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TOPCAT, a third time around
Shakespeare, in Romeo and Juliet, refers to the proverb, “A cat has nine lives. For three he plays, for three he strays, and for the last he stays.”
TOPCAT is back again, having randomized its first patient with heart failure with preserved ejection fraction (HFpEF) almost 10 years ago for its treatment with spironolactone (SPIRO), a mineralocorticoid receptor antagonist.
The first report of the results of TOPCAT in 2014 indicated that there was no benefit associate with SPIRO therapy tested in the 3,445 patients randomized in 244 sites around the world (N Engl J Med. 2014 Apr 10;370[15]:1383-92). A subsequent analysis of data carried out in 2015 reported a striking regional difference in the outcome of patients randomized in the 1,767 patients in the Americas, compared with the 1,678 randomized in Russia and Georgia (Circulation. 2015 Jan 6;131[1]:34-42). In the Americas, there was an 18% decrease in the primary event of death and heart failure rehospitalization (3.6% in the SPIRO vs. 4.9% in the placebo; hazard ratio, 0.82; P = .026). There was essentially no difference in the groups randomized in Russia and Georgia, which had a 1.6% placebo event rate.
And now in 2016, at the recent meeting of the Heart Failure Society of America, we were informed that there was no detectable level of blood canrenone, a metabolite of SPIRO, in 30% of the 66 randomized patients in Russia and Georgia, compared with 3% of the patients randomized in the Americas (Cardiology News. Oct 2016. p 8). These data tend to confirm that the patients randomized in Russia and Georgia were either undertreated or not treated. In fact, after examination of the baseline characteristics of the two groups it is possible that many of the patients may not have had heart failure at all.
So what are we left with? One thing that is clear is that the management of TOPCAT was flawed and constitutes an example of how not to run an international clinical trial. Can we make any conclusion about the benefit of SPIRO? TOPCAT initially was powered for over 3,515 patients and 630 events in order to achieve a 85% benefit. The current analysis has now narrowed the population down to 1,787 patients with 522 events with an 18% decrease (P = .02) in the primary end point. During the mean follow-up of 3.3 years there was a placebo mortality of 4.9%, which is impressive in the setting of concomitant beta-blocker and renin angiotensin-converting enzyme inhibitor therapy. The only significant adverse observation was a threefold occurrence in hyperkalemia (potassium greater than 5.5 mmols/L) in the 25.2% in the Americas group treated with SPIRO, compared with the Russian-Georgian patients
Unfortunately the answer is not entirely clear. We all know who HFpEF patients are when they walk into the clinic but identifying them for a clinical trial has been difficult if not impossible. As for me, I will choose to treat their hypertension aggressively (not an easy task) and prevent or suppress their arrhythmias. In that project I will use beta-blockers and SPIRO to prevent their next heart failure episode and hope for the best.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
Shakespeare, in Romeo and Juliet, refers to the proverb, “A cat has nine lives. For three he plays, for three he strays, and for the last he stays.”
TOPCAT is back again, having randomized its first patient with heart failure with preserved ejection fraction (HFpEF) almost 10 years ago for its treatment with spironolactone (SPIRO), a mineralocorticoid receptor antagonist.
The first report of the results of TOPCAT in 2014 indicated that there was no benefit associate with SPIRO therapy tested in the 3,445 patients randomized in 244 sites around the world (N Engl J Med. 2014 Apr 10;370[15]:1383-92). A subsequent analysis of data carried out in 2015 reported a striking regional difference in the outcome of patients randomized in the 1,767 patients in the Americas, compared with the 1,678 randomized in Russia and Georgia (Circulation. 2015 Jan 6;131[1]:34-42). In the Americas, there was an 18% decrease in the primary event of death and heart failure rehospitalization (3.6% in the SPIRO vs. 4.9% in the placebo; hazard ratio, 0.82; P = .026). There was essentially no difference in the groups randomized in Russia and Georgia, which had a 1.6% placebo event rate.
And now in 2016, at the recent meeting of the Heart Failure Society of America, we were informed that there was no detectable level of blood canrenone, a metabolite of SPIRO, in 30% of the 66 randomized patients in Russia and Georgia, compared with 3% of the patients randomized in the Americas (Cardiology News. Oct 2016. p 8). These data tend to confirm that the patients randomized in Russia and Georgia were either undertreated or not treated. In fact, after examination of the baseline characteristics of the two groups it is possible that many of the patients may not have had heart failure at all.
So what are we left with? One thing that is clear is that the management of TOPCAT was flawed and constitutes an example of how not to run an international clinical trial. Can we make any conclusion about the benefit of SPIRO? TOPCAT initially was powered for over 3,515 patients and 630 events in order to achieve a 85% benefit. The current analysis has now narrowed the population down to 1,787 patients with 522 events with an 18% decrease (P = .02) in the primary end point. During the mean follow-up of 3.3 years there was a placebo mortality of 4.9%, which is impressive in the setting of concomitant beta-blocker and renin angiotensin-converting enzyme inhibitor therapy. The only significant adverse observation was a threefold occurrence in hyperkalemia (potassium greater than 5.5 mmols/L) in the 25.2% in the Americas group treated with SPIRO, compared with the Russian-Georgian patients
Unfortunately the answer is not entirely clear. We all know who HFpEF patients are when they walk into the clinic but identifying them for a clinical trial has been difficult if not impossible. As for me, I will choose to treat their hypertension aggressively (not an easy task) and prevent or suppress their arrhythmias. In that project I will use beta-blockers and SPIRO to prevent their next heart failure episode and hope for the best.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
Shakespeare, in Romeo and Juliet, refers to the proverb, “A cat has nine lives. For three he plays, for three he strays, and for the last he stays.”
TOPCAT is back again, having randomized its first patient with heart failure with preserved ejection fraction (HFpEF) almost 10 years ago for its treatment with spironolactone (SPIRO), a mineralocorticoid receptor antagonist.
The first report of the results of TOPCAT in 2014 indicated that there was no benefit associate with SPIRO therapy tested in the 3,445 patients randomized in 244 sites around the world (N Engl J Med. 2014 Apr 10;370[15]:1383-92). A subsequent analysis of data carried out in 2015 reported a striking regional difference in the outcome of patients randomized in the 1,767 patients in the Americas, compared with the 1,678 randomized in Russia and Georgia (Circulation. 2015 Jan 6;131[1]:34-42). In the Americas, there was an 18% decrease in the primary event of death and heart failure rehospitalization (3.6% in the SPIRO vs. 4.9% in the placebo; hazard ratio, 0.82; P = .026). There was essentially no difference in the groups randomized in Russia and Georgia, which had a 1.6% placebo event rate.
And now in 2016, at the recent meeting of the Heart Failure Society of America, we were informed that there was no detectable level of blood canrenone, a metabolite of SPIRO, in 30% of the 66 randomized patients in Russia and Georgia, compared with 3% of the patients randomized in the Americas (Cardiology News. Oct 2016. p 8). These data tend to confirm that the patients randomized in Russia and Georgia were either undertreated or not treated. In fact, after examination of the baseline characteristics of the two groups it is possible that many of the patients may not have had heart failure at all.
So what are we left with? One thing that is clear is that the management of TOPCAT was flawed and constitutes an example of how not to run an international clinical trial. Can we make any conclusion about the benefit of SPIRO? TOPCAT initially was powered for over 3,515 patients and 630 events in order to achieve a 85% benefit. The current analysis has now narrowed the population down to 1,787 patients with 522 events with an 18% decrease (P = .02) in the primary end point. During the mean follow-up of 3.3 years there was a placebo mortality of 4.9%, which is impressive in the setting of concomitant beta-blocker and renin angiotensin-converting enzyme inhibitor therapy. The only significant adverse observation was a threefold occurrence in hyperkalemia (potassium greater than 5.5 mmols/L) in the 25.2% in the Americas group treated with SPIRO, compared with the Russian-Georgian patients
Unfortunately the answer is not entirely clear. We all know who HFpEF patients are when they walk into the clinic but identifying them for a clinical trial has been difficult if not impossible. As for me, I will choose to treat their hypertension aggressively (not an easy task) and prevent or suppress their arrhythmias. In that project I will use beta-blockers and SPIRO to prevent their next heart failure episode and hope for the best.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
Plecanatide safe, effective for chronic constipation
LAS VEGAS – Two new studies suggest that the peptide plecanatide is safe and effective in the treatment of chronic idiopathic constipation. The drug had a low rate of diarrhea, about 7.1%.
The research, presented in two posters at the annual meeting of the American College of Gastroenterology, includes a pooled efficacy and safety analysis from two previous phase III clinical trials, as well as an open-label extension study.
Though there is no way to be sure in the absence of head-to-head studies, plecanatide could have a better tolerability profile than the existing constipation drugs like lubiprostone (Amitiza) and linaclotide (Linzess).
The drug is a derivative of uroguanylin, a peptide found in the gastrointestinal tract. Like the native peptide, plecanatide stimulates digestive fluid movement in the proximal small intestine, which in turn encourages regular bowel function. “I think because it is so much closer to the innate uroguanylin molecule, it will have better tolerability,” said Dr. Rao in an interview.
The open-label study followed 2,370 patients who received 3-mg or 6-mg doses of plecanatide once daily for up to 72 weeks. The most common adverse events were diarrhea (7.1%) and urinary tract infection (2.2%), and these were the only adverse events that occurred at a frequency above 2%.
About 5% of patients discontinued due to adverse events, 3.1% because of diarrhea. Patients were also asked to score their satisfaction with the drug and their willingness to continue on it, and the median values to those answers corresponded to quite satisfied and quite likely to continue.
The other study was a pooled analysis of two previously presented double-blind, placebo-controlled phase III trials of plecanatide. These studies included 2,791 patients with chronic idiopathic constipation who were treated over the course of 12 weeks, with 3- and 6-mg doses. Both groups showed significant improvements in the rate of durable overall complete spontaneous bowel movements: 20.5% in the 3-mg group and 19.8% in the 6-mg group, compared with 11.5% in the placebo group (P less than .001 for both comparisons).
Patients experienced improvements as early as the first week of treatment (31.6% in the 3-mg group versus 16.1% in placebo, P less than .001), and improvements were maintained through the end of the treatment period. There were also significant improvements in secondary endpoints, including stool consistency, straining, and bloating.
Adverse events occurred in 30.6% of subjects taking the 3-mg dose and 31.1% of those taking 6 mg, compared with 28.7% in the placebo group. As with the long-term study, the most common adverse event was diarrhea (4.6% in 3 mg and 5.1% in 6 mg, compared with 1.3% in placebo). Of those in the 3-mg group, 4.1% discontinued, as did 4.5% in the 6-mg group, and 2.2% in the placebo group.
“I think these are very exciting results. They clearly show a benefit of plecanatide in patients with chronic constipation. These are really methodologically rigorous, large clinical trials that should provide doctors and patients with confidence that the drug will provide benefits,” commented William D. Chey, MD, a professor of medicine at the University of Michigan, Ann Arbor.
Plecanatide is also being developed for irritable bowel syndrome with constipation, and has finished recruitment for two phase III clinical trials, which Synergy expects to report on later this year.
Dr. Rao is a member of an advisory committee for Forest Laboratories, Hollister, In Control Medical, Ironwood, Sucampo, and Vibrant. Dr. Chey is a consultant for Ironwood and Synergy.
AGA Resource
AGA offers information for your patients about constipation at http://www.gastro.org/patient-care/conditions-diseases/constipation.
LAS VEGAS – Two new studies suggest that the peptide plecanatide is safe and effective in the treatment of chronic idiopathic constipation. The drug had a low rate of diarrhea, about 7.1%.
The research, presented in two posters at the annual meeting of the American College of Gastroenterology, includes a pooled efficacy and safety analysis from two previous phase III clinical trials, as well as an open-label extension study.
