Background: HAIs are key drivers of morbidity and mortality for hospitalized patients. In 2011, the Centers for Disease Control and Prevention (CDC) conducted a point-prevalence survey that revealed an HAI in 4% of hospitalized patients. The most common infections included pneumonia, gastrointestinal infections, and surgical-site infections. Over time, efforts in patient safety and quality have expanded to reduce the rate of HAIs. This same survey was repeated in 2015 to assess for improvements.

The reduction in HAIs was primarily driven by a reduction in surgical-site infections and urinary tract infections. There was no reduction in the prevalence of health care–associated pneumonia, Clostridium difficile infection, or mortality. Consequently, this emphasizes the necessity of further work in these domains.

Bottom line: The overall prevalence of HAIs has decreased, but further quality improvement work is needed in order to expand this reduction to health care–associated pneumonia, C. difficile infection, and mortality from HAIs.

Citation: Magill SS et al. Changes in prevalence of heath care–associated infections in U.S. hospitals. N Engl J Med. 2018;379(18):1732-44.

Dr. McIntyre is an associate physician in the division of hospital medicine at the University of California, San Diego.

Background: HAIs are key drivers of morbidity and mortality for hospitalized patients. In 2011, the Centers for Disease Control and Prevention (CDC) conducted a point-prevalence survey that revealed an HAI in 4% of hospitalized patients. The most common infections included pneumonia, gastrointestinal infections, and surgical-site infections. Over time, efforts in patient safety and quality have expanded to reduce the rate of HAIs. This same survey was repeated in 2015 to assess for improvements.

The reduction in HAIs was primarily driven by a reduction in surgical-site infections and urinary tract infections. There was no reduction in the prevalence of health care–associated pneumonia, Clostridium difficile infection, or mortality. Consequently, this emphasizes the necessity of further work in these domains.

Bottom line: The overall prevalence of HAIs has decreased, but further quality improvement work is needed in order to expand this reduction to health care–associated pneumonia, C. difficile infection, and mortality from HAIs.

Citation: Magill SS et al. Changes in prevalence of heath care–associated infections in U.S. hospitals. N Engl J Med. 2018;379(18):1732-44.

Dr. McIntyre is an associate physician in the division of hospital medicine at the University of California, San Diego.

Background: HAIs are key drivers of morbidity and mortality for hospitalized patients. In 2011, the Centers for Disease Control and Prevention (CDC) conducted a point-prevalence survey that revealed an HAI in 4% of hospitalized patients. The most common infections included pneumonia, gastrointestinal infections, and surgical-site infections. Over time, efforts in patient safety and quality have expanded to reduce the rate of HAIs. This same survey was repeated in 2015 to assess for improvements.

The reduction in HAIs was primarily driven by a reduction in surgical-site infections and urinary tract infections. There was no reduction in the prevalence of health care–associated pneumonia, Clostridium difficile infection, or mortality. Consequently, this emphasizes the necessity of further work in these domains.

Bottom line: The overall prevalence of HAIs has decreased, but further quality improvement work is needed in order to expand this reduction to health care–associated pneumonia, C. difficile infection, and mortality from HAIs.

Citation: Magill SS et al. Changes in prevalence of heath care–associated infections in U.S. hospitals. N Engl J Med. 2018;379(18):1732-44.

Dr. McIntyre is an associate physician in the division of hospital medicine at the University of California, San Diego.

Some people are civil; others are not. Some patients are polite, grateful, and courteous to a fault; others are angry, truculent, and aggressive. There may be reasons why such people are uncivil. Knowing those reasons does not make them any more civil than they aren’t, or any easier to take.

********

Charlie is 18. His mother is with him.

“I see my colleague prescribed an antibiotic for your acne.”

“No. I stopped the medicine after 2 weeks. It’s not acne.”

“Then what do you think it is?”

“Some sort of allergic reaction. I have a dog. I’ve taken two courses of prednisone.”

“Prednisone? That is not a good treatment for acne.”

“It’s not acne.”

“If that’s how you feel, then I think you will need to get another opinion.”

“My son can be difficult,” says his mother. “But just tell me – why do you think it’s acne?”

(Because I have been a skin doctor forever? Because Charlie is 18 and has pimples on his face?)

“If this were acne,” his mother goes on, “wouldn’t the pimples come in one place and go away in another?”

“Actually, no.”

“I don’t think I’ve ever been so offended,” says Charlie, who gets up and leaves.

“This is the most useless medical visit I have ever had,” says his mother. On the way out, she berates my secretary for working for such a worthless doctor.

Later that day Charlie calls back. He asks my secretary where he can post a bad review.

“Try our website,” suggests my staffer.

********

Gwen has many moles. Two were severely dysplastic and required re-excision.

“There is one mole on your back that I think needs to be tested.”

“Why?”

“Because it shows irregularity at the border.”

“I really hate surgery.”

“You may not need more surgery. We should find out, though.”

“I’m not saying you’re doing this just to get more money.”

“Well, thank you for that.”

“I’m not trying to be difficult.”

(But you are succeeding, aren’t you?)

“I also have warts on my finger.”

“I can freeze those for you.”

“Wait. Before you do, let me show you where to freeze. Put the nitrogen over here, where the wart is.”

“Thank you. I will try to do it correctly.”

“I just want to advocate for myself.”

********

“The emergency patient you worked in this morning is coming at 1:30,” says my secretary. “I couldn’t find his name in the system, so I called back.”

“Sorry sir, but I wanted to confirm your last name. It’s Jones, correct?”

“Are all of you incompetent there? I told you my name, didn’t I?”

“Just once more, if you wouldn’t mind.”

“It’s Jomes, J-O-M-E-S. Have you got that?”

“Why, yes, and thank you for your patience. Your appointment is at 1:30.”

“It may rain.”

“Yes, so they say.”

“Well?”

“I’m sorry?”

“I asked you a question.”

“What question?”

“I asked you if it is going to rain.”

“I’m sorry Mr. Jomes. I just book appointments.”

Amor Towles named his recent novel “Rules of Civility” after a note George Washington penned for his youthful self as a guide for getting along with people. Most of us intuit such rules just by noticing what works and what doesn’t, what pleases other people, or what makes them embarrassed or angry.

But there are people who don’t notice such things, or don’t care. They see nothing wrong with asking an old-time skin doctor how he knows that pimples are acne or demanding that he justify his opinion. (Or asking his staffer the best way to attack her boss.) They think it’s fine to suggest that a biopsy has been proposed for profit – after two prior biopsies arguably prevented severe disease – or making sure that a geezer with a spray can knows to put the nitrogen on the wart, not near it. Or berating a clerk for misspelling a last name of which he must have spent his life correcting other people’s misspellings.

I always taught students: “When people ask you how you know something, never invoke your experience or authority. If they don’t already think you have them, telling them you do won’t change their minds.”

Our job, often hard, is to always be civil. Society has zero tolerance for our ever being anything else. We know the rules. Uncivil people play by their own.

Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available at amazon.com and barnesandnoble.com. Write to him at dermnews@mdedge.com.

Some people are civil; others are not. Some patients are polite, grateful, and courteous to a fault; others are angry, truculent, and aggressive. There may be reasons why such people are uncivil. Knowing those reasons does not make them any more civil than they aren’t, or any easier to take.

********

Charlie is 18. His mother is with him.

“I see my colleague prescribed an antibiotic for your acne.”

“No. I stopped the medicine after 2 weeks. It’s not acne.”

“Then what do you think it is?”

“Some sort of allergic reaction. I have a dog. I’ve taken two courses of prednisone.”

“Prednisone? That is not a good treatment for acne.”

“It’s not acne.”

“If that’s how you feel, then I think you will need to get another opinion.”

“My son can be difficult,” says his mother. “But just tell me – why do you think it’s acne?”

(Because I have been a skin doctor forever? Because Charlie is 18 and has pimples on his face?)

“If this were acne,” his mother goes on, “wouldn’t the pimples come in one place and go away in another?”

“Actually, no.”

“I don’t think I’ve ever been so offended,” says Charlie, who gets up and leaves.

“This is the most useless medical visit I have ever had,” says his mother. On the way out, she berates my secretary for working for such a worthless doctor.

Later that day Charlie calls back. He asks my secretary where he can post a bad review.

“Try our website,” suggests my staffer.

********

Gwen has many moles. Two were severely dysplastic and required re-excision.

“There is one mole on your back that I think needs to be tested.”

“Why?”

“Because it shows irregularity at the border.”

“I really hate surgery.”

“You may not need more surgery. We should find out, though.”

“I’m not saying you’re doing this just to get more money.”

“Well, thank you for that.”

“I’m not trying to be difficult.”

(But you are succeeding, aren’t you?)

“I also have warts on my finger.”

“I can freeze those for you.”

“Wait. Before you do, let me show you where to freeze. Put the nitrogen over here, where the wart is.”

“Thank you. I will try to do it correctly.”

“I just want to advocate for myself.”

********

“The emergency patient you worked in this morning is coming at 1:30,” says my secretary. “I couldn’t find his name in the system, so I called back.”

“Sorry sir, but I wanted to confirm your last name. It’s Jones, correct?”

“Are all of you incompetent there? I told you my name, didn’t I?”

“Just once more, if you wouldn’t mind.”

“It’s Jomes, J-O-M-E-S. Have you got that?”

“Why, yes, and thank you for your patience. Your appointment is at 1:30.”

“It may rain.”

“Yes, so they say.”

“Well?”

“I’m sorry?”

“I asked you a question.”

“What question?”

“I asked you if it is going to rain.”

“I’m sorry Mr. Jomes. I just book appointments.”

Amor Towles named his recent novel “Rules of Civility” after a note George Washington penned for his youthful self as a guide for getting along with people. Most of us intuit such rules just by noticing what works and what doesn’t, what pleases other people, or what makes them embarrassed or angry.

But there are people who don’t notice such things, or don’t care. They see nothing wrong with asking an old-time skin doctor how he knows that pimples are acne or demanding that he justify his opinion. (Or asking his staffer the best way to attack her boss.) They think it’s fine to suggest that a biopsy has been proposed for profit – after two prior biopsies arguably prevented severe disease – or making sure that a geezer with a spray can knows to put the nitrogen on the wart, not near it. Or berating a clerk for misspelling a last name of which he must have spent his life correcting other people’s misspellings.

I always taught students: “When people ask you how you know something, never invoke your experience or authority. If they don’t already think you have them, telling them you do won’t change their minds.”

Our job, often hard, is to always be civil. Society has zero tolerance for our ever being anything else. We know the rules. Uncivil people play by their own.

Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available at amazon.com and barnesandnoble.com. Write to him at dermnews@mdedge.com.

Some people are civil; others are not. Some patients are polite, grateful, and courteous to a fault; others are angry, truculent, and aggressive. There may be reasons why such people are uncivil. Knowing those reasons does not make them any more civil than they aren’t, or any easier to take.

********

Charlie is 18. His mother is with him.

“I see my colleague prescribed an antibiotic for your acne.”

“No. I stopped the medicine after 2 weeks. It’s not acne.”

“Then what do you think it is?”

“Some sort of allergic reaction. I have a dog. I’ve taken two courses of prednisone.”

“Prednisone? That is not a good treatment for acne.”

“It’s not acne.”

“If that’s how you feel, then I think you will need to get another opinion.”

“My son can be difficult,” says his mother. “But just tell me – why do you think it’s acne?”

(Because I have been a skin doctor forever? Because Charlie is 18 and has pimples on his face?)

“If this were acne,” his mother goes on, “wouldn’t the pimples come in one place and go away in another?”

“Actually, no.”

“I don’t think I’ve ever been so offended,” says Charlie, who gets up and leaves.

“This is the most useless medical visit I have ever had,” says his mother. On the way out, she berates my secretary for working for such a worthless doctor.

Later that day Charlie calls back. He asks my secretary where he can post a bad review.

“Try our website,” suggests my staffer.

********

Gwen has many moles. Two were severely dysplastic and required re-excision.

“There is one mole on your back that I think needs to be tested.”

“Why?”

“Because it shows irregularity at the border.”

“I really hate surgery.”

“You may not need more surgery. We should find out, though.”

“I’m not saying you’re doing this just to get more money.”

“Well, thank you for that.”

“I’m not trying to be difficult.”

(But you are succeeding, aren’t you?)

“I also have warts on my finger.”

“I can freeze those for you.”

“Wait. Before you do, let me show you where to freeze. Put the nitrogen over here, where the wart is.”

“Thank you. I will try to do it correctly.”

“I just want to advocate for myself.”

********

“The emergency patient you worked in this morning is coming at 1:30,” says my secretary. “I couldn’t find his name in the system, so I called back.”

“Sorry sir, but I wanted to confirm your last name. It’s Jones, correct?”

“Are all of you incompetent there? I told you my name, didn’t I?”

“Just once more, if you wouldn’t mind.”

“It’s Jomes, J-O-M-E-S. Have you got that?”

“Why, yes, and thank you for your patience. Your appointment is at 1:30.”

“It may rain.”

“Yes, so they say.”

“Well?”

“I’m sorry?”

“I asked you a question.”

“What question?”

“I asked you if it is going to rain.”

“I’m sorry Mr. Jomes. I just book appointments.”

Amor Towles named his recent novel “Rules of Civility” after a note George Washington penned for his youthful self as a guide for getting along with people. Most of us intuit such rules just by noticing what works and what doesn’t, what pleases other people, or what makes them embarrassed or angry.

But there are people who don’t notice such things, or don’t care. They see nothing wrong with asking an old-time skin doctor how he knows that pimples are acne or demanding that he justify his opinion. (Or asking his staffer the best way to attack her boss.) They think it’s fine to suggest that a biopsy has been proposed for profit – after two prior biopsies arguably prevented severe disease – or making sure that a geezer with a spray can knows to put the nitrogen on the wart, not near it. Or berating a clerk for misspelling a last name of which he must have spent his life correcting other people’s misspellings.

I always taught students: “When people ask you how you know something, never invoke your experience or authority. If they don’t already think you have them, telling them you do won’t change their minds.”

Our job, often hard, is to always be civil. Society has zero tolerance for our ever being anything else. We know the rules. Uncivil people play by their own.

Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available at amazon.com and barnesandnoble.com. Write to him at dermnews@mdedge.com.

Patients with multiple myeloma who don’t respond to induction therapy may be better off advancing straight to autologous stem cell therapy, rather than undergoing salvage therapy before transplant, according to findings of an analysis that included both real-world and clinical trial patients.

Wikimedia Commons/KGH/Creative Commons License

Joanna Blocka, MD, of the University Hospital of Heidelberg (Germany) and colleagues found similar progression-free and overall survival rates for patients who had progressive disease and underwent autologous stem cell therapy (ASCT), compared with patients who underwent salvage therapy and improved to at least stable disease before proceeding to transplant. The findings were published in Leukemia & Lymphoma.

The real-world analysis included 1,599 patients with multiple myeloma who had undergone ASCT between 1991 and 2016. More than half of the patients (58%) were not enrolled in clinical trials. The remainder were split between the German-Speaking Myeloma Multicenter Group (GMMG)-HD3 and GMMG-HD4 trials, which compared various induction regimens.

Just 23 patients in the analysis received salvage therapy because of progressive disease and deepened their response before ASCT. Of these patients, 12 received novel agents in induction therapy and 11 received older medications.

Looking across all 1,599 patients, 5.3% achieved complete remission before first ASCT. Most patients (71.8%) achieved partial remission, 9.7% had a minimal response, and 5.7% had stable disease. A group of 120 patients (7.5%) progressed between the last course of induction and ASCT.

The researchers compared the progression-free and overall survival rates of patients with progressive disease versus those who had stable disease or better before their first transplant. Both univariable and multivariable analysis showed no statistically significant differences in either survival outcome between the two groups.

In the multivariable analysis, there was a hazard ratio of 1.23 (95% confidence interval, 0.98-1.56) for progression-free survival for patients with progressive disease versus those who responded to induction therapy. Similarly, the HR for overall survival between the two groups was 1.24 (95% CI, 0.93-1.65).

The researchers also analyzed the groups based on whether they received novel or older agents during induction.

Patients with progressive disease who received novel agents had significantly worse progression-free survival (22.2 months), compared with patients who responded to treatment with novel agents (22.2 months vs. 29.1 months; P = .03). The same trend was seen with overall survival in these groups (54.4 months vs. 97.5 months; P less than .001).

Rates of survival were similar for patients with progressive disease and responders who had received older medications at induction.

“This might be explained by a prognostically disadvantageous disease biology in patients nonresponsive to novel agents,” the researchers wrote.

The researchers also compared survival outcomes for the 120 patients who underwent ASCT with progressive disease versus the 23 patients who received salvage therapy and improved their response to at least stable disease before transplant. Univariable analysis showed that salvage patients actually did worse than those with progressive disease who proceeded straight to transplant – 12.1 months versus 22.9 months of progression-free survival (P = .04) and 33.1 versus 69.5 months of overall survival (P = .08). But on multivariable analysis, there was no significant difference between the two groups for progression-free survival (HR, 0.71; 95% CI, 0.28-1.80; P = .5) or overall survival (HR, 0.77; 95% CI, 0.30-1.95; P = .6). The use of novel agents did not appear to affect the survival outcomes in these patients.

The worse outcomes seen among salvage patients observed in univariable analysis “might be due to a cumulative toxic effect of salvage therapy,” the researchers suggested. “An alternative explanation could be that the patients who were offered salvage therapy might have had more aggressive disease than those who did not undergo salvage therapy.”

Dr. Blocka reported having no relevant financial disclosures. Other coauthors reported relationships with Janssen, Amgen, Bristol-Myers Squibb, Celgene, and others.

mschneider@mdedge.com

SOURCE: Blocka J et al. Leuk Lymphoma. 2019 Aug 19. doi: 10.1080/10428194.2019.1646905.

Patients with multiple myeloma who don’t respond to induction therapy may be better off advancing straight to autologous stem cell therapy, rather than undergoing salvage therapy before transplant, according to findings of an analysis that included both real-world and clinical trial patients.

