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Tofacitinib succeeds as ulcerative colitis induction therapy
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.
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.
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.
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.
EXPERT ANALYSIS FROM ECCO
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
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).
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).
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).
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.
AT OARSI 2016
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
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. 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. 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. 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.
FROM HOSPITAL MEDICINE 2016
Health Information Technology Ramps Up Its Presence
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.
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.
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.
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
New Ideas Showcased in Research at RIV Competition
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.
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.
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.
Discovery could aid development of new sepsis therapies
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.”
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.”
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.”
FDA requires labeling changes to metformin-containing drugs
Metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function, according to the FDA’s recent review of several medical studies.
These findings have prompted the FDA to require manufacturers to change the labeling for metformin-containing drugs. These drugs’ labels now must include the results of the medical studies and new measures of kidney function for determining if a patient can use metformin, says a written statement from the FDA.
Metformin’s current labeling strongly recommends against its use in some patients with kidneys that do not work normally. The FDA is specifically requiring that new labels include the recommendation that the measure of kidney function used to determine whether a patient can receive metformin be changed from one based on a single laboratory parameter (blood creatinine concentration) to one that provides a better estimate of renal function (that is, the glomerular filtration rate estimating equation, eGFR).
The full labeling recommendations are available in the FDA’s written statement.
Additional information including a data summary and a list of metformin-containing drugs is available in the FDA Drug Safety Communication.
The FDA asks that healthcare professionals and patients report adverse events or side effects related to the use of metformin-containing drugs to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function, according to the FDA’s recent review of several medical studies.
These findings have prompted the FDA to require manufacturers to change the labeling for metformin-containing drugs. These drugs’ labels now must include the results of the medical studies and new measures of kidney function for determining if a patient can use metformin, says a written statement from the FDA.
Metformin’s current labeling strongly recommends against its use in some patients with kidneys that do not work normally. The FDA is specifically requiring that new labels include the recommendation that the measure of kidney function used to determine whether a patient can receive metformin be changed from one based on a single laboratory parameter (blood creatinine concentration) to one that provides a better estimate of renal function (that is, the glomerular filtration rate estimating equation, eGFR).
The full labeling recommendations are available in the FDA’s written statement.
Additional information including a data summary and a list of metformin-containing drugs is available in the FDA Drug Safety Communication.
The FDA asks that healthcare professionals and patients report adverse events or side effects related to the use of metformin-containing drugs to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function, according to the FDA’s recent review of several medical studies.
These findings have prompted the FDA to require manufacturers to change the labeling for metformin-containing drugs. These drugs’ labels now must include the results of the medical studies and new measures of kidney function for determining if a patient can use metformin, says a written statement from the FDA.
Metformin’s current labeling strongly recommends against its use in some patients with kidneys that do not work normally. The FDA is specifically requiring that new labels include the recommendation that the measure of kidney function used to determine whether a patient can receive metformin be changed from one based on a single laboratory parameter (blood creatinine concentration) to one that provides a better estimate of renal function (that is, the glomerular filtration rate estimating equation, eGFR).
The full labeling recommendations are available in the FDA’s written statement.
Additional information including a data summary and a list of metformin-containing drugs is available in the FDA Drug Safety Communication.
The FDA asks that healthcare professionals and patients report adverse events or side effects related to the use of metformin-containing drugs to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
U.S. sepsis-related mortality rates differ based on data source
Despite challenges in estimating sepsis-related mortality in the U.S. because of its complex clinical nature and variety of underlying causes, estimates based on administrative claims data may be more accurate than those derived from death certificates, according to a report published April 8 in the Morbidity and Mortality Weekly Report.
Dr. Lauren Epstein of the division of healthcare quality promotion at the National Center for Emerging and Zoonotic Infectious Diseases, and her colleagues, compared U.S. sepsis-related mortality estimates from different sources. Deaths attributable to diagnoses corresponding to ICD-10 diagnosis codes A40 (streptococcal septicemia) and A41 (other septicemia) from 1999 to 2014 were extracted from the CDC WONDER (Wide-ranging Online Data for Epidemiologic Research) database. Administrative claims data using various combinations of the ICD-9-CM administrative codes for primary or secondary infection and organ dysfunction to identify severe sepsis from 2004 to 2009 were extracted from the largest all-payer, publicly available inpatient database in the United States, the Nationwide Inpatient Sample. (MMWR. 2016 Apr 8;65[13]:342-5).
