Micrograph showing CLL

Patients with chronic lymphocytic leukemia (CLL) should be routinely monitored for melanoma, according to researchers.

A study of 470 CLL patients showed they have a significantly higher risk of invasive melanoma than the general population.

Most of the melanomas reported in this study were detected via routine surveillance, and most were discovered before they reached an advanced stage.

Clive Zent, MD, of Wilmot Cancer Institute at the University of Rochester Medical Center in Rochester, New York, and his colleagues described this study in Leukemia Research.

The researchers analyzed data on 470 CLL patients followed for 2849 person-years. Eighteen of these patients developed 22 melanomas. This included 14 cases of invasive melanoma in 13 patients.

The rate of invasive melanoma was significantly higher in this CLL cohort than the rate observed in the age- and sex-matched general population. The standardized incidence ratio was 6.32.

“We do not for sure know why CLL patients are more susceptible to melanoma, but the most likely cause is a suppressed immune system,” Dr Zent noted.

“Normally, in people with healthy immune systems, malignant skin cells might be detected and destroyed before they become a problem. But in CLL patients, failure of this control system increases the rate at which cancer cells can grow into tumors and also the likelihood that they will become invasive or spread to distant sites.”

Detection and management

Fifteen of the 22 melanomas (68.2%) in the CLL cohort were detected via surveillance in a dermatology clinic, and 2 (9.1%) were detected at the CLL/lymphoma clinic.

Three cases of melanoma (14.3%) were detected within the first year of a patient’s CLL diagnosis.

Seven melanomas (33.3%) were detected at pathologic stage 0, 8 (38.1%) at stage I, 2 (9.5%) at stage II, 3 (14.3%) at stage III, and 1 (4.8%) at stage IV. Detailed data were not available for the remaining case.

Melanomas were managed with wide local excision (n=19), sentinel node biopsies (n=6), Mohs surgery (n=1), drugs (n=2), palliative care (n=1), and comfort care (n=1).

The 4 patients who received drugs, palliative care, or comfort care had advanced melanoma.

The patient who received palliative care was still alive at 2.4 years of follow-up. The patient who received comfort care died of metastatic melanoma 1.4 years after diagnosis.

The third patient with advanced melanoma received 2 cycles of dacarbazine and palliative radiation to lung and brain metastases. This patient died 3.6 years after melanoma diagnosis.

The fourth patient received ipilimumab for the melanoma while also receiving ibrutinib to treat her CLL. When the ipilimumab failed, the patient proceeded to pembrolizumab and achieved a near-complete response within 3 months. Then, an intensely hypermetabolic abdominal node was detected and successfully treated with radiation.

The patient continued on pembrolizumab, and her melanoma was in sustained remission at last follow-up, after 23 cycles of pembrolizumab. Her CLL was still responding to ibrutinib at that point as well.

Based on these data, Dr Zent and his colleagues recommend routine melanoma screening for CLL patients. The team believes such surveillance might decrease morbidity and mortality in these patients, although more research is needed to confirm this theory.

Micrograph showing CLL

Patients with chronic lymphocytic leukemia (CLL) should be routinely monitored for melanoma, according to researchers.

A study of 470 CLL patients showed they have a significantly higher risk of invasive melanoma than the general population.

Most of the melanomas reported in this study were detected via routine surveillance, and most were discovered before they reached an advanced stage.

Clive Zent, MD, of Wilmot Cancer Institute at the University of Rochester Medical Center in Rochester, New York, and his colleagues described this study in Leukemia Research.

The researchers analyzed data on 470 CLL patients followed for 2849 person-years. Eighteen of these patients developed 22 melanomas. This included 14 cases of invasive melanoma in 13 patients.

The rate of invasive melanoma was significantly higher in this CLL cohort than the rate observed in the age- and sex-matched general population. The standardized incidence ratio was 6.32.

“We do not for sure know why CLL patients are more susceptible to melanoma, but the most likely cause is a suppressed immune system,” Dr Zent noted.

“Normally, in people with healthy immune systems, malignant skin cells might be detected and destroyed before they become a problem. But in CLL patients, failure of this control system increases the rate at which cancer cells can grow into tumors and also the likelihood that they will become invasive or spread to distant sites.”

Detection and management

Fifteen of the 22 melanomas (68.2%) in the CLL cohort were detected via surveillance in a dermatology clinic, and 2 (9.1%) were detected at the CLL/lymphoma clinic.

Three cases of melanoma (14.3%) were detected within the first year of a patient’s CLL diagnosis.

Seven melanomas (33.3%) were detected at pathologic stage 0, 8 (38.1%) at stage I, 2 (9.5%) at stage II, 3 (14.3%) at stage III, and 1 (4.8%) at stage IV. Detailed data were not available for the remaining case.

Melanomas were managed with wide local excision (n=19), sentinel node biopsies (n=6), Mohs surgery (n=1), drugs (n=2), palliative care (n=1), and comfort care (n=1).

The 4 patients who received drugs, palliative care, or comfort care had advanced melanoma.

The patient who received palliative care was still alive at 2.4 years of follow-up. The patient who received comfort care died of metastatic melanoma 1.4 years after diagnosis.

The third patient with advanced melanoma received 2 cycles of dacarbazine and palliative radiation to lung and brain metastases. This patient died 3.6 years after melanoma diagnosis.

The fourth patient received ipilimumab for the melanoma while also receiving ibrutinib to treat her CLL. When the ipilimumab failed, the patient proceeded to pembrolizumab and achieved a near-complete response within 3 months. Then, an intensely hypermetabolic abdominal node was detected and successfully treated with radiation.

The patient continued on pembrolizumab, and her melanoma was in sustained remission at last follow-up, after 23 cycles of pembrolizumab. Her CLL was still responding to ibrutinib at that point as well.

Based on these data, Dr Zent and his colleagues recommend routine melanoma screening for CLL patients. The team believes such surveillance might decrease morbidity and mortality in these patients, although more research is needed to confirm this theory.

Micrograph showing CLL

Patients with chronic lymphocytic leukemia (CLL) should be routinely monitored for melanoma, according to researchers.

A study of 470 CLL patients showed they have a significantly higher risk of invasive melanoma than the general population.

Most of the melanomas reported in this study were detected via routine surveillance, and most were discovered before they reached an advanced stage.

Clive Zent, MD, of Wilmot Cancer Institute at the University of Rochester Medical Center in Rochester, New York, and his colleagues described this study in Leukemia Research.

The researchers analyzed data on 470 CLL patients followed for 2849 person-years. Eighteen of these patients developed 22 melanomas. This included 14 cases of invasive melanoma in 13 patients.

The rate of invasive melanoma was significantly higher in this CLL cohort than the rate observed in the age- and sex-matched general population. The standardized incidence ratio was 6.32.

“We do not for sure know why CLL patients are more susceptible to melanoma, but the most likely cause is a suppressed immune system,” Dr Zent noted.

“Normally, in people with healthy immune systems, malignant skin cells might be detected and destroyed before they become a problem. But in CLL patients, failure of this control system increases the rate at which cancer cells can grow into tumors and also the likelihood that they will become invasive or spread to distant sites.”

Detection and management

Fifteen of the 22 melanomas (68.2%) in the CLL cohort were detected via surveillance in a dermatology clinic, and 2 (9.1%) were detected at the CLL/lymphoma clinic.

Three cases of melanoma (14.3%) were detected within the first year of a patient’s CLL diagnosis.

Seven melanomas (33.3%) were detected at pathologic stage 0, 8 (38.1%) at stage I, 2 (9.5%) at stage II, 3 (14.3%) at stage III, and 1 (4.8%) at stage IV. Detailed data were not available for the remaining case.

Melanomas were managed with wide local excision (n=19), sentinel node biopsies (n=6), Mohs surgery (n=1), drugs (n=2), palliative care (n=1), and comfort care (n=1).

The 4 patients who received drugs, palliative care, or comfort care had advanced melanoma.

The patient who received palliative care was still alive at 2.4 years of follow-up. The patient who received comfort care died of metastatic melanoma 1.4 years after diagnosis.

The third patient with advanced melanoma received 2 cycles of dacarbazine and palliative radiation to lung and brain metastases. This patient died 3.6 years after melanoma diagnosis.

The fourth patient received ipilimumab for the melanoma while also receiving ibrutinib to treat her CLL. When the ipilimumab failed, the patient proceeded to pembrolizumab and achieved a near-complete response within 3 months. Then, an intensely hypermetabolic abdominal node was detected and successfully treated with radiation.

The patient continued on pembrolizumab, and her melanoma was in sustained remission at last follow-up, after 23 cycles of pembrolizumab. Her CLL was still responding to ibrutinib at that point as well.

Based on these data, Dr Zent and his colleagues recommend routine melanoma screening for CLL patients. The team believes such surveillance might decrease morbidity and mortality in these patients, although more research is needed to confirm this theory.

Clinical question: In patients with infective endocarditis, does a vegetation size greater than 10 mm impart a greater embolic risk?

