IMPACT study: Matched targeted therapy improves survival in advanced cancer

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Matched targeted therapy improved long-term survival in patients with advanced cancer, according to findings from a retrospective analysis of molecularly profiled patients.

Of 3,743 patients tested as part of IMPACT (Initiative for Molecular Profiling and Advanced Cancer Therapy), 1,307 (34.9%) had at least one targetable molecular alteration. Of those, 711 (54.4%) received either matched targeted therapy that was being tested in a clinical trial or – in a small number of cases – therapy with an approved treatment used off label, and 596 (45.6%) received nonmatched therapy, Apostolia-Maria Tsimberidou, MD, reported during a press briefing at the annual meeting of the American Society of Clinical Oncology.

The objective response rates in 697 evaluable matched therapy patients was 16.2% versus 5.4% in 571 evaluable nonmatched patients, and stable disease for at least 6 months occurred in 18.7% and 14.7% of patients, respectively, for an overall disease control rate of 34.9% versus 20.1%, said Dr. Tsimberidou, a professor at the University of Texas MD Anderson Cancer Center, Houston.

Median progression-free survival in those who received matched versus nonmatched therapy was 4.0 months and 2.8 months, respectively (hazard ratio, 0.67), and median overall survival was 9.3 and 7.3 months, respectively (HR, 0.72), she said.

The 3-year overall survival rate was 15% versus 7%, respectively, and 10-year survival was 6% and 1%, respectively.

Patients included in IMPACT had a mean age of 57 years, and 39% were men. They were heavily pretreated (mean number of prior therapies was 4); only 2.8% of patients had no prior treatment. Cancers included gastrointestinal (24.2%), gynecologic (19.4%), breast (13.5%), melanoma (11.9%) and lung (8.7%).

In this video interview, Dr. Tsimberidou describes the rationale, methodology, and findings of IMPACT, including the use of a prognostic scoring system developed as part of the study to predict overall survival based on baseline characteristics, such as baseline p13K/AKT/mTOR pathway molecular alterations, which were shown on multivariate analysis in IMPACT to predict shorter overall survival versus other alterations. Other predictors of shorter survival included liver metastases, elevated lactate dehydrogenase levels, poor functional status, low albumin levels, elevated platelet counts, and age of 60 years or older.

 

 


“We [also] wanted to see if adding the intervention ... would hold significance in this multivariate model, and we found that ... nonmatched therapy was associated with adverse survival; it was an independent factor associated with worse survival,” she said. “Therefore, matched targeted therapy is associated with longer survival.”

In the randomized, phase 2 trial IMPACT 2, progression-free survival will be compared in patients with and without matched targeted therapy, and the prognostic scoring system developed as part of IMPACT to predict overall survival based on baseline characteristics will be further evaluated, she said.

During a discussion of the findings during the press briefing, ASCO Expert Catherine M. Diefenbach, MD, said the type of precision medicine studied in IMPACT is “the wave of the future.

“Large scale efforts such as ASCO’s TAPUR or the NCI-MATCH trial will bring these efforts to many, many more patients, and hopefully usher in a new way of treating advanced cancer patients that will improve overall survival for many more patients,” said Dr. Diefenbach, of New York University.

Dr. Tsimberidou reported a consulting or advisory role with Roche, as well as research funding to her institution from EMD Serono, Baxter, Foundation Medicine, ONYX, Bayer, Boston Biomedical, Placon, IMMATICS, Karus Therapeutics, and StemCells.

SOURCE: Tsimberidou AM et al. ASCO 2018, Abstract LBA 2553.

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Matched targeted therapy improved long-term survival in patients with advanced cancer, according to findings from a retrospective analysis of molecularly profiled patients.

Of 3,743 patients tested as part of IMPACT (Initiative for Molecular Profiling and Advanced Cancer Therapy), 1,307 (34.9%) had at least one targetable molecular alteration. Of those, 711 (54.4%) received either matched targeted therapy that was being tested in a clinical trial or – in a small number of cases – therapy with an approved treatment used off label, and 596 (45.6%) received nonmatched therapy, Apostolia-Maria Tsimberidou, MD, reported during a press briefing at the annual meeting of the American Society of Clinical Oncology.

The objective response rates in 697 evaluable matched therapy patients was 16.2% versus 5.4% in 571 evaluable nonmatched patients, and stable disease for at least 6 months occurred in 18.7% and 14.7% of patients, respectively, for an overall disease control rate of 34.9% versus 20.1%, said Dr. Tsimberidou, a professor at the University of Texas MD Anderson Cancer Center, Houston.

Median progression-free survival in those who received matched versus nonmatched therapy was 4.0 months and 2.8 months, respectively (hazard ratio, 0.67), and median overall survival was 9.3 and 7.3 months, respectively (HR, 0.72), she said.

The 3-year overall survival rate was 15% versus 7%, respectively, and 10-year survival was 6% and 1%, respectively.

Patients included in IMPACT had a mean age of 57 years, and 39% were men. They were heavily pretreated (mean number of prior therapies was 4); only 2.8% of patients had no prior treatment. Cancers included gastrointestinal (24.2%), gynecologic (19.4%), breast (13.5%), melanoma (11.9%) and lung (8.7%).

In this video interview, Dr. Tsimberidou describes the rationale, methodology, and findings of IMPACT, including the use of a prognostic scoring system developed as part of the study to predict overall survival based on baseline characteristics, such as baseline p13K/AKT/mTOR pathway molecular alterations, which were shown on multivariate analysis in IMPACT to predict shorter overall survival versus other alterations. Other predictors of shorter survival included liver metastases, elevated lactate dehydrogenase levels, poor functional status, low albumin levels, elevated platelet counts, and age of 60 years or older.

 

 


“We [also] wanted to see if adding the intervention ... would hold significance in this multivariate model, and we found that ... nonmatched therapy was associated with adverse survival; it was an independent factor associated with worse survival,” she said. “Therefore, matched targeted therapy is associated with longer survival.”

In the randomized, phase 2 trial IMPACT 2, progression-free survival will be compared in patients with and without matched targeted therapy, and the prognostic scoring system developed as part of IMPACT to predict overall survival based on baseline characteristics will be further evaluated, she said.

During a discussion of the findings during the press briefing, ASCO Expert Catherine M. Diefenbach, MD, said the type of precision medicine studied in IMPACT is “the wave of the future.

“Large scale efforts such as ASCO’s TAPUR or the NCI-MATCH trial will bring these efforts to many, many more patients, and hopefully usher in a new way of treating advanced cancer patients that will improve overall survival for many more patients,” said Dr. Diefenbach, of New York University.

Dr. Tsimberidou reported a consulting or advisory role with Roche, as well as research funding to her institution from EMD Serono, Baxter, Foundation Medicine, ONYX, Bayer, Boston Biomedical, Placon, IMMATICS, Karus Therapeutics, and StemCells.

SOURCE: Tsimberidou AM et al. ASCO 2018, Abstract LBA 2553.

 

Matched targeted therapy improved long-term survival in patients with advanced cancer, according to findings from a retrospective analysis of molecularly profiled patients.

Of 3,743 patients tested as part of IMPACT (Initiative for Molecular Profiling and Advanced Cancer Therapy), 1,307 (34.9%) had at least one targetable molecular alteration. Of those, 711 (54.4%) received either matched targeted therapy that was being tested in a clinical trial or – in a small number of cases – therapy with an approved treatment used off label, and 596 (45.6%) received nonmatched therapy, Apostolia-Maria Tsimberidou, MD, reported during a press briefing at the annual meeting of the American Society of Clinical Oncology.

The objective response rates in 697 evaluable matched therapy patients was 16.2% versus 5.4% in 571 evaluable nonmatched patients, and stable disease for at least 6 months occurred in 18.7% and 14.7% of patients, respectively, for an overall disease control rate of 34.9% versus 20.1%, said Dr. Tsimberidou, a professor at the University of Texas MD Anderson Cancer Center, Houston.

Median progression-free survival in those who received matched versus nonmatched therapy was 4.0 months and 2.8 months, respectively (hazard ratio, 0.67), and median overall survival was 9.3 and 7.3 months, respectively (HR, 0.72), she said.

The 3-year overall survival rate was 15% versus 7%, respectively, and 10-year survival was 6% and 1%, respectively.

Patients included in IMPACT had a mean age of 57 years, and 39% were men. They were heavily pretreated (mean number of prior therapies was 4); only 2.8% of patients had no prior treatment. Cancers included gastrointestinal (24.2%), gynecologic (19.4%), breast (13.5%), melanoma (11.9%) and lung (8.7%).

In this video interview, Dr. Tsimberidou describes the rationale, methodology, and findings of IMPACT, including the use of a prognostic scoring system developed as part of the study to predict overall survival based on baseline characteristics, such as baseline p13K/AKT/mTOR pathway molecular alterations, which were shown on multivariate analysis in IMPACT to predict shorter overall survival versus other alterations. Other predictors of shorter survival included liver metastases, elevated lactate dehydrogenase levels, poor functional status, low albumin levels, elevated platelet counts, and age of 60 years or older.

 

 


“We [also] wanted to see if adding the intervention ... would hold significance in this multivariate model, and we found that ... nonmatched therapy was associated with adverse survival; it was an independent factor associated with worse survival,” she said. “Therefore, matched targeted therapy is associated with longer survival.”

In the randomized, phase 2 trial IMPACT 2, progression-free survival will be compared in patients with and without matched targeted therapy, and the prognostic scoring system developed as part of IMPACT to predict overall survival based on baseline characteristics will be further evaluated, she said.

During a discussion of the findings during the press briefing, ASCO Expert Catherine M. Diefenbach, MD, said the type of precision medicine studied in IMPACT is “the wave of the future.

“Large scale efforts such as ASCO’s TAPUR or the NCI-MATCH trial will bring these efforts to many, many more patients, and hopefully usher in a new way of treating advanced cancer patients that will improve overall survival for many more patients,” said Dr. Diefenbach, of New York University.

Dr. Tsimberidou reported a consulting or advisory role with Roche, as well as research funding to her institution from EMD Serono, Baxter, Foundation Medicine, ONYX, Bayer, Boston Biomedical, Placon, IMMATICS, Karus Therapeutics, and StemCells.

SOURCE: Tsimberidou AM et al. ASCO 2018, Abstract LBA 2553.

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Key clinical point: Matched targeted therapy improved survival in patients with advanced cancer.

Major finding: The 3-yearoverall survival rate with matched versus nonmatched therapy was 15% and 7%, respectively.

Study details: A retrospective analysis (IMPACT) of 3,743 molecularly profiled advanced cancer patients.

Disclosures: Dr. Tsimberidou reported a consulting or advisory role with Roche, as well as research funding to her institution from EMD Serono, Baxter, Foundation Medicine, ONYX Medical, Bayer, Boston Biomedical, Placon, IMMATICS, Karus Therapeutics, and StemCells.

Source: Tsimberidou AM et al. ASCO 2018, Abstract LBA 2553.

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Frontline immunotherapy boosts survival in NSCLC patients

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CHICAGO – Pembrolizumab (Keytruda) as first-line treatment of advanced non–small-cell lung cancer (NSCLC) offered longer overall survival with better tolerability compared with chemotherapy, results of the Keynote-042 phase 3 randomized trial show.

Among 1,274 patients with advanced, previously untreated NSCLC with expression of the PD-L1 on 1% or more of tumor cells, median overall survival after a median follow-up of 12.8 months was 16.7 months for patients treated with pembrolizumab monotherapy, compared with 12.1 months for patients treated with either paclitaxel or pemetrexed plus carboplatin, reported lead author Gilberto Lopes, MD, of the Sylvester Comprehensive Cancer Center at the University of Miami.

Neil Osterweil/MDedge News
Dr. Gilberto Lopes
The survival benefit for immunotherapy was even greater for patients with higher levels of PD-L1 expression: 20 vs. 12.2 months for patients with PD-L1 expression of 50% or greater, and 17.7 vs. 13 months for patients with PD-L1 expression of 20% or greater, Dr. Lopes noted at the annual meeting of the American Society of Clinical Oncology.

For all three PD-L1 expression groups, the median duration of response was 20.2 months, compared with 10.8-8.3 months for patients in the chemotherapy arm.

“These are responses that are unlike anything that we have seen with chemotherapy in the past for non–small-cell lung cancer,” Dr. Lopes said at a briefing prior to his presentation of the data in a plenary session.

“In addition to that, and probably more importantly, patients had fewer adverse events [with pembrolizumab]. Overall, about 60% had any treatment-related adverse event with pembrolizumab, vs. 90% with chemotherapy,” he added.
 

‘A true milestone’

ASCO expert John Heymach, MD, PhD, of the University of Texas MD Anderson Cancer Center in Houston, said at the briefing that “this study represents a true milestone for the field, because now, for the first time, we can say that among non–small-cell lung cancer patients receiving first-line therapy, the vast majority can receive immunotherapy with pembrolizumab instead of chemotherapy.”

 

 

He noted that an earlier study, Keynote-024, showed that pembrolizumab significantly improved progression-free survival in patients with tumors expressing PD-L1 on at least 50% of cells compared with standard platinum-based chemotherapy (10.3 vs. 6 months).

Neil Osterweil/MDedge News
Dr. John Heymach
“This now more than doubles that population that can start immunotherapy as a first-line treatment, assuming the [Food and Drug Administration] modifies the label in accordance with this study,” he added.

The Keynote-042 investigators enrolled 1,274 patients with locally advanced or metastatic NSCLC, and randomly assigned them to receive either a maximum of 35 cycles of pembrolizumab 200 mg every 3 weeks, or the investigators’ choice of not more than 6 cycles of either paclitaxel/carboplatin or pemetrexed/carboplatin, with optional pemetrexed maintenance for patients with nonsquamous histologies only.

The randomization was stratified by region (Asia vs. non–East Asia), Eastern Cooperative Oncology Group performance status 0 or 1, squamous vs. nonsquamous histology, and PD-L1 expression, or TPS (tumor proportion score) greater than 50% vs. 1%-49%.

 

 


As noted before, the primary endpoint of overall survival among all patients with a TPS of 1% or greater was met, with respective median overall survival in the pembrolizumab vs. chemotherapy groups of 16.7 vs. 12.1 months, translating into a hazard ratio favoring pembrolizumab of 0.81 (P = .0018). Respective hazard ratios for the TPS 20% or greater and TPS 50% or greater groups were 0.77 (P = .0020), and 0.69 (P = .0003).

At 12.8 months of median follow-up, 13% of patients assigned to pembrolizumab were still on the drug, and 4.3% of patients were receiving maintenance pemetrexed.

Treatment-related adverse events of any grade occurred in 399 of 636 patients assigned to pembrolizumab (62.7%), vs. 553 of 615 patients assigned to chemotherapy (89.9%).

Grade 3 or greater events occurred in 17.8% vs. 41% of patients, respectively, There were 13 deaths related to therapy in the pembrolizumab arm (2.0%), and 14 in the chemotherapy arm (2.3%).

 

 


Adverse events leading to discontinuation were similar between the groups, at 9% and 9.4%, respectively.

There were more immune-mediated adverse events in the pembrolizumab arm (27.8% vs. 7.2%), and of these, grade 3 or greater events occurred in 8% vs. 1.5% of patients, respectively.

There was one immune-mediated death, from pneumonitis, in the immunotherapy arm; there were no deaths related to immune-mediated side effects in the chemotherapy arm.

“I really view this as a ‘double whammy’ for patients,” Dr. Heymach said at the briefing. “Often advances in survival for our lung cancer patients come at the cost of significant toxicities. Here, by contrast, not only are patients living longer and having a much higher likelihood of prolonged survival in years, often instead of months, but they’re also receiving a treatment that has substantially less toxicity across virtually all measures, and this really impacts the day-to-day life of these patients.”

 

 


Leena Gandhi, MD, PhD, of the Perlmutter Cancer Center at New York University, the invited discussant at the plenary, agreed that pembrolizumab improves survival, compared with chemotherapy patients with PD-L1 expression levels greater than 1%, but noted that most of the benefit – as also seen in Keynote-024 – was in those patients whose tumors had high levels of PD-L1 expression.

She emphasized that although PD-L1 is an imperfect biomarker, it should still be used to help select patients for therapy, and may be complementary with tumor mutational burden for more precise treatment selection.

“What we know, and what this study adds to, is that PD-L1 really does define a patient population that could receive benefit from pembrolizumab over chemotherapy. Patients with low or no PD-L1 expression likely should get some type of combination therapy,” she said.

“I do think this study extends what we’ve seen from other recent studies, which is that chemotherapy alone is no longer a first-line standard of care in non–small-cell lung cancer,” she added.

 

 


Merck funded the study. Dr. Lopes disclosed institutional research funding from Merck Sharp & Dohme, EMD Serono, and AstraZeneca. Dr. Heymach disclosed stock/ownership in Bio-Tree and Cardinal Spine, a consulting or advisory role for Abbvie, ARIAD, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Calithera Biosciences, Genentech, Medivation, Novartis, Oncomed, and Synta, and institutional research funding from AstraZeneca. Dr. Gandhi reported having no relevant disclosures.

SOURCE: Lobes G et al. ASCO 2018, abstract LBA4.

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CHICAGO – Pembrolizumab (Keytruda) as first-line treatment of advanced non–small-cell lung cancer (NSCLC) offered longer overall survival with better tolerability compared with chemotherapy, results of the Keynote-042 phase 3 randomized trial show.

Among 1,274 patients with advanced, previously untreated NSCLC with expression of the PD-L1 on 1% or more of tumor cells, median overall survival after a median follow-up of 12.8 months was 16.7 months for patients treated with pembrolizumab monotherapy, compared with 12.1 months for patients treated with either paclitaxel or pemetrexed plus carboplatin, reported lead author Gilberto Lopes, MD, of the Sylvester Comprehensive Cancer Center at the University of Miami.

Neil Osterweil/MDedge News
Dr. Gilberto Lopes
The survival benefit for immunotherapy was even greater for patients with higher levels of PD-L1 expression: 20 vs. 12.2 months for patients with PD-L1 expression of 50% or greater, and 17.7 vs. 13 months for patients with PD-L1 expression of 20% or greater, Dr. Lopes noted at the annual meeting of the American Society of Clinical Oncology.

For all three PD-L1 expression groups, the median duration of response was 20.2 months, compared with 10.8-8.3 months for patients in the chemotherapy arm.

“These are responses that are unlike anything that we have seen with chemotherapy in the past for non–small-cell lung cancer,” Dr. Lopes said at a briefing prior to his presentation of the data in a plenary session.

“In addition to that, and probably more importantly, patients had fewer adverse events [with pembrolizumab]. Overall, about 60% had any treatment-related adverse event with pembrolizumab, vs. 90% with chemotherapy,” he added.
 

‘A true milestone’

ASCO expert John Heymach, MD, PhD, of the University of Texas MD Anderson Cancer Center in Houston, said at the briefing that “this study represents a true milestone for the field, because now, for the first time, we can say that among non–small-cell lung cancer patients receiving first-line therapy, the vast majority can receive immunotherapy with pembrolizumab instead of chemotherapy.”

 

 

He noted that an earlier study, Keynote-024, showed that pembrolizumab significantly improved progression-free survival in patients with tumors expressing PD-L1 on at least 50% of cells compared with standard platinum-based chemotherapy (10.3 vs. 6 months).

Neil Osterweil/MDedge News
Dr. John Heymach
“This now more than doubles that population that can start immunotherapy as a first-line treatment, assuming the [Food and Drug Administration] modifies the label in accordance with this study,” he added.

The Keynote-042 investigators enrolled 1,274 patients with locally advanced or metastatic NSCLC, and randomly assigned them to receive either a maximum of 35 cycles of pembrolizumab 200 mg every 3 weeks, or the investigators’ choice of not more than 6 cycles of either paclitaxel/carboplatin or pemetrexed/carboplatin, with optional pemetrexed maintenance for patients with nonsquamous histologies only.

The randomization was stratified by region (Asia vs. non–East Asia), Eastern Cooperative Oncology Group performance status 0 or 1, squamous vs. nonsquamous histology, and PD-L1 expression, or TPS (tumor proportion score) greater than 50% vs. 1%-49%.

 

 


As noted before, the primary endpoint of overall survival among all patients with a TPS of 1% or greater was met, with respective median overall survival in the pembrolizumab vs. chemotherapy groups of 16.7 vs. 12.1 months, translating into a hazard ratio favoring pembrolizumab of 0.81 (P = .0018). Respective hazard ratios for the TPS 20% or greater and TPS 50% or greater groups were 0.77 (P = .0020), and 0.69 (P = .0003).

At 12.8 months of median follow-up, 13% of patients assigned to pembrolizumab were still on the drug, and 4.3% of patients were receiving maintenance pemetrexed.

Treatment-related adverse events of any grade occurred in 399 of 636 patients assigned to pembrolizumab (62.7%), vs. 553 of 615 patients assigned to chemotherapy (89.9%).

Grade 3 or greater events occurred in 17.8% vs. 41% of patients, respectively, There were 13 deaths related to therapy in the pembrolizumab arm (2.0%), and 14 in the chemotherapy arm (2.3%).

 

 


Adverse events leading to discontinuation were similar between the groups, at 9% and 9.4%, respectively.

There were more immune-mediated adverse events in the pembrolizumab arm (27.8% vs. 7.2%), and of these, grade 3 or greater events occurred in 8% vs. 1.5% of patients, respectively.

There was one immune-mediated death, from pneumonitis, in the immunotherapy arm; there were no deaths related to immune-mediated side effects in the chemotherapy arm.