Of the roughly 2.5 million death certificates listing sepsis as a cause of death, 22% identified sepsis as the underlying cause of death during the time period assessed. The results of the comparison demonstrated that the estimated range of sepsis-related mortality based on death certificate data was lower than that obtained using administrative claims data (ranges, 146,000-159,000 and 168,000-381,000, respectively). These results indicate that the annual estimate based on administrative claims data during the time period assessed was 15%-140% higher than the estimate based on death certificate data.
To explain the difference between the estimated sepsis-related mortality ranges, the authors said that while both death certificate and administrative claims data are important sources of public health information, they are each associated with limitations that can affect such estimates. For example, the authors said that death certificate certifiers may be more prone to record sepsis as an immediate cause of death, resulting in lower estimates of sepsis-related mortality based on underlying causes of death. Regarding administrative claims data, the authors said that such data cannot be all inclusive, as only those sepsis-related deaths occurring in health care facilities are captured.
The authors said that their results highlight the need for a better defined and more reliable sepsis surveillance system that should be based on objective clinical data. This approach would allow for increased accuracy in the tracking of sepsis trends in the United States, as well as an improved system for gauging the impact of sepsis awareness and prevention efforts.
No funding sources or conflicts of interest were reported.
Despite challenges in estimating sepsis-related mortality in the U.S. because of its complex clinical nature and variety of underlying causes, estimates based on administrative claims data may be more accurate than those derived from death certificates, according to a report published April 8 in the Morbidity and Mortality Weekly Report.
Dr. Lauren Epstein of the division of healthcare quality promotion at the National Center for Emerging and Zoonotic Infectious Diseases, and her colleagues, compared U.S. sepsis-related mortality estimates from different sources. Deaths attributable to diagnoses corresponding to ICD-10 diagnosis codes A40 (streptococcal septicemia) and A41 (other septicemia) from 1999 to 2014 were extracted from the CDC WONDER (Wide-ranging Online Data for Epidemiologic Research) database. Administrative claims data using various combinations of the ICD-9-CM administrative codes for primary or secondary infection and organ dysfunction to identify severe sepsis from 2004 to 2009 were extracted from the largest all-payer, publicly available inpatient database in the United States, the Nationwide Inpatient Sample. (MMWR. 2016 Apr 8;65[13]:342-5).
Of the roughly 2.5 million death certificates listing sepsis as a cause of death, 22% identified sepsis as the underlying cause of death during the time period assessed. The results of the comparison demonstrated that the estimated range of sepsis-related mortality based on death certificate data was lower than that obtained using administrative claims data (ranges, 146,000-159,000 and 168,000-381,000, respectively). These results indicate that the annual estimate based on administrative claims data during the time period assessed was 15%-140% higher than the estimate based on death certificate data.
To explain the difference between the estimated sepsis-related mortality ranges, the authors said that while both death certificate and administrative claims data are important sources of public health information, they are each associated with limitations that can affect such estimates. For example, the authors said that death certificate certifiers may be more prone to record sepsis as an immediate cause of death, resulting in lower estimates of sepsis-related mortality based on underlying causes of death. Regarding administrative claims data, the authors said that such data cannot be all inclusive, as only those sepsis-related deaths occurring in health care facilities are captured.
The authors said that their results highlight the need for a better defined and more reliable sepsis surveillance system that should be based on objective clinical data. This approach would allow for increased accuracy in the tracking of sepsis trends in the United States, as well as an improved system for gauging the impact of sepsis awareness and prevention efforts.
No funding sources or conflicts of interest were reported.
Despite challenges in estimating sepsis-related mortality in the U.S. because of its complex clinical nature and variety of underlying causes, estimates based on administrative claims data may be more accurate than those derived from death certificates, according to a report published April 8 in the Morbidity and Mortality Weekly Report.