Background: A vegetation size greater than 10 mm has historically been used as the cutoff for increased risk of embolization in infective endocarditis, and this cutoff forms a key part of the American Heart Association guidelines for early surgical intervention. However, this cutoff is derived primarily from observational data from small studies.

Study design: Meta-analysis of observational studies and randomized clinical trials.

Dr. Winters is a hospitalist at Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, Boston.

Clinical question: In patients with infective endocarditis, does a vegetation size greater than 10 mm impart a greater embolic risk?

Background: A vegetation size greater than 10 mm has historically been used as the cutoff for increased risk of embolization in infective endocarditis, and this cutoff forms a key part of the American Heart Association guidelines for early surgical intervention. However, this cutoff is derived primarily from observational data from small studies.

Study design: Meta-analysis of observational studies and randomized clinical trials.

Dr. Winters is a hospitalist at Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, Boston.

Clinical question: In patients with infective endocarditis, does a vegetation size greater than 10 mm impart a greater embolic risk?

Background: A vegetation size greater than 10 mm has historically been used as the cutoff for increased risk of embolization in infective endocarditis, and this cutoff forms a key part of the American Heart Association guidelines for early surgical intervention. However, this cutoff is derived primarily from observational data from small studies.

Study design: Meta-analysis of observational studies and randomized clinical trials.

Dr. Winters is a hospitalist at Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, Boston.

Combining the vascular endothelial growth factor (VEGF) receptor–targeting tyrosine kinase inhibitor apatinib with oral etoposide in people with platinum resistant or refractory ovarian cancer has shown promising efficacy and manageable toxicity in a Phase 2 study.

Angiogenesis was a “hallmark” process in cancer, and antiangiogenic therapy, including anti-VEGF antibodies and multireceptor tyrosine kinase inhibitors, has been shown to be an attractive therapeutic strategy for ovarian cancer.

“Increasing evidence suggests that the combination of antiangiogenic therapy and single-agent chemotherapy improves the outcome of platinum-resistant ovarian cancer,” Chun-Yan Lan, MD, of the Collaborative Innovation Center for Cancer Medicine at Sun Yat-sen University Cancer Center in Guangzhou, China, and colleagues wrote in Lancet Oncology.

The investigators chose apatinib because it has shown encouraging antitumor activities and tolerable toxicities in several malignant tumors and was available in mainland China, they said.

The single-arm prospective study enrolled 35 women aged 18-70 years with heavily pretreated ovarian cancer that was refractory to platinum (defined as progression during the initial platinum-based treatment) or resistant to platinum (defined as progression within 6 months after the last platinum treatment).

Women were treated with apatinib at an initial dose of 500 mg once daily on a continuous basis and with oral etoposide at a dose of 50 mg once daily on days 1-14 of a 21-day cycle. Oral etoposide was administered for a maximum of six cycles. Dose modifications, including dose interruptions, were allowed in order to manage adverse events.

Treatment was continued until disease progression, patient withdrawal, or unacceptable toxic effects. The primary endpoint of the study was the proportion of patients achieving an objective response according to Response Evaluation Criteria in Solid Tumors (RECIST). The study authors analyzed efficacy data using three populations: intention-to-treat, per-protocol, and safety populations.

Results showed that 19 of 35 patients achieved an objective response (54%; 95% confidence interval, 36.6%-71.2%) in an intention-to-treat analysis. In the per-protocol population, 19 of 31 patients (61%; 95% CI, 42.2%-78.2%) achieved an objective response.

Median progression-free survival was 8.1 months (interquartile range, 4.3-14.6; 95% CI, 2.8-13.4), and the median duration of response was 7.4 months (IQR, 4.0-13.0; 95% CI, 2.3-12.0).

The most common grade 3 or 4 adverse events reported were neutropenia (n = 17), fatigue (n = 11), anemia n = 10), and mucositis (n = 8). Serious adverse events were reported in two patients who were admitted to the hospital.

Dose reductions were required in 82% (n = 28) of 34 patients on apatinib and 77% (n = 26) for etoposide. The authors said they would suggest future studies use a lower starting dose of apatinib and give etoposide for 10 days rather than 14.

“Our study showed that the combination therapy of apatinib with oral etoposide shows promising efficacy and manageable toxicities in patients with platinum-resistant or platinum-refractory recurrent ovarian cancer and further study in phase 3 trials is warranted,” the study authors concluded.

They said that a strength of their study was that both apatinib and oral etoposide were able to be given orally without the need for hospital admission or an infusion pump, factors that could improve adherence and cost effectiveness for patients.

However, they noted that one limitation was that it was a single-arm study with no control group, which meant the selection bias could not be ruled out.

Source: Lan CY et al. Lancet Oncol. 2018 Aug 3. doi: 10.1016/ S1470-2045(18)30349-8.

Combining the vascular endothelial growth factor (VEGF) receptor–targeting tyrosine kinase inhibitor apatinib with oral etoposide in people with platinum resistant or refractory ovarian cancer has shown promising efficacy and manageable toxicity in a Phase 2 study.

Angiogenesis was a “hallmark” process in cancer, and antiangiogenic therapy, including anti-VEGF antibodies and multireceptor tyrosine kinase inhibitors, has been shown to be an attractive therapeutic strategy for ovarian cancer.

“Increasing evidence suggests that the combination of antiangiogenic therapy and single-agent chemotherapy improves the outcome of platinum-resistant ovarian cancer,” Chun-Yan Lan, MD, of the Collaborative Innovation Center for Cancer Medicine at Sun Yat-sen University Cancer Center in Guangzhou, China, and colleagues wrote in Lancet Oncology.

The investigators chose apatinib because it has shown encouraging antitumor activities and tolerable toxicities in several malignant tumors and was available in mainland China, they said.

The single-arm prospective study enrolled 35 women aged 18-70 years with heavily pretreated ovarian cancer that was refractory to platinum (defined as progression during the initial platinum-based treatment) or resistant to platinum (defined as progression within 6 months after the last platinum treatment).

Women were treated with apatinib at an initial dose of 500 mg once daily on a continuous basis and with oral etoposide at a dose of 50 mg once daily on days 1-14 of a 21-day cycle. Oral etoposide was administered for a maximum of six cycles. Dose modifications, including dose interruptions, were allowed in order to manage adverse events.

Treatment was continued until disease progression, patient withdrawal, or unacceptable toxic effects. The primary endpoint of the study was the proportion of patients achieving an objective response according to Response Evaluation Criteria in Solid Tumors (RECIST). The study authors analyzed efficacy data using three populations: intention-to-treat, per-protocol, and safety populations.

Results showed that 19 of 35 patients achieved an objective response (54%; 95% confidence interval, 36.6%-71.2%) in an intention-to-treat analysis. In the per-protocol population, 19 of 31 patients (61%; 95% CI, 42.2%-78.2%) achieved an objective response.

Median progression-free survival was 8.1 months (interquartile range, 4.3-14.6; 95% CI, 2.8-13.4), and the median duration of response was 7.4 months (IQR, 4.0-13.0; 95% CI, 2.3-12.0).

The most common grade 3 or 4 adverse events reported were neutropenia (n = 17), fatigue (n = 11), anemia n = 10), and mucositis (n = 8). Serious adverse events were reported in two patients who were admitted to the hospital.

Dose reductions were required in 82% (n = 28) of 34 patients on apatinib and 77% (n = 26) for etoposide. The authors said they would suggest future studies use a lower starting dose of apatinib and give etoposide for 10 days rather than 14.

“Our study showed that the combination therapy of apatinib with oral etoposide shows promising efficacy and manageable toxicities in patients with platinum-resistant or platinum-refractory recurrent ovarian cancer and further study in phase 3 trials is warranted,” the study authors concluded.

They said that a strength of their study was that both apatinib and oral etoposide were able to be given orally without the need for hospital admission or an infusion pump, factors that could improve adherence and cost effectiveness for patients.

However, they noted that one limitation was that it was a single-arm study with no control group, which meant the selection bias could not be ruled out.

Source: Lan CY et al. Lancet Oncol. 2018 Aug 3. doi: 10.1016/ S1470-2045(18)30349-8.

Combining the vascular endothelial growth factor (VEGF) receptor–targeting tyrosine kinase inhibitor apatinib with oral etoposide in people with platinum resistant or refractory ovarian cancer has shown promising efficacy and manageable toxicity in a Phase 2 study.

Angiogenesis was a “hallmark” process in cancer, and antiangiogenic therapy, including anti-VEGF antibodies and multireceptor tyrosine kinase inhibitors, has been shown to be an attractive therapeutic strategy for ovarian cancer.

“Increasing evidence suggests that the combination of antiangiogenic therapy and single-agent chemotherapy improves the outcome of platinum-resistant ovarian cancer,” Chun-Yan Lan, MD, of the Collaborative Innovation Center for Cancer Medicine at Sun Yat-sen University Cancer Center in Guangzhou, China, and colleagues wrote in Lancet Oncology.