“I really view this as a ‘double whammy’ for patients,” Dr. Heymach said at the briefing. “Often advances in survival for our lung cancer patients come at the cost of significant toxicities. Here, by contrast, not only are patients living longer and having a much higher likelihood of prolonged survival in years, often instead of months, but they’re also receiving a treatment that has substantially less toxicity across virtually all measures, and this really impacts the day-to-day life of these patients.”

 

 


Leena Gandhi, MD, PhD, of the Perlmutter Cancer Center at New York University, the invited discussant at the plenary, agreed that pembrolizumab improves survival, compared with chemotherapy patients with PD-L1 expression levels greater than 1%, but noted that most of the benefit – as also seen in Keynote-024 – was in those patients whose tumors had high levels of PD-L1 expression.

She emphasized that although PD-L1 is an imperfect biomarker, it should still be used to help select patients for therapy, and may be complementary with tumor mutational burden for more precise treatment selection.

“What we know, and what this study adds to, is that PD-L1 really does define a patient population that could receive benefit from pembrolizumab over chemotherapy. Patients with low or no PD-L1 expression likely should get some type of combination therapy,” she said.

“I do think this study extends what we’ve seen from other recent studies, which is that chemotherapy alone is no longer a first-line standard of care in non–small-cell lung cancer,” she added.

 

 


Merck funded the study. Dr. Lopes disclosed institutional research funding from Merck Sharp & Dohme, EMD Serono, and AstraZeneca. Dr. Heymach disclosed stock/ownership in Bio-Tree and Cardinal Spine, a consulting or advisory role for Abbvie, ARIAD, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Calithera Biosciences, Genentech, Medivation, Novartis, Oncomed, and Synta, and institutional research funding from AstraZeneca. Dr. Gandhi reported having no relevant disclosures.

SOURCE: Lobes G et al. ASCO 2018, abstract LBA4.

 

CHICAGO – Pembrolizumab (Keytruda) as first-line treatment of advanced non–small-cell lung cancer (NSCLC) offered longer overall survival with better tolerability compared with chemotherapy, results of the Keynote-042 phase 3 randomized trial show.

Among 1,274 patients with advanced, previously untreated NSCLC with expression of the PD-L1 on 1% or more of tumor cells, median overall survival after a median follow-up of 12.8 months was 16.7 months for patients treated with pembrolizumab monotherapy, compared with 12.1 months for patients treated with either paclitaxel or pemetrexed plus carboplatin, reported lead author Gilberto Lopes, MD, of the Sylvester Comprehensive Cancer Center at the University of Miami.

Neil Osterweil/MDedge News
Dr. Gilberto Lopes
The survival benefit for immunotherapy was even greater for patients with higher levels of PD-L1 expression: 20 vs. 12.2 months for patients with PD-L1 expression of 50% or greater, and 17.7 vs. 13 months for patients with PD-L1 expression of 20% or greater, Dr. Lopes noted at the annual meeting of the American Society of Clinical Oncology.

For all three PD-L1 expression groups, the median duration of response was 20.2 months, compared with 10.8-8.3 months for patients in the chemotherapy arm.

“These are responses that are unlike anything that we have seen with chemotherapy in the past for non–small-cell lung cancer,” Dr. Lopes said at a briefing prior to his presentation of the data in a plenary session.

“In addition to that, and probably more importantly, patients had fewer adverse events [with pembrolizumab]. Overall, about 60% had any treatment-related adverse event with pembrolizumab, vs. 90% with chemotherapy,” he added.
 

‘A true milestone’

ASCO expert John Heymach, MD, PhD, of the University of Texas MD Anderson Cancer Center in Houston, said at the briefing that “this study represents a true milestone for the field, because now, for the first time, we can say that among non–small-cell lung cancer patients receiving first-line therapy, the vast majority can receive immunotherapy with pembrolizumab instead of chemotherapy.”

 

 

He noted that an earlier study, Keynote-024, showed that pembrolizumab significantly improved progression-free survival in patients with tumors expressing PD-L1 on at least 50% of cells compared with standard platinum-based chemotherapy (10.3 vs. 6 months).

Neil Osterweil/MDedge News
Dr. John Heymach
“This now more than doubles that population that can start immunotherapy as a first-line treatment, assuming the [Food and Drug Administration] modifies the label in accordance with this study,” he added.

The Keynote-042 investigators enrolled 1,274 patients with locally advanced or metastatic NSCLC, and randomly assigned them to receive either a maximum of 35 cycles of pembrolizumab 200 mg every 3 weeks, or the investigators’ choice of not more than 6 cycles of either paclitaxel/carboplatin or pemetrexed/carboplatin, with optional pemetrexed maintenance for patients with nonsquamous histologies only.

The randomization was stratified by region (Asia vs. non–East Asia), Eastern Cooperative Oncology Group performance status 0 or 1, squamous vs. nonsquamous histology, and PD-L1 expression, or TPS (tumor proportion score) greater than 50% vs. 1%-49%.

 

 


As noted before, the primary endpoint of overall survival among all patients with a TPS of 1% or greater was met, with respective median overall survival in the pembrolizumab vs. chemotherapy groups of 16.7 vs. 12.1 months, translating into a hazard ratio favoring pembrolizumab of 0.81 (P = .0018). Respective hazard ratios for the TPS 20% or greater and TPS 50% or greater groups were 0.77 (P = .0020), and 0.69 (P = .0003).

At 12.8 months of median follow-up, 13% of patients assigned to pembrolizumab were still on the drug, and 4.3% of patients were receiving maintenance pemetrexed.

Treatment-related adverse events of any grade occurred in 399 of 636 patients assigned to pembrolizumab (62.7%), vs. 553 of 615 patients assigned to chemotherapy (89.9%).

Grade 3 or greater events occurred in 17.8% vs. 41% of patients, respectively, There were 13 deaths related to therapy in the pembrolizumab arm (2.0%), and 14 in the chemotherapy arm (2.3%).

 

 


Adverse events leading to discontinuation were similar between the groups, at 9% and 9.4%, respectively.

There were more immune-mediated adverse events in the pembrolizumab arm (27.8% vs. 7.2%), and of these, grade 3 or greater events occurred in 8% vs. 1.5% of patients, respectively.

There was one immune-mediated death, from pneumonitis, in the immunotherapy arm; there were no deaths related to immune-mediated side effects in the chemotherapy arm.

“I really view this as a ‘double whammy’ for patients,” Dr. Heymach said at the briefing. “Often advances in survival for our lung cancer patients come at the cost of significant toxicities. Here, by contrast, not only are patients living longer and having a much higher likelihood of prolonged survival in years, often instead of months, but they’re also receiving a treatment that has substantially less toxicity across virtually all measures, and this really impacts the day-to-day life of these patients.”

 

 


Leena Gandhi, MD, PhD, of the Perlmutter Cancer Center at New York University, the invited discussant at the plenary, agreed that pembrolizumab improves survival, compared with chemotherapy patients with PD-L1 expression levels greater than 1%, but noted that most of the benefit – as also seen in Keynote-024 – was in those patients whose tumors had high levels of PD-L1 expression.

She emphasized that although PD-L1 is an imperfect biomarker, it should still be used to help select patients for therapy, and may be complementary with tumor mutational burden for more precise treatment selection.

“What we know, and what this study adds to, is that PD-L1 really does define a patient population that could receive benefit from pembrolizumab over chemotherapy. Patients with low or no PD-L1 expression likely should get some type of combination therapy,” she said.

“I do think this study extends what we’ve seen from other recent studies, which is that chemotherapy alone is no longer a first-line standard of care in non–small-cell lung cancer,” she added.

 

 


Merck funded the study. Dr. Lopes disclosed institutional research funding from Merck Sharp & Dohme, EMD Serono, and AstraZeneca. Dr. Heymach disclosed stock/ownership in Bio-Tree and Cardinal Spine, a consulting or advisory role for Abbvie, ARIAD, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Calithera Biosciences, Genentech, Medivation, Novartis, Oncomed, and Synta, and institutional research funding from AstraZeneca. Dr. Gandhi reported having no relevant disclosures.

SOURCE: Lobes G et al. ASCO 2018, abstract LBA4.

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REPORTING FROM ASCO 2018

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No Gating (article Unlocked/Free)
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Key clinical point: Many patients with previously untreated non–small-cell lung cancer could benefit from first-line therapy with the checkpoint inhibitor pembrolizumab.

Major finding: Among all patients with expression of PD-L1 on 1% or more of tumor, overall survival was 16.7 months with pembrolizumab, vs. 12.1 months for chemotherapy.

Study details: Randomized phase 3 trial of 1,274 patients with advanced or metastatic non–small-cell lung cancer.

Disclosures: Merck funded the study. Dr. Lopes disclosed institutional research funding from Merck Sharp & Dohme, EMD Serono, and AstraZeneca. Dr. Heymach disclosed stock/ownership in Bio-Tree and Cardinal Spine, a consulting or advisory role for Abbvie, ARIAD, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Calithera Biosciences, Genentech, Medivation, Novartis, Oncomed, and Synta, and institutional research funding from AstraZeneca. Dr. Gandhi reported having no relevant disclosures.

Source: Lobes G et al. ASCO 2018, abstract LBA4.

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Opioids and us: Designed to fail

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Fri, 02/01/2019 - 12:04

 

AIDS, the Vietnam War, whatever your preferred scale for measuring horrific events, the numbers from the opioid crisis are as grave or worse. And, once again, it is the young who are dying. How we got to this point is an unbelievable story of corporate greed, government incompetence, regulatory commission overreach, and, unfortunately, physician ignorance.

Every one of us has contributed to this tragedy, and most of us still do. There are some easy first steps surgeons can take, but first let’s review the mistakes made that drove our country into addiction.

BackyardProduction/Thinkstock

In 1995, as their patent on MS Contin was set to expire, Purdue Pharma gained Food and Drug Administration approval for OxyContin (“contin” is pharma talk for continuous). At this time, opioids generally were considered to be dangerous and mainly prescribed for cancer or end-of-life patients. Purdue representatives began an aggressive marketing campaign to break out of this niche. They were aided in this pursuit by the FDA, which wrote in the package insert that iatrogenic addiction was rare and the delayed absorption of OxyContin “is believed to reduce the abuse liability of a drug.” These statements were made without the backing of any clinical trials. But with an on-label statement of reduced addiction risk, representatives could sell OxyContin based on a diminished potential for abuse.

In addition to oncologists, the drug was now marketed to rheumatologists, primary care physicians, and surgeons. OxyContin, therefore, broke through the cancer barrier and became one of the most widely prescribed painkillers in the United States. While generating billions in profits, OxyContin also would become one of the most abused drugs in history.

There were several issues with OxyContin that led to its widespread misuse. The preparation contained up to 160 mg of oxycodone per pill, 16 times more than the strongest Percocet formulary. The tablet also could easily be crushed, overcoming the delayed-release formulation. Because of the FDA insert, sales representatives were free to report an addiction risk of less than 1%, which they did. Widely.

But what science backed this claim? The study referenced was not a study at all. The citation was a one-paragraph, five-sentence letter to the editor published by the New England Journal of Medicine in 1980. In it, the authors briefly described their experience with inpatient opioid therapy. No reference was made to outpatient opioid prescriptions. Still, this letter has been scientifically cited more than 600 times, with a spike starting in 1995, the year OxyContin was released. Even as thousands of Americans were dying each year from opioid use, the “study” continued to be offered as proof of a low risk of addiction. As recently as 2014, the letter was cited in the journal OncoTargets and Therapy to support the statement, “In reality, medical opioid addiction is very rare.”

Maybe if we knew our history we could avoid repeating it. Previously, the drug diacetylmorphine was introduced as a safe, nonaddictive substitute for morphine by Bayer Pharmaceutical in the late 1890s. Diacetylmorphine is better known by its trademarked name, Heroin.

 

 


In 1996, the American Pain Society and the American Academy of Pain Medicine formed a committee to issue a joint statement that advocated opioid use for chronic pain and again stating a low risk of addiction. The committee was chaired by J. David Haddox, DDS, MD, a paid speaker (and later executive) for Purdue Pharma. The American Pain Society also launched a campaign to treat pain more aggressively. “Pain is the fifth vital sign” became a far-reaching strategy, which was adopted by the Department of Veterans Affairs and, ultimately, nearly every hospital in the country. The campaign was so successful that, in 2001, the Joint Commission required hospitals to:

  • Assess pain in every patient.
  • Record the results.
  • Provide treatment for the pain.
  • Reassess the effectiveness of the treatment.
  • Teach staff how to manage pain.

The Joint Commission is not alone in creating opioid-friendly regulations. The Hospital Consumer Assessment of Healthcare Providers and Systems surveys patients after hospital stays. Several of the questions include pain management. One asks the patient whether the hospital staff did “everything they could” to assist with the patient’s pain. The satisfaction scores from these surveys are directly tied to hospital payments.

In 1998, the Federation of State Medical Boards published a statement reassuring doctors that they would not be punished for prescribing even large amounts of opioids if it were in the course of medical treatment. In 2004, the FSMB went further, stating that medical boards should consider “undertreatment of pain” to be a “departure from an acceptable standard of practice,” suggesting that state medical boards should sanction doctors who undertreated pain. According to a report by Catan et al. in the Wall Street Journal, this policy was drawn up with help from Dr. Haddox, who is now a senior executive with Purdue. The FSMB also would later disclose nearly $2 million in funding from opioid manufacturers.

 

 


These regulatory groups created widespread legal and financial pressure for doctors to diagnose and quickly treat pain in every patient. But what resources did we have to do this swiftly and effectively? Opioid prescriptions soared. There were 116 million opioid prescriptions issued in 1999; by 2013, it was 207 million. Annually, there are now more opioid prescriptions filled in the United States than there are people. Overdose deaths rose 500% between 1999 and 2016. Last year, there were more than 42,000 opioid-related mortalities in the United States. Like an untended fire, the crisis now spreads unabated.

What about vascular surgeons? Few of us prescribe OxyContin. Surely the 30 Percocets we give out after surgery are safe? In reality, Percocet contains oxycodone, the same opioid found in OxyContin, and therefore, carries a high risk of addiction. Norco, Vicodin, and Lortab all contain the opioid hydrocodone. Some studies have shown a higher risk of addiction with oxycodone, but all opioids carry a significant danger of abuse and dependence. As surgeons, we came into to this crisis with little or no training. This made us susceptible to bad science, bad-faith marketing, and bad ideas from regulatory commissions. Most of us learned how to prescribe postop opioids during the “hidden curriculum” of our third and fourth years of medical school: In other words, the residents taught us. Much like learning sex education on the streets, your mileage may vary. It is no wonder that a 2016 JAMA Internal Medicine news release found that simply having surgery was a risk factor for developing an opioid addiction. Surgeons don’t have an evidence-based plan to treat postoperative pain with opioids. About 6.5% of patients are still taking “postop” opioids 3-6 months after minor surgery; the numbers are about the same for major surgery (5.9%). Therefore, it is unlikely that pain is driving this chronic use.

Richard J. Barth Jr., MD, of Dartmouth-Hitchcock Medical Center in Lebanon, N.H., has studied opioid use following surgery extensively. He found there is a wide variety in surgeons’ opioid-prescribing habits and most of us overprescribe. In one study, 72% of the prescribed pills after surgery were not taken. He recommends the following guideline for opioid prescriptions after inpatient surgical procedures: If the patient took no opioids the day before discharge, no script is needed. For patients taking 1-3 pills the day before discharge, 15 pills are given; and for those taking 4 or more pills, a script for 30 is given.

As vascular surgeons, we must break out of our bubble and address our contributions to this crisis. It is past time to look at our own habits. Overprescribing is dangerous; the excess pills often are found by abusers, sold, or used recreationally by others in the household. Some patients take all of the pills simply because that is what the doctor prescribed; to the patient, he or she is merely following the doctor’s orders, and therefore not engaging in a risky behavior.

 

 


As vascular surgeons, there are several steps we can take immediately to reduce our contributions to the opioid epidemic and protect our patients:

  • Always use the lowest effective dose of opioids and dramatically reduce the number of pills in your postop scripts. Fewer than 15 pills will cover most surgeries we perform.
  • New data show that acetaminophen combined with ibuprofen works better for acute pain than acetaminophen combined with an opioid. Increase your use of nonnarcotic pain medications.
  • Counsel your patients on the risk of addiction. If you plan to issue a script with only a few pills or nonnarcotics, let them know why in advance.
  • Use caution when prescribing opioids to patients with anxiety or depression. The risk of addiction is much higher in these patients because of the anxiolytic and antidepressant qualities that opioids have.
  • Avoid opioids in patients taking benzodiazepines, which can exacerbate the risk of respiratory depression and death.
  • Help patients safely dispose of unused opioids.
  • Use drug-monitoring programs whenever available.
  • Use opioids for acute pain only. We do not have the training to manage long-term use.

Meanwhile, OxyContin still is available and sold exclusively by Purdue Pharma. Before its patent expired, Purdue altered the formulation to make it harder to abuse when crushing the tablets. They then lobbied the FDA to block generic production of the original formula because it was “unsafe.” Though Purdue (under Mundipharma) now markets this original version in South America, Europe, and Asia.

Many lawsuits have been brought against Purdue. Even with such high-profile lawyers as Rudy Giuliani and Eric Holder, Purdue has paid more than $600 million in fines and pleaded guilty to marketing OxyContin with “the intent to defraud or mislead.” Three Purdue executives have pleaded guilty to criminal misdemeanor charges.

 

 


In 2015, the FDA approved marketing OxyContin to children as young as age 11 years..

Dr. Malachi Sheahan
Dr. Malachi Sheahan

To address their role in the opioid crisis, the Joint Commission issued a statement on April 18, 2016. It was not a master class in self-awareness; the statement claimed that it is a “misconception” that Joint Commission standards pushed doctors to prescribe opioids. Yet, according to a Class Action complaint (Kenova v. JCAHO), in a 2001 monograph published by the Joint Commission (and funded by Purdue Pharma), they wrote “Some clinicians have inaccurate and exaggerated concerns about addiction, tolerance, and risk of death. This attitude prevails despite the fact that there is no evidence that addiction is a significant issue when persons are given opioids for pain control.”

In 2016, the AMA passed a resolution to drop pain as a vital sign. They also urged the Joint Commission to stop requiring hospitals to ask patients about the quality of their pain care. The American College of Surgeons has started an education initiative to help surgeons and patients learn about opioids and surgery (funded by Pacira Pharmaceuticals, makers of EXPAREL, an injectable long-lasting local anesthetic). In a March 2016 statement in the New England Journal of Medicine, Centers for Disease Control and Prevention representatives said of opioids “We know of no other medication routinely used for a nonfatal condition that kills patients so frequently.” As vascular surgeons, we are long overdue for a self-assessment. It is now time to change our practices and habits to help end this national addiction.

Dr. Sheahan is the Claude C. Craighead Jr. Professor and chair, division of vascular and endovascular surgery, Louisiana State University Health Sciences Center, New Orleans.

 

 

Resources

1. Hill M et al. Guideline for discharge opioid prescriptions after inpatient general surgical procedures. J Am Coll Surg. In Press.

2. Kenova v. JCAHO Class Action Complaint. United States District Court for the Southern District of West Virginia.

3. Mandell BF. The fifth vital sign: a complex story of politics and patient care. Cleveland Clinic Journal of Medicine 2016 Jun:83:400.

4. Leung PT et al. A 1980 letter on the risk of opioid addiction. New England Journal of Medicine 2017;376:2194-5.

5. www.jointcommission.org/joint_commission_statement_on_pain_management

6. www.cdc.gov/drugoverdose/epidemic/index.html

7. Catan T et al. A pain-drug champion has second thoughts. Wall Street Journal. Dec. 17, 2012 (updated online version).

8. Federation of State Medical Boards news release. www.fsmb.org/globalassets/advocacy/news-releases/2014/rems-grant-press-release-jan2014-final.pdf

9. Chou R et al. American Pain Society – American Academy of Pain Medicine Opioids Guidelines Panel. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain 2009;10:113-130.

10. Van Zee A. The promotion and marketing of OxyContin: Commercial triumph, public health tragedy. Am J Public Health 2009;99:221-7.

11. Keefe, PR. The family that built an empire of pain. The New Yorker. October 30, 2017.

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AIDS, the Vietnam War, whatever your preferred scale for measuring horrific events, the numbers from the opioid crisis are as grave or worse. And, once again, it is the young who are dying. How we got to this point is an unbelievable story of corporate greed, government incompetence, regulatory commission overreach, and, unfortunately, physician ignorance.

Every one of us has contributed to this tragedy, and most of us still do. There are some easy first steps surgeons can take, but first let’s review the mistakes made that drove our country into addiction.

BackyardProduction/Thinkstock

In 1995, as their patent on MS Contin was set to expire, Purdue Pharma gained Food and Drug Administration approval for OxyContin (“contin” is pharma talk for continuous). At this time, opioids generally were considered to be dangerous and mainly prescribed for cancer or end-of-life patients. Purdue representatives began an aggressive marketing campaign to break out of this niche. They were aided in this pursuit by the FDA, which wrote in the package insert that iatrogenic addiction was rare and the delayed absorption of OxyContin “is believed to reduce the abuse liability of a drug.” These statements were made without the backing of any clinical trials. But with an on-label statement of reduced addiction risk, representatives could sell OxyContin based on a diminished potential for abuse.

In addition to oncologists, the drug was now marketed to rheumatologists, primary care physicians, and surgeons. OxyContin, therefore, broke through the cancer barrier and became one of the most widely prescribed painkillers in the United States. While generating billions in profits, OxyContin also would become one of the most abused drugs in history.