Dr. Lauren Epstein of the division of healthcare quality promotion at the National Center for Emerging and Zoonotic Infectious Diseases, and her colleagues, compared U.S. sepsis-related mortality estimates from different sources. Deaths attributable to diagnoses corresponding to ICD-10 diagnosis codes A40 (streptococcal septicemia) and A41 (other septicemia) from 1999 to 2014 were extracted from the CDC WONDER (Wide-ranging Online Data for Epidemiologic Research) database. Administrative claims data using various combinations of the ICD-9-CM administrative codes for primary or secondary infection and organ dysfunction to identify severe sepsis from 2004 to 2009 were extracted from the largest all-payer, publicly available inpatient database in the United States, the Nationwide Inpatient Sample. (MMWR. 2016 Apr 8;65[13]:342-5).
Of the roughly 2.5 million death certificates listing sepsis as a cause of death, 22% identified sepsis as the underlying cause of death during the time period assessed. The results of the comparison demonstrated that the estimated range of sepsis-related mortality based on death certificate data was lower than that obtained using administrative claims data (ranges, 146,000-159,000 and 168,000-381,000, respectively). These results indicate that the annual estimate based on administrative claims data during the time period assessed was 15%-140% higher than the estimate based on death certificate data.
To explain the difference between the estimated sepsis-related mortality ranges, the authors said that while both death certificate and administrative claims data are important sources of public health information, they are each associated with limitations that can affect such estimates. For example, the authors said that death certificate certifiers may be more prone to record sepsis as an immediate cause of death, resulting in lower estimates of sepsis-related mortality based on underlying causes of death. Regarding administrative claims data, the authors said that such data cannot be all inclusive, as only those sepsis-related deaths occurring in health care facilities are captured.
The authors said that their results highlight the need for a better defined and more reliable sepsis surveillance system that should be based on objective clinical data. This approach would allow for increased accuracy in the tracking of sepsis trends in the United States, as well as an improved system for gauging the impact of sepsis awareness and prevention efforts.
No funding sources or conflicts of interest were reported.
FROM MMWR
Key clinical point: Sepsis surveillance should be based on objective clinical data rather than on data obtained from death certificates.
Major finding: Using administrative codes, the U.S. sepsis-related mortality estimate from 2004 to 2009 was 15%-140% higher than the estimate derived from the use of death certificates (ranges; 168,000-381,000 and 146,000-159,000, respectively).
Data source: Death certificate data from the CDC WONDER database and administrative claims data from a previously published report of sepsis mortality estimates based on the Nationwide Inpatient Sample, Healthcare Cost and Utilization Project, Agency for Healthcare Research and Quality.
Disclosures: No funding sources or conflicts of interest were reported.
Clazakizumab safe, effective for PsA treatment
Treatment with clazakizumab was well tolerated and effective at treating musculoskeletal stress in patients with psoriatic arthritis (PsA), Dr. Philip Mease and his associates reported in a phase IIB study published in Arthritis & Rheumatology.
After 16 weeks, American College of Rheumatology (ACR) 20 response rates were highest in the group that received 100-mg doses of clazakizumab at 52.4%, compared with 46.3% for the 25-mg group, 39% for the 200-mg group, and 29.3% for the placebo group. ACR 50/ACR 70 response rates were higher for clazakizumab than for placebo after 16 weeks and 24 weeks, without clear evidence of a dose response.
Adverse events were more common for patients taking clazakizumab and occurred most frequently in the 200-mg group. However, serious adverse events were no more common in the 25-mg and 100-mg groups, compared with the placebo group. Discontinuations due to adverse events were highest in the 200-mg group, and were similar in all other groups.
“Clazakizumab may be particularly suited for patients with PsA in whom skin disease is well controlled with topical agents, ultraviolet therapy, and/or oral systemic therapy such as MTX [methotrexate], but whose musculoskeletal manifestations, such as joint signs and symptoms, enthesitis, and dactylitis, require more potent systemic therapy. Furthermore, some PsA patients do not present with skin lesions at diagnosis; those patients may also benefit from clazakizumab treatment,” the investigators noted.
Find the full study in Arthritis & Rheumatology (doi: 10.1002/art.39700).
Treatment with clazakizumab was well tolerated and effective at treating musculoskeletal stress in patients with psoriatic arthritis (PsA), Dr. Philip Mease and his associates reported in a phase IIB study published in Arthritis & Rheumatology.
