLOW

Kaleigh Evans, MD, THIRD TROPONIN ORDER OVERUSE IN THE SETTING OF CLINICAL STABILITY

David Paje, MD, SFHM, RISK OF VENOUS THROMBOEMBOLISM IN HOSPITALIZED PATIENTS WITH INFLAMMATORY BOWEL DISEASE

Rehan Qayyum, MD, COMPARISON OF TIME-TRENDS IN PATIENT SATISFACTION BETWEEN TEACHING AND NONTEACHING HOSPITAL

Joshua Rolnick, MD, VALIDATION OF TEST PERFORMANCE AND CLINICAL TIME ZERO FOR AN ELECTRONIC HEALTH RECORD-EMBEDDED SEVERE SEPSIS ALERT

Allison Louis, MD, BLIND SIDED: MISSING POOR VISUAL ACUITY AND DECREASED SELF-EFFICACY IN HOSPITALIZED PATIENTS WITH DIABETES

G. Randy Smith, MD, MS, SFHM, ASSOCIATION OF HOSPITAL ADMISSION SERVICE STRUCTURE WITH EARLY TRANSFER TO CRITICAL CARE, HOSPITAL READMISSION, AND LENGTH OF STAY

Kathleene Wooldridge, MD, R-VA-MARQUIS: IMPLEMENTING BEST PRACTICES IN MEDICATION RECONCILIATION FOR RURAL VETERANS

INNOVATION CATEGORY

WINNER:

Dr. Crockett

Baely Crockett, PharmD, NOVEL PHARMACIST-MANAGED RIVAROXABAN CLINIC FOR OUTPATIENT TREATMENT OF VENOUS THROMBOEMBOLISM

TRAINEE WINNER:

Wells

Monika Wells, MD, MPH, DESIGNING HOSPITALIST SHIFTS AROUND ADMISSION DEMAND REDUCES PATIENT WAIT TIMES AND COST

FINALISTS:

Jessica Dong, WHO MOVED MY EHR CHEESE? A NEW APPROACH TO CURATING AND INDIVIDUALIZING COMMUNICATIONS TO PHYSICIANS ABOUT EHR SOFTWARE UPDATES

Stephanie Rennke, MD, MED REC: A SKILLS-BASED CURRICULUM ON MEDICATION SAFETY AND MEDICATION RECONCILIATION FOR MEDICAL STUDENTS

Jens Langsjoen, MD, DEVELOPING AN INPATIENT DELIRIUM PREVENTION PROTOCOL

Mark Goldin, MD, BUILDING PARALLEL CO-MANAGEMENT SERVICES IN A LARGE ACADEMIC HOSPITALIST GROUP

Brian Lichtenstein, MD, IMPROVING RISK-ADJUSTED OUTCOME MEASURES WITH PHYSICIAN-ORIENTED DOCUMENTATION INTERVENTIONS

Matthew Cerasale, MD, REAL-TIME PADUA: AN AUTOMATED EHR INTEGRATED VENOUS THROMBOEMBOLISM RISK ASSESSMENT TOOL

Franziska Jovin, MD, MMM, FHM, IMPLEMENTATION OF A PAY-FOR-PERFOMANCE STRUCTURE FOR HOSPITALIST-LED QUALITY IMPROVEMENT PROJECTS

Arpit Khandelwal, MD, MANAGING CHALLENGING PATIENTS: FROM CONFLICT TO TEACHING OPPORTUNITY

Justin Lotfi, MD, MAKING IT SIMPLE - PROCESS IMPROVEMENT FOR OUTSIDE MEDICAL RECORDS

David McCollum, MD, FIXING WHAT IS BROKEN: QUALITY IMPROVEMENT IN THE CRITICAL LAB VALUE PROCESS

Nidhi Rohatgi, MD, MS, A NOVEL MD-RN COLLABORATIVE PROTOCOL TO PREVENT AND MANAGE ACUTE DELIRIUM IN INPATIENT WARDS

Lesley Schmaltz, MD, UNNECESSARY TRANSFUSIONS: HOSPITAL MEDICINE LEADING INSTITUTION-WIDE CHANGE

Anuj Dalal, MD, FHM, IMPLEMENTATION OF A PATIENT-CENTERED ‘MICROBLOG' MESSAGING PLATFORM TO IMPROVE CARE TEAM COMMUNICATION

Willard Ellis, MD, PhD, FHM, INTENSIVE FOLLOW UP AFTER PALLIATIVE CARE CONSULTATIONS TO REDUCE READMISSIONS

Lakshmi Swaminathan, MD, MHSA, FHM, USING “MAGIC” TO FACILITATE APPROPRIATE PICC USE: RESULTS OF IMPLEMENTATION OF A PICC APPROPRIATENESS ASSESSMENT TOOL