There were several issues with OxyContin that led to its widespread misuse. The preparation contained up to 160 mg of oxycodone per pill, 16 times more than the strongest Percocet formulary. The tablet also could easily be crushed, overcoming the delayed-release formulation. Because of the FDA insert, sales representatives were free to report an addiction risk of less than 1%, which they did. Widely.

But what science backed this claim? The study referenced was not a study at all. The citation was a one-paragraph, five-sentence letter to the editor published by the New England Journal of Medicine in 1980. In it, the authors briefly described their experience with inpatient opioid therapy. No reference was made to outpatient opioid prescriptions. Still, this letter has been scientifically cited more than 600 times, with a spike starting in 1995, the year OxyContin was released. Even as thousands of Americans were dying each year from opioid use, the “study” continued to be offered as proof of a low risk of addiction. As recently as 2014, the letter was cited in the journal OncoTargets and Therapy to support the statement, “In reality, medical opioid addiction is very rare.”

Maybe if we knew our history we could avoid repeating it. Previously, the drug diacetylmorphine was introduced as a safe, nonaddictive substitute for morphine by Bayer Pharmaceutical in the late 1890s. Diacetylmorphine is better known by its trademarked name, Heroin.

 

 


In 1996, the American Pain Society and the American Academy of Pain Medicine formed a committee to issue a joint statement that advocated opioid use for chronic pain and again stating a low risk of addiction. The committee was chaired by J. David Haddox, DDS, MD, a paid speaker (and later executive) for Purdue Pharma. The American Pain Society also launched a campaign to treat pain more aggressively. “Pain is the fifth vital sign” became a far-reaching strategy, which was adopted by the Department of Veterans Affairs and, ultimately, nearly every hospital in the country. The campaign was so successful that, in 2001, the Joint Commission required hospitals to:

  • Assess pain in every patient.
  • Record the results.
  • Provide treatment for the pain.
  • Reassess the effectiveness of the treatment.
  • Teach staff how to manage pain.

The Joint Commission is not alone in creating opioid-friendly regulations. The Hospital Consumer Assessment of Healthcare Providers and Systems surveys patients after hospital stays. Several of the questions include pain management. One asks the patient whether the hospital staff did “everything they could” to assist with the patient’s pain. The satisfaction scores from these surveys are directly tied to hospital payments.

In 1998, the Federation of State Medical Boards published a statement reassuring doctors that they would not be punished for prescribing even large amounts of opioids if it were in the course of medical treatment. In 2004, the FSMB went further, stating that medical boards should consider “undertreatment of pain” to be a “departure from an acceptable standard of practice,” suggesting that state medical boards should sanction doctors who undertreated pain. According to a report by Catan et al. in the Wall Street Journal, this policy was drawn up with help from Dr. Haddox, who is now a senior executive with Purdue. The FSMB also would later disclose nearly $2 million in funding from opioid manufacturers.

 

 


These regulatory groups created widespread legal and financial pressure for doctors to diagnose and quickly treat pain in every patient. But what resources did we have to do this swiftly and effectively? Opioid prescriptions soared. There were 116 million opioid prescriptions issued in 1999; by 2013, it was 207 million. Annually, there are now more opioid prescriptions filled in the United States than there are people. Overdose deaths rose 500% between 1999 and 2016. Last year, there were more than 42,000 opioid-related mortalities in the United States. Like an untended fire, the crisis now spreads unabated.

What about vascular surgeons? Few of us prescribe OxyContin. Surely the 30 Percocets we give out after surgery are safe? In reality, Percocet contains oxycodone, the same opioid found in OxyContin, and therefore, carries a high risk of addiction. Norco, Vicodin, and Lortab all contain the opioid hydrocodone. Some studies have shown a higher risk of addiction with oxycodone, but all opioids carry a significant danger of abuse and dependence. As surgeons, we came into to this crisis with little or no training. This made us susceptible to bad science, bad-faith marketing, and bad ideas from regulatory commissions. Most of us learned how to prescribe postop opioids during the “hidden curriculum” of our third and fourth years of medical school: In other words, the residents taught us. Much like learning sex education on the streets, your mileage may vary. It is no wonder that a 2016 JAMA Internal Medicine news release found that simply having surgery was a risk factor for developing an opioid addiction. Surgeons don’t have an evidence-based plan to treat postoperative pain with opioids. About 6.5% of patients are still taking “postop” opioids 3-6 months after minor surgery; the numbers are about the same for major surgery (5.9%). Therefore, it is unlikely that pain is driving this chronic use.

Richard J. Barth Jr., MD, of Dartmouth-Hitchcock Medical Center in Lebanon, N.H., has studied opioid use following surgery extensively. He found there is a wide variety in surgeons’ opioid-prescribing habits and most of us overprescribe. In one study, 72% of the prescribed pills after surgery were not taken. He recommends the following guideline for opioid prescriptions after inpatient surgical procedures: If the patient took no opioids the day before discharge, no script is needed. For patients taking 1-3 pills the day before discharge, 15 pills are given; and for those taking 4 or more pills, a script for 30 is given.

As vascular surgeons, we must break out of our bubble and address our contributions to this crisis. It is past time to look at our own habits. Overprescribing is dangerous; the excess pills often are found by abusers, sold, or used recreationally by others in the household. Some patients take all of the pills simply because that is what the doctor prescribed; to the patient, he or she is merely following the doctor’s orders, and therefore not engaging in a risky behavior.

 

 


As vascular surgeons, there are several steps we can take immediately to reduce our contributions to the opioid epidemic and protect our patients:

  • Always use the lowest effective dose of opioids and dramatically reduce the number of pills in your postop scripts. Fewer than 15 pills will cover most surgeries we perform.
  • New data show that acetaminophen combined with ibuprofen works better for acute pain than acetaminophen combined with an opioid. Increase your use of nonnarcotic pain medications.
  • Counsel your patients on the risk of addiction. If you plan to issue a script with only a few pills or nonnarcotics, let them know why in advance.
  • Use caution when prescribing opioids to patients with anxiety or depression. The risk of addiction is much higher in these patients because of the anxiolytic and antidepressant qualities that opioids have.
  • Avoid opioids in patients taking benzodiazepines, which can exacerbate the risk of respiratory depression and death.
  • Help patients safely dispose of unused opioids.
  • Use drug-monitoring programs whenever available.
  • Use opioids for acute pain only. We do not have the training to manage long-term use.

Meanwhile, OxyContin still is available and sold exclusively by Purdue Pharma. Before its patent expired, Purdue altered the formulation to make it harder to abuse when crushing the tablets. They then lobbied the FDA to block generic production of the original formula because it was “unsafe.” Though Purdue (under Mundipharma) now markets this original version in South America, Europe, and Asia.

Many lawsuits have been brought against Purdue. Even with such high-profile lawyers as Rudy Giuliani and Eric Holder, Purdue has paid more than $600 million in fines and pleaded guilty to marketing OxyContin with “the intent to defraud or mislead.” Three Purdue executives have pleaded guilty to criminal misdemeanor charges.

 

 


In 2015, the FDA approved marketing OxyContin to children as young as age 11 years..

Dr. Malachi Sheahan
Dr. Malachi Sheahan

To address their role in the opioid crisis, the Joint Commission issued a statement on April 18, 2016. It was not a master class in self-awareness; the statement claimed that it is a “misconception” that Joint Commission standards pushed doctors to prescribe opioids. Yet, according to a Class Action complaint (Kenova v. JCAHO), in a 2001 monograph published by the Joint Commission (and funded by Purdue Pharma), they wrote “Some clinicians have inaccurate and exaggerated concerns about addiction, tolerance, and risk of death. This attitude prevails despite the fact that there is no evidence that addiction is a significant issue when persons are given opioids for pain control.”

In 2016, the AMA passed a resolution to drop pain as a vital sign. They also urged the Joint Commission to stop requiring hospitals to ask patients about the quality of their pain care. The American College of Surgeons has started an education initiative to help surgeons and patients learn about opioids and surgery (funded by Pacira Pharmaceuticals, makers of EXPAREL, an injectable long-lasting local anesthetic). In a March 2016 statement in the New England Journal of Medicine, Centers for Disease Control and Prevention representatives said of opioids “We know of no other medication routinely used for a nonfatal condition that kills patients so frequently.” As vascular surgeons, we are long overdue for a self-assessment. It is now time to change our practices and habits to help end this national addiction.

Dr. Sheahan is the Claude C. Craighead Jr. Professor and chair, division of vascular and endovascular surgery, Louisiana State University Health Sciences Center, New Orleans.

 

 

Resources

1. Hill M et al. Guideline for discharge opioid prescriptions after inpatient general surgical procedures. J Am Coll Surg. In Press.

2. Kenova v. JCAHO Class Action Complaint. United States District Court for the Southern District of West Virginia.

3. Mandell BF. The fifth vital sign: a complex story of politics and patient care. Cleveland Clinic Journal of Medicine 2016 Jun:83:400.

4. Leung PT et al. A 1980 letter on the risk of opioid addiction. New England Journal of Medicine 2017;376:2194-5.

5. www.jointcommission.org/joint_commission_statement_on_pain_management

6. www.cdc.gov/drugoverdose/epidemic/index.html

7. Catan T et al. A pain-drug champion has second thoughts. Wall Street Journal. Dec. 17, 2012 (updated online version).

8. Federation of State Medical Boards news release. www.fsmb.org/globalassets/advocacy/news-releases/2014/rems-grant-press-release-jan2014-final.pdf

9. Chou R et al. American Pain Society – American Academy of Pain Medicine Opioids Guidelines Panel. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain 2009;10:113-130.

10. Van Zee A. The promotion and marketing of OxyContin: Commercial triumph, public health tragedy. Am J Public Health 2009;99:221-7.

11. Keefe, PR. The family that built an empire of pain. The New Yorker. October 30, 2017.

 

AIDS, the Vietnam War, whatever your preferred scale for measuring horrific events, the numbers from the opioid crisis are as grave or worse. And, once again, it is the young who are dying. How we got to this point is an unbelievable story of corporate greed, government incompetence, regulatory commission overreach, and, unfortunately, physician ignorance.

Every one of us has contributed to this tragedy, and most of us still do. There are some easy first steps surgeons can take, but first let’s review the mistakes made that drove our country into addiction.

BackyardProduction/Thinkstock

In 1995, as their patent on MS Contin was set to expire, Purdue Pharma gained Food and Drug Administration approval for OxyContin (“contin” is pharma talk for continuous). At this time, opioids generally were considered to be dangerous and mainly prescribed for cancer or end-of-life patients. Purdue representatives began an aggressive marketing campaign to break out of this niche. They were aided in this pursuit by the FDA, which wrote in the package insert that iatrogenic addiction was rare and the delayed absorption of OxyContin “is believed to reduce the abuse liability of a drug.” These statements were made without the backing of any clinical trials. But with an on-label statement of reduced addiction risk, representatives could sell OxyContin based on a diminished potential for abuse.

In addition to oncologists, the drug was now marketed to rheumatologists, primary care physicians, and surgeons. OxyContin, therefore, broke through the cancer barrier and became one of the most widely prescribed painkillers in the United States. While generating billions in profits, OxyContin also would become one of the most abused drugs in history.

There were several issues with OxyContin that led to its widespread misuse. The preparation contained up to 160 mg of oxycodone per pill, 16 times more than the strongest Percocet formulary. The tablet also could easily be crushed, overcoming the delayed-release formulation. Because of the FDA insert, sales representatives were free to report an addiction risk of less than 1%, which they did. Widely.

But what science backed this claim? The study referenced was not a study at all. The citation was a one-paragraph, five-sentence letter to the editor published by the New England Journal of Medicine in 1980. In it, the authors briefly described their experience with inpatient opioid therapy. No reference was made to outpatient opioid prescriptions. Still, this letter has been scientifically cited more than 600 times, with a spike starting in 1995, the year OxyContin was released. Even as thousands of Americans were dying each year from opioid use, the “study” continued to be offered as proof of a low risk of addiction. As recently as 2014, the letter was cited in the journal OncoTargets and Therapy to support the statement, “In reality, medical opioid addiction is very rare.”

Maybe if we knew our history we could avoid repeating it. Previously, the drug diacetylmorphine was introduced as a safe, nonaddictive substitute for morphine by Bayer Pharmaceutical in the late 1890s. Diacetylmorphine is better known by its trademarked name, Heroin.

 

 


In 1996, the American Pain Society and the American Academy of Pain Medicine formed a committee to issue a joint statement that advocated opioid use for chronic pain and again stating a low risk of addiction. The committee was chaired by J. David Haddox, DDS, MD, a paid speaker (and later executive) for Purdue Pharma. The American Pain Society also launched a campaign to treat pain more aggressively. “Pain is the fifth vital sign” became a far-reaching strategy, which was adopted by the Department of Veterans Affairs and, ultimately, nearly every hospital in the country. The campaign was so successful that, in 2001, the Joint Commission required hospitals to:

  • Assess pain in every patient.
  • Record the results.
  • Provide treatment for the pain.
  • Reassess the effectiveness of the treatment.
  • Teach staff how to manage pain.

The Joint Commission is not alone in creating opioid-friendly regulations. The Hospital Consumer Assessment of Healthcare Providers and Systems surveys patients after hospital stays. Several of the questions include pain management. One asks the patient whether the hospital staff did “everything they could” to assist with the patient’s pain. The satisfaction scores from these surveys are directly tied to hospital payments.

In 1998, the Federation of State Medical Boards published a statement reassuring doctors that they would not be punished for prescribing even large amounts of opioids if it were in the course of medical treatment. In 2004, the FSMB went further, stating that medical boards should consider “undertreatment of pain” to be a “departure from an acceptable standard of practice,” suggesting that state medical boards should sanction doctors who undertreated pain. According to a report by Catan et al. in the Wall Street Journal, this policy was drawn up with help from Dr. Haddox, who is now a senior executive with Purdue. The FSMB also would later disclose nearly $2 million in funding from opioid manufacturers.

 

 


These regulatory groups created widespread legal and financial pressure for doctors to diagnose and quickly treat pain in every patient. But what resources did we have to do this swiftly and effectively? Opioid prescriptions soared. There were 116 million opioid prescriptions issued in 1999; by 2013, it was 207 million. Annually, there are now more opioid prescriptions filled in the United States than there are people. Overdose deaths rose 500% between 1999 and 2016. Last year, there were more than 42,000 opioid-related mortalities in the United States. Like an untended fire, the crisis now spreads unabated.

What about vascular surgeons? Few of us prescribe OxyContin. Surely the 30 Percocets we give out after surgery are safe? In reality, Percocet contains oxycodone, the same opioid found in OxyContin, and therefore, carries a high risk of addiction. Norco, Vicodin, and Lortab all contain the opioid hydrocodone. Some studies have shown a higher risk of addiction with oxycodone, but all opioids carry a significant danger of abuse and dependence. As surgeons, we came into to this crisis with little or no training. This made us susceptible to bad science, bad-faith marketing, and bad ideas from regulatory commissions. Most of us learned how to prescribe postop opioids during the “hidden curriculum” of our third and fourth years of medical school: In other words, the residents taught us. Much like learning sex education on the streets, your mileage may vary. It is no wonder that a 2016 JAMA Internal Medicine news release found that simply having surgery was a risk factor for developing an opioid addiction. Surgeons don’t have an evidence-based plan to treat postoperative pain with opioids. About 6.5% of patients are still taking “postop” opioids 3-6 months after minor surgery; the numbers are about the same for major surgery (5.9%). Therefore, it is unlikely that pain is driving this chronic use.

Richard J. Barth Jr., MD, of Dartmouth-Hitchcock Medical Center in Lebanon, N.H., has studied opioid use following surgery extensively. He found there is a wide variety in surgeons’ opioid-prescribing habits and most of us overprescribe. In one study, 72% of the prescribed pills after surgery were not taken. He recommends the following guideline for opioid prescriptions after inpatient surgical procedures: If the patient took no opioids the day before discharge, no script is needed. For patients taking 1-3 pills the day before discharge, 15 pills are given; and for those taking 4 or more pills, a script for 30 is given.

As vascular surgeons, we must break out of our bubble and address our contributions to this crisis. It is past time to look at our own habits. Overprescribing is dangerous; the excess pills often are found by abusers, sold, or used recreationally by others in the household. Some patients take all of the pills simply because that is what the doctor prescribed; to the patient, he or she is merely following the doctor’s orders, and therefore not engaging in a risky behavior.

 

 


As vascular surgeons, there are several steps we can take immediately to reduce our contributions to the opioid epidemic and protect our patients:

  • Always use the lowest effective dose of opioids and dramatically reduce the number of pills in your postop scripts. Fewer than 15 pills will cover most surgeries we perform.
  • New data show that acetaminophen combined with ibuprofen works better for acute pain than acetaminophen combined with an opioid. Increase your use of nonnarcotic pain medications.
  • Counsel your patients on the risk of addiction. If you plan to issue a script with only a few pills or nonnarcotics, let them know why in advance.
  • Use caution when prescribing opioids to patients with anxiety or depression. The risk of addiction is much higher in these patients because of the anxiolytic and antidepressant qualities that opioids have.
  • Avoid opioids in patients taking benzodiazepines, which can exacerbate the risk of respiratory depression and death.
  • Help patients safely dispose of unused opioids.
  • Use drug-monitoring programs whenever available.
  • Use opioids for acute pain only. We do not have the training to manage long-term use.

Meanwhile, OxyContin still is available and sold exclusively by Purdue Pharma. Before its patent expired, Purdue altered the formulation to make it harder to abuse when crushing the tablets. They then lobbied the FDA to block generic production of the original formula because it was “unsafe.” Though Purdue (under Mundipharma) now markets this original version in South America, Europe, and Asia.

Many lawsuits have been brought against Purdue. Even with such high-profile lawyers as Rudy Giuliani and Eric Holder, Purdue has paid more than $600 million in fines and pleaded guilty to marketing OxyContin with “the intent to defraud or mislead.” Three Purdue executives have pleaded guilty to criminal misdemeanor charges.

 

 


In 2015, the FDA approved marketing OxyContin to children as young as age 11 years..

Dr. Malachi Sheahan
Dr. Malachi Sheahan

To address their role in the opioid crisis, the Joint Commission issued a statement on April 18, 2016. It was not a master class in self-awareness; the statement claimed that it is a “misconception” that Joint Commission standards pushed doctors to prescribe opioids. Yet, according to a Class Action complaint (Kenova v. JCAHO), in a 2001 monograph published by the Joint Commission (and funded by Purdue Pharma), they wrote “Some clinicians have inaccurate and exaggerated concerns about addiction, tolerance, and risk of death. This attitude prevails despite the fact that there is no evidence that addiction is a significant issue when persons are given opioids for pain control.”

In 2016, the AMA passed a resolution to drop pain as a vital sign. They also urged the Joint Commission to stop requiring hospitals to ask patients about the quality of their pain care. The American College of Surgeons has started an education initiative to help surgeons and patients learn about opioids and surgery (funded by Pacira Pharmaceuticals, makers of EXPAREL, an injectable long-lasting local anesthetic). In a March 2016 statement in the New England Journal of Medicine, Centers for Disease Control and Prevention representatives said of opioids “We know of no other medication routinely used for a nonfatal condition that kills patients so frequently.” As vascular surgeons, we are long overdue for a self-assessment. It is now time to change our practices and habits to help end this national addiction.

Dr. Sheahan is the Claude C. Craighead Jr. Professor and chair, division of vascular and endovascular surgery, Louisiana State University Health Sciences Center, New Orleans.

 

 

Resources

1. Hill M et al. Guideline for discharge opioid prescriptions after inpatient general surgical procedures. J Am Coll Surg. In Press.

2. Kenova v. JCAHO Class Action Complaint. United States District Court for the Southern District of West Virginia.

3. Mandell BF. The fifth vital sign: a complex story of politics and patient care. Cleveland Clinic Journal of Medicine 2016 Jun:83:400.

4. Leung PT et al. A 1980 letter on the risk of opioid addiction. New England Journal of Medicine 2017;376:2194-5.

5. www.jointcommission.org/joint_commission_statement_on_pain_management

6. www.cdc.gov/drugoverdose/epidemic/index.html

7. Catan T et al. A pain-drug champion has second thoughts. Wall Street Journal. Dec. 17, 2012 (updated online version).

8. Federation of State Medical Boards news release. www.fsmb.org/globalassets/advocacy/news-releases/2014/rems-grant-press-release-jan2014-final.pdf

9. Chou R et al. American Pain Society – American Academy of Pain Medicine Opioids Guidelines Panel. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain 2009;10:113-130.

10. Van Zee A. The promotion and marketing of OxyContin: Commercial triumph, public health tragedy. Am J Public Health 2009;99:221-7.

11. Keefe, PR. The family that built an empire of pain. The New Yorker. October 30, 2017.

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Identifying insomnia in people with mental disorders

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The Insomnia Severity Index might be the most effective screening tool at identifying insomnia among outpatients with mental disorders, according to a study published in Sleep Medicine.

The cross-sectional study compared six self-administered sleep measures – the Pittsburgh Sleep Quality Index, Insomnia Severity Index (ISI), Epworth Sleepiness Scale, Flinders Fatigue Scale, Functional Outcomes of Sleep Questionnaire, and Dysfunctional Beliefs and Attitudes about Sleep scale – in 400 psychiatric outpatients.

Of those, the Insomnia Severity Index was the most accurate way to discriminate between cases of insomnia and noncases according to both the DSM-5 and ICD-10 criteria. In fact, the Insomnia Severity Index was the only scale that was able to discriminate both with good accuracy.

The area under the curve for the ISI was 0.88 for the ICD definition, and 0.82 for the DSM-5 criteria. Researchers found that the best sensitivity and specificity for the ISI was achieved using cutoff scores of less than or equal to 14 for ICD-10 insomnia and less than or equal to 11 for DSM-5 insomnia.