Wikimedia Commons/KGH/Creative Commons License

Joanna Blocka, MD, of the University Hospital of Heidelberg (Germany) and colleagues found similar progression-free and overall survival rates for patients who had progressive disease and underwent autologous stem cell therapy (ASCT), compared with patients who underwent salvage therapy and improved to at least stable disease before proceeding to transplant. The findings were published in Leukemia & Lymphoma.

The real-world analysis included 1,599 patients with multiple myeloma who had undergone ASCT between 1991 and 2016. More than half of the patients (58%) were not enrolled in clinical trials. The remainder were split between the German-Speaking Myeloma Multicenter Group (GMMG)-HD3 and GMMG-HD4 trials, which compared various induction regimens.

Just 23 patients in the analysis received salvage therapy because of progressive disease and deepened their response before ASCT. Of these patients, 12 received novel agents in induction therapy and 11 received older medications.

Looking across all 1,599 patients, 5.3% achieved complete remission before first ASCT. Most patients (71.8%) achieved partial remission, 9.7% had a minimal response, and 5.7% had stable disease. A group of 120 patients (7.5%) progressed between the last course of induction and ASCT.

The researchers compared the progression-free and overall survival rates of patients with progressive disease versus those who had stable disease or better before their first transplant. Both univariable and multivariable analysis showed no statistically significant differences in either survival outcome between the two groups.

In the multivariable analysis, there was a hazard ratio of 1.23 (95% confidence interval, 0.98-1.56) for progression-free survival for patients with progressive disease versus those who responded to induction therapy. Similarly, the HR for overall survival between the two groups was 1.24 (95% CI, 0.93-1.65).

The researchers also analyzed the groups based on whether they received novel or older agents during induction.

Patients with progressive disease who received novel agents had significantly worse progression-free survival (22.2 months), compared with patients who responded to treatment with novel agents (22.2 months vs. 29.1 months; P = .03). The same trend was seen with overall survival in these groups (54.4 months vs. 97.5 months; P less than .001).

Rates of survival were similar for patients with progressive disease and responders who had received older medications at induction.

“This might be explained by a prognostically disadvantageous disease biology in patients nonresponsive to novel agents,” the researchers wrote.

The researchers also compared survival outcomes for the 120 patients who underwent ASCT with progressive disease versus the 23 patients who received salvage therapy and improved their response to at least stable disease before transplant. Univariable analysis showed that salvage patients actually did worse than those with progressive disease who proceeded straight to transplant – 12.1 months versus 22.9 months of progression-free survival (P = .04) and 33.1 versus 69.5 months of overall survival (P = .08). But on multivariable analysis, there was no significant difference between the two groups for progression-free survival (HR, 0.71; 95% CI, 0.28-1.80; P = .5) or overall survival (HR, 0.77; 95% CI, 0.30-1.95; P = .6). The use of novel agents did not appear to affect the survival outcomes in these patients.

The worse outcomes seen among salvage patients observed in univariable analysis “might be due to a cumulative toxic effect of salvage therapy,” the researchers suggested. “An alternative explanation could be that the patients who were offered salvage therapy might have had more aggressive disease than those who did not undergo salvage therapy.”

Dr. Blocka reported having no relevant financial disclosures. Other coauthors reported relationships with Janssen, Amgen, Bristol-Myers Squibb, Celgene, and others.

mschneider@mdedge.com

SOURCE: Blocka J et al. Leuk Lymphoma. 2019 Aug 19. doi: 10.1080/10428194.2019.1646905.

Patients with multiple myeloma who don’t respond to induction therapy may be better off advancing straight to autologous stem cell therapy, rather than undergoing salvage therapy before transplant, according to findings of an analysis that included both real-world and clinical trial patients.

Wikimedia Commons/KGH/Creative Commons License

Joanna Blocka, MD, of the University Hospital of Heidelberg (Germany) and colleagues found similar progression-free and overall survival rates for patients who had progressive disease and underwent autologous stem cell therapy (ASCT), compared with patients who underwent salvage therapy and improved to at least stable disease before proceeding to transplant. The findings were published in Leukemia & Lymphoma.

The real-world analysis included 1,599 patients with multiple myeloma who had undergone ASCT between 1991 and 2016. More than half of the patients (58%) were not enrolled in clinical trials. The remainder were split between the German-Speaking Myeloma Multicenter Group (GMMG)-HD3 and GMMG-HD4 trials, which compared various induction regimens.

Just 23 patients in the analysis received salvage therapy because of progressive disease and deepened their response before ASCT. Of these patients, 12 received novel agents in induction therapy and 11 received older medications.

Looking across all 1,599 patients, 5.3% achieved complete remission before first ASCT. Most patients (71.8%) achieved partial remission, 9.7% had a minimal response, and 5.7% had stable disease. A group of 120 patients (7.5%) progressed between the last course of induction and ASCT.

The researchers compared the progression-free and overall survival rates of patients with progressive disease versus those who had stable disease or better before their first transplant. Both univariable and multivariable analysis showed no statistically significant differences in either survival outcome between the two groups.

In the multivariable analysis, there was a hazard ratio of 1.23 (95% confidence interval, 0.98-1.56) for progression-free survival for patients with progressive disease versus those who responded to induction therapy. Similarly, the HR for overall survival between the two groups was 1.24 (95% CI, 0.93-1.65).

The researchers also analyzed the groups based on whether they received novel or older agents during induction.

Patients with progressive disease who received novel agents had significantly worse progression-free survival (22.2 months), compared with patients who responded to treatment with novel agents (22.2 months vs. 29.1 months; P = .03). The same trend was seen with overall survival in these groups (54.4 months vs. 97.5 months; P less than .001).

Rates of survival were similar for patients with progressive disease and responders who had received older medications at induction.

“This might be explained by a prognostically disadvantageous disease biology in patients nonresponsive to novel agents,” the researchers wrote.

The researchers also compared survival outcomes for the 120 patients who underwent ASCT with progressive disease versus the 23 patients who received salvage therapy and improved their response to at least stable disease before transplant. Univariable analysis showed that salvage patients actually did worse than those with progressive disease who proceeded straight to transplant – 12.1 months versus 22.9 months of progression-free survival (P = .04) and 33.1 versus 69.5 months of overall survival (P = .08). But on multivariable analysis, there was no significant difference between the two groups for progression-free survival (HR, 0.71; 95% CI, 0.28-1.80; P = .5) or overall survival (HR, 0.77; 95% CI, 0.30-1.95; P = .6). The use of novel agents did not appear to affect the survival outcomes in these patients.

The worse outcomes seen among salvage patients observed in univariable analysis “might be due to a cumulative toxic effect of salvage therapy,” the researchers suggested. “An alternative explanation could be that the patients who were offered salvage therapy might have had more aggressive disease than those who did not undergo salvage therapy.”

Dr. Blocka reported having no relevant financial disclosures. Other coauthors reported relationships with Janssen, Amgen, Bristol-Myers Squibb, Celgene, and others.

mschneider@mdedge.com

SOURCE: Blocka J et al. Leuk Lymphoma. 2019 Aug 19. doi: 10.1080/10428194.2019.1646905.

Women who have tested positive for Chlamydia trachomatis have an increased risk for pelvic inflammatory disease (PID), ectopic pregnancy, and infertility, compared with women who have tested negative for C. trachomatis or who have not been tested for the bacterium, according to a retrospective cohort study.

CDC/Dr. E. Arum; Dr. N. Jacobs

The risk of PID increases with repeat chlamydial infections, and the use of antibiotics that are effective against C. trachomatis does not decrease the risk of subsequent PID, the researchers reported in Clinical Infectious Diseases.

Prior studies have yielded different estimates of the risk of reproductive complications after chlamydia infection, said Casper den Heijer, MD, PhD, a researcher at Utrecht Institute of Pharmaceutical Sciences in Heerlen, the Netherlands, and colleagues. To assess the risk of PID, ectopic pregnancy, and infertility in women with a previous C. trachomatis diagnosis, Dr. den Heijer and coauthors conducted a retrospective study of women aged 12-25 years at baseline in the Clinical Practice Research Datalink GOLD database. Their analysis included data from women living in England between 2000 and 2013. The investigators used Cox proportional hazard models to evaluate the risk of adverse outcomes.

The researchers analyzed data from 857,324 women with a mean follow-up of 7.5 years. Patients’ mean age at baseline was 15 years. In all, the participants had 8,346 occurrences of PID, 2,484 occurrences of ectopic pregnancy, and 2,066 occurrences of female infertility.

For PID, incidence rates per 1,000 person-years were 1.1 among women untested for C. trachomatis, 1.4 among women who tested negative, and 5.4 among women who tested positive. For ectopic pregnancy, the incidence rates were 0.3 for untested women, 0.4 for negatively tested women, and 1.2 for positively tested women. Infertility incidence rates were 0.3 for untested women, 0.3 for negatively tested women, and 0.9 for positively tested women.

Compared with women who tested negative for C. trachomatis, women who tested positive had an increased risk of PID (adjusted hazard ratio, 2.36), ectopic pregnancy (aHR, 1.87), and female infertility (aHR, 1.85). Untested women had a lower risk for PID, compared with women who tested negative (aHR, 0.57).

C. trachomatis–effective antibiotic use was associated with higher PID risk, and that risk increased as the women used more of the antibiotic prescriptions, Dr. den Heijer and associates said. This occurred in all three groups of women. A possible explanation for this association between the antibiotics and higher PID risk could be that PID can be caused by other infectious diseases that could be treated with C. trachomatis–effective antibiotics.

While the study relied on primary care data, genitourinary medicine clinics diagnose and treat “a sizable proportion” of sexually transmitted infections in the United Kingdom, the authors noted. This limitation means that the study underestimates the number of C. trachomatis diagnoses in the cohort, they said.

Nonetheless, “Our results confirm the reproductive health burden of [C. trachomatis] and show the need for adequate public health interventions,” Dr. den Heijer and associates concluded.

jremaly@mdedge.com

SOURCE: den Heijer CDJ et al. Clin Infect Dis. 2019 Aug 24. doi: 10.1093/cid/ciz429.

Women who have tested positive for Chlamydia trachomatis have an increased risk for pelvic inflammatory disease (PID), ectopic pregnancy, and infertility, compared with women who have tested negative for C. trachomatis or who have not been tested for the bacterium, according to a retrospective cohort study.

CDC/Dr. E. Arum; Dr. N. Jacobs

The risk of PID increases with repeat chlamydial infections, and the use of antibiotics that are effective against C. trachomatis does not decrease the risk of subsequent PID, the researchers reported in Clinical Infectious Diseases.

Prior studies have yielded different estimates of the risk of reproductive complications after chlamydia infection, said Casper den Heijer, MD, PhD, a researcher at Utrecht Institute of Pharmaceutical Sciences in Heerlen, the Netherlands, and colleagues. To assess the risk of PID, ectopic pregnancy, and infertility in women with a previous C. trachomatis diagnosis, Dr. den Heijer and coauthors conducted a retrospective study of women aged 12-25 years at baseline in the Clinical Practice Research Datalink GOLD database. Their analysis included data from women living in England between 2000 and 2013. The investigators used Cox proportional hazard models to evaluate the risk of adverse outcomes.

The researchers analyzed data from 857,324 women with a mean follow-up of 7.5 years. Patients’ mean age at baseline was 15 years. In all, the participants had 8,346 occurrences of PID, 2,484 occurrences of ectopic pregnancy, and 2,066 occurrences of female infertility.

For PID, incidence rates per 1,000 person-years were 1.1 among women untested for C. trachomatis, 1.4 among women who tested negative, and 5.4 among women who tested positive. For ectopic pregnancy, the incidence rates were 0.3 for untested women, 0.4 for negatively tested women, and 1.2 for positively tested women. Infertility incidence rates were 0.3 for untested women, 0.3 for negatively tested women, and 0.9 for positively tested women.

Compared with women who tested negative for C. trachomatis, women who tested positive had an increased risk of PID (adjusted hazard ratio, 2.36), ectopic pregnancy (aHR, 1.87), and female infertility (aHR, 1.85). Untested women had a lower risk for PID, compared with women who tested negative (aHR, 0.57).

C. trachomatis–effective antibiotic use was associated with higher PID risk, and that risk increased as the women used more of the antibiotic prescriptions, Dr. den Heijer and associates said. This occurred in all three groups of women. A possible explanation for this association between the antibiotics and higher PID risk could be that PID can be caused by other infectious diseases that could be treated with C. trachomatis–effective antibiotics.

While the study relied on primary care data, genitourinary medicine clinics diagnose and treat “a sizable proportion” of sexually transmitted infections in the United Kingdom, the authors noted. This limitation means that the study underestimates the number of C. trachomatis diagnoses in the cohort, they said.

Nonetheless, “Our results confirm the reproductive health burden of [C. trachomatis] and show the need for adequate public health interventions,” Dr. den Heijer and associates concluded.

jremaly@mdedge.com

SOURCE: den Heijer CDJ et al. Clin Infect Dis. 2019 Aug 24. doi: 10.1093/cid/ciz429.

Women who have tested positive for Chlamydia trachomatis have an increased risk for pelvic inflammatory disease (PID), ectopic pregnancy, and infertility, compared with women who have tested negative for C. trachomatis or who have not been tested for the bacterium, according to a retrospective cohort study.

CDC/Dr. E. Arum; Dr. N. Jacobs

The risk of PID increases with repeat chlamydial infections, and the use of antibiotics that are effective against C. trachomatis does not decrease the risk of subsequent PID, the researchers reported in Clinical Infectious Diseases.

Prior studies have yielded different estimates of the risk of reproductive complications after chlamydia infection, said Casper den Heijer, MD, PhD, a researcher at Utrecht Institute of Pharmaceutical Sciences in Heerlen, the Netherlands, and colleagues. To assess the risk of PID, ectopic pregnancy, and infertility in women with a previous C. trachomatis diagnosis, Dr. den Heijer and coauthors conducted a retrospective study of women aged 12-25 years at baseline in the Clinical Practice Research Datalink GOLD database. Their analysis included data from women living in England between 2000 and 2013. The investigators used Cox proportional hazard models to evaluate the risk of adverse outcomes.

The researchers analyzed data from 857,324 women with a mean follow-up of 7.5 years. Patients’ mean age at baseline was 15 years. In all, the participants had 8,346 occurrences of PID, 2,484 occurrences of ectopic pregnancy, and 2,066 occurrences of female infertility.

For PID, incidence rates per 1,000 person-years were 1.1 among women untested for C. trachomatis, 1.4 among women who tested negative, and 5.4 among women who tested positive. For ectopic pregnancy, the incidence rates were 0.3 for untested women, 0.4 for negatively tested women, and 1.2 for positively tested women. Infertility incidence rates were 0.3 for untested women, 0.3 for negatively tested women, and 0.9 for positively tested women.

Compared with women who tested negative for C. trachomatis, women who tested positive had an increased risk of PID (adjusted hazard ratio, 2.36), ectopic pregnancy (aHR, 1.87), and female infertility (aHR, 1.85). Untested women had a lower risk for PID, compared with women who tested negative (aHR, 0.57).

C. trachomatis–effective antibiotic use was associated with higher PID risk, and that risk increased as the women used more of the antibiotic prescriptions, Dr. den Heijer and associates said. This occurred in all three groups of women. A possible explanation for this association between the antibiotics and higher PID risk could be that PID can be caused by other infectious diseases that could be treated with C. trachomatis–effective antibiotics.

While the study relied on primary care data, genitourinary medicine clinics diagnose and treat “a sizable proportion” of sexually transmitted infections in the United Kingdom, the authors noted. This limitation means that the study underestimates the number of C. trachomatis diagnoses in the cohort, they said.

Nonetheless, “Our results confirm the reproductive health burden of [C. trachomatis] and show the need for adequate public health interventions,” Dr. den Heijer and associates concluded.

jremaly@mdedge.com

SOURCE: den Heijer CDJ et al. Clin Infect Dis. 2019 Aug 24. doi: 10.1093/cid/ciz429.

EVIDENCE SUMMARY

Efficacy. A 2014 double-blind RCT compared ondansetron with pyridoxine plus doxylamine (standard care) for outpatient treatment of nausea and vomiting in pregnancy.¹ The 36 patients had an average gestational age of 8 weeks and received either 4 mg oral ondansetron plus placebo or 25 mg pyridoxine plus 12.5 mg doxylamine 3 times daily for 5 days. Nausea and vomiting severity was measured using 2 separate 10-cm visual analog scales (VAS) with scores ranging from 0 to 10 (worst nausea or vomiting imaginable). Researchers determined that a VAS score reduction of 2.5 cm was clinically significant.

Patients treated with ondansetron described greater improvements in nausea (mean VAS change −5.1 cm vs −2 cm; P = .019) and vomiting (mean VAS change −4.1 cm vs −1.7 cm; P = .049). No patient required hospitalization. The researchers didn’t report on adverse effects or birth outcomes. The study was limited by the small sample size and a high rate (17%) of patients with missing data or who were lost to follow-up.

IV ondansetron vs metoclopramide: Similar efficacy, fewer adverse effects

A 2014 double-blind RCT compared IV ondansetron with IV metoclopramide (standard care) for treating hyperemesis gravidarum.² The 160 patients had an average gestational age of 9.5 weeks and intractable nausea and vomiting severe enough to cause dehydration, metabolic disturbance, and hospitalization. Patients received either 4 mg ondansetron or 10 mg metoclopramide IV every 8 hours for 24 hours. The primary outcomes were number of episodes of vomiting over 24 hours and self-reported sense of well-being rated on a 10-point scale.

No differences were found between the ondansetron- and metoclopramide-treated groups in terms of vomiting over 24 hours (median episodes 1 and 1; P = .38) or sense of well-being (mean scores 8.7 vs 8.3; P = .13). Patients treated with ondansetron were less likely to have persistent ketonuria at 24 hours (relative risk [RR] = 0.3; 95% confidence interval [CI], 0.1-0.8; number needed to treat [NNT] = 6). They also were less likely to feel drowsy (RR = 0.3; 95% CI, 0.1–0.8; NNT = 6) or complain of dry mouth (RR = 0.4; 95% CI, 0.1-0.9; NNT = 8). The study didn’t report birth outcomes or adverse fetal effects.