Charles Coffey, MD, MSc, FHM, IMPLEMENTING GUIDELINE-BASED INDICATIONS FOR CARDIAC MONITORING AT CEDARS-SINAI MEDICAL CENTER

Erik Hoyer, MD, USE OF A HOSPITALIST CLINICAL COMMUNITY TO FACILITATE DISSEMINATION OF AN EARLY MOBILITY QUALITY IMPROVEMENT PROGRAM

Elizabeth Stewart, MD, A MULTIDISCIPLINARY APPROACH TO HIGH VALUE CARDIAC BIOMARKER

CLINICAL VIGNETTES CATEGORY

WINNER (ADULT):

Kantor

Molly Kantor, MD, THE TIP OF THE ICEBERG: A RARE CAUSE OF ACUTE LIVER FAILURE

WINNER (PEDIATRIC):

Ladd

Jennifer Ladd, MD, MORE THAN JUST THE “TERRIBLE TWOS”: A CASE OF RESISTANT HSV ENCEPHALITIS

TRAINEE WINNER:

Shah

Bhakti Shah, MD, UNMASKING THE TERATOMA

FINALISTS:

Weijen Chang, MD, SFHM, UNCOILING A PROBLEMATIC TICKLE IN THE THROAT

Kenton Dover, MD, KEEPING AN EYE OUT FOR THE DIAGNOSIS

Stephanie Royer, MD, THE YOUNGEST REPORTED CASE OF EOSINOPHILIC CHOLANGITIS

Oluremi Ajala, MD, ANGINA OF ABDOMINAL ORIGIN

Asana Anderson, MBBS, A PARATHYROID CRISIS BURIED IN A SEPTIC OTOMASTOIDITIS

Kyle Bennett, DO, BULLS-EYE MARKS THE SPOT: LYME CARDITIS PRESENTING AS RASH AND PRESYNCOPE

John Biebelhausen, MD, MBA, CROSSFIT CATASTROPHE: CHEST PAIN IN A HEALTHY YOUNG WOMAN

Xuan Gao, MD, A CASE OF THE UNSEEN: KLEBSIELLA PNEUMONIA PYOGENIC LIVER ABSCESS WITH PNEUMONIA AND SEPTIC ENDOPHTHALMITIS IN A NON-ASIAN U.S. RESIDENT

Sana Grover, MBBS, 'ABSTINENT AND INTOXICATED'. A RARE CASE OF AUTO-BREWERY SYNDROME

Andrew Hawrylak, MD, WHEN IT'S NOT AN ALLERGIC REACTION: AN UNUSUAL CASE OF ECTHYEMA GANGRENOSUM ASSOCIATED WITH PROTEUS BACTEREMIA

Rasheen Imtiaz, MD, LACTIC ACIDOSIS IN ASTHMA

Jessie King, MD, PhD, THE SMOKING WOMAN

Bradley Manning, MD, A SUPER-ANTIGEN-MEDIATED MIMIC OF ACUTE APPENDICITIS

Hiroki Matsuura, IMPAIRED CONSCIOUSNESS WITH INDOLENT BREAST MASS

Niharika Singh, MD, LOWER EXTREMITY NECROTIZING FASCIITIS: AN UNUSUAL PRESENTATION OF PERFORATED SIGMOID DIVERTICULITIS

Vivan Tran, DO, PUTTING THE PEE IN PREGNANCY: A CASE OF GESTATIONAL DIABETES INSIPIDUS YOU DON'T WANT TO MISS

Kristen Welch, THE MYSTERIOUS DANCE: A RARE CASE OF DELAYED ONSET DIABETIC STRIATOPATHY

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Discovery could aid development of new sepsis therapies

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Discovery could aid development of new sepsis therapies

Monocytes immunostained with

antibodies toward SHARPIN

(red) and caspase 1 (green).

Cell on right showing increase

in caspase 1 upon stimulation

with LPS and ATP and co-

localization with SHARPIN as

visualized by the merged

fluorescence (yellow). Nuclei

are stained blue with DAPI.

Image courtesy of The

American Journal of Pathology

A new study suggests that SHARPIN, a protein involved in regulating inflammation, has anti-septic effects.

Researchers believe this discovery, reported in The American Journal of Pathology, could spur the development of novel treatments for sepsis.

“Sepsis has been linked to enhanced activity of the enzyme caspase 1 and aberrant expression of pro-inflammatory interleukins 1β and 18,” said Liliana Schaefer, MD, of Goethe-Universität in Frankfurt, Germany.