Though there is no way to be sure in the absence of head-to-head studies, plecanatide could have a better tolerability profile than the existing constipation drugs like lubiprostone (Amitiza) and linaclotide (Linzess).
The drug is a derivative of uroguanylin, a peptide found in the gastrointestinal tract. Like the native peptide, plecanatide stimulates digestive fluid movement in the proximal small intestine, which in turn encourages regular bowel function. “I think because it is so much closer to the innate uroguanylin molecule, it will have better tolerability,” said Dr. Rao in an interview.
The open-label study followed 2,370 patients who received 3-mg or 6-mg doses of plecanatide once daily for up to 72 weeks. The most common adverse events were diarrhea (7.1%) and urinary tract infection (2.2%), and these were the only adverse events that occurred at a frequency above 2%.
About 5% of patients discontinued due to adverse events, 3.1% because of diarrhea. Patients were also asked to score their satisfaction with the drug and their willingness to continue on it, and the median values to those answers corresponded to quite satisfied and quite likely to continue.
The other study was a pooled analysis of two previously presented double-blind, placebo-controlled phase III trials of plecanatide. These studies included 2,791 patients with chronic idiopathic constipation who were treated over the course of 12 weeks, with 3- and 6-mg doses. Both groups showed significant improvements in the rate of durable overall complete spontaneous bowel movements: 20.5% in the 3-mg group and 19.8% in the 6-mg group, compared with 11.5% in the placebo group (P less than .001 for both comparisons).
Patients experienced improvements as early as the first week of treatment (31.6% in the 3-mg group versus 16.1% in placebo, P less than .001), and improvements were maintained through the end of the treatment period. There were also significant improvements in secondary endpoints, including stool consistency, straining, and bloating.
Adverse events occurred in 30.6% of subjects taking the 3-mg dose and 31.1% of those taking 6 mg, compared with 28.7% in the placebo group. As with the long-term study, the most common adverse event was diarrhea (4.6% in 3 mg and 5.1% in 6 mg, compared with 1.3% in placebo). Of those in the 3-mg group, 4.1% discontinued, as did 4.5% in the 6-mg group, and 2.2% in the placebo group.
“I think these are very exciting results. They clearly show a benefit of plecanatide in patients with chronic constipation. These are really methodologically rigorous, large clinical trials that should provide doctors and patients with confidence that the drug will provide benefits,” commented William D. Chey, MD, a professor of medicine at the University of Michigan, Ann Arbor.
Plecanatide is also being developed for irritable bowel syndrome with constipation, and has finished recruitment for two phase III clinical trials, which Synergy expects to report on later this year.
Dr. Rao is a member of an advisory committee for Forest Laboratories, Hollister, In Control Medical, Ironwood, Sucampo, and Vibrant. Dr. Chey is a consultant for Ironwood and Synergy.
AGA Resource
AGA offers information for your patients about constipation at http://www.gastro.org/patient-care/conditions-diseases/constipation.
LAS VEGAS – Two new studies suggest that the peptide plecanatide is safe and effective in the treatment of chronic idiopathic constipation. The drug had a low rate of diarrhea, about 7.1%.
The research, presented in two posters at the annual meeting of the American College of Gastroenterology, includes a pooled efficacy and safety analysis from two previous phase III clinical trials, as well as an open-label extension study.
Though there is no way to be sure in the absence of head-to-head studies, plecanatide could have a better tolerability profile than the existing constipation drugs like lubiprostone (Amitiza) and linaclotide (Linzess).
The drug is a derivative of uroguanylin, a peptide found in the gastrointestinal tract. Like the native peptide, plecanatide stimulates digestive fluid movement in the proximal small intestine, which in turn encourages regular bowel function. “I think because it is so much closer to the innate uroguanylin molecule, it will have better tolerability,” said Dr. Rao in an interview.
The open-label study followed 2,370 patients who received 3-mg or 6-mg doses of plecanatide once daily for up to 72 weeks. The most common adverse events were diarrhea (7.1%) and urinary tract infection (2.2%), and these were the only adverse events that occurred at a frequency above 2%.
About 5% of patients discontinued due to adverse events, 3.1% because of diarrhea. Patients were also asked to score their satisfaction with the drug and their willingness to continue on it, and the median values to those answers corresponded to quite satisfied and quite likely to continue.
The other study was a pooled analysis of two previously presented double-blind, placebo-controlled phase III trials of plecanatide. These studies included 2,791 patients with chronic idiopathic constipation who were treated over the course of 12 weeks, with 3- and 6-mg doses. Both groups showed significant improvements in the rate of durable overall complete spontaneous bowel movements: 20.5% in the 3-mg group and 19.8% in the 6-mg group, compared with 11.5% in the placebo group (P less than .001 for both comparisons).
Patients experienced improvements as early as the first week of treatment (31.6% in the 3-mg group versus 16.1% in placebo, P less than .001), and improvements were maintained through the end of the treatment period. There were also significant improvements in secondary endpoints, including stool consistency, straining, and bloating.
Adverse events occurred in 30.6% of subjects taking the 3-mg dose and 31.1% of those taking 6 mg, compared with 28.7% in the placebo group. As with the long-term study, the most common adverse event was diarrhea (4.6% in 3 mg and 5.1% in 6 mg, compared with 1.3% in placebo). Of those in the 3-mg group, 4.1% discontinued, as did 4.5% in the 6-mg group, and 2.2% in the placebo group.
“I think these are very exciting results. They clearly show a benefit of plecanatide in patients with chronic constipation. These are really methodologically rigorous, large clinical trials that should provide doctors and patients with confidence that the drug will provide benefits,” commented William D. Chey, MD, a professor of medicine at the University of Michigan, Ann Arbor.
Plecanatide is also being developed for irritable bowel syndrome with constipation, and has finished recruitment for two phase III clinical trials, which Synergy expects to report on later this year.
Dr. Rao is a member of an advisory committee for Forest Laboratories, Hollister, In Control Medical, Ironwood, Sucampo, and Vibrant. Dr. Chey is a consultant for Ironwood and Synergy.
AGA Resource
AGA offers information for your patients about constipation at http://www.gastro.org/patient-care/conditions-diseases/constipation.
AT ACG 2016
Key clinical point: Plecanatide is safe and effective in the treatment of idiopathic chronic constipation.
Major finding: A long-term study and an analysis of two phase III clinical trials show the drug is effective at reducing constipation and has low rates of adverse events and discontinuation.
Data source: Open-label extension trial and randomized, placebo-controlled, clinical trials.
Disclosures: Dr. Rao is a member of an advisory committee for Forest Laboratories, Hollister, In Control Medical, Ironwood, Sucampo, and Vibrant. Dr. Chey is a consultant for Ironwood.
Protein May Predict Risk for Chemotherapy-Induced Peripheral Neuropathy
A promising biomarker strategy may help identify patients at risk for severe paclitaxel-induced neuropathy. Although weekly paclitaxel is more effective than a 3-weekly regimen, the treatment comes at the price of more severe sensory peripheral neuropathy (PN). As yet, treatment for chemotherapy-induced peripheral neuropathy (CIPN) is only symptomatic, say researchers from University of Singapore and National University Cancer Institute, Singapore.
Related: Is Chemotherapy a Good Choice for Neuroendocrine Tumors?
Their previous research, however, suggested that a protein called NDRG1 might be useful in predicting paclitaxel-induced PN. NDRG1 is a protein “ubiquitously” expressed in human tissues and tumors, the researchers note, particularly in peripheral nerve tissue. The protein also has been implicated in degrading myelin in Charcot-Marie-Tooth disease, a hereditary motor and sensory neuropathy.
Related: ASCO's Chemotherapy Administration Safety Standards
To expand on their earlier research, the researchers conducted another study in 111 patients with early stage breast cancer. Of those patients, 41% had human epidermal growth factor receptor (HER)-2 positive breast cancer and received adjuvant trastuzumab along with paclitaxel. Over a median of 12 weeks, 77 patients (69%) developed all-grade PN; in 17, the neuropathy was severe enough to mandate reducing or delaying doses or stopping paclitaxel. Peripheral neuropathy occurred before cycle 6 in 48%. Not surprisingly, patients with diabetes had more severe neuropathy (44% vs 11%). The researchers found no differences in neuropathy among various age groups or races; however, they also noted that most of the patients were Chinese.
Related: Palliative Chemotherapy May Be Harmful
The mean NDRG1 score of patients without severe neuropathy was 7.7, compared with 5.4 for patients with severe neuropathy. Fifty-four patients had an NDRGI score of < 7; of those, 13 (24%) developed severe neuropathy compared with only 4 of 57 (7%) of patients with a score above 7.
The researchers are performing a larger prospective study to explore the mechanisms of NDRG1 regulation to support their findings.
Source:
Sundar R, Jeyasekharan AD, Pang B, et al. PLoS ONE. 2016;11(10):e0164319.
doi:10.1371/journal.pone.0164319.
A promising biomarker strategy may help identify patients at risk for severe paclitaxel-induced neuropathy. Although weekly paclitaxel is more effective than a 3-weekly regimen, the treatment comes at the price of more severe sensory peripheral neuropathy (PN). As yet, treatment for chemotherapy-induced peripheral neuropathy (CIPN) is only symptomatic, say researchers from University of Singapore and National University Cancer Institute, Singapore.
Related: Is Chemotherapy a Good Choice for Neuroendocrine Tumors?
Their previous research, however, suggested that a protein called NDRG1 might be useful in predicting paclitaxel-induced PN. NDRG1 is a protein “ubiquitously” expressed in human tissues and tumors, the researchers note, particularly in peripheral nerve tissue. The protein also has been implicated in degrading myelin in Charcot-Marie-Tooth disease, a hereditary motor and sensory neuropathy.
Related: ASCO's Chemotherapy Administration Safety Standards
To expand on their earlier research, the researchers conducted another study in 111 patients with early stage breast cancer. Of those patients, 41% had human epidermal growth factor receptor (HER)-2 positive breast cancer and received adjuvant trastuzumab along with paclitaxel. Over a median of 12 weeks, 77 patients (69%) developed all-grade PN; in 17, the neuropathy was severe enough to mandate reducing or delaying doses or stopping paclitaxel. Peripheral neuropathy occurred before cycle 6 in 48%. Not surprisingly, patients with diabetes had more severe neuropathy (44% vs 11%). The researchers found no differences in neuropathy among various age groups or races; however, they also noted that most of the patients were Chinese.
Related: Palliative Chemotherapy May Be Harmful
The mean NDRG1 score of patients without severe neuropathy was 7.7, compared with 5.4 for patients with severe neuropathy. Fifty-four patients had an NDRGI score of < 7; of those, 13 (24%) developed severe neuropathy compared with only 4 of 57 (7%) of patients with a score above 7.
The researchers are performing a larger prospective study to explore the mechanisms of NDRG1 regulation to support their findings.
Source:
Sundar R, Jeyasekharan AD, Pang B, et al. PLoS ONE. 2016;11(10):e0164319.
doi:10.1371/journal.pone.0164319.
A promising biomarker strategy may help identify patients at risk for severe paclitaxel-induced neuropathy. Although weekly paclitaxel is more effective than a 3-weekly regimen, the treatment comes at the price of more severe sensory peripheral neuropathy (PN). As yet, treatment for chemotherapy-induced peripheral neuropathy (CIPN) is only symptomatic, say researchers from University of Singapore and National University Cancer Institute, Singapore.
Related: Is Chemotherapy a Good Choice for Neuroendocrine Tumors?
Their previous research, however, suggested that a protein called NDRG1 might be useful in predicting paclitaxel-induced PN. NDRG1 is a protein “ubiquitously” expressed in human tissues and tumors, the researchers note, particularly in peripheral nerve tissue. The protein also has been implicated in degrading myelin in Charcot-Marie-Tooth disease, a hereditary motor and sensory neuropathy.