After 16 weeks, American College of Rheumatology (ACR) 20 response rates were highest in the group that received 100-mg doses of clazakizumab at 52.4%, compared with 46.3% for the 25-mg group, 39% for the 200-mg group, and 29.3% for the placebo group. ACR 50/ACR 70 response rates were higher for clazakizumab than for placebo after 16 weeks and 24 weeks, without clear evidence of a dose response.
Adverse events were more common for patients taking clazakizumab and occurred most frequently in the 200-mg group. However, serious adverse events were no more common in the 25-mg and 100-mg groups, compared with the placebo group. Discontinuations due to adverse events were highest in the 200-mg group, and were similar in all other groups.
“Clazakizumab may be particularly suited for patients with PsA in whom skin disease is well controlled with topical agents, ultraviolet therapy, and/or oral systemic therapy such as MTX [methotrexate], but whose musculoskeletal manifestations, such as joint signs and symptoms, enthesitis, and dactylitis, require more potent systemic therapy. Furthermore, some PsA patients do not present with skin lesions at diagnosis; those patients may also benefit from clazakizumab treatment,” the investigators noted.
Find the full study in Arthritis & Rheumatology (doi: 10.1002/art.39700).
Treatment with clazakizumab was well tolerated and effective at treating musculoskeletal stress in patients with psoriatic arthritis (PsA), Dr. Philip Mease and his associates reported in a phase IIB study published in Arthritis & Rheumatology.
After 16 weeks, American College of Rheumatology (ACR) 20 response rates were highest in the group that received 100-mg doses of clazakizumab at 52.4%, compared with 46.3% for the 25-mg group, 39% for the 200-mg group, and 29.3% for the placebo group. ACR 50/ACR 70 response rates were higher for clazakizumab than for placebo after 16 weeks and 24 weeks, without clear evidence of a dose response.
Adverse events were more common for patients taking clazakizumab and occurred most frequently in the 200-mg group. However, serious adverse events were no more common in the 25-mg and 100-mg groups, compared with the placebo group. Discontinuations due to adverse events were highest in the 200-mg group, and were similar in all other groups.
“Clazakizumab may be particularly suited for patients with PsA in whom skin disease is well controlled with topical agents, ultraviolet therapy, and/or oral systemic therapy such as MTX [methotrexate], but whose musculoskeletal manifestations, such as joint signs and symptoms, enthesitis, and dactylitis, require more potent systemic therapy. Furthermore, some PsA patients do not present with skin lesions at diagnosis; those patients may also benefit from clazakizumab treatment,” the investigators noted.
Find the full study in Arthritis & Rheumatology (doi: 10.1002/art.39700).
FROM ARTHRITIS & RHEUMATOLOGY
Persistent knee pain predicts structural osteoarthritis early
AMSTERDAM – Persistent knee pain is an important predictor of structural joint damage and could potentially be used to predict knee osteoarthritis (OA) earlier, according to Dutch research reported at the World Congress on Osteoarthritis.
The analysis found that women participating in the Rotterdam Study who had knee pain on most days of the preceding month were more than four times more likely to develop knee OA within 5 years on MRI (odds ratio, 4.53) than were those without frequent knee pain.
Other signs and symptoms predictive of later OA on MRI included a history of knee injury (OR, 2.52), pain on palpation (OR, 2.30) or during activity (OR, 2.13), the feeling of the knee giving way (OR, 2.13), joint line tenderness (OR, 2.04), crepitus (or grating sounds or sensations; OR, 1.85), and Heberden’s nodes (OR, 1.67).
“Signs and symptoms can predict structural knee OA in 5 years in women without knee OA at baseline,” said the presenting study author Dieuwke Schiphof, Ph.D., a postdoctoral researcher at Erasmus University Medical Center in Rotterdam, at the meeting sponsored by the Osteoarthritis Research Society International.
“Knee pain on most days of the last month is an important predictive symptom for all structural OA definitions,” she said, adding that crepitus was an important sign of patellofemoral OA, and the feeling of giving way and joint line tenderness were important signs for tibiofemoral OA.