The investigators chose apatinib because it has shown encouraging antitumor activities and tolerable toxicities in several malignant tumors and was available in mainland China, they said.

The single-arm prospective study enrolled 35 women aged 18-70 years with heavily pretreated ovarian cancer that was refractory to platinum (defined as progression during the initial platinum-based treatment) or resistant to platinum (defined as progression within 6 months after the last platinum treatment).

Women were treated with apatinib at an initial dose of 500 mg once daily on a continuous basis and with oral etoposide at a dose of 50 mg once daily on days 1-14 of a 21-day cycle. Oral etoposide was administered for a maximum of six cycles. Dose modifications, including dose interruptions, were allowed in order to manage adverse events.

Treatment was continued until disease progression, patient withdrawal, or unacceptable toxic effects. The primary endpoint of the study was the proportion of patients achieving an objective response according to Response Evaluation Criteria in Solid Tumors (RECIST). The study authors analyzed efficacy data using three populations: intention-to-treat, per-protocol, and safety populations.

Results showed that 19 of 35 patients achieved an objective response (54%; 95% confidence interval, 36.6%-71.2%) in an intention-to-treat analysis. In the per-protocol population, 19 of 31 patients (61%; 95% CI, 42.2%-78.2%) achieved an objective response.

Median progression-free survival was 8.1 months (interquartile range, 4.3-14.6; 95% CI, 2.8-13.4), and the median duration of response was 7.4 months (IQR, 4.0-13.0; 95% CI, 2.3-12.0).

The most common grade 3 or 4 adverse events reported were neutropenia (n = 17), fatigue (n = 11), anemia n = 10), and mucositis (n = 8). Serious adverse events were reported in two patients who were admitted to the hospital.

Dose reductions were required in 82% (n = 28) of 34 patients on apatinib and 77% (n = 26) for etoposide. The authors said they would suggest future studies use a lower starting dose of apatinib and give etoposide for 10 days rather than 14.

“Our study showed that the combination therapy of apatinib with oral etoposide shows promising efficacy and manageable toxicities in patients with platinum-resistant or platinum-refractory recurrent ovarian cancer and further study in phase 3 trials is warranted,” the study authors concluded.

They said that a strength of their study was that both apatinib and oral etoposide were able to be given orally without the need for hospital admission or an infusion pump, factors that could improve adherence and cost effectiveness for patients.

However, they noted that one limitation was that it was a single-arm study with no control group, which meant the selection bias could not be ruled out.

Source: Lan CY et al. Lancet Oncol. 2018 Aug 3. doi: 10.1016/ S1470-2045(18)30349-8.

NEW ORLEANS – A national practice transformation initiative aimed at increasing laggardly adult immunization rates and reducing health disparities has scored an impressive success in a pilot project carried out in seven rural southwestern Georgia counties.

Bruce Jancin/MDedge News

“We saw increases of 52%-93% in our pneumococcal vaccination rates in our nine adult medicine clinics,” Frances E. Ferguson, MD, said at the annual meeting of the American College of Physicians.

The project, conducted through the ACP’s quality improvement program, known as Quality Connect, with funding from the Centers for Disease Control and Prevention, has as its ultimate goal making adult immunization standard practice across the country in general internal medicine and primary care. One of the initial pilot projects was conducted at Albany (Ga.) Area Primary Health Care, a federally qualified community health center with 28 service delivery sites in seven mainly rural southwestern Georgia counties. The majority of the center’s patients are at or below the poverty level. The lessons learned from this and other successful local projects will be disseminated nationally, according to Dr. Ferguson, a general internist at the health center.

The project utilizes the ACP Quality Connect “Plan, Do, Study, Act” approach to implementing constructive changes in medical practice, coupled with an abundance of resources readily available from the nonprofit Immunization Action Coalition, which has been funded by the CDC for more than 20 years.

The coalition’s website includes easily downloadable and custom-modifiable standing orders, plain-language information handouts on pneumococcal pneumonia and other vaccine-preventable illnesses and possible vaccine side effects for patients to read in the waiting room before their office visit, concise CDC-standardized talking points for providers to use in convincing patients to get vaccinated, as well as a detailed 10-point action plan for medical practice leadership to make it all happen.

“You don’t have to reinvent the wheel with this. You just go to their website,” Dr. Ferguson explained.

She cited her personal experience as representative of that of her fellow general internists who got on board with the project’s goal. As of April 2016, just before rollout of the pilot project, Dr. Ferguson’s pneumococcal vaccination rate stood at 22.5%. One month into the project, her vaccination rate had zoomed to 60%. When the formal pilot project ended in February 2017, her rate was 88.2%, an absolute 65.7% increase in 10 months. And since the pilot project’s conclusion, adult pneumococcal vaccination rates across Albany Area Primary Health Care have continued to climb.

“We have continued to improve because our champions are still in place, and our standing orders are, too,” she noted.

Standing orders are at the core of the project’s success, according to Dr. Ferguson. They provide nurses with the legal authority to determine if a patient is eligible for a vaccine and to go ahead and give it before seeing the physician.

“The most important thing for me is that nurses are an essential and invaluable asset to your practice, especially when you empower them to function fully within the scope of their practice. They can do amazing things. I just feel like the nurses are the winners here. We are winners because of our nurses,” she said.

It wasn’t easy at first, Dr. Ferguson recalled.

“We had pushback from nurses because they were afraid to do anything without the doctor directly telling them to do it. And we had physicians who didn’t want to have standing orders because they didn’t want anybody to do anything until they told them to. But we managed to get all that straightened out in the first month,” according to the internist.

Other keys to the program’s success included designating champions of the project at every clinic. Often this was the director of nursing, who was appointed to be in charge of the standing orders program. This “champions” concept is detailed in the ACP Quality Connect website. The champion – Dr. Ferguson was one – gets staff buy in on promoting the importance of immunizations, teaches strategies, and engages in community outreach.

“They lead the practice in the quality improvement project. We found that was very important, to have someone at each site who could keep the fire under the staff, keep the project going even when it’s very busy and everybody’s running around. There has to be someone there who’s encouraging people to remember to keep giving immunizations in spite of everything that’s going on that day,” she explained.

A central principle of successful quality improvement programs is accurate performance data gathering and dissemination. “Doctors are very competitive people,” Dr. Ferguson observed. “When I tell you you’re not doing as well as your colleagues and I can show you a graph that shows how far you are lagging behind, you get the fire under you and get moving.”

Audience members were agog at the community health center’s stratospheric vaccination rates. What about all the vaccine skeptics? they asked.

“I think for us it’s a matter of trust,” she replied. “We are a community health center and many of our patients and our providers have been with us for a long time. The nursing staff live in those communities, so the patients know them well. The CDC’s cards with talking points are a big help. I take the time to talk to patients and explain how the vaccine is going to build an army of immunologic protection. There are always going to be the diehards who say, ‘My cousin’s foot fell off when he got the pneumonia vaccine,’ though. You can’t get past those people. There’s just nothing you can say to them that will change their mind.”

She reported having no financial conflicts regarding her presentation or the adult immunization initiative.

[email protected]
 

NEW ORLEANS – A national practice transformation initiative aimed at increasing laggardly adult immunization rates and reducing health disparities has scored an impressive success in a pilot project carried out in seven rural southwestern Georgia counties.

Bruce Jancin/MDedge News

“We saw increases of 52%-93% in our pneumococcal vaccination rates in our nine adult medicine clinics,” Frances E. Ferguson, MD, said at the annual meeting of the American College of Physicians.

The project, conducted through the ACP’s quality improvement program, known as Quality Connect, with funding from the Centers for Disease Control and Prevention, has as its ultimate goal making adult immunization standard practice across the country in general internal medicine and primary care. One of the initial pilot projects was conducted at Albany (Ga.) Area Primary Health Care, a federally qualified community health center with 28 service delivery sites in seven mainly rural southwestern Georgia counties. The majority of the center’s patients are at or below the poverty level. The lessons learned from this and other successful local projects will be disseminated nationally, according to Dr. Ferguson, a general internist at the health center.

The project utilizes the ACP Quality Connect “Plan, Do, Study, Act” approach to implementing constructive changes in medical practice, coupled with an abundance of resources readily available from the nonprofit Immunization Action Coalition, which has been funded by the CDC for more than 20 years.

The coalition’s website includes easily downloadable and custom-modifiable standing orders, plain-language information handouts on pneumococcal pneumonia and other vaccine-preventable illnesses and possible vaccine side effects for patients to read in the waiting room before their office visit, concise CDC-standardized talking points for providers to use in convincing patients to get vaccinated, as well as a detailed 10-point action plan for medical practice leadership to make it all happen.

“You don’t have to reinvent the wheel with this. You just go to their website,” Dr. Ferguson explained.