Related: ASCO's Chemotherapy Administration Safety Standards
To expand on their earlier research, the researchers conducted another study in 111 patients with early stage breast cancer. Of those patients, 41% had human epidermal growth factor receptor (HER)-2 positive breast cancer and received adjuvant trastuzumab along with paclitaxel. Over a median of 12 weeks, 77 patients (69%) developed all-grade PN; in 17, the neuropathy was severe enough to mandate reducing or delaying doses or stopping paclitaxel. Peripheral neuropathy occurred before cycle 6 in 48%. Not surprisingly, patients with diabetes had more severe neuropathy (44% vs 11%). The researchers found no differences in neuropathy among various age groups or races; however, they also noted that most of the patients were Chinese.
Related: Palliative Chemotherapy May Be Harmful
The mean NDRG1 score of patients without severe neuropathy was 7.7, compared with 5.4 for patients with severe neuropathy. Fifty-four patients had an NDRGI score of < 7; of those, 13 (24%) developed severe neuropathy compared with only 4 of 57 (7%) of patients with a score above 7.
The researchers are performing a larger prospective study to explore the mechanisms of NDRG1 regulation to support their findings.
Source:
Sundar R, Jeyasekharan AD, Pang B, et al. PLoS ONE. 2016;11(10):e0164319.
doi:10.1371/journal.pone.0164319.
MACRA final rule exempts many more doctors
Physicians who do not have a large Medicare population or who do not bill much to Medicare Part B will get a bit more breathing room to avoid having to participate in MACRA’s Quality Payment Program.
In a final rule posted Oct. 14 that sets out how the Medicare Access and CHIP Reauthorization Act (MACRA) will work, the Centers for Medicare & Medicaid Services increased the threshold for inclusion in the new value-based payment program from the initial proposal of physicians who bill Medicare more than $10,000 per year or treat more than 100 Medicare patients per year to those who bill more than $30,000 per year or provide care to more than 100 Medicare patients per year.
However, agency officials noted that it is committed to helping these small and solo practices become active participants in the Quality Payment Program.
“We heard these concerns and are taking additional steps to aid small practices, including reducing the time and cost to participate, excluding more small practices, increasing the availability of Advanced APMs [Alternative Payment Models] to small practices, allowing practices to begin participation at their own pace, changing one of the qualifications for participation in Advanced APMs to be practice-based as an alternative to total cost–based, and conducting significant technical support and outreach to small practices using $20 million a year over the next 5 years.”
CMS officials estimate that the new threshold will exclude an estimated 380,000 physicians and health care providers, up from about 225,000 under the initially proposed threshold.
Mr. Slavitt added that with these changes, “we estimate that small [practice] physicians will have the same level of participation as that of other practice sizes.”
The flexibility of participation was first announced Sept. 8, in a blog post outlining four options for participation in the Quality Payment Program:
• Option 1: Test the quality payment program in 2017 by submitting data without facing any negative payment adjustments. This will give physicians the year to make sure their processes are in place and ready for broader participation in 2018 and beyond.
• Option 2: Delay the start of the performance period and participate for just part of 2017. Depending on how long a physician delays reporting quality information back to CMS, they could still qualify for a smaller bonus payment.
• Option 3: Participate for the entire calendar year as called for by the law and be eligible for the full participation bonuses.
• Option 4: For those who qualify, participate in an Advanced Alternative Payment Model beginning next year.
That said, under the final rule, those who fail to do the bare minimum and report no data in 2017 will face a 4% pay cut in 2019.
“We are pleased CMS listened to the AGA’s concerns regarding the complexity of MACRA, its implementation, and its impact on small practices, among other issues,” said Timothy C. Wang, MD, AGAF, AGA Institute President, Columbia University, New York. “We believe that designation of 2017 as a transition year will allow GI’s the opportunity to understand the new value-based reimbursement system, and AGA stands ready to guide the GI community to survive and thrive in the new environment.”
“I am sure [the pay cuts are] going to impact some providers,” John Feore, director at Avalere Health, said in an interview. “But with the options, you can report on a very small number of measures, one for each of the categories, for a continuous 90-day period, and you will be sort of held harmless [and able] to transition over time into the program.”
Physician organizations were supportive of the final rule, particularly regarding how it addresses the concerns of small/solo practices.
CMS officials “took a significant step last month to address AMA concerns about the original proposal,” American Medical Association President Andrew W. Gurman, MD, said in a statement. “The final rule includes additional steps to help small and rural practices by raising the low-volume threshold exemption, and practices of all sizes will benefit from reduced MIPS reporting requirements. Our initial review indicates that CMS has been responsive to many concerns raised by the AMA.”
CMS officials said that the agency is looking into creating an accountable care organization (ACO) “Track 1 Plus” model that would qualify as an APM. Currently, ACOs that are in Track 1 share savings but do not assume risk. The agency said that the Track 1 Plus model would have organizations assuming some nominal level of risk that would be smaller, compared with those in the Medicare Shared Savings Program (MSSP) Track 2 and Track 3, as well as those that qualify as Next Generation ACOs. CMS plans to have the ACO Track 1 Plus Model ready for the 2018 reporting year.
Physicians who do not have a large Medicare population or who do not bill much to Medicare Part B will get a bit more breathing room to avoid having to participate in MACRA’s Quality Payment Program.
In a final rule posted Oct. 14 that sets out how the Medicare Access and CHIP Reauthorization Act (MACRA) will work, the Centers for Medicare & Medicaid Services increased the threshold for inclusion in the new value-based payment program from the initial proposal of physicians who bill Medicare more than $10,000 per year or treat more than 100 Medicare patients per year to those who bill more than $30,000 per year or provide care to more than 100 Medicare patients per year.
However, agency officials noted that it is committed to helping these small and solo practices become active participants in the Quality Payment Program.
“We heard these concerns and are taking additional steps to aid small practices, including reducing the time and cost to participate, excluding more small practices, increasing the availability of Advanced APMs [Alternative Payment Models] to small practices, allowing practices to begin participation at their own pace, changing one of the qualifications for participation in Advanced APMs to be practice-based as an alternative to total cost–based, and conducting significant technical support and outreach to small practices using $20 million a year over the next 5 years.”
CMS officials estimate that the new threshold will exclude an estimated 380,000 physicians and health care providers, up from about 225,000 under the initially proposed threshold.
Mr. Slavitt added that with these changes, “we estimate that small [practice] physicians will have the same level of participation as that of other practice sizes.”
The flexibility of participation was first announced Sept. 8, in a blog post outlining four options for participation in the Quality Payment Program:
• Option 1: Test the quality payment program in 2017 by submitting data without facing any negative payment adjustments. This will give physicians the year to make sure their processes are in place and ready for broader participation in 2018 and beyond.
• Option 2: Delay the start of the performance period and participate for just part of 2017. Depending on how long a physician delays reporting quality information back to CMS, they could still qualify for a smaller bonus payment.
• Option 3: Participate for the entire calendar year as called for by the law and be eligible for the full participation bonuses.
• Option 4: For those who qualify, participate in an Advanced Alternative Payment Model beginning next year.
That said, under the final rule, those who fail to do the bare minimum and report no data in 2017 will face a 4% pay cut in 2019.
“We are pleased CMS listened to the AGA’s concerns regarding the complexity of MACRA, its implementation, and its impact on small practices, among other issues,” said Timothy C. Wang, MD, AGAF, AGA Institute President, Columbia University, New York. “We believe that designation of 2017 as a transition year will allow GI’s the opportunity to understand the new value-based reimbursement system, and AGA stands ready to guide the GI community to survive and thrive in the new environment.”
“I am sure [the pay cuts are] going to impact some providers,” John Feore, director at Avalere Health, said in an interview. “But with the options, you can report on a very small number of measures, one for each of the categories, for a continuous 90-day period, and you will be sort of held harmless [and able] to transition over time into the program.”
Physician organizations were supportive of the final rule, particularly regarding how it addresses the concerns of small/solo practices.
CMS officials “took a significant step last month to address AMA concerns about the original proposal,” American Medical Association President Andrew W. Gurman, MD, said in a statement. “The final rule includes additional steps to help small and rural practices by raising the low-volume threshold exemption, and practices of all sizes will benefit from reduced MIPS reporting requirements. Our initial review indicates that CMS has been responsive to many concerns raised by the AMA.”
CMS officials said that the agency is looking into creating an accountable care organization (ACO) “Track 1 Plus” model that would qualify as an APM. Currently, ACOs that are in Track 1 share savings but do not assume risk. The agency said that the Track 1 Plus model would have organizations assuming some nominal level of risk that would be smaller, compared with those in the Medicare Shared Savings Program (MSSP) Track 2 and Track 3, as well as those that qualify as Next Generation ACOs. CMS plans to have the ACO Track 1 Plus Model ready for the 2018 reporting year.
Physicians who do not have a large Medicare population or who do not bill much to Medicare Part B will get a bit more breathing room to avoid having to participate in MACRA’s Quality Payment Program.
In a final rule posted Oct. 14 that sets out how the Medicare Access and CHIP Reauthorization Act (MACRA) will work, the Centers for Medicare & Medicaid Services increased the threshold for inclusion in the new value-based payment program from the initial proposal of physicians who bill Medicare more than $10,000 per year or treat more than 100 Medicare patients per year to those who bill more than $30,000 per year or provide care to more than 100 Medicare patients per year.
However, agency officials noted that it is committed to helping these small and solo practices become active participants in the Quality Payment Program.
“We heard these concerns and are taking additional steps to aid small practices, including reducing the time and cost to participate, excluding more small practices, increasing the availability of Advanced APMs [Alternative Payment Models] to small practices, allowing practices to begin participation at their own pace, changing one of the qualifications for participation in Advanced APMs to be practice-based as an alternative to total cost–based, and conducting significant technical support and outreach to small practices using $20 million a year over the next 5 years.”
CMS officials estimate that the new threshold will exclude an estimated 380,000 physicians and health care providers, up from about 225,000 under the initially proposed threshold.
Mr. Slavitt added that with these changes, “we estimate that small [practice] physicians will have the same level of participation as that of other practice sizes.”
The flexibility of participation was first announced Sept. 8, in a blog post outlining four options for participation in the Quality Payment Program:
• Option 1: Test the quality payment program in 2017 by submitting data without facing any negative payment adjustments. This will give physicians the year to make sure their processes are in place and ready for broader participation in 2018 and beyond.
• Option 2: Delay the start of the performance period and participate for just part of 2017. Depending on how long a physician delays reporting quality information back to CMS, they could still qualify for a smaller bonus payment.
• Option 3: Participate for the entire calendar year as called for by the law and be eligible for the full participation bonuses.
• Option 4: For those who qualify, participate in an Advanced Alternative Payment Model beginning next year.
That said, under the final rule, those who fail to do the bare minimum and report no data in 2017 will face a 4% pay cut in 2019.
“We are pleased CMS listened to the AGA’s concerns regarding the complexity of MACRA, its implementation, and its impact on small practices, among other issues,” said Timothy C. Wang, MD, AGAF, AGA Institute President, Columbia University, New York. “We believe that designation of 2017 as a transition year will allow GI’s the opportunity to understand the new value-based reimbursement system, and AGA stands ready to guide the GI community to survive and thrive in the new environment.”
“I am sure [the pay cuts are] going to impact some providers,” John Feore, director at Avalere Health, said in an interview. “But with the options, you can report on a very small number of measures, one for each of the categories, for a continuous 90-day period, and you will be sort of held harmless [and able] to transition over time into the program.”
Physician organizations were supportive of the final rule, particularly regarding how it addresses the concerns of small/solo practices.
CMS officials “took a significant step last month to address AMA concerns about the original proposal,” American Medical Association President Andrew W. Gurman, MD, said in a statement. “The final rule includes additional steps to help small and rural practices by raising the low-volume threshold exemption, and practices of all sizes will benefit from reduced MIPS reporting requirements. Our initial review indicates that CMS has been responsive to many concerns raised by the AMA.”