A cutoff of 14 or above for the ISI yielded a sensitivity of 81.3%, specificity of 80.9%, positive predictive value of 66.7%, and negative predictive value of 90.2%.

The Pittsburgh Sleep Quality Index was found to have good accuracy in discriminating between cases and noncases using the ICD-10 criteria, but only had fair accuracy for the DSM-5 criteria. However, it was slightly better than the ISI at detecting insomnia cases, according to the DSM-5 criteria, in people with either bipolar affective or anxiety disorders.

The Flinders Fatigue Scale, Functional Outcomes of Sleep Questionnaire, and Dysfunctional Beliefs and Attitudes about Sleep scale all showed fair accuracy for the ICD-10 criteria but low accuracy for the DSM-5 criteria, while the Epworth Sleepiness Scale had low accuracy for the ICD-10 criteria and was nondiscriminatory for the DSM-5 criteria.

 

 


The scales were all self-administered, were designed to take 15 minutes or fewer to complete, and were chosen because they covered the six key aspects of sleep, including sleep quality, daytime sleepiness, sleep-related quality of life, and sleep-disruptive cognitions.

The investigators cited one limitation that might limit the generalizability of their findings: Only outpatients with psychiatric disorders were recruited for the study. Nevertheless, the findings have clinical implications, they wrote. “Identifying a self-report sleep measure that can detect clinically significant insomnia depending on these systems not only provides the clinicians with the ease of administration but also helps them in detecting and treating psychiatric patients whose conditions may be aggravated by the presence of comorbid insomnia,” wrote Lee Seng Esmond Seow, BA, and his colleagues at the Institute of Mental Health in Singapore.

The study was supported by the Singapore Ministry of Health’s National Medical Research Council. No conflicts of interest were declared.

SOURCE: Seow LSE et al. Sleep Med. 2018 Jan;41:86-93.
 

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The Insomnia Severity Index might be the most effective screening tool at identifying insomnia among outpatients with mental disorders, according to a study published in Sleep Medicine.

The cross-sectional study compared six self-administered sleep measures – the Pittsburgh Sleep Quality Index, Insomnia Severity Index (ISI), Epworth Sleepiness Scale, Flinders Fatigue Scale, Functional Outcomes of Sleep Questionnaire, and Dysfunctional Beliefs and Attitudes about Sleep scale – in 400 psychiatric outpatients.

Of those, the Insomnia Severity Index was the most accurate way to discriminate between cases of insomnia and noncases according to both the DSM-5 and ICD-10 criteria. In fact, the Insomnia Severity Index was the only scale that was able to discriminate both with good accuracy.

The area under the curve for the ISI was 0.88 for the ICD definition, and 0.82 for the DSM-5 criteria. Researchers found that the best sensitivity and specificity for the ISI was achieved using cutoff scores of less than or equal to 14 for ICD-10 insomnia and less than or equal to 11 for DSM-5 insomnia.

A cutoff of 14 or above for the ISI yielded a sensitivity of 81.3%, specificity of 80.9%, positive predictive value of 66.7%, and negative predictive value of 90.2%.

The Pittsburgh Sleep Quality Index was found to have good accuracy in discriminating between cases and noncases using the ICD-10 criteria, but only had fair accuracy for the DSM-5 criteria. However, it was slightly better than the ISI at detecting insomnia cases, according to the DSM-5 criteria, in people with either bipolar affective or anxiety disorders.

The Flinders Fatigue Scale, Functional Outcomes of Sleep Questionnaire, and Dysfunctional Beliefs and Attitudes about Sleep scale all showed fair accuracy for the ICD-10 criteria but low accuracy for the DSM-5 criteria, while the Epworth Sleepiness Scale had low accuracy for the ICD-10 criteria and was nondiscriminatory for the DSM-5 criteria.

 

 


The scales were all self-administered, were designed to take 15 minutes or fewer to complete, and were chosen because they covered the six key aspects of sleep, including sleep quality, daytime sleepiness, sleep-related quality of life, and sleep-disruptive cognitions.

The investigators cited one limitation that might limit the generalizability of their findings: Only outpatients with psychiatric disorders were recruited for the study. Nevertheless, the findings have clinical implications, they wrote. “Identifying a self-report sleep measure that can detect clinically significant insomnia depending on these systems not only provides the clinicians with the ease of administration but also helps them in detecting and treating psychiatric patients whose conditions may be aggravated by the presence of comorbid insomnia,” wrote Lee Seng Esmond Seow, BA, and his colleagues at the Institute of Mental Health in Singapore.

The study was supported by the Singapore Ministry of Health’s National Medical Research Council. No conflicts of interest were declared.

SOURCE: Seow LSE et al. Sleep Med. 2018 Jan;41:86-93.
 

 

The Insomnia Severity Index might be the most effective screening tool at identifying insomnia among outpatients with mental disorders, according to a study published in Sleep Medicine.

The cross-sectional study compared six self-administered sleep measures – the Pittsburgh Sleep Quality Index, Insomnia Severity Index (ISI), Epworth Sleepiness Scale, Flinders Fatigue Scale, Functional Outcomes of Sleep Questionnaire, and Dysfunctional Beliefs and Attitudes about Sleep scale – in 400 psychiatric outpatients.

Of those, the Insomnia Severity Index was the most accurate way to discriminate between cases of insomnia and noncases according to both the DSM-5 and ICD-10 criteria. In fact, the Insomnia Severity Index was the only scale that was able to discriminate both with good accuracy.

The area under the curve for the ISI was 0.88 for the ICD definition, and 0.82 for the DSM-5 criteria. Researchers found that the best sensitivity and specificity for the ISI was achieved using cutoff scores of less than or equal to 14 for ICD-10 insomnia and less than or equal to 11 for DSM-5 insomnia.

A cutoff of 14 or above for the ISI yielded a sensitivity of 81.3%, specificity of 80.9%, positive predictive value of 66.7%, and negative predictive value of 90.2%.

The Pittsburgh Sleep Quality Index was found to have good accuracy in discriminating between cases and noncases using the ICD-10 criteria, but only had fair accuracy for the DSM-5 criteria. However, it was slightly better than the ISI at detecting insomnia cases, according to the DSM-5 criteria, in people with either bipolar affective or anxiety disorders.

The Flinders Fatigue Scale, Functional Outcomes of Sleep Questionnaire, and Dysfunctional Beliefs and Attitudes about Sleep scale all showed fair accuracy for the ICD-10 criteria but low accuracy for the DSM-5 criteria, while the Epworth Sleepiness Scale had low accuracy for the ICD-10 criteria and was nondiscriminatory for the DSM-5 criteria.

 

 


The scales were all self-administered, were designed to take 15 minutes or fewer to complete, and were chosen because they covered the six key aspects of sleep, including sleep quality, daytime sleepiness, sleep-related quality of life, and sleep-disruptive cognitions.

The investigators cited one limitation that might limit the generalizability of their findings: Only outpatients with psychiatric disorders were recruited for the study. Nevertheless, the findings have clinical implications, they wrote. “Identifying a self-report sleep measure that can detect clinically significant insomnia depending on these systems not only provides the clinicians with the ease of administration but also helps them in detecting and treating psychiatric patients whose conditions may be aggravated by the presence of comorbid insomnia,” wrote Lee Seng Esmond Seow, BA, and his colleagues at the Institute of Mental Health in Singapore.

The study was supported by the Singapore Ministry of Health’s National Medical Research Council. No conflicts of interest were declared.

SOURCE: Seow LSE et al. Sleep Med. 2018 Jan;41:86-93.
 

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Key clinical point: The Insomnia Severity Index was the most accurate screen for insomnia in patients with mental disorders.

Major finding: The Insomnia Severity Index had the greatest area under the curve for insomnia detection.

Study details: A cross-sectional study of six self-administered sleep measures tested in 400 psychiatric outpatients.

Disclosures: The study was supported by the Singapore Ministry of Health’s National Medical Research Council. No conflicts of interest were declared.

Source: Seow LSE et al. Sleep Med. 2018 Jan;41:86-93.

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Hip pain predicts OA mortality beyond comorbidities

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– Hip pain increases all-cause mortality in people with OA by a third, according to data obtained from a large, community-based study.

The hazard ratio for all-cause mortality was 1.33 (95% confidence interval, 1.17-1.51) in people who self-reported hip pain over the course of up to 25 years’ follow-up. The presence of hip pain also increased the risk of cardiovascular mortality (HR, 1.22; 95% CI, 0.99-1.50).

Sara Freeman/MDedge News
Dr. Rebecca Cleveland
“The finding that hip pain more than radiographic hip OA is associated with mortality warrants further investigation,” said study investigator Rebecca J. Cleveland, PhD, at the World Congress on Osteoarthritis.

The hazard ratios for all-cause and cardiovascular mortality in patients with radiographic hip pain were 1.04 (95% CI, 0.91-1.17) and 1.01(95% CI, 0.82-1.24), and the all-cause and cardiovascular mortality hazard ratios in patients with both hip pain and radiographic OA were 1.01 (95% CI, 0.87-1.18) and 1.01 (95% CI, 0.80-1.28).

These data support hip pain as a predictor of mortality, observed Dr. Cleveland, of the University of North Carolina at Chapel Hill. “While there have been a number of studies that have looked at osteoarthritis as a risk factor for mortality, a lot of these studies have looked at arthritis in general or have looked at specifically knee osteoarthritis.

“There have been only a handful of studies that have looked at hip osteoarthritis as a risk factor for mortality,” she added, and considered all together, the results have been equivocal.

The aim of the current study she presented at the congress sponsored by the Osteoarthritis Research Society International was to explore whether or not hip OA was associated with all-cause and cardiovascular disease–specific mortality, independent of any comorbidities. The comorbidities considered were cancer, liver disease, hypertension, type 2 diabetes mellitus, and cardiovascular disease.

 

 


Data on 3,919 people with and without hip OA were obtained from the Johnston County Osteoarthritis Project, a longitudinal cohort of white and African American residents aged 45 years or older. Enrollment was carried out in two waves, with 3,185 people recruited between 1990 and 1998 and 1,015 people recruited between 2003 and 2004. Only those with baseline and follow-up assessment data, including at least one hip radiograph, were included in the present analysis.

The mean age at recruitment was 62 years, 61% were women, and two-thirds were white. Around 17% (n = 655) had radiographic hip OA and hip pain (symptomatic OA) at baseline, 10% (n = 787) had radiographic OA alone, and 27% (n = 1,156) had hip pain alone. The remaining 45% (n = 1,321) had neither hip pain nor radiographic damage.

Over the course of up to 25 years’ follow-up, there were 1,762 deaths from any cause – 311 occurred in the group with symptomatic OA at baseline, 382 in the group with radiographic OA alone, 509 in those with hip pain alone, and 560 in those with neither hip pain nor radiographic OA.

Median survival was lowest in individuals with symptomatic OA, at 16.1 years, and highest in individuals without either, at 22.8 years. Median survival was similar for those with hip pain only (18.6 years) and with radiographic hip OA only (18.5 years).
 

 

Stratified by race, all-cause mortality was increased with hip pain alone, and was more pronounced in white patients (HR, 1.39) than in African American patients (HR, 1.24). Interestingly, the risk of all-cause death was lower in African American patients who had symptomatic hip OA than their white counterparts (HR, 0.78 and 1.16, respectively).

Furthermore, Dr. Cleveland reported that hip pain was strongly associated with all-cause mortality in those younger than 65 years (HR, 1.56) when compared with those who were 65 years and up (HR, 1.18). Of note, the risk of death was higher in younger patients with symptomatic hip pain than in older patients (HR, 1.33 and 0.88, respectively).

A 41% increased death risk was also observed in patients with hip pain who had a body mass index of 30 kg/m2 (HR, 1.41 vs. HR, 1.29 for those with hip pain and a body mass index of less than 30 kg/m2).

“Our results are independent of comorbidities and sociodemographic measures,” Dr. Cleveland said. “This suggests there are mechanisms beyond comorbidities in the link between radiographic hip OA and mortality risk.”
 

 


The Johnston County Osteoarthritis Project is funded by the Centers for Disease Control and Prevention and the National Institutes of Arthritis and Musculoskeletal and Skin Diseases. Dr. Cleveland had no conflicts of interest to report.

SOURCE: Cleveland RJ et al. Osteoarthritis Cartilage. 2018:26(1):S10-1. Abstract 1.

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– Hip pain increases all-cause mortality in people with OA by a third, according to data obtained from a large, community-based study.

The hazard ratio for all-cause mortality was 1.33 (95% confidence interval, 1.17-1.51) in people who self-reported hip pain over the course of up to 25 years’ follow-up. The presence of hip pain also increased the risk of cardiovascular mortality (HR, 1.22; 95% CI, 0.99-1.50).

Sara Freeman/MDedge News
Dr. Rebecca Cleveland
“The finding that hip pain more than radiographic hip OA is associated with mortality warrants further investigation,” said study investigator Rebecca J. Cleveland, PhD, at the World Congress on Osteoarthritis.

The hazard ratios for all-cause and cardiovascular mortality in patients with radiographic hip pain were 1.04 (95% CI, 0.91-1.17) and 1.01(95% CI, 0.82-1.24), and the all-cause and cardiovascular mortality hazard ratios in patients with both hip pain and radiographic OA were 1.01 (95% CI, 0.87-1.18) and 1.01 (95% CI, 0.80-1.28).

These data support hip pain as a predictor of mortality, observed Dr. Cleveland, of the University of North Carolina at Chapel Hill. “While there have been a number of studies that have looked at osteoarthritis as a risk factor for mortality, a lot of these studies have looked at arthritis in general or have looked at specifically knee osteoarthritis.

“There have been only a handful of studies that have looked at hip osteoarthritis as a risk factor for mortality,” she added, and considered all together, the results have been equivocal.

The aim of the current study she presented at the congress sponsored by the Osteoarthritis Research Society International was to explore whether or not hip OA was associated with all-cause and cardiovascular disease–specific mortality, independent of any comorbidities. The comorbidities considered were cancer, liver disease, hypertension, type 2 diabetes mellitus, and cardiovascular disease.

 

 


Data on 3,919 people with and without hip OA were obtained from the Johnston County Osteoarthritis Project, a longitudinal cohort of white and African American residents aged 45 years or older. Enrollment was carried out in two waves, with 3,185 people recruited between 1990 and 1998 and 1,015 people recruited between 2003 and 2004. Only those with baseline and follow-up assessment data, including at least one hip radiograph, were included in the present analysis.

The mean age at recruitment was 62 years, 61% were women, and two-thirds were white. Around 17% (n = 655) had radiographic hip OA and hip pain (symptomatic OA) at baseline, 10% (n = 787) had radiographic OA alone, and 27% (n = 1,156) had hip pain alone. The remaining 45% (n = 1,321) had neither hip pain nor radiographic damage.

Over the course of up to 25 years’ follow-up, there were 1,762 deaths from any cause – 311 occurred in the group with symptomatic OA at baseline, 382 in the group with radiographic OA alone, 509 in those with hip pain alone, and 560 in those with neither hip pain nor radiographic OA.

Median survival was lowest in individuals with symptomatic OA, at 16.1 years, and highest in individuals without either, at 22.8 years. Median survival was similar for those with hip pain only (18.6 years) and with radiographic hip OA only (18.5 years).
 

 

Stratified by race, all-cause mortality was increased with hip pain alone, and was more pronounced in white patients (HR, 1.39) than in African American patients (HR, 1.24). Interestingly, the risk of all-cause death was lower in African American patients who had symptomatic hip OA than their white counterparts (HR, 0.78 and 1.16, respectively).

Furthermore, Dr. Cleveland reported that hip pain was strongly associated with all-cause mortality in those younger than 65 years (HR, 1.56) when compared with those who were 65 years and up (HR, 1.18). Of note, the risk of death was higher in younger patients with symptomatic hip pain than in older patients (HR, 1.33 and 0.88, respectively).

A 41% increased death risk was also observed in patients with hip pain who had a body mass index of 30 kg/m2 (HR, 1.41 vs. HR, 1.29 for those with hip pain and a body mass index of less than 30 kg/m2).

“Our results are independent of comorbidities and sociodemographic measures,” Dr. Cleveland said. “This suggests there are mechanisms beyond comorbidities in the link between radiographic hip OA and mortality risk.”
 

 


The Johnston County Osteoarthritis Project is funded by the Centers for Disease Control and Prevention and the National Institutes of Arthritis and Musculoskeletal and Skin Diseases. Dr. Cleveland had no conflicts of interest to report.

SOURCE: Cleveland RJ et al. Osteoarthritis Cartilage. 2018:26(1):S10-1. Abstract 1.

 

– Hip pain increases all-cause mortality in people with OA by a third, according to data obtained from a large, community-based study.

The hazard ratio for all-cause mortality was 1.33 (95% confidence interval, 1.17-1.51) in people who self-reported hip pain over the course of up to 25 years’ follow-up. The presence of hip pain also increased the risk of cardiovascular mortality (HR, 1.22; 95% CI, 0.99-1.50).

Sara Freeman/MDedge News
Dr. Rebecca Cleveland
“The finding that hip pain more than radiographic hip OA is associated with mortality warrants further investigation,” said study investigator Rebecca J. Cleveland, PhD, at the World Congress on Osteoarthritis.

The hazard ratios for all-cause and cardiovascular mortality in patients with radiographic hip pain were 1.04 (95% CI, 0.91-1.17) and 1.01(95% CI, 0.82-1.24), and the all-cause and cardiovascular mortality hazard ratios in patients with both hip pain and radiographic OA were 1.01 (95% CI, 0.87-1.18) and 1.01 (95% CI, 0.80-1.28).

These data support hip pain as a predictor of mortality, observed Dr. Cleveland, of the University of North Carolina at Chapel Hill. “While there have been a number of studies that have looked at osteoarthritis as a risk factor for mortality, a lot of these studies have looked at arthritis in general or have looked at specifically knee osteoarthritis.

“There have been only a handful of studies that have looked at hip osteoarthritis as a risk factor for mortality,” she added, and considered all together, the results have been equivocal.

The aim of the current study she presented at the congress sponsored by the Osteoarthritis Research Society International was to explore whether or not hip OA was associated with all-cause and cardiovascular disease–specific mortality, independent of any comorbidities. The comorbidities considered were cancer, liver disease, hypertension, type 2 diabetes mellitus, and cardiovascular disease.

 

 


Data on 3,919 people with and without hip OA were obtained from the Johnston County Osteoarthritis Project, a longitudinal cohort of white and African American residents aged 45 years or older. Enrollment was carried out in two waves, with 3,185 people recruited between 1990 and 1998 and 1,015 people recruited between 2003 and 2004. Only those with baseline and follow-up assessment data, including at least one hip radiograph, were included in the present analysis.

The mean age at recruitment was 62 years, 61% were women, and two-thirds were white. Around 17% (n = 655) had radiographic hip OA and hip pain (symptomatic OA) at baseline, 10% (n = 787) had radiographic OA alone, and 27% (n = 1,156) had hip pain alone. The remaining 45% (n = 1,321) had neither hip pain nor radiographic damage.

Over the course of up to 25 years’ follow-up, there were 1,762 deaths from any cause – 311 occurred in the group with symptomatic OA at baseline, 382 in the group with radiographic OA alone, 509 in those with hip pain alone, and 560 in those with neither hip pain nor radiographic OA.

Median survival was lowest in individuals with symptomatic OA, at 16.1 years, and highest in individuals without either, at 22.8 years. Median survival was similar for those with hip pain only (18.6 years) and with radiographic hip OA only (18.5 years).
 

 

Stratified by race, all-cause mortality was increased with hip pain alone, and was more pronounced in white patients (HR, 1.39) than in African American patients (HR, 1.24). Interestingly, the risk of all-cause death was lower in African American patients who had symptomatic hip OA than their white counterparts (HR, 0.78 and 1.16, respectively).

Furthermore, Dr. Cleveland reported that hip pain was strongly associated with all-cause mortality in those younger than 65 years (HR, 1.56) when compared with those who were 65 years and up (HR, 1.18). Of note, the risk of death was higher in younger patients with symptomatic hip pain than in older patients (HR, 1.33 and 0.88, respectively).

A 41% increased death risk was also observed in patients with hip pain who had a body mass index of 30 kg/m2 (HR, 1.41 vs. HR, 1.29 for those with hip pain and a body mass index of less than 30 kg/m2).

“Our results are independent of comorbidities and sociodemographic measures,” Dr. Cleveland said. “This suggests there are mechanisms beyond comorbidities in the link between radiographic hip OA and mortality risk.”
 

 


The Johnston County Osteoarthritis Project is funded by the Centers for Disease Control and Prevention and the National Institutes of Arthritis and Musculoskeletal and Skin Diseases. Dr. Cleveland had no conflicts of interest to report.

SOURCE: Cleveland RJ et al. Osteoarthritis Cartilage. 2018:26(1):S10-1. Abstract 1.

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Key clinical point: Hip pain is a predictor of mortality in patients with OA and is independent of any comorbidities.

Major finding: The hazard ratios for all-cause and cardiovascular mortality in patients with hip pain were 1.33 and 1.22.

Study details: A longitudinal cohort study of almost 4,000 people, with up to 25 years’ follow-up.

Disclosures: The Johnston County Osteoarthritis Project is funded by the Centers for Disease Control and Prevention and the National Institutes of Arthritis and Musculoskeletal and Skin Diseases. Dr. Cleveland had no conflicts of interest to report.