Oral ondansetron outperforms oral metoclopramide in small study

A 2013 double-blind RCT compared ondansetron with metoclopramide (standard care) for controlling severe nausea and vomiting.³ The 83 patients, with an average gestational age of 8.7 weeks, had more than 3 vomiting episodes daily, weight loss, and ketonuria. They received either 4 mg oral ondansetron or 10 mg oral metoclopramide for 2 weeks as follows: 3 times daily for 1 week, then twice daily for 3 days, then once daily for 4 days. Patients rated nausea severity using a 10-cm VAS from 0 to 10 (severe nausea) and recorded the number of vomiting episodes.

Women treated with ondansetron had significantly lower VAS scores on Days 3 and 4 of treatment (5.4 vs 6, P = .024 on Day­ 3; 4.1 vs 5.7, P = .023 on Day 4). They also had fewer episodes of vomiting on Days 2, 3, and 4 (3.7 vs 6, P = .006 on Day 2; 3.2 vs 5.3, P = .006 on Day 3; and 3.3 vs 5, P = .013 on Day 4). The study was limited by the small sample size.

Safety. A 2016 systematic review examining the risk of birth defects associated with ondansetron exposure in pregnancy found 8 reports: 5 birth registries, 2 case-control studies, and 1 prospective cohort study.⁴ Investigators compared rates of major malformations—cleft lips, cleft palates, neural tube defects, cardiac defects, and hypospadias—in 5101 women exposed to ondansetron in the first trimester with birth defect rates in more than 3.1 million nonexposed women.

Continue to: No study demonstrated...

No study demonstrated an increased rate of major malformations associated with ondansetron exposure except for 2 disease registry studies with nearly 2.4 million patients that reported a slight increase in the risk of cardiac defects (odds ratio [OR] = 2; 95% CI, 1.3-3.1; OR = 1.6, 95% CI, 1-2.1). Comparisons of other birth defect rates associated with ondansetron exposure were inconsistent, with studies showing small increases, decreases, or no difference in rates between exposed and nonexposed women.

Exposure vs nonexposure: No difference in adverse outcomes

A 2013 retrospective cohort study looked at 608,385 pregnancies among women in Denmark, of whom 1970 (0.3%) had been exposed to ondansetron.⁵ The study found that exposure to ondansetron compared with nonexposure was associated with a lower risk for spontaneous abortion between 7 and 12 weeks’ gestation (1.1% vs 3.7%; hazard ratio [HR] = 0.5; 95% CI, 0.3-0.9).

Oral ondansetron is more effective than pyridoxine plus doxylamine for outpatient treatment of nausea and vomiting in pregnancy.

No significant differences between ­ondansetron exposure and nonexposure were found for the following adverse outcomes: spontaneous abortion between 13 and 22 weeks’ gestation (1% vs 2.1%; HR = 0.6; 95% CI, 0.3-1.2); stillbirth (0.3% vs 0.4%;  HR = 0.4; 95% CI, 0.1-1.7); any major birth defect (2.9% in both exposed and nonexposed women; OR = 1.12; 95% CI, 0.69-1.82); preterm delivery (6.2% vs 5.2%; OR = 0.9; 95% CI, 0.7-1.3), low birth weight infant (4.1% vs 3.7%; OR = 0.8; 95% CI, 0.5-1.1); and small-for-­gestational-age infant (10.4% vs 9.2%; OR = 1.1; 95% CI, 0.9-1.4).

RECOMMENDATIONS

The American College of Obstetricians and Gynecologists (ACOG) states that insufficient data exist regarding the safety of ondansetron for the fetus.⁶ ACOG recommends individualizing the use of ondansetron before 10 weeks of pregnancy after weighing the risks and benefits. ACOG also recommends adding ondansetron as third-line treatment for nausea and vomiting unresponsive to first- and second-line treatments.

EDITOR'S TAKEAWAY

Higher-quality studies showed ondansetron to be an effective treatment for hyperemesis gravidarum. Lower-quality studies raised some concerns about adverse fetal effects. Although the adverse effects were rare and the quality of the evidence was lower, the cautionary principle suggests that ondansetron should be a second-line option.

EVIDENCE SUMMARY

Efficacy. A 2014 double-blind RCT compared ondansetron with pyridoxine plus doxylamine (standard care) for outpatient treatment of nausea and vomiting in pregnancy.¹ The 36 patients had an average gestational age of 8 weeks and received either 4 mg oral ondansetron plus placebo or 25 mg pyridoxine plus 12.5 mg doxylamine 3 times daily for 5 days. Nausea and vomiting severity was measured using 2 separate 10-cm visual analog scales (VAS) with scores ranging from 0 to 10 (worst nausea or vomiting imaginable). Researchers determined that a VAS score reduction of 2.5 cm was clinically significant.

Patients treated with ondansetron described greater improvements in nausea (mean VAS change −5.1 cm vs −2 cm; P = .019) and vomiting (mean VAS change −4.1 cm vs −1.7 cm; P = .049). No patient required hospitalization. The researchers didn’t report on adverse effects or birth outcomes. The study was limited by the small sample size and a high rate (17%) of patients with missing data or who were lost to follow-up.

IV ondansetron vs metoclopramide: Similar efficacy, fewer adverse effects

A 2014 double-blind RCT compared IV ondansetron with IV metoclopramide (standard care) for treating hyperemesis gravidarum.² The 160 patients had an average gestational age of 9.5 weeks and intractable nausea and vomiting severe enough to cause dehydration, metabolic disturbance, and hospitalization. Patients received either 4 mg ondansetron or 10 mg metoclopramide IV every 8 hours for 24 hours. The primary outcomes were number of episodes of vomiting over 24 hours and self-reported sense of well-being rated on a 10-point scale.

No differences were found between the ondansetron- and metoclopramide-treated groups in terms of vomiting over 24 hours (median episodes 1 and 1; P = .38) or sense of well-being (mean scores 8.7 vs 8.3; P = .13). Patients treated with ondansetron were less likely to have persistent ketonuria at 24 hours (relative risk [RR] = 0.3; 95% confidence interval [CI], 0.1-0.8; number needed to treat [NNT] = 6). They also were less likely to feel drowsy (RR = 0.3; 95% CI, 0.1–0.8; NNT = 6) or complain of dry mouth (RR = 0.4; 95% CI, 0.1-0.9; NNT = 8). The study didn’t report birth outcomes or adverse fetal effects.

Oral ondansetron outperforms oral metoclopramide in small study

A 2013 double-blind RCT compared ondansetron with metoclopramide (standard care) for controlling severe nausea and vomiting.³ The 83 patients, with an average gestational age of 8.7 weeks, had more than 3 vomiting episodes daily, weight loss, and ketonuria. They received either 4 mg oral ondansetron or 10 mg oral metoclopramide for 2 weeks as follows: 3 times daily for 1 week, then twice daily for 3 days, then once daily for 4 days. Patients rated nausea severity using a 10-cm VAS from 0 to 10 (severe nausea) and recorded the number of vomiting episodes.

Women treated with ondansetron had significantly lower VAS scores on Days 3 and 4 of treatment (5.4 vs 6, P = .024 on Day­ 3; 4.1 vs 5.7, P = .023 on Day 4). They also had fewer episodes of vomiting on Days 2, 3, and 4 (3.7 vs 6, P = .006 on Day 2; 3.2 vs 5.3, P = .006 on Day 3; and 3.3 vs 5, P = .013 on Day 4). The study was limited by the small sample size.

Safety. A 2016 systematic review examining the risk of birth defects associated with ondansetron exposure in pregnancy found 8 reports: 5 birth registries, 2 case-control studies, and 1 prospective cohort study.⁴ Investigators compared rates of major malformations—cleft lips, cleft palates, neural tube defects, cardiac defects, and hypospadias—in 5101 women exposed to ondansetron in the first trimester with birth defect rates in more than 3.1 million nonexposed women.

Continue to: No study demonstrated...

No study demonstrated an increased rate of major malformations associated with ondansetron exposure except for 2 disease registry studies with nearly 2.4 million patients that reported a slight increase in the risk of cardiac defects (odds ratio [OR] = 2; 95% CI, 1.3-3.1; OR = 1.6, 95% CI, 1-2.1). Comparisons of other birth defect rates associated with ondansetron exposure were inconsistent, with studies showing small increases, decreases, or no difference in rates between exposed and nonexposed women.

Exposure vs nonexposure: No difference in adverse outcomes

A 2013 retrospective cohort study looked at 608,385 pregnancies among women in Denmark, of whom 1970 (0.3%) had been exposed to ondansetron.⁵ The study found that exposure to ondansetron compared with nonexposure was associated with a lower risk for spontaneous abortion between 7 and 12 weeks’ gestation (1.1% vs 3.7%; hazard ratio [HR] = 0.5; 95% CI, 0.3-0.9).

Oral ondansetron is more effective than pyridoxine plus doxylamine for outpatient treatment of nausea and vomiting in pregnancy.

No significant differences between ­ondansetron exposure and nonexposure were found for the following adverse outcomes: spontaneous abortion between 13 and 22 weeks’ gestation (1% vs 2.1%; HR = 0.6; 95% CI, 0.3-1.2); stillbirth (0.3% vs 0.4%;  HR = 0.4; 95% CI, 0.1-1.7); any major birth defect (2.9% in both exposed and nonexposed women; OR = 1.12; 95% CI, 0.69-1.82); preterm delivery (6.2% vs 5.2%; OR = 0.9; 95% CI, 0.7-1.3), low birth weight infant (4.1% vs 3.7%; OR = 0.8; 95% CI, 0.5-1.1); and small-for-­gestational-age infant (10.4% vs 9.2%; OR = 1.1; 95% CI, 0.9-1.4).

RECOMMENDATIONS

The American College of Obstetricians and Gynecologists (ACOG) states that insufficient data exist regarding the safety of ondansetron for the fetus.⁶ ACOG recommends individualizing the use of ondansetron before 10 weeks of pregnancy after weighing the risks and benefits. ACOG also recommends adding ondansetron as third-line treatment for nausea and vomiting unresponsive to first- and second-line treatments.

EDITOR'S TAKEAWAY

Higher-quality studies showed ondansetron to be an effective treatment for hyperemesis gravidarum. Lower-quality studies raised some concerns about adverse fetal effects. Although the adverse effects were rare and the quality of the evidence was lower, the cautionary principle suggests that ondansetron should be a second-line option.

EVIDENCE SUMMARY

Efficacy. A 2014 double-blind RCT compared ondansetron with pyridoxine plus doxylamine (standard care) for outpatient treatment of nausea and vomiting in pregnancy.¹ The 36 patients had an average gestational age of 8 weeks and received either 4 mg oral ondansetron plus placebo or 25 mg pyridoxine plus 12.5 mg doxylamine 3 times daily for 5 days. Nausea and vomiting severity was measured using 2 separate 10-cm visual analog scales (VAS) with scores ranging from 0 to 10 (worst nausea or vomiting imaginable). Researchers determined that a VAS score reduction of 2.5 cm was clinically significant.

Patients treated with ondansetron described greater improvements in nausea (mean VAS change −5.1 cm vs −2 cm; P = .019) and vomiting (mean VAS change −4.1 cm vs −1.7 cm; P = .049). No patient required hospitalization. The researchers didn’t report on adverse effects or birth outcomes. The study was limited by the small sample size and a high rate (17%) of patients with missing data or who were lost to follow-up.

IV ondansetron vs metoclopramide: Similar efficacy, fewer adverse effects

A 2014 double-blind RCT compared IV ondansetron with IV metoclopramide (standard care) for treating hyperemesis gravidarum.² The 160 patients had an average gestational age of 9.5 weeks and intractable nausea and vomiting severe enough to cause dehydration, metabolic disturbance, and hospitalization. Patients received either 4 mg ondansetron or 10 mg metoclopramide IV every 8 hours for 24 hours. The primary outcomes were number of episodes of vomiting over 24 hours and self-reported sense of well-being rated on a 10-point scale.

No differences were found between the ondansetron- and metoclopramide-treated groups in terms of vomiting over 24 hours (median episodes 1 and 1; P = .38) or sense of well-being (mean scores 8.7 vs 8.3; P = .13). Patients treated with ondansetron were less likely to have persistent ketonuria at 24 hours (relative risk [RR] = 0.3; 95% confidence interval [CI], 0.1-0.8; number needed to treat [NNT] = 6). They also were less likely to feel drowsy (RR = 0.3; 95% CI, 0.1–0.8; NNT = 6) or complain of dry mouth (RR = 0.4; 95% CI, 0.1-0.9; NNT = 8). The study didn’t report birth outcomes or adverse fetal effects.

Oral ondansetron outperforms oral metoclopramide in small study

A 2013 double-blind RCT compared ondansetron with metoclopramide (standard care) for controlling severe nausea and vomiting.³ The 83 patients, with an average gestational age of 8.7 weeks, had more than 3 vomiting episodes daily, weight loss, and ketonuria. They received either 4 mg oral ondansetron or 10 mg oral metoclopramide for 2 weeks as follows: 3 times daily for 1 week, then twice daily for 3 days, then once daily for 4 days. Patients rated nausea severity using a 10-cm VAS from 0 to 10 (severe nausea) and recorded the number of vomiting episodes.

Women treated with ondansetron had significantly lower VAS scores on Days 3 and 4 of treatment (5.4 vs 6, P = .024 on Day­ 3; 4.1 vs 5.7, P = .023 on Day 4). They also had fewer episodes of vomiting on Days 2, 3, and 4 (3.7 vs 6, P = .006 on Day 2; 3.2 vs 5.3, P = .006 on Day 3; and 3.3 vs 5, P = .013 on Day 4). The study was limited by the small sample size.

Safety. A 2016 systematic review examining the risk of birth defects associated with ondansetron exposure in pregnancy found 8 reports: 5 birth registries, 2 case-control studies, and 1 prospective cohort study.⁴ Investigators compared rates of major malformations—cleft lips, cleft palates, neural tube defects, cardiac defects, and hypospadias—in 5101 women exposed to ondansetron in the first trimester with birth defect rates in more than 3.1 million nonexposed women.

Continue to: No study demonstrated...

No study demonstrated an increased rate of major malformations associated with ondansetron exposure except for 2 disease registry studies with nearly 2.4 million patients that reported a slight increase in the risk of cardiac defects (odds ratio [OR] = 2; 95% CI, 1.3-3.1; OR = 1.6, 95% CI, 1-2.1). Comparisons of other birth defect rates associated with ondansetron exposure were inconsistent, with studies showing small increases, decreases, or no difference in rates between exposed and nonexposed women.

Exposure vs nonexposure: No difference in adverse outcomes

A 2013 retrospective cohort study looked at 608,385 pregnancies among women in Denmark, of whom 1970 (0.3%) had been exposed to ondansetron.⁵ The study found that exposure to ondansetron compared with nonexposure was associated with a lower risk for spontaneous abortion between 7 and 12 weeks’ gestation (1.1% vs 3.7%; hazard ratio [HR] = 0.5; 95% CI, 0.3-0.9).

Oral ondansetron is more effective than pyridoxine plus doxylamine for outpatient treatment of nausea and vomiting in pregnancy.

No significant differences between ­ondansetron exposure and nonexposure were found for the following adverse outcomes: spontaneous abortion between 13 and 22 weeks’ gestation (1% vs 2.1%; HR = 0.6; 95% CI, 0.3-1.2); stillbirth (0.3% vs 0.4%;  HR = 0.4; 95% CI, 0.1-1.7); any major birth defect (2.9% in both exposed and nonexposed women; OR = 1.12; 95% CI, 0.69-1.82); preterm delivery (6.2% vs 5.2%; OR = 0.9; 95% CI, 0.7-1.3), low birth weight infant (4.1% vs 3.7%; OR = 0.8; 95% CI, 0.5-1.1); and small-for-­gestational-age infant (10.4% vs 9.2%; OR = 1.1; 95% CI, 0.9-1.4).

RECOMMENDATIONS

The American College of Obstetricians and Gynecologists (ACOG) states that insufficient data exist regarding the safety of ondansetron for the fetus.⁶ ACOG recommends individualizing the use of ondansetron before 10 weeks of pregnancy after weighing the risks and benefits. ACOG also recommends adding ondansetron as third-line treatment for nausea and vomiting unresponsive to first- and second-line treatments.

EDITOR'S TAKEAWAY

Higher-quality studies showed ondansetron to be an effective treatment for hyperemesis gravidarum. Lower-quality studies raised some concerns about adverse fetal effects. Although the adverse effects were rare and the quality of the evidence was lower, the cautionary principle suggests that ondansetron should be a second-line option.

THE CASE

A 49-year-old woman presented to our clinic with concerns about the changing appearance of her tongue over the past 2 to 3 weeks. She had been given a diagnosis of celiac disease by her gastroenterologist approximately 5 years earlier. At the time of that diagnosis, she had smooth patches on the surface of her tongue with missing papillae and slightly raised borders. (This gave her tongue a map-like appearance, consistent with geographic tongue [GT].) The patient’s symptoms improved after she started a gluten-free diet, but she reported occasional noncompliance over the past year.

At the current presentation, the patient noted that new lesions on the tongue had started as diffuse shiny red patches surrounded by clearly delineated white borders, ultimately progressing to structural changes. She denied any burning of the tongue or other oral symptoms but reported feelings of anxiety, a “foggy mind,” and diffuse arthralgia for the past several weeks. The patient’s list of medications included vitamin D and magnesium supplements, a multivitamin, and probiotics.

On physical examination, her tongue showed areas of shiny erythematous mucosa and deep central grooves with small radiating furrows giving a wrinkled appearance ­(FIGURE). A review of systems revealed nonspecific abdominal pain including bloating, cramping, and gas for the previous few months. An examination of her throat and oral cavity was unremarkable, and the remainder of the physical examination was normal.