CMS officials said that the agency is looking into creating an accountable care organization (ACO) “Track 1 Plus” model that would qualify as an APM. Currently, ACOs that are in Track 1 share savings but do not assume risk. The agency said that the Track 1 Plus model would have organizations assuming some nominal level of risk that would be smaller, compared with those in the Medicare Shared Savings Program (MSSP) Track 2 and Track 3, as well as those that qualify as Next Generation ACOs. CMS plans to have the ACO Track 1 Plus Model ready for the 2018 reporting year.
High-status occupation spells worse response to antidepressant therapy
VIENNA – Depressed patients with a high-status job appear to be significantly less responsive to antidepressant therapy than other workers, Joseph Zohar, MD, reported at the annual congress of the European College of Neuropsychopharmacology.
He presented a multicenter study of 654 Austrian, Israeli, Belgian, and Italian working adults with major depressive disorder. Those categorized as having a high occupational level were significantly less likely to have responded to the most recent trial of antidepressant medication for their current episode. They also had a significantly higher rate of treatment-resistant depression as defined by nonresponse to at least two previous adequate treatment trials, compared with the patients with mid- or low-level occupations.
“These results show that the need for precise prescribing is not only related to the symptoms and genetics but also to occupational level. One might need to prescribe different medication for the same disorder and need to take into account the occupational level in order to reach optimum effect,” he continued.
He and his coinvestigators categorized occupational level according to Hollingshead’s Occupational Scale, a tool widely used by sociologists. Occupational level is a different concept from socioeconomic status. It incorporates prestige, entry qualifications, job responsibilities, and skill requirements – as well as earnings. Examples of high occupational level jobs in this construct include physicians, engineers, architects, scientists, lawyers, CEOs, and professors.
Fifty-one percent of the study participants were classified as having high-status occupations, with the rest evenly divided between mid- and low-level occupations. Only 43.2% of patients in the high-level group had responded to their last treatment episode based upon clinical judgment and a Hamilton Depression Rating Scale score of 17 or less, compared with 58.4% of patients with mid- and 49.7% with low-level jobs. 
At this point the explanation for the observed relationship between occupation level and antidepressant treatment response remains speculative. This is the first large study of its kind, and the results require confirmation. If the findings hold up, the results could have important implications for employers, who might want to discourage patients with high-status jobs and a history of treatment-resistant depression from particularly high work stress environments in order to reduce depression-related disability in the workplace, according to the psychiatrist.
Potential explanations for the findings include the possibility that depressed patients in high-level occupations are more likely to have poor illness acceptance, be less adherent to prescribed medications, or possess certain personality, cognitive, or behavioral differences that predispose to poor treatment outcome.
The study was funded by the ECNP’s Expert Platform on Mental Health – Focus on Depression. Dr. Zohar reported having no relevant financial conflicts.
VIENNA – Depressed patients with a high-status job appear to be significantly less responsive to antidepressant therapy than other workers, Joseph Zohar, MD, reported at the annual congress of the European College of Neuropsychopharmacology.
He presented a multicenter study of 654 Austrian, Israeli, Belgian, and Italian working adults with major depressive disorder. Those categorized as having a high occupational level were significantly less likely to have responded to the most recent trial of antidepressant medication for their current episode. They also had a significantly higher rate of treatment-resistant depression as defined by nonresponse to at least two previous adequate treatment trials, compared with the patients with mid- or low-level occupations.
“These results show that the need for precise prescribing is not only related to the symptoms and genetics but also to occupational level. One might need to prescribe different medication for the same disorder and need to take into account the occupational level in order to reach optimum effect,” he continued.
He and his coinvestigators categorized occupational level according to Hollingshead’s Occupational Scale, a tool widely used by sociologists. Occupational level is a different concept from socioeconomic status. It incorporates prestige, entry qualifications, job responsibilities, and skill requirements – as well as earnings. Examples of high occupational level jobs in this construct include physicians, engineers, architects, scientists, lawyers, CEOs, and professors.
Fifty-one percent of the study participants were classified as having high-status occupations, with the rest evenly divided between mid- and low-level occupations. Only 43.2% of patients in the high-level group had responded to their last treatment episode based upon clinical judgment and a Hamilton Depression Rating Scale score of 17 or less, compared with 58.4% of patients with mid- and 49.7% with low-level jobs.
At this point the explanation for the observed relationship between occupation level and antidepressant treatment response remains speculative. This is the first large study of its kind, and the results require confirmation. If the findings hold up, the results could have important implications for employers, who might want to discourage patients with high-status jobs and a history of treatment-resistant depression from particularly high work stress environments in order to reduce depression-related disability in the workplace, according to the psychiatrist.
Potential explanations for the findings include the possibility that depressed patients in high-level occupations are more likely to have poor illness acceptance, be less adherent to prescribed medications, or possess certain personality, cognitive, or behavioral differences that predispose to poor treatment outcome.
The study was funded by the ECNP’s Expert Platform on Mental Health – Focus on Depression. Dr. Zohar reported having no relevant financial conflicts.
VIENNA – Depressed patients with a high-status job appear to be significantly less responsive to antidepressant therapy than other workers, Joseph Zohar, MD, reported at the annual congress of the European College of Neuropsychopharmacology.
He presented a multicenter study of 654 Austrian, Israeli, Belgian, and Italian working adults with major depressive disorder. Those categorized as having a high occupational level were significantly less likely to have responded to the most recent trial of antidepressant medication for their current episode. They also had a significantly higher rate of treatment-resistant depression as defined by nonresponse to at least two previous adequate treatment trials, compared with the patients with mid- or low-level occupations.
“These results show that the need for precise prescribing is not only related to the symptoms and genetics but also to occupational level. One might need to prescribe different medication for the same disorder and need to take into account the occupational level in order to reach optimum effect,” he continued.
He and his coinvestigators categorized occupational level according to Hollingshead’s Occupational Scale, a tool widely used by sociologists. Occupational level is a different concept from socioeconomic status. It incorporates prestige, entry qualifications, job responsibilities, and skill requirements – as well as earnings. Examples of high occupational level jobs in this construct include physicians, engineers, architects, scientists, lawyers, CEOs, and professors.
Fifty-one percent of the study participants were classified as having high-status occupations, with the rest evenly divided between mid- and low-level occupations. Only 43.2% of patients in the high-level group had responded to their last treatment episode based upon clinical judgment and a Hamilton Depression Rating Scale score of 17 or less, compared with 58.4% of patients with mid- and 49.7% with low-level jobs.
At this point the explanation for the observed relationship between occupation level and antidepressant treatment response remains speculative. This is the first large study of its kind, and the results require confirmation. If the findings hold up, the results could have important implications for employers, who might want to discourage patients with high-status jobs and a history of treatment-resistant depression from particularly high work stress environments in order to reduce depression-related disability in the workplace, according to the psychiatrist.
Potential explanations for the findings include the possibility that depressed patients in high-level occupations are more likely to have poor illness acceptance, be less adherent to prescribed medications, or possess certain personality, cognitive, or behavioral differences that predispose to poor treatment outcome.
The study was funded by the ECNP’s Expert Platform on Mental Health – Focus on Depression. Dr. Zohar reported having no relevant financial conflicts.
AT THE ECNP CONGRESS
Key clinical point:
Major finding: Fifty-six percent of patients with high-status occupations who were treated for major depression were classified as treatment resistant, compared with 40% of patients with midlevel occupations and 44% with low-level occupations.
Data source: A study of 654 working adults with major depression in four countries.
Disclosures: The study was funded by the Expert Platform on Mental Health Focus on Depression. The presenter reported having no relevant financial conflicts.
Few non-ICU patients receive palliative care consults
LOS ANGELES – A significant percentage of patients who meet criteria for palliative care consultations do not receive a consult during their hospital stay, results from a single-center retrospective analysis showed.
“Physicians need to recognize the palliative care needs of patients with chronic illnesses other than malignancy before they get admitted to the ICU, especially when these patients are admitted repeatedly for the same problem [and] have a significant decline in functional status with a large symptom burden,” Mohleen Kang, MD, said in an interview in advance of the annual meeting of the American College of Chest Physicians. “There is a potential missed opportunity for these conversations to occur with the patients and their family prior to their decompensation and crisis.”
Twenty-nine percent (132) of the patients studied met an indication for a palliative care consult (PCC), with only 35 (27%) of such patients having received a PCC. Patients with metastatic cancer were significantly more likely to have received a PCC, compared with non-cancer patients (64% vs. 21%, respectively; P less than .001), while patients with New York Heart Association Class III or IV congestive heart failure were less likely to receive a PCC, compared with those who did not have congestive heart failure (5.6% vs. 29.8%; P = .014).
Criteria for PCC on admission include a life-limiting diagnosis and more than one admission in the past 3 months, decline in function, or complex care requirements. Criteria for PCC during hospitalization include life-limiting diagnosis and uncertainty about decisions, an ICU stay greater than 7 days, or lack of goals of care.
Dr. Kang, chief resident in the department of medicine at New Jersey Medical School, Newark, presented the results, which were of patients admitted to the department of medicine at University Hospital in Newark in 2015. Those admitted to the ICU within 24 hours of admission were excluded from the analysis, leaving 461 patient charts that were screened for PCC needs based on the consensus report from the Center to Advance Palliative Care.
The patients who met an indication for PCC had a mean age of 60 years and an average length of stay of 7 days. The percentages of these patients who were female, African American, and Hispanic were 45%, 40%, and 21%, respectively.
On multivariate analysis, patients who had a PCC within 72 hours of admission were eight times more likely to have a hospital length of stay less than 7 days (P = .019), while those who had a PCC within 48 hours of admission were 20 times more likely to have a hospital length of stay less than 7 days (P = .017). “So if we intervened early, we were able to decrease their length of stay to less than 7 days,” Dr. Kang said at the meeting.
She acknowledged certain limitations of the study, including its small sample size, retrospective design, and lack of follow-up. “This study also has a lot of confounding socioeconomic factors that do not make it applicable to every hospital across the country,” she said. “This is not a homogeneous patient population.”
The study’s principal investigator was Anne Sutherland, MD, medical intensive care unit director at University Hospital. Dr. Kang reported having no financial disclosures.
LOS ANGELES – A significant percentage of patients who meet criteria for palliative care consultations do not receive a consult during their hospital stay, results from a single-center retrospective analysis showed.
“Physicians need to recognize the palliative care needs of patients with chronic illnesses other than malignancy before they get admitted to the ICU, especially when these patients are admitted repeatedly for the same problem [and] have a significant decline in functional status with a large symptom burden,” Mohleen Kang, MD, said in an interview in advance of the annual meeting of the American College of Chest Physicians. “There is a potential missed opportunity for these conversations to occur with the patients and their family prior to their decompensation and crisis.”
Twenty-nine percent (132) of the patients studied met an indication for a palliative care consult (PCC), with only 35 (27%) of such patients having received a PCC. Patients with metastatic cancer were significantly more likely to have received a PCC, compared with non-cancer patients (64% vs. 21%, respectively; P less than .001), while patients with New York Heart Association Class III or IV congestive heart failure were less likely to receive a PCC, compared with those who did not have congestive heart failure (5.6% vs. 29.8%; P = .014).
Criteria for PCC on admission include a life-limiting diagnosis and more than one admission in the past 3 months, decline in function, or complex care requirements. Criteria for PCC during hospitalization include life-limiting diagnosis and uncertainty about decisions, an ICU stay greater than 7 days, or lack of goals of care.
Dr. Kang, chief resident in the department of medicine at New Jersey Medical School, Newark, presented the results, which were of patients admitted to the department of medicine at University Hospital in Newark in 2015. Those admitted to the ICU within 24 hours of admission were excluded from the analysis, leaving 461 patient charts that were screened for PCC needs based on the consensus report from the Center to Advance Palliative Care.