Source: Cleveland RJ et al. Osteoarthritis Cartilage. 2018 Apr:26(1):S10-1. Abstract 1

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Acute Kidney Injury. 2017 Hospital Medicine Revised Core Competencies

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1.2 Acute Kidney Injury

Acute kidney injury (AKI), also known as acute renal failure (ARF), is a decline in renal function over a period of hours or days that results in the accumulation of nitrogenous waste products and an impaired ability to maintain fluid/electrolyte/acid-base homeostasis. Epidemiologic studies of AKI are confounded by inconsistent definitions and underreporting. The average incidence is estimated to be 23.8 cases per 1000 hospital discharges.1Approximately 5% to 20% of critically ill patients experience AKI during the course of their illness.2 AKI may present in isolation, develop as a complication of other comorbid illness, or result as a deleterious adverse effect of treatment or diagnostic interventions. Uncomplicated AKI is associated with a mortality rate of up to 10%.3-6 Patients with AKI and multiorgan failure have mortality rates higher than 50%.3-6 AKI is associated with an increased length of hospital stay; a rise in serum creatinine of 0.5 mg/dL or greater while hospitalized confers a 3.5-day increase in length of stay.7 Hospitalists facilitate the expeditious evaluation and management of AKI to improve patient outcomes, optimize resource use, and reduce length of stay. Hospitalists can also advocate and initiate preventive strategies to reduce the incidence of secondary AKI. 

KNOWLEDGE

Hospitalists should be able to:

  • Describe the symptoms and signs of AKI.

  • Describe and differentiate pathophysiologic causes of AKI including prerenal, intrinsic renal, and postrenal processes.

  • Differentiate among the causes of prerenal, intrinsic renal, and postrenal types of AKI.

  • Describe a logical sequence of indicated tests required to evaluate etiologies of AKI based on classification of AKI type.

  • List common potentially nephrotoxic agents that can cause or worsen AKI.

  • Explain the indications, contraindications, and mechanisms of action of the interventions used to treat AKI.

  • Explain the indications, contraindications, benefits, and risks of acute hemodialysis.

  • Recognize indications for specialty consultation for AKI and the role of nephrology and/or urology specialists.

  • Describe criteria, including specific measures of clinical stability, that must be met before discharging patients with AKI.

  • Explain the specific goals that should be met to ensure safe transitions of care for patients with AKI.

 

 

SKILLS

 

Hospitalists should be able to:

  • Assess patients with suspected AKI in a timely manner and manage or comanage the patient with the primary requesting service.

  • Elicit a thorough and relevant medical history with emphasis on factors predisposing or contributing to the development of AKI.

  • Review all drug use including prescription and over-the-counter medications, herbal remedies, nutritional supplements, and illicit drugs to identify common potential nephrotoxins.

  • Perform a physical examination to assess volume status and to identify underlying comorbid states that may predispose to the development of AKI.

  • Order and interpret results of indicated diagnostic studies that may include urinalysis and microscopic sediment analysis, urinary diagnostic indices, urinary protein excretion, serologic evaluation, and renal imaging.

  • Interpret common clinical, laboratory, and imaging findings used to evaluate and follow the severity of AKI.

  • Diagnose common complications, such as electrolyte abnormalities, that occur with AKI and institute corrective measures.

  • Calculate estimated creatinine clearance for medication dosage adjustments when indicated.

  • Identify patients at risk for developing AKI and institute appropriate preventive measures including avoidance of unnecessary radiographic contrast exposure and adherence to evidence-based interventions to reduce the risk of contrast-induced nephropathy.

  • Coordinate appropriate nutritional and metabolic interventions.

  • Formulate an AKI treatment plan tailored to the individual patient, which may include fluid management, pharmacologic agents, nutritional recommendations, and patient education.

  • Identify and treat factors that may complicate the management of AKI, including extreme blood pressure, underlying infections, and the sequelae of electrolyte abnormalities.

  • Communicate with patients and families to explain the cause and prognosis of AKI.

  • Communicate with patients and families to explain the rationale for the use of radiographic tests and procedures and the benefit and potential adverse effects of radiographic contrast agents.

  • Facilitate discharge planning early during hospitalization.

  • Communicate with patients and families to explain the goals of care, discharge instructions, and management after hospital discharge to ensure safe follow-up and transitions of care.

  • Document the treatment plan and provide clear discharge instructions for postdischarge clinicians. 

 

 

ATTITUDES 

 

 

Hospitalists should be able to:

  • Employ a multidisciplinary approach, which may include nursing, nutrition, and pharmacy services, in the care of patients with AKI that begins at admission and continues through all care transitions.

  • Follow evidence-based recommendations, protocols, and risk-stratification tools for the treatment of AKI. 

 

 

SYSTEM ORGANIZATION AND IMPROVEMENT 

To improve efficiency and quality within their organizations, hospitalists should:

  • Advocate for, establish, and support initiatives to reduce the incidence of iatrogenic AKI.

  • Lead, coordinate, and/or participate in multidisciplinary teams (including nephrology, nursing, pharmacy, and nutrition services) to improve processes that facilitate early identification of AKI and improved patient outcomes.

  • Lead, coordinate, and/or participate in multidisciplinary initiatives to promote patient safety and optimize management strategies for AKI.

 

 
References

1. Xue JL, Daniels F, Star RA, Kimmel PL, Eggers PW, Molitoris BA, et al. Incidence and mortality of acute renal failure in Medicare beneficiaries, 1992-2001. J Am Soc Nephrol. 2006;17(4):1135-1142.
2. Metnitz PG, Krenn CG, Steltzer H, Lang T, Ploder J, Lenz K, et al. Effect of acute renal failure requiring renal replacement therapy on outcome in critically ill patients. Crit Care Med. 2002;30(9):2051-2058.
3. Cosentino F, Chaff C, Piedmonte M. Risk factors influencing survival in ICU acute renal failure. Nephrol Dial Transplant. 1994;9(Suppl 4):179-182.
4. Hou SH, Bushinsky DA, Wish JB, Cohen JJ, Harrington JT. Hospital-acquired renal insufficiency: a prospective study. Am H Med. 1983;74(2):243-248.
5. Liano F, Junco E, Pascual J, Madero R, Verde E. The spectrum of acute renal failure in the intensive care unit compared with that seen in other settings. The Madrid Acute Renal Failure Study Group. Kidney Int Suppl. 1998;66:S16-S24.
6. Shusterman N, Strom BL, Murray TG, Morrison G, West SL, Maislin G. Risk factors and outcome of hospital-acquired acute renal failure. Clinical epidemiologic study. Am J Med. 1987;83(1):65-71.
7. Chertow GM, Burdick E, Honour M, Bonventre JV, Bates DW. Acute kidney injury, mortality, length of stay, and costs in hospitalized patients. J Am Soc Nephrol. 2005;16(11):3365-3370.

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Acute kidney injury (AKI), also known as acute renal failure (ARF), is a decline in renal function over a period of hours or days that results in the accumulation of nitrogenous waste products and an impaired ability to maintain fluid/electrolyte/acid-base homeostasis. Epidemiologic studies of AKI are confounded by inconsistent definitions and underreporting. The average incidence is estimated to be 23.8 cases per 1000 hospital discharges.1Approximately 5% to 20% of critically ill patients experience AKI during the course of their illness.2 AKI may present in isolation, develop as a complication of other comorbid illness, or result as a deleterious adverse effect of treatment or diagnostic interventions. Uncomplicated AKI is associated with a mortality rate of up to 10%.3-6 Patients with AKI and multiorgan failure have mortality rates higher than 50%.3-6 AKI is associated with an increased length of hospital stay; a rise in serum creatinine of 0.5 mg/dL or greater while hospitalized confers a 3.5-day increase in length of stay.7 Hospitalists facilitate the expeditious evaluation and management of AKI to improve patient outcomes, optimize resource use, and reduce length of stay. Hospitalists can also advocate and initiate preventive strategies to reduce the incidence of secondary AKI. 

KNOWLEDGE

Hospitalists should be able to:

  • Describe the symptoms and signs of AKI.

  • Describe and differentiate pathophysiologic causes of AKI including prerenal, intrinsic renal, and postrenal processes.

  • Differentiate among the causes of prerenal, intrinsic renal, and postrenal types of AKI.

  • Describe a logical sequence of indicated tests required to evaluate etiologies of AKI based on classification of AKI type.

  • List common potentially nephrotoxic agents that can cause or worsen AKI.

  • Explain the indications, contraindications, and mechanisms of action of the interventions used to treat AKI.

  • Explain the indications, contraindications, benefits, and risks of acute hemodialysis.

  • Recognize indications for specialty consultation for AKI and the role of nephrology and/or urology specialists.

  • Describe criteria, including specific measures of clinical stability, that must be met before discharging patients with AKI.

  • Explain the specific goals that should be met to ensure safe transitions of care for patients with AKI.

 

 

SKILLS

 

Hospitalists should be able to:

  • Assess patients with suspected AKI in a timely manner and manage or comanage the patient with the primary requesting service.

  • Elicit a thorough and relevant medical history with emphasis on factors predisposing or contributing to the development of AKI.

  • Review all drug use including prescription and over-the-counter medications, herbal remedies, nutritional supplements, and illicit drugs to identify common potential nephrotoxins.

  • Perform a physical examination to assess volume status and to identify underlying comorbid states that may predispose to the development of AKI.

  • Order and interpret results of indicated diagnostic studies that may include urinalysis and microscopic sediment analysis, urinary diagnostic indices, urinary protein excretion, serologic evaluation, and renal imaging.

  • Interpret common clinical, laboratory, and imaging findings used to evaluate and follow the severity of AKI.

  • Diagnose common complications, such as electrolyte abnormalities, that occur with AKI and institute corrective measures.

  • Calculate estimated creatinine clearance for medication dosage adjustments when indicated.

  • Identify patients at risk for developing AKI and institute appropriate preventive measures including avoidance of unnecessary radiographic contrast exposure and adherence to evidence-based interventions to reduce the risk of contrast-induced nephropathy.

  • Coordinate appropriate nutritional and metabolic interventions.

  • Formulate an AKI treatment plan tailored to the individual patient, which may include fluid management, pharmacologic agents, nutritional recommendations, and patient education.

  • Identify and treat factors that may complicate the management of AKI, including extreme blood pressure, underlying infections, and the sequelae of electrolyte abnormalities.

  • Communicate with patients and families to explain the cause and prognosis of AKI.

  • Communicate with patients and families to explain the rationale for the use of radiographic tests and procedures and the benefit and potential adverse effects of radiographic contrast agents.

  • Facilitate discharge planning early during hospitalization.

  • Communicate with patients and families to explain the goals of care, discharge instructions, and management after hospital discharge to ensure safe follow-up and transitions of care.

  • Document the treatment plan and provide clear discharge instructions for postdischarge clinicians. 

 

 

ATTITUDES 

 

 

Hospitalists should be able to:

  • Employ a multidisciplinary approach, which may include nursing, nutrition, and pharmacy services, in the care of patients with AKI that begins at admission and continues through all care transitions.

  • Follow evidence-based recommendations, protocols, and risk-stratification tools for the treatment of AKI. 

 

 

SYSTEM ORGANIZATION AND IMPROVEMENT 

To improve efficiency and quality within their organizations, hospitalists should:

  • Advocate for, establish, and support initiatives to reduce the incidence of iatrogenic AKI.

  • Lead, coordinate, and/or participate in multidisciplinary teams (including nephrology, nursing, pharmacy, and nutrition services) to improve processes that facilitate early identification of AKI and improved patient outcomes.

  • Lead, coordinate, and/or participate in multidisciplinary initiatives to promote patient safety and optimize management strategies for AKI.

 

 

Acute kidney injury (AKI), also known as acute renal failure (ARF), is a decline in renal function over a period of hours or days that results in the accumulation of nitrogenous waste products and an impaired ability to maintain fluid/electrolyte/acid-base homeostasis. Epidemiologic studies of AKI are confounded by inconsistent definitions and underreporting. The average incidence is estimated to be 23.8 cases per 1000 hospital discharges.1Approximately 5% to 20% of critically ill patients experience AKI during the course of their illness.2 AKI may present in isolation, develop as a complication of other comorbid illness, or result as a deleterious adverse effect of treatment or diagnostic interventions. Uncomplicated AKI is associated with a mortality rate of up to 10%.3-6 Patients with AKI and multiorgan failure have mortality rates higher than 50%.3-6 AKI is associated with an increased length of hospital stay; a rise in serum creatinine of 0.5 mg/dL or greater while hospitalized confers a 3.5-day increase in length of stay.7 Hospitalists facilitate the expeditious evaluation and management of AKI to improve patient outcomes, optimize resource use, and reduce length of stay. Hospitalists can also advocate and initiate preventive strategies to reduce the incidence of secondary AKI. 

KNOWLEDGE

Hospitalists should be able to:

  • Describe the symptoms and signs of AKI.

  • Describe and differentiate pathophysiologic causes of AKI including prerenal, intrinsic renal, and postrenal processes.

  • Differentiate among the causes of prerenal, intrinsic renal, and postrenal types of AKI.

  • Describe a logical sequence of indicated tests required to evaluate etiologies of AKI based on classification of AKI type.

  • List common potentially nephrotoxic agents that can cause or worsen AKI.

  • Explain the indications, contraindications, and mechanisms of action of the interventions used to treat AKI.

  • Explain the indications, contraindications, benefits, and risks of acute hemodialysis.

  • Recognize indications for specialty consultation for AKI and the role of nephrology and/or urology specialists.

  • Describe criteria, including specific measures of clinical stability, that must be met before discharging patients with AKI.

  • Explain the specific goals that should be met to ensure safe transitions of care for patients with AKI.

 

 

SKILLS

 

Hospitalists should be able to:

  • Assess patients with suspected AKI in a timely manner and manage or comanage the patient with the primary requesting service.

  • Elicit a thorough and relevant medical history with emphasis on factors predisposing or contributing to the development of AKI.

  • Review all drug use including prescription and over-the-counter medications, herbal remedies, nutritional supplements, and illicit drugs to identify common potential nephrotoxins.

  • Perform a physical examination to assess volume status and to identify underlying comorbid states that may predispose to the development of AKI.

  • Order and interpret results of indicated diagnostic studies that may include urinalysis and microscopic sediment analysis, urinary diagnostic indices, urinary protein excretion, serologic evaluation, and renal imaging.

  • Interpret common clinical, laboratory, and imaging findings used to evaluate and follow the severity of AKI.

  • Diagnose common complications, such as electrolyte abnormalities, that occur with AKI and institute corrective measures.

  • Calculate estimated creatinine clearance for medication dosage adjustments when indicated.

  • Identify patients at risk for developing AKI and institute appropriate preventive measures including avoidance of unnecessary radiographic contrast exposure and adherence to evidence-based interventions to reduce the risk of contrast-induced nephropathy.

  • Coordinate appropriate nutritional and metabolic interventions.

  • Formulate an AKI treatment plan tailored to the individual patient, which may include fluid management, pharmacologic agents, nutritional recommendations, and patient education.

  • Identify and treat factors that may complicate the management of AKI, including extreme blood pressure, underlying infections, and the sequelae of electrolyte abnormalities.

  • Communicate with patients and families to explain the cause and prognosis of AKI.

  • Communicate with patients and families to explain the rationale for the use of radiographic tests and procedures and the benefit and potential adverse effects of radiographic contrast agents.

  • Facilitate discharge planning early during hospitalization.

  • Communicate with patients and families to explain the goals of care, discharge instructions, and management after hospital discharge to ensure safe follow-up and transitions of care.

  • Document the treatment plan and provide clear discharge instructions for postdischarge clinicians. 

 

 

ATTITUDES 

 

 

Hospitalists should be able to:

  • Employ a multidisciplinary approach, which may include nursing, nutrition, and pharmacy services, in the care of patients with AKI that begins at admission and continues through all care transitions.

  • Follow evidence-based recommendations, protocols, and risk-stratification tools for the treatment of AKI. 

 

 

SYSTEM ORGANIZATION AND IMPROVEMENT 

To improve efficiency and quality within their organizations, hospitalists should:

  • Advocate for, establish, and support initiatives to reduce the incidence of iatrogenic AKI.

  • Lead, coordinate, and/or participate in multidisciplinary teams (including nephrology, nursing, pharmacy, and nutrition services) to improve processes that facilitate early identification of AKI and improved patient outcomes.

  • Lead, coordinate, and/or participate in multidisciplinary initiatives to promote patient safety and optimize management strategies for AKI.

 

 
References

1. Xue JL, Daniels F, Star RA, Kimmel PL, Eggers PW, Molitoris BA, et al. Incidence and mortality of acute renal failure in Medicare beneficiaries, 1992-2001. J Am Soc Nephrol. 2006;17(4):1135-1142.
2. Metnitz PG, Krenn CG, Steltzer H, Lang T, Ploder J, Lenz K, et al. Effect of acute renal failure requiring renal replacement therapy on outcome in critically ill patients. Crit Care Med. 2002;30(9):2051-2058.
3. Cosentino F, Chaff C, Piedmonte M. Risk factors influencing survival in ICU acute renal failure. Nephrol Dial Transplant. 1994;9(Suppl 4):179-182.
4. Hou SH, Bushinsky DA, Wish JB, Cohen JJ, Harrington JT. Hospital-acquired renal insufficiency: a prospective study. Am H Med. 1983;74(2):243-248.
5. Liano F, Junco E, Pascual J, Madero R, Verde E. The spectrum of acute renal failure in the intensive care unit compared with that seen in other settings. The Madrid Acute Renal Failure Study Group. Kidney Int Suppl. 1998;66:S16-S24.
6. Shusterman N, Strom BL, Murray TG, Morrison G, West SL, Maislin G. Risk factors and outcome of hospital-acquired acute renal failure. Clinical epidemiologic study. Am J Med. 1987;83(1):65-71.
7. Chertow GM, Burdick E, Honour M, Bonventre JV, Bates DW. Acute kidney injury, mortality, length of stay, and costs in hospitalized patients. J Am Soc Nephrol. 2005;16(11):3365-3370.

References

1. Xue JL, Daniels F, Star RA, Kimmel PL, Eggers PW, Molitoris BA, et al. Incidence and mortality of acute renal failure in Medicare beneficiaries, 1992-2001. J Am Soc Nephrol. 2006;17(4):1135-1142.
2. Metnitz PG, Krenn CG, Steltzer H, Lang T, Ploder J, Lenz K, et al. Effect of acute renal failure requiring renal replacement therapy on outcome in critically ill patients. Crit Care Med. 2002;30(9):2051-2058.
3. Cosentino F, Chaff C, Piedmonte M. Risk factors influencing survival in ICU acute renal failure. Nephrol Dial Transplant. 1994;9(Suppl 4):179-182.
4. Hou SH, Bushinsky DA, Wish JB, Cohen JJ, Harrington JT. Hospital-acquired renal insufficiency: a prospective study. Am H Med. 1983;74(2):243-248.
5. Liano F, Junco E, Pascual J, Madero R, Verde E. The spectrum of acute renal failure in the intensive care unit compared with that seen in other settings. The Madrid Acute Renal Failure Study Group. Kidney Int Suppl. 1998;66:S16-S24.
6. Shusterman N, Strom BL, Murray TG, Morrison G, West SL, Maislin G. Risk factors and outcome of hospital-acquired acute renal failure. Clinical epidemiologic study. Am J Med. 1987;83(1):65-71.
7. Chertow GM, Burdick E, Honour M, Bonventre JV, Bates DW. Acute kidney injury, mortality, length of stay, and costs in hospitalized patients. J Am Soc Nephrol. 2005;16(11):3365-3370.

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Alcohol and Drug Withdrawal. 2017 Hospital Medicine Revised Core Competencies

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1.3 Alcohol and Drug Withdrawal

Alcohol and drug withdrawal is a set of signs and symptoms that develops in association with sudden cessation or reduction in the use of alcohol or a number of prescription (particularly opioids and benzodiazepines), over-the-counter (OTC), or illicit drugs. Withdrawal syndromes encompass a broad range of symptoms from mild anxiety and tremulousness to more serious manifestations such as delirium tremens, which occurs in up to 5% of alcohol-dependent persons who undergo withdrawal.1 Withdrawal may occur before hospitalization or during the course of hospitalization. Alcohol- and substance-related disorders account for more than 400,000 hospital discharges each year and are associated with a mean length of stay of approximately 4.6 days.2 Alcohol and drug dependence is often an end product of a combination of biopsychosocial influences, and in most cases, a multidisciplinary approach is necessary to successfully treat affected individuals. Hospitalists can lead their institutions in evidence-based treatment protocols that improve care, reduce costs and length of stay, and facilitate better overall outcomes in patients with substance-related withdrawal syndromes. 

Want all 52 JHM Core Competency articles in an easy-to-read compendium? Order your copy now from Amazon.com.

KNOWLEDGE

Hospitalists should be able to:

  • Describe the effects of drug and alcohol withdrawal on medical illness and the effects of medical illness on substance withdrawal.

  • Recognize the symptoms and signs of alcohol and drug withdrawal, including withdrawal from prescription and OTC drugs.

  • Recognize the medical complications from substance use and dependence.

  • Determine when consultation with a medical toxicologist or expert is necessary.

  • Distinguish alcohol or drug withdrawal from other causes of delirium.

  • Differentiate delirium tremens from other alcohol withdrawal syndromes.

  • Differentiate the clinical manifestations of alcohol or drug intoxication from those of withdrawal.

  • Recognize different characteristic withdrawal syndromes, such as abstinence syndrome of opioid withdrawal and delirium tremens of alcohol withdrawal.

  • Describe the tests indicated to evaluate alcohol or drug withdrawal.

  • Identify patients at increased risk for drug and alcohol withdrawal according to current diagnostic criteria.