She cited her personal experience as representative of that of her fellow general internists who got on board with the project’s goal. As of April 2016, just before rollout of the pilot project, Dr. Ferguson’s pneumococcal vaccination rate stood at 22.5%. One month into the project, her vaccination rate had zoomed to 60%. When the formal pilot project ended in February 2017, her rate was 88.2%, an absolute 65.7% increase in 10 months. And since the pilot project’s conclusion, adult pneumococcal vaccination rates across Albany Area Primary Health Care have continued to climb.

“We have continued to improve because our champions are still in place, and our standing orders are, too,” she noted.

Standing orders are at the core of the project’s success, according to Dr. Ferguson. They provide nurses with the legal authority to determine if a patient is eligible for a vaccine and to go ahead and give it before seeing the physician.

“The most important thing for me is that nurses are an essential and invaluable asset to your practice, especially when you empower them to function fully within the scope of their practice. They can do amazing things. I just feel like the nurses are the winners here. We are winners because of our nurses,” she said.

It wasn’t easy at first, Dr. Ferguson recalled.

“We had pushback from nurses because they were afraid to do anything without the doctor directly telling them to do it. And we had physicians who didn’t want to have standing orders because they didn’t want anybody to do anything until they told them to. But we managed to get all that straightened out in the first month,” according to the internist.

Other keys to the program’s success included designating champions of the project at every clinic. Often this was the director of nursing, who was appointed to be in charge of the standing orders program. This “champions” concept is detailed in the ACP Quality Connect website. The champion – Dr. Ferguson was one – gets staff buy in on promoting the importance of immunizations, teaches strategies, and engages in community outreach.

“They lead the practice in the quality improvement project. We found that was very important, to have someone at each site who could keep the fire under the staff, keep the project going even when it’s very busy and everybody’s running around. There has to be someone there who’s encouraging people to remember to keep giving immunizations in spite of everything that’s going on that day,” she explained.

A central principle of successful quality improvement programs is accurate performance data gathering and dissemination. “Doctors are very competitive people,” Dr. Ferguson observed. “When I tell you you’re not doing as well as your colleagues and I can show you a graph that shows how far you are lagging behind, you get the fire under you and get moving.”

Audience members were agog at the community health center’s stratospheric vaccination rates. What about all the vaccine skeptics? they asked.

“I think for us it’s a matter of trust,” she replied. “We are a community health center and many of our patients and our providers have been with us for a long time. The nursing staff live in those communities, so the patients know them well. The CDC’s cards with talking points are a big help. I take the time to talk to patients and explain how the vaccine is going to build an army of immunologic protection. There are always going to be the diehards who say, ‘My cousin’s foot fell off when he got the pneumonia vaccine,’ though. You can’t get past those people. There’s just nothing you can say to them that will change their mind.”

She reported having no financial conflicts regarding her presentation or the adult immunization initiative.

[email protected]
 

NEW ORLEANS – A national practice transformation initiative aimed at increasing laggardly adult immunization rates and reducing health disparities has scored an impressive success in a pilot project carried out in seven rural southwestern Georgia counties.

Bruce Jancin/MDedge News

“We saw increases of 52%-93% in our pneumococcal vaccination rates in our nine adult medicine clinics,” Frances E. Ferguson, MD, said at the annual meeting of the American College of Physicians.

The project, conducted through the ACP’s quality improvement program, known as Quality Connect, with funding from the Centers for Disease Control and Prevention, has as its ultimate goal making adult immunization standard practice across the country in general internal medicine and primary care. One of the initial pilot projects was conducted at Albany (Ga.) Area Primary Health Care, a federally qualified community health center with 28 service delivery sites in seven mainly rural southwestern Georgia counties. The majority of the center’s patients are at or below the poverty level. The lessons learned from this and other successful local projects will be disseminated nationally, according to Dr. Ferguson, a general internist at the health center.

The project utilizes the ACP Quality Connect “Plan, Do, Study, Act” approach to implementing constructive changes in medical practice, coupled with an abundance of resources readily available from the nonprofit Immunization Action Coalition, which has been funded by the CDC for more than 20 years.

The coalition’s website includes easily downloadable and custom-modifiable standing orders, plain-language information handouts on pneumococcal pneumonia and other vaccine-preventable illnesses and possible vaccine side effects for patients to read in the waiting room before their office visit, concise CDC-standardized talking points for providers to use in convincing patients to get vaccinated, as well as a detailed 10-point action plan for medical practice leadership to make it all happen.

“You don’t have to reinvent the wheel with this. You just go to their website,” Dr. Ferguson explained.

She cited her personal experience as representative of that of her fellow general internists who got on board with the project’s goal. As of April 2016, just before rollout of the pilot project, Dr. Ferguson’s pneumococcal vaccination rate stood at 22.5%. One month into the project, her vaccination rate had zoomed to 60%. When the formal pilot project ended in February 2017, her rate was 88.2%, an absolute 65.7% increase in 10 months. And since the pilot project’s conclusion, adult pneumococcal vaccination rates across Albany Area Primary Health Care have continued to climb.

“We have continued to improve because our champions are still in place, and our standing orders are, too,” she noted.

Standing orders are at the core of the project’s success, according to Dr. Ferguson. They provide nurses with the legal authority to determine if a patient is eligible for a vaccine and to go ahead and give it before seeing the physician.

“The most important thing for me is that nurses are an essential and invaluable asset to your practice, especially when you empower them to function fully within the scope of their practice. They can do amazing things. I just feel like the nurses are the winners here. We are winners because of our nurses,” she said.

It wasn’t easy at first, Dr. Ferguson recalled.

“We had pushback from nurses because they were afraid to do anything without the doctor directly telling them to do it. And we had physicians who didn’t want to have standing orders because they didn’t want anybody to do anything until they told them to. But we managed to get all that straightened out in the first month,” according to the internist.

Other keys to the program’s success included designating champions of the project at every clinic. Often this was the director of nursing, who was appointed to be in charge of the standing orders program. This “champions” concept is detailed in the ACP Quality Connect website. The champion – Dr. Ferguson was one – gets staff buy in on promoting the importance of immunizations, teaches strategies, and engages in community outreach.

“They lead the practice in the quality improvement project. We found that was very important, to have someone at each site who could keep the fire under the staff, keep the project going even when it’s very busy and everybody’s running around. There has to be someone there who’s encouraging people to remember to keep giving immunizations in spite of everything that’s going on that day,” she explained.

A central principle of successful quality improvement programs is accurate performance data gathering and dissemination. “Doctors are very competitive people,” Dr. Ferguson observed. “When I tell you you’re not doing as well as your colleagues and I can show you a graph that shows how far you are lagging behind, you get the fire under you and get moving.”

Audience members were agog at the community health center’s stratospheric vaccination rates. What about all the vaccine skeptics? they asked.

“I think for us it’s a matter of trust,” she replied. “We are a community health center and many of our patients and our providers have been with us for a long time. The nursing staff live in those communities, so the patients know them well. The CDC’s cards with talking points are a big help. I take the time to talk to patients and explain how the vaccine is going to build an army of immunologic protection. There are always going to be the diehards who say, ‘My cousin’s foot fell off when he got the pneumonia vaccine,’ though. You can’t get past those people. There’s just nothing you can say to them that will change their mind.”

She reported having no financial conflicts regarding her presentation or the adult immunization initiative.

[email protected]
 

Doctors have expressed their displeasure at the lack of response by the Centers for Medicare & Medicaid Services to launch physician-focused advanced alternative payment models (APMs).

Courtesy Health Subcommittee

As part of the MACRA law, Congress created a process by which physicians could seek to implement specialty-specific APMs that they had developed and tested. The purpose was to provide more avenues for specialist participation in the Quality Payment Program’s APM track.

The process goes like this: Doctors create and implement an APM that focuses on providing value-based care in their particular specialty arena. They submit the program and early outcomes to the Physician-Focused Payment Model Technical Advisory Committee or PTAC. The committee reviews the APM and, if it has merit, forwards it to the CMS. The CMS can either approve the APM or ask for additional testing.

So far, PTAC has sent at least 10 APMs to the CMS. To date, not a single one has been approved or even tested on a limited scale.

“Physicians want to be engaged and involved in this process,” David Barbe, MD, immediate past president of the American Medical Association, told members of the House Energy and Commerce Health Subcommittee during a July 26 hearing. “PTAC was created for that very reason. They have received dozens of proposals that come from the ground level. Physicians that are practicing know what will work in their practices and perhaps in their specialty. And yet, none of these have been adopted by CMS or really, we think, given serious consideration.”

Frank Opelka, MD, medical director for quality and health policy at the American College of Surgeons, noted that a proposal they had submitted to PTAC appears to be the one that has gotten furthest along in the process.

Courtesy Health Subcommittee

The model was “accepted in a letter by the Secretary for consideration by the [CMS Innovation Center],” Dr. Opelka testified at the hearing. “The innovation center had a few conference calls with us and one 2-hour in-person meeting on a product that we’d developed that took almost 5 years in the making. There are no resources and no capability in the innovation center to complete a design and then to create an implementation and have a sandbox or pilot area in which to test. The PTAC has done a fantastic job. The Secretary vetted us. I think [ours was] the only one that went from the Secretary and was recommended to the innovation center and it died in there because [the Center] is just not wired to really innovate and we really need to turn that on.”