The patients who met an indication for PCC had a mean age of 60 years and an average length of stay of 7 days. The percentages of these patients who were female, African American, and Hispanic were 45%, 40%, and 21%, respectively.
On multivariate analysis, patients who had a PCC within 72 hours of admission were eight times more likely to have a hospital length of stay less than 7 days (P = .019), while those who had a PCC within 48 hours of admission were 20 times more likely to have a hospital length of stay less than 7 days (P = .017). “So if we intervened early, we were able to decrease their length of stay to less than 7 days,” Dr. Kang said at the meeting.
She acknowledged certain limitations of the study, including its small sample size, retrospective design, and lack of follow-up. “This study also has a lot of confounding socioeconomic factors that do not make it applicable to every hospital across the country,” she said. “This is not a homogeneous patient population.”
The study’s principal investigator was Anne Sutherland, MD, medical intensive care unit director at University Hospital. Dr. Kang reported having no financial disclosures.
LOS ANGELES – A significant percentage of patients who meet criteria for palliative care consultations do not receive a consult during their hospital stay, results from a single-center retrospective analysis showed.
“Physicians need to recognize the palliative care needs of patients with chronic illnesses other than malignancy before they get admitted to the ICU, especially when these patients are admitted repeatedly for the same problem [and] have a significant decline in functional status with a large symptom burden,” Mohleen Kang, MD, said in an interview in advance of the annual meeting of the American College of Chest Physicians. “There is a potential missed opportunity for these conversations to occur with the patients and their family prior to their decompensation and crisis.”
Twenty-nine percent (132) of the patients studied met an indication for a palliative care consult (PCC), with only 35 (27%) of such patients having received a PCC. Patients with metastatic cancer were significantly more likely to have received a PCC, compared with non-cancer patients (64% vs. 21%, respectively; P less than .001), while patients with New York Heart Association Class III or IV congestive heart failure were less likely to receive a PCC, compared with those who did not have congestive heart failure (5.6% vs. 29.8%; P = .014).
Criteria for PCC on admission include a life-limiting diagnosis and more than one admission in the past 3 months, decline in function, or complex care requirements. Criteria for PCC during hospitalization include life-limiting diagnosis and uncertainty about decisions, an ICU stay greater than 7 days, or lack of goals of care.
Dr. Kang, chief resident in the department of medicine at New Jersey Medical School, Newark, presented the results, which were of patients admitted to the department of medicine at University Hospital in Newark in 2015. Those admitted to the ICU within 24 hours of admission were excluded from the analysis, leaving 461 patient charts that were screened for PCC needs based on the consensus report from the Center to Advance Palliative Care.
The patients who met an indication for PCC had a mean age of 60 years and an average length of stay of 7 days. The percentages of these patients who were female, African American, and Hispanic were 45%, 40%, and 21%, respectively.
On multivariate analysis, patients who had a PCC within 72 hours of admission were eight times more likely to have a hospital length of stay less than 7 days (P = .019), while those who had a PCC within 48 hours of admission were 20 times more likely to have a hospital length of stay less than 7 days (P = .017). “So if we intervened early, we were able to decrease their length of stay to less than 7 days,” Dr. Kang said at the meeting.
She acknowledged certain limitations of the study, including its small sample size, retrospective design, and lack of follow-up. “This study also has a lot of confounding socioeconomic factors that do not make it applicable to every hospital across the country,” she said. “This is not a homogeneous patient population.”
The study’s principal investigator was Anne Sutherland, MD, medical intensive care unit director at University Hospital. Dr. Kang reported having no financial disclosures.
AT CHEST 2016
Key clinical point:
Major finding: Patients with metastatic cancer were significantly more likely to have received a PCC, compared with non-cancer patients (64% vs. 21%, respectively; P less than .001).
Data source: A retrospective study of 132 patients admitted to the department of medicine at University Hospital in Newark, N.J., in 2015.
Disclosures: Dr. Kang reported having no financial disclosures.
Fluid administration in sepsis did not increase need for dialysis
LOS ANGELES – Fluid administration of at least 1 L did not increase the incidence of acute respiratory or heart failure in severe sepsis, and actually seemed to decrease the need for dialysis in a review of 164 patients at Scott and White Memorial Hospital in Temple, Tex.
For every 1 mL of fluid administered per kilogram of body weight, the likelihood of dialysis decreased by 8.5% (odds ratio, 0.915; 95% confidence interval, 0.854-0.980; P = .0111), with no increase in heart or respiratory failure on univariate analysis. The 126 patients (77%) who received at least 1 L had a 68% reduction in the need for dialysis (OR, 0.32; CI, 0.117-0.890; P = .0288).
“The No. 1 reason we weren’t meeting benchmarks was fluid administration,” explained lead investigator Aruna Jahoor, MD, a pulmonary critical care and sleep medicine fellow at Texas Tech University Health Sciences Center.
Seventeen percent of patients received greater than or equal to 30 mL/kg of fluid resuscitation, while 28% received greater than or equal to 20 mL/kg of intravenous fluid resuscitation. It turned out that staff in the emergency department - where most of the patients were treated in the critical first 6 hours - were concerned about fluid overload and throwing patients into respiratory, heart, or renal failure, Dr. Jahoor said. The team didn’t find a difference in mortality when patients received 30 mL/kg - just over 2 L in a 70-kg patient - versus 20 mL/kg or 1 L. The patients’ in-hospital mortality rate and 28-day mortality rate were 27%, and 32%, respectively.
There also weren’t increased rates of heart failure, acute respiratory failure, or mechanical ventilation when patients received at least 1 L of fluid. “There were [also] lower rates of dialysis, which indicated that we weren’t overloading patients. Even when we looked at fluid as a continuous variable, we still didn’t see” complications, Dr. Jahoor said.
The findings should be reassuring to treating physicians. “When you have pushback against 30-mL/kg administration, you can say ‘well, at least let’s give a liter. You don’t have to worry as much about some of the complications you are citing,’ ” she said.
For very obese patients, “it can get a little uncomfortable to be given” enough fluid to meet the 30-mL/kg goal, “but you can give at least a liter” without having to worry too much, she said. The patients in the study were treated from 2010 to 2013; normal saline was the most common resuscitation fluid. The hospital has since added the 30-mL/kg fluid resuscitation to its sepsis admission orders, and compliance has increased significantly.
A multivariate analysis is in the works to control for confounders. “We will probably [still] see you are not having increased rates of congestive heart or respiratory failure, or needing dialysis,” Dr. Jahoor said. The protective effect against dialysis might drop out, “but I am hoping it doesn’t,” he said.
The investigators had no relevant financial disclosures.
LOS ANGELES – Fluid administration of at least 1 L did not increase the incidence of acute respiratory or heart failure in severe sepsis, and actually seemed to decrease the need for dialysis in a review of 164 patients at Scott and White Memorial Hospital in Temple, Tex.
For every 1 mL of fluid administered per kilogram of body weight, the likelihood of dialysis decreased by 8.5% (odds ratio, 0.915; 95% confidence interval, 0.854-0.980; P = .0111), with no increase in heart or respiratory failure on univariate analysis. The 126 patients (77%) who received at least 1 L had a 68% reduction in the need for dialysis (OR, 0.32; CI, 0.117-0.890; P = .0288).
“The No. 1 reason we weren’t meeting benchmarks was fluid administration,” explained lead investigator Aruna Jahoor, MD, a pulmonary critical care and sleep medicine fellow at Texas Tech University Health Sciences Center.
Seventeen percent of patients received greater than or equal to 30 mL/kg of fluid resuscitation, while 28% received greater than or equal to 20 mL/kg of intravenous fluid resuscitation. It turned out that staff in the emergency department - where most of the patients were treated in the critical first 6 hours - were concerned about fluid overload and throwing patients into respiratory, heart, or renal failure, Dr. Jahoor said. The team didn’t find a difference in mortality when patients received 30 mL/kg - just over 2 L in a 70-kg patient - versus 20 mL/kg or 1 L. The patients’ in-hospital mortality rate and 28-day mortality rate were 27%, and 32%, respectively.
There also weren’t increased rates of heart failure, acute respiratory failure, or mechanical ventilation when patients received at least 1 L of fluid. “There were [also] lower rates of dialysis, which indicated that we weren’t overloading patients. Even when we looked at fluid as a continuous variable, we still didn’t see” complications, Dr. Jahoor said.
The findings should be reassuring to treating physicians. “When you have pushback against 30-mL/kg administration, you can say ‘well, at least let’s give a liter. You don’t have to worry as much about some of the complications you are citing,’ ” she said.
For very obese patients, “it can get a little uncomfortable to be given” enough fluid to meet the 30-mL/kg goal, “but you can give at least a liter” without having to worry too much, she said. The patients in the study were treated from 2010 to 2013; normal saline was the most common resuscitation fluid. The hospital has since added the 30-mL/kg fluid resuscitation to its sepsis admission orders, and compliance has increased significantly.
A multivariate analysis is in the works to control for confounders. “We will probably [still] see you are not having increased rates of congestive heart or respiratory failure, or needing dialysis,” Dr. Jahoor said. The protective effect against dialysis might drop out, “but I am hoping it doesn’t,” he said.
The investigators had no relevant financial disclosures.
LOS ANGELES – Fluid administration of at least 1 L did not increase the incidence of acute respiratory or heart failure in severe sepsis, and actually seemed to decrease the need for dialysis in a review of 164 patients at Scott and White Memorial Hospital in Temple, Tex.
For every 1 mL of fluid administered per kilogram of body weight, the likelihood of dialysis decreased by 8.5% (odds ratio, 0.915; 95% confidence interval, 0.854-0.980; P = .0111), with no increase in heart or respiratory failure on univariate analysis. The 126 patients (77%) who received at least 1 L had a 68% reduction in the need for dialysis (OR, 0.32; CI, 0.117-0.890; P = .0288).
“The No. 1 reason we weren’t meeting benchmarks was fluid administration,” explained lead investigator Aruna Jahoor, MD, a pulmonary critical care and sleep medicine fellow at Texas Tech University Health Sciences Center.
Seventeen percent of patients received greater than or equal to 30 mL/kg of fluid resuscitation, while 28% received greater than or equal to 20 mL/kg of intravenous fluid resuscitation. It turned out that staff in the emergency department - where most of the patients were treated in the critical first 6 hours - were concerned about fluid overload and throwing patients into respiratory, heart, or renal failure, Dr. Jahoor said. The team didn’t find a difference in mortality when patients received 30 mL/kg - just over 2 L in a 70-kg patient - versus 20 mL/kg or 1 L. The patients’ in-hospital mortality rate and 28-day mortality rate were 27%, and 32%, respectively.
There also weren’t increased rates of heart failure, acute respiratory failure, or mechanical ventilation when patients received at least 1 L of fluid. “There were [also] lower rates of dialysis, which indicated that we weren’t overloading patients. Even when we looked at fluid as a continuous variable, we still didn’t see” complications, Dr. Jahoor said.
The findings should be reassuring to treating physicians. “When you have pushback against 30-mL/kg administration, you can say ‘well, at least let’s give a liter. You don’t have to worry as much about some of the complications you are citing,’ ” she said.
For very obese patients, “it can get a little uncomfortable to be given” enough fluid to meet the 30-mL/kg goal, “but you can give at least a liter” without having to worry too much, she said. The patients in the study were treated from 2010 to 2013; normal saline was the most common resuscitation fluid. The hospital has since added the 30-mL/kg fluid resuscitation to its sepsis admission orders, and compliance has increased significantly.
A multivariate analysis is in the works to control for confounders. “We will probably [still] see you are not having increased rates of congestive heart or respiratory failure, or needing dialysis,” Dr. Jahoor said. The protective effect against dialysis might drop out, “but I am hoping it doesn’t,” he said.
The investigators had no relevant financial disclosures.