THE DIAGNOSIS

A diagnosis of fissured tongue (FT) was suspected based on the clinical appearance of the patient’s tongue. Laboratory studies including a complete blood count; antinuclear antibody test; rheumatoid factor test; anticyclic citrullinated peptide test; a comprehensive metabolic panel; and thyroid-stimulating hormone, 25-hydroxyvitamin D, and vitamin B₁₂ level tests were performed based on her symptoms and current medications to rule out any other potential diagnoses. All laboratory results were normal, and a tissue transglutaminase IgA test was not repeated because it was positive when previously tested by the gastroenterologist at the time of her celiac disease diagnosis. A diagnosis of FT due to incompletely treated celiac disease was confirmed.

DISCUSSION

Clinical presentation. FT commonly presents in association with GT,^1,2 with some cases of GT naturally progressing to FT.^3,4 In most cases, FT is asymptomatic unless debris becomes entrapped in the fissures. Rarely, patients may complain of a burning sensation on the tongue. The clinical appearance of the tongue includes deep grooves with possible malodor or halitosis along with discoloration if trapping of debris and subsequent inflammation occurs.¹

Etiology. FT has been linked to celiac disease; systemic conditions such as arthritis, iron deficiency, depression, anxiety, and neuropathy; and poor oral hygiene. Genetics also may play a role, as some cases of FT may be inherited. Getting to the source requires a careful history to uncover signs and symptoms (that may not have been reported until now) and to determine if other family members also have FT. A careful examination of the oral cavity, with an eye toward the patient’s oral hygiene, is also instructive (TABLE).^5-8 In general, FT is believed to be a normal tongue variant in less than 10% of the general population.^5,6 Additionally, local factors such as ill-fitting prosthesis, infection, parafunctional habits, allergic reaction, xerostomia, and galvanism have been implicated in the etiology of FT.⁵

In most cases, fissured tongue is asymptomatic unless debris becomes entrapped in the fissures.

In our patient, progression of GT to FT was caused by incompletely treated celiac disease. Both FT and GT may represent different reaction patterns caused by the same hematologic and immunologic diseases.³ In fact, the appearance of the tongue may aid in the diagnosis of celiac disease, which has been observed in 15% of patients with GT.⁷ Fissured tongue also may indicate an inability of the gastrointestinal mucosa to absorb nutrients; therefore, close nutrition monitoring is recommended.⁹

Continue to: Other oral and dental manifestations...

Other oral and dental manifestations of celiac disease include enamel defects, delayed tooth eruption, recurrent aphthous ulcers, cheilosis, oral lichen planus, and atrophic glossitis.¹⁰ Our patient also reported anxiety, “foggy mind,” diffuse arthralgia, and abdominal pain, which are symptoms of uncontrolled celiac disease. There is no known etiology of tongue manifestations in patients with incompletely treated celiac disease.

Treatment. FT generally does not require specific therapy other than the treatment of the underlying inflammatory condition. It is important to maintain proper oral and dental care, such as brushing the top surface of the tongue to clean and remove food debris. Bacteria and plaque can collect in the fissures, leading to bad breath and an increased potential for tooth decay.

Our patient was referred to a dietitian to assist with adherence to the gluten-free diet. At follow-up 3 months later, the appearance of her tongue had improved and fewer fissures were visible. The majority of her other symptoms also had resolved.

THE TAKEAWAY

FT may be a normal variant of the tongue in some patients or may be associated with poor oral hygiene. Additionally, FT often is associated with an underlying medical or inherited condition and may serve as a marker for an untreated or partially treated condition such as celiac disease, as was the case with our patient. When other signs or symptoms of systemic disease are present, further laboratory and endoscopic workup is necessary to rule out other causes and to diagnose celiac disease, if present.

As FT has been reported to be a natural progression from GT, the appearance of FT may indicate partial treatment of the underlying disease process and therefore more intensive therapy and follow-up would be needed. In this case, more intensive dietary guidance was provided with subsequent improvement of symptoms.

CORRESPONDENCE
Peter J. Carek, MD, MS, Department of Community Health and Family Medicine, College of Medicine, University of Florida, P.O. Box 100237, Gainesville, FL 32610-0237; carek@ufl.edu

THE CASE

A 49-year-old woman presented to our clinic with concerns about the changing appearance of her tongue over the past 2 to 3 weeks. She had been given a diagnosis of celiac disease by her gastroenterologist approximately 5 years earlier. At the time of that diagnosis, she had smooth patches on the surface of her tongue with missing papillae and slightly raised borders. (This gave her tongue a map-like appearance, consistent with geographic tongue [GT].) The patient’s symptoms improved after she started a gluten-free diet, but she reported occasional noncompliance over the past year.

At the current presentation, the patient noted that new lesions on the tongue had started as diffuse shiny red patches surrounded by clearly delineated white borders, ultimately progressing to structural changes. She denied any burning of the tongue or other oral symptoms but reported feelings of anxiety, a “foggy mind,” and diffuse arthralgia for the past several weeks. The patient’s list of medications included vitamin D and magnesium supplements, a multivitamin, and probiotics.

On physical examination, her tongue showed areas of shiny erythematous mucosa and deep central grooves with small radiating furrows giving a wrinkled appearance ­(FIGURE). A review of systems revealed nonspecific abdominal pain including bloating, cramping, and gas for the previous few months. An examination of her throat and oral cavity was unremarkable, and the remainder of the physical examination was normal.

THE DIAGNOSIS

A diagnosis of fissured tongue (FT) was suspected based on the clinical appearance of the patient’s tongue. Laboratory studies including a complete blood count; antinuclear antibody test; rheumatoid factor test; anticyclic citrullinated peptide test; a comprehensive metabolic panel; and thyroid-stimulating hormone, 25-hydroxyvitamin D, and vitamin B₁₂ level tests were performed based on her symptoms and current medications to rule out any other potential diagnoses. All laboratory results were normal, and a tissue transglutaminase IgA test was not repeated because it was positive when previously tested by the gastroenterologist at the time of her celiac disease diagnosis. A diagnosis of FT due to incompletely treated celiac disease was confirmed.

DISCUSSION

Clinical presentation. FT commonly presents in association with GT,^1,2 with some cases of GT naturally progressing to FT.^3,4 In most cases, FT is asymptomatic unless debris becomes entrapped in the fissures. Rarely, patients may complain of a burning sensation on the tongue. The clinical appearance of the tongue includes deep grooves with possible malodor or halitosis along with discoloration if trapping of debris and subsequent inflammation occurs.¹

Etiology. FT has been linked to celiac disease; systemic conditions such as arthritis, iron deficiency, depression, anxiety, and neuropathy; and poor oral hygiene. Genetics also may play a role, as some cases of FT may be inherited. Getting to the source requires a careful history to uncover signs and symptoms (that may not have been reported until now) and to determine if other family members also have FT. A careful examination of the oral cavity, with an eye toward the patient’s oral hygiene, is also instructive (TABLE).^5-8 In general, FT is believed to be a normal tongue variant in less than 10% of the general population.^5,6 Additionally, local factors such as ill-fitting prosthesis, infection, parafunctional habits, allergic reaction, xerostomia, and galvanism have been implicated in the etiology of FT.⁵

In most cases, fissured tongue is asymptomatic unless debris becomes entrapped in the fissures.

In our patient, progression of GT to FT was caused by incompletely treated celiac disease. Both FT and GT may represent different reaction patterns caused by the same hematologic and immunologic diseases.³ In fact, the appearance of the tongue may aid in the diagnosis of celiac disease, which has been observed in 15% of patients with GT.⁷ Fissured tongue also may indicate an inability of the gastrointestinal mucosa to absorb nutrients; therefore, close nutrition monitoring is recommended.⁹

Continue to: Other oral and dental manifestations...

Other oral and dental manifestations of celiac disease include enamel defects, delayed tooth eruption, recurrent aphthous ulcers, cheilosis, oral lichen planus, and atrophic glossitis.¹⁰ Our patient also reported anxiety, “foggy mind,” diffuse arthralgia, and abdominal pain, which are symptoms of uncontrolled celiac disease. There is no known etiology of tongue manifestations in patients with incompletely treated celiac disease.

Treatment. FT generally does not require specific therapy other than the treatment of the underlying inflammatory condition. It is important to maintain proper oral and dental care, such as brushing the top surface of the tongue to clean and remove food debris. Bacteria and plaque can collect in the fissures, leading to bad breath and an increased potential for tooth decay.

Our patient was referred to a dietitian to assist with adherence to the gluten-free diet. At follow-up 3 months later, the appearance of her tongue had improved and fewer fissures were visible. The majority of her other symptoms also had resolved.

THE TAKEAWAY

FT may be a normal variant of the tongue in some patients or may be associated with poor oral hygiene. Additionally, FT often is associated with an underlying medical or inherited condition and may serve as a marker for an untreated or partially treated condition such as celiac disease, as was the case with our patient. When other signs or symptoms of systemic disease are present, further laboratory and endoscopic workup is necessary to rule out other causes and to diagnose celiac disease, if present.

As FT has been reported to be a natural progression from GT, the appearance of FT may indicate partial treatment of the underlying disease process and therefore more intensive therapy and follow-up would be needed. In this case, more intensive dietary guidance was provided with subsequent improvement of symptoms.

CORRESPONDENCE
Peter J. Carek, MD, MS, Department of Community Health and Family Medicine, College of Medicine, University of Florida, P.O. Box 100237, Gainesville, FL 32610-0237; carek@ufl.edu

THE CASE

A 49-year-old woman presented to our clinic with concerns about the changing appearance of her tongue over the past 2 to 3 weeks. She had been given a diagnosis of celiac disease by her gastroenterologist approximately 5 years earlier. At the time of that diagnosis, she had smooth patches on the surface of her tongue with missing papillae and slightly raised borders. (This gave her tongue a map-like appearance, consistent with geographic tongue [GT].) The patient’s symptoms improved after she started a gluten-free diet, but she reported occasional noncompliance over the past year.

At the current presentation, the patient noted that new lesions on the tongue had started as diffuse shiny red patches surrounded by clearly delineated white borders, ultimately progressing to structural changes. She denied any burning of the tongue or other oral symptoms but reported feelings of anxiety, a “foggy mind,” and diffuse arthralgia for the past several weeks. The patient’s list of medications included vitamin D and magnesium supplements, a multivitamin, and probiotics.

On physical examination, her tongue showed areas of shiny erythematous mucosa and deep central grooves with small radiating furrows giving a wrinkled appearance ­(FIGURE). A review of systems revealed nonspecific abdominal pain including bloating, cramping, and gas for the previous few months. An examination of her throat and oral cavity was unremarkable, and the remainder of the physical examination was normal.

THE DIAGNOSIS

A diagnosis of fissured tongue (FT) was suspected based on the clinical appearance of the patient’s tongue. Laboratory studies including a complete blood count; antinuclear antibody test; rheumatoid factor test; anticyclic citrullinated peptide test; a comprehensive metabolic panel; and thyroid-stimulating hormone, 25-hydroxyvitamin D, and vitamin B₁₂ level tests were performed based on her symptoms and current medications to rule out any other potential diagnoses. All laboratory results were normal, and a tissue transglutaminase IgA test was not repeated because it was positive when previously tested by the gastroenterologist at the time of her celiac disease diagnosis. A diagnosis of FT due to incompletely treated celiac disease was confirmed.

DISCUSSION

Clinical presentation. FT commonly presents in association with GT,^1,2 with some cases of GT naturally progressing to FT.^3,4 In most cases, FT is asymptomatic unless debris becomes entrapped in the fissures. Rarely, patients may complain of a burning sensation on the tongue. The clinical appearance of the tongue includes deep grooves with possible malodor or halitosis along with discoloration if trapping of debris and subsequent inflammation occurs.¹

Etiology. FT has been linked to celiac disease; systemic conditions such as arthritis, iron deficiency, depression, anxiety, and neuropathy; and poor oral hygiene. Genetics also may play a role, as some cases of FT may be inherited. Getting to the source requires a careful history to uncover signs and symptoms (that may not have been reported until now) and to determine if other family members also have FT. A careful examination of the oral cavity, with an eye toward the patient’s oral hygiene, is also instructive (TABLE).^5-8 In general, FT is believed to be a normal tongue variant in less than 10% of the general population.^5,6 Additionally, local factors such as ill-fitting prosthesis, infection, parafunctional habits, allergic reaction, xerostomia, and galvanism have been implicated in the etiology of FT.⁵

In most cases, fissured tongue is asymptomatic unless debris becomes entrapped in the fissures.

In our patient, progression of GT to FT was caused by incompletely treated celiac disease. Both FT and GT may represent different reaction patterns caused by the same hematologic and immunologic diseases.³ In fact, the appearance of the tongue may aid in the diagnosis of celiac disease, which has been observed in 15% of patients with GT.⁷ Fissured tongue also may indicate an inability of the gastrointestinal mucosa to absorb nutrients; therefore, close nutrition monitoring is recommended.⁹

Continue to: Other oral and dental manifestations...

Other oral and dental manifestations of celiac disease include enamel defects, delayed tooth eruption, recurrent aphthous ulcers, cheilosis, oral lichen planus, and atrophic glossitis.¹⁰ Our patient also reported anxiety, “foggy mind,” diffuse arthralgia, and abdominal pain, which are symptoms of uncontrolled celiac disease. There is no known etiology of tongue manifestations in patients with incompletely treated celiac disease.

Treatment. FT generally does not require specific therapy other than the treatment of the underlying inflammatory condition. It is important to maintain proper oral and dental care, such as brushing the top surface of the tongue to clean and remove food debris. Bacteria and plaque can collect in the fissures, leading to bad breath and an increased potential for tooth decay.

Our patient was referred to a dietitian to assist with adherence to the gluten-free diet. At follow-up 3 months later, the appearance of her tongue had improved and fewer fissures were visible. The majority of her other symptoms also had resolved.

THE TAKEAWAY

FT may be a normal variant of the tongue in some patients or may be associated with poor oral hygiene. Additionally, FT often is associated with an underlying medical or inherited condition and may serve as a marker for an untreated or partially treated condition such as celiac disease, as was the case with our patient. When other signs or symptoms of systemic disease are present, further laboratory and endoscopic workup is necessary to rule out other causes and to diagnose celiac disease, if present.

As FT has been reported to be a natural progression from GT, the appearance of FT may indicate partial treatment of the underlying disease process and therefore more intensive therapy and follow-up would be needed. In this case, more intensive dietary guidance was provided with subsequent improvement of symptoms.

CORRESPONDENCE
Peter J. Carek, MD, MS, Department of Community Health and Family Medicine, College of Medicine, University of Florida, P.O. Box 100237, Gainesville, FL 32610-0237; carek@ufl.edu

Leaders in health care and practicing physicians recognize the need for changes in how health care is delivered.^1-3 Despite this awareness, though, barriers to meaningful change persist and the current practice environment wherein physicians must routinely spend 2 hours on electronic health records (EHRs) and desk work for every hour of direct face time with patients⁴ is driving trainees away from ambulatory specialties and is contributing to physicians’ decisions to reduce their practices to part-time, retire early, or leave medicine altogether.^5,6 Those who persevere in this environment with heavy administrative burdens run the increasing risk of burnout.⁷

Some physicians and practices are responding by taking creative measures to reform the way patient care is delivered. Bellin Health—a 160-provider, multispecialty health system in northeast Wisconsin where one of the authors (JJ) works—introduced an advanced team-based care (aTBC) model between November 2014 and November 2018, starting with our primary care providers. The development and introduction of this new model arose from an iterative, multidisciplinary process driven by the desire to transform the Triple Aim—enhancing patient experience, improving population health, and reducing costs—into a Quadruple Aim⁸ by additionally focusing on improving the work life of health care providers, which, in turn, will help achieve the first 3 goals. In introducing an aTBC model, Bellin Health focused on 3 elements: office visit redesign, in-basket management redesign, and the use of extended care team members and system and community resources to assist in the care of complex and high-risk patients.

We trained certified medical assistants and licensed practical nurses to become care team coordinators and optimized the direct clinical support ratio for busier physicians.

Herein we describe the 3 components of our aTBC model,^1,9 identify the barriers that existed in the minds of multiple stakeholders (from patients to clinicians and Bellin executives), and describe the strategies that enabled us to overcome these barriers.

The impetus behind our move to aTBC

Bellin Health considered a move to an aTBC model to be critical in light of factors in the health care environment, in general, and at Bellin, in particular. The factors included

• an industry-wide shift to value-based payments, which requires new models for long-term financial viability.
• recognition that physician and medical staff burnout leads to lower productivity and, in some cases, workforce losses.^5,6 Replacing a physician in a practice can be difficult and expensive, with cost estimates of $500,000 to more than $1 million per physician.^10,11
• a belief that aTBC could help the Bellin Health leadership team meet its organizational goals of improved patient satisfaction, achieve gains in quality measures, enhance engagement and loyalty among patients and employees, and lower recruitment costs.

A 3-part aTBC initiative

■ Part 1: Redesign the office visit

We redesigned staffing and workflow for office visits to maximize the core skills of physicians, which required distributing ancillary tasks among support staff. We up-trained certified medical assistants (CMAs) and licensed practical nurses (LPNs) to take on the new role of care team coordinator (CTC) and optimized the direct clinical support ratio for busier physicians. For physicians who were seeing 15 to 19 patients a day, a ratio of 3 CTCs to 2 physicians was implemented; for those seeing 20 or more patients a day, we used a support ratio of 2:1.

The role of CTC was designed so that he or she would accompany a patient throughout the entire appointment. Responsibilities were broken out as follows:

Pre-visit. Before the physician enters the room, the CTC would now perform expanded rooming functions including pending orders, refill management, care gap closure using standing orders, agenda setting, and preliminary documentation.¹²

Visit. The CTC would now hand off the patient to the physician and stay in the room to document details of the visit and record new orders for consults, x-ray films, referrals, or prescriptions.¹³ This intensive EHR support was established to ensure that the physician could focus directly on the patient without the distraction of the computer.