The CMS issued a letter on June 13 essentially rejecting eight of the models that PTAC recommended. The AMA asked the agency to reconsider at least four of the proposals in a June 21 letter.

AMA leadership does not think that the CMS gave serious consideration to any of the PTAC recommendations, Dr. Barbe said. “These span from very focused proposals in GI medicine to reduce rehospitalization in Crohn’s patients all the way up to the end-stage renal disease that could have very broad effect on improving care and reducing cost for dialysis patients. We think there is great opportunity there if CMS will listen to us.”

The AMA is “especially concerned because the statute to reform Medicare physician payment provided only 6 years of bonus payments to facilitate physicians’ migration to APMs,” according to the group’s letter to the CMS. “We are approaching the 3-year mark for the initial implementation and there is still not a robust APM pathway for physicians.”

Dr. Barbe also expressed concern that physicians’ taste for innovation could wane, given 3 years without successful implementation or testing of a physician-focused APM.

The CMS “seems to be interested in coming up with ideas on their own and I think that’s not only reinventing the wheel potentially, but it is not taking advantage of some very creative and innovated proposals that have come forward,” Dr. Barbe said.

The AMA recognizes “that the APMs recommended by PTAC needed some refinement. Data and pilot test experience likely would help in addressing some of the concerns raised by both PTAC and HHS,” according to the letter. “PTAC has indicated in its recommendations to HHS that it felt the issues it had identified could be resolved with assistance from CMS. Moreover, PTAC concluded that the positive attributes of the APM proposals outweigh the concerns they had identified, but the department does not seem to agree.”

Dr. Opelka, in his written testimony to the subcommittee, suggested that “it may be invaluable to commission a study on these challenges, including CMS’ ability to measure the true quality of care provided by physicians of all specialties, the availability of cost measures that are meaningful and actionable in concert with these quality measures, physicians’ ability to access patient health information when they need it and in a standardized predictable format, and the availability of APMs that grant physicians of all specialties the opportunity to be creative in using their expertise to increase quality and value of care to the patient.”

[email protected]

Doctors have expressed their displeasure at the lack of response by the Centers for Medicare & Medicaid Services to launch physician-focused advanced alternative payment models (APMs).

Courtesy Health Subcommittee

As part of the MACRA law, Congress created a process by which physicians could seek to implement specialty-specific APMs that they had developed and tested. The purpose was to provide more avenues for specialist participation in the Quality Payment Program’s APM track.

The process goes like this: Doctors create and implement an APM that focuses on providing value-based care in their particular specialty arena. They submit the program and early outcomes to the Physician-Focused Payment Model Technical Advisory Committee or PTAC. The committee reviews the APM and, if it has merit, forwards it to the CMS. The CMS can either approve the APM or ask for additional testing.

So far, PTAC has sent at least 10 APMs to the CMS. To date, not a single one has been approved or even tested on a limited scale.

“Physicians want to be engaged and involved in this process,” David Barbe, MD, immediate past president of the American Medical Association, told members of the House Energy and Commerce Health Subcommittee during a July 26 hearing. “PTAC was created for that very reason. They have received dozens of proposals that come from the ground level. Physicians that are practicing know what will work in their practices and perhaps in their specialty. And yet, none of these have been adopted by CMS or really, we think, given serious consideration.”

Frank Opelka, MD, medical director for quality and health policy at the American College of Surgeons, noted that a proposal they had submitted to PTAC appears to be the one that has gotten furthest along in the process.

Courtesy Health Subcommittee

The model was “accepted in a letter by the Secretary for consideration by the [CMS Innovation Center],” Dr. Opelka testified at the hearing. “The innovation center had a few conference calls with us and one 2-hour in-person meeting on a product that we’d developed that took almost 5 years in the making. There are no resources and no capability in the innovation center to complete a design and then to create an implementation and have a sandbox or pilot area in which to test. The PTAC has done a fantastic job. The Secretary vetted us. I think [ours was] the only one that went from the Secretary and was recommended to the innovation center and it died in there because [the Center] is just not wired to really innovate and we really need to turn that on.”

The CMS issued a letter on June 13 essentially rejecting eight of the models that PTAC recommended. The AMA asked the agency to reconsider at least four of the proposals in a June 21 letter.

AMA leadership does not think that the CMS gave serious consideration to any of the PTAC recommendations, Dr. Barbe said. “These span from very focused proposals in GI medicine to reduce rehospitalization in Crohn’s patients all the way up to the end-stage renal disease that could have very broad effect on improving care and reducing cost for dialysis patients. We think there is great opportunity there if CMS will listen to us.”

The AMA is “especially concerned because the statute to reform Medicare physician payment provided only 6 years of bonus payments to facilitate physicians’ migration to APMs,” according to the group’s letter to the CMS. “We are approaching the 3-year mark for the initial implementation and there is still not a robust APM pathway for physicians.”

Dr. Barbe also expressed concern that physicians’ taste for innovation could wane, given 3 years without successful implementation or testing of a physician-focused APM.

The CMS “seems to be interested in coming up with ideas on their own and I think that’s not only reinventing the wheel potentially, but it is not taking advantage of some very creative and innovated proposals that have come forward,” Dr. Barbe said.

The AMA recognizes “that the APMs recommended by PTAC needed some refinement. Data and pilot test experience likely would help in addressing some of the concerns raised by both PTAC and HHS,” according to the letter. “PTAC has indicated in its recommendations to HHS that it felt the issues it had identified could be resolved with assistance from CMS. Moreover, PTAC concluded that the positive attributes of the APM proposals outweigh the concerns they had identified, but the department does not seem to agree.”

Dr. Opelka, in his written testimony to the subcommittee, suggested that “it may be invaluable to commission a study on these challenges, including CMS’ ability to measure the true quality of care provided by physicians of all specialties, the availability of cost measures that are meaningful and actionable in concert with these quality measures, physicians’ ability to access patient health information when they need it and in a standardized predictable format, and the availability of APMs that grant physicians of all specialties the opportunity to be creative in using their expertise to increase quality and value of care to the patient.”

[email protected]

Doctors have expressed their displeasure at the lack of response by the Centers for Medicare & Medicaid Services to launch physician-focused advanced alternative payment models (APMs).

Courtesy Health Subcommittee

As part of the MACRA law, Congress created a process by which physicians could seek to implement specialty-specific APMs that they had developed and tested. The purpose was to provide more avenues for specialist participation in the Quality Payment Program’s APM track.

The process goes like this: Doctors create and implement an APM that focuses on providing value-based care in their particular specialty arena. They submit the program and early outcomes to the Physician-Focused Payment Model Technical Advisory Committee or PTAC. The committee reviews the APM and, if it has merit, forwards it to the CMS. The CMS can either approve the APM or ask for additional testing.

So far, PTAC has sent at least 10 APMs to the CMS. To date, not a single one has been approved or even tested on a limited scale.

“Physicians want to be engaged and involved in this process,” David Barbe, MD, immediate past president of the American Medical Association, told members of the House Energy and Commerce Health Subcommittee during a July 26 hearing. “PTAC was created for that very reason. They have received dozens of proposals that come from the ground level. Physicians that are practicing know what will work in their practices and perhaps in their specialty. And yet, none of these have been adopted by CMS or really, we think, given serious consideration.”

Frank Opelka, MD, medical director for quality and health policy at the American College of Surgeons, noted that a proposal they had submitted to PTAC appears to be the one that has gotten furthest along in the process.

Courtesy Health Subcommittee

The model was “accepted in a letter by the Secretary for consideration by the [CMS Innovation Center],” Dr. Opelka testified at the hearing. “The innovation center had a few conference calls with us and one 2-hour in-person meeting on a product that we’d developed that took almost 5 years in the making. There are no resources and no capability in the innovation center to complete a design and then to create an implementation and have a sandbox or pilot area in which to test. The PTAC has done a fantastic job. The Secretary vetted us. I think [ours was] the only one that went from the Secretary and was recommended to the innovation center and it died in there because [the Center] is just not wired to really innovate and we really need to turn that on.”

The CMS issued a letter on June 13 essentially rejecting eight of the models that PTAC recommended. The AMA asked the agency to reconsider at least four of the proposals in a June 21 letter.

AMA leadership does not think that the CMS gave serious consideration to any of the PTAC recommendations, Dr. Barbe said. “These span from very focused proposals in GI medicine to reduce rehospitalization in Crohn’s patients all the way up to the end-stage renal disease that could have very broad effect on improving care and reducing cost for dialysis patients. We think there is great opportunity there if CMS will listen to us.”

The AMA is “especially concerned because the statute to reform Medicare physician payment provided only 6 years of bonus payments to facilitate physicians’ migration to APMs,” according to the group’s letter to the CMS. “We are approaching the 3-year mark for the initial implementation and there is still not a robust APM pathway for physicians.”