AT CHEST 2016
Key clinical point:
Major finding: For every 1 mL/kg of fluid administered, the likelihood of dialysis decreased by 8.5% (OR, 0.915; 95% CI, 0.854-0.980; P = .0111), with no increase in heart or respiratory failure on univariate analysis.
Data source: A review of 164 septic patients.
Disclosures: The investigators had no relevant financial disclosures.
Data point to optimal window for endoscopy in sicker patients with peptic ulcer bleeding
The timing of endoscopy may make the difference between life and death in sicker patients with peptic ulcer bleeding, according to an analysis of more than 12,000 patients treated in Denmark.
Patients who were hemodynamically stable but had a higher level of comorbidity were about half as likely to die during their hospital stay if they underwent endoscopy within 12-36 hours of presentation as compared with sooner or later, results showed (Gastrointest Endosc. 2016 Sep 10. doi: 10.1016/j.gie.2016.08.049). And hemodynamically unstable patients had a roughly one-fourth reduction in the odds of death if they underwent the procedure within 6-24 hours.
“Although caution should be applied when interpreting these data, the current recommendation of endoscopy within 0-24 hours may not be optimal for all patients,” wrote the investigators, who were led by Stig B. Laursen, PhD, department of medical gastroenterology, Odense (Denmark) University Hospital.
“Our data may suggest that in patients with major comorbidities, the first few hours of hospital admission might be best used for optimising treatment of comorbidities, which may include correction of severe anaemia, reversal of anticoagulants, and investigation for possible infection that requires rapid treatment with antibiotics,” they elaborate. “Likewise, in patients with hemodynamic instability, endoscopy between 6 and 24 hours from time of admission to hospital allows time for optimal resuscitation and initiating treatment of comorbid diseases before endoscopy. However, these data should not lead to delayed endoscopy in patients with severe hemodynamic instability not responding to intensive resuscitation.”
The investigators analyzed data from 12,601 consecutive patients with peptic ulcer bleeding admitted between January 2005 and September 2013 to Danish hospitals, where all patients had access to 24-hour endoscopy. Time to endoscopy was assessed from hospital admission, defined as arrival in the emergency department, or from symptom onset in patients who developed bleeding when already hospitalized.
For analyses, the patients were stratified by hemodynamic status (a marker for the severity of bleeding) and by American Society of Anesthesiologists score (a marker for the extent of comorbidity).
The timing of endoscopy did not significantly influence in-hospital or 30-day mortality in hemodynamically stable patients with an American Society of Anesthesiologists score of 1-2 as a whole, Dr. Laursen and his colleagues report. Subgroup analyses suggested a reduction of in-hospital mortality when it was done between 0 and 24 hours in those patients whose bleeding began outside the hospital (adjusted odds ratio, 0.48).
In contrast, analyses revealed a U-shaped association between timing and mortality for hemodynamically stable patients with an American Society of Anesthesiologists score of 3-5. For this group, in-hospital mortality was significantly lower when endoscopy was performed within 12-36 hours as compared with times outside this window (adjusted OR, 0.48), and 30-day mortality tended to be lower as well.
Similarly, timing appeared to influence outcome for hemodynamically unstable patients, having both systolic blood pressure below 100 mm Hg and heart rate above 100 beats/min. For this group, performance of endoscopy within 6-24 hours was associated with significantly lower in-hospital mortality (adjusted OR, 0.73) and also 30-day mortality (adjusted OR, 0.66). Patients’ American Society of Anesthesiologists score did not appear to play a role here.
The study’s findings may have been affected by unmeasured and unknown confounders, acknowledge the investigators, who declared that they have no competing interests related to the research.
“Although a well-powered randomized controlled trial represents the best way to account for these problems, randomizing patients with [peptic ulcer bleeding] to early versus late endoscopy will be very difficult, including from an ethical and methodological point of view,” they note.
The timing of endoscopy may make the difference between life and death in sicker patients with peptic ulcer bleeding, according to an analysis of more than 12,000 patients treated in Denmark.
Patients who were hemodynamically stable but had a higher level of comorbidity were about half as likely to die during their hospital stay if they underwent endoscopy within 12-36 hours of presentation as compared with sooner or later, results showed (Gastrointest Endosc. 2016 Sep 10. doi: 10.1016/j.gie.2016.08.049). And hemodynamically unstable patients had a roughly one-fourth reduction in the odds of death if they underwent the procedure within 6-24 hours.
“Although caution should be applied when interpreting these data, the current recommendation of endoscopy within 0-24 hours may not be optimal for all patients,” wrote the investigators, who were led by Stig B. Laursen, PhD, department of medical gastroenterology, Odense (Denmark) University Hospital.
“Our data may suggest that in patients with major comorbidities, the first few hours of hospital admission might be best used for optimising treatment of comorbidities, which may include correction of severe anaemia, reversal of anticoagulants, and investigation for possible infection that requires rapid treatment with antibiotics,” they elaborate. “Likewise, in patients with hemodynamic instability, endoscopy between 6 and 24 hours from time of admission to hospital allows time for optimal resuscitation and initiating treatment of comorbid diseases before endoscopy. However, these data should not lead to delayed endoscopy in patients with severe hemodynamic instability not responding to intensive resuscitation.”
The investigators analyzed data from 12,601 consecutive patients with peptic ulcer bleeding admitted between January 2005 and September 2013 to Danish hospitals, where all patients had access to 24-hour endoscopy. Time to endoscopy was assessed from hospital admission, defined as arrival in the emergency department, or from symptom onset in patients who developed bleeding when already hospitalized.
For analyses, the patients were stratified by hemodynamic status (a marker for the severity of bleeding) and by American Society of Anesthesiologists score (a marker for the extent of comorbidity).
The timing of endoscopy did not significantly influence in-hospital or 30-day mortality in hemodynamically stable patients with an American Society of Anesthesiologists score of 1-2 as a whole, Dr. Laursen and his colleagues report. Subgroup analyses suggested a reduction of in-hospital mortality when it was done between 0 and 24 hours in those patients whose bleeding began outside the hospital (adjusted odds ratio, 0.48).
In contrast, analyses revealed a U-shaped association between timing and mortality for hemodynamically stable patients with an American Society of Anesthesiologists score of 3-5. For this group, in-hospital mortality was significantly lower when endoscopy was performed within 12-36 hours as compared with times outside this window (adjusted OR, 0.48), and 30-day mortality tended to be lower as well.
Similarly, timing appeared to influence outcome for hemodynamically unstable patients, having both systolic blood pressure below 100 mm Hg and heart rate above 100 beats/min. For this group, performance of endoscopy within 6-24 hours was associated with significantly lower in-hospital mortality (adjusted OR, 0.73) and also 30-day mortality (adjusted OR, 0.66). Patients’ American Society of Anesthesiologists score did not appear to play a role here.
The study’s findings may have been affected by unmeasured and unknown confounders, acknowledge the investigators, who declared that they have no competing interests related to the research.
“Although a well-powered randomized controlled trial represents the best way to account for these problems, randomizing patients with [peptic ulcer bleeding] to early versus late endoscopy will be very difficult, including from an ethical and methodological point of view,” they note.
The timing of endoscopy may make the difference between life and death in sicker patients with peptic ulcer bleeding, according to an analysis of more than 12,000 patients treated in Denmark.
Patients who were hemodynamically stable but had a higher level of comorbidity were about half as likely to die during their hospital stay if they underwent endoscopy within 12-36 hours of presentation as compared with sooner or later, results showed (Gastrointest Endosc. 2016 Sep 10. doi: 10.1016/j.gie.2016.08.049). And hemodynamically unstable patients had a roughly one-fourth reduction in the odds of death if they underwent the procedure within 6-24 hours.
“Although caution should be applied when interpreting these data, the current recommendation of endoscopy within 0-24 hours may not be optimal for all patients,” wrote the investigators, who were led by Stig B. Laursen, PhD, department of medical gastroenterology, Odense (Denmark) University Hospital.
“Our data may suggest that in patients with major comorbidities, the first few hours of hospital admission might be best used for optimising treatment of comorbidities, which may include correction of severe anaemia, reversal of anticoagulants, and investigation for possible infection that requires rapid treatment with antibiotics,” they elaborate. “Likewise, in patients with hemodynamic instability, endoscopy between 6 and 24 hours from time of admission to hospital allows time for optimal resuscitation and initiating treatment of comorbid diseases before endoscopy. However, these data should not lead to delayed endoscopy in patients with severe hemodynamic instability not responding to intensive resuscitation.”
The investigators analyzed data from 12,601 consecutive patients with peptic ulcer bleeding admitted between January 2005 and September 2013 to Danish hospitals, where all patients had access to 24-hour endoscopy. Time to endoscopy was assessed from hospital admission, defined as arrival in the emergency department, or from symptom onset in patients who developed bleeding when already hospitalized.
For analyses, the patients were stratified by hemodynamic status (a marker for the severity of bleeding) and by American Society of Anesthesiologists score (a marker for the extent of comorbidity).
The timing of endoscopy did not significantly influence in-hospital or 30-day mortality in hemodynamically stable patients with an American Society of Anesthesiologists score of 1-2 as a whole, Dr. Laursen and his colleagues report. Subgroup analyses suggested a reduction of in-hospital mortality when it was done between 0 and 24 hours in those patients whose bleeding began outside the hospital (adjusted odds ratio, 0.48).
In contrast, analyses revealed a U-shaped association between timing and mortality for hemodynamically stable patients with an American Society of Anesthesiologists score of 3-5. For this group, in-hospital mortality was significantly lower when endoscopy was performed within 12-36 hours as compared with times outside this window (adjusted OR, 0.48), and 30-day mortality tended to be lower as well.
Similarly, timing appeared to influence outcome for hemodynamically unstable patients, having both systolic blood pressure below 100 mm Hg and heart rate above 100 beats/min. For this group, performance of endoscopy within 6-24 hours was associated with significantly lower in-hospital mortality (adjusted OR, 0.73) and also 30-day mortality (adjusted OR, 0.66). Patients’ American Society of Anesthesiologists score did not appear to play a role here.
The study’s findings may have been affected by unmeasured and unknown confounders, acknowledge the investigators, who declared that they have no competing interests related to the research.
“Although a well-powered randomized controlled trial represents the best way to account for these problems, randomizing patients with [peptic ulcer bleeding] to early versus late endoscopy will be very difficult, including from an ethical and methodological point of view,” they note.
Key clinical point:
Major finding: In-hospital mortality was lower when endoscopy was performed within 12-36 hours in hemodynamically stable patients with higher comorbidity (odds ratio, 0.48) and within 6-24 hours in hemodynamically unstable patients (OR, 0.73).
Data source: A nationwide cohort study of 12,601 consecutive patients admitted to Danish hospitals with peptic ulcer bleeding.
Disclosures: The investigators declare that they do not have any competing interests.
Surgical infections, early discharge hike readmissions in extrahepatic cholangiocarcinoma
WASHINGTON – Hospital readmissions are common after resection of extrahepatic cholangiocarcinoma, with about 20% of patients returning in the first 90 days after surgery.
Two factors – surgical site infections and an abbreviated length of stay – both quadrupled the risk of readmission, Michail Mavros, MD, said at the American College of Surgeons Clinical Congress.
“Surgeons are scrutinized over length of stay and, as a result, these fast-track recovery pathways are increasingly important. Readmission rates are being used as a quality metric and performance indicator, and tied to reimbursement. But our data suggest that we should be somewhat cautious in implementing those with this surgery. The patient may look great with good pain control, and be eating and ambulating by day 4 or 5, but it may be premature to discharge at that point, and safer to wait a little longer. The financial penalty for readmission is probably not worth that small bonus we get for early discharge.”
The study comprised 422 patients who underwent resection with curative intent for extrahepatic cholangiocarcinoma. This is a rare tumor with about 5,000 cases presenting each year. Dr. Mavros and his colleagues extracted their data from the U.S. Extrahepatic Cholangiocarcinoma Collaborative. The primary outcomes were 30- and 90-day readmission rates.