Continue to: Post-visit

Post-visit. After a physician leaves a room, the CTC was now charged with finishing the pending orders, setting up the patient’s next appointment and pre-visit labs, reviewing details of the after-visit summary, and doing any basic health coaching with the patient. During this time, the physician would use the co-location space to review and edit the documentation, cosign the orders and prescriptions submitted by the CTC, and close the chart before going into the next room with the second CTC. The need to revisit these details after clinic hours was eliminated.

Another change … The role of our phone triage registered nurses (RN) was expanded. Care team RNs began providing diabetes counseling, blood pressure checks, annual wellness visits (AWV), and follow-up through the Centers for Medicare and Medicaid Services (CMS)'s Chronic Care Management and Transitional Care Management programs.

■ Part 2: Redesign between-visit in-basket management

Responding to an increasing number of inbox messages had become overwhelming for our physicians. Bellin Health’s management was aware that strategic delegation of inbox messages could save an hour or more of a physician’s time each day.¹⁴ Bellin implemented a procedure whereby inbox test results would be handled by the same CTC who saw the patient, thereby extending continuity. If the results were normal, the CTC would contact the patient. If the results were abnormal, the physician and the CTC would discuss them and develop a plan. Co-location of the RN, the CTC, and the physician would leverage face-to-face communication and make in-basket management more efficient.

■ Part 3: Redesign population health management

We developed an Extended Care Team (ECT), including social workers, clinical pharmacists, RN care coordinators, and diabetes educators, to assist with the care of patients with high-risk disorders or otherwise complex issues. These team members would work closely with the CTC, care team RN, and physician to review patients, develop plans of care, optimize management, and improve outcomes. Patients would be identified as candidates for potential ECT involvement based on the physician’s judgment in consultation with an EHR-based risk score for hospitalization or emergency department visit.

Team coordinators document details of the patient visit, thereby allowing the physician to focus directly on the patient.

As we developed new processes, such as screening for determinants of health, we engaged additional system and community resources to help meet the needs of our patients.

Continue to: A look at stakeholder concerns and overcoming the barriers

Critical to our success was being attentive to the concerns of our stakeholders and addressing them. Along the way, we gained valuable implementation insights, which we share here along with some specifics about how, exactly, we did things at Bellin.

Patients

Some patients expressed hesitation at having a person other than their physician in the exam room. They worried that the intimacy and privacy with their physician would be lost. In light of this, we gave patients the option not to have the CTC remain in the room. However, patients quickly saw the value of this team-based care approach and seldom asked to be seen without the CTC.

Throughout the process, we surveyed patients for feedback on their experiences. Comments indicated that the presence of the CTC in our team-based model led to positive patient experiences:

My physician is fully attentive. Patients appreciated that physicians were not distracted by the computer in the exam room. “I feel like I’ve got my doctor back” has been a common refrain.

The office staff is more responsive. The CTC, having been present during the appointment, has a deeper understanding of the care plan and can respond to calls or emails between visits, thereby reducing the time patients must wait for answers. One patient commented that, “I love [the doctor’s] team; his nurses are willing to answer every question I have.”

Continue to: I increasingly feel that I'm understood

I increasingly feel that I’m understood. We have seen patients develop meaningful relationships with other team members, confiding in them in ways that they hadn’t always done with physicians and advanced practice clinicians (APCs). Team members, in turn, have added valuable insights that help optimize patients’ care. In particular, the care of patients with multiple needs has been enhanced with the addition of ECT members who work with the core team and use their expertise to optimize the care of these patients.

Certified medical assistants and licensed practical nurses

Bellin’s leadership knew that team documentation could cause stress for the CMA, who, acting as a CTC, wanted to avoid misrepresenting details of the clinical encounter.¹³ Adding to the stress were other duties that would need to be learned, including agenda setting, refill management, care gap closure, and health coaching. With thorough training and preparation, many—but not all—of our CMAs and LPNs were able to successfully make the transition and flourish.

Implementation strategies

Provide thorough training. Our training process started 8 weeks before it was time to “go live.” There were weekly hour-long training sessions in population health basics, team culture and change management, documentation basics, and new roles and responsibilities. In the final week, the entire aTBC team sat together for 3 days of EHR training. All new teams shadowed existing teams to get a clear picture of the new processes.

Create a community of support. As our CMAs adapted to their new CTC roles, it was critical that they had support from experienced CTCs. Encouragement and patience from physicians were—and are—essential for CTCs to develop confidence in their new roles.

Enable ongoing feedback. We introduced weekly team meetings to enhance team communication and dynamics. Forums for all roles are held periodically to facilitate discussion, share learning, and enable support between teams.

Continue to: Use EHR tools to facilitate this work

Use EHR tools to facilitate this work. Using standard templates and documentation tools helped CTCs develop the confidence needed to thrive in their new role. Knowing these tools were available helped CTCs become effective in helping the team manage the between-visit work.

In our aTBC model, the percentage of patients receiving age- appropriate screening is higher now in every domain we measure, and metrics have improved in most quality measures.

Monitor workload. As we developed more workflows and processes, we took care to monitor the amount of additional work for those in this role. We offloaded work whenever possible. For example, coordinated refill management at time of service, coupled with a back-up centralized refill system, can significantly decrease the number of refill requests made to CTCs. We continue to adjust staffing, where appropriate, to provide adequate support for those in this valuable role.

Be prepared for turnover. As CTCs became empowered in their new roles, some decided to advance their training into other roles. We developed a plan for replacing and training new staff. Higher pay can also be used to help attract and retain these staff members. Bellin uses LPNs in this role to ensure adequate staffing. Other health systems have developed a tier system for CMAs to improve retention.

Registered nurses

Before our move to an aTBC model, our office RNs primarily managed phone triage. Now the nurses were enlisted to play a more active role in patient care and team leadership. Although it was a dramatic departure from prior responsibilities, the majority of Bellin’s RNs have found increased satisfaction in taking on direct patient care.

Implementation strategies

Define new roles and provide training. In addition to participating in acute patient visits, consider ways that care team RNs can expand responsibilities as they pertain to disease counseling, population health management, and team leadership.¹⁵ At Bellin, the expanded role of the RN is evident in diabetes education and Medicare AWVs. Specifically, RNs now provide diabetes education to appropriate patients following a warm handoff from the physician at the time of the visit. RNs now also complete Medicare AWVs, which frees up physicians for other tasks and helps ensure sustainability for the new RN roles. Rates of completed AWVs at Bellin are now more than 70%, compared with reported national rates of less than 30%.¹⁶

Continue to: Maximize co-location

Maximize co-location. It is helpful to have the team members whose work is closely related—such as the CTCs and the RN for the team—to be situated near each other, rather than down a hall or in separate offices. Since the RN is co-located with the core teams at Bellin, there is now greater opportunity for verbal interaction, rather than just electronic communications, for matters such as triage calls and results management. RNs also provide a valuable resource for CMAs and LPNs, as well as help oversee team management of the in-basket.

Evaluate sustainability. Additional roles for the RNs required additional RN staffing. We assessed the new workload duties and balanced that against potential revenue from RN visits. This analysis indicated that an optimal ratio was 1 RN to every 3000 patients. This would allow an adequate number of RNs to fulfill additional roles and was financially sustainable with the goal of 4 billable RN visits per day.

Physicians

Bellin’s leadership recognized that some physicians might perceive team-based care as eroding their primary responsibility for patients’ care. Physicians have historically been trained in a model based on the primacy of the individual physician and that can be a hurdle to embracing team culture as a new paradigm of care. Several strategies helped us and can help others, too.

Implementation strategies

Cultivate trust. Thorough training of CTCs and RNs is critical to helping physicians develop trust and reliance in the team. The physician retains final authority over the team for cosigning orders, editing and finalizing documentation, and overseeing results management. Physicians invested in training and educating their staff will reap the rewards of a highly functioning, more satisfied team.

Encourage leadership. This can be a cultural shift for physicians, yet it is critical that they take a leadership role in this transformation.¹⁷ Physicians and their team leaders attended training sessions in team culture and change management. Prior to the go-live date, team leaders also met with the physician individually to explore their concerns and discuss ways to effectively lead and support their teams.

Continue to: Urge acceptance of support

Urge acceptance of support. The complexity of patient care today makes it difficult for a physician to manage all of a patient’s needs single-handedly. Complexity arises from the variety of plan co-pays and deductibles, the number of patients with chronic diseases, and the increased emphasis on improving quality measures.¹⁸ Enhanced support during any office visit and the extra support of an ECT for complex patients improves the ability of the physician to more effectively meet the needs of the patient.

Emphasize the benefit of an empowered team. The demands of the EHR on physicians and the resultant frustrations are well chronicled.^4,19-22 Strategically delegating much of this work to other team members allows the physician to focus on the patient and perform physician-level work. At Bellin, we observed that our most successful care teams were those in which the physician fully accepted team-based care principles and empowered the staff to work at the top of their skill set.

Advanced practice clinicians

APCs in our system had traditionally practiced in 1 of 3 ways: independently handling defined panels with physician supervision; handling overflow or acute visits; or working collaboratively with a supervising physician to share a larger “team panel.” The third approach has become our preferred model. aTBC provides opportunities for APCs to thrive and collaborate with the physician to provide excellent care for patients.

Provider satisfaction has increased, with 83% of aTBC physicians at Bellin being moderately or very satisfied with their experience.

APCs underwent the same process changes as physicians, including appropriate CTC support. Implementation strategies for APCs were similar to those that were useful for physicians.

Risk management professionals

At Bellin, we found that risk-management professionals had concerns about the scope of practice assigned to various team members, particularly regarding documentation. CMS allows for elements of a patient visit to be documented by CMAs and other members of the care team in real time as authorized by the physician.^23,24 CTCs at Bellin also have other clinical duties in patient and EHR management. aTBC practices generally prefer the term team documentation over scribing, since it more accurately reflects the scope of the CTC’s work.

Continue to: Implementation strategies

Clarify regulatory issues. Extensive use of standing orders and protocols allowed us to increase involvement of various team members. State laws vary in what functions CMAs and LPNs are allowed to perform, so it is important to check your state guidelines.²⁵ There is a tendency for some risk managers to overinterpret regulations. Challenge them to provide exact documentation from regulatory agencies to support their decisions.

Give assurances of physician oversight and processes. The physician assumes responsibility for standing orders, protocols, and documentation. We made sure that we had clear and consistent processes in place and worked closely with our risk managers as we developed our model. aTBC provides checks and balances to ensure accurate records, since team members are able to contribute and check for accuracy. A recent study suggested that CMAs perform documentation that is of equal or higher quality than that performed by the physician.²⁶

Financial leadership

Like any organization adopting aTBC, Bellin’s leadership was concerned about the expense of adopting this approach. However, the leadership also recognized that the transition to aTBC could increase revenue by more than the increased staffing costs. In addition, we expected that capacity, access, continuity, and financial margins would increase.^2,3,27,28 We also anticipated a decrease in downstream services, such as unnecessary tests, emergency department visits, and hospitalizations—a benefit of accountable care payment models.

Our efforts have been successful from a financial point of view. We attribute the financial sustainability that we have experienced to 4 factors:

1. Increased productivity. We knew that the increased efficiency of team-based care enables physicians to see 1 to 2 more patients per half day, and sometimes more.^3,28,29 An increase of at least 1 patient visit per half-day was expected of our physicians and APCs on aTBC. In addition, they were expected to support the care team RN in achieving at least 4 billable visits per day. Our current level of RN visits is at 3.5 per nurse per day. There is significant variability in the increase of patients seen by a physician per day, ranging from 1 to 4 additional patients. These increased visits have helped us achieve financial viability, even in a predominantly fee-for-service environment.

2. More thorough service. The ability to keep patients in primary care and to focus on the patient’s full range of needs has led to higher levels of service and, consequently, to appropriately higher levels of billing codes. For example, Bellin’s revenue from billing increased by $724 per patient, related (in part) to higher rates of immunizations, cancer screenings with mammography, and colonoscopies.

Continue to: 3. New billable services

3. New billable services. Billing for RN blood pressure checks, AWVs, and extended care team services have helped make aTBC at Bellin financially feasible. Revenue from RN visits, for example, was $630,000 in 2018.

4. Improved access for patients. Of the 130 primary care providers now on aTBC, 15 (11.5%) had closed their practices to new patients before aTBC. Now, all of their practices are open to new patients, which has improved access to care. In a 2018 patient access survey, 96.6% of patients obtained an appointment as soon as they thought it was needed, compared with 70.7% of patients before the transition to aTBC.

Greater opportunity for financial sustainability. The combination of improved quality measures and decreased cost of care in the Bellin aTBC bodes well for future success in a value-based world. We have realized a significant increase in value-based payments for improved quality, and in our Next Gen Accountable Care Organization (ACO) patients, we have seen a decrease of $29 in per-member-per-month costs, likely due to the use of nonphysicians in expanded roles. In addition, hospital admissions have decreased by 5% due to the ability of ambulatory teams to manage more complex patients in the office setting. This model has also allowed physicians and APCs to increase their panel size, another key value-based metric. From 2016 to 2018, panel size for primary care providers increased by an average of 8%.

Enhanced ability to retain and recruit. Several of Bellin’s primary care recruits indicated that they had interviewed only at practices incorporating team-based care. This trend may increase as residencies transition to team-based models of care.

So how did we do?

Metrics of Bellin’s aTBC success

By the end of 2018, all 130 primary care physicians and APCs at Bellin had made the transition to this model, representing family medicine, internal medicine, and pediatrics. We have now begun the transition of our non-primary care specialties to team-based care.

Continue to: In the aTBC model...

In the aTBC model, the percentage of patients receiving age-appropriate screening is higher than before in every domain we measure (FIGURE 1). There has also been improvement in major quality metrics (FIGURE 2).

In a survey done in Spring 2018 by St. Norbert College Strategic Research Center, provider satisfaction increased, with 83% of physicians having made the transition to an aTBC practice moderately or very satisfied with their Bellin Health experience, compared with 70% in the traditional model. More recent 2019 survey data show a satisfaction rate of 90% for team-based care providers. Finally, in our aTBC model—in CMS’s Next-Gen ACO initiative—the cost per patient per month is significantly less than for those in a non-team-based care model ($796 vs $940).

CORRESPONDENCE
James Jerzak, MD, 1630 Commanche Ave, Green Bay, WI 54313; james.jerzak@bellin.org.

ACKNOWLEDGEMENTS
The authors would like to thank Lindsey E. Carlasare, MBA, from the American Medical Association, and Brad Wozney, MD, Kathy Kerscher, and Christopher Elfner from Bellin Health, for their contributions to the content and review of this manuscript.

Leaders in health care and practicing physicians recognize the need for changes in how health care is delivered.^1-3 Despite this awareness, though, barriers to meaningful change persist and the current practice environment wherein physicians must routinely spend 2 hours on electronic health records (EHRs) and desk work for every hour of direct face time with patients⁴ is driving trainees away from ambulatory specialties and is contributing to physicians’ decisions to reduce their practices to part-time, retire early, or leave medicine altogether.^5,6 Those who persevere in this environment with heavy administrative burdens run the increasing risk of burnout.⁷

Some physicians and practices are responding by taking creative measures to reform the way patient care is delivered. Bellin Health—a 160-provider, multispecialty health system in northeast Wisconsin where one of the authors (JJ) works—introduced an advanced team-based care (aTBC) model between November 2014 and November 2018, starting with our primary care providers. The development and introduction of this new model arose from an iterative, multidisciplinary process driven by the desire to transform the Triple Aim—enhancing patient experience, improving population health, and reducing costs—into a Quadruple Aim⁸ by additionally focusing on improving the work life of health care providers, which, in turn, will help achieve the first 3 goals. In introducing an aTBC model, Bellin Health focused on 3 elements: office visit redesign, in-basket management redesign, and the use of extended care team members and system and community resources to assist in the care of complex and high-risk patients.

We trained certified medical assistants and licensed practical nurses to become care team coordinators and optimized the direct clinical support ratio for busier physicians.

Herein we describe the 3 components of our aTBC model,^1,9 identify the barriers that existed in the minds of multiple stakeholders (from patients to clinicians and Bellin executives), and describe the strategies that enabled us to overcome these barriers.

The impetus behind our move to aTBC

Bellin Health considered a move to an aTBC model to be critical in light of factors in the health care environment, in general, and at Bellin, in particular. The factors included

• an industry-wide shift to value-based payments, which requires new models for long-term financial viability.
• recognition that physician and medical staff burnout leads to lower productivity and, in some cases, workforce losses.^5,6 Replacing a physician in a practice can be difficult and expensive, with cost estimates of $500,000 to more than $1 million per physician.^10,11
• a belief that aTBC could help the Bellin Health leadership team meet its organizational goals of improved patient satisfaction, achieve gains in quality measures, enhance engagement and loyalty among patients and employees, and lower recruitment costs.

A 3-part aTBC initiative

■ Part 1: Redesign the office visit

We redesigned staffing and workflow for office visits to maximize the core skills of physicians, which required distributing ancillary tasks among support staff. We up-trained certified medical assistants (CMAs) and licensed practical nurses (LPNs) to take on the new role of care team coordinator (CTC) and optimized the direct clinical support ratio for busier physicians. For physicians who were seeing 15 to 19 patients a day, a ratio of 3 CTCs to 2 physicians was implemented; for those seeing 20 or more patients a day, we used a support ratio of 2:1.

The role of CTC was designed so that he or she would accompany a patient throughout the entire appointment. Responsibilities were broken out as follows:

Pre-visit. Before the physician enters the room, the CTC would now perform expanded rooming functions including pending orders, refill management, care gap closure using standing orders, agenda setting, and preliminary documentation.¹²

Visit. The CTC would now hand off the patient to the physician and stay in the room to document details of the visit and record new orders for consults, x-ray films, referrals, or prescriptions.¹³ This intensive EHR support was established to ensure that the physician could focus directly on the patient without the distraction of the computer.