Dr. Barbe also expressed concern that physicians’ taste for innovation could wane, given 3 years without successful implementation or testing of a physician-focused APM.

The CMS “seems to be interested in coming up with ideas on their own and I think that’s not only reinventing the wheel potentially, but it is not taking advantage of some very creative and innovated proposals that have come forward,” Dr. Barbe said.

The AMA recognizes “that the APMs recommended by PTAC needed some refinement. Data and pilot test experience likely would help in addressing some of the concerns raised by both PTAC and HHS,” according to the letter. “PTAC has indicated in its recommendations to HHS that it felt the issues it had identified could be resolved with assistance from CMS. Moreover, PTAC concluded that the positive attributes of the APM proposals outweigh the concerns they had identified, but the department does not seem to agree.”

Dr. Opelka, in his written testimony to the subcommittee, suggested that “it may be invaluable to commission a study on these challenges, including CMS’ ability to measure the true quality of care provided by physicians of all specialties, the availability of cost measures that are meaningful and actionable in concert with these quality measures, physicians’ ability to access patient health information when they need it and in a standardized predictable format, and the availability of APMs that grant physicians of all specialties the opportunity to be creative in using their expertise to increase quality and value of care to the patient.”

[email protected]

Comedy can be about pushing the limits of topics explored and questioning societal norms. For those comedians bold enough to push hard, the result can be societal pushback. As just one example, consider the arrest of George Carlin by Milwaukee police for allegedly violating public obscenity laws for uttering those seven naughty words not to be said on television (the charge was subsequently dismissed).

David Sedaris is a present-day boundary pusher. His sources of humor have ranged from his early life growing up in a family with five siblings to the challenges of getting older with aging parents, and from American attitudes about race to his own ambivalence about guns.

Pushback against his humor has come from both ends of the political spectrum. “I don’t know which is worse: a far-right audience or a far-left audience. Each of them is a hand around my throat slowly choking the life out of me,” Mr. Sedaris said in an interview with The Economist correspondent Anne McElvoy.

Mr. Sedaris’s take on the oddities of everyday life are side splitting to some, to the tune of millions of book sales and accolades as a giant of humor – and deeply offensive to others.

His career in making people laugh began in art school with monologues on the paintings of fellow students. What has followed is a life of keeping his eyes and ears open, and a notebook at the ready to record the goings-on of daily life.

Often, something bad can happen that can prove to be funny, at least in hindsight, Mr. Sedaris explains. He cites the example of his medical examination for a kidney stone that went sideways, with him ending up in the hospital’s waiting area clad only in his underwear.

“The thought came that someday, this will be funny to me. Today it’s not, but someday it will be,” Mr. Sedaris says.

Such humor seems global. Laughs at his stories may come at different parts, based on the language and cultural interpretations. But the basic premise of the story can hit home in far-flung places.

The path to the humor in his stories can prove perilous. “It’s so hard to talk about race in the United States. ... The audience thinks: ‘Wait a minute, if I laugh at this, does it mean I’m racist?’ You can feel them getting snagged there, so oftentimes I just leave that element out of the story because I want the story to move,” Mr. Sedaris says.

Does that mean humor has a limit that should not be crossed? Not to Mr. Sedaris.

Click here to listen to the interview.

Comedy can be about pushing the limits of topics explored and questioning societal norms. For those comedians bold enough to push hard, the result can be societal pushback. As just one example, consider the arrest of George Carlin by Milwaukee police for allegedly violating public obscenity laws for uttering those seven naughty words not to be said on television (the charge was subsequently dismissed).

David Sedaris is a present-day boundary pusher. His sources of humor have ranged from his early life growing up in a family with five siblings to the challenges of getting older with aging parents, and from American attitudes about race to his own ambivalence about guns.

Pushback against his humor has come from both ends of the political spectrum. “I don’t know which is worse: a far-right audience or a far-left audience. Each of them is a hand around my throat slowly choking the life out of me,” Mr. Sedaris said in an interview with The Economist correspondent Anne McElvoy.

Mr. Sedaris’s take on the oddities of everyday life are side splitting to some, to the tune of millions of book sales and accolades as a giant of humor – and deeply offensive to others.

His career in making people laugh began in art school with monologues on the paintings of fellow students. What has followed is a life of keeping his eyes and ears open, and a notebook at the ready to record the goings-on of daily life.

Often, something bad can happen that can prove to be funny, at least in hindsight, Mr. Sedaris explains. He cites the example of his medical examination for a kidney stone that went sideways, with him ending up in the hospital’s waiting area clad only in his underwear.

“The thought came that someday, this will be funny to me. Today it’s not, but someday it will be,” Mr. Sedaris says.

Such humor seems global. Laughs at his stories may come at different parts, based on the language and cultural interpretations. But the basic premise of the story can hit home in far-flung places.

The path to the humor in his stories can prove perilous. “It’s so hard to talk about race in the United States. ... The audience thinks: ‘Wait a minute, if I laugh at this, does it mean I’m racist?’ You can feel them getting snagged there, so oftentimes I just leave that element out of the story because I want the story to move,” Mr. Sedaris says.

Does that mean humor has a limit that should not be crossed? Not to Mr. Sedaris.

Click here to listen to the interview.

Comedy can be about pushing the limits of topics explored and questioning societal norms. For those comedians bold enough to push hard, the result can be societal pushback. As just one example, consider the arrest of George Carlin by Milwaukee police for allegedly violating public obscenity laws for uttering those seven naughty words not to be said on television (the charge was subsequently dismissed).

David Sedaris is a present-day boundary pusher. His sources of humor have ranged from his early life growing up in a family with five siblings to the challenges of getting older with aging parents, and from American attitudes about race to his own ambivalence about guns.

Pushback against his humor has come from both ends of the political spectrum. “I don’t know which is worse: a far-right audience or a far-left audience. Each of them is a hand around my throat slowly choking the life out of me,” Mr. Sedaris said in an interview with The Economist correspondent Anne McElvoy.

Mr. Sedaris’s take on the oddities of everyday life are side splitting to some, to the tune of millions of book sales and accolades as a giant of humor – and deeply offensive to others.

His career in making people laugh began in art school with monologues on the paintings of fellow students. What has followed is a life of keeping his eyes and ears open, and a notebook at the ready to record the goings-on of daily life.

Often, something bad can happen that can prove to be funny, at least in hindsight, Mr. Sedaris explains. He cites the example of his medical examination for a kidney stone that went sideways, with him ending up in the hospital’s waiting area clad only in his underwear.

“The thought came that someday, this will be funny to me. Today it’s not, but someday it will be,” Mr. Sedaris says.

Such humor seems global. Laughs at his stories may come at different parts, based on the language and cultural interpretations. But the basic premise of the story can hit home in far-flung places.

The path to the humor in his stories can prove perilous. “It’s so hard to talk about race in the United States. ... The audience thinks: ‘Wait a minute, if I laugh at this, does it mean I’m racist?’ You can feel them getting snagged there, so oftentimes I just leave that element out of the story because I want the story to move,” Mr. Sedaris says.

Does that mean humor has a limit that should not be crossed? Not to Mr. Sedaris.

Click here to listen to the interview.

Established criteria for identifying inflammatory back pain in people with ankylosing spondylitis do not perform well in identifying axial involvement in people with psoriatic arthritis and neither does clinical judgment, a study shows.

feellife/Thinkstock

Radiology data from these patients showed that 27 with baseline x-rays fulfilled the New York radiographic criteria for AS, and 45 had radiographic sacroiliitis not satisfying NY criteria (excluding grade 1) and/or syndesmophytes. Nine out of 31 patients with no axial disease on x-ray had evidence of axial disease on MRI. Eighteen out of 54 patients had axial involvement without back pain.

Results showed that agreement (kappa coefficient) between rheumatologist judgment of IBP and IBP criteria in patients with back pain was moderate and was highest for the Calin criteria (0.70; 95% confidence interval, 0.56-0.85), followed by the ASAS criteria (0.61; 95% CI, 0.46-0.76) and the Rudwaleit criteria (0.59; 95% CI, 0.44-0.74).

When x-ray or MRI change was considered “gold standard” for axial involvement for all patients, the specificity was high for rheumatologist judgment of IBP as well as Calin, Rudwaleit, and ASAS criteria, but their sensitivity was low, the researchers reported.

When the investigators compared positive likelihood ratios (LRs) for the presence of back pain, the Rudwaleit criteria (2.17) performed the best in ruling in axial disease, whereas the LRs were 1.75 for Calin and 1.86 for ASAS criteria. Rheumatologist-reported back pain (0.68) performed the best for ruling out axial disease when comparing negative LRs.

“The low positive LRs of the Calin, Rudwaleit, and ASAS criteria as well as that of rheumatologist report of back pain or judgment of IBP for [axial] PsA defined as any axial radiological change found in our study suggests that none of these criteria performed well in detecting axial disease in patients with PsA,” the study authors wrote.