The aim of their study was to try to determine the value of previously identified clinical signs and symptoms for determining the onset of structural knee OA. Around 600 women aged 45-60 years without OA at baseline were included from the population-based cohort Rotterdam study. Participants had completed a standard questionnaire and had physical, radiographic, and MRI examination of both knees at baseline and at a mean follow-up of 5 years later.
The mean age of women was 59.5 years and 33 of 1,137 knees had isolated patellofemoral OA and 69 had isolated tibiofemoral OA, 111 one or the other, and 22 had radiographic knee OA.
Results showed that knee pain on most days of the last month (OR, 7.57) and crepitus (OR, 3.05) were most predictive of isolated patellofemoral OA on MRI. The prevalence of patellofemoral OA was 3% but this increased to 20% if both these signs and symptoms were present.
Knee pain on most days of the last month (OR, 4.13) was also predictive of isolated tibiofemoral OA on MRI, together with a history of knee pain (OR, 2.48), knee pain during activities (OR, 2.04), and the feeling of the knee giving way (OR, 3.15). If two or three or more signs and symptoms were present, the predictive value increased from a prevalence of 6% to 12% to 18%.
Knee pain on most days of the last month was also highly predictive of radiographic OA (OR, 7.77), as was pain at palpation (OR, 4.36), prior injury (OR, 3.64), and the feeling of the knee giving way (OR, 2.75). Again, when additional signs or symptoms were present the prevalence increased from a prevalence of 3% at follow-up to 4% with one, 8% with two, and up to 14% for three or more.
These signs and symptoms could potentially be used to help identify patients that may benefit from preventive treatment for knee OA, the researchers believe.
The study was funded by The Netherlands Organisation for Health Research and Development and Reumafonds, the Dutch Arthritis Association. Dr. Schiphof had no financial disclosures.
AMSTERDAM – Persistent knee pain is an important predictor of structural joint damage and could potentially be used to predict knee osteoarthritis (OA) earlier, according to Dutch research reported at the World Congress on Osteoarthritis.
The analysis found that women participating in the Rotterdam Study who had knee pain on most days of the preceding month were more than four times more likely to develop knee OA within 5 years on MRI (odds ratio, 4.53) than were those without frequent knee pain.
Other signs and symptoms predictive of later OA on MRI included a history of knee injury (OR, 2.52), pain on palpation (OR, 2.30) or during activity (OR, 2.13), the feeling of the knee giving way (OR, 2.13), joint line tenderness (OR, 2.04), crepitus (or grating sounds or sensations; OR, 1.85), and Heberden’s nodes (OR, 1.67).
“Signs and symptoms can predict structural knee OA in 5 years in women without knee OA at baseline,” said the presenting study author Dieuwke Schiphof, Ph.D., a postdoctoral researcher at Erasmus University Medical Center in Rotterdam, at the meeting sponsored by the Osteoarthritis Research Society International.
“Knee pain on most days of the last month is an important predictive symptom for all structural OA definitions,” she said, adding that crepitus was an important sign of patellofemoral OA, and the feeling of giving way and joint line tenderness were important signs for tibiofemoral OA.
The aim of their study was to try to determine the value of previously identified clinical signs and symptoms for determining the onset of structural knee OA. Around 600 women aged 45-60 years without OA at baseline were included from the population-based cohort Rotterdam study. Participants had completed a standard questionnaire and had physical, radiographic, and MRI examination of both knees at baseline and at a mean follow-up of 5 years later.
The mean age of women was 59.5 years and 33 of 1,137 knees had isolated patellofemoral OA and 69 had isolated tibiofemoral OA, 111 one or the other, and 22 had radiographic knee OA.
Results showed that knee pain on most days of the last month (OR, 7.57) and crepitus (OR, 3.05) were most predictive of isolated patellofemoral OA on MRI. The prevalence of patellofemoral OA was 3% but this increased to 20% if both these signs and symptoms were present.
Knee pain on most days of the last month (OR, 4.13) was also predictive of isolated tibiofemoral OA on MRI, together with a history of knee pain (OR, 2.48), knee pain during activities (OR, 2.04), and the feeling of the knee giving way (OR, 3.15). If two or three or more signs and symptoms were present, the predictive value increased from a prevalence of 6% to 12% to 18%.