“SHARPIN binds to caspase 1 and inhibits its activation. Our study proposes that the caspase 1/SHARPIN interaction may be a key pharmacological target in sepsis and perhaps in other inflammatory conditions where SHARPIN is involved.”

The researchers found that sepsis in mice bred to be deficient in SHARPIN resulted in enhanced levels of interleukins 1β and 18 and active caspase 1, as well as shortened survival.

Treatment with a caspase 1 inhibitor reversed these effects—reducing levels of interleukins 1β and 18, decreasing cell death in the spleen, and prolonging survival.

The researchers also found evidence to suggest this mechanism may be relevant to human sepsis.

“We found a decline in SHARPIN levels in septic patients correlating with enhanced activation of caspase 1 in circulating mononuclear cells and an increase of interleukin 1β/18 in the plasma,” Dr Schaefer said.

“Our findings suggest that using pharmacological caspase 1 inhibitors could be beneficial in septic patients with low SHARPIN levels, and these therapies may be more efficient than other anti-inflammatory therapies.”

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Monocytes immunostained with

antibodies toward SHARPIN

(red) and caspase 1 (green).

Cell on right showing increase

in caspase 1 upon stimulation

with LPS and ATP and co-

localization with SHARPIN as

visualized by the merged

fluorescence (yellow). Nuclei

are stained blue with DAPI.

Image courtesy of The

American Journal of Pathology

A new study suggests that SHARPIN, a protein involved in regulating inflammation, has anti-septic effects.

Researchers believe this discovery, reported in The American Journal of Pathology, could spur the development of novel treatments for sepsis.

“Sepsis has been linked to enhanced activity of the enzyme caspase 1 and aberrant expression of pro-inflammatory interleukins 1β and 18,” said Liliana Schaefer, MD, of Goethe-Universität in Frankfurt, Germany.

“SHARPIN binds to caspase 1 and inhibits its activation. Our study proposes that the caspase 1/SHARPIN interaction may be a key pharmacological target in sepsis and perhaps in other inflammatory conditions where SHARPIN is involved.”

The researchers found that sepsis in mice bred to be deficient in SHARPIN resulted in enhanced levels of interleukins 1β and 18 and active caspase 1, as well as shortened survival.

Treatment with a caspase 1 inhibitor reversed these effects—reducing levels of interleukins 1β and 18, decreasing cell death in the spleen, and prolonging survival.

The researchers also found evidence to suggest this mechanism may be relevant to human sepsis.

“We found a decline in SHARPIN levels in septic patients correlating with enhanced activation of caspase 1 in circulating mononuclear cells and an increase of interleukin 1β/18 in the plasma,” Dr Schaefer said.

“Our findings suggest that using pharmacological caspase 1 inhibitors could be beneficial in septic patients with low SHARPIN levels, and these therapies may be more efficient than other anti-inflammatory therapies.”

Monocytes immunostained with

antibodies toward SHARPIN

(red) and caspase 1 (green).

Cell on right showing increase

in caspase 1 upon stimulation

with LPS and ATP and co-

localization with SHARPIN as

visualized by the merged

fluorescence (yellow). Nuclei

are stained blue with DAPI.

Image courtesy of The

American Journal of Pathology

A new study suggests that SHARPIN, a protein involved in regulating inflammation, has anti-septic effects.

Researchers believe this discovery, reported in The American Journal of Pathology, could spur the development of novel treatments for sepsis.

“Sepsis has been linked to enhanced activity of the enzyme caspase 1 and aberrant expression of pro-inflammatory interleukins 1β and 18,” said Liliana Schaefer, MD, of Goethe-Universität in Frankfurt, Germany.

“SHARPIN binds to caspase 1 and inhibits its activation. Our study proposes that the caspase 1/SHARPIN interaction may be a key pharmacological target in sepsis and perhaps in other inflammatory conditions where SHARPIN is involved.”

The researchers found that sepsis in mice bred to be deficient in SHARPIN resulted in enhanced levels of interleukins 1β and 18 and active caspase 1, as well as shortened survival.

Treatment with a caspase 1 inhibitor reversed these effects—reducing levels of interleukins 1β and 18, decreasing cell death in the spleen, and prolonging survival.

The researchers also found evidence to suggest this mechanism may be relevant to human sepsis.

“We found a decline in SHARPIN levels in septic patients correlating with enhanced activation of caspase 1 in circulating mononuclear cells and an increase of interleukin 1β/18 in the plasma,” Dr Schaefer said.

“Our findings suggest that using pharmacological caspase 1 inhibitors could be beneficial in septic patients with low SHARPIN levels, and these therapies may be more efficient than other anti-inflammatory therapies.”

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Discovery could aid development of new sepsis therapies
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