The authors also conducted an exploratory analysis within patients with PsA with back involvement (defined by x-rays or MRI) and compared those with back pain (n = 36) or without (n = 18). The back pain group had a significantly higher Bath Ankylosing Spondylitis Disease Activity Index score (5.72 vs. 4.27), a finding that the authors said they expected because it is a patient-reported measure.

The back pain group also had a lower prevalence of human leukocyte antigen-B*38 (2.78 vs. 27.78), a finding that the authors said was interesting but would need to be replicated in future studies.

The prevalence of HLA-B*27, HLA-B*08, and HLA-C*06 was similar between patients with and without back pain, indicating “that the two groups are largely similar and hence, for the purpose of defining axial disease in PsA, symptoms (back pain) may not be important.”

“The findings of this study suggest that rheumatologist-judged IBP or the criteria for IBP developed for AS may not perform well when ascertaining axial involvement in PsA,” the study authors concluded.

“Moreover, patients with axial radiological changes without back pain were similar to those with back pain. ... In order to stratify patients with poorer prognosis, rheumatologists should consider conducting axial imaging in all patients with PsA regardless of the presence or the nature of back pain,” they added.

The study was funded by the University of Toronto Psoriatic Arthritis Program, which is supported by the Krembil Foundation.

SOURCE: Yap KS et al. Ann Rheum Dis. 2018 Aug 4. doi: 10.1136/annrheumdis-2018-213334.

Established criteria for identifying inflammatory back pain in people with ankylosing spondylitis do not perform well in identifying axial involvement in people with psoriatic arthritis and neither does clinical judgment, a study shows.

feellife/Thinkstock

Radiology data from these patients showed that 27 with baseline x-rays fulfilled the New York radiographic criteria for AS, and 45 had radiographic sacroiliitis not satisfying NY criteria (excluding grade 1) and/or syndesmophytes. Nine out of 31 patients with no axial disease on x-ray had evidence of axial disease on MRI. Eighteen out of 54 patients had axial involvement without back pain.

Results showed that agreement (kappa coefficient) between rheumatologist judgment of IBP and IBP criteria in patients with back pain was moderate and was highest for the Calin criteria (0.70; 95% confidence interval, 0.56-0.85), followed by the ASAS criteria (0.61; 95% CI, 0.46-0.76) and the Rudwaleit criteria (0.59; 95% CI, 0.44-0.74).

When x-ray or MRI change was considered “gold standard” for axial involvement for all patients, the specificity was high for rheumatologist judgment of IBP as well as Calin, Rudwaleit, and ASAS criteria, but their sensitivity was low, the researchers reported.

When the investigators compared positive likelihood ratios (LRs) for the presence of back pain, the Rudwaleit criteria (2.17) performed the best in ruling in axial disease, whereas the LRs were 1.75 for Calin and 1.86 for ASAS criteria. Rheumatologist-reported back pain (0.68) performed the best for ruling out axial disease when comparing negative LRs.

“The low positive LRs of the Calin, Rudwaleit, and ASAS criteria as well as that of rheumatologist report of back pain or judgment of IBP for [axial] PsA defined as any axial radiological change found in our study suggests that none of these criteria performed well in detecting axial disease in patients with PsA,” the study authors wrote.

The authors also conducted an exploratory analysis within patients with PsA with back involvement (defined by x-rays or MRI) and compared those with back pain (n = 36) or without (n = 18). The back pain group had a significantly higher Bath Ankylosing Spondylitis Disease Activity Index score (5.72 vs. 4.27), a finding that the authors said they expected because it is a patient-reported measure.

The back pain group also had a lower prevalence of human leukocyte antigen-B*38 (2.78 vs. 27.78), a finding that the authors said was interesting but would need to be replicated in future studies.

The prevalence of HLA-B*27, HLA-B*08, and HLA-C*06 was similar between patients with and without back pain, indicating “that the two groups are largely similar and hence, for the purpose of defining axial disease in PsA, symptoms (back pain) may not be important.”

“The findings of this study suggest that rheumatologist-judged IBP or the criteria for IBP developed for AS may not perform well when ascertaining axial involvement in PsA,” the study authors concluded.

“Moreover, patients with axial radiological changes without back pain were similar to those with back pain. ... In order to stratify patients with poorer prognosis, rheumatologists should consider conducting axial imaging in all patients with PsA regardless of the presence or the nature of back pain,” they added.

The study was funded by the University of Toronto Psoriatic Arthritis Program, which is supported by the Krembil Foundation.

SOURCE: Yap KS et al. Ann Rheum Dis. 2018 Aug 4. doi: 10.1136/annrheumdis-2018-213334.

Established criteria for identifying inflammatory back pain in people with ankylosing spondylitis do not perform well in identifying axial involvement in people with psoriatic arthritis and neither does clinical judgment, a study shows.

feellife/Thinkstock

Radiology data from these patients showed that 27 with baseline x-rays fulfilled the New York radiographic criteria for AS, and 45 had radiographic sacroiliitis not satisfying NY criteria (excluding grade 1) and/or syndesmophytes. Nine out of 31 patients with no axial disease on x-ray had evidence of axial disease on MRI. Eighteen out of 54 patients had axial involvement without back pain.

Results showed that agreement (kappa coefficient) between rheumatologist judgment of IBP and IBP criteria in patients with back pain was moderate and was highest for the Calin criteria (0.70; 95% confidence interval, 0.56-0.85), followed by the ASAS criteria (0.61; 95% CI, 0.46-0.76) and the Rudwaleit criteria (0.59; 95% CI, 0.44-0.74).

When x-ray or MRI change was considered “gold standard” for axial involvement for all patients, the specificity was high for rheumatologist judgment of IBP as well as Calin, Rudwaleit, and ASAS criteria, but their sensitivity was low, the researchers reported.

When the investigators compared positive likelihood ratios (LRs) for the presence of back pain, the Rudwaleit criteria (2.17) performed the best in ruling in axial disease, whereas the LRs were 1.75 for Calin and 1.86 for ASAS criteria. Rheumatologist-reported back pain (0.68) performed the best for ruling out axial disease when comparing negative LRs.

“The low positive LRs of the Calin, Rudwaleit, and ASAS criteria as well as that of rheumatologist report of back pain or judgment of IBP for [axial] PsA defined as any axial radiological change found in our study suggests that none of these criteria performed well in detecting axial disease in patients with PsA,” the study authors wrote.

The authors also conducted an exploratory analysis within patients with PsA with back involvement (defined by x-rays or MRI) and compared those with back pain (n = 36) or without (n = 18). The back pain group had a significantly higher Bath Ankylosing Spondylitis Disease Activity Index score (5.72 vs. 4.27), a finding that the authors said they expected because it is a patient-reported measure.

The back pain group also had a lower prevalence of human leukocyte antigen-B*38 (2.78 vs. 27.78), a finding that the authors said was interesting but would need to be replicated in future studies.

The prevalence of HLA-B*27, HLA-B*08, and HLA-C*06 was similar between patients with and without back pain, indicating “that the two groups are largely similar and hence, for the purpose of defining axial disease in PsA, symptoms (back pain) may not be important.”

“The findings of this study suggest that rheumatologist-judged IBP or the criteria for IBP developed for AS may not perform well when ascertaining axial involvement in PsA,” the study authors concluded.

“Moreover, patients with axial radiological changes without back pain were similar to those with back pain. ... In order to stratify patients with poorer prognosis, rheumatologists should consider conducting axial imaging in all patients with PsA regardless of the presence or the nature of back pain,” they added.

The study was funded by the University of Toronto Psoriatic Arthritis Program, which is supported by the Krembil Foundation.

SOURCE: Yap KS et al. Ann Rheum Dis. 2018 Aug 4. doi: 10.1136/annrheumdis-2018-213334.

Janssen has applied to the Food and Drug Administration and the European Medicines Agency to allow splitting of the first infusion of daratumumab (Darzalex) in multiple myeloma patients over 2 consecutive days.

Courtesy Janssen Biotech

The goal is to improve the treatment experience for patients and physicians, according to the announcement from Janssen.

The regulatory submissions are based on the global, multi-arm, phase 1b MMY1001 study (NCT01998971). The study evaluated daratumumab in combination with various other treatments in 240 patients with multiple myeloma. It found that both the safety profile and the pharmacokinetics concentrations seen with either single dosing or split dosing were similar.

Daratumumab is the first approved monoclonal antibody that targets CD38, which is expressed across multiple myeloma cells regardless of disease stage. Daratumumab is currently approved for treatment of multiple myeloma in both the United States and the European Union either as monotherapy or in conjunction with other treatments.

Daratumumab is known to sometimes cause severe/serious infusion reactions, such as anaphylactic reactions; interfere with serological testing; and cause neutropenia or thrombocytopenia.

[email protected]

Janssen has applied to the Food and Drug Administration and the European Medicines Agency to allow splitting of the first infusion of daratumumab (Darzalex) in multiple myeloma patients over 2 consecutive days.