Knee pain on most days of the last month was also highly predictive of radiographic OA (OR, 7.77), as was pain at palpation (OR, 4.36), prior injury (OR, 3.64), and the feeling of the knee giving way (OR, 2.75). Again, when additional signs or symptoms were present the prevalence increased from a prevalence of 3% at follow-up to 4% with one, 8% with two, and up to 14% for three or more.
These signs and symptoms could potentially be used to help identify patients that may benefit from preventive treatment for knee OA, the researchers believe.
The study was funded by The Netherlands Organisation for Health Research and Development and Reumafonds, the Dutch Arthritis Association. Dr. Schiphof had no financial disclosures.
AMSTERDAM – Persistent knee pain is an important predictor of structural joint damage and could potentially be used to predict knee osteoarthritis (OA) earlier, according to Dutch research reported at the World Congress on Osteoarthritis.
The analysis found that women participating in the Rotterdam Study who had knee pain on most days of the preceding month were more than four times more likely to develop knee OA within 5 years on MRI (odds ratio, 4.53) than were those without frequent knee pain.
Other signs and symptoms predictive of later OA on MRI included a history of knee injury (OR, 2.52), pain on palpation (OR, 2.30) or during activity (OR, 2.13), the feeling of the knee giving way (OR, 2.13), joint line tenderness (OR, 2.04), crepitus (or grating sounds or sensations; OR, 1.85), and Heberden’s nodes (OR, 1.67).
“Signs and symptoms can predict structural knee OA in 5 years in women without knee OA at baseline,” said the presenting study author Dieuwke Schiphof, Ph.D., a postdoctoral researcher at Erasmus University Medical Center in Rotterdam, at the meeting sponsored by the Osteoarthritis Research Society International.
“Knee pain on most days of the last month is an important predictive symptom for all structural OA definitions,” she said, adding that crepitus was an important sign of patellofemoral OA, and the feeling of giving way and joint line tenderness were important signs for tibiofemoral OA.
The aim of their study was to try to determine the value of previously identified clinical signs and symptoms for determining the onset of structural knee OA. Around 600 women aged 45-60 years without OA at baseline were included from the population-based cohort Rotterdam study. Participants had completed a standard questionnaire and had physical, radiographic, and MRI examination of both knees at baseline and at a mean follow-up of 5 years later.
The mean age of women was 59.5 years and 33 of 1,137 knees had isolated patellofemoral OA and 69 had isolated tibiofemoral OA, 111 one or the other, and 22 had radiographic knee OA.
Results showed that knee pain on most days of the last month (OR, 7.57) and crepitus (OR, 3.05) were most predictive of isolated patellofemoral OA on MRI. The prevalence of patellofemoral OA was 3% but this increased to 20% if both these signs and symptoms were present.
Knee pain on most days of the last month (OR, 4.13) was also predictive of isolated tibiofemoral OA on MRI, together with a history of knee pain (OR, 2.48), knee pain during activities (OR, 2.04), and the feeling of the knee giving way (OR, 3.15). If two or three or more signs and symptoms were present, the predictive value increased from a prevalence of 6% to 12% to 18%.
Knee pain on most days of the last month was also highly predictive of radiographic OA (OR, 7.77), as was pain at palpation (OR, 4.36), prior injury (OR, 3.64), and the feeling of the knee giving way (OR, 2.75). Again, when additional signs or symptoms were present the prevalence increased from a prevalence of 3% at follow-up to 4% with one, 8% with two, and up to 14% for three or more.
These signs and symptoms could potentially be used to help identify patients that may benefit from preventive treatment for knee OA, the researchers believe.
The study was funded by The Netherlands Organisation for Health Research and Development and Reumafonds, the Dutch Arthritis Association. Dr. Schiphof had no financial disclosures.
AT OARSI 2016
Key clinical point: Several signs and symptoms could be used to help identify patients with osteoarthritis (OA) up to 5 years before joint damage occurs.
Major finding: Knee pain on most days of the last month was predictive of both MRI and radiographic knee damage.
Data source: 592 women from the Rotterdam Study without knee OA at baseline.
Disclosures: The study was funded by The Netherlands Organisation for Health Research and Development and Reumafonds, the Dutch Arthritis Association. Dr. Schiphof had no financial disclosures.