Continue to: Post-visit

Post-visit. After a physician leaves a room, the CTC was now charged with finishing the pending orders, setting up the patient’s next appointment and pre-visit labs, reviewing details of the after-visit summary, and doing any basic health coaching with the patient. During this time, the physician would use the co-location space to review and edit the documentation, cosign the orders and prescriptions submitted by the CTC, and close the chart before going into the next room with the second CTC. The need to revisit these details after clinic hours was eliminated.

Another change … The role of our phone triage registered nurses (RN) was expanded. Care team RNs began providing diabetes counseling, blood pressure checks, annual wellness visits (AWV), and follow-up through the Centers for Medicare and Medicaid Services (CMS)'s Chronic Care Management and Transitional Care Management programs.

■ Part 2: Redesign between-visit in-basket management

Responding to an increasing number of inbox messages had become overwhelming for our physicians. Bellin Health’s management was aware that strategic delegation of inbox messages could save an hour or more of a physician’s time each day.¹⁴ Bellin implemented a procedure whereby inbox test results would be handled by the same CTC who saw the patient, thereby extending continuity. If the results were normal, the CTC would contact the patient. If the results were abnormal, the physician and the CTC would discuss them and develop a plan. Co-location of the RN, the CTC, and the physician would leverage face-to-face communication and make in-basket management more efficient.

■ Part 3: Redesign population health management

We developed an Extended Care Team (ECT), including social workers, clinical pharmacists, RN care coordinators, and diabetes educators, to assist with the care of patients with high-risk disorders or otherwise complex issues. These team members would work closely with the CTC, care team RN, and physician to review patients, develop plans of care, optimize management, and improve outcomes. Patients would be identified as candidates for potential ECT involvement based on the physician’s judgment in consultation with an EHR-based risk score for hospitalization or emergency department visit.

Team coordinators document details of the patient visit, thereby allowing the physician to focus directly on the patient.

As we developed new processes, such as screening for determinants of health, we engaged additional system and community resources to help meet the needs of our patients.

Continue to: A look at stakeholder concerns and overcoming the barriers

Critical to our success was being attentive to the concerns of our stakeholders and addressing them. Along the way, we gained valuable implementation insights, which we share here along with some specifics about how, exactly, we did things at Bellin.

Patients

Some patients expressed hesitation at having a person other than their physician in the exam room. They worried that the intimacy and privacy with their physician would be lost. In light of this, we gave patients the option not to have the CTC remain in the room. However, patients quickly saw the value of this team-based care approach and seldom asked to be seen without the CTC.

Throughout the process, we surveyed patients for feedback on their experiences. Comments indicated that the presence of the CTC in our team-based model led to positive patient experiences:

My physician is fully attentive. Patients appreciated that physicians were not distracted by the computer in the exam room. “I feel like I’ve got my doctor back” has been a common refrain.

The office staff is more responsive. The CTC, having been present during the appointment, has a deeper understanding of the care plan and can respond to calls or emails between visits, thereby reducing the time patients must wait for answers. One patient commented that, “I love [the doctor’s] team; his nurses are willing to answer every question I have.”

Continue to: I increasingly feel that I'm understood

I increasingly feel that I’m understood. We have seen patients develop meaningful relationships with other team members, confiding in them in ways that they hadn’t always done with physicians and advanced practice clinicians (APCs). Team members, in turn, have added valuable insights that help optimize patients’ care. In particular, the care of patients with multiple needs has been enhanced with the addition of ECT members who work with the core team and use their expertise to optimize the care of these patients.

Certified medical assistants and licensed practical nurses

Bellin’s leadership knew that team documentation could cause stress for the CMA, who, acting as a CTC, wanted to avoid misrepresenting details of the clinical encounter.¹³ Adding to the stress were other duties that would need to be learned, including agenda setting, refill management, care gap closure, and health coaching. With thorough training and preparation, many—but not all—of our CMAs and LPNs were able to successfully make the transition and flourish.

Implementation strategies

Provide thorough training. Our training process started 8 weeks before it was time to “go live.” There were weekly hour-long training sessions in population health basics, team culture and change management, documentation basics, and new roles and responsibilities. In the final week, the entire aTBC team sat together for 3 days of EHR training. All new teams shadowed existing teams to get a clear picture of the new processes.

Create a community of support. As our CMAs adapted to their new CTC roles, it was critical that they had support from experienced CTCs. Encouragement and patience from physicians were—and are—essential for CTCs to develop confidence in their new roles.

Enable ongoing feedback. We introduced weekly team meetings to enhance team communication and dynamics. Forums for all roles are held periodically to facilitate discussion, share learning, and enable support between teams.

Continue to: Use EHR tools to facilitate this work

Use EHR tools to facilitate this work. Using standard templates and documentation tools helped CTCs develop the confidence needed to thrive in their new role. Knowing these tools were available helped CTCs become effective in helping the team manage the between-visit work.

In our aTBC model, the percentage of patients receiving age- appropriate screening is higher now in every domain we measure, and metrics have improved in most quality measures.

Monitor workload. As we developed more workflows and processes, we took care to monitor the amount of additional work for those in this role. We offloaded work whenever possible. For example, coordinated refill management at time of service, coupled with a back-up centralized refill system, can significantly decrease the number of refill requests made to CTCs. We continue to adjust staffing, where appropriate, to provide adequate support for those in this valuable role.

Be prepared for turnover. As CTCs became empowered in their new roles, some decided to advance their training into other roles. We developed a plan for replacing and training new staff. Higher pay can also be used to help attract and retain these staff members. Bellin uses LPNs in this role to ensure adequate staffing. Other health systems have developed a tier system for CMAs to improve retention.

Registered nurses

Before our move to an aTBC model, our office RNs primarily managed phone triage. Now the nurses were enlisted to play a more active role in patient care and team leadership. Although it was a dramatic departure from prior responsibilities, the majority of Bellin’s RNs have found increased satisfaction in taking on direct patient care.

Implementation strategies

Define new roles and provide training. In addition to participating in acute patient visits, consider ways that care team RNs can expand responsibilities as they pertain to disease counseling, population health management, and team leadership.¹⁵ At Bellin, the expanded role of the RN is evident in diabetes education and Medicare AWVs. Specifically, RNs now provide diabetes education to appropriate patients following a warm handoff from the physician at the time of the visit. RNs now also complete Medicare AWVs, which frees up physicians for other tasks and helps ensure sustainability for the new RN roles. Rates of completed AWVs at Bellin are now more than 70%, compared with reported national rates of less than 30%.¹⁶

Continue to: Maximize co-location

Maximize co-location. It is helpful to have the team members whose work is closely related—such as the CTCs and the RN for the team—to be situated near each other, rather than down a hall or in separate offices. Since the RN is co-located with the core teams at Bellin, there is now greater opportunity for verbal interaction, rather than just electronic communications, for matters such as triage calls and results management. RNs also provide a valuable resource for CMAs and LPNs, as well as help oversee team management of the in-basket.

Evaluate sustainability. Additional roles for the RNs required additional RN staffing. We assessed the new workload duties and balanced that against potential revenue from RN visits. This analysis indicated that an optimal ratio was 1 RN to every 3000 patients. This would allow an adequate number of RNs to fulfill additional roles and was financially sustainable with the goal of 4 billable RN visits per day.

Physicians

Bellin’s leadership recognized that some physicians might perceive team-based care as eroding their primary responsibility for patients’ care. Physicians have historically been trained in a model based on the primacy of the individual physician and that can be a hurdle to embracing team culture as a new paradigm of care. Several strategies helped us and can help others, too.

Implementation strategies

Cultivate trust. Thorough training of CTCs and RNs is critical to helping physicians develop trust and reliance in the team. The physician retains final authority over the team for cosigning orders, editing and finalizing documentation, and overseeing results management. Physicians invested in training and educating their staff will reap the rewards of a highly functioning, more satisfied team.

Encourage leadership. This can be a cultural shift for physicians, yet it is critical that they take a leadership role in this transformation.¹⁷ Physicians and their team leaders attended training sessions in team culture and change management. Prior to the go-live date, team leaders also met with the physician individually to explore their concerns and discuss ways to effectively lead and support their teams.

Continue to: Urge acceptance of support

Urge acceptance of support. The complexity of patient care today makes it difficult for a physician to manage all of a patient’s needs single-handedly. Complexity arises from the variety of plan co-pays and deductibles, the number of patients with chronic diseases, and the increased emphasis on improving quality measures.¹⁸ Enhanced support during any office visit and the extra support of an ECT for complex patients improves the ability of the physician to more effectively meet the needs of the patient.

Emphasize the benefit of an empowered team. The demands of the EHR on physicians and the resultant frustrations are well chronicled.^4,19-22 Strategically delegating much of this work to other team members allows the physician to focus on the patient and perform physician-level work. At Bellin, we observed that our most successful care teams were those in which the physician fully accepted team-based care principles and empowered the staff to work at the top of their skill set.

Advanced practice clinicians

APCs in our system had traditionally practiced in 1 of 3 ways: independently handling defined panels with physician supervision; handling overflow or acute visits; or working collaboratively with a supervising physician to share a larger “team panel.” The third approach has become our preferred model. aTBC provides opportunities for APCs to thrive and collaborate with the physician to provide excellent care for patients.

Provider satisfaction has increased, with 83% of aTBC physicians at Bellin being moderately or very satisfied with their experience.

APCs underwent the same process changes as physicians, including appropriate CTC support. Implementation strategies for APCs were similar to those that were useful for physicians.

Risk management professionals

At Bellin, we found that risk-management professionals had concerns about the scope of practice assigned to various team members, particularly regarding documentation. CMS allows for elements of a patient visit to be documented by CMAs and other members of the care team in real time as authorized by the physician.^23,24 CTCs at Bellin also have other clinical duties in patient and EHR management. aTBC practices generally prefer the term team documentation over scribing, since it more accurately reflects the scope of the CTC’s work.

Continue to: Implementation strategies

Clarify regulatory issues. Extensive use of standing orders and protocols allowed us to increase involvement of various team members. State laws vary in what functions CMAs and LPNs are allowed to perform, so it is important to check your state guidelines.²⁵ There is a tendency for some risk managers to overinterpret regulations. Challenge them to provide exact documentation from regulatory agencies to support their decisions.

Give assurances of physician oversight and processes. The physician assumes responsibility for standing orders, protocols, and documentation. We made sure that we had clear and consistent processes in place and worked closely with our risk managers as we developed our model. aTBC provides checks and balances to ensure accurate records, since team members are able to contribute and check for accuracy. A recent study suggested that CMAs perform documentation that is of equal or higher quality than that performed by the physician.²⁶

Financial leadership

Like any organization adopting aTBC, Bellin’s leadership was concerned about the expense of adopting this approach. However, the leadership also recognized that the transition to aTBC could increase revenue by more than the increased staffing costs. In addition, we expected that capacity, access, continuity, and financial margins would increase.^2,3,27,28 We also anticipated a decrease in downstream services, such as unnecessary tests, emergency department visits, and hospitalizations—a benefit of accountable care payment models.

Our efforts have been successful from a financial point of view. We attribute the financial sustainability that we have experienced to 4 factors:

1. Increased productivity. We knew that the increased efficiency of team-based care enables physicians to see 1 to 2 more patients per half day, and sometimes more.^3,28,29 An increase of at least 1 patient visit per half-day was expected of our physicians and APCs on aTBC. In addition, they were expected to support the care team RN in achieving at least 4 billable visits per day. Our current level of RN visits is at 3.5 per nurse per day. There is significant variability in the increase of patients seen by a physician per day, ranging from 1 to 4 additional patients. These increased visits have helped us achieve financial viability, even in a predominantly fee-for-service environment.

2. More thorough service. The ability to keep patients in primary care and to focus on the patient’s full range of needs has led to higher levels of service and, consequently, to appropriately higher levels of billing codes. For example, Bellin’s revenue from billing increased by $724 per patient, related (in part) to higher rates of immunizations, cancer screenings with mammography, and colonoscopies.

Continue to: 3. New billable services

3. New billable services. Billing for RN blood pressure checks, AWVs, and extended care team services have helped make aTBC at Bellin financially feasible. Revenue from RN visits, for example, was $630,000 in 2018.

4. Improved access for patients. Of the 130 primary care providers now on aTBC, 15 (11.5%) had closed their practices to new patients before aTBC. Now, all of their practices are open to new patients, which has improved access to care. In a 2018 patient access survey, 96.6% of patients obtained an appointment as soon as they thought it was needed, compared with 70.7% of patients before the transition to aTBC.

Greater opportunity for financial sustainability. The combination of improved quality measures and decreased cost of care in the Bellin aTBC bodes well for future success in a value-based world. We have realized a significant increase in value-based payments for improved quality, and in our Next Gen Accountable Care Organization (ACO) patients, we have seen a decrease of $29 in per-member-per-month costs, likely due to the use of nonphysicians in expanded roles. In addition, hospital admissions have decreased by 5% due to the ability of ambulatory teams to manage more complex patients in the office setting. This model has also allowed physicians and APCs to increase their panel size, another key value-based metric. From 2016 to 2018, panel size for primary care providers increased by an average of 8%.

Enhanced ability to retain and recruit. Several of Bellin’s primary care recruits indicated that they had interviewed only at practices incorporating team-based care. This trend may increase as residencies transition to team-based models of care.

So how did we do?

Metrics of Bellin’s aTBC success

By the end of 2018, all 130 primary care physicians and APCs at Bellin had made the transition to this model, representing family medicine, internal medicine, and pediatrics. We have now begun the transition of our non-primary care specialties to team-based care.

Continue to: In the aTBC model...

In the aTBC model, the percentage of patients receiving age-appropriate screening is higher than before in every domain we measure (FIGURE 1). There has also been improvement in major quality metrics (FIGURE 2).

In a survey done in Spring 2018 by St. Norbert College Strategic Research Center, provider satisfaction increased, with 83% of physicians having made the transition to an aTBC practice moderately or very satisfied with their Bellin Health experience, compared with 70% in the traditional model. More recent 2019 survey data show a satisfaction rate of 90% for team-based care providers. Finally, in our aTBC model—in CMS’s Next-Gen ACO initiative—the cost per patient per month is significantly less than for those in a non-team-based care model ($796 vs $940).

CORRESPONDENCE
James Jerzak, MD, 1630 Commanche Ave, Green Bay, WI 54313; james.jerzak@bellin.org.

ACKNOWLEDGEMENTS
The authors would like to thank Lindsey E. Carlasare, MBA, from the American Medical Association, and Brad Wozney, MD, Kathy Kerscher, and Christopher Elfner from Bellin Health, for their contributions to the content and review of this manuscript.

Leaders in health care and practicing physicians recognize the need for changes in how health care is delivered.^1-3 Despite this awareness, though, barriers to meaningful change persist and the current practice environment wherein physicians must routinely spend 2 hours on electronic health records (EHRs) and desk work for every hour of direct face time with patients⁴ is driving trainees away from ambulatory specialties and is contributing to physicians’ decisions to reduce their practices to part-time, retire early, or leave medicine altogether.^5,6 Those who persevere in this environment with heavy administrative burdens run the increasing risk of burnout.⁷

Some physicians and practices are responding by taking creative measures to reform the way patient care is delivered. Bellin Health—a 160-provider, multispecialty health system in northeast Wisconsin where one of the authors (JJ) works—introduced an advanced team-based care (aTBC) model between November 2014 and November 2018, starting with our primary care providers. The development and introduction of this new model arose from an iterative, multidisciplinary process driven by the desire to transform the Triple Aim—enhancing patient experience, improving population health, and reducing costs—into a Quadruple Aim⁸ by additionally focusing on improving the work life of health care providers, which, in turn, will help achieve the first 3 goals. In introducing an aTBC model, Bellin Health focused on 3 elements: office visit redesign, in-basket management redesign, and the use of extended care team members and system and community resources to assist in the care of complex and high-risk patients.

We trained certified medical assistants and licensed practical nurses to become care team coordinators and optimized the direct clinical support ratio for busier physicians.

Herein we describe the 3 components of our aTBC model,^1,9 identify the barriers that existed in the minds of multiple stakeholders (from patients to clinicians and Bellin executives), and describe the strategies that enabled us to overcome these barriers.

The impetus behind our move to aTBC

Bellin Health considered a move to an aTBC model to be critical in light of factors in the health care environment, in general, and at Bellin, in particular. The factors included

• an industry-wide shift to value-based payments, which requires new models for long-term financial viability.
• recognition that physician and medical staff burnout leads to lower productivity and, in some cases, workforce losses.^5,6 Replacing a physician in a practice can be difficult and expensive, with cost estimates of $500,000 to more than $1 million per physician.^10,11
• a belief that aTBC could help the Bellin Health leadership team meet its organizational goals of improved patient satisfaction, achieve gains in quality measures, enhance engagement and loyalty among patients and employees, and lower recruitment costs.

A 3-part aTBC initiative

■ Part 1: Redesign the office visit

We redesigned staffing and workflow for office visits to maximize the core skills of physicians, which required distributing ancillary tasks among support staff. We up-trained certified medical assistants (CMAs) and licensed practical nurses (LPNs) to take on the new role of care team coordinator (CTC) and optimized the direct clinical support ratio for busier physicians. For physicians who were seeing 15 to 19 patients a day, a ratio of 3 CTCs to 2 physicians was implemented; for those seeing 20 or more patients a day, we used a support ratio of 2:1.

The role of CTC was designed so that he or she would accompany a patient throughout the entire appointment. Responsibilities were broken out as follows:

Pre-visit. Before the physician enters the room, the CTC would now perform expanded rooming functions including pending orders, refill management, care gap closure using standing orders, agenda setting, and preliminary documentation.¹²

Visit. The CTC would now hand off the patient to the physician and stay in the room to document details of the visit and record new orders for consults, x-ray films, referrals, or prescriptions.¹³ This intensive EHR support was established to ensure that the physician could focus directly on the patient without the distraction of the computer.

Continue to: Post-visit

Post-visit. After a physician leaves a room, the CTC was now charged with finishing the pending orders, setting up the patient’s next appointment and pre-visit labs, reviewing details of the after-visit summary, and doing any basic health coaching with the patient. During this time, the physician would use the co-location space to review and edit the documentation, cosign the orders and prescriptions submitted by the CTC, and close the chart before going into the next room with the second CTC. The need to revisit these details after clinic hours was eliminated.