Courtesy Janssen Biotech

The goal is to improve the treatment experience for patients and physicians, according to the announcement from Janssen.

The regulatory submissions are based on the global, multi-arm, phase 1b MMY1001 study (NCT01998971). The study evaluated daratumumab in combination with various other treatments in 240 patients with multiple myeloma. It found that both the safety profile and the pharmacokinetics concentrations seen with either single dosing or split dosing were similar.

Daratumumab is the first approved monoclonal antibody that targets CD38, which is expressed across multiple myeloma cells regardless of disease stage. Daratumumab is currently approved for treatment of multiple myeloma in both the United States and the European Union either as monotherapy or in conjunction with other treatments.

Daratumumab is known to sometimes cause severe/serious infusion reactions, such as anaphylactic reactions; interfere with serological testing; and cause neutropenia or thrombocytopenia.

[email protected]

Janssen has applied to the Food and Drug Administration and the European Medicines Agency to allow splitting of the first infusion of daratumumab (Darzalex) in multiple myeloma patients over 2 consecutive days.

Courtesy Janssen Biotech

The goal is to improve the treatment experience for patients and physicians, according to the announcement from Janssen.

The regulatory submissions are based on the global, multi-arm, phase 1b MMY1001 study (NCT01998971). The study evaluated daratumumab in combination with various other treatments in 240 patients with multiple myeloma. It found that both the safety profile and the pharmacokinetics concentrations seen with either single dosing or split dosing were similar.

Daratumumab is the first approved monoclonal antibody that targets CD38, which is expressed across multiple myeloma cells regardless of disease stage. Daratumumab is currently approved for treatment of multiple myeloma in both the United States and the European Union either as monotherapy or in conjunction with other treatments.

Daratumumab is known to sometimes cause severe/serious infusion reactions, such as anaphylactic reactions; interfere with serological testing; and cause neutropenia or thrombocytopenia.

[email protected]

Since the approval of infliximab in 2005 as the first biologic agent to treat ulcerative colitis, more UC patients are having multiple operations to manage their disease and their surgical outcomes tend to be worse, according to a study published in Annals of Surgery.

“Encouragingly, early randomized controlled trials demonstrated that infliximab may reduce the short-term need for surgery,” wrote Jonathan Abelson, MD, of the department of surgery, Cornell University, New York, and his coauthors. “However, even after the development and approval of several other biologic agents to treat UC, 30%-66% of patients treated with biologic agents still ultimately require surgical intervention.”

The study reviewed records of 7,070 patients with UC in a New York State Department of Health database who had colorectal surgery in two comparative time periods: 3,803 from 1995 to 2005, before biologics were available, and 3,267 from 2006 to 2013, after infliximab was approved. Dr. Abelson and coauthors said this is the first study to look at long-term surgical outcomes in a large group of patients with UC over an extended time period. Previous studies have reported conflicting results of how biologic agents for UC can impact surgical outcomes. The researchers set out to explore two hypotheses: whether staged procedures increased after 2005 and whether UC patients had worse outcomes over the past decade. The study results validated both hypotheses. Up until 2005, the proportion of patients who underwent at least three procedures after the index hospitalization was 9%; after 2006, that proportion was 14% (P less than .01).

SOURCE: Abelson JS et al. Ann Surg. 2018:268;311-7.

Since the approval of infliximab in 2005 as the first biologic agent to treat ulcerative colitis, more UC patients are having multiple operations to manage their disease and their surgical outcomes tend to be worse, according to a study published in Annals of Surgery.

“Encouragingly, early randomized controlled trials demonstrated that infliximab may reduce the short-term need for surgery,” wrote Jonathan Abelson, MD, of the department of surgery, Cornell University, New York, and his coauthors. “However, even after the development and approval of several other biologic agents to treat UC, 30%-66% of patients treated with biologic agents still ultimately require surgical intervention.”

The study reviewed records of 7,070 patients with UC in a New York State Department of Health database who had colorectal surgery in two comparative time periods: 3,803 from 1995 to 2005, before biologics were available, and 3,267 from 2006 to 2013, after infliximab was approved. Dr. Abelson and coauthors said this is the first study to look at long-term surgical outcomes in a large group of patients with UC over an extended time period. Previous studies have reported conflicting results of how biologic agents for UC can impact surgical outcomes. The researchers set out to explore two hypotheses: whether staged procedures increased after 2005 and whether UC patients had worse outcomes over the past decade. The study results validated both hypotheses. Up until 2005, the proportion of patients who underwent at least three procedures after the index hospitalization was 9%; after 2006, that proportion was 14% (P less than .01).

SOURCE: Abelson JS et al. Ann Surg. 2018:268;311-7.

Since the approval of infliximab in 2005 as the first biologic agent to treat ulcerative colitis, more UC patients are having multiple operations to manage their disease and their surgical outcomes tend to be worse, according to a study published in Annals of Surgery.

“Encouragingly, early randomized controlled trials demonstrated that infliximab may reduce the short-term need for surgery,” wrote Jonathan Abelson, MD, of the department of surgery, Cornell University, New York, and his coauthors. “However, even after the development and approval of several other biologic agents to treat UC, 30%-66% of patients treated with biologic agents still ultimately require surgical intervention.”

The study reviewed records of 7,070 patients with UC in a New York State Department of Health database who had colorectal surgery in two comparative time periods: 3,803 from 1995 to 2005, before biologics were available, and 3,267 from 2006 to 2013, after infliximab was approved. Dr. Abelson and coauthors said this is the first study to look at long-term surgical outcomes in a large group of patients with UC over an extended time period. Previous studies have reported conflicting results of how biologic agents for UC can impact surgical outcomes. The researchers set out to explore two hypotheses: whether staged procedures increased after 2005 and whether UC patients had worse outcomes over the past decade. The study results validated both hypotheses. Up until 2005, the proportion of patients who underwent at least three procedures after the index hospitalization was 9%; after 2006, that proportion was 14% (P less than .01).

SOURCE: Abelson JS et al. Ann Surg. 2018:268;311-7.

New estimates of chronic obstructive pulmonary disease (COPD) may have Utah residents breathing a sigh of relief. West Virginians, not so much.

The Beehive State has the lowest prevalence of COPD in the country at 2,710 per 100,000 population, while the Mountain State tops the charts at 11,130 per 100,000, according to estimates from the American Lung Association. (Crude rates were calculated by MDedge News using the ALA’s estimates for total persons with COPD in each state and Census Bureau estimates for population.)

Other states with freer-breathing residents include Minnesota, which was just behind Utah with an estimated rate of 3,000 per 100,000 population, Hawaii (3,182), Colorado (3,334), and California (3,409). West Virginia’s rate, however, seems to be an outlier. The state with the next-highest rate, Kentucky, has a calculated prevalence of 8,890 per 100,000 population, followed by Tennessee at 7,880, Alabama at 7,400, and Arkansas at 7,330, using the ALA’s estimates, which were based on data from the 2016 Behavioral Risk Factor Surveillance System survey.

[email protected]

New estimates of chronic obstructive pulmonary disease (COPD) may have Utah residents breathing a sigh of relief. West Virginians, not so much.

The Beehive State has the lowest prevalence of COPD in the country at 2,710 per 100,000 population, while the Mountain State tops the charts at 11,130 per 100,000, according to estimates from the American Lung Association. (Crude rates were calculated by MDedge News using the ALA’s estimates for total persons with COPD in each state and Census Bureau estimates for population.)

Other states with freer-breathing residents include Minnesota, which was just behind Utah with an estimated rate of 3,000 per 100,000 population, Hawaii (3,182), Colorado (3,334), and California (3,409). West Virginia’s rate, however, seems to be an outlier. The state with the next-highest rate, Kentucky, has a calculated prevalence of 8,890 per 100,000 population, followed by Tennessee at 7,880, Alabama at 7,400, and Arkansas at 7,330, using the ALA’s estimates, which were based on data from the 2016 Behavioral Risk Factor Surveillance System survey.

[email protected]

New estimates of chronic obstructive pulmonary disease (COPD) may have Utah residents breathing a sigh of relief. West Virginians, not so much.

The Beehive State has the lowest prevalence of COPD in the country at 2,710 per 100,000 population, while the Mountain State tops the charts at 11,130 per 100,000, according to estimates from the American Lung Association. (Crude rates were calculated by MDedge News using the ALA’s estimates for total persons with COPD in each state and Census Bureau estimates for population.)

Other states with freer-breathing residents include Minnesota, which was just behind Utah with an estimated rate of 3,000 per 100,000 population, Hawaii (3,182), Colorado (3,334), and California (3,409). West Virginia’s rate, however, seems to be an outlier. The state with the next-highest rate, Kentucky, has a calculated prevalence of 8,890 per 100,000 population, followed by Tennessee at 7,880, Alabama at 7,400, and Arkansas at 7,330, using the ALA’s estimates, which were based on data from the 2016 Behavioral Risk Factor Surveillance System survey.

[email protected]