The patients’ median age was 67 years. About a third had mild comorbidities with an American Society of Anesthesiologist (ASA) comorbidity class of 1-2. The rest had moderate to severe comorbidities (ASA class 3-4). Hypertension was common (48%); 18% had diabetes.
Tumor location was split almost equally between distal and hilar; the median tumor size was 2.3 cm.
Final margins were positive in 28% and half of the cohort had positive regional lymph nodes.
The procedures were quite varied, and included common bile duct resection (18%); hepatectomy plus common bile duct resection (40%); and Whipple procedure (42%). The median estimated blood loss was 500 cc; 28% of the cohort required transfusion with packed red blood cells and 8% with fresh frozen plasma.
Postoperative complications were common (63%), with half of those being classed as serious. Infectious complications were most common, including superficial (11%), deep (7%), and organ space infections (16%).
Bile leaks occurred in 4% of cases. Reoperations were necessary in 7%. The 30-day mortality was 4.5% and 90-day mortality, 8%.The median length of stay was 8 days but this ranged from 7 to 18 days.
The 30-day readmission rate was 19% and the 90-day readmission rate was 23%. Most readmissions occurred fairly quickly – the median time to readmission was 12 days, with a range of 6-24 days.
The investigators conducted a multivariate analysis to determine independent predictors of readmission. The strongest predictors were any surgical complications (odds ratio, 8.4); organ-space infection (OR, 4.5); and length of stay of 8 days or less (OR, 4.3). Other predictors were advancing age (OR, 1.5 for each 10 years) and having had a liver resection (OR, 2.0).
“It’s clear from these results that avoidance of complications, especially infectious complications, may improve readmission rates dramatically,” Dr. Mavros said. “We would advise caution in implementing any fast-track protocols with these patients, given the finding that early discharge was associated with a higher rate of readmission.”
Dr. Mavros had no financial disclosures.
[email protected]
On Twitter @alz_gal
WASHINGTON – Hospital readmissions are common after resection of extrahepatic cholangiocarcinoma, with about 20% of patients returning in the first 90 days after surgery.
Two factors – surgical site infections and an abbreviated length of stay – both quadrupled the risk of readmission, Michail Mavros, MD, said at the American College of Surgeons Clinical Congress.
“Surgeons are scrutinized over length of stay and, as a result, these fast-track recovery pathways are increasingly important. Readmission rates are being used as a quality metric and performance indicator, and tied to reimbursement. But our data suggest that we should be somewhat cautious in implementing those with this surgery. The patient may look great with good pain control, and be eating and ambulating by day 4 or 5, but it may be premature to discharge at that point, and safer to wait a little longer. The financial penalty for readmission is probably not worth that small bonus we get for early discharge.”
The study comprised 422 patients who underwent resection with curative intent for extrahepatic cholangiocarcinoma. This is a rare tumor with about 5,000 cases presenting each year. Dr. Mavros and his colleagues extracted their data from the U.S. Extrahepatic Cholangiocarcinoma Collaborative. The primary outcomes were 30- and 90-day readmission rates.
The patients’ median age was 67 years. About a third had mild comorbidities with an American Society of Anesthesiologist (ASA) comorbidity class of 1-2. The rest had moderate to severe comorbidities (ASA class 3-4). Hypertension was common (48%); 18% had diabetes.
Tumor location was split almost equally between distal and hilar; the median tumor size was 2.3 cm.
Final margins were positive in 28% and half of the cohort had positive regional lymph nodes.
The procedures were quite varied, and included common bile duct resection (18%); hepatectomy plus common bile duct resection (40%); and Whipple procedure (42%). The median estimated blood loss was 500 cc; 28% of the cohort required transfusion with packed red blood cells and 8% with fresh frozen plasma.
Postoperative complications were common (63%), with half of those being classed as serious. Infectious complications were most common, including superficial (11%), deep (7%), and organ space infections (16%).
Bile leaks occurred in 4% of cases. Reoperations were necessary in 7%. The 30-day mortality was 4.5% and 90-day mortality, 8%.The median length of stay was 8 days but this ranged from 7 to 18 days.
The 30-day readmission rate was 19% and the 90-day readmission rate was 23%. Most readmissions occurred fairly quickly – the median time to readmission was 12 days, with a range of 6-24 days.
The investigators conducted a multivariate analysis to determine independent predictors of readmission. The strongest predictors were any surgical complications (odds ratio, 8.4); organ-space infection (OR, 4.5); and length of stay of 8 days or less (OR, 4.3). Other predictors were advancing age (OR, 1.5 for each 10 years) and having had a liver resection (OR, 2.0).
“It’s clear from these results that avoidance of complications, especially infectious complications, may improve readmission rates dramatically,” Dr. Mavros said. “We would advise caution in implementing any fast-track protocols with these patients, given the finding that early discharge was associated with a higher rate of readmission.”
Dr. Mavros had no financial disclosures.
[email protected]
On Twitter @alz_gal
WASHINGTON – Hospital readmissions are common after resection of extrahepatic cholangiocarcinoma, with about 20% of patients returning in the first 90 days after surgery.
Two factors – surgical site infections and an abbreviated length of stay – both quadrupled the risk of readmission, Michail Mavros, MD, said at the American College of Surgeons Clinical Congress.
“Surgeons are scrutinized over length of stay and, as a result, these fast-track recovery pathways are increasingly important. Readmission rates are being used as a quality metric and performance indicator, and tied to reimbursement. But our data suggest that we should be somewhat cautious in implementing those with this surgery. The patient may look great with good pain control, and be eating and ambulating by day 4 or 5, but it may be premature to discharge at that point, and safer to wait a little longer. The financial penalty for readmission is probably not worth that small bonus we get for early discharge.”
The study comprised 422 patients who underwent resection with curative intent for extrahepatic cholangiocarcinoma. This is a rare tumor with about 5,000 cases presenting each year. Dr. Mavros and his colleagues extracted their data from the U.S. Extrahepatic Cholangiocarcinoma Collaborative. The primary outcomes were 30- and 90-day readmission rates.
The patients’ median age was 67 years. About a third had mild comorbidities with an American Society of Anesthesiologist (ASA) comorbidity class of 1-2. The rest had moderate to severe comorbidities (ASA class 3-4). Hypertension was common (48%); 18% had diabetes.
Tumor location was split almost equally between distal and hilar; the median tumor size was 2.3 cm.
Final margins were positive in 28% and half of the cohort had positive regional lymph nodes.
The procedures were quite varied, and included common bile duct resection (18%); hepatectomy plus common bile duct resection (40%); and Whipple procedure (42%). The median estimated blood loss was 500 cc; 28% of the cohort required transfusion with packed red blood cells and 8% with fresh frozen plasma.
Postoperative complications were common (63%), with half of those being classed as serious. Infectious complications were most common, including superficial (11%), deep (7%), and organ space infections (16%).
Bile leaks occurred in 4% of cases. Reoperations were necessary in 7%. The 30-day mortality was 4.5% and 90-day mortality, 8%.The median length of stay was 8 days but this ranged from 7 to 18 days.
The 30-day readmission rate was 19% and the 90-day readmission rate was 23%. Most readmissions occurred fairly quickly – the median time to readmission was 12 days, with a range of 6-24 days.
The investigators conducted a multivariate analysis to determine independent predictors of readmission. The strongest predictors were any surgical complications (odds ratio, 8.4); organ-space infection (OR, 4.5); and length of stay of 8 days or less (OR, 4.3). Other predictors were advancing age (OR, 1.5 for each 10 years) and having had a liver resection (OR, 2.0).
“It’s clear from these results that avoidance of complications, especially infectious complications, may improve readmission rates dramatically,” Dr. Mavros said. “We would advise caution in implementing any fast-track protocols with these patients, given the finding that early discharge was associated with a higher rate of readmission.”
Dr. Mavros had no financial disclosures.
[email protected]
On Twitter @alz_gal
Key clinical point:
Major finding: Organ space infections and a shorter length of stay both quadrupled the risk of a readmission.
Data source: The database review comprised 422 patients.
Disclosures: Dr. Mavros had no financial disclosures.
VA Treats Patients’ Impatience With Clinical Pharmacists
MADISON, WIS.— Something astonishing has happened in the past year to outpatient treatment at the Veterans Affairs hospital here.
Vets regularly get next-day and even same-day appointments for primary care now, no longer waiting a month or more to see a doctor as many once did.
The reason is they don’t all see doctors. Clinical pharmacists — whose special training permits them to prescribe drugs, order lab tests, make referrals to specialists and do physical examinations — are handling more patients’ chronic care needs. That frees physicians to concentrate on new patients and others with complex needs.
A quarter of primary care appointments at the Madison hospital are now handled by clinical pharmacists since they were integrated in patient care teams in 2015. Several VA hospitals — in El Paso, Texas, and Kansas City, Mo., among them — have followed Madison’s approach and more than 36 others are considering it, according to hospital officials.
“It’s made a tremendous positive impact in improving access,” said Dr. Jean Montgomery, chief of primary care services at the Madison hospital.
That’s critical for the VA, the focus of a national scandal in 2014 after news reports revealed the Phoenix VA hospital had booked primary care appointments months in advance, schedulers falsified wait times to make them look shorter and dozens had died awaiting care. Further investigations uncovered similar problems at other VA facilities. More than two years later, tens of thousands of vets are still waiting a month or two for an appointment, according to the latest data from the VA.
The Obama administration has allowed some veterans to seek care in the private sector if they choose, but VA wait times remain long and more action is needed, theGeneral Accountability Office reported in April.
Expanding clinical pharmacists’ role is a solution.
They receive two more years of education than regular pharmacists and they can handle many primary care needs for patients, particularly after physicians have diagnosed their conditions.
The VA has had them for more than 20 years, but their growing involvement in patient care is more recent. This year it employs 3,185 clinical pharmacists with authority to prescribe medications, order lab tests and perform physical assessments — nearly a 50 percent increase since 2011.
“It’s having a significant impact on reducing wait times and our office is trying to expand more of them nationally to increase access,” said Heather Ourth, national clinical program manager for VA Pharmacy Benefits Management Services.
In 2015, VA clinical pharmacists wrote 1.9 million prescriptions for chronic diseases, according to a report co-authored by Ourth and published in September in the American Journal of Health-System Pharmacy.
A goal is to increase the use of clinical pharmacists to help patients with mental health needs and pain management.
“This helps open up appointment slots for physicians to meet patients with acute care needs,” Ourth said.
Clinical pharmacists’ authority is determined at each VA hospital based on their training and knowledge.
The Madison VA allowed clinical pharmacists to take over management of patients with chronic diseases such as diabetes and high blood pressure, participate in weekly meetings with doctors and other members of patients’ care teams and handle patients’ calls about medications.
They typically see five patients in their office each day, usually for 30 minutes each, and they talk to another 10 by telephone, said Ellina Seckel, the clinical pharmacist who led the changes at the hospital.
Many issues involve adjusting medication dosages such as insulin, which do not require a face-to-face visit. When Seckel sees patients, she often helps them lower the number of drugs they take because they may cause unnecessary complications.
Expanding clinical pharmacists’ role in primary care has cut readmission rates and helped more patients keep their diabetes under control, Seckel said.
VA hospital officials in both Madison and El Paso said they faced challenges initially in persuading doctors to delegate some duties to qualified pharmacists.
“Some physicians feel like it’s a turf war and don’t want to refer their patients because they feel the clinical pharmacist is trying to practice medicine,” said Lanre’ Obisesan, a clinical pharmacist and assistant chief of pharmacy at the El Paso VA.
Even so, the El Paso VA’s average wait time fell from two months to two weeks, he said, after it added several clinical pharmacists and gave them independence to help patients. About 30 percent of the VA patients in El Paso have used clinical pharmacists, Obisesan said.