Another change … The role of our phone triage registered nurses (RN) was expanded. Care team RNs began providing diabetes counseling, blood pressure checks, annual wellness visits (AWV), and follow-up through the Centers for Medicare and Medicaid Services (CMS)'s Chronic Care Management and Transitional Care Management programs.

■ Part 2: Redesign between-visit in-basket management

Responding to an increasing number of inbox messages had become overwhelming for our physicians. Bellin Health’s management was aware that strategic delegation of inbox messages could save an hour or more of a physician’s time each day.¹⁴ Bellin implemented a procedure whereby inbox test results would be handled by the same CTC who saw the patient, thereby extending continuity. If the results were normal, the CTC would contact the patient. If the results were abnormal, the physician and the CTC would discuss them and develop a plan. Co-location of the RN, the CTC, and the physician would leverage face-to-face communication and make in-basket management more efficient.

■ Part 3: Redesign population health management

We developed an Extended Care Team (ECT), including social workers, clinical pharmacists, RN care coordinators, and diabetes educators, to assist with the care of patients with high-risk disorders or otherwise complex issues. These team members would work closely with the CTC, care team RN, and physician to review patients, develop plans of care, optimize management, and improve outcomes. Patients would be identified as candidates for potential ECT involvement based on the physician’s judgment in consultation with an EHR-based risk score for hospitalization or emergency department visit.

Team coordinators document details of the patient visit, thereby allowing the physician to focus directly on the patient.

As we developed new processes, such as screening for determinants of health, we engaged additional system and community resources to help meet the needs of our patients.

Continue to: A look at stakeholder concerns and overcoming the barriers

Critical to our success was being attentive to the concerns of our stakeholders and addressing them. Along the way, we gained valuable implementation insights, which we share here along with some specifics about how, exactly, we did things at Bellin.

Patients

Some patients expressed hesitation at having a person other than their physician in the exam room. They worried that the intimacy and privacy with their physician would be lost. In light of this, we gave patients the option not to have the CTC remain in the room. However, patients quickly saw the value of this team-based care approach and seldom asked to be seen without the CTC.

Throughout the process, we surveyed patients for feedback on their experiences. Comments indicated that the presence of the CTC in our team-based model led to positive patient experiences:

My physician is fully attentive. Patients appreciated that physicians were not distracted by the computer in the exam room. “I feel like I’ve got my doctor back” has been a common refrain.

The office staff is more responsive. The CTC, having been present during the appointment, has a deeper understanding of the care plan and can respond to calls or emails between visits, thereby reducing the time patients must wait for answers. One patient commented that, “I love [the doctor’s] team; his nurses are willing to answer every question I have.”

Continue to: I increasingly feel that I'm understood

I increasingly feel that I’m understood. We have seen patients develop meaningful relationships with other team members, confiding in them in ways that they hadn’t always done with physicians and advanced practice clinicians (APCs). Team members, in turn, have added valuable insights that help optimize patients’ care. In particular, the care of patients with multiple needs has been enhanced with the addition of ECT members who work with the core team and use their expertise to optimize the care of these patients.

Certified medical assistants and licensed practical nurses

Bellin’s leadership knew that team documentation could cause stress for the CMA, who, acting as a CTC, wanted to avoid misrepresenting details of the clinical encounter.¹³ Adding to the stress were other duties that would need to be learned, including agenda setting, refill management, care gap closure, and health coaching. With thorough training and preparation, many—but not all—of our CMAs and LPNs were able to successfully make the transition and flourish.

Implementation strategies

Provide thorough training. Our training process started 8 weeks before it was time to “go live.” There were weekly hour-long training sessions in population health basics, team culture and change management, documentation basics, and new roles and responsibilities. In the final week, the entire aTBC team sat together for 3 days of EHR training. All new teams shadowed existing teams to get a clear picture of the new processes.

Create a community of support. As our CMAs adapted to their new CTC roles, it was critical that they had support from experienced CTCs. Encouragement and patience from physicians were—and are—essential for CTCs to develop confidence in their new roles.

Enable ongoing feedback. We introduced weekly team meetings to enhance team communication and dynamics. Forums for all roles are held periodically to facilitate discussion, share learning, and enable support between teams.

Continue to: Use EHR tools to facilitate this work

Use EHR tools to facilitate this work. Using standard templates and documentation tools helped CTCs develop the confidence needed to thrive in their new role. Knowing these tools were available helped CTCs become effective in helping the team manage the between-visit work.

In our aTBC model, the percentage of patients receiving age- appropriate screening is higher now in every domain we measure, and metrics have improved in most quality measures.

Monitor workload. As we developed more workflows and processes, we took care to monitor the amount of additional work for those in this role. We offloaded work whenever possible. For example, coordinated refill management at time of service, coupled with a back-up centralized refill system, can significantly decrease the number of refill requests made to CTCs. We continue to adjust staffing, where appropriate, to provide adequate support for those in this valuable role.

Be prepared for turnover. As CTCs became empowered in their new roles, some decided to advance their training into other roles. We developed a plan for replacing and training new staff. Higher pay can also be used to help attract and retain these staff members. Bellin uses LPNs in this role to ensure adequate staffing. Other health systems have developed a tier system for CMAs to improve retention.

Registered nurses

Before our move to an aTBC model, our office RNs primarily managed phone triage. Now the nurses were enlisted to play a more active role in patient care and team leadership. Although it was a dramatic departure from prior responsibilities, the majority of Bellin’s RNs have found increased satisfaction in taking on direct patient care.

Implementation strategies

Define new roles and provide training. In addition to participating in acute patient visits, consider ways that care team RNs can expand responsibilities as they pertain to disease counseling, population health management, and team leadership.¹⁵ At Bellin, the expanded role of the RN is evident in diabetes education and Medicare AWVs. Specifically, RNs now provide diabetes education to appropriate patients following a warm handoff from the physician at the time of the visit. RNs now also complete Medicare AWVs, which frees up physicians for other tasks and helps ensure sustainability for the new RN roles. Rates of completed AWVs at Bellin are now more than 70%, compared with reported national rates of less than 30%.¹⁶

Continue to: Maximize co-location

Maximize co-location. It is helpful to have the team members whose work is closely related—such as the CTCs and the RN for the team—to be situated near each other, rather than down a hall or in separate offices. Since the RN is co-located with the core teams at Bellin, there is now greater opportunity for verbal interaction, rather than just electronic communications, for matters such as triage calls and results management. RNs also provide a valuable resource for CMAs and LPNs, as well as help oversee team management of the in-basket.

Evaluate sustainability. Additional roles for the RNs required additional RN staffing. We assessed the new workload duties and balanced that against potential revenue from RN visits. This analysis indicated that an optimal ratio was 1 RN to every 3000 patients. This would allow an adequate number of RNs to fulfill additional roles and was financially sustainable with the goal of 4 billable RN visits per day.

Physicians

Bellin’s leadership recognized that some physicians might perceive team-based care as eroding their primary responsibility for patients’ care. Physicians have historically been trained in a model based on the primacy of the individual physician and that can be a hurdle to embracing team culture as a new paradigm of care. Several strategies helped us and can help others, too.

Implementation strategies

Cultivate trust. Thorough training of CTCs and RNs is critical to helping physicians develop trust and reliance in the team. The physician retains final authority over the team for cosigning orders, editing and finalizing documentation, and overseeing results management. Physicians invested in training and educating their staff will reap the rewards of a highly functioning, more satisfied team.

Encourage leadership. This can be a cultural shift for physicians, yet it is critical that they take a leadership role in this transformation.¹⁷ Physicians and their team leaders attended training sessions in team culture and change management. Prior to the go-live date, team leaders also met with the physician individually to explore their concerns and discuss ways to effectively lead and support their teams.

Continue to: Urge acceptance of support

Urge acceptance of support. The complexity of patient care today makes it difficult for a physician to manage all of a patient’s needs single-handedly. Complexity arises from the variety of plan co-pays and deductibles, the number of patients with chronic diseases, and the increased emphasis on improving quality measures.¹⁸ Enhanced support during any office visit and the extra support of an ECT for complex patients improves the ability of the physician to more effectively meet the needs of the patient.

Emphasize the benefit of an empowered team. The demands of the EHR on physicians and the resultant frustrations are well chronicled.^4,19-22 Strategically delegating much of this work to other team members allows the physician to focus on the patient and perform physician-level work. At Bellin, we observed that our most successful care teams were those in which the physician fully accepted team-based care principles and empowered the staff to work at the top of their skill set.

Advanced practice clinicians

APCs in our system had traditionally practiced in 1 of 3 ways: independently handling defined panels with physician supervision; handling overflow or acute visits; or working collaboratively with a supervising physician to share a larger “team panel.” The third approach has become our preferred model. aTBC provides opportunities for APCs to thrive and collaborate with the physician to provide excellent care for patients.

Provider satisfaction has increased, with 83% of aTBC physicians at Bellin being moderately or very satisfied with their experience.

APCs underwent the same process changes as physicians, including appropriate CTC support. Implementation strategies for APCs were similar to those that were useful for physicians.

Risk management professionals

At Bellin, we found that risk-management professionals had concerns about the scope of practice assigned to various team members, particularly regarding documentation. CMS allows for elements of a patient visit to be documented by CMAs and other members of the care team in real time as authorized by the physician.^23,24 CTCs at Bellin also have other clinical duties in patient and EHR management. aTBC practices generally prefer the term team documentation over scribing, since it more accurately reflects the scope of the CTC’s work.

Continue to: Implementation strategies

Clarify regulatory issues. Extensive use of standing orders and protocols allowed us to increase involvement of various team members. State laws vary in what functions CMAs and LPNs are allowed to perform, so it is important to check your state guidelines.²⁵ There is a tendency for some risk managers to overinterpret regulations. Challenge them to provide exact documentation from regulatory agencies to support their decisions.

Give assurances of physician oversight and processes. The physician assumes responsibility for standing orders, protocols, and documentation. We made sure that we had clear and consistent processes in place and worked closely with our risk managers as we developed our model. aTBC provides checks and balances to ensure accurate records, since team members are able to contribute and check for accuracy. A recent study suggested that CMAs perform documentation that is of equal or higher quality than that performed by the physician.²⁶

Financial leadership

Like any organization adopting aTBC, Bellin’s leadership was concerned about the expense of adopting this approach. However, the leadership also recognized that the transition to aTBC could increase revenue by more than the increased staffing costs. In addition, we expected that capacity, access, continuity, and financial margins would increase.^2,3,27,28 We also anticipated a decrease in downstream services, such as unnecessary tests, emergency department visits, and hospitalizations—a benefit of accountable care payment models.

Our efforts have been successful from a financial point of view. We attribute the financial sustainability that we have experienced to 4 factors:

1. Increased productivity. We knew that the increased efficiency of team-based care enables physicians to see 1 to 2 more patients per half day, and sometimes more.^3,28,29 An increase of at least 1 patient visit per half-day was expected of our physicians and APCs on aTBC. In addition, they were expected to support the care team RN in achieving at least 4 billable visits per day. Our current level of RN visits is at 3.5 per nurse per day. There is significant variability in the increase of patients seen by a physician per day, ranging from 1 to 4 additional patients. These increased visits have helped us achieve financial viability, even in a predominantly fee-for-service environment.

2. More thorough service. The ability to keep patients in primary care and to focus on the patient’s full range of needs has led to higher levels of service and, consequently, to appropriately higher levels of billing codes. For example, Bellin’s revenue from billing increased by $724 per patient, related (in part) to higher rates of immunizations, cancer screenings with mammography, and colonoscopies.

Continue to: 3. New billable services

3. New billable services. Billing for RN blood pressure checks, AWVs, and extended care team services have helped make aTBC at Bellin financially feasible. Revenue from RN visits, for example, was $630,000 in 2018.

4. Improved access for patients. Of the 130 primary care providers now on aTBC, 15 (11.5%) had closed their practices to new patients before aTBC. Now, all of their practices are open to new patients, which has improved access to care. In a 2018 patient access survey, 96.6% of patients obtained an appointment as soon as they thought it was needed, compared with 70.7% of patients before the transition to aTBC.

Greater opportunity for financial sustainability. The combination of improved quality measures and decreased cost of care in the Bellin aTBC bodes well for future success in a value-based world. We have realized a significant increase in value-based payments for improved quality, and in our Next Gen Accountable Care Organization (ACO) patients, we have seen a decrease of $29 in per-member-per-month costs, likely due to the use of nonphysicians in expanded roles. In addition, hospital admissions have decreased by 5% due to the ability of ambulatory teams to manage more complex patients in the office setting. This model has also allowed physicians and APCs to increase their panel size, another key value-based metric. From 2016 to 2018, panel size for primary care providers increased by an average of 8%.

Enhanced ability to retain and recruit. Several of Bellin’s primary care recruits indicated that they had interviewed only at practices incorporating team-based care. This trend may increase as residencies transition to team-based models of care.

So how did we do?

Metrics of Bellin’s aTBC success

By the end of 2018, all 130 primary care physicians and APCs at Bellin had made the transition to this model, representing family medicine, internal medicine, and pediatrics. We have now begun the transition of our non-primary care specialties to team-based care.

Continue to: In the aTBC model...

In the aTBC model, the percentage of patients receiving age-appropriate screening is higher than before in every domain we measure (FIGURE 1). There has also been improvement in major quality metrics (FIGURE 2).

In a survey done in Spring 2018 by St. Norbert College Strategic Research Center, provider satisfaction increased, with 83% of physicians having made the transition to an aTBC practice moderately or very satisfied with their Bellin Health experience, compared with 70% in the traditional model. More recent 2019 survey data show a satisfaction rate of 90% for team-based care providers. Finally, in our aTBC model—in CMS’s Next-Gen ACO initiative—the cost per patient per month is significantly less than for those in a non-team-based care model ($796 vs $940).

CORRESPONDENCE
James Jerzak, MD, 1630 Commanche Ave, Green Bay, WI 54313; james.jerzak@bellin.org.

ACKNOWLEDGEMENTS
The authors would like to thank Lindsey E. Carlasare, MBA, from the American Medical Association, and Brad Wozney, MD, Kathy Kerscher, and Christopher Elfner from Bellin Health, for their contributions to the content and review of this manuscript.

EVIDENCE SUMMARY

All NSAIDs at maximum clinical doses reduced large joint OA pain more effectively than placebo and acetaminophen based on data from a network meta-analysis of 129 RCTs with 32,129 patients (TABLE 1).¹ When various doses of NSAIDs are ranked for efficacy based on their effect size compared to placebo, diclofenac 150 mg/d had the greatest treatment effect, followed by ibuprofen 2400 mg/d.² Lower doses of NSAIDs—including diclofenac 70 mg/d, naproxen 750 mg/d, and ibuprofen 1200 mg/d—were not statistically superior to placebo (TABLE 2).²

Selective vs nonselective. There was no statistical difference in pain relief between the selective COX-2 inhibitor celecoxib and the nonselective NSAIDs naproxen, diclofenac, and ibuprofen (TABLE 1).¹

Meloxicam. A systematic review of 16 RCTs and 22,886 patients found that meloxicam reduced pain more effectively than placebo (10-point visual analogue scale [VAS] score pain difference of –6.8; 95% CI, –9.3 to –4.2) but was marginally less effective than other NSAIDs (VAS score pain difference of 1.7; 95% CI, 0.8 to 2.7).³

Acetaminophen. Data from 6 RCTs involving 2083 adults with knee OA indicate acetaminophen did not achieve clinical significance compared to placebo (TABLE 1).¹ Another meta-analysis of 5 RCTs involving 1741 patients with hip or knee OA also demonstrated that acetaminophen failed to achieve a clinically significant effect on pain, defined as a reduction of 9 mm on a 0 to 100 mm VAS (–3.7; 95% CI, –5.5 to –1.9).⁴ Another network meta-analysis of 6 RCTs including 58,556 patients with knee or hip OA, with the primary outcome of pain (using a hierarchy of pain scores, with global pain score taking precedence) also found no clinically significant difference between acetaminophen at the highest dose (4000 mg/d) and placebo (–0.17; 95% credible interval [CrI], –0.27 to –0.6).²

RECOMMENDATIONS

In a systematic review of mixed evidence-based and expert opinion recommendations and guidelines on the management of OA, 10 of the 11 guidelines that included pharmacologic management recommended acetaminophen as a first-line agent, followed by topical NSAIDs, and then oral NSAIDs. The exception is the most recent American Academy of Orthopaedic Surgeons guideline, which continues to recommend NSAIDs but is now unable to recommend for or against acetaminophen.⁵

EVIDENCE SUMMARY

All NSAIDs at maximum clinical doses reduced large joint OA pain more effectively than placebo and acetaminophen based on data from a network meta-analysis of 129 RCTs with 32,129 patients (TABLE 1).¹ When various doses of NSAIDs are ranked for efficacy based on their effect size compared to placebo, diclofenac 150 mg/d had the greatest treatment effect, followed by ibuprofen 2400 mg/d.² Lower doses of NSAIDs—including diclofenac 70 mg/d, naproxen 750 mg/d, and ibuprofen 1200 mg/d—were not statistically superior to placebo (TABLE 2).²

Selective vs nonselective. There was no statistical difference in pain relief between the selective COX-2 inhibitor celecoxib and the nonselective NSAIDs naproxen, diclofenac, and ibuprofen (TABLE 1).¹

Meloxicam. A systematic review of 16 RCTs and 22,886 patients found that meloxicam reduced pain more effectively than placebo (10-point visual analogue scale [VAS] score pain difference of –6.8; 95% CI, –9.3 to –4.2) but was marginally less effective than other NSAIDs (VAS score pain difference of 1.7; 95% CI, 0.8 to 2.7).³