  • Explain indications, contraindications, and mechanisms of action of pharmacologic agents used to treat acute alcohol and drug withdrawal.

  • Identify local trends in illicit drug use.

  • Determine the best setting within the hospital to initiate, monitor, evaluate, and treat patients with drug or alcohol withdrawal.

  • Explain patient characteristics that portend a poor prognosis.

  • Explain patient characteristics that indicate a requirement for a higher level of care and/or monitoring.

  • Explain goals for hospital discharge, including specific measures of clinical stability for safe care transitions.

 

 

SKILLS

 

Hospitalists should be able to:

  • Elicit a thorough and relevant medical history, with emphasis on substance use.

  • Assess patients with suspected alcohol or drug withdrawal in a timely manner, identify the level of care required, and manage or comanage the patient with the primary requesting service.

  • Perform a rapid, efficient, and targeted physical examination to assess for alcohol or drug withdrawal and determine whether life-threatening comorbidities are present.

  • Assess for common comorbidities in patients with a history of alcohol and drug use.

  • Formulate a treatment plan tailored to the individual patient, which may include appropriate pharmacologic agents and dosing, route of administration, and nutritional supplementation.

  • Integrate existing literature and federal regulations into the management of patients with opioid withdrawal syndromes. For patients who are undergoing existing treatment for opioid dependency, communicate with outpatient treatment centers and integrate dosing regimens into care management.

  • Manage withdrawal syndromes in patients with concomitant medical or surgical issues.

  • Diagnose oversedation and other complications associated with withdrawal therapies.

  • Recommend the use of restraints and direct observation to ensure patient safety when appropriate.

  • Reassure, reorient, and frequently monitor patients in a calm environment.

  • Use the acute hospitalization as an opportunity to counsel patients about abstinence, recovery, and the medical risks of drug and alcohol use.

  • Initiate preventive measures before discharge, including alcohol and drug cessation measures.

  • Facilitate discharge planning early in the hospitalization, including communicating with the primary care provider and presenting the patient with contact information for follow-up care, support, and rehabilitation.

  • Communicate with patients and families to explain the goals of care, discharge instructions, and management after hospital discharge to ensure safe follow-up and transition of care. 

 

 

ATTITUDES 

 

 

Hospitalists should be able to:

  • Employ a multidisciplinary approach, which may include psychiatry, pharmacy, nursing, and social services, in the treatment of patients with substance use or dependency.

  • Follow evidence-based national recommendations to guide diagnosis, monitoring, and treatment of withdrawal symptoms.

  • Act in a nonjudgmental manner when managing the hospitalized patient with substance use.

  • Establish and maintain an open dialogue with patients and families regarding care goals and limitations.

  • Appreciate and document the value of appropriate treatment in reducing mortality, duration of delirium, time required to control agitation, adequate control of delirium, treatment of complications, and cost. 

 

 

SYSTEM ORGANIZATION AND IMPROVEMENT 

To improve efficiency and quality within their organizations, hospitalists should:

  • Lead, coordinate, and/or participate in multidisciplinary teams, which may include psychiatry and toxicology, to improve patient safety and management strategies for patients with substance abuse.

  • Lead, coordinate, and/or participate in the development and promotion of guidelines and/or pathways that facilitate efficient and timely evaluation and treatment of patients with alcohol and drug withdrawal.

  • Promote the development and use of evidence-based guidelines and protocols for the treatment of withdrawal syndromes.

  • Advocate for hospital resources to improve the care of patients with substance withdrawal and the environment in which the care is delivered.

  • Establish relationships with and develop knowledge of community-based organizations that provide support to patients with substance use disorders.

  • Promote awareness of substance use disorders and screening for them.

  • Coordinate initiatives to address the increased risk of readmissions associated with substance and polysubstance abuse.

 

 
References

1. Mayo-Smith MF. Pharmacological management of alcohol withdrawal. A meta-analysis and evidence-based practice guideline. American Society of Addiction Medicine Working Group on Pharmacological Management of Alcohol Withdrawal. JAMA. 1997;278(2):144-151.
2. Agency for Healthcare Research and Quality. Healthcare Cost and Utilization Project. U.S. Department of Health & Human Services. Available at: http://hcupnet.ahrq.gov/. Accessed May 2015.

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Alcohol and drug withdrawal is a set of signs and symptoms that develops in association with sudden cessation or reduction in the use of alcohol or a number of prescription (particularly opioids and benzodiazepines), over-the-counter (OTC), or illicit drugs. Withdrawal syndromes encompass a broad range of symptoms from mild anxiety and tremulousness to more serious manifestations such as delirium tremens, which occurs in up to 5% of alcohol-dependent persons who undergo withdrawal.1 Withdrawal may occur before hospitalization or during the course of hospitalization. Alcohol- and substance-related disorders account for more than 400,000 hospital discharges each year and are associated with a mean length of stay of approximately 4.6 days.2 Alcohol and drug dependence is often an end product of a combination of biopsychosocial influences, and in most cases, a multidisciplinary approach is necessary to successfully treat affected individuals. Hospitalists can lead their institutions in evidence-based treatment protocols that improve care, reduce costs and length of stay, and facilitate better overall outcomes in patients with substance-related withdrawal syndromes. 

Want all 52 JHM Core Competency articles in an easy-to-read compendium? Order your copy now from Amazon.com.

KNOWLEDGE

Hospitalists should be able to:

  • Describe the effects of drug and alcohol withdrawal on medical illness and the effects of medical illness on substance withdrawal.

  • Recognize the symptoms and signs of alcohol and drug withdrawal, including withdrawal from prescription and OTC drugs.

  • Recognize the medical complications from substance use and dependence.

  • Determine when consultation with a medical toxicologist or expert is necessary.

  • Distinguish alcohol or drug withdrawal from other causes of delirium.

  • Differentiate delirium tremens from other alcohol withdrawal syndromes.

  • Differentiate the clinical manifestations of alcohol or drug intoxication from those of withdrawal.

  • Recognize different characteristic withdrawal syndromes, such as abstinence syndrome of opioid withdrawal and delirium tremens of alcohol withdrawal.

  • Describe the tests indicated to evaluate alcohol or drug withdrawal.

  • Identify patients at increased risk for drug and alcohol withdrawal according to current diagnostic criteria.

  • Explain indications, contraindications, and mechanisms of action of pharmacologic agents used to treat acute alcohol and drug withdrawal.

  • Identify local trends in illicit drug use.

  • Determine the best setting within the hospital to initiate, monitor, evaluate, and treat patients with drug or alcohol withdrawal.

  • Explain patient characteristics that portend a poor prognosis.

  • Explain patient characteristics that indicate a requirement for a higher level of care and/or monitoring.

  • Explain goals for hospital discharge, including specific measures of clinical stability for safe care transitions.

 

 

SKILLS

 

Hospitalists should be able to:

  • Elicit a thorough and relevant medical history, with emphasis on substance use.

  • Assess patients with suspected alcohol or drug withdrawal in a timely manner, identify the level of care required, and manage or comanage the patient with the primary requesting service.

  • Perform a rapid, efficient, and targeted physical examination to assess for alcohol or drug withdrawal and determine whether life-threatening comorbidities are present.

  • Assess for common comorbidities in patients with a history of alcohol and drug use.

  • Formulate a treatment plan tailored to the individual patient, which may include appropriate pharmacologic agents and dosing, route of administration, and nutritional supplementation.

  • Integrate existing literature and federal regulations into the management of patients with opioid withdrawal syndromes. For patients who are undergoing existing treatment for opioid dependency, communicate with outpatient treatment centers and integrate dosing regimens into care management.

  • Manage withdrawal syndromes in patients with concomitant medical or surgical issues.

  • Diagnose oversedation and other complications associated with withdrawal therapies.

  • Recommend the use of restraints and direct observation to ensure patient safety when appropriate.

  • Reassure, reorient, and frequently monitor patients in a calm environment.

  • Use the acute hospitalization as an opportunity to counsel patients about abstinence, recovery, and the medical risks of drug and alcohol use.

  • Initiate preventive measures before discharge, including alcohol and drug cessation measures.

  • Facilitate discharge planning early in the hospitalization, including communicating with the primary care provider and presenting the patient with contact information for follow-up care, support, and rehabilitation.

  • Communicate with patients and families to explain the goals of care, discharge instructions, and management after hospital discharge to ensure safe follow-up and transition of care. 

 

 

ATTITUDES 

 

 

Hospitalists should be able to:

  • Employ a multidisciplinary approach, which may include psychiatry, pharmacy, nursing, and social services, in the treatment of patients with substance use or dependency.

  • Follow evidence-based national recommendations to guide diagnosis, monitoring, and treatment of withdrawal symptoms.

  • Act in a nonjudgmental manner when managing the hospitalized patient with substance use.

  • Establish and maintain an open dialogue with patients and families regarding care goals and limitations.

  • Appreciate and document the value of appropriate treatment in reducing mortality, duration of delirium, time required to control agitation, adequate control of delirium, treatment of complications, and cost. 

 

 

SYSTEM ORGANIZATION AND IMPROVEMENT 

To improve efficiency and quality within their organizations, hospitalists should:

  • Lead, coordinate, and/or participate in multidisciplinary teams, which may include psychiatry and toxicology, to improve patient safety and management strategies for patients with substance abuse.

  • Lead, coordinate, and/or participate in the development and promotion of guidelines and/or pathways that facilitate efficient and timely evaluation and treatment of patients with alcohol and drug withdrawal.

  • Promote the development and use of evidence-based guidelines and protocols for the treatment of withdrawal syndromes.

  • Advocate for hospital resources to improve the care of patients with substance withdrawal and the environment in which the care is delivered.

  • Establish relationships with and develop knowledge of community-based organizations that provide support to patients with substance use disorders.

  • Promote awareness of substance use disorders and screening for them.

  • Coordinate initiatives to address the increased risk of readmissions associated with substance and polysubstance abuse.

 

 

Alcohol and drug withdrawal is a set of signs and symptoms that develops in association with sudden cessation or reduction in the use of alcohol or a number of prescription (particularly opioids and benzodiazepines), over-the-counter (OTC), or illicit drugs. Withdrawal syndromes encompass a broad range of symptoms from mild anxiety and tremulousness to more serious manifestations such as delirium tremens, which occurs in up to 5% of alcohol-dependent persons who undergo withdrawal.1 Withdrawal may occur before hospitalization or during the course of hospitalization. Alcohol- and substance-related disorders account for more than 400,000 hospital discharges each year and are associated with a mean length of stay of approximately 4.6 days.2 Alcohol and drug dependence is often an end product of a combination of biopsychosocial influences, and in most cases, a multidisciplinary approach is necessary to successfully treat affected individuals. Hospitalists can lead their institutions in evidence-based treatment protocols that improve care, reduce costs and length of stay, and facilitate better overall outcomes in patients with substance-related withdrawal syndromes. 

Want all 52 JHM Core Competency articles in an easy-to-read compendium? Order your copy now from Amazon.com.

KNOWLEDGE

Hospitalists should be able to:

  • Describe the effects of drug and alcohol withdrawal on medical illness and the effects of medical illness on substance withdrawal.

  • Recognize the symptoms and signs of alcohol and drug withdrawal, including withdrawal from prescription and OTC drugs.

  • Recognize the medical complications from substance use and dependence.

  • Determine when consultation with a medical toxicologist or expert is necessary.

  • Distinguish alcohol or drug withdrawal from other causes of delirium.

  • Differentiate delirium tremens from other alcohol withdrawal syndromes.

  • Differentiate the clinical manifestations of alcohol or drug intoxication from those of withdrawal.

  • Recognize different characteristic withdrawal syndromes, such as abstinence syndrome of opioid withdrawal and delirium tremens of alcohol withdrawal.

  • Describe the tests indicated to evaluate alcohol or drug withdrawal.

  • Identify patients at increased risk for drug and alcohol withdrawal according to current diagnostic criteria.

  • Explain indications, contraindications, and mechanisms of action of pharmacologic agents used to treat acute alcohol and drug withdrawal.

  • Identify local trends in illicit drug use.

  • Determine the best setting within the hospital to initiate, monitor, evaluate, and treat patients with drug or alcohol withdrawal.

  • Explain patient characteristics that portend a poor prognosis.

  • Explain patient characteristics that indicate a requirement for a higher level of care and/or monitoring.

  • Explain goals for hospital discharge, including specific measures of clinical stability for safe care transitions.

 

 

SKILLS

 

Hospitalists should be able to:

  • Elicit a thorough and relevant medical history, with emphasis on substance use.

  • Assess patients with suspected alcohol or drug withdrawal in a timely manner, identify the level of care required, and manage or comanage the patient with the primary requesting service.

  • Perform a rapid, efficient, and targeted physical examination to assess for alcohol or drug withdrawal and determine whether life-threatening comorbidities are present.

  • Assess for common comorbidities in patients with a history of alcohol and drug use.

  • Formulate a treatment plan tailored to the individual patient, which may include appropriate pharmacologic agents and dosing, route of administration, and nutritional supplementation.

  • Integrate existing literature and federal regulations into the management of patients with opioid withdrawal syndromes. For patients who are undergoing existing treatment for opioid dependency, communicate with outpatient treatment centers and integrate dosing regimens into care management.

  • Manage withdrawal syndromes in patients with concomitant medical or surgical issues.

  • Diagnose oversedation and other complications associated with withdrawal therapies.

  • Recommend the use of restraints and direct observation to ensure patient safety when appropriate.

  • Reassure, reorient, and frequently monitor patients in a calm environment.

  • Use the acute hospitalization as an opportunity to counsel patients about abstinence, recovery, and the medical risks of drug and alcohol use.

  • Initiate preventive measures before discharge, including alcohol and drug cessation measures.

  • Facilitate discharge planning early in the hospitalization, including communicating with the primary care provider and presenting the patient with contact information for follow-up care, support, and rehabilitation.

  • Communicate with patients and families to explain the goals of care, discharge instructions, and management after hospital discharge to ensure safe follow-up and transition of care. 

 

 

ATTITUDES 

 

 

Hospitalists should be able to:

  • Employ a multidisciplinary approach, which may include psychiatry, pharmacy, nursing, and social services, in the treatment of patients with substance use or dependency.

  • Follow evidence-based national recommendations to guide diagnosis, monitoring, and treatment of withdrawal symptoms.

  • Act in a nonjudgmental manner when managing the hospitalized patient with substance use.

  • Establish and maintain an open dialogue with patients and families regarding care goals and limitations.

  • Appreciate and document the value of appropriate treatment in reducing mortality, duration of delirium, time required to control agitation, adequate control of delirium, treatment of complications, and cost. 

 

 

SYSTEM ORGANIZATION AND IMPROVEMENT 

To improve efficiency and quality within their organizations, hospitalists should:

  • Lead, coordinate, and/or participate in multidisciplinary teams, which may include psychiatry and toxicology, to improve patient safety and management strategies for patients with substance abuse.

  • Lead, coordinate, and/or participate in the development and promotion of guidelines and/or pathways that facilitate efficient and timely evaluation and treatment of patients with alcohol and drug withdrawal.

  • Promote the development and use of evidence-based guidelines and protocols for the treatment of withdrawal syndromes.

  • Advocate for hospital resources to improve the care of patients with substance withdrawal and the environment in which the care is delivered.

  • Establish relationships with and develop knowledge of community-based organizations that provide support to patients with substance use disorders.

  • Promote awareness of substance use disorders and screening for them.

  • Coordinate initiatives to address the increased risk of readmissions associated with substance and polysubstance abuse.

 

 
References

1. Mayo-Smith MF. Pharmacological management of alcohol withdrawal. A meta-analysis and evidence-based practice guideline. American Society of Addiction Medicine Working Group on Pharmacological Management of Alcohol Withdrawal. JAMA. 1997;278(2):144-151.
2. Agency for Healthcare Research and Quality. Healthcare Cost and Utilization Project. U.S. Department of Health & Human Services. Available at: http://hcupnet.ahrq.gov/. Accessed May 2015.

References

1. Mayo-Smith MF. Pharmacological management of alcohol withdrawal. A meta-analysis and evidence-based practice guideline. American Society of Addiction Medicine Working Group on Pharmacological Management of Alcohol Withdrawal. JAMA. 1997;278(2):144-151.
2. Agency for Healthcare Research and Quality. Healthcare Cost and Utilization Project. U.S. Department of Health & Human Services. Available at: http://hcupnet.ahrq.gov/. Accessed May 2015.

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Asthma. 2017 Hospital Medicine Revised Core Competencies

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1.4 Asthma

Asthma is a chronic disease characterized by airway inflammation and reversible airflow limitation. It is one of the most common chronic conditions and it leads to marked morbidity and mortality in hospitalized patients. In the United States, 1 in 12 persons has asthma and nearly 50% of affected individuals experience an asthma exacerbation each year, accounting for 1.8 million emergency department visits.1,2 Annually, more than 400,000 hospital discharges occur with asthma as the primary diagnosis, with an average length of stay of 3.2 days.2Hospitalists are central to the provision of care for patients with asthma through the use of evidence-based approaches to manage acute exacerbations and to prevent their recurrence. Hospitalists should strive to lead multidisciplinary teams to develop institutional guidelines and/or care pathways to improve efficiency and quality of care and to reduce readmission rates and morbidity and mortality from asthma. 

Want all 52 JHM Core Competency articles in an easy-to-read compendium? Order your copy now from Amazon.com.

KNOWLEDGE

Hospitalists should be able to:

  • Define asthma and describe the pathophysiologic processes that lead to reversible airway obstruction and inflammation.

  • Identify precipitants of asthma exacerbation, including environmental and occupational exposures.

  • Recognize the clinical presentation of asthma exacerbation and differentiate it from other acute respiratory and nonrespiratory syndromes.

  • Describe the role of diagnostic testing, including peak flow monitoring, used for evaluation of asthma exacerbation.

  • Recognize indications for specialty consultation, including pulmonary and allergy medicine.

  • Describe evidence-based therapies for the treatment of asthma exacerbations, which may include bronchodilators, systemic corticosteroids, and oxygen.

  • Explain indications, contraindications, and mechanisms of action of pharmacologic agents used to treat asthma.

  • Recognize signs and symptoms of impending respiratory failure.

  • Explain the indications for invasive and noninvasive ventilatory support.

  • List the risk factors for disease severity and death from asthma.

  • Explain goals for hospital discharge, including specific measures of clinical stability for safe care transition.

 

 

SKILLS

 

Hospitalists should be able to:

  • Elicit a thorough and relevant medical history to identify triggers of asthma and symptoms consistent with asthma exacerbation.

  • Perform a targeted physical examination to elicit signs consistent with asthma exacerbation, differentiate findings from those of other mimicking conditions, and assess illness severity.

  • Select appropriate diagnostic studies to evaluate severity of asthma exacerbation and interpret the results.

  • Recognize indications for transfer to the intensive care unit, including impending respiratory failure, and coordinate intubation or noninvasive mechanical ventilation when indicated.

  • Prescribe appropriate evidence-based pharmacologic therapies during asthma exacerbation, recommending the most appropriate route, dose, frequency, and duration of treatment.

  • Communicate with patients and families to explain the natural history and prognosis of asthma.

  • Facilitate discharge planning early during hospitalization.

  • Develop an asthma action plan in preparation for discharge.

  • Educate patients and families regarding the indications and appropriate use of daily use inhalers and rescue inhalers for asthmatic control.

  • Ensure that patients receive training of proper inhaler and peak flow techniques before hospital discharge.

  • Communicate with patients and families to explain symptoms and signs that should prompt emergent medical attention.

  • Communicate with patients and families to explain the goals of care, including clinical stability criteria, the importance of preventive measures (such as smoking cessation, avoidance of second-hand smoke, appropriate vaccinations, and modification of environmental exposures), and required follow-up care.

  • Communicate with patients and families to explain discharge medications, potential adverse effects, duration of therapy and dosing, and taper schedule.

  • Document the treatment plan and provide clear discharge instructions for postdischarge clinicians.

  • Provide and coordinate resources to ensure safe transition from the hospital to arranged follow-up care. 

 

 

ATTITUDES 

 

 

Hospitalists should be able to:

  • Work collaboratively with primary care physicians and emergency physicians in making admission decisions.

  • Employ a multidisciplinary approach, which may include pulmonary medicine, respiratory therapy, nursing, and social services, in the care of patients with asthma exacerbation.

  • Follow evidence-based recommendations for the treatment of patients with asthma exacerbations. 

 

 

SYSTEM ORGANIZATION AND IMPROVEMENT 

To improve efficiency and quality within their organizations, hospitalists should:

  • Contribute to and/or develop educational modules, order sets, and/or pathways that facilitate use of evidence-based strategies for asthma exacerbation in the emergency department and the hospital, with goals of improving outcomes, decreasing length of stay, and reducing rehospitalization rates.

  • Lead, coordinate, and/or participate in efforts to educate staff on the importance of smoking cessation counseling and other preventive measures.

  • Lead, coordinate, and/or participate in multidisciplinary initiatives, which may include collaborative efforts with pulmonologists and respiratory therapists, to promote patient safety and optimize cost-effective diagnostic and management strategies for patients with asthma.

 

 
References

1. Centers for Disease Control and Prevention. CDC Vital Signs: Asthma in the US. Available at: http://www.cdc.gov/vitalsigns/asthma/. Accessed June 2015.
2. Agency for Healthcare Research and Quality. Healthcare Cost and Utilization Project. U.S. Department of Health & Human Services. Available at: http://hcupnet.ahrq.gov/. Accessed June 2015.