That share will rise. The hospital now has one clinical pharmacist for every six physicians, but it aims to add more pharmacists to reduce the ratio to 1 to 3.
The Madison VA is close to that ratio now after adding four clinical pharmacist positions in the past year.
Patients there can choose whether to see a doctor or a pharmacist. With approval from primary care physicians, pharmacists took over 27 percent of the follow-up appointments for patients with chronic illnesses, Seckel said.
That shift yields benefits for both doctors and patients, said Montgomery, the head of primary care services at the Madison VA.
Many VA doctors only have time to deal with patients’ acute care issues, such as knee or back pain, with little time to focus on a patient’s multiple chronic illnesses and often a dozen or more medications they may be taking for them.
“The more we can have members of the team to do routine things that do not require a physician’s time the better the quality of the visit and the better patient outcomes,” he said.
Patients seem to like what the hospital is doing.
Stephen Howard Foster saw a clinical pharmacist recently who told him he could stop taking one heartburn medication and switched him to another medicine to reduce side effects. He said he was comfortable with the pharmacist advising him without first consulting his physician and he saved time.
“This is a good idea rather than put up with normal delays,” said Foster, 51.
Another Madison VA patient, Mike Fonger, 71, saw clinical pharmacist Anita Kashyap recently to get a blood pressure check, lab test results, a review of his medications and to change an ointment he was taking for back and shoulder pain. Kashyap also helped him ease the side effects from the cholesterol-lowering drug he takes by cutting his dosage in half.
“I like the extra attention I get here,” Fonger said.
This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.
MADISON, WIS.— Something astonishing has happened in the past year to outpatient treatment at the Veterans Affairs hospital here.
Vets regularly get next-day and even same-day appointments for primary care now, no longer waiting a month or more to see a doctor as many once did.
The reason is they don’t all see doctors. Clinical pharmacists — whose special training permits them to prescribe drugs, order lab tests, make referrals to specialists and do physical examinations — are handling more patients’ chronic care needs. That frees physicians to concentrate on new patients and others with complex needs.
A quarter of primary care appointments at the Madison hospital are now handled by clinical pharmacists since they were integrated in patient care teams in 2015. Several VA hospitals — in El Paso, Texas, and Kansas City, Mo., among them — have followed Madison’s approach and more than 36 others are considering it, according to hospital officials.
“It’s made a tremendous positive impact in improving access,” said Dr. Jean Montgomery, chief of primary care services at the Madison hospital.
That’s critical for the VA, the focus of a national scandal in 2014 after news reports revealed the Phoenix VA hospital had booked primary care appointments months in advance, schedulers falsified wait times to make them look shorter and dozens had died awaiting care. Further investigations uncovered similar problems at other VA facilities. More than two years later, tens of thousands of vets are still waiting a month or two for an appointment, according to the latest data from the VA.
The Obama administration has allowed some veterans to seek care in the private sector if they choose, but VA wait times remain long and more action is needed, theGeneral Accountability Office reported in April.
Expanding clinical pharmacists’ role is a solution.
They receive two more years of education than regular pharmacists and they can handle many primary care needs for patients, particularly after physicians have diagnosed their conditions.
The VA has had them for more than 20 years, but their growing involvement in patient care is more recent. This year it employs 3,185 clinical pharmacists with authority to prescribe medications, order lab tests and perform physical assessments — nearly a 50 percent increase since 2011.
“It’s having a significant impact on reducing wait times and our office is trying to expand more of them nationally to increase access,” said Heather Ourth, national clinical program manager for VA Pharmacy Benefits Management Services.
In 2015, VA clinical pharmacists wrote 1.9 million prescriptions for chronic diseases, according to a report co-authored by Ourth and published in September in the American Journal of Health-System Pharmacy.
A goal is to increase the use of clinical pharmacists to help patients with mental health needs and pain management.
“This helps open up appointment slots for physicians to meet patients with acute care needs,” Ourth said.
Clinical pharmacists’ authority is determined at each VA hospital based on their training and knowledge.
The Madison VA allowed clinical pharmacists to take over management of patients with chronic diseases such as diabetes and high blood pressure, participate in weekly meetings with doctors and other members of patients’ care teams and handle patients’ calls about medications.
They typically see five patients in their office each day, usually for 30 minutes each, and they talk to another 10 by telephone, said Ellina Seckel, the clinical pharmacist who led the changes at the hospital.
Many issues involve adjusting medication dosages such as insulin, which do not require a face-to-face visit. When Seckel sees patients, she often helps them lower the number of drugs they take because they may cause unnecessary complications.
Expanding clinical pharmacists’ role in primary care has cut readmission rates and helped more patients keep their diabetes under control, Seckel said.
VA hospital officials in both Madison and El Paso said they faced challenges initially in persuading doctors to delegate some duties to qualified pharmacists.
“Some physicians feel like it’s a turf war and don’t want to refer their patients because they feel the clinical pharmacist is trying to practice medicine,” said Lanre’ Obisesan, a clinical pharmacist and assistant chief of pharmacy at the El Paso VA.
Even so, the El Paso VA’s average wait time fell from two months to two weeks, he said, after it added several clinical pharmacists and gave them independence to help patients. About 30 percent of the VA patients in El Paso have used clinical pharmacists, Obisesan said.
That share will rise. The hospital now has one clinical pharmacist for every six physicians, but it aims to add more pharmacists to reduce the ratio to 1 to 3.
The Madison VA is close to that ratio now after adding four clinical pharmacist positions in the past year.
Patients there can choose whether to see a doctor or a pharmacist. With approval from primary care physicians, pharmacists took over 27 percent of the follow-up appointments for patients with chronic illnesses, Seckel said.
That shift yields benefits for both doctors and patients, said Montgomery, the head of primary care services at the Madison VA.
Many VA doctors only have time to deal with patients’ acute care issues, such as knee or back pain, with little time to focus on a patient’s multiple chronic illnesses and often a dozen or more medications they may be taking for them.
“The more we can have members of the team to do routine things that do not require a physician’s time the better the quality of the visit and the better patient outcomes,” he said.
Patients seem to like what the hospital is doing.
Stephen Howard Foster saw a clinical pharmacist recently who told him he could stop taking one heartburn medication and switched him to another medicine to reduce side effects. He said he was comfortable with the pharmacist advising him without first consulting his physician and he saved time.
“This is a good idea rather than put up with normal delays,” said Foster, 51.
Another Madison VA patient, Mike Fonger, 71, saw clinical pharmacist Anita Kashyap recently to get a blood pressure check, lab test results, a review of his medications and to change an ointment he was taking for back and shoulder pain. Kashyap also helped him ease the side effects from the cholesterol-lowering drug he takes by cutting his dosage in half.
“I like the extra attention I get here,” Fonger said.
This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.
MADISON, WIS.— Something astonishing has happened in the past year to outpatient treatment at the Veterans Affairs hospital here.
Vets regularly get next-day and even same-day appointments for primary care now, no longer waiting a month or more to see a doctor as many once did.
The reason is they don’t all see doctors. Clinical pharmacists — whose special training permits them to prescribe drugs, order lab tests, make referrals to specialists and do physical examinations — are handling more patients’ chronic care needs. That frees physicians to concentrate on new patients and others with complex needs.
A quarter of primary care appointments at the Madison hospital are now handled by clinical pharmacists since they were integrated in patient care teams in 2015. Several VA hospitals — in El Paso, Texas, and Kansas City, Mo., among them — have followed Madison’s approach and more than 36 others are considering it, according to hospital officials.
“It’s made a tremendous positive impact in improving access,” said Dr. Jean Montgomery, chief of primary care services at the Madison hospital.
That’s critical for the VA, the focus of a national scandal in 2014 after news reports revealed the Phoenix VA hospital had booked primary care appointments months in advance, schedulers falsified wait times to make them look shorter and dozens had died awaiting care. Further investigations uncovered similar problems at other VA facilities. More than two years later, tens of thousands of vets are still waiting a month or two for an appointment, according to the latest data from the VA.
The Obama administration has allowed some veterans to seek care in the private sector if they choose, but VA wait times remain long and more action is needed, theGeneral Accountability Office reported in April.
Expanding clinical pharmacists’ role is a solution.
They receive two more years of education than regular pharmacists and they can handle many primary care needs for patients, particularly after physicians have diagnosed their conditions.
The VA has had them for more than 20 years, but their growing involvement in patient care is more recent. This year it employs 3,185 clinical pharmacists with authority to prescribe medications, order lab tests and perform physical assessments — nearly a 50 percent increase since 2011.
“It’s having a significant impact on reducing wait times and our office is trying to expand more of them nationally to increase access,” said Heather Ourth, national clinical program manager for VA Pharmacy Benefits Management Services.
In 2015, VA clinical pharmacists wrote 1.9 million prescriptions for chronic diseases, according to a report co-authored by Ourth and published in September in the American Journal of Health-System Pharmacy.
A goal is to increase the use of clinical pharmacists to help patients with mental health needs and pain management.
“This helps open up appointment slots for physicians to meet patients with acute care needs,” Ourth said.
Clinical pharmacists’ authority is determined at each VA hospital based on their training and knowledge.
The Madison VA allowed clinical pharmacists to take over management of patients with chronic diseases such as diabetes and high blood pressure, participate in weekly meetings with doctors and other members of patients’ care teams and handle patients’ calls about medications.
They typically see five patients in their office each day, usually for 30 minutes each, and they talk to another 10 by telephone, said Ellina Seckel, the clinical pharmacist who led the changes at the hospital.
Many issues involve adjusting medication dosages such as insulin, which do not require a face-to-face visit. When Seckel sees patients, she often helps them lower the number of drugs they take because they may cause unnecessary complications.
Expanding clinical pharmacists’ role in primary care has cut readmission rates and helped more patients keep their diabetes under control, Seckel said.
VA hospital officials in both Madison and El Paso said they faced challenges initially in persuading doctors to delegate some duties to qualified pharmacists.
“Some physicians feel like it’s a turf war and don’t want to refer their patients because they feel the clinical pharmacist is trying to practice medicine,” said Lanre’ Obisesan, a clinical pharmacist and assistant chief of pharmacy at the El Paso VA.
Even so, the El Paso VA’s average wait time fell from two months to two weeks, he said, after it added several clinical pharmacists and gave them independence to help patients. About 30 percent of the VA patients in El Paso have used clinical pharmacists, Obisesan said.
That share will rise. The hospital now has one clinical pharmacist for every six physicians, but it aims to add more pharmacists to reduce the ratio to 1 to 3.
The Madison VA is close to that ratio now after adding four clinical pharmacist positions in the past year.
Patients there can choose whether to see a doctor or a pharmacist. With approval from primary care physicians, pharmacists took over 27 percent of the follow-up appointments for patients with chronic illnesses, Seckel said.
That shift yields benefits for both doctors and patients, said Montgomery, the head of primary care services at the Madison VA.
Many VA doctors only have time to deal with patients’ acute care issues, such as knee or back pain, with little time to focus on a patient’s multiple chronic illnesses and often a dozen or more medications they may be taking for them.
“The more we can have members of the team to do routine things that do not require a physician’s time the better the quality of the visit and the better patient outcomes,” he said.
Patients seem to like what the hospital is doing.
Stephen Howard Foster saw a clinical pharmacist recently who told him he could stop taking one heartburn medication and switched him to another medicine to reduce side effects. He said he was comfortable with the pharmacist advising him without first consulting his physician and he saved time.
“This is a good idea rather than put up with normal delays,” said Foster, 51.
Another Madison VA patient, Mike Fonger, 71, saw clinical pharmacist Anita Kashyap recently to get a blood pressure check, lab test results, a review of his medications and to change an ointment he was taking for back and shoulder pain. Kashyap also helped him ease the side effects from the cholesterol-lowering drug he takes by cutting his dosage in half.
“I like the extra attention I get here,” Fonger said.
This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.