Acetaminophen. Data from 6 RCTs involving 2083 adults with knee OA indicate acetaminophen did not achieve clinical significance compared to placebo (TABLE 1).¹ Another meta-analysis of 5 RCTs involving 1741 patients with hip or knee OA also demonstrated that acetaminophen failed to achieve a clinically significant effect on pain, defined as a reduction of 9 mm on a 0 to 100 mm VAS (–3.7; 95% CI, –5.5 to –1.9).⁴ Another network meta-analysis of 6 RCTs including 58,556 patients with knee or hip OA, with the primary outcome of pain (using a hierarchy of pain scores, with global pain score taking precedence) also found no clinically significant difference between acetaminophen at the highest dose (4000 mg/d) and placebo (–0.17; 95% credible interval [CrI], –0.27 to –0.6).²

RECOMMENDATIONS

In a systematic review of mixed evidence-based and expert opinion recommendations and guidelines on the management of OA, 10 of the 11 guidelines that included pharmacologic management recommended acetaminophen as a first-line agent, followed by topical NSAIDs, and then oral NSAIDs. The exception is the most recent American Academy of Orthopaedic Surgeons guideline, which continues to recommend NSAIDs but is now unable to recommend for or against acetaminophen.⁵

EVIDENCE SUMMARY

All NSAIDs at maximum clinical doses reduced large joint OA pain more effectively than placebo and acetaminophen based on data from a network meta-analysis of 129 RCTs with 32,129 patients (TABLE 1).¹ When various doses of NSAIDs are ranked for efficacy based on their effect size compared to placebo, diclofenac 150 mg/d had the greatest treatment effect, followed by ibuprofen 2400 mg/d.² Lower doses of NSAIDs—including diclofenac 70 mg/d, naproxen 750 mg/d, and ibuprofen 1200 mg/d—were not statistically superior to placebo (TABLE 2).²

Selective vs nonselective. There was no statistical difference in pain relief between the selective COX-2 inhibitor celecoxib and the nonselective NSAIDs naproxen, diclofenac, and ibuprofen (TABLE 1).¹

Meloxicam. A systematic review of 16 RCTs and 22,886 patients found that meloxicam reduced pain more effectively than placebo (10-point visual analogue scale [VAS] score pain difference of –6.8; 95% CI, –9.3 to –4.2) but was marginally less effective than other NSAIDs (VAS score pain difference of 1.7; 95% CI, 0.8 to 2.7).³

Acetaminophen. Data from 6 RCTs involving 2083 adults with knee OA indicate acetaminophen did not achieve clinical significance compared to placebo (TABLE 1).¹ Another meta-analysis of 5 RCTs involving 1741 patients with hip or knee OA also demonstrated that acetaminophen failed to achieve a clinically significant effect on pain, defined as a reduction of 9 mm on a 0 to 100 mm VAS (–3.7; 95% CI, –5.5 to –1.9).⁴ Another network meta-analysis of 6 RCTs including 58,556 patients with knee or hip OA, with the primary outcome of pain (using a hierarchy of pain scores, with global pain score taking precedence) also found no clinically significant difference between acetaminophen at the highest dose (4000 mg/d) and placebo (–0.17; 95% credible interval [CrI], –0.27 to –0.6).²

RECOMMENDATIONS

In a systematic review of mixed evidence-based and expert opinion recommendations and guidelines on the management of OA, 10 of the 11 guidelines that included pharmacologic management recommended acetaminophen as a first-line agent, followed by topical NSAIDs, and then oral NSAIDs. The exception is the most recent American Academy of Orthopaedic Surgeons guideline, which continues to recommend NSAIDs but is now unable to recommend for or against acetaminophen.⁵

In this issue of JFP, Weinstein and Worster provide a wealth of information about prescribing marijuana. Medical marijuana (Cannabis) is now legal in the majority of states, so it’s likely that some of your patients are using marijuana for symptom relief. For those physicians who elect to prescribe marijuana, reading this review will help you avoid harming patients while maximizing potential benefits.

I say “potential benefits” because the research evidence to support benefit for most conditions and symptoms is weak at best. In addition to the JAMA meta-analysis cited by Weinstein and Worster,¹ several meta-analyses and systematic reviews published since January 2018 reach similar conclusions.^2-4

Marijuana can provide significant relief from chemotherapy-induced nausea and vomiting, and it is effective in reducing intractable seizures in 2 rare pediatric seizure disorders. There may be some benefit for treatment of spasticity, and there may be some therapeutic value for relief of neuropathic pain, although the evidence is not strong. Interestingly, there is some preliminary evidence that cannabis can improve gastrointestinal symptoms in patients with Crohn's disease and ulcerative colitis.^5,6

Why do people use marijuana as medicine? A meta-analysis found that pain (64%), anxiety (50%), and depression/mood (34%) were common reasons.⁷ People use marijuana for a plethora of other conditions and symptoms, which is reflected in the long list of “approved” conditions in most state medical marijuana laws. The problem I have with prescribing cannabis for non-neuropathic pain, anxiety, and depression is that there is no good randomized trial evidence of its effectiveness beyond a placebo effect (which is probably quite strong considering the psychotropic effects of marijuana). And, as Weinstein and Worster point out, there is evidence of increased mental health symptoms in chronic marijuana users.

It behooves us to be prepared to discuss the pros and cons of Cannabis use with our patients—even if we decide not to prescribe it.

Regardless of the scientific evidence, use of cannabis for symptom relief is unlikely to be a passing fad. Surveys show that about 70% of users believe they receive benefit from it.⁸ Therefore, it behooves us to be prepared to discuss the pros and cons of cannabis use with our patients—even if we decide not to prescribe it. Warn patients with anxiety and depression that it is unlikely to be effective and may make matters worse.

There is intense interest in medical marijuana and better research will likely change the way we use cannabis for medical purposes in the future. So, for now, our best approach is to stay informed as the research unfolds.

In this issue of JFP, Weinstein and Worster provide a wealth of information about prescribing marijuana. Medical marijuana (Cannabis) is now legal in the majority of states, so it’s likely that some of your patients are using marijuana for symptom relief. For those physicians who elect to prescribe marijuana, reading this review will help you avoid harming patients while maximizing potential benefits.

I say “potential benefits” because the research evidence to support benefit for most conditions and symptoms is weak at best. In addition to the JAMA meta-analysis cited by Weinstein and Worster,¹ several meta-analyses and systematic reviews published since January 2018 reach similar conclusions.^2-4

Marijuana can provide significant relief from chemotherapy-induced nausea and vomiting, and it is effective in reducing intractable seizures in 2 rare pediatric seizure disorders. There may be some benefit for treatment of spasticity, and there may be some therapeutic value for relief of neuropathic pain, although the evidence is not strong. Interestingly, there is some preliminary evidence that cannabis can improve gastrointestinal symptoms in patients with Crohn's disease and ulcerative colitis.^5,6

Why do people use marijuana as medicine? A meta-analysis found that pain (64%), anxiety (50%), and depression/mood (34%) were common reasons.⁷ People use marijuana for a plethora of other conditions and symptoms, which is reflected in the long list of “approved” conditions in most state medical marijuana laws. The problem I have with prescribing cannabis for non-neuropathic pain, anxiety, and depression is that there is no good randomized trial evidence of its effectiveness beyond a placebo effect (which is probably quite strong considering the psychotropic effects of marijuana). And, as Weinstein and Worster point out, there is evidence of increased mental health symptoms in chronic marijuana users.

It behooves us to be prepared to discuss the pros and cons of Cannabis use with our patients—even if we decide not to prescribe it.

Regardless of the scientific evidence, use of cannabis for symptom relief is unlikely to be a passing fad. Surveys show that about 70% of users believe they receive benefit from it.⁸ Therefore, it behooves us to be prepared to discuss the pros and cons of cannabis use with our patients—even if we decide not to prescribe it. Warn patients with anxiety and depression that it is unlikely to be effective and may make matters worse.

There is intense interest in medical marijuana and better research will likely change the way we use cannabis for medical purposes in the future. So, for now, our best approach is to stay informed as the research unfolds.

In this issue of JFP, Weinstein and Worster provide a wealth of information about prescribing marijuana. Medical marijuana (Cannabis) is now legal in the majority of states, so it’s likely that some of your patients are using marijuana for symptom relief. For those physicians who elect to prescribe marijuana, reading this review will help you avoid harming patients while maximizing potential benefits.

I say “potential benefits” because the research evidence to support benefit for most conditions and symptoms is weak at best. In addition to the JAMA meta-analysis cited by Weinstein and Worster,¹ several meta-analyses and systematic reviews published since January 2018 reach similar conclusions.^2-4

Marijuana can provide significant relief from chemotherapy-induced nausea and vomiting, and it is effective in reducing intractable seizures in 2 rare pediatric seizure disorders. There may be some benefit for treatment of spasticity, and there may be some therapeutic value for relief of neuropathic pain, although the evidence is not strong. Interestingly, there is some preliminary evidence that cannabis can improve gastrointestinal symptoms in patients with Crohn's disease and ulcerative colitis.^5,6

Why do people use marijuana as medicine? A meta-analysis found that pain (64%), anxiety (50%), and depression/mood (34%) were common reasons.⁷ People use marijuana for a plethora of other conditions and symptoms, which is reflected in the long list of “approved” conditions in most state medical marijuana laws. The problem I have with prescribing cannabis for non-neuropathic pain, anxiety, and depression is that there is no good randomized trial evidence of its effectiveness beyond a placebo effect (which is probably quite strong considering the psychotropic effects of marijuana). And, as Weinstein and Worster point out, there is evidence of increased mental health symptoms in chronic marijuana users.

It behooves us to be prepared to discuss the pros and cons of Cannabis use with our patients—even if we decide not to prescribe it.

Regardless of the scientific evidence, use of cannabis for symptom relief is unlikely to be a passing fad. Surveys show that about 70% of users believe they receive benefit from it.⁸ Therefore, it behooves us to be prepared to discuss the pros and cons of cannabis use with our patients—even if we decide not to prescribe it. Warn patients with anxiety and depression that it is unlikely to be effective and may make matters worse.

There is intense interest in medical marijuana and better research will likely change the way we use cannabis for medical purposes in the future. So, for now, our best approach is to stay informed as the research unfolds.

A 21-year-old woman presented with a rash on her right thigh of 3 to 4 months’ duration. She reported that the patch was asymptomatic. She was not taking any medications and otherwise was in good health. A review of systems was negative. The patient was a student who used her laptop frequently. On physical examination, a 10×5-cm reticulated, hyperpigmented patch was seen on her right thigh (FIGURE).

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

Erythema ab igne (EAI) is a common dermatosis caused by repeated exposure to infrared radiation, most commonly in the form of low-grade heat (43–47°C).¹ Common heat sources include heating pads, heaters, fire, and battery-charged devices. The distribution of the rash is dependent on the location of the heat source and appears as a hyperpigmented, reticulated rash. The pathophysiology is not well understood, but likely involves changes in dermal elastic fibers as well as the dermal venous plexus.² Though rare, chronic cases of EAI have been associated with cutaneous dysplasia.³

Inquire about possible heat sources in cases of suspected erythema ab igne.

Diagnosis of EAI is made by a combination of medical history and clinical features. Laboratory tests are not required. Additionally, clinicians should inquire about possible heat sources. In this case, we asked the patient whether she rested anything on her thighs, and she acknowledged that this was where she typically placed her laptop computer.

Differential includes other reticulated conditions

The differential diagnosis of a reticulated patch includes other entities likely sharing vascular pathology. The age, sex, and medical history of the patient offer additional diagnostic clues.

Livedo reticularis presents with reticulated erythema. It is unrelated to heat exposure, but may be associated with cold exposure. It can be physiologic or can be associated with vasculitis or another obstruction of blood flow.

Erythema infectiosum is a parvovirus B19 infection that usually presents in young children. It often results in a lacy reticulated exanthem on the face that resembles a slapped cheek in children. Adolescent and adult contacts often present with a more petechial rash in an acral to periflexural distribution.⁴

Continue to: Polyarteritis nodosa

Polyarteritis nodosa is a rare necrotizing vasculitis of small and medium arteries with an incidence of 4 to 16 cases per million.⁴ It usually is painful and can present with nodules, ulcers, or bullae and may be associated with livedo-like reticulated pigmentation.

Livedoid vasculitis is a hyalinization of blood vessels leading to the obstruction of vessels due to a hypercoagulable state. It can be acquired or congenital and usually manifests in middle-aged women.⁴

Management is straight-forward: Remove the heat source

EAI typically is asymptomatic, although there are reports of mild pruritus or a burning sensation. Management includes withdrawal of the heat source and patient education. Our patient’s rash went away when she stopped resting her laptop computer on her lap.

CORRESPONDENCE
Lorraine C. Young, MD, 200 UCLA, Medical Plaza Driveway, Suites 450 & 465, Los Angeles, CA 90095; lcyoung@mednet.ucla.edu

A 21-year-old woman presented with a rash on her right thigh of 3 to 4 months’ duration. She reported that the patch was asymptomatic. She was not taking any medications and otherwise was in good health. A review of systems was negative. The patient was a student who used her laptop frequently. On physical examination, a 10×5-cm reticulated, hyperpigmented patch was seen on her right thigh (FIGURE).

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

Erythema ab igne (EAI) is a common dermatosis caused by repeated exposure to infrared radiation, most commonly in the form of low-grade heat (43–47°C).¹ Common heat sources include heating pads, heaters, fire, and battery-charged devices. The distribution of the rash is dependent on the location of the heat source and appears as a hyperpigmented, reticulated rash. The pathophysiology is not well understood, but likely involves changes in dermal elastic fibers as well as the dermal venous plexus.² Though rare, chronic cases of EAI have been associated with cutaneous dysplasia.³

Inquire about possible heat sources in cases of suspected erythema ab igne.

Diagnosis of EAI is made by a combination of medical history and clinical features. Laboratory tests are not required. Additionally, clinicians should inquire about possible heat sources. In this case, we asked the patient whether she rested anything on her thighs, and she acknowledged that this was where she typically placed her laptop computer.

Differential includes other reticulated conditions

The differential diagnosis of a reticulated patch includes other entities likely sharing vascular pathology. The age, sex, and medical history of the patient offer additional diagnostic clues.

Livedo reticularis presents with reticulated erythema. It is unrelated to heat exposure, but may be associated with cold exposure. It can be physiologic or can be associated with vasculitis or another obstruction of blood flow.

Erythema infectiosum is a parvovirus B19 infection that usually presents in young children. It often results in a lacy reticulated exanthem on the face that resembles a slapped cheek in children. Adolescent and adult contacts often present with a more petechial rash in an acral to periflexural distribution.⁴

Continue to: Polyarteritis nodosa

Polyarteritis nodosa is a rare necrotizing vasculitis of small and medium arteries with an incidence of 4 to 16 cases per million.⁴ It usually is painful and can present with nodules, ulcers, or bullae and may be associated with livedo-like reticulated pigmentation.

Livedoid vasculitis is a hyalinization of blood vessels leading to the obstruction of vessels due to a hypercoagulable state. It can be acquired or congenital and usually manifests in middle-aged women.⁴

Management is straight-forward: Remove the heat source

EAI typically is asymptomatic, although there are reports of mild pruritus or a burning sensation. Management includes withdrawal of the heat source and patient education. Our patient’s rash went away when she stopped resting her laptop computer on her lap.

CORRESPONDENCE
Lorraine C. Young, MD, 200 UCLA, Medical Plaza Driveway, Suites 450 & 465, Los Angeles, CA 90095; lcyoung@mednet.ucla.edu

A 21-year-old woman presented with a rash on her right thigh of 3 to 4 months’ duration. She reported that the patch was asymptomatic. She was not taking any medications and otherwise was in good health. A review of systems was negative. The patient was a student who used her laptop frequently. On physical examination, a 10×5-cm reticulated, hyperpigmented patch was seen on her right thigh (FIGURE).

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

Erythema ab igne (EAI) is a common dermatosis caused by repeated exposure to infrared radiation, most commonly in the form of low-grade heat (43–47°C).¹ Common heat sources include heating pads, heaters, fire, and battery-charged devices. The distribution of the rash is dependent on the location of the heat source and appears as a hyperpigmented, reticulated rash. The pathophysiology is not well understood, but likely involves changes in dermal elastic fibers as well as the dermal venous plexus.² Though rare, chronic cases of EAI have been associated with cutaneous dysplasia.³

Inquire about possible heat sources in cases of suspected erythema ab igne.

Diagnosis of EAI is made by a combination of medical history and clinical features. Laboratory tests are not required. Additionally, clinicians should inquire about possible heat sources. In this case, we asked the patient whether she rested anything on her thighs, and she acknowledged that this was where she typically placed her laptop computer.

Differential includes other reticulated conditions

The differential diagnosis of a reticulated patch includes other entities likely sharing vascular pathology. The age, sex, and medical history of the patient offer additional diagnostic clues.

Livedo reticularis presents with reticulated erythema. It is unrelated to heat exposure, but may be associated with cold exposure. It can be physiologic or can be associated with vasculitis or another obstruction of blood flow.

Erythema infectiosum is a parvovirus B19 infection that usually presents in young children. It often results in a lacy reticulated exanthem on the face that resembles a slapped cheek in children. Adolescent and adult contacts often present with a more petechial rash in an acral to periflexural distribution.⁴

Continue to: Polyarteritis nodosa

Polyarteritis nodosa is a rare necrotizing vasculitis of small and medium arteries with an incidence of 4 to 16 cases per million.⁴ It usually is painful and can present with nodules, ulcers, or bullae and may be associated with livedo-like reticulated pigmentation.

Livedoid vasculitis is a hyalinization of blood vessels leading to the obstruction of vessels due to a hypercoagulable state. It can be acquired or congenital and usually manifests in middle-aged women.⁴

Management is straight-forward: Remove the heat source

EAI typically is asymptomatic, although there are reports of mild pruritus or a burning sensation. Management includes withdrawal of the heat source and patient education. Our patient’s rash went away when she stopped resting her laptop computer on her lap.

CORRESPONDENCE
Lorraine C. Young, MD, 200 UCLA, Medical Plaza Driveway, Suites 450 & 465, Los Angeles, CA 90095; lcyoung@mednet.ucla.edu