Article PDF
Issue
Journal of Hospital Medicine 12(S1)
Topics
Sections
Article PDF
Article PDF

Asthma is a chronic disease characterized by airway inflammation and reversible airflow limitation. It is one of the most common chronic conditions and it leads to marked morbidity and mortality in hospitalized patients. In the United States, 1 in 12 persons has asthma and nearly 50% of affected individuals experience an asthma exacerbation each year, accounting for 1.8 million emergency department visits.1,2 Annually, more than 400,000 hospital discharges occur with asthma as the primary diagnosis, with an average length of stay of 3.2 days.2Hospitalists are central to the provision of care for patients with asthma through the use of evidence-based approaches to manage acute exacerbations and to prevent their recurrence. Hospitalists should strive to lead multidisciplinary teams to develop institutional guidelines and/or care pathways to improve efficiency and quality of care and to reduce readmission rates and morbidity and mortality from asthma. 

Want all 52 JHM Core Competency articles in an easy-to-read compendium? Order your copy now from Amazon.com.

KNOWLEDGE

Hospitalists should be able to:

  • Define asthma and describe the pathophysiologic processes that lead to reversible airway obstruction and inflammation.

  • Identify precipitants of asthma exacerbation, including environmental and occupational exposures.

  • Recognize the clinical presentation of asthma exacerbation and differentiate it from other acute respiratory and nonrespiratory syndromes.

  • Describe the role of diagnostic testing, including peak flow monitoring, used for evaluation of asthma exacerbation.

  • Recognize indications for specialty consultation, including pulmonary and allergy medicine.

  • Describe evidence-based therapies for the treatment of asthma exacerbations, which may include bronchodilators, systemic corticosteroids, and oxygen.

  • Explain indications, contraindications, and mechanisms of action of pharmacologic agents used to treat asthma.

  • Recognize signs and symptoms of impending respiratory failure.

  • Explain the indications for invasive and noninvasive ventilatory support.

  • List the risk factors for disease severity and death from asthma.

  • Explain goals for hospital discharge, including specific measures of clinical stability for safe care transition.

 

 

SKILLS

 

Hospitalists should be able to:

  • Elicit a thorough and relevant medical history to identify triggers of asthma and symptoms consistent with asthma exacerbation.

  • Perform a targeted physical examination to elicit signs consistent with asthma exacerbation, differentiate findings from those of other mimicking conditions, and assess illness severity.

  • Select appropriate diagnostic studies to evaluate severity of asthma exacerbation and interpret the results.

  • Recognize indications for transfer to the intensive care unit, including impending respiratory failure, and coordinate intubation or noninvasive mechanical ventilation when indicated.

  • Prescribe appropriate evidence-based pharmacologic therapies during asthma exacerbation, recommending the most appropriate route, dose, frequency, and duration of treatment.

  • Communicate with patients and families to explain the natural history and prognosis of asthma.

  • Facilitate discharge planning early during hospitalization.

  • Develop an asthma action plan in preparation for discharge.

  • Educate patients and families regarding the indications and appropriate use of daily use inhalers and rescue inhalers for asthmatic control.

  • Ensure that patients receive training of proper inhaler and peak flow techniques before hospital discharge.

  • Communicate with patients and families to explain symptoms and signs that should prompt emergent medical attention.

  • Communicate with patients and families to explain the goals of care, including clinical stability criteria, the importance of preventive measures (such as smoking cessation, avoidance of second-hand smoke, appropriate vaccinations, and modification of environmental exposures), and required follow-up care.

  • Communicate with patients and families to explain discharge medications, potential adverse effects, duration of therapy and dosing, and taper schedule.

  • Document the treatment plan and provide clear discharge instructions for postdischarge clinicians.

  • Provide and coordinate resources to ensure safe transition from the hospital to arranged follow-up care. 

 

 

ATTITUDES 

 

 

Hospitalists should be able to:

  • Work collaboratively with primary care physicians and emergency physicians in making admission decisions.

  • Employ a multidisciplinary approach, which may include pulmonary medicine, respiratory therapy, nursing, and social services, in the care of patients with asthma exacerbation.

  • Follow evidence-based recommendations for the treatment of patients with asthma exacerbations. 

 

 

SYSTEM ORGANIZATION AND IMPROVEMENT 

To improve efficiency and quality within their organizations, hospitalists should:

  • Contribute to and/or develop educational modules, order sets, and/or pathways that facilitate use of evidence-based strategies for asthma exacerbation in the emergency department and the hospital, with goals of improving outcomes, decreasing length of stay, and reducing rehospitalization rates.

  • Lead, coordinate, and/or participate in efforts to educate staff on the importance of smoking cessation counseling and other preventive measures.

  • Lead, coordinate, and/or participate in multidisciplinary initiatives, which may include collaborative efforts with pulmonologists and respiratory therapists, to promote patient safety and optimize cost-effective diagnostic and management strategies for patients with asthma.

 

 

Asthma is a chronic disease characterized by airway inflammation and reversible airflow limitation. It is one of the most common chronic conditions and it leads to marked morbidity and mortality in hospitalized patients. In the United States, 1 in 12 persons has asthma and nearly 50% of affected individuals experience an asthma exacerbation each year, accounting for 1.8 million emergency department visits.1,2 Annually, more than 400,000 hospital discharges occur with asthma as the primary diagnosis, with an average length of stay of 3.2 days.2Hospitalists are central to the provision of care for patients with asthma through the use of evidence-based approaches to manage acute exacerbations and to prevent their recurrence. Hospitalists should strive to lead multidisciplinary teams to develop institutional guidelines and/or care pathways to improve efficiency and quality of care and to reduce readmission rates and morbidity and mortality from asthma. 

Want all 52 JHM Core Competency articles in an easy-to-read compendium? Order your copy now from Amazon.com.

KNOWLEDGE

Hospitalists should be able to:

  • Define asthma and describe the pathophysiologic processes that lead to reversible airway obstruction and inflammation.

  • Identify precipitants of asthma exacerbation, including environmental and occupational exposures.

  • Recognize the clinical presentation of asthma exacerbation and differentiate it from other acute respiratory and nonrespiratory syndromes.

  • Describe the role of diagnostic testing, including peak flow monitoring, used for evaluation of asthma exacerbation.

  • Recognize indications for specialty consultation, including pulmonary and allergy medicine.

  • Describe evidence-based therapies for the treatment of asthma exacerbations, which may include bronchodilators, systemic corticosteroids, and oxygen.

  • Explain indications, contraindications, and mechanisms of action of pharmacologic agents used to treat asthma.

  • Recognize signs and symptoms of impending respiratory failure.

  • Explain the indications for invasive and noninvasive ventilatory support.

  • List the risk factors for disease severity and death from asthma.

  • Explain goals for hospital discharge, including specific measures of clinical stability for safe care transition.

 

 

SKILLS

 

Hospitalists should be able to:

  • Elicit a thorough and relevant medical history to identify triggers of asthma and symptoms consistent with asthma exacerbation.

  • Perform a targeted physical examination to elicit signs consistent with asthma exacerbation, differentiate findings from those of other mimicking conditions, and assess illness severity.

  • Select appropriate diagnostic studies to evaluate severity of asthma exacerbation and interpret the results.

  • Recognize indications for transfer to the intensive care unit, including impending respiratory failure, and coordinate intubation or noninvasive mechanical ventilation when indicated.

  • Prescribe appropriate evidence-based pharmacologic therapies during asthma exacerbation, recommending the most appropriate route, dose, frequency, and duration of treatment.

  • Communicate with patients and families to explain the natural history and prognosis of asthma.

  • Facilitate discharge planning early during hospitalization.

  • Develop an asthma action plan in preparation for discharge.

  • Educate patients and families regarding the indications and appropriate use of daily use inhalers and rescue inhalers for asthmatic control.

  • Ensure that patients receive training of proper inhaler and peak flow techniques before hospital discharge.

  • Communicate with patients and families to explain symptoms and signs that should prompt emergent medical attention.

  • Communicate with patients and families to explain the goals of care, including clinical stability criteria, the importance of preventive measures (such as smoking cessation, avoidance of second-hand smoke, appropriate vaccinations, and modification of environmental exposures), and required follow-up care.

  • Communicate with patients and families to explain discharge medications, potential adverse effects, duration of therapy and dosing, and taper schedule.

  • Document the treatment plan and provide clear discharge instructions for postdischarge clinicians.

  • Provide and coordinate resources to ensure safe transition from the hospital to arranged follow-up care. 

 

 

ATTITUDES 

 

 

Hospitalists should be able to:

  • Work collaboratively with primary care physicians and emergency physicians in making admission decisions.

  • Employ a multidisciplinary approach, which may include pulmonary medicine, respiratory therapy, nursing, and social services, in the care of patients with asthma exacerbation.

  • Follow evidence-based recommendations for the treatment of patients with asthma exacerbations. 

 

 

SYSTEM ORGANIZATION AND IMPROVEMENT 

To improve efficiency and quality within their organizations, hospitalists should:

  • Contribute to and/or develop educational modules, order sets, and/or pathways that facilitate use of evidence-based strategies for asthma exacerbation in the emergency department and the hospital, with goals of improving outcomes, decreasing length of stay, and reducing rehospitalization rates.

  • Lead, coordinate, and/or participate in efforts to educate staff on the importance of smoking cessation counseling and other preventive measures.

  • Lead, coordinate, and/or participate in multidisciplinary initiatives, which may include collaborative efforts with pulmonologists and respiratory therapists, to promote patient safety and optimize cost-effective diagnostic and management strategies for patients with asthma.

 

 
References

1. Centers for Disease Control and Prevention. CDC Vital Signs: Asthma in the US. Available at: http://www.cdc.gov/vitalsigns/asthma/. Accessed June 2015.
2. Agency for Healthcare Research and Quality. Healthcare Cost and Utilization Project. U.S. Department of Health & Human Services. Available at: http://hcupnet.ahrq.gov/. Accessed June 2015.

References

1. Centers for Disease Control and Prevention. CDC Vital Signs: Asthma in the US. Available at: http://www.cdc.gov/vitalsigns/asthma/. Accessed June 2015.
2. Agency for Healthcare Research and Quality. Healthcare Cost and Utilization Project. U.S. Department of Health & Human Services. Available at: http://hcupnet.ahrq.gov/. Accessed June 2015.

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Cardiac Arrhythmia. 2017 Hospital Medicine Revised Core Competencies

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Display Headline
1.5 Cardiac Arrhythmia

Cardiac arrhythmias are a group of conditions characterized by an abnormal heart rate or rhythm. These are common and affect approximately 5% of the population in the United States. More than 250,000 Americans die each year of sudden cardiac arrest, and most cases are thought to be due to ventricular fibrillation or ventricular tachycardia.1 Several cardiac arrhythmias can cause instability, prompting hospitalization, or they may result from complications during hospitalization. Annually, more than 740,000 hospital discharges are associated with a primary diagnosis of cardiac arrhythmia.2 Hospitalists identify and treat all types of arrhythmias, coordinate specialty and primary care resources, and transition patients safely and cost-effectively through the acute hospitalization and into the outpatient setting. 

Want all 52 JHM Core Competency articles in an easy-to-read compendium? Order your copy now from Amazon.com.

KNOWLEDGE

Hospitalists should be able to:

  • Identify and differentiate the common clinical presentations of both benign and pathologic arrhythmias.

  • Explain the causes of atrial and ventricular arrhythmias.

  • Describe the indicated tests required to evaluate arrhythmias.

  • Explain how medications, metabolic abnormalities, and medical comorbidities may precipitate various arrhythmias.

  • Explain indications, contraindications, and mechanisms of action of pharmacologic agents used to treat cardiac arrhythmias. Discuss the management options and goals for patients hospitalized with arrhythmias.

  • Describe the patient characteristics and comorbid conditions that predict outcomes in patients with arrhythmias.

  • Recognize indications for specialty consultation, which may include cardiology and cardiac electrophysiology.

  • Explain goals for hospital discharge, including specific measures of clinical stability for safe care transitions.

  • Recall appropriate indications for both initiation and discontinuation of continuous telemetry monitoring in the hospitalized patient.

 

 

SKILLS

 

Hospitalists should be able to:

  • Elicit a thorough and relevant medical history, including medications, family history, and social history.

  • Perform a targeted physical examination with emphasis on identifying signs associated with hemodynamic instability, tissue perfusion, and occult cardiac and vascular disease.

  • Identify common benign and pathologic arrhythmias on electrocardiography, rhythm strips, and continuous telemetry monitoring.

  • Determine the appropriate level of care required based on risk stratification of patients with cardiac arrhythmias.

  • Identify and prioritize high-risk arrhythmias that require urgent intervention and implement emergency protocols as indicated.

  • Formulate patient-specific and evidence-based care plans incorporating diagnostic findings, prognosis, and patient characteristics.

  • Develop patient-specific care plans that may include rate-controlling interventions, cardioversion, defibrillation, or implantable medical devices.

  • Communicate with patients and families to explain the natural history and prognosis of cardiac arrhythmias.

  • Communicate with patients and families to explain tests and procedures and their indications and to obtain informed consent.

  • Communicate with patients and families to explain drug interactions for antiarrhythmic drugs and the importance of strict adherence to medication regimens and laboratory monitoring.

  • Facilitate discharge planning early during hospitalization.

  • Communicate with patients and families to explain the goals of care, discharge instructions, and management after hospital discharge to ensure safe follow-up and transitions of care.

  • Document the treatment plan and provide clear discharge instructions for postdischarge clinicians. 

 

 

ATTITUDES 

 

 

Hospitalists should be able to:

  • Employ a multidisciplinary approach, which may include primary care, cardiology, nursing, and social services, in the care of patients with cardiac arrhythmias that begins at admission and continues through all care transitions.

  • Follow evidence-based recommendations to guide diagnosis, monitoring, and treatment of cardiac arrhythmias.

  • Acknowledge and ameliorate patient discomfort from uncontrolled arrhythmias and electrical cardioversion therapies. 

 

 

SYSTEM ORGANIZATION AND IMPROVEMENT 

To improve efficiency and quality within their organizations, hospitalists should:

  • Lead, coordinate, and/or participate in multidisciplinary teams to develop patient care guidelines and/or pathways on the basis of peer-reviewed outcomes research, patient and physician satisfaction, and cost.

  • Implement systems to ensure hospital-wide adherence to national standards and document those measures as specified by recognized organizations (eg, The Joint Commission, American Heart Association, American College of Cardiology, Agency for Healthcare Research and Quality).

  • Lead, coordinate, and/or participate in quality improvement initiatives to promote early identification of arrhythmias, reduce preventable complications, and promote appropriate use of telemetry resources.

 

 
Article PDF
Issue
Journal of Hospital Medicine 12(S1)
Topics
Sections
Article PDF
Article PDF

Cardiac arrhythmias are a group of conditions characterized by an abnormal heart rate or rhythm. These are common and affect approximately 5% of the population in the United States. More than 250,000 Americans die each year of sudden cardiac arrest, and most cases are thought to be due to ventricular fibrillation or ventricular tachycardia.1 Several cardiac arrhythmias can cause instability, prompting hospitalization, or they may result from complications during hospitalization. Annually, more than 740,000 hospital discharges are associated with a primary diagnosis of cardiac arrhythmia.2 Hospitalists identify and treat all types of arrhythmias, coordinate specialty and primary care resources, and transition patients safely and cost-effectively through the acute hospitalization and into the outpatient setting. 

Want all 52 JHM Core Competency articles in an easy-to-read compendium? Order your copy now from Amazon.com.

KNOWLEDGE

Hospitalists should be able to:

  • Identify and differentiate the common clinical presentations of both benign and pathologic arrhythmias.

  • Explain the causes of atrial and ventricular arrhythmias.

  • Describe the indicated tests required to evaluate arrhythmias.

  • Explain how medications, metabolic abnormalities, and medical comorbidities may precipitate various arrhythmias.

  • Explain indications, contraindications, and mechanisms of action of pharmacologic agents used to treat cardiac arrhythmias. Discuss the management options and goals for patients hospitalized with arrhythmias.

  • Describe the patient characteristics and comorbid conditions that predict outcomes in patients with arrhythmias.

  • Recognize indications for specialty consultation, which may include cardiology and cardiac electrophysiology.

  • Explain goals for hospital discharge, including specific measures of clinical stability for safe care transitions.

  • Recall appropriate indications for both initiation and discontinuation of continuous telemetry monitoring in the hospitalized patient.

 

 

SKILLS

 

Hospitalists should be able to:

  • Elicit a thorough and relevant medical history, including medications, family history, and social history.

  • Perform a targeted physical examination with emphasis on identifying signs associated with hemodynamic instability, tissue perfusion, and occult cardiac and vascular disease.

  • Identify common benign and pathologic arrhythmias on electrocardiography, rhythm strips, and continuous telemetry monitoring.

  • Determine the appropriate level of care required based on risk stratification of patients with cardiac arrhythmias.

  • Identify and prioritize high-risk arrhythmias that require urgent intervention and implement emergency protocols as indicated.

  • Formulate patient-specific and evidence-based care plans incorporating diagnostic findings, prognosis, and patient characteristics.

  • Develop patient-specific care plans that may include rate-controlling interventions, cardioversion, defibrillation, or implantable medical devices.

  • Communicate with patients and families to explain the natural history and prognosis of cardiac arrhythmias.

  • Communicate with patients and families to explain tests and procedures and their indications and to obtain informed consent.

  • Communicate with patients and families to explain drug interactions for antiarrhythmic drugs and the importance of strict adherence to medication regimens and laboratory monitoring.

  • Facilitate discharge planning early during hospitalization.

  • Communicate with patients and families to explain the goals of care, discharge instructions, and management after hospital discharge to ensure safe follow-up and transitions of care.

  • Document the treatment plan and provide clear discharge instructions for postdischarge clinicians. 

 

 

ATTITUDES 

 

 

Hospitalists should be able to:

  • Employ a multidisciplinary approach, which may include primary care, cardiology, nursing, and social services, in the care of patients with cardiac arrhythmias that begins at admission and continues through all care transitions.

  • Follow evidence-based recommendations to guide diagnosis, monitoring, and treatment of cardiac arrhythmias.

  • Acknowledge and ameliorate patient discomfort from uncontrolled arrhythmias and electrical cardioversion therapies. 

 

 

SYSTEM ORGANIZATION AND IMPROVEMENT 

To improve efficiency and quality within their organizations, hospitalists should:

  • Lead, coordinate, and/or participate in multidisciplinary teams to develop patient care guidelines and/or pathways on the basis of peer-reviewed outcomes research, patient and physician satisfaction, and cost.

  • Implement systems to ensure hospital-wide adherence to national standards and document those measures as specified by recognized organizations (eg, The Joint Commission, American Heart Association, American College of Cardiology, Agency for Healthcare Research and Quality).

  • Lead, coordinate, and/or participate in quality improvement initiatives to promote early identification of arrhythmias, reduce preventable complications, and promote appropriate use of telemetry resources.

 

 

Cardiac arrhythmias are a group of conditions characterized by an abnormal heart rate or rhythm. These are common and affect approximately 5% of the population in the United States. More than 250,000 Americans die each year of sudden cardiac arrest, and most cases are thought to be due to ventricular fibrillation or ventricular tachycardia.1 Several cardiac arrhythmias can cause instability, prompting hospitalization, or they may result from complications during hospitalization. Annually, more than 740,000 hospital discharges are associated with a primary diagnosis of cardiac arrhythmia.2 Hospitalists identify and treat all types of arrhythmias, coordinate specialty and primary care resources, and transition patients safely and cost-effectively through the acute hospitalization and into the outpatient setting. 

Want all 52 JHM Core Competency articles in an easy-to-read compendium? Order your copy now from Amazon.com.

KNOWLEDGE

Hospitalists should be able to:

  • Identify and differentiate the common clinical presentations of both benign and pathologic arrhythmias.

  • Explain the causes of atrial and ventricular arrhythmias.

  • Describe the indicated tests required to evaluate arrhythmias.

  • Explain how medications, metabolic abnormalities, and medical comorbidities may precipitate various arrhythmias.

  • Explain indications, contraindications, and mechanisms of action of pharmacologic agents used to treat cardiac arrhythmias. Discuss the management options and goals for patients hospitalized with arrhythmias.

  • Describe the patient characteristics and comorbid conditions that predict outcomes in patients with arrhythmias.

  • Recognize indications for specialty consultation, which may include cardiology and cardiac electrophysiology.

  • Explain goals for hospital discharge, including specific measures of clinical stability for safe care transitions.

  • Recall appropriate indications for both initiation and discontinuation of continuous telemetry monitoring in the hospitalized patient.

 

 

SKILLS

 

Hospitalists should be able to:

  • Elicit a thorough and relevant medical history, including medications, family history, and social history.

  • Perform a targeted physical examination with emphasis on identifying signs associated with hemodynamic instability, tissue perfusion, and occult cardiac and vascular disease.

  • Identify common benign and pathologic arrhythmias on electrocardiography, rhythm strips, and continuous telemetry monitoring.

  • Determine the appropriate level of care required based on risk stratification of patients with cardiac arrhythmias.

  • Identify and prioritize high-risk arrhythmias that require urgent intervention and implement emergency protocols as indicated.

  • Formulate patient-specific and evidence-based care plans incorporating diagnostic findings, prognosis, and patient characteristics.

  • Develop patient-specific care plans that may include rate-controlling interventions, cardioversion, defibrillation, or implantable medical devices.

  • Communicate with patients and families to explain the natural history and prognosis of cardiac arrhythmias.

  • Communicate with patients and families to explain tests and procedures and their indications and to obtain informed consent.

  • Communicate with patients and families to explain drug interactions for antiarrhythmic drugs and the importance of strict adherence to medication regimens and laboratory monitoring.

  • Facilitate discharge planning early during hospitalization.

  • Communicate with patients and families to explain the goals of care, discharge instructions, and management after hospital discharge to ensure safe follow-up and transitions of care.

  • Document the treatment plan and provide clear discharge instructions for postdischarge clinicians. 

 

 

ATTITUDES 

 

 

Hospitalists should be able to:

  • Employ a multidisciplinary approach, which may include primary care, cardiology, nursing, and social services, in the care of patients with cardiac arrhythmias that begins at admission and continues through all care transitions.

  • Follow evidence-based recommendations to guide diagnosis, monitoring, and treatment of cardiac arrhythmias.

  • Acknowledge and ameliorate patient discomfort from uncontrolled arrhythmias and electrical cardioversion therapies. 

 

 

SYSTEM ORGANIZATION AND IMPROVEMENT 

To improve efficiency and quality within their organizations, hospitalists should:

  • Lead, coordinate, and/or participate in multidisciplinary teams to develop patient care guidelines and/or pathways on the basis of peer-reviewed outcomes research, patient and physician satisfaction, and cost.

  • Implement systems to ensure hospital-wide adherence to national standards and document those measures as specified by recognized organizations (eg, The Joint Commission, American Heart Association, American College of Cardiology, Agency for Healthcare Research and Quality).

  • Lead, coordinate, and/or participate in quality improvement initiatives to promote early identification of arrhythmias, reduce preventable complications, and promote appropriate use of telemetry resources.

 

 
Issue
Journal of Hospital Medicine 12(S1)
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1.5 Cardiac Arrhythmia
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Chronic Obstructive Pulmonary Disease. 2017 Hospital Medicine Revised Core Competencies

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1.6 Chronic Obstructive Pulmonary Disease

Chronic obstructive pulmonary disease (COPD) is a heterogeneous group of respiratory conditions, predominantly composed of chronic bronchitis and emphysema. COPD is defined by airflow limitation that is not completely reversible, and it is associated with an abnormal airway inflammatory response. Exposure to tobacco smoke is the main risk factor. COPD affects more than 12 million Americans and is the third leading cause of death in the United States. A COPD exacerbation is defined as an increase in the usual symptoms of COPD that is beyond day-to-day variations and leads to a change in medication and often results in hospitalization. Annually, more than 670,000 hospital discharges occur with COPD as the primary diagnosis, and nearly 1 of every 5 hospitalized patients 40 years or older has COPD.1,2The average length of stay is 4.3 days.1 COPD is a substantial cause of disability and carries a large economic burden, accounting for almost $17 billion of total hospital charges billed to Medicare each year.3 The early detection and prompt treatment of exacerbations are essential to ensure optimal outcomes and to reduce the burden of COPD. Hospitalists use evidence-based approaches to optimize care, and they should strive to lead multidisciplinary teams to develop institutional guidelines and/or care pathways to reduce readmission rates and mortality from COPD exacerbations. 

Want all 52 JHM Core Competency articles in an easy-to-read compendium? Order your copy now from Amazon.com.

KNOWLEDGE

Hospitalists should be able to:

  • Define COPD and describe the pathophysiologic processes that lead to small airway obstruction and alveolar destruction.

  • Describe potential precipitants of exacerbation, including both infectious and noninfectious etiologies.

  • Differentiate the clinical presentation of a COPD exacerbation from asthma, heart failure, and other acute respiratory and nonrespiratory syndromes.

  • List the indicators of disease severity.

  • Describe the role of diagnostic testing used for the evaluation of COPD.

  • Describe the role of pulmonary function tests in the treatment of a COPD exacerbation.

  • Distinguish the medical management of patients with COPD exacerbations from that of patients with stable COPD.

  • Recognize indications for specialty consultation, which may include pulmonary medicine.

  • Describe the evidence-based therapies for treatment of COPD exacerbations, which may include bronchodilators, systemic corticosteroids, oxygen, and antibiotics.

  • Identify the potential risks of supplemental oxygen therapy, including development of hypercarbia in patients with chronic respiratory acidosis.

  • Explain indications, contraindications, and mechanisms of action of pharmacologic agents used to treat COPD.

  • Describe and differentiate the means of ventilatory support, including the use of noninvasive positive pressure ventilation in COPD exacerbation.

  • Recognize anxiety and depression as important comorbid conditions that negatively affect outcomes.

  • Explain goals for hospital discharge, including specific measures of clinical stability for safe care transition.

 

 

SKILLS

 

Hospitalists should be able to:

  • Elicit a thorough and relevant medical history to identify symptoms consistent with a COPD exacerbation and etiologic precipitants.

  • Perform a targeted physical examination to elicit signs consistent with a COPD exacerbation, differentiate findings from those of other mimicking conditions, and assess illness severity.

  • Diagnose a COPD exacerbation on the basis of history, physical examination, and radiographic data.

  • Select and interpret appropriate diagnostic studies to evaluate the severity of a COPD exacerbation.

  • Recognize symptoms, signs, and severity of impending respiratory failure and select the indicated evidence-based ventilatory approach.

  • Select patients with COPD exacerbation who would benefit from use of positive pressure ventilation and identify those in whom this intervention is contraindicated.

  • Prescribe appropriate evidence-based pharmacologic therapies during COPD exacerbation, recommending the most appropriate drug route, dose, frequency, and duration of treatment.

  • Address treatment preferences, including advance directives early during hospital stay; implement end-of-life decisions by patients and/or families when indicated or desired.

  • Evaluate COPD in perioperative risk assessment, recommend measures to optimize perioperative management of COPD, and manage postoperative complications related to underlying COPD.

  • Identify patients with COPD who may benefit from pulmonary rehabilitation.

  • Communicate with patients and families to explain the natural history and prognosis of COPD.

  • Facilitate discharge planning early during hospitalization.

  • Communicate with patients and families to explain discharge medications, potential adverse effects, duration of therapy and dosing, and taper schedule.

  • Ensure that patients receive training on proper inhaler techniques and use before hospital discharge.

  • Communicate with patients and families to explain the goals of care (including clinical stability criteria, the importance of preventive measures), discharge instructions, and management after hospital discharge to ensure safe follow-up and transitions of care.

  • Document the treatment plan and provide clear discharge instructions for postdischarge clinicians.

  • Provide and coordinate resources to ensure safe transition from the hospital to arranged follow-up care. 

 

 

ATTITUDES 

 

 

Hospitalists should be able to:

  • Employ a multidisciplinary approach, which may include pulmonary medicine, respiratory therapy, nursing, and social services, in the care of patients with a COPD exacerbation, beginning at admission and continuing through all care transitions.

  • Engage in a collaborative way with primary care physicians and emergency physicians in making admission decisions.

  • Promote and encourage preventive strategies, including smoking cessation, vaccinations, and venous thromboembolism prophylaxis.

  • Establish and maintain an open dialogue with patients and/or families regarding goals and limitations of care, including palliative care and end-of-life wishes. 

 

 

SYSTEM ORGANIZATION AND IMPROVEMENT 

To improve efficiency and quality within their organizations, hospitalists should:

  • Lead, coordinate, and/or participate in multidisciplinary initiatives, which may include collaborative efforts with pulmonologists, to promote patient safety and optimize cost-effective diagnostic and management strategies for patients with COPD.

  • Lead, coordinate, and/or participate in the development of educational modules, order sets, and/or pathways that facilitate use of evidence-based strategies for COPD exacerbation in the emergency department and the hospital, with goals of improving outcomes, decreasing length of stay, and reducing rehospitalization rates.

  • Lead efforts to educate patients and staff on the importance of smoking cessation and other preventive measures.

 

 
References

1. Agency for Healthcare Research and Quality. Healthcare Cost and Utilization Project. U.S. Department of Health & Human Services. Available at: http://hcupnet.ahrq.gov/. Accessed June 2015.
2. Wier LM, Elizhauser A, Pfuntner A, Au DH. Healthcare Cost and Utilization Project (HCUP) Statistical Briefs. Overview of Hospitalizations Among Patients With COPD, 2008. Statistical Brief #106. Rockville, MD; Agency for Health Care Policy and Research (US). 2011. Available at: http://www.ncbi.nlm.nih.gov/books/NBK53969/. Accessed June 2015.
3. Agency for Healthcare Research and Quality. Chronic obstructive pulmonary disease (COPD): hospital 30-day, all-cause, risk-standardized mortality rate following acute exacerbation of COPD. Available at http://www.qualitymeasures.ahrq.gov/content.aspx?id=48198. Accessed June 2015.

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Chronic obstructive pulmonary disease (COPD) is a heterogeneous group of respiratory conditions, predominantly composed of chronic bronchitis and emphysema. COPD is defined by airflow limitation that is not completely reversible, and it is associated with an abnormal airway inflammatory response. Exposure to tobacco smoke is the main risk factor. COPD affects more than 12 million Americans and is the third leading cause of death in the United States. A COPD exacerbation is defined as an increase in the usual symptoms of COPD that is beyond day-to-day variations and leads to a change in medication and often results in hospitalization. Annually, more than 670,000 hospital discharges occur with COPD as the primary diagnosis, and nearly 1 of every 5 hospitalized patients 40 years or older has COPD.1,2The average length of stay is 4.3 days.1 COPD is a substantial cause of disability and carries a large economic burden, accounting for almost $17 billion of total hospital charges billed to Medicare each year.3 The early detection and prompt treatment of exacerbations are essential to ensure optimal outcomes and to reduce the burden of COPD. Hospitalists use evidence-based approaches to optimize care, and they should strive to lead multidisciplinary teams to develop institutional guidelines and/or care pathways to reduce readmission rates and mortality from COPD exacerbations. 

Want all 52 JHM Core Competency articles in an easy-to-read compendium? Order your copy now from Amazon.com.

KNOWLEDGE

Hospitalists should be able to:

  • Define COPD and describe the pathophysiologic processes that lead to small airway obstruction and alveolar destruction.

  • Describe potential precipitants of exacerbation, including both infectious and noninfectious etiologies.

  • Differentiate the clinical presentation of a COPD exacerbation from asthma, heart failure, and other acute respiratory and nonrespiratory syndromes.

  • List the indicators of disease severity.

  • Describe the role of diagnostic testing used for the evaluation of COPD.

  • Describe the role of pulmonary function tests in the treatment of a COPD exacerbation.

  • Distinguish the medical management of patients with COPD exacerbations from that of patients with stable COPD.

  • Recognize indications for specialty consultation, which may include pulmonary medicine.

  • Describe the evidence-based therapies for treatment of COPD exacerbations, which may include bronchodilators, systemic corticosteroids, oxygen, and antibiotics.

  • Identify the potential risks of supplemental oxygen therapy, including development of hypercarbia in patients with chronic respiratory acidosis.

  • Explain indications, contraindications, and mechanisms of action of pharmacologic agents used to treat COPD.

  • Describe and differentiate the means of ventilatory support, including the use of noninvasive positive pressure ventilation in COPD exacerbation.

  • Recognize anxiety and depression as important comorbid conditions that negatively affect outcomes.

  • Explain goals for hospital discharge, including specific measures of clinical stability for safe care transition.

 

 

SKILLS

 

Hospitalists should be able to:

  • Elicit a thorough and relevant medical history to identify symptoms consistent with a COPD exacerbation and etiologic precipitants.

  • Perform a targeted physical examination to elicit signs consistent with a COPD exacerbation, differentiate findings from those of other mimicking conditions, and assess illness severity.

  • Diagnose a COPD exacerbation on the basis of history, physical examination, and radiographic data.

  • Select and interpret appropriate diagnostic studies to evaluate the severity of a COPD exacerbation.

  • Recognize symptoms, signs, and severity of impending respiratory failure and select the indicated evidence-based ventilatory approach.

  • Select patients with COPD exacerbation who would benefit from use of positive pressure ventilation and identify those in whom this intervention is contraindicated.

  • Prescribe appropriate evidence-based pharmacologic therapies during COPD exacerbation, recommending the most appropriate drug route, dose, frequency, and duration of treatment.

  • Address treatment preferences, including advance directives early during hospital stay; implement end-of-life decisions by patients and/or families when indicated or desired.

  • Evaluate COPD in perioperative risk assessment, recommend measures to optimize perioperative management of COPD, and manage postoperative complications related to underlying COPD.

  • Identify patients with COPD who may benefit from pulmonary rehabilitation.

  • Communicate with patients and families to explain the natural history and prognosis of COPD.

  • Facilitate discharge planning early during hospitalization.

  • Communicate with patients and families to explain discharge medications, potential adverse effects, duration of therapy and dosing, and taper schedule.

  • Ensure that patients receive training on proper inhaler techniques and use before hospital discharge.

  • Communicate with patients and families to explain the goals of care (including clinical stability criteria, the importance of preventive measures), discharge instructions, and management after hospital discharge to ensure safe follow-up and transitions of care.

  • Document the treatment plan and provide clear discharge instructions for postdischarge clinicians.

  • Provide and coordinate resources to ensure safe transition from the hospital to arranged follow-up care. 

 

 

ATTITUDES 

 

 

Hospitalists should be able to:

  • Employ a multidisciplinary approach, which may include pulmonary medicine, respiratory therapy, nursing, and social services, in the care of patients with a COPD exacerbation, beginning at admission and continuing through all care transitions.

  • Engage in a collaborative way with primary care physicians and emergency physicians in making admission decisions.

  • Promote and encourage preventive strategies, including smoking cessation, vaccinations, and venous thromboembolism prophylaxis.

  • Establish and maintain an open dialogue with patients and/or families regarding goals and limitations of care, including palliative care and end-of-life wishes. 

 

 

SYSTEM ORGANIZATION AND IMPROVEMENT 

To improve efficiency and quality within their organizations, hospitalists should:

  • Lead, coordinate, and/or participate in multidisciplinary initiatives, which may include collaborative efforts with pulmonologists, to promote patient safety and optimize cost-effective diagnostic and management strategies for patients with COPD.

  • Lead, coordinate, and/or participate in the development of educational modules, order sets, and/or pathways that facilitate use of evidence-based strategies for COPD exacerbation in the emergency department and the hospital, with goals of improving outcomes, decreasing length of stay, and reducing rehospitalization rates.

  • Lead efforts to educate patients and staff on the importance of smoking cessation and other preventive measures.

 

 

Chronic obstructive pulmonary disease (COPD) is a heterogeneous group of respiratory conditions, predominantly composed of chronic bronchitis and emphysema. COPD is defined by airflow limitation that is not completely reversible, and it is associated with an abnormal airway inflammatory response. Exposure to tobacco smoke is the main risk factor. COPD affects more than 12 million Americans and is the third leading cause of death in the United States. A COPD exacerbation is defined as an increase in the usual symptoms of COPD that is beyond day-to-day variations and leads to a change in medication and often results in hospitalization. Annually, more than 670,000 hospital discharges occur with COPD as the primary diagnosis, and nearly 1 of every 5 hospitalized patients 40 years or older has COPD.1,2The average length of stay is 4.3 days.1 COPD is a substantial cause of disability and carries a large economic burden, accounting for almost $17 billion of total hospital charges billed to Medicare each year.3 The early detection and prompt treatment of exacerbations are essential to ensure optimal outcomes and to reduce the burden of COPD. Hospitalists use evidence-based approaches to optimize care, and they should strive to lead multidisciplinary teams to develop institutional guidelines and/or care pathways to reduce readmission rates and mortality from COPD exacerbations. 

Want all 52 JHM Core Competency articles in an easy-to-read compendium? Order your copy now from Amazon.com.

KNOWLEDGE

Hospitalists should be able to:

  • Define COPD and describe the pathophysiologic processes that lead to small airway obstruction and alveolar destruction.

  • Describe potential precipitants of exacerbation, including both infectious and noninfectious etiologies.

  • Differentiate the clinical presentation of a COPD exacerbation from asthma, heart failure, and other acute respiratory and nonrespiratory syndromes.

  • List the indicators of disease severity.

  • Describe the role of diagnostic testing used for the evaluation of COPD.

  • Describe the role of pulmonary function tests in the treatment of a COPD exacerbation.

  • Distinguish the medical management of patients with COPD exacerbations from that of patients with stable COPD.

  • Recognize indications for specialty consultation, which may include pulmonary medicine.

  • Describe the evidence-based therapies for treatment of COPD exacerbations, which may include bronchodilators, systemic corticosteroids, oxygen, and antibiotics.

  • Identify the potential risks of supplemental oxygen therapy, including development of hypercarbia in patients with chronic respiratory acidosis.

  • Explain indications, contraindications, and mechanisms of action of pharmacologic agents used to treat COPD.

  • Describe and differentiate the means of ventilatory support, including the use of noninvasive positive pressure ventilation in COPD exacerbation.

  • Recognize anxiety and depression as important comorbid conditions that negatively affect outcomes.

  • Explain goals for hospital discharge, including specific measures of clinical stability for safe care transition.

 

 

SKILLS

 

Hospitalists should be able to:

  • Elicit a thorough and relevant medical history to identify symptoms consistent with a COPD exacerbation and etiologic precipitants.

  • Perform a targeted physical examination to elicit signs consistent with a COPD exacerbation, differentiate findings from those of other mimicking conditions, and assess illness severity.

  • Diagnose a COPD exacerbation on the basis of history, physical examination, and radiographic data.

  • Select and interpret appropriate diagnostic studies to evaluate the severity of a COPD exacerbation.

  • Recognize symptoms, signs, and severity of impending respiratory failure and select the indicated evidence-based ventilatory approach.

  • Select patients with COPD exacerbation who would benefit from use of positive pressure ventilation and identify those in whom this intervention is contraindicated.

  • Prescribe appropriate evidence-based pharmacologic therapies during COPD exacerbation, recommending the most appropriate drug route, dose, frequency, and duration of treatment.

  • Address treatment preferences, including advance directives early during hospital stay; implement end-of-life decisions by patients and/or families when indicated or desired.

  • Evaluate COPD in perioperative risk assessment, recommend measures to optimize perioperative management of COPD, and manage postoperative complications related to underlying COPD.

  • Identify patients with COPD who may benefit from pulmonary rehabilitation.

  • Communicate with patients and families to explain the natural history and prognosis of COPD.

  • Facilitate discharge planning early during hospitalization.

  • Communicate with patients and families to explain discharge medications, potential adverse effects, duration of therapy and dosing, and taper schedule.

  • Ensure that patients receive training on proper inhaler techniques and use before hospital discharge.

  • Communicate with patients and families to explain the goals of care (including clinical stability criteria, the importance of preventive measures), discharge instructions, and management after hospital discharge to ensure safe follow-up and transitions of care.

  • Document the treatment plan and provide clear discharge instructions for postdischarge clinicians.

  • Provide and coordinate resources to ensure safe transition from the hospital to arranged follow-up care. 

 

 

ATTITUDES 

 

 

Hospitalists should be able to:

  • Employ a multidisciplinary approach, which may include pulmonary medicine, respiratory therapy, nursing, and social services, in the care of patients with a COPD exacerbation, beginning at admission and continuing through all care transitions.

  • Engage in a collaborative way with primary care physicians and emergency physicians in making admission decisions.

  • Promote and encourage preventive strategies, including smoking cessation, vaccinations, and venous thromboembolism prophylaxis.

  • Establish and maintain an open dialogue with patients and/or families regarding goals and limitations of care, including palliative care and end-of-life wishes. 

 

 

SYSTEM ORGANIZATION AND IMPROVEMENT 

To improve efficiency and quality within their organizations, hospitalists should:

  • Lead, coordinate, and/or participate in multidisciplinary initiatives, which may include collaborative efforts with pulmonologists, to promote patient safety and optimize cost-effective diagnostic and management strategies for patients with COPD.

  • Lead, coordinate, and/or participate in the development of educational modules, order sets, and/or pathways that facilitate use of evidence-based strategies for COPD exacerbation in the emergency department and the hospital, with goals of improving outcomes, decreasing length of stay, and reducing rehospitalization rates.

  • Lead efforts to educate patients and staff on the importance of smoking cessation and other preventive measures.

 

 
References

1. Agency for Healthcare Research and Quality. Healthcare Cost and Utilization Project. U.S. Department of Health & Human Services. Available at: http://hcupnet.ahrq.gov/. Accessed June 2015.
2. Wier LM, Elizhauser A, Pfuntner A, Au DH. Healthcare Cost and Utilization Project (HCUP) Statistical Briefs. Overview of Hospitalizations Among Patients With COPD, 2008. Statistical Brief #106. Rockville, MD; Agency for Health Care Policy and Research (US). 2011. Available at: http://www.ncbi.nlm.nih.gov/books/NBK53969/. Accessed June 2015.
3. Agency for Healthcare Research and Quality. Chronic obstructive pulmonary disease (COPD): hospital 30-day, all-cause, risk-standardized mortality rate following acute exacerbation of COPD. Available at http://www.qualitymeasures.ahrq.gov/content.aspx?id=48198. Accessed June 2015.

References

1. Agency for Healthcare Research and Quality. Healthcare Cost and Utilization Project. U.S. Department of Health & Human Services. Available at: http://hcupnet.ahrq.gov/. Accessed June 2015.
2. Wier LM, Elizhauser A, Pfuntner A, Au DH. Healthcare Cost and Utilization Project (HCUP) Statistical Briefs. Overview of Hospitalizations Among Patients With COPD, 2008. Statistical Brief #106. Rockville, MD; Agency for Health Care Policy and Research (US). 2011. Available at: http://www.ncbi.nlm.nih.gov/books/NBK53969/. Accessed June 2015.
3. Agency for Healthcare Research and Quality. Chronic obstructive pulmonary disease (COPD): hospital 30-day, all-cause, risk-standardized mortality rate following acute exacerbation of COPD. Available at http://www.qualitymeasures.ahrq.gov/content.aspx?id=48198. Accessed June 